The fight for access to aff ordable medicines is every day. That line from Che ryl sum s up our purpose at Sandoz, the critical importance of access to biosimilar medicines, and the ultimate reason we're all here today. Good afternoon, good morning, or maybe even good evening, depending upon where you are in the world, and welcome. It's fantastic to see so many familiar faces today. My name is Craig Marks, Head of Investor Relations at Sandoz, and thank you for joining us in person and online. For those in person, there are goodie bags by your feet. There are copies of slides and some very expensive chocolates. That's where most of the budget has gone. It's a real pleasure to introduce you to our Capital Markets Day. Before we begin, I'd like to just cover some practicalities.
In the event of an emergency, please, whatever you do, run, and also leave the room immediately. If you hear the word evacuate, event staff can be on hand. If you require assistance or notice any issue, please alert a member of staff. You'll find Wi-Fi details on your badge for easy access. In your goodie bag you'll also find a copy of the slides to write on. If you're joining via the webcast, you're very welcome to participate in the Q&A sessions. We have two. Please submit your questions using the ask a question function. Finally, please note today's session is being recorded and a replay will be available on the website soon. You can see our disclaimer here. Let me briefly walk you through today's agenda. Gilbert Ghostine, our Chairman, will kick off by outlining how we're translating our potential into excellent progress.
Richard, our CEO, will then take you through how we will enh ance our long-term growth and profitability. He'll be followed by Rebecca, who will explain why Sandoz is best positioned to make the most of the upcoming Loss of Exclusivity opportunity in biosimilars by accelerating our leading pipeline. Armin, our President for Biosimilar Development, Manufacturing, and Supply, will focus on how we are scaling biosimilar development and driving vertical integration of our manufacturing and supply network. Following Armin's presentation, we'll pause to cover any questions you have, and then we'll have time for a cup of tea. When we come back, we'll shift to commercial execution when our three regional presidents, Christophe, Peter, and Keren for Europe, International, and North America respectively, will bring our world-class commercial engines to life for you.
Remco, our world-class CFO, will then take you through how all of this will translate into attractive and sustainable value creation for our shareholders, but even more import antly, into value for the patients we serve. Richard will close the presentation, and then we'll move to the final Q&A session. We will finish, we think, around 5:00 P.M. U.K. time. For those in the room, we would be delighted if you could join us for drinks outside. With that, it's my pleasure to hand over to Gilbert.
Thank you, Craig, and thank you all for joining us here today. It is an honor to be with you all. Moving from promise to performance. At Sandoz, our ambition has always been clear: to improve patient access to medicines around the world. Over the past three years, we have sharpened our focus, prioritized the right medicines, strengthened our development engine, and built a more resilient, scalable supply network. At the same time, we have become more disciplined commercially, capturing the full value of our portfolio. What defines Sandoz is not a single attribute, but a combination of strength that few companies can match. We are a company built on leadership in biosimilars and generics, on scientific innovation, on quality and integrity, and on a deep commitment to patients. Our Swiss heritage gives us strong foundations, but our impact is global.
Every day, our medicines reach millions of people around the world and help healthcare systems expand access to treatment. At Sandoz, these principles are not independent of one another. Innovation without access has limited impact. Scale without quality cannot be sustained. Leadership without integrity cannot endure. The strength of Sandoz comes from bringing all of these elements together. That combination has allowed us to build a leading position in biosimilars and generics, and has made Sandoz one of the most respected companies in affordable healthcare. As we look ahead, this strength will become even more important. Healthcare systems need partners that can deliver innovation, quality, reliability, and access simultaneously. We believe Sandoz is uniquely positioned to do that exactly. 2026 marks a special year for Sandoz.
It brings together three significant milestones: 20 years of pioneering leadership in biosimilars, 80 years at the forefront of antibiotics, and 140 years of Swiss heritage rooted in entrepreneurship. These anniversaries are about more than longevity. They reflect our ability to adapt, innovate, and remain relevant in a constantly evolving healthcare landscape. Over the decades, Sandoz has continuously adapted to scientific advances and societal needs. From expanding access to life-saving antibiotics in the mid-20th century to scaling complex biologics today, the company has grown alongside breakthroughs in medicine and alongside the patients it serves. This progression is underpinned by a clear and enduring ambition: improving access to high-quality, affordable medicines worldwide. While Sandoz began its latest chapter as an independent, publicly listed company only in 2023, we stand on the shoulders of giants.
The company traces its origins back to 1886 in Basel, a legacy shaped by generations of pioneers, entrepreneurs, and creators who laid the groundwork for what Sandoz is today. The three anniversaries we are celebrating this year tell us that story. Over 140 years of heritage gave us the entrepreneurial spirit to adapt and evolve. Our 80 years of antibiotics demonstrate our ability to bring essential medicines to patients at scale. And our 20 years in biosimilars show how we continue to lead in some of the most complex and innovative areas of healthcare. Together, these milestones are more than markers of our history. They are the foundation of the impact we deliver today and the ambition we have for tomorrow. The reason these milestones matter is not simply because they reflect our past. They matter because of what they enable us to do today.
In 2023, we set out to become an independent company. Today, we can proudly say that we have delivered on the commitment we made, and most importantly, that we are living up to our purpose of pioneering access for patients. The same strength that allows us to thrive for 140 years, lead antibiotic for 80 years, and pioneer biosimilars for 20 years, are now translating into measurable impact for patients and healthcare systems around the world. Biosimilars and generics account for around 80% of global prescriptions, yet only about 30% of their total cost. This is why access and affordability matter. In 2025, we reached more than 1 billion patients. We delivered $26 billion in healthcare system savings and generated an estimated $400 billion in broader social impact. Looking ahead, we are significantly raising our ambition.
We see a clear path to reaching over $1 trillion in social impact through accelerated portfolio expansion, increasing biosimilars penetration, and our expanding global scale. This is ambitious, but after you hear the rest of today's presentation, I believe you will also see it is realistic. Sandoz is not only a growth and a margin story, but also a company uniquely positioned to benefit patients and healthcare system at an unequaled scale. As we build on our rich heritage and prepare for the opportunities ahead, we have also evolved our leadership team. Since listing, seven members of our executive committee have either been appointed or changed positions, bringing additional capabilities in the areas that are critical as we further develop our business. Commercial excellence, biosimilars, manufacturing, supply chain, and financial discipline.
What you see here is a highly experienced and globally diverse executive committee, bringing together deep expertise across commercial, science, supply network, finance, legal, and intellectual property, with a strong track record of execution where scale, discipline, and operational excellence matter most. The board fully supports the executive committee, and I am extremely pleased with the performance of the team and the platform they have constructed to deliver this new and exciting phase in our history. The first three years were about building the platform. The next decade is about capturing this opportunity. Turning to our board, all our directors are independent, providing objective oversight and supporting balanced decision-making. This is a board that combines independence experience and diversity, providing the governance framework we need to execute our strategy with discipline.
I am honored to serve as chairman of Sandoz, and at the same time, very proud of the board we have assembled. I am also grateful for the strong support it provides Richard and the executive committee. With the right governance, the right leadership team, and a clear strategy, Sandoz is well positioned to capture the significant opportunities ahead. Together, Richard and his team have built a strong platform over the past three years. Today, you will hear how we intend to build on that momentum and further accelerate our impact for patients, healthcare systems, and shareholders. With that, let me hand it over to our best CEO, Richard Saynor. Richard, over to you.
It's going to be hard to live up to. Thank you so much. It's a real pleasure to be here, and thank you so much, Gilbert, for the introduction. I'm incredibly proud and privileged to be here today. As you heard from Gilbert, since we launched the first ever biosimilar 20 years ago, we have shaped and defined the global biosimilar market. We've built the industry's broadest portfolio, delivering medicines across a range of therapy areas, and serving patients globally. Today, we stand at the beginning of our golden decade of opportunity with an unprecedented loss of exclusivity. The originators talk about a patent cliff. Their patent cliff is what we see as Sandoz's golden decade, where more importantly, it is the golden decade for people like Cheryl, whom you just watched on the video, as more patients will have more access to affordable medicines.
In the last three years, we have established our business credibility, our global scale, and the value that we add to patients and the healthcare systems around the world. Now, we can do so much more. We are already a leader in our field, but we can accelerate and amplify that leadership. Bio 100 is how we will meet this huge opportunity. It is a clear strategy for how we will deliver more than 100 biosimilars to the market by 2040, supported by a vast and vertically integrated development, manufacturing, and supply engine. This is not just a pipeline aspiration. It is a comprehensive, clear plan that will shape how we will invest, how we will operate, and how we will grow over the next decade and beyond. If there's only three things that you should leave with today, firstly, our purpose. This remains the same.
We remain driven by our purpose and committed to expanding access to high quality, affordable medicines, and driving meaningful benefit for millions of patients like Cheryl. Second, we have a clear ambition to have more than 100 biosimilars in the market by 2040. This scale will enable us to broaden our reach, deepen our presence across therapy areas, and drive long-term sustainable growth. Thirdly, along the way to our 2040 ambition, we have a clear delivery plan on how to at least double net sales by 2035 versus last year and deliver a core EBITDA margin above 30%. That margin will be one critical element, although not the only one, of our long-term value creation. We are building a high growth biosimilar platform designed to provide differentiated capabilities at scale.
The following presentations will show you how Sandoz is in a unique position and how we're turning this ambition into reality. We are focused on two businesses where we have a clear competitive advantage: biosimilars and generics. Together, they create a complementary and resilient platform combining innovation, scale, and cash generation. Critically, we have the proven capabilities to deliver. We have the commercial reach and the financial strength to invest, a leading and expanding pipeline, strong development platforms and strategic partnerships, a robust global manufacturing and supply network. Deep regulatory and IP expertise, and as I said before, financial strength to continue that investment. This consistent strategy is already delivering, and with these same fundamentals now we can do so much more. Looking ahead, we're significantly raising our ambition.
As Gilbert already mentioned, we see a clear path to reaching over trillion dollars in social impact and delivering high-quality, affordable medicines to ever more patients. Why do we believe this? Well, the best place to start is our track record. We are the largest pure-play generics and biosimilar company operating at scale worldwide. This scale matters as it gives us the relevance with our customers, leverage in our operations, and a strong foundation for future growth. At the same time, we are a true European championship with leadership positions in around 95% of the markets that we serve, and a presence in Europe of over 40 markets. This breadth and scale deliver both a huge competitive advantage and a significant expansion potential. Importantly, our growth is consistent and proven. We have now delivered 19 consecutive quarters of top-line growth, driven specifically by our biosimilar business.
In addition, we have delivered strong operating margin expansion. A core EBITDA of 21.7% last year, representing a near four percentage point improvement since we became an independent company. Underpinning all of this, we have developed the strongest pipeline in the industry, with 39 biosimilars and more than 300 generics, giving us clear visibility on future launches and strong momentum. Finally, our global footprint is comprehensive, serving more than 100 markets. I hope that you will agree that Sandoz has a unique combination of pipeline breadth and commercial scale, backed by a strong financial position. In terms of our sales growth, we started at $9.6 billion in 2023, and we have produced a compounded growth rate of 7% at constant currencies. Biosimilars continue to be a key driver, while our generic business provides scale, resilience, and strong cash generation. You can also see the increasing contribution and momentum from biosimilars.
Our sales growth and increased profitability reflect excellent value drivers. Firstly, pipeline execution ensuring successful launches. Secondly, the strength of our portfolio with increasing contribution from higher value biosimilars. Thirdly, a continued focus on operational excellence across the supply chain. Finally, ongoing organizational efficiency as we simplify and scale our business. We see a clear path to further margin expansion. With around $15 billion in gross sales, we are significantly ahead of our closest competitors. Importantly, this leadership is not concentrated in just one region. It is global, spanning Europe, North America, and international markets, reflecting both scale and diversification. What differentiates Sandoz more than anything else is our end-to-end integrated model. We combine deep capabilities across development, manufacturing, the supply network, and business development, and then commercialization, allowing us consistently to bring biosimilars to market and scale them effectively.
We have been building this opportunity for several years now. We have committed to around $1 billion to build a leading, fully integrated European biosimilars hub. This was a deliberate strategic decision to invest ahead of the opportunity and create another competitive advantage. This delivers a highly differentiated end-to-end platform spanning technical development, drug substance, fill finish manufacturing, all anchored in Europe. You are going to see this across our footprint with Ljubljana as a core development hub, Lendava for drug substance production, Brnik for injectables and manufacturing, and Toulouse as an important development and supply network center, complemented by additional capabilities in Germany and the U.K.
We have created this network so that we have control, speed, and reliability needed to internalize biosimilar manufacturing and strengthen our capacity for growth. It allows us to accelerate development timelines, ensure availability of supply at leading cost, and support global launches at scale.
This translates directly into value as we will have greater resilience, flexibility of supply, improved margin profile over time. This now brings us to Bio 100. The slide shows the overall size of the opportunity and how it breaks down into biosimilars compared to generics, including GLP-1. As I said, whilst originators talk of the patent cliff, we see this as our golden decade. We see a huge step up in the volume and value of LOEs, particularly in biosimilars. And whilst at the same time, generics continue to provide a broad, resilient base, as I said, delivering sustainable cash, customer intimacy, and overall generational support. You will hear more in detail about how we are positioning ourselves to ride this wave from my colleagues.
However, I first wanted to cover why now is the right time for Sandoz to introduce Bio 100 to you and provide you with more detail of the opportunity ahead. We are launching Bio 100 now because the window of opportunity is wide open. We believe it is our responsibility to capitalize on this opportunity in the interest of patients, shareholders, and stakeholders worldwide. Firstly, there is a significant untapped value. Over $300 billion of originator sales are not targeted by Sandoz today. This is clearly an actionable expansion opportunity. Secondly, the environment is becoming more supportive. Regulatory streamlining, including the removal of phase III requirements, is accelerating our development timelines and lowering our costs per program. And thirdly, there is an evolving industry focus on biosimilar development, but this remains a complex space requiring capital, scale, and technical expertise.
The players that can do this are few and far between, and given the sheer scale of LOEs ahead, competitive intensity at an asset level is expected to moderate. To pull all this together, the conclusion is clear, this is a unique alignment of market opportunity, favorable regulation, and competitive dynamics. Sandoz is perfectly positioned to double down, scale faster, and affirm leadership in biosimilars. Today, we have a pipeline that covers about 50% of the LOE value. By 2035, we plan to have around 70 biosimilars in the market, covering around 80% of the available opportunity. And by 2040, we intend to have more than 100 biosimilars, sustainably covering about 80% of the relevant valuable. We are building this engine to deliver this, significantly ramping up internal development from around two assets entering the pipeline per year to around seven by 2035 and up to 10 by 2040.
That step up is critical because it gives us greater control, delivers higher margins over time, and offers us more attractive returns. These targets are also supported by being the partner of choice. A great recent example is our deal with Henlius that can deliver an additional further 10 assets in key therapeutic areas. In summary, Bio 100 is not simply an aspiration, it is a structured phased scaling plan with key milestones, delivering coverage and a disciplined buildup of capabilities. It positions Sandoz to translate the originator patent cliff into long-term shareholder and patient value. Bio 100 is the heart of our equity story. We are the only pure-play generics and affordable medicines company offering a global scale. Number one globally with deep market intimacy, a combination that is critical to drive adoption and win share consistently across regions.
We pair that with an industry's leading pipeline, not just in size, in quality, but also the disciplined purpose framework protection and acceleration of our pipeline. Rebecca in a while will take you through that. Importantly, we control more of the value chain. Through in-house development and a strong partnership model, we combine flexibility and capital efficiency, accelerating delivery while enhancing returns. Underpinning this will be a fully integrated, scalable biosimilar manufacturing and supply network, giving us reliability, speed, and flexibility and the cost advantages at scale. Add to that our regulatory and IP expertise. We have a proven track record of successfully challenging weak or duplicative patents. For example, some 89% of cases we challenge with the European Patent Office are ultimately revoked or amended, enabling to around eight years earlier in terms of patient access.
That clearly generates huge savings for healthcare systems and great opportunities for patients. We also go beyond litigation by tackling complex patent structures such as patent thickets, whilst also engaging directly with policymakers to address the practices, including serial patent litigation. Finally, we have the financial strength to invest with a disciplined capital allocation and a clear commitment to sustainable, profitable growth. This is why we believe Sandoz is in a powerful position to win in biosimilars. That's the why. Now for the what. What will this look like in terms of net sales over the next decade and beyond? Our new midterm outlook from 2025- 2030 is to accelerate net sales to grow at mid to high single digit percentages by 2030, and then to deliver more than $ 22 billion of net sales by 2035.
That is more than double our net sales of 2025, which were just over $ 11 billion. At the same time, the sales mix will continue to improve. Biosimilars are expected to grow from around 30% of our sales today to around 55% of our sales by 2035, becoming the majority of Sandoz's revenues by then. The number of biosimilars in our portfolio is expected to increase from 13 today to around 30 by 2030 and to around 70 by 2035, providing clear visibility on how this growth is delivered. This is not just a volume story. It's a deliberate shift towards larger, higher quality, faster-growing businesses with Bio 100 acting as an engine to drive both scale and value over the next decade and beyond.
It would be remiss not to mention the meaningful opportunity in GLP-1s, an additional growth factor that is not part of the core Bio 100 trajectory. GLP-1s present a significant opportunity, and our approach is phased and disciplined. We will start with early market entries such as Canada and Brazil and other international markets, allowing us to build capabilities, establish presence, and de-risk execution. Through 2030, this phase is additive to our group growth. From 2031- 2035, we plan to move into the major markets, the U.S. and Europe, where GLP-1s will become a material benefit to Sandoz's sales.
Whilst it is too early to make sales forecasts, given the many uncertainties around how this very new, very different market will evolve, we see considerable potential sales upside here over that period. Firstly, selecting the right molecules, i.e., the most competitive, with semaglutide as our anchor, liraglutide, and tirzepatide and so forth, is critical. These medicines are where we expect we can compete effectively and create value. Secondly, ensuring continuous, flexible, competitive supply. This is a key differentiator in this category. Thirdly, delivering timely launches with the right commercial model to capture share quickly and efficiently. GLP-1s provide a meaningful opportunity on top of the core Bio 100 strategy to further enhance our sales growth and drive incremental value. In summary, I want to bring all of this together so that our ambition becomes very clear. Our targets are explicit.
Over the next few years, we will build our portfolio, resulting in more than 100 biosimilars in 2040, giving us a commanding breadth and depth. This would be around 80% of the biosimilar LOE coverage opportunity by value, which we are systematically capturing the most attractive pools. Along the way, we will have more than doubled our net sales by 2035, with GLP-1s as an additional potential source of growth. What underpins this is equally important, and you will hear from Rebecca about how we are building structural advantages in the way that we accelerate our biosimilar pipeline. From Armin, you will hear how we continue to differentiate through development, manufacturing, and supply chain capabilities. Later, you will hear from our three regional presidents about how we will leverage our world-class commercial engines, translating launches into rapidly increasing market share and thus patient access.
Finally, you will hear from Remco on how we are stepping up value creation, combining growth, margin expansion, and other key financial deliverables to provide high-quality returns. This is a commitment with clear milestones, and I am incredibly proud of what we have achieved so far, and amazingly excited about what we will deliver for patients, shareholders, and stakeholders in the years to come. With that, I hand over to Rebecca.
Thank you, Richard, for the introduction, and good afternoon, everyone also in the room. It is a great pleasure to be here at the London Stock Exchange today. I am Rebecca Guntern, Chief Commercial Officer at Sandoz. Since the spin-off, the last three years have been an exciting period of growth. Together with Richard and my colleagues, we have been working hard to deliver on our vision to be the leading and most valued biosimilar and generic company. We are proud of what we have achieved so far, and we are even more excited about the future. In my 20 years with the company, I have never seen an opportunity as compelling as the one ahead of us. Today's presentation is a key opportunity to get you equally excited about our growth story and how we are going to drive value in the future.
I will focus now on one of the most important drivers of our ambition, accelerating the leading Sandoz biosimilar pipeline. Let's dive right in. We are at the start of the largest opportunity in the history of biosimilars and generics. We are entering a uniquely attractive period driven by a record number and value of LOEs. As you can see on the left-hand side, the value of LOE opportunities across biosimilar and generics is expected to increase around 5x , reaching about a trillion dollars by 2040. Sandoz is uniquely positioned to translate this opportunity into value. In generics, we are a leading company with global scale. With over 300 assets in our pipeline, we are targeting a significant LOE opportunity of $450 billion.
In biosimilars, our ambition is to extend our lead by addressing an LOE opportunity of $550 billion, supported by a pipeline of 39 assets that already by now leads the industry. Let's start with our generic business. Generics remain core to what we do. They offer scale and a strong platform for growth with attractive financial returns. Indeed, we are the only global pure-play biosimilar and generic company. The two businesses have strong synergies that are central to our competitive advantage. Our generic portfolio strategy is focused on areas where we can compete and win, particularly in oral solids and injectables. Oral solids account for 80% of the LOE ahead of us, thus further supporting our portfolio strategy. Our strong pipeline of more than 300 generics provides a steady flow of planned launches over the coming years, translating into a LOE coverage of 70%.
This strategic focus is already translating into delivery, with recent successful first-to-market launches, including nintedanib, dapagliflozin, and sitagliptin. Before I move to biosimilars, let me take a moment to share with you our GLP-1 ambition. GLP-1s represent an additional meaningful long-term growth opportunity for Sandoz. We are approaching it with the same pioneering mindset and discipline that has underpinned our leadership in biosimilars and generics. Our ambition is clear. We want to be a leading player in expanding access for GLP-1 treatments for more than 2 billion patients around the globe. Our initial focus is on semaglutide and on launches in selected early markets, starting with Brazil and Canada. This would be followed by launches in major markets in Europe and the U.S. From 2036 and beyond, we plan to continue strengthening our position through next-generation product launches. We have already made significant progress.
We have received our first GLP-1 approval in Brazil for the indication of type 2 diabetes in July this year. We are now aiming for a Q4 launch. Weight management is anticipated to follow. With only a single-digit percentage of patients getting access to GLP-1 treatments across indications, Brazil offers substantial headroom for market expansion and a great opportunity to improve access. Following our first approval in Brazil, our next major opportunity is Canada, the second-largest market after the U.S., with the GLP-1 segment valued at approximately $2.6 billion. Across both markets, we are following our multi-source supply strategy, which provides flexibility, resilience, and scalability. This strategy supports sustainable growth and supply resilience. Importantly, these early markets are helping us to build the capabilities, experience, and platform that will support further expansion into larger markets, including Europe and the U.S. How do we build a sustainable leadership position in GLP-1s?
Let me show the playbook. To realize this ambition, we are building a broad and sustainable platform. First, portfolio relevance. We already have eight assets in our pipeline addressing some of the most attractive LOE opportunities over the next 15 years. These assets extend our pipeline beyond semaglutide into key future products, including tirzepatide, orforglipron, and retatrutide. We have already reached our first important milestone with our in-house tirzepatide application accepted for review by the FDA. Second, supply. We are also establishing a multi-source supply strategy tailored by market, complemented by in-house manufacturing capabilities, pen device expertise, and fill finish capacity. This approach is designed to provide scale in a market where demand, capacity, and market access dynamics matter most. Finally, our preferred commercial partner position and patient-first approach set us up to have strong go-to-market strategies and local access pathway.
Note that our opportunity is not simply to compete for share within today's market. Our opportunity is to play a leading role in expanding the overall size of the market and those total access to GLP-1 treatments over the next decade. Today, less than 2%-3% of 2 billion patients are getting access to GLP-1 treatments. We estimate a market expansion in patient number in the range of two to seven times, depending on market maturity and treatment affordability. The combination of market expansion, portfolio breadth, and commercial strengths is what gives us confidence to deliver on our long-term GLP-1 ambition. Let me now turn to biosimilars, where I will spend most of my time today. Biosimilars are the single biggest opportunity and the major driver of our growth trajectory. This is a space we know exceptionally well.
Sandoz is the pioneer of biosimilars, and 20 years on, we are the leading biosimilar company globally, with 19% market share and a diversified portfolio of 13 in-market products. There are two key points I would like to highlight. First, as you can see on the left-hand side, we have proven time and again our ability to successfully launch products across regions. Today, eight of our 13 biosimilars are ranked either number one or number two globally, demonstrating the breadth and competitiveness of our portfolio. Second, we are leading at scale across therapeutic areas, market archetypes, and regions. It shows that we can consistently bring a wide range of biosimilars to market and execute well. Our diversified portfolio reduces reliance on a single product and provides a balanced risk profile. In summary, we combine scale, proven execution, and diversification. That is what underpins our leading global position today.
As I always like to say, it is no coincidence that we are the global leader. We have worked diligently over decades to get there. However, we can never be complacent. As the global leader with an industry-leading pipeline, we must remain very ambitious and very focused to stay consistently ahead of the competition. This slide demonstrates our Bio 100 ambition, as already outlined by Richard, to expand from 13 assets today to more than 100 assets by 2040, creating the broadest and most competitive biosimilar portfolio in the industry, targeting an LOE coverage of about 80%. We have a clear plan to get there. First, through disciplined and rigorous pipeline selection, focusing on the most attractive and commercially relevant assets. Second, by combining in-house development with strategic partnerships. This allows us to scale faster while managing risk and capital efficiently. And third, by leveraging our strong commercial platform.
As I shared before, we have consistently demonstrated our ability to translate launches into leading market positions. In essence, Bio 100 is all about building on a success story with sustained global leadership in biosimilars, reinforced by a rapidly expanding pipeline. Let me talk briefly about another development that could significantly and materially benefit Sandoz. Recent moves towards regulatory streamlining worldwide are a major structural tailwind for biosimilars and a clear accelerator for our Bio 100 ambition, over and above the LOE opportunity. What has changed is not the underlying science. It is the regulatory thinking. With phase III efficacy trials no longer required, development timelines and development costs can be reduced substantially. This allows us to redeploy capital into additional assets, expand our pipeline faster, and ultimately bring more biosimilars to more patients sooner.
In other words, regulatory streamlining significantly increases both the speed and the scale of what we can achieve through Bio 100. Indeed, recent progress on streamlining will play a key role in addressing a critical remaining gap in the biosimilar landscape, the biosimilar void. To illustrate this, over the next few years, more than 60 biologics will lose exclusivity, many with no biosimilars yet in late-stage clinical development. This is a clear and significant opportunity where Sandoz can lead. As streamlining makes more molecules economically viable, you may see some smaller assets in our pipeline that will have the advantage of limited competition. Why does this matter? By targeting these gaps, we can accelerate access for patients, reduce healthcare costs, and further strengthen our leadership in biosimilars. Our advantages in commercial scale, balance sheet strengths, and vertical integration in manufacturing compare very favorably to many competitors.
The key to successfully realizing this opportunity is a rigorous pipeline selection framework. This slide shows how we bring discipline and scalability to the process. First, we filter for attractive opportunities, now focusing on products with over $0.5 billion in LOE sales. The effects of regulatory streamlining have reduced it to that level. Second, we refine based on operational feasibility and longevity assessment, including make versus buy decisions, ensuring we allocate capital efficiently and build the right balance of in-house and partnered assets. We also assess IP feasibility early on, providing visibility on the timing and likelihood of market entry and helping us to focus resources on opportunities with the clearest path to value creation. Third, we select the assets based on commercial value, risk, and strategic fit, ensuring a high-quality pipeline. In short, Bio 100 is not about pursuing every opportunity.
It is about selecting the right assets to drive sustainable, high-quality growth. In the coming slides, I will show how this framework helps us to build our Bio 100 ambition. Let me now quantify the opportunity behind the ambition. This chart shows the biologic LOE landscape over time and the opportunities it creates for Sandoz. A quick word on how to read it. The dark blue segments represent the LOE value already covered by our current pipeline, while the lighter blue segments show the additional opportunity enabled by Bio 100, and the white portions represent LOE opportunities that exceed the Bio 100 opportunity. Directly below, you can see the corresponding number of assets in each period, again, split between our current pipeline and the incremental Bio 100 opportunity. Let me highlight a few key messages. First, the sheer scale of the opportunity.
Our current pipeline already addresses an LOE opportunity of approximately $250 billion through 2040. Bio 100 expands that by $200 billion, thus almost doubling the LOE value we will pursue. Second, Bio 100 adds more than 50 assets to our existing leading pipeline of 39 assets. Combined with the 13 biosimilars we market today, this creates a pathway to more than 100 biosimilars by 2040. Third, it materially increases the share of the biologic LOE opportunity we can address. Beyond 2035, as many of these biologics are still being developed and the LOE landscape evolves, our ambition remains to steadily maintain coverage at around 80%. Ultimately, Bio 100 is much more than a pipeline expansion exercise. It gives us access to a deep and evolving pool of biologic opportunities and creates sustainable long-term growth, extending well beyond 2035.
This slide now provides a more qualitative look at how we designed the Bio 100 ambition. First, modalities. Monoclonal antibodies will remain core, covering around 60% of the value, complemented by emerging technologies such as ADCs and other modalities. Second, therapeutic areas. Most of the opportunities are in oncology and immunology. Together, these account for roughly 80% of the total and represent some of the largest and most attractive assets losing exclusivity. We can leverage our strong market presence and establish commercial capabilities and infrastructure for future launches. Third, development type. Bio 100 will be driven primarily through in-house development, complemented by partnerships for acceleration. Let me share our approach in more detail. Bio 100 is explicitly designed to increase the in-house share over time. Up to 70% are targeted to come from in-house development.
This is our default approach because it delivers the best economics and allows us to fully leverage our end-to-end capabilities. We will continue to prioritize in-house until capacity is fully used. The remainder will be delivered to strategic core development partnerships and targeted BD&L. Development partnerships are critical to accelerate pipeline expansion in a capital-efficient way beyond internal capacity. Great examples are the recent strategic core development agreements with Samsung and Henlius. These will be complemented by targeted in-licensing deals used to selectively capture near-term opportunities. Taking a step back, let me now help you to size the Bio 100 opportunity for Sandoz. Starting with volume, there are three key drivers. First, market expansion. Biosimilars are not just substituting originators. They enable earlier treatment and broader patient access. While the range of market expansion ou tcome has been wide, we estimate an average expansion of around 10%-20%.
Second, biosimilar penetration. This is essentially the adoption rate, which varies significantly by market archetype and channel. Europe continues to lead the U.S., driven by more favorable pricing, reimbursement, and market regulations, including incentives. We expect an average biosimilar penetration rate of around 60%-80%. Third, our market share within biosimilars. This is where execution really matters. Share is driven by the level of competition and by the launch timing, but critically also by our commercial scale and capabilities. Bas ed on our past performance, we would expect an average share of around 20%-30%. Then on price, the key factor is the discount to the originator. We assume peak sales typically occur several years after market formation, and pricing at that point reflects the net discount in a competitive biosimilar market. We assume a price discount of at least 65%.
Overall, this would translate to an approximate 5% share of the total LOE value for Sandoz. When we put this all together, the Bio 100 opportunity is not just the function of originator size. It is the result of access-driven market expansion, adoption dynamics, execution on market share targets, and disciplined pricing. Let me now illustrate how Sandoz wins in practice using the Hyrimoz launch in Europe as a case study. Hyrimoz targets HUMIRA, historically the largest biologic globally, with close to $18 billion in peak sales in a market characterized by intense competition. What you see on the left side is the critical dynamic since the introduction of biosimilars in 2018. Driven by broader and earlier patient access, the adalimumab market in Europe expanded by roughly 90% in volume.
Biosimilar penetration increased consistently, reaching around 80% by 2025, mainly driven by fast adoption in tender markets, but also share-of-voice markets like Germany. Sandoz captured meaningful, sustainable share, around 20%, despite increasing competition. This demonstrates two key capabilities. First, our ability to win share in a highly competitive market where success is determined by scale, access, and commercial strengths. Second, our strengths in sustaining share over time, even as more competitors are entering. We are seeing a similar playbook developing in the U.S., where we have now reached number two position in adalimumab. How will we ramp up Bio 100? In the near term, our focus is on execution. We will ramp up development and manufacturing capabilities as well as strategic partnerships, which will build the foundation to reach around 30 assets by 2030.
To put this into perspective, since the launch of our first biosimilar in 2006, we have launched 13 products. Over the next five years, we plan to launch 17, meaning we would more than double our in-market portfolio by 2030. By 2035, we plan to further expand our global leadership position by reaching our goal of 70 in-market products. Beyond 2035, the focus shifts to sustaining and extending our leadership further. We expect to reach 100 launches by 2040, with even more expansion into emerging technologies. Armin will talk more about how we will get there and the preconditions for success. Let me close by bringing it all together. We will remain relentless in our focus on what matters most, delivering excellence for patients, and expanding access to high-quality medicines around the world. We have a clear roadmap establishing Sandoz as a sustainable long-term leader by 2035.
We are building our next chapter of leadership in biosimilars with a pipeline designed to cover around 80% of LOE by value and more than 100 biosi milars in our portfolio by 2040. Perhaps most importantly, we have the capabilities, the commercial platform, and the execution track record to turn this ambition into reality. Sandoz stands alone as the only global integrated pure-play company across biosimilars and generics. That is why we are so strongly positioned to shape the next era of affordable medicines, delivering sustainable growth, strengthening our leadership for years to come, and continuing to pioneer access for patients more than ever before. With that, I would like to hand over to my colleague, Armin.
Thanks, Rebecca, and welcome everyone. My name is Armin Metzger, and I am responsible for our end-to-end biosimilar development and manufacturing, all the way from early development through to manufacturing and supply. To put it simply, my team takes what is in our pipeline and develops and manufactures those assets. I was delighted to join Sandoz around six months ago. It is a true honor to hold this key position in the company that is doing more than any other to redefine affordable healthcare, and it is a pleasure to be with you all day to talk about our plans to make this all happen.
I would like to focus now on how we are going to translate the Bio 100 ambition into reality. Specifically, I want to explain why our biosimilar development, manufacturing, and supply chain platform can be a unique competitive advantage. In biosimilars, success is not just about the pipeline.
It is about execution at scale, supply reliability, and cost leadership. Actually, six months ago, like you, I looked at Sandoz investment decisions from the outside, and I was really impressed how the foundation was set to achieve those objectives. At the core of the model, we are creating this full vertical integration. As our in-house network comes online, we are going to be in full control of the end-to-end value chain, from development to drug substance manufacturing, to fill and finish. Our setup is flexible, with significant capacity and built-in opportunities for further expansion and the network spanning Slovenia, France, and Germany. This will be a true European geopolitical stronghold, producing reliably and at competitive cost. I am looking forward to a site visit in November, when we will show many of you our new fit-for-purpose biosimilar development and manufacturing facilities in Slovenia.
This, along with our acquired site in France, provides an excellent platform across both fed-batch and continuous manufacturing. Of course, we cannot and we will not do everything ourselves. We will continue to work with third parties where appropriate. For instance, our recent agreement with Henlius to commercialize up to 10 additional biosimilars. As Rebecca already said, our in-house capabilities will be complemented by strategic partnering to ensure that we optimize our overall use of resources in light of rapidly expanding demand. The map here shows our integrated European biosimilar hub. Some is still under construction, but I will take you through the timelines in a moment. Once completed, it is going to be fully integrated along the value chain, geopolitically resilient, anchored in Europe, and designed from the ground up to operate at significant scale.
Importantly, it will allow us to serve all major global markets and launch many new medicines cost-effectively. Let us look in more detail at the fully integrated end-to-end biosimilar engine we are building and how that will support a distinct, sustainable advantage. How we do turn our biosimilar development capabilities into a true competitive edge to ensure success of Bio 100? As a disclaimer, at this point, I am focusing today on our development manufacturing control setup, but of course, we will continue to benefit from our strong clinical and regulatory functions, which are equally essential for our biosimilar business. Back to the slide. Along the top row, you can see our key development locations across Europe, each with a clearly defined role. Ljubljana is our core hub for CMC development, particularly for fed-batch development.
This is a huge step up in our biosimilar development capabilities, covering drug substance, drug product, and analytics. Toulouse complements this, and complement is a very important word here. Complements with CMC development for continuous manufacturing. With Kirchhain in Germany focusing on analytical characterization, clinical bioanalytics, and bioassay development. Cambridge adds device development capabilities. Note that Dave, our Head of Device Development in Cambridge, is here with us today. As I mentioned earlier, and Rebecca also stressed it, all this will be complemented by our strategic partnerships with, for example, Samsung Bioepis, providing additional external development capabilities and capacity. Overall, the in-house share is increasing over time. This int egrated and strategic leap forward in the scale-of and access to development capability is one key reason why I am confident in our ability to deliver Bio 100.
That development engine that seamlessly connects into our industrial-scale supply network also benefits from geographic proximity. Turning to the manufacturing side. In Lendava, we will produce soon drug substance at large scale using stainless steel fed-batch technology. In Toulouse, we will operate continuous manufacturing technology. Alongside them, as announced earlier today, will give us disposable fed-batch capacity for our low to medium volume products. For fill and finish, Ljubljana covers vials, while our new site in Brnik completes the value chain with syringes, cartridges, and auto-injectors. By the way, all this could be eventually also used for GLP-1 fill and finish operations. This is not just a network of individual sites and technologies. It is a fully coordinated end-to-end ecosystem that for us is the ideal platform to deliver Bio 100.
Let me go into a bit more detail on the newest part of the network, the new kid on the block. As we announced this morning in Ljubljana, next to our development center, we are building an 8,000 L disposable fed-batch drug substance facility. Around $300 million of investment due to be operational from 2029. This will do two things. It expands clinical and commercial production capacity for our low to medium volume drug substance products, and it puts drug substance production right next to the development site, taking real time out of tech transfers. Note, this is advanced disposable fed-batch technology in Ljubljana is for us an important bridge technology for our biosimilar platform, complementing our in-house high volume platform in Lendava and the continuous capabilities we have in Toulouse for low to medium volume production. A key point is that our hub is already being built and funded.
In Ljubljana, our new state-of-the-art, digitally integrated biosimilar development center was recently opened. Alongside it, we are building our disposable fed-batch drug substance facility, while next to the airport in Brnik, we will finish construction of the aseptic site in 2028. In Lendava, the 120,000 L stainless steel drug substance center completes construction this year and will start validation for commercial production in 2027. In Toulouse, the development center is already up and running with continuous manufacturing on the same timetable. All the sites will use state-of-the-art digitally integrated systems and will follow, of course, the highest quality standards. Timing works for us. We are already beginning to feel the positive effects of regulatory streamlining on our biosimilar development programs, and major LOE opportunities are kicking in.
Volumes will ramp up, and the capacity for growth will exist with our network, significantly reducing execution risk and supporting reliable delivery of our programs. Bringing development and supply in-house is one of the most important levers for value creation in our model. Today, as is the case for many other industry players, a large part of biosimilar development and manufacturing is externally sourced. What we are doing at Sandoz is fundamentally changing that with a clear ambition to move between 50% and 70% in-house in development and around 60% in manufacturing. The real benefit to our financials will be felt in the 2030s, and is aligned with our new midterm outlook that Remco will take you through later. By creating and expanding these in-house capabilities and development, we will decrease development cost and provide greater production flexibility, allowing us to prioritize, accelerate, or adapt programs based on market dynamics.
In the near term, external partners will continue to help us bridge capacity and share investment. But over time, we will shift toward owning the critical capabilities, which will significantly improve returns. On the supply network side, the impact will be even more direct. Lower product cost through in-house capabilities, higher supply flexibility, which is critical in tender-driven markets, and ultimately, greater competitiveness in pricing and access. At the same time, we retain flexibility to access adjacent technologies through selective partnerships. When you bring both sides together, this is a fully integrated operating model. This shift to in-house is structurally margin attractive. It enables us to grow faster, compete more effectively, and expand margins over time. All of this will translate into clear financial outcomes over time. We expect year term benefits from procurement as well as sourcing and productivity improvements across development and our supply network.
From 2030, the impact becomes more structural through insourcing, vertical integration, and scale. The internalization is not only about control, it is also a key lever for lowering cost, improving supply resilience, and strengthening our long-term economics. Diving deeper into manufacturing, we are going to go from making none of our biosimilars volume, which was the post-spin-off status quo, to making the majority. Along with significant scale of the facilities, a key differentiator is our three technology drug substance platform. Disposable Fed-Batch at 2,000 L- 4,000 L in Ljubljana gives us the flexibility to run moderate volume products and clinical batches on the same platform. Stainless steel Fed-Batch at 15,000 L in Lendava will deliver significant reliable output for our highest volume products at low cost per gram.
Continuous manufacturing in Toulouse will provide higher yields for appropriate molecules with their technology at limited cost and with more output per unit of bioreactor volume. By leveraging this complementary set of technologies across our network, we can allocate products to the most appropriate platform and optimize manufacturing performance. This approach will enhance operation flexibility, allow us to respond efficiently to evolving demand profiles, and support cost competitiveness. What does all this mean for our cost base? The network I have just described does not only give us more control, it changes the economics of biosimilar supply as the effect builds over time. Three things will drive it. First, top line growth. As Bio 100 volumes come through, we will absorb more output across the same asset base. Scale and the flexibility to move products between our three drug sub technologies will keep us utilization high as portfolio expands.
That flows straight through to unit cost. Second, continued disciplined working capital. We will keep inventory and planning tight across the network so that growing volumes do not tie up more cash than they need to. Third, productivity. Process optimization, better yields, and procurement excellence across a much larger in-house space. This will be steady compounding improvement rather than one-off steps. Put those together and the implication is clear. Significant unit cost reduction from 2030 and a structurally lower cost of cost of goods sold through the decade that follows. The step change will come as the network reaches scale. Remco will take you through what this means for our margins later. We have also put in place a range of extensive capabilities to support delivery of Bio 100.
We will drive cost competitiveness from early development and accelerate our speed to market through in-house efficiencies while increasing our flexibility via selective partnering. On the right, you will see that we are going to combine supply reliability, specialized knowhow, and disciplined cost control within a scalable network. Together, this capability will create an end-to-end model from cell line development to commercialization, positioning Sandoz as a leading biosimilar company with the ability to scale based on substantial and high diverse development and manufacturing capacity. To conclude, the foundation of our future success is already largely in place. We have actively invested to support growth with a fully integrated European network already increasingly in place. This is about ensuring scale, reliability, and efficiency across our key markets. By 2030, we will move into the next phase, optimizing how we develop and manufacture biosimilar medicine.
Here, the focus will be on achieving the right balance between internal and external development and manufacturing. By combining in-house capabilities with targeted external partnerships, we can accelerate speed to market while maintaining disciplined resource allocation. By 2035, the model will have evolved further with greater in-house strengths, including leading manufacturing capacity and capabilities that deliver significant benefits. At this stage, we will have leveraged our internal capabilities to accelerate growth, turning our integrated platform into sustainable competitive advantage. The 2030s will be the decade when the full benefit of the in-house network come through with greater control, faster execution, and stronger value creation. In summary, this is a multi-stage process that starts with building the foundation, progresses to optimizing the model, and concludes by fully realizing the value of an integrated self-reinforcing network.
With that, thank you for attention, and I would like to invite Richard, Rebecca, and Craig back on stage, and we will pause here so that people in the room and through the webcast can ask questions about what you have heard so far before we go to a short break.
Thank you.
Thank you very much.
Thanks, Armin. Bearing in mind for those online, you cannot see, but there are more people than a U2 concert here, so we really should have charged, and we have over 1,000 people online right now. We are expecting quite a few questions. This is the shorter of the two Q&A sessions, but feel free to put your hands up. What I would say for those in the room, if you can make yourself very visible, because the lights are really bright, just so we can see you. If you let us know your name and where you are from, that would be great. As I said, we will take questions from the webcast and moderate through this iPad. Maybe I think, James, you had your hand up, James Vane-Tempest?
Hi. Thanks for taking my questions. It is James Vane-Tempest from Jefferies. Two, if I can please, just on the growth drivers. Firstly, how much of the value growth from biosimilars is from the larger products to give us a sense of product concentration versus the smaller opportunities with the removal of the requirement for phase III? My second question is if you have an aspiration to double the business excluding GLP-1s by 2035, how much of that can be underwritten from current business and pipeline versus expected new pipeline and business development in the outer years to give a sense in terms of to bridge what can be delivered from the business today? Thank you.
Thank you so much, James. Perhaps if I take the first question, Rebecca, do you want to have a stab at the second?
On the—
On the growth drivers. So, large.
Yeah.
Growth, it's in a sense, it's more affection for me as a function of competition. If you look at a product like denosumab, I think we have seven competitors in the U.S., and clearly it's been a very attractive growth driver. We've taken a leadership position both in Europe and in the U.S. I think the smaller asset, and it goes back in slide 33 in Rebecca's presentation, gets into this slightly counterintuitive view. A question I get a lot is, aren't we going to get more competition? I think perversely we see less competition, particularly in the small and mid-size assets. You see this described, I think IQVIA describe it as this biosimilar void. So I think you see a materially lower number of competitors. So actually, I think over time, there's a significant value opportunity from some of the more modest assets.
And I guess the best proof point is Omnitrope. We launched it 20 years ago. It is still one of our largest products. And the one thing I guarantee, it is never going to go off patent. So it continues to drive value. I think it is going to be a combination of two. Very hard to predict, but I do think perversely, we are seeing this reduction in competitive intensity rather than increasing. Rebecca?
Yeah. So thank you, James, for the question. I think one big strength of the Bio 100 ambition, which we just presented, is actually diversification of the pipeline, across therapeutic areas, across different technologies, and also size, different sizes of the products. And I think this is giving us a great risk profile, which is very balanced and really reduces the, I would say, reliability on the dependency on a single asset or a single market. So I believe actually this is a core strength, and of course, why the larger products will contribute a large portion of growth.
We actually benefit and will benefit also from the smaller asset, which Richard just explained, because we expect limited competition. Infliximab, which we just signed with Henlius, is a fantastic example. It is a mid-size asset, and actually what we are seeing currently is there is very limited competition. We do believe we are going to create great access in this product, but also long-term value.
But I think there is also still some lungs in it, to your point, the existing products. If you look at the Etanercept, it is one of my big frustrations. We launched it 2017 in Europe. We still have not launched it in the U.S. because the U.S. courts perceived that it had a patent expiry in 2030. That is still an asset that is going to create value for us as a company. It just happens to be 10 years later, more than 10 years later than we first launched it in Europe. And similarly, I could say exactly the same with the Filibacets. So I think there is still momentum and growth. And then you will hear from Peter later on, a lot of the portfolio that we are still currently launching in Europe, we are still yet to launch in international markets.
On top of that, I think there is a formula, I think this is page 35 on Rebecca's slide, that actually we tried to think about how we could explain to everybody how to model the market expansion element of how that value creates. I think again, here our existing portfolio has a significant opportunity to do that. So, there is still a lot of legs left in the portfolio with existing launches as well.
We have James Gordon. Over to you, sir.
Thank you. James Gordon from Barclays. Thanks for taking the questions. I know we have not heard from Remco yet, so I will not ask on margins yet, but I will have a question there. So a couple of questions on biosimilars. One was, can you talk about the flex on the mid to high single digit sales outlook? Because it is quite a wide range. I assume the flex really is in biosimilars, and slide 38 was useful in terms of talking about some of the factors to get to our peak. But is the key flex one really about the competitive question? It might be that there is not as much competition in some of the smaller biosimilars, but if the outlook is as strong as you describe, it sounds like why would not lots of companies want to go for this?
Is that the key flex, whether we get lots of new players coming in, maybe from Asia, trying to go after some of the Western markets? So what are you assuming about more competitive intensity when you build this out? That would be the first question, please. The other two are quicker, which would be, when you talk about the peak, how quickly do you think that fades away? Because you can get some really big numbers, but do they stay there for a long time, or do you think they erode from that peak quite quickly?
Then finally, it sounds like a sustained double-digit bi osimilar growth CAGR all the way out to 2030. But how linear is that? Could there be a big slowdown in that in 2027 and 2028, and then it gets really exciting? Or could you do double-digit biosimilar growth for the next couple of years as well?
Well, three great questions. Perhaps if I start with the sustained growth, I think, look, if you look at the last three years, we have consistently delivered sustainable growth out of those biosimilars. They are still launching. We look to launch aflibercept later in the year in the U.S. Then clearly, I mean, I will get Rebecca to comment on some of the launches that bridge to 2030. I think there is some very nice momentum in the existing portfolio and clearly some of those deals. I am not too concerned. I think there is some very nice momentum. In many ways, part of the rea son we are here is, look, we committed to delivering 30% of our net sales from biosimilars by 2028, and clearly we have done that, I think, nearly three years early.
The momentum and the access, and also I think the bit we consistently underestimate is the expansion of the market as we serve more patients. Biosimilar effect. Honestly, I do not see it so much. It goes back to slide 33. I think the IQVIA, this biosimilar void, these $500 million to a billion dollar assets. Do I expect to see 10 competitors? No. Do I expect to see one or two? Yeah, maybe. Are we good at competing? I think absolutely. I think we have a strong platform in Europe. You will hear from Christophe, Keren, and Peter in a little while. I think we build a strong commercial moat. Also Sandoz is unique. A lot of our competition maybe are in-licensing a portfolio. They are losing the flexibility that Armin had. We have a great front engine. We have a great IP capability. We are building the manufacturing.
We have partners that want to work with it. I think we are pretty unique, and so competition, we are used to it. Do I expect to see more? Actually, I think I will see less going to my other one. Do you want to talk about peak, Rebecca?
Yeah. Maybe just quickly on 2027, 2028, because you asked me also to comment on the 2027, 2028. I think an important driver of our biosimilar growth is actually also that you have, of course, the in-market portfolio, and we have proven this in the past, right? If you look at the European performance, even in years, and there was two, three years without a launch, we continuously grew the business based on market expansion, based on the formula we have presented, because you see this broader and earlier access for patient, which is then driving volume, which is driving at the end, your top line.
On 2027, 2028, don't forget, we just had recent launches with denosumab in Europe and the U.S. We're still going to see the aflibercept launch in Q4 this year happening in the U.S. So we will have benefit of exactly those launches also translating into 2027 and even I would say in 2028 in the case of Europe and beyond.
There is growth momentum. There are big LOEs to come. We will launch insulins in Europe with Christophe. We're going to launch potentially pertuzumab in those timeframe. There's a couple of really exciting opportunities for us to grow the business and drive patient access, 2027, 2028. Then of course post 2028 is exciting period to step in with the big oncology launches coming to the plate, and I think we have a lot of opportunities to build on our existing strong commercial platform to drive incremental growth. Then on the peak sales, I think it depends. What we try to do with this value creation slide is to help you, and I hope you found it useful, the way we think about value creation, right?
You saw three metrics which are on volume, which is this market expansion, the penetration, the adoption rate, and then the market share, and then of course you have at the end the price. So peak sales depends, depending on the market archetype, the product, the therapeutic area. If you take Omnitrope, I think we have not yet seen peak, right, 20 years in a row because we're still growing, we're still expanding the market and driving access. While of course in other oncology assets, you might see these peak sales five to seven years post in market formation. So that's why we are giving ranges in this value creation because there is not a one size fits all formula, depending on the asset.
And don't forget etanercept in the U.S. as well.
Yeah.
Thanks, James. I'm just going to take one from the webcast, if that's okay. So, this is Joris from Octavian. So hi, Joris. Good to hear from you. I've touched on these, so it's whether you have any other comments. So for the 2026 to 2030 period, you have 10 biosimilars in development to target LOE opportunities with a further four planned under the Bio 100 ambition. Can you provide more detail on when exactly you expect to launch these next biosimilars?
Again, there's a slide in the backup that highlights LOE. And again, it's the LOE. So don't get misled. I know we laugh a little bit about it, but Tenascet, there's an 11-year gap between first launch and last launch. So it's not as though we launch everything on one day all over the world. And that's just the nature of the business. So the slide shows, I guess, the first regulated market formation, the first large market. But clearly there's value creation for years afterwards. And I think that gets underappreciated a little bit. So there is a very good slide. We've tried to disclose as much as we can without me getting into too much trouble in terms of my colleagues making our competitors' life any easier. But there should be enough detail in the backup there for you.
Thanks. Okay. It's difficult to see you guys, but we'll go to Thibault in just a second.
Thank you. Just a question on CapEx. Since the spin-off plan, the CapEx plan, I think for the period, I think it was 2023-2028, was $23 billion. There was a ramp-up of one more billion dollars that has been announced since. Then there was the Evotec deal and the recent announcement for the manufacturing facility in Slovenia. Just with this sort of additional CapEx that you have announced over the period, how much of the Bio 100 is covered with that capacity? If you could comment in general on the capital intensity you are expecting for the business as you want to expand the number of biosimilar on market to 100 over the next to 2040.
Thank you so much. I will ask Remco to comment briefly, but effectively, you have just summarized most of his presentation. Perhaps if I do not know if you want to add anything, Remco, other than I would rather let Remco perhaps cover quite a lot of that in detail, and if then if it is not adequately covered, perhaps then we can come back to you right at the beginning of the next session. Is that okay, Craig?
Sounds good.
Thank you.
Thanks, Thibault. We have someone with a question directly to your left, Thibault.
Good afternoon. Florent Cespedes from ODDO BHF. Two quick questions. First, regarding the U.S. market. You are very strong in Europe. You have great ambitions. Could you maybe share with us how you will increase your presence in the U.S. market, which is very relevant for biosimilars? Second question, quick one on GLP-1s. Are you planning to also develop the oral formulation of semaglutide, so Wegovy pill as well when it will be off patent, or will you remain focused on the injectable formulations? Thank you.
First of all, thank you so much for your questions. Again, I'll let Keren. I don't want to steal Keren's presentation again. I think exactly to your point, I'm very delighted how the U.S. business is performing. You're seeing great execution, but I really don't want to steal Keren's thunder, so I'll let her answer that. We're a generic and biosimilars company. In a sense, of course, our job is to develop copies. We're pretty agnostic. As you've seen our filing, I think our portfolio of GLPs is very broad, both oral and injectable. We would look to be at market formation for both injectables and orals for Europe. Obviously, we've just had our first file accepted in the U.S. for tirzepatide. This is the joy. In a sense, I'm relatively agnostic on products and molecules. Our job is to deliver the broadest possible portfolio to patients.
Yeah, the strategy is hybrid, right? We have in-house development, and so we will launch our own semaglutide post 2030, which we are also investing now very targeted manufacturing capacities and fill and finish. As Armin has presented, we can leverage Brnik. Then we have a huge portfolio of eight assets, which we're also going to look into in-house development beyond semaglutide, tirzepatide, where we got the approval from FDA. Fundamentally, I think it's bringing those assets to patients. Of course, we're going to target both oral formulations and injectables to really reflect the customer needs and I would say the evolving market you currently see.
Right. I am going to take one from the webcast. So this is Nicolas from Kepler. Good to hear from you, Nicolas. The second question on profitability, I may well suggest that is covered by Remco in the second half of the session. So on the first is around IP. When it comes to patent litigation, I believe you have mentioned you had an 89% win rate in Europe. Any color on what the rate would be in the U.S. and the rate in the larger assets, so $ 10 billion plus peak sales, as we would expect much higher patent tickets on the massive LOE coming early next decade?
It is a great question. I am looking at my general counsel. I do not know the specific answer, actually, on the percent in the U.S. I think we said we win more than we lose, which is good. Ingrid, I do not know if you want to comment.
Yes, I think we need to differentiate because the system is very different between the U.S. and Europe, so comparing the numbers would not give a clear answer. What we can say is that our litigation track record on both sides in the U.S. and Europe is very strong. We are very committed to continue doing that.
In addition, as I heard patent thicket serial litigation, I think we are really the thought leader in the industry when it comes to challenging these patent tactics and these what we see as abusive behavior, and we will continue doing that because we are fully committed to also be the voice for patients and accelerate the access for them.
Thanks. Simon?
Thanks, Craig. Thank you. Simon Baker from Rothschild & Co Redburn. Two quick ones if I may, please. Just picking up on something you said, Rebecca, your slide on thinking about the value generation was very comprehensive. The one bit that was missing was something you just mentioned, which was the time to peak as about five to seven years. I just wonder if you could give us any idea of how that varies by region and by therapeutic area. Was five to seven a reasonable estimate for the whole piece? On the GLP-1 opportunity, I believe at the moment all of the API manufacturing is outside your network. Presumably, as that opportunity develops, you will start to bring that in-house.
What is the capacity at the moment? Because if this market really does become two to seven times peak or two times volumes at peak, it could be colossal. I wonder if you could sort of talk us through how big this could be and how much of that scale is an advantage again to Sandoz given the difficulty of replicating manufacturing at that sort of volume. Thanks so much.
Perhaps if I take the GLP and then Rebecca, I will pass to you on that. We are not an API manufacturer. We want to be clearly vertically integrated in biosimilars. We have no intention of being vertically integrated in peptides. There is plenty of peptide availability in terms of a number of suppliers that we work with. Where I do think we have a unique position is really certainly in injectables fill finish. So we have numerous partners that we are working with. As well as Armin described, we are building injectable capacity in Brnik, which again, certainly as we look to launch in some of the regulated markets, we would leverage in combination with a number of strategic partners. But to be absolutely clear, I do not see a point where we would want to get into industrial manufacture of GLP-1 peptides.
There are plenty of suppliers out there that we can work with who are investing in building capacity. Do you want to pick on peak sales, Rebecca?
Yes. On the peak sales, I said it depends, right? On product and therapeutic areas. It's not every time, five to seven times. In Europe, of course, we benefit really from a very favorable biosimilar adoption framework. So in a sense, what you would see adalimumab in Europe, we launched in 2018, that the product is still growing. Meaning it's more than five to seven years post LOE that the product is still growing. I think we see the same as I was mentioning also in pegfilgrastim. So it really depends, and the most important part of the entire value creation, if you think about why we are here, is the market expansion. This is really the broad range where you see up to 100%. I brought the example of adalimumab, which was doubling actually access for patient.
We do see the same, by the way, in pegfilgrastim, infliximab, where we're really driving and doubling market expansion over time. Which means in Europe, these peak sales could go endlessly, theoretically, right? There is not a dead end. Also in the U.S., we saw some great examples where we really see continuous adoption rate because it takes a bit more time, right? It's more gradual than what you would see in Europe with the benefit that also here, especially in the medical benefit part, that you're really driving continuously access. But they have different dynamics. Then last but not least, don't forget the international markets. For us, a huge opportunity to drive access and expand the market. In many cases in markets, we're seeing patients not even having access to biologic treatments as of today.
So another huge opportunity for us to drive access, and there we have a very customized approach market by market, and depending on the current maturity.
But I think as you launch 100 assets, again, back to etanercept, peak sales are going to be 12 years after we first launched it. And clearly, you have this very and as you launch potentially 10 products a year, the momentum that builds in terms of cash generation, value generation, the ability to accelerate is I think really a huge opportunity for us over the next decade.
Okay, we'll take the last one before the break. Harry?
Thank y ou very much. It's Harry Sephton from RBC. My first question is on your top-down view of the biosimilars market, and specifically that price discount, which you set at about 65%. Much of your pipeline is in very high-priced oncology products, which are much more expensive than some of the originators of your current biosimilar portfolio. My question is whether that price discount that we've seen historically with some of those products actually holds going forward when you see a product like KEYTRUDA, which in the U.S. is $200,000 a year to treat, whether we still see that level of price decline or actually is meaningfully higher, especially as some of the development costs have come down. My second question is on the Henlius deal. One interesting portion of that was the Halozyme asset. Your portfolio has a number of subcutaneous products.
My question is whether you have good line of sight that the regulatory framework actually allows to use that Henlius enzyme for your subcutaneous products, and whether that could be a meaningful competitive advantage.
Okay. I think probably the second part, you probably answered your own question slightly, Harry. In a sense, maybe I'll get Armin to comment on that. The first, in a sense, we don't price our products on cost. It's basically a function of competition. In the case of pembrolizumab, if there's a lot of competitors, in a sense, the market will set the price based on the level of competition. The 65%, in a sense, is a slightly historical view. Clearly, if there's lower levels of competition, we price it to be attractive to drive access, but also sustainable to us as a business. So in a sense, it's a guide. It can't be a rule, but I think historically, it's around about that sort of figure.
Equally, if we launch a lot more smaller as sets with lower levels of competition, then clearly we wouldn't expect to give away 65%. On a drug like pembrolizumab, I think you probably give more because you're going to see more competition. Oncology assets tend to be more tender-driven through hospital-based post procurement. Retail assets tend to be more fragmented, but it's a guide. It really is more, I guess, a function of competition. I don't know. Armin?
Sure. Thanks, Harry, for the question. Yes, indeed, we have a couple of SC programs in the pipeline, and of course, this enzyme is very important. But I think it's a question also of different countries' regulatory processes, how much you can use certain enzymes from different manufacturers. But of course, we built this in our program on, therefore it adds value to our pipeline, right? Therefore, definitely.
Thank you. Okay.
Can I add something on the pricing? I think one other part which is important is even in the most competitive markets, and if you take adalimumab, it's at the end still not on price only, right? We're winning in these highly competitive markets not only because of pricing, but because of portfolio breadth, trusted brand, access, I think contracting tender capabilities when it comes to Europe and tender markets. This is how we have built the Bio 100 assumption, right? We did an asset-by-asset level analysis to exactly what Richard said. What is the future competition looking like? So we build it really on a very detailed plan and also taking into account what we have seen on the recent, I would say, highly competitive launches. So I feel really confident on how we have built the Bio 100 ambition. Again, price is one of the criterias to win.
Okay, thank you. Just to add, we have some colleagues outside, so Dave and James from the Cambridge site, if you want to have a look at some of our devices, including some of the potential GLP-1 devices, heaven forbid, are outside. When you are grabbing a cup of tea, I know they would be delighted to show you some of our device technology. Just the device. Obviously, it is not free GLP-1s. That is in your goody bag. Alongside the chocolates, which you go figure.
Just to let you know, Richard just massively stole my thunder because I was going to say exactly that.
I do apologize.
We are going to come back and restart at 25 past. Thank you for your time and thanks for listening.
Thanks.
[Break]
W elcome back everyone. I hope you had a go od break. Before we start, I'd like to play a second video that reinforces once again the critical importance of biosimilar access.
[Presentation]
Powerful words from Gustavo. "Access for me doesn't mean when we celebrate the first person gets this life-changing drug. We celebrate when the last person gets this drug." In other words, everybody who needs it has access. Now let's talk about what we at Sandoz will do to get these critical medicines to the people who need them, region by region. You'll see from the following three presentations that we have a very well diversified and balanced geographic footprint. Europe, our champion, represented the majority of our sales last year, followed by International and then North America, both roughly similar in size. In biosimilars alone, we generated over $3 billion in net sales last year. Now about 1/3 of our total net sales. All regions are expected to continue to see strong biosimilar growth over the next decade.
In Europe, our scale and deep local presence gives us a strong market penetration rate and high conversion rates, supporting expected market growth rates of around 15% in biosimilars and 5% in generics. In our international markets, we benefited from disciplined market and pipeline execution, continuously expanding patient access. Here, we anticipate market growth rates of 19% in biosimilars and 4% in generics. And in North America, our broad portfolio and our commercial strength positions us as a partner of choice, particularly with strong market growth prospects of 23% in biosimilars and 11% in generics. You'll now hear more details from our three regional presidents on how we're committed to deliver on the Bio 100 ambition. Representing Europe will be Christophe Delenta. Representing International will be Peter Stenico, and for North America, you'll hear from Keren Haruvi.
Fin ally, Remco will take you through how Bio 100 will translate into attractive and sustainable value creation. I will close the presentation and then we'll move on to the final Q&A, finishing around 5:00 P.M., ready for drinks outside. Okay, so Christophe, over to you.
Thank you, Richard, and good afternoon everyone. It's really my pleasure to be here with you today. My name is Christophe Delenta, I'm the President of Sandoz Europe, and over the next 10-15 minutes, I'd like to walk you through our European business, what makes it special, and how we will contribute to realizing Bio 100. As you have heard previously from Richard, Europe plays a central role within Sandoz, as we represent over half of Sandoz net sales. It is a stable foundation from which we operate in the rest of the world. You can see that in our numbers. We have delivered 21 consecutive quarters of growth in Europe, consistently supporting Sandoz overall performance. That is all thanks to our team wide commitment to delivering on purpose with strong execution supported by distinctive market expertise.
While biosimilars are the key growth engine, our generic business remains the backbone of our European platform, providing scale, resilience, trusted customer relationships, and broad patient access. Today I'd like to begin by sharing how Region Europe has built a world-class commercial engine, leveraging scale and portfolio strength to expand access and capture new opportunities across the markets. Let me start with the big picture. We are Europe's leading biosimilar and generic company with 11% market share, roughly twice the size of our nearest competitor, and we continue to expand that lead year on year. From an external market perspective, we operate in a large, attractive and growing sector. The European biosimilar market alone is worth $18 billion in 2025, and is set to grow by 15% per year over the next decade, creating a significant and sustained opportunity for us.
What differentiates Sandoz Europe is the strength of our commercial platform across 40 countries, and the associated expertise that allows us to succeed equally across all the three market archetypes, so tenders, share of voice, and substitution. This footprint gives us critical reach and proximity to local customers and patients. Indeed, we are not only the overall regional market leader, we hold leading positions in almost all individual European markets. We have strong go-to-market capabilities, leading in first-to-market execution, with strong market access and commercialization excellence. These capabilities allow us to consistently capture new opportunities that translate into purpose-driven impact at scale. Last year, we delivered 455 million treatments to patients across Europe. That's the equivalent to about one treatment for everybody living in the 27 countries of the European Union.
Because that is what we really mean when we talk about world-class commercial engine, that we combine scale, growth, and execution to drive patient access and performance. It's also the reason why Re gion Europe is at the center of our Bio 100 ambition. As the largest Sandoz region, accounting for over half of global sales, our growth is critical to overall Sandoz success. We'll continue to provide the greatest absolute growth and will therefore always be the foundation for success through Bio 100, and also beyond. To repeat, the fundamentals here are highly attractive. We see the European biosimilar and generic market growing from roughly $75 billion in 2023 to over $180 billion by 2035. But what is particularly important is the mix.
Biosimilars are the key growth engine, with a projected market growth of 15% per year, while generics continue to grow steadily at mid-single digits per year. As you can see on the right side of the slide, we look at a market that is expected to grow strongly and become more biologic-driven, which plays directly to our strengths. Growth is expected to be driven by three structural trends. The first one is a larger wave of biologic expiries of up to 115 molecules by 2035. The second one is a deep generic loss of exclusivity pipeline, which will secure our growth in generics. The third one is ongoing biosimilars launches that will lift the biosimilar contribution from 21% in 2025 to around 39% in 2035. Now, turning to our performance over the last few years. This slide shows that we are already well on track.
As you can see, European net sales increased from approximately $5 billion in 2023 to around $6 billion in 2025, representing 6% annual constant currency growth and 9% volume growth, with biosimilar growing 15% per year, more than twice as fast as the overall business. This steady growth, underpinned by a constantly improving product mix, reinforces our leadership position and gives us confidence as we start to execute on Bio 100. Now, digging a little bit deeper, you see here that our biosimilar market share has now reached 28%, driven by both the continuous strong performance of our 13 in-market biosimilars and our proven leadership in biosimilar launches, one of our key competitive advantages. Note that we successfully recovered share after previously growing slightly below the market.
When we launch a biosimilar, regardless of competitive density in the market, we typically achieve a number one or number two position, consistently demonstrating our ability to execute at scale and speed. Thanks to our launch preparedness and capabilities, we are now with nine out of 13 launched biosimilars being number one. Coupled with over 86% tender win rates, we are the number one biosimilar company in Europe. Now with 28% biosimilar market share, demonstrating clear evidence of both commercial strength and excellence in market access. Moreover, we anticipate a wave of five launches in the next 24 months, which will further reinforce our leadership and support continued growth. Let's look into more details at our two most recent launches, ustekinumab and Wyost and Jubbonti. With ustekinumab, success started well before launch. We combined IP strategy, a differentiated formulation, manufacturing readiness, and country-specific execution to achieve first-to-market availability across Europe.
In tender markets such as the U.K., we translated early availability into rapid contract wins. In substitution-based markets, we ensure broad supply and pharmacy confidence from day one. In physician-driven markets, we engage customer early and focus on reliability of supply and execution. The result was a rapid leadership uptake with a biosimilar market share of around 80% for the region. We see the same playbook when it comes to Wyost and Jubbonti. Despite a highly competitive environment, rapid launch preparation enabled day one availability across multiple countries, while our broad European footprint allowed us to execute simultaneously across different market archetypes. This resulted in strong early market position across both osteoporosis and oncology segment, despite intense competition. This proven and repeatable launch model continues to deliver market leading position, and I'm confident that we will continue to perform consistently well as we execute on Bio 100.
Now, this is an important slide, so I will spend a little bit more time on it. In addition to launch excellence, two other key differentiators are what we call our local market intimacy and our local execution model. It is a model that is easy to describe but extremely hard to replicate successfully. It is like the old adage, think global, but act local. What sets us apart is our ability to consistently take what is a major barrier for most of our competitors, the sheer complexity of the European market, and turn it into a competitive advantage. As I explained earlier, we have built commercial platforms based on all three market archetypes, and we win at every level, from tenders with healthcare or government organizations, through share of voice with prescribers, to substitution at pharmacy level.
All of this enabled by our competitive products as well as capabilities built over time through deep stakeholders relationship and best-in-class market access. Importantly, these archetypes continue to evolve. We see increasing elements of pharmacy substitution in markets such as France or Switzerland, while procurement mechanisms in Germany are becoming more structured. We view this development as a continuation of trends we already manage across Europe rather than a fundamental change in the competitive landscape. Because we operate successfully across all three archetypes today, we are well-positioned to adapt our model as the market will continue to evolve. For example, in the U.K., success is often driven by tender execution and supply reliability. In France, market access increasingly depends on the ability to execute at pharmacy level. In Germany, physician engagement remains critical while procurement mechanisms continue to evolve.
In most of the countries, we have an end-to-end approach. We are one of the few companies with the capability to support both prescriber engagement and pharmacy execution, helping ensuring patient access from prescription to dispensing. Our strength comes from being able to win across all three environments rather than trying to apply or adapt a single commercial model to different market frameworks. Finally, on the right-hand side of the slide, you can see the impact of two tangible biosimilar examples. Both pegfilgrastim and adalimumab biosimilars have demonstrated rapid biosimilar uptake, driven double-digit growth, ensured significant healthcare system savings, and help us to deliver on our purpose, pioneering access for patients. We have talked about launch excellence and our strong local affinity. Our scale and heritage are also significant competitive advantages for us in Europe, supporting sustainable growth and leadership in our home markets.
Europe's healthcare system face budget pressure, fragmented market dynamics, and evolving regulation, posing significant commercialization barriers. In this environment, scale, local presence, and end-to-end capabilities really matter. Our strengths extend beyond commercial execution and include IP strategy, regulatory expertise, manufacturing reliability, and supply network execution, allowing us to consistently launch and scale biosimilars across Europe. All of which brings me back to my main point, why Europe is the foundation of our Bio 100 strategy. As Europe is the largest Sandoz region, it is the engine for all of our future growth plans. As I mentioned before, it is the absolute growth that matters because this translates into patient treatment and also into absolute sales. Now to how we will get there. We already operate at significant scale across more than 40 countries, with above-market growth and a clear number one position in both biosimilars and generics.
At the same time, we are building for the future. The targeted expansion from 13 in-market biosimilars globally today to more than 100 by 2040 is supported by an increasingly broad biosimilar pipeline, which has recently expanded to 39 assets and with the potential to increase up to 46. This will be done through our cooperation with Henlius. This does not require a complete transformation or significant expansion of our existing commercial organization. Our existing teams already manage a field force of over 2,300 sales reps. They already engage with the relevant customers and stakeholders daily. As a result, each additional biosimilar can increasingly leverage the same commercial platform, creating attractive operating leverage as the portfolio expands. In Europe, Bio 100 is a highly focused progression from a position of strength and heritage today.
We are already set up for success thanks to our scale, our existing number one position in biosimilars, and our proven ability to execute across all three market archetypes. This is the solid foundation that I believe will allow us to carry on winning as the market develops and grows. Until 2030, the focus will be on expansion, and the next five launches will be an important proof point. Unlike some recent launches where we benefited from first-to-market positions, several upcoming products will enter a more established competitive market. Our focus, therefore, extends beyond launch timing alone and will include leveraging our scale, market access capabilities, customer relationships, and execution excellence to continue gaining leadership positions. In the affordable medicines industry, leadership is defined less by individual products and more by the depth and the breadth and continuity of the portfolio we build.
By 2035, the ambition is clear: to accelerate Sandoz as Europe's leading and most trusted biosimilar and generic company, not just by size, but by consistency of execution, reliability, and value delivered to healthcare systems and obviously to patients. Thank you very much for listening. With that, let me hand over to Peter, who will take you through how we plan to continue our success in the international region.
Thank you, Christophe, and good afternoon, everyone. It's a pleasure being here today. My name is Peter Stenico and I'm the President of Region International, the second of our three world-class commercial engines worldwide. I have spent 25 years with Sandoz, from seeing Omnitrope come to market in 2006, to launching multiple biosimilars across Europe and Germany. This experience has given me a first-hand perspective on how we have built, scaled, and led in that space. Our international markets represent a significant and highly attractive growth opportunity, powered by expanding access, rising demand for affordable medicines, and rapidly evolving healthcare systems around the world. All this is made possible thanks to a highly experienced, passionate, and fantastic team in Region International.
In the next few minutes, I will walk you through how we are scaling our platform, accelerating our growth, and how we intend to further strengthen our leadership in both biosimilars and generics across these markets. Our international business is a focused, scalable platform with a strong history of growth and even stronger growth prospects. In 2025, the biosimilar market in our region was worth $3 billion, and is set to grow by 19% per year in coming years, a clear tailwind for sustained expansion. We are highly selective in how and where we deploy capital, focusing on the most attractive markets, i.e., those where our capabilities best set us up to succeed and make a difference for patients. We have a direct presence in more than 20 countries, and an additional 30 markets are served through a capital light distributor model.
We have a leading position across our core markets, with well-established commercial infrastructure and the proven ability to maximize global scale with highly tailored, localized execution. Our strong position translates into impact at scale, as we reach around 280 million patients annually while helping to improve access and strengthen healthcare systems. All in all, this is a disciplined, high-growth platform combining sharp market focus and strong local execution, backed by a strong global pipeline to drive sustained value creation. International is shifting structurally towards the higher value segment of biosimilars, and we are well positioned to capture that upside at scale. The overall market is expected to grow from around $70 billion in 2023 to more than $140 billion by 2035, with a particular focus on biosimilars, which are expected to grow by 19% per year.
Biosimilars have historically represented a smaller share of overall sales compared with our European markets and the U.S. This has largely reflected structural market dynamics, including varying levels of healthcare system maturity and a slower pace of biosimilar adoption. Today, however, we are seeing a clear inflection point. Healthcare stakeholders are increasingly focused on expanding patient access and improving system sustainability. This dynamic, together with the volume of LOEs over the next decade and the strong growth trajectory of Region International markets, is creating a more favorable environment for biosimilars in international markets, with total biosimilar sales expected to reach $17 billion by 2035. Biosimilar growth in our markets is clearly reflected in our financials, with sales up 27% per year over the past three years, significantly outpacing generics and accounting for 21% of our total sales today.
Crucially, this has translated into consistent commercial performance, and we are number one in biosimilars across the region, giving us both scale and diversification across key molecules and therapy areas. Our biosimilar market share in the region has expanded to around 14%, clearly ahead of competitors, supported by a strong track record in tenders. Over the past five years, we have translated market share gains into clear regional leadership. Interestingly, our market share is growing thanks to both new launches, such as Wyost and Jubbonti, and long-term assets like Omnitrope. On the next slide, let me dive deeper into Omnitrope as an example that highlights how we win consistently and across our markets. Over the past four years, we doubled our market share in Omnitrope across the region from 16%- 32%, gaining significant ground against incumbent competitors.
This success has been driven by a unique combination of local execution and global scale. In our markets, we build preference through targeted physician engagement, comprehensive patient and caregiver support programs, and market-specific pricing strategies tailored to both share of voice and tender markets. At the same time, our global supply network and in-house development capabilities ensure reliable access, device innovation, strong patient adherence. These are clear differentiators in a competitive set of markets. The outcome is a proven scalable model that consistently delivers growth, expands patient access, and sustains our leadership position even after substantial time on the market with a given asset. Our ability to turn regional complexity into true competitive advantage allows us to establish new brands as well as keep growing in long-standing assets such as Omnitrope.
With 12 in-market assets across more than 50 countries, our breadth across markets and products creates a durable leadership position that we continue to build on. We do not apply a one-size-fits-all approach. We are disciplined in where and how we deploy capital, combining scale and flexibility in over 20 markets with a direct presence, complemented by a capital light distributor model across 30 additional countries. We constantly review our footprint to ensure we can compete effectively and make a difference for patients. At the same time, we remain open to innovative partnership models, further enhancing our ability to scale efficiently and with speed. Our global scale is amplified by strong local customer trust and a tailored go-to-market model. I will now take you through some examples in the following slides. We hold number one positions across Australia, Japan, and Brazil, each underpinned by locally tailored execution models.
In Australia, we lead with breadth and first-to-market execution, supported by a strong presence across both retail and hospital channels. Our position as the number one biosimilar player in Australia with 11 molecules commercialized across community and hospital channels gives us deep customer relations, strong distribution capability, and illustrates our proven launch execution. Combined with one of the industry's strongest biosimilar pipelines, Australia is well-positioned to remain an important growth market for Sandoz over the coming decade. Over in Japan, we combine strong customer relationships across a broad spectrum of stakeholders, including prescribers, co-medicals, and pharmacists, with targeted partnerships allowing us to maximize reach in a more complex substitution environment. By 2030, we aim to have over 10 biosimilars on the market in Japan, commercialized jointly with strong local partners to extend our reach.
Now in Brazil, success is driven by a dedicated specialty model and long-term government partnerships that give us access and scale. Sandoz Brazil therefore holds a strong position in the local healthcare sector with a broad portfolio coverage among nationwide retail partners, established relationships with major non-retail specialist channels, and a relevant presence in the public market through public-private technology transfer agreements, tenders, and strategic alliances. On the following page, I'll give a practical example of how Sandoz translate biosimilar scale into tangible patient impact in Brazil, one of our most important Region International markets. In Brazil, we have built a productive development partnership with the Ministry of Health, combining long-term supply with progressive technology transfer to local manufacturing. This model delivers three things. First, access. We bring biologic therapies to patients who would otherwise not be able to afford private care. Second, system strengthening.
We support the development of long-term public healthcare infrastructure and know-how. Third, scalability. This is not a one-off. We have proven that this is a repeatable, sustainable model to expand biosimilar access. You can see the impact clearly with adalimumab. Since the introduction of the PDP, the number of treated patients has increased by approximately 45%, from 58,000- 84,000, with over 25,000 additional patients gaining access. Today, around 30% of public demand is covered by Sandoz. This is exactly how we think about biosimilars, not just as a treatment opportunity, but as a long-term access platform, creating value for patients and healthcare systems. So far, I took you through our track record for our footprint and portfolio. Now, looking into the future, we are at a critical turning point. Over the past 20 years, we have successfully delivered 57 launches across our largest biosimilar markets.
Over the next five years, we expect to double that number. With healthcare systems and regulatory frameworks maturing in our region, complemented by the appropriate internal regulatory strategies and commercial capabilities, we are now well-positioned to accelerate our growth going forward. Our strategies are already taking effect. To give you some examples, last year we launched Jubbonti, first to market in Australia and in Brazil. For the first time in 20 years, we launched a biosimilar in the International Region in the same year as we reached in Europe. Going forward, this will become the norm. This year, we received approval for Tyruko in Mexico in 30 days, and Jubbonti in Egypt in 45 days, leveraging fast track and reliance procedures. These achievements highlight that over the last two decades, we have built the commercial, regulatory, and operational engine required to operate impactfully.
With that foundation firmly in place, today, we are now well-positioned to capture a substantial market opportunity and extend our leadership over the coming years. Now, to bring it all together on one slide, the roadmap to how Sandoz International Region will be a key driver of incremental value with the context of Bio 100 strategy. First, we start today from a position of strength. Across Sandoz International, we are the number one player in biosimilars, and number two when we combine biosimilar and generics. Second, our global scale is amplified by strong local customer trust and a tailored go-to market model. Third, we are highly disciplined in how we prioritize launches across countries, aligning each asset with the most attractive markets to maximize value.
Over the next five years, our in-market portfolio will expand significantly, and more importantly, we are increasingly launching those assets first to market, reinforcing our competitive edge, and increasing our patient impact. Our ambition for 2035 is to be the clear market leader, but it doesn't stop there. We also want to drive higher adoption of biosimilars to further increase patient access and to expand the market. We are looking at roughly doubling International Region's biosimilar penetration in the next 10 years, with key markets like Australia going from 26% today to 51% by 2035, and Japan increasing penetration from 15% today to 51% by 2035. So in closing, what will Sandoz International Region look like in 2035? We expect to have extended market leadership based on a high-growth platform with the capabilities to translate Sandoz global scale into clear local leadership.
The international region is not simply participating in Bio 100 opportunity. We are one of the key engines that will convert that opportunity into sustainable growth, attractive returns, and lasting value for patients and healthcare systems. With that, I will hand over to Keren to walk you through our third regional commercial engine, North America.
Thank you, Peter. Good afternoon, everyone. Every day, millions of patients depend on medicines that can improve and extend their life. Yet for many, access remains a barrier. Expanding access to the medicines they need at a cost they can afford is what drives my team every day. I am Keren Haruvi, President of North America. It is a privilege to be here and a moment I approach with both pride and humility. Over the past several years, the team in North America has remained firmly focused on doing what we said we would do. We delivered consistent growth, advanced our position in the market, and most importantly, built capabilities that are increasingly difficult to replicate in one of the world's most complex healthcare markets. The one message I want you to take away today is that the question is no longer whether we can win.
We have already demonstrated that we can. The question now is how we can replicate that success across the next wave of biosimilars consistently and at scale. North America, the world's most dynamic and competitive healthcare market, stands as a core growth engine for Sandoz. The region represents 22% of our global net sales, serves approximately 140 million patients annually, and Sandoz ranks second in the region across the biosimilar and generic markets. That scale did not happen by accident. It reflects a focused strategy, disciplined execution, and a deeper understanding of what it takes to win in this market. Our success in the region is built on a focused portfolio strategy. Biosimilars drive growth, while generics provide stability, scale, and a strong foundation. The biosimilar market in North America is highly attractive, growing at approximately 23% and representing one of the most significant growth opportunities of the next decade.
In the U.S., approval does not automatically translate into adoption. Access is fragmented across pharmacy benefit managers, payers, providers, and health systems, and uptake is shaped by formulary design, reimbursement dynamics, and provider confidence. To capitalize on this opportunity requires the capabilities to convert access into adoption through market access expertise, trusted customer relationships, and disciplined execution. Approvals create opportunity. Adoption creates value. The biosimilar market is at its inflection point. Biologics today account for a disproportionate share of healthcare spending, yet access remains limited. In the U.S. today, approximately 2% of patients receive biologic medicines, while those treatments account for roughly 50% of total drug spend. At its core, this reflects one of the largest opportunities in healthcare today, expanding access to advanced therapies while improving the sustainability of the healthcare system. We are also seeing encouraging momentum across the broader environment.
Policy makers are increasingly focused on affordability, payers are under growing pressure to manage specialty drug spend, and the U.S. healthcare system already understands the value of competition through decades of generic adoption. But as the U.S. experience shows, access and adoptions are not the same thing. Take HUMIRA, the largest loss of exclusivity in history. Despite multiple biosimilar launches, adoption is taking time. Six months after 10 companies launched, biosimilars had captured just 1% of total adalimumab share. One year later, biosimilars still accounted for less than 20% of total volume across channels. Even into 2025, HUMIRA continued to retain a majority share in key markets. The lesson is clear. Market entry alone does not guarantee adoption. In contrast, markets like Canada demonstrate what is possible when barriers to biosimilar adoptions are removed. When transition policies are aligned, biosimilars adoption has been faster, and penetration has increased significantly.
Our responsibility and opportunity are clear, but success will still depend on execution. That means accelerating adoption through policy engagement, partnerships, customer education, and disciplined commercial execution to ensure biosimilars deliver on their full potential. Because we are not waiting for the market to evolve, we are actively shaping it. Let's turn to our recent performance. Since 2023, total net sales from biosimilars and generics have increased by an average of 7% per year. Biosimilars have been the key growth driver, expanding from $500 million- $800 million, a 36% CAGR. At the same time, our generic business has remained broadly stable at around $1.6 billion, reflecting disciplined portfolio management in a more mature and competitive market. What you see here is the evolution of our portfolio, with biosimilars becoming an increasingly important growth driver in North America, while generics continue to provide scale and resilience.
What is also important to mention is that since 2022, we have successfully stabilized the generic business in the U.S. after multiple years of decline. Our results demonstrate that we are well-positioned for future growth, and our recent performance gives us confidence that we are already making meaningful progress and impact. Strong performance in both the U.S. and Canada now makes Sandoz the third biosimilar player in the region. This reinforces that we are not only competing at scale, but we are also leading with many of the biosimilars we have launched. Across key biosimilars, including adalimumab and denosumab, we have achieved leading positions, demonstrating that we can translate launches into competitive share gains in highly dynamic markets. This reflects our access capabilities, customer relationship, and disciplined execution. But the largest growth opportunity remains in the U.S., and winning there requires more than strong position today.
It requires understanding how decisions are made, how adoption happens, and how to convert market complexity into sustained growth. To understand how we win in the U.S., it's important to recognize that the U.S. is not a single market. It is two access systems operating side by side. On one side is the pharmacy benefit channel, where access is largely controlled by pharmacy benefit managers through formulary decisions that shape patient access and prescription volume. Winning here requires strong contracting, formulary access, and reliable supply at scale. In the medical benefit channel, medicines are administered by physicians or infusion centers, and adoptions happen across a highly fragmented provider landscape with more than 20,000 sites of care. Winning here requires reimbursement confidence, trusted customer relationship, and local execution, along with reliable supply.
What sets Sandoz apart is our ability to compete across both channels. We don't view this complexity as a barrier. We view it as a competitive advantage. We've built the capabilities, relationships, and expertise required to navigate both markets at scale. Let me bring the U.S. model to life through two examples. On the pharmacy benefit side, Hyrimoz, our adalimumab biosimilar, shows how we can expand access at scale in a crowded U.S. market. When traditional access pathways were constrained by originator contracting and formulary dynamics, we took a different approach. By introducing private label, we created an additional access to patients, expanding both reach and market share. This was made possible by strong customer partnerships, reliable supply, and disciplined execution. On the medical benefit side, Wyost and Jubbonti, our denosumab biosimilars, show what it takes to lead in a fragmented market.
Success required expertise in IP, disciplined launch execution, a deep understanding of the provider landscape, reimbursement support, and reliable execution across many sites of care. Together, these capabilities allowed us to move quickly, establish an early leadership position, and demonstrate our ability to win. The question is no longer whether we can win. The question now is how we replicate that success across the next wave of biosimilars consistently and at scale. What makes us successful? It starts with our people, a team with deep market expertise, trusted customer relationships, and the ability to win in one of the world's most complex healthcare markets, all grounded in our purpose of pioneering access for patients. Three capabilities define how we compete. First, a commercial mindset. We see complexity not as a constraint, but as an opportunity to create new pathways to access.
Private label and Sandoz Direct are great examples of how we've turned that mindset into action. Second, agility. In a constantly evolving market, success requires speed, adaptability, and decisiveness. And third, execution, because strategy creates value only when it is delivered consistently, launch after launch, customer by customer, patient by patient. Everything we do is focused on one goal, expanding patient access at scale. Bio 100 is not simply about launching more biosimilars. It's about scaling the model we have already proven to win consistently across the next wave of biosimilars. As our portfolio expands, the capabilities we have built become even more important. We will continue to build on our leadership in the region through scale, supply reliability, disciplined execution, and ongoing policy and regulatory engagement that helps us remove barriers to biosimilar adoption.
At the heart of Bio 100 is a simple goal, turning portfolio breadth into greater patient reach and sustainable growth. We have the capabilities, experience, and focus to become the leading biosimilar company in the market. As we look ahead, we have a clear roadmap to set an industry standard for biosimilars in North America. We've defined strategic ambition at each stage. Today, we are already a leading player. We have delivered consistent pipeline execution, pioneered new models to expand access, and built the customer relationships and local market expertise required to win. By 2030, our ambition is to become the leader in biosimilars. That means advancing a leading pipeline, scaling a proven operating model, and being the partner of choice.
By 2035, our ambition is to be the market leader in the region with the largest biosimilar portfolio, strong customer partnerships, and North America serving as a strategic growth engine for Sandoz. What matters most is the patients we reach. Every few seconds, a new patient starts on a Sandoz medicine. That is the impact behind everything I shared today. Thank you, and I will hand over to Remco.
Thank you, Keren, and hello, everyone. It is great to have you with us today. It is my pleasure to walk you through how Sandoz will transform these ambitious plans we have just heard into reality. My colleagues have already highlighted the progress we have made since we became independent. I want to highlight what this means for us from a financial perspective and why it matters as we prepare to deliver on our next chapter in Bio 100. As you can see on this slide, we have had strong sales growth and, through sustained operating leverage, we expanded our core EBITDA margin and driven strong levels of cash. The return on invested capital has increased above our expectations, and we have driven material core earnings per share growth, at the same time as strengthening our balance sheet.
To summarize, we have been disciplined in our execution and absolutely laser-focused on our strategy, which has translated directly into clear value for Sandoz and therefore the patients we serve. Now, let me outline what this looks like at the business and regional level. From a business perspective, I would like to share with you how we performed across both our biosimilar and generic businesses. Between 2023 and 2025, net sales increased on average by 7%. Biosimilars were the key driver, with annual growth of 21%. Importantly, we reached our 2028 ambition of 30% of net sales coming from biosimilars three years earlier than planned in 2025. That achievement underlines both the market demand and our successful execution, including such launches as Hyrimoz, Pyzchiva, and Vyepti. With a market share of 19%, we remain a clear global leader in biosimilars.
At the same time, our generic business has continued to be strong and resilient, growing in line with the market at around 2%, and providing a unique foundation for our biosimilar growth. With a market share of 4%, we are one of the top two generic companies globally. Overall, we are combining high growth biosimilars with a strong generic business, driving both the scale and the quality of our growth. As you have heard from our regional presidents, our geographic track record also underlines the strength of our biosimilar and generic portfolio. With the former as the key engine of growth across every geography. As you have heard from Christophe, Europe delivers the majority of our sales and remains our most established market. Growing from $5 billion in 2023 to around $6 billion last year.
That translated into a 6% CAGR overall, with 15% for biosimilars, again, for the period 2023 through 2025, reflecting continued market expansion and our ability to grow our leadership position. In International, an overall annual average growth of 8% and 27% growth in biosimilars for the period 2023 through 2025 also shows the incredible potential for this region with Bio 100. North America is where we see the most pronounced momentum, with a 36% biosimilar CAGR driving 7% overall growth for the period 2023 through 2025. This reflects the strength of our execution in both the U.S. and Canada, with strong recent launches, increasing physician adoption, and ultimately improved access for patients. Now turning to the future and the impact we believe we will have at Bio 100. Today, our pipeline covers around 50% of biologic LOEs by value.
With Bio 100, we intend to increase that coverage to around 80%. This is a real change in scale, meaningfully benefiting patients and healthcare systems all around the world, and positioning us to fully capture the upcoming wave of biologic LOEs. In the next few years, a significant part of these new launches will be enabled through business development and licensing, allowing us to move quickly and secure attractive exits. Over time, however, our internal pipeline will become the main contributor, reflecting the strength we have built in development capabilities and platform expertise with targeted benchmark cost levels for development and manufacturing. Now I want to focus on how we will translate this momentum into long-term growth. As Richard said earlier, we expect to more than double our net sales by 2035 versus last year.
By that time, biosimilars would represent a majority of our net sales. Looking further ahead, we are targeting to increase our biosimilar global market share from around 9% currently to around 20%-40%. At the same time, our generic business will remain very important and cash generative, and we expect to grow in line with generic markets. What you see here is the transformation of our business from a generic-led portfolio to a biosimilar-led growth company. In addition, we also expect to see a step-change opportunity for GLP-1s by 2035, which, as Rebecca said earlier, is too early to quantify now. To be clear, this long-term GLP-1 ambition is over and above the doubling of net sales by 2035 through Bio 100. Now, let me break this down a little bit further by first looking at the midterm outlook.
I am delighted that we are today confirming an unchanged 2028 outlook. This includes the expectation for net sales to grow by a mid-single-digit percentage at constant currencies through 2028, with a core EBITDA margin in the range of 24%-26% by that time. As of today, we are also extending the lens beyond 2028. With our new midterm outlook, we expect net sales growth to accelerate to a mid-to high single-digit CAGR from 2025 through 2030. This will be back-end loaded. The core EBITDA margin is also expected to expand further to within a range of 25%-27% by 2030. To be clear, the new 2030 midterm outlook includes GLP-1s. Our dividend policy will remain unchanged, with dividends expected to increase to a range of 30%-40% of core net income from 27% in 2025.
Strong capital discipline will continue, with investments in Bio 100 expected to pay off, not only in terms of higher growth, but also in terms of increased core ROIC, which is targeted to be in the range of 16%-18% by 2030, versus 14.5% last year. Upfront funding is set to be followed by accelerated growth. Bio 100 is about deliberately investing an additional $2 billion- $2.5 billion over the coming five years. Investing in our pipeline, portfolio capabilities, and manufacturing assets to unlock even more value accretive growth. But 2030 is not the endpoint. In fact, this is when it will really get interesting. We are targeting to more than double our 2025 net sales by 2035, plus GLP-1s related sales that are expected to be material, but again, are too early to quantify now.
That means double-digit growth in the 2030s, which will be accompanied by targeted core EBITDA margin of at least 30% and targeted core ROIC of at least 20%. We believe that this is an attractive, high growth, high quality earnings profile, which we see as a real opportunity for Sandoz and our shareholders. For those of you who are thinking, "This is ambitious, but how realistic is it?" Let me point out that between now and 2030, we have multiple well-identified levers that support increase in core EBITDA margin. First, price erosion is expected at a mid-single digit percentage, reflecting the increasing size of the biosimilar launches over the coming years. But more than offsetting this, we see strong tailwinds from the mix of sales. Second, we expect to deliver further operational improvements and procurement savings each year, which should result in efficiency gains and reduced cost.
Third, with our top line increasing significantly, operating leverage is expected to further improve as we absorb operational expenses more efficiently. We expect these SG&A costs to decline as a percentage of sales, reinforcing the margin trajectory. Finally, we are making targeted, disciplined R&D investments while benefiting from regulatory streamlining. Some of these investments will continue to be capitalized in line with our existing accounting policy, but it means that R&D as a percentage of sales is expected to remain broadly in line with current levels.
The 2030s is where the real step change cost of goods sold opportunity begins, reflecting in-house vertical integration of biosimilar development and manufacturing, as Armin outlined earlier. As of the 2030, we will have biosimilar development and manufacturing operating at scale in-house, strengthening by the multiple new biosimilar development, drug substance, and fill finish sites in Slovenia and by the Just - Evotec Biologics acquisition.
This means greater control, faster execution, and importantly, capturing more of the value chain in-house. With these sites, we will be driving ongoing process optimization, continually improving yields with proportionally fewer third-party additional costs. Finally, scale. As we grow, we intend to unlock significant capacity advantages, allowing us to produce more efficiently and support future pipeline expansion at limited incremental cost. So we intend to structurally redefine our cost base and strengthen our long-term competitive advantage. That's the real impact of Bio 100 from 2030. Now turning to one-off cost. As you can see, this peaked in 2024 at around $700 million, and expected to decline to around $300 million this year. This is expected to reduce to around $200 million in 2027 and around $100 million in each of the years thereafter.
This reflects the final phase of a transformation and separation programs, the completion of the simplification and transformation of our supply network and organizational structure, and the implementation of new state-of-the-art IT systems. Next year, we still expect around $100 million of IT separation costs from our former parent company and around $100 million for transformation programs, which we expect to continue around this level in the years thereafter. As such, we expect only limited one-off costs going forward. For completeness, this excludes legacy litigation costs and software implementation cost accounting impact. Now turning to CapEx. As you have heard from Armin, we have already significant investments underway in Slovenia. You see that reflected in our CapEx expectation of around $1.1 billion for this year.
We expect similar annual U.S. dollar capital investments for each of the years over the midterm, which means that CapEx should decline as a ratio to net sales from this year's 9%. With Bio 100, we will see better asset use, higher throughput, and more efficient tech transfers, allowing us to absorb growing volumes within our existing footprint. In terms of free cash flow, as I mentioned earlier, versus our prior plan, we intend to spend around $2 billion-$2.5 billion more, mostly in R&D, but also partly on further manufacturing expansion. This includes the benefit from regulatory streamlining. At the same time, we intend to continue our very disciplined working capital management. Therefore, free cash flow is expected to grow by around a further 50% by 2030 versus last year.
Consequently, a further reduction in the ratio of net debt to core EBITDA is expected by 2030. Overall, this underpins a clear plan of investments in Bio 100 while ensuring growing cash generation and continued deleveraging. This slide brings together the three pillars that underpin our financial strategy. Disciplined capital allocation, improving quality returns, core ROIC, and financial resilience. Our Bio 100 priority for capital is clear. We are going to reinvest into our biosimilar business for accelerated growth. At the same time, we remain selective on business development, focusing on value-accretive opportunity. All of this will be complemented by a progressive dividend policy. What we will do is anchored in maximizing capital efficiency. We will be focused on driving the further step-up in core ROIC over the midterm, supported by Bio 100 and continued margin expansion, while maintaining strict discipline on working capital.
Finally, financial resilience will remain key, and our track record shows that we do this well. Our model is built on sustained cash generation, a clear commitment to maintaining an investment-grade rating, and a strong balance sheet that gives us the flexibility to invest and grow. Moving on, I want to take you through more details of our plans to increase core ROIC as set out on the prior slide. We have a very deliberate focus on quality growth and investment discipline. On growth and profitability, we are accelerating our shift towards biosimilars, where we see structurally higher returns. At the same time, vertical integration and biosimilars will deliver significant long-term benefits, and we expect further operating leverage as OpEx costs grow slower than net sales. On invested capital, we are focusing on deploying capital with discipline.
Investments into the biosimilar pipeline will benefit from regulatory streamlining, while vertical integration will further enhance efficiently. Importantly, our generic business will continue to act as a cash engine. Therefore, we are targeting to improve the speed and the quality of growth through a better business mix and drive higher margins, disciplined capital deployment, and resilient cash management, resulting in a structural step-up in core ROIC. The strong growth and the higher core ROIC combined are intended to deliver excellent long-term value creation. Bringing this all together, what you see is a company with proven leadership and targeting clear acceleration ahead. Since the spin, we have performed consistently well, driven by our strong and sustained growth in biosimilars across every region.
At the same time, I hope you see that we're providing clear visibility, confirming our 2028 outlook while providing a new and exciting midterm outlook for 2030, as well as significant ambitions for 2035 and beyond. With Bio 100, we will be doubling down by targeting a portfolio of more than 100 biosimilars supported by increased absolute R&D investments and opportunities enabled by regulatory streamlining, and we are optimizing our supply network. With all of this, we expect to drive enhanced top-line growth, profitability, and ROIC. Now, before I hand back to Richard to close us out, I have to say that as a CFO, it's incredibly rare in a career to be in this position, presenting to you with this company with a proven track record at this moment in time, when we have an unprecedented commercial opportunity ahead of us.
If we get this right, correction, when we get this right, it will mean we can make affordable healthcare a reality for countless patients. This is a moment which is not lost on me or any of us. Richard, over to you.
Thank you, Remco. You'll be glad to know I'll just take a couple more minutes to get us over the finish line. This could not be a better time for Bio 100 and patient access. Firstly, there is a huge patient access need, as biosimilars and generics represent the vast majority of prescriptions worldwide, but only account for around 30% of their total cost. These medicines are affordable and a core healthcare provision, supporting scalable adoption. Secondly, there's an exceptional market opening. We are entering an unprecedented wave of loss of exclusivity for biologics, with over $300 billion up to 2040, creating a once-in-a-generation opportunity. Thirdly, development and manufacturing. Regulatory streamline is now a significant tailwind for Sandoz, and is now combined with a first-rate supply chain capabilities with capacity.
Together, this creates a uniquely attractive environment and timing that positions Sandoz perfectly to scale growth while expanding patient access faster than ever before. In case I wasn't already clear, Bio 100 is not just an ambition, it is a clear strategic roadmap. We start from a position of strength today with a deep biosimilar portfolio and a proven global platform. From here on in, it's about disciplined execution, building our launch engine to get around 30 biosimilars in the portfolio by 2030. Then scaling investment as we plan to expand by around 70 by 2035, and then over 100 by 2040. I said at the beginning that there are only really three messages that I should leave you with today: purpose, ambition, and delivery. Our purpose remains the same.
We are remaining driven by our commitment to expand access to high quality, affordable medicines and drive meaningful benefit for more than a billion patients. We have a clear ambition to have more than 100 biosimilars in market by 2040. Along the way, we have a comprehensive delivery roadmap on how at least to double our net sales by 2035 versus last year and deliver a core EBITDA margin of above 30%. Finally, I would like to take this opportunity to acknowledge our 23,000 colleagues who have been and will be the ones that bring this opportunity to life. All of us are united with a clear purpose, pioneering access for patients, because by pioneering access, we expand it. As Gilbert said right at the beginning, this is anchored in strong values, collaboration, ambition, accountability, and openness.
Together, this gives us a highly aligned, motivated organization ready to deliver on our Bio 100 targets. We're making the most of this upcoming golden decade for our colleagues and our shareholders, and most of all, the billions of people like Cheryl and Gustavo, who have the basic right to affordable healthcare. Thank you. Now, I would be happy to take your questions.
Okay, same format as before. Wow, look at the hands up already. That is amazing in terms of the hands up race.
I'm going to start with Harry because I'm conscious. Harry, did we answer your question? Because I think that was
Harry, over to you.
Sorry, Harry.
Thank you very much. Harry Sephton from RBC. It's actually going back to the CapEx point, which I think Thibault raised earlier. You previously talked about CapEx spend really peaking in 2026. You're now saying that that absolute level of CapEx is going to carry forward. That has quite a meaningful impact on free cash flow going forward. Just want to challenge what's changed. That means you've got a higher capital intensity going forward.
Harry, thank you for the question. As I said, Bio 100 requires to additionally invest about $2 billion-$2.5 billion. That is partly in R&D and it is partly related to CapEx. The manufacturing will have to ramp up as you go to the 80% LOEs. The CapEx also include part of the development costs, which are capitalized, so that is also included because that is also more than we originally had foreseen. As a percentage, it comes down. As an absolute amount, it will stay roughly flat rather than go slightly down.
James.
Thanks. James Gordon from Barclays. One question was on the top line. If I look at the slides, you have given a projection out to 2030 for what the group is going to do, which is mid to high single digit, and you have also said what proportion is going to be biosimilars. But if I back that out, it looks like then that generics would be growing at about 4% versus about 2%, which is what you have done the last couple of years. I know that the IQVIA projections, though, on there look like it is faster growth, like about 5% growth for the generics market.
But I think that is gross without the pricing headwind, which you would face. Is that right, that the guidance is assuming you are going to do better in generics now because you are going to take more share or the market is going to change, or am I misinterpreting that?
That is the first question, please. So what to put in our models for the generics growth rate for the next few years. The other one was on margins. On gross margin, I think you previously said biosimilars were something like 20 percentage points higher gross margin, and then there is a shift of selling more biosimilars, and then you are going to get better at making biosimilars. So there should be quite a big uplift there. But if I look at slide 96, it looks like much of the benefit there is swallowed up by pricing headwinds. Is that the right interpretation, that there is not much gross margin benefit from that sort of mix shift to 2030, and it is really at 2030 to 2035, we get that benefit once the Slovenia site is going?
Remco, do you want to have a go?
Yeah, of course. There is one element on the growth, as you asked, correct? There is one, the market growth, that is shown in, and underlying is what we expect of our own growth. We expect biosimilar to grow in the double digits. There is no change from what we had before. It might even accelerate a little bit. Gx, the market numbers you see is including GLP-1, but these are estimates from the market expectation. Correct? We would expect still low single digit growth of the Gx market excluding GLP-1, and the GLP-1s will come on top of. We have guided for 2030 from mid to high single digit, including GLP-1. I would say that without GLP-1, we would also probably sit in the mid to high single digit kind of growth range. The biosimilar is really picking up along the way.
The range of biosimilar being in gross margin higher than the average of the group that is higher than generics, it is on average still correct. The only thing we have to still keep in mind, that it is very different if it is a partnered biosimilar asset or it is an own development asset. In the shorter years when we have partnered assets, we share the cost, but we also share the profit with the other party. Then net gross margin is not to the same level when it is fully in-house. In terms of the EBITDA improvement, yes, price erosion is not low single digit, mid-single digit, but we have also seen, and we see that the first half of this year, biosimilar grows really a lot and you launch new product. Of course, in the first year, the price erosion significantly.
That is not so much a margin topic, it is just an inherent implication of launching a lot of biosimilars. Procurement savings, we still expect to continue, but not completely offset the 5%. The mix impact will really remain significant and therefore net-net, we expect the benefit on the gross margin, and we expect that over the coming years through 2030. Of course, in 2030, when the vertical integration comes in and we do a lot in-house, we expect significant benefit on our cost prices. Then in principle, the gross margin should go more up, but then depends as well, what the price erosion is in the thirties, and that is too early to say. However, net-net, we still expect to come to at least the 30% by 2035. How much is then the equation of how the price erosion during that time comes out and the competitive environment.
Also bear in mind, we will be tech transferring a number of the assets that we currently take from our parent into our own network with a corresponding improvement in COGS over time. But that does not really kick in until the other side of 2030.
The last part is also what the regional presidents clearly indicated, the infrastructure we have on marketing and sales, but also general administrative cost, they should benefit, in percentage vis-à-vis the top line very clearly. That benefit comes then on top of the gross margin and both should drive the EBITDA margin up over time. It's just a mathematical equation.
Great. Thanks, James. I'm going to take a question from the webcast, if that's okay. This is from Victor at BNP Paribas. Hi, Victor. It's a U.S. question. You recently said that you wouldn't rule out investing in additional capacity outside Europe in response to the potential threat of U.S. tariffs on generics. With the new investment in Slovenia announced this morning, should we take this as a sign that you remain fully committed to expanding your European manufacturing footprint or are investments outside Europe still on the table?
I guess the simple answer, I'll let Keren comment about the U.S. We have a clear roadmap in Europe. The U.S. is clearly, as a single market, the single most important growth market, and the industry is the largest biosimilar market in the world. Clearly, it's a significant opportunity. I'll let Keren comment about the conversation we're having. We clearly have good dialogues with the U.S. I think if you take a step back, generics and biosimilars account for what? 90% of all the drugs dispensed in the U.S. for about 11% of the cost. The vast majority are supplied overseas. I think in terms of sustainability of healthcare, it's a critical part, and we're aligned with the administration in terms of how we think about it. But Keren?
Absolutely aligned with the administration. I think we strongly believe that generics and biosimilars should be exempted from tariff. So far as an industry, we did a very good job. We would not manufacture in the U.S. just as an answer for tariff, but we are absolutely thinking, as Richard said, as critical market, that we will continue to have the conversation and find a path. It needs to be sustainable and make sense, so we'll continue to work on that, but absolutely committed to this market.
Okay. On the left-hand side, Casey.
Hi, Beatrice Fairbairn with Berenberg. Thank you for taking my questions. You've talked about moving from a reliance on external CMO supply to about 60% in-house manufacturing. What do you view as the key risks for this, and how conservative are you being about the ramp-up assumptions for this internal capacity? If I may, would you be able to give us a bit more of a quantification about how much of your margin expansion target is driven by this ramp-up? Thank you.
I think that's a great question for Armin. Can perhaps give Armin a microphone?
Yeah, thank you for the question. Currently, we are ramping up the capacity on our various sites. I don't know where I should look at, actually.
Here.
Maybe I stand up.
Stand up so we can hear you.
We are currently ramping up. We are building up. We are starting tech transfer. Basically, it is a purely execution risk, what we say. Now we have experience in tech transferring, so we are doing it. Actually, we start with products to be tech transfer in-house, which we see there is a lower risk of failure because we know the molecule very well. It maybe not the most complex molecule, so we are doing it step by step. It is what we see. Basically, it is rigorous execution, it is performance management, getting a good knowledge transfer from our contract manufacturer where we tech transfer in.
But it is normal business, actually, and we are in the process of starting it as we speak now on the drug substance side, continued with the drug product side. The second part I did not get actually, acoustically, sorry. What the question. What is the second part of the question?
Yeah.
It was about margin expansion.
Well, that's a question of from whom we tech transfer, basically, and what technology we tech transfer. Let's say on an average contract manufacturer basis, you can have on the drug product side, on the finished side, 30%-50% benefit of the internal cost. Of course, if you be on the drug sub, it can be it varies. But actually for us, important that we can leverage our scale, right? Because the tech transfer alone doesn't save the cost challenge, basically. It's about how we utilize our various platforms in the most efficient way, and this basically drives the cost down. Thank you.
Okay. Charlie at the back. Casey, sorry, it's on you. Sorry, Charlie at the back.
Charlie Haywood, Bank of America. Two questions on sales growth. The first one is to double your sales growth from 2025 to 2035 implies a roughly 7% sales CAGR. If we take the midpoint of your mid to high 2025- 2030 sales guide, that would imply maybe 7%-8% sales CAGR in the 2030 period. You guide to double-digit sales growth beyond 2030. Does that suggest 2025 to 2030 sales growth closer to the lower end of that, so closer to mid, or does that actually imply upside to the out year targets, i.e. doubling a bit more upside there? Then second one, just on sales phasing. So 2025- 2030 mid, high single digits. I think, this year you're looking at mid high. I think the implied 2027, 2028 commentary is mid.
Then to get to your mid high, you are looking at maybe high for 2029 and 2030. On the moving parts to get to high single digits, is that upside to 2029 and 2030, or could we actually see upside to 2027 and 2028? Thank you.
I think I understood the question. I am going to let Remco try and answer that one. I mean, we cannot win. We have given directional guidance to 2035, and you are asking for levels of accuracy, but I think—
No. Thank you, Charlie. I think you did the math very correctly. We have guided at least 2x by 2035, right? We said mid to high through 2030. We expect double digit through to 2035, and that would be at least doubling. So you can draw your own conclusions from this, then GLP-1 will come on top of. If you will do the math also based on the molecules and the launches and the different market share, you will see that you will come in a similar equation there. We have guided mid to high. I have said as well that it is more back-loaded. Correct? So it also gives already the answer your question. It is too early to say on 2027, 2028. Correct? We will give the guidance at the beginning of next year. How that will pan out. Is it mid?
Is it mid to high? We will have to see what coming years. But for the moment, it is indeed, we say back-loaded. But thank you for the very good quick math you did. But we are aligned.
Okay. I'm just going to take one from the webcast. You might have to bear with me because it's Nicolas from Kepler, and I think he's paid by the word, because this is quite long. I'll try to paraphrase as much as I can. Hi, Nicolas, again. This was his second question we didn't get to in the first half. The first question is about manufacturing upside. I believe that in one of the slides you mentioned you'd be able to have a significant unit cost reduction from 2030. Any way you can quantify that if we were to compare it to some of your previous comments on biosimilar profitability? If I could squeeze a last one, probably for Christophe. I'd be curious to know if you have perceived any changes in the discussion with the different administrations in Europe since all the MFN noise started.
Is there any risk that E.U. countries would potentially further reduce the price of off-patent drugs, mostly biosimilars, to free some additional budget for innovative drugs? Also, do you see any upside in the mid to long-term potential from your full E.U. production footprint when it comes to winning in Europe? More from a European sovereignty angle, again, as the U.S. is trying to pull the industry there. Sorry for the question length.
Christophe, do you want to have a go at that first part? I think we've partly answered some of that on the manufacturing side. Clearly, look, it depends also, as we define our own pipeline, sell lines, all of those things. There's a lot of opportunities to expand margins. I think Armin covered the bulk of that question. So, Europe?
The discussion on the MFN and the prices is more about how can we accelerate the penetrations of the biosimilar to generate the savings that we are generating today. You think about generating savings, it's around $10 billion. Today, annually, from the biosimilars we are launching. This will be what will be used to obviously accept the launch and the prices for the innovators and the innovative products. We do not see prices declining beyond what we have observed in the last five years. No accelerating trend here. Nonetheless, what we see is a shift in archetypes in some of the countries, as I said before. When it comes to protecting the European manufacturing, tomorrow we'll have the Public Procurement Act being disclosed.
We believe that most of what we have advocating for in the Critical Medicines Act, meaning favoring European production, in the tenders, for example, having a single slot from Europeans productions and the medicines will be there. This is moving on the right direction, and it will help not only to preserve our European autonomy for the biosimilars, but I am thinking also for our anti-infective plant in Kundl. Moving forward, a definite advantage for us as we will produce in Europe most of our biosimilars.
And perhaps to build on that, interestingly, MFN, you see a number of originators questioning whether they are going to launch assets in Europe. Actually, there is a sort of philosophical opportunity for us, I think, in the mid to long term, that we need to get our head around a little bit. Price in most European markets is not a function of the regulator, it is a function of competition. That is nothing different to today. So if there is 10 competitors, you are competing in a very different way to if there is no competitors.
So I think in the majority of European markets, and let us be clear, as we bring Bio 100, that is where the European governments can deliver savings. That is a huge opportunity to bring massive savings and access to patients across Europe. Quite honestly, trying to scrape a little bit more out of the 30% that is doing it. The money on the table is really sitting with the originators and their patent cliff.
Shyam up the front. Casey?
Thank you. Shyam Kotadia from Goldman Sachs. I had a question on going back to the SC point. You've got a fair few SC biosimilars in your pipeline with KEYTRUDA SC and you've also got other formulations like Eylea HD. I just wanted to check, once that compound patent goes off, is that an appropriate time for you to go after it, or would you need to wait for the actual formulation patents for KEYTRUDA SC or Eylea HD to go off end of 2039, early 2040s? That's the first question. How does that differ in Europe, U.S.?
The second one, I think you've touched on it a bit anyway, but before I know you mentioned being a European-focused company and launching in the U.S. was like an optionality and opportunity. Now with Bio 100 and the regulatory streamlining, are you planning to launch all your pipeline biosimilars in both territories, or will you be selective still in the U.S.? Thank you.
Yeah, I guess I'll comment on the E.U. focus first. Let's be clear, my point was more about, we talked about it, Etanercept embol. Of course, we're going to launch it in the U.S., but there's always that degree of uncertainty around the U.S. because you've got to go to court, and there's always a question mark whenever you go to court. Of course, the vast majority of Bio 100 we will launch in the U.S., either through the strategic partnerships, you've seen the deal terms there, or clearly through our own development. Absolutely, but I think it's a subtle shift to say, look, we've got a very clear runway when we launch in Europe, and clearly the U.S. becomes the opportunity. I think historically, everyone sort of over-indexed the U.S. It's just that uncertainty around the patent framework.
We tend not to disclose too much about what we're doing in terms of patent because I don't want to make— and I think we disclose a lot in terms of our pipeline, but there is a limit. So that's probably the limit about where we would disclose in terms of what we intend to do with things like SC and the patent strategy around that. I'm getting a thumbs up from Ingrid, so clearly I've said the right thing.
Yeah, I think we'll go maybe a couple of minutes past 5:00 P.M. because there's still plenty of hands going up. James down the front.
Hi, thanks for taking my questions. James Vane-Tempest from Jefferies. First, I wanted to come back to the double-digit growth from 2030, which is an acceleration. Just wondering how much of that can be delivered from visibility today versus further new pipeline and business development. As new deals are announced, you essentially know what that means versus your guidance. Second question is, clearly you're expecting to maintain the level of investments if aiming for more than 100 biosimilars in your portfolio by 2040. So how should we think about the phasing to more than 30% margins over time in 2035, given a 25%-27% range in 2030, and is that sustainable?
My final question is, it's great to have a longer-term vision, but I was interested in, I guess, your framework and philosophy to regulatory changes, just given how much of that can happen unexpectedly given the long-term framework you're given. I guess on the positive side, in Europe there's the Critical Medicines Act, which clearly could be beneficial if that expands. I know it's mainly directed at anti-infectives at the moment, but it could be expanded into other areas. But on the flip side, you've got the Urban Wastewater Treatment Directive. So how are you thinking about sort of managing both the pros and cons of the regulatory framework in your guidance? Thank you.
Okay. Perhaps if I take the third, Remco can take the phasing, and I'm going to pass to Rebecca for the growth drivers beyond 2030. So have we planned in the growth drivers? I'll give you a moment to think about it. Yeah, I guess just a couple on, it's not really the, it's the regulator, but it's actually the patent framework that drives it, not the regulatory framework. So I don't see clearly as the regulators think about that. But also bear in mind the next wave of things like ADCs, bispecifics, trispecifics, we're having very constructive conversations with the regulators in that space.
Again, I think that's what driving it. I'll perhaps get Christophe to comment on urban wastewater, because actually I think there's as much an opportunity as a risk there, which is interesting. And then I'll pass to Remco. Christophe, do you want to talk about urban wastewater?
About the urban wastewater, if we think about the cost, today it is extremely hard to understand exactly what will be the cost for pharmaceutical industry and the cosmetics. If you have seen the news from last Thursday, on 3rd of September, the general advocate has issued her opinion against the EPR scheme, which is the extended producer responsibility, which we are allocating the quaternary treatment cost to cosmetics and pharmaceutical industry. Today we are in a good position, and we are waiting to see whether the European Court of Justice will follow the advocate general and annul the EPR scheme.
Also, it is against the whole industry. It is not aimed at Sandoz. Also bear in mind, as Remco has got, in a sense, into the 2030s, we become predominantly a biologics company, which tends to be more value-driven rather than volume-driven. I think at the moment, philosophically, it is a volume tax. It is not a value tax. As we become more and more of a value portfolio company, that exposure also shifts. But I think to be fair, it is one thing that is a level playing field across the whole industry. But clearly we are working hard to help regulators and governments understand the implications of that.
We have never been in such better position, right? Since it started.
Remco?
I go first?
Sure you want to.
You go first.
Yeah. Perhaps first on the growth drivers, then Rebecca will add. Our growth is always our existing business plus the new launches. You can see also in 2029, 2030, there are significant launches which are coming in, and of course, they contribute to the double-digit growth, and in the years thereafter. I am sure Rebecca can be a little bit more specific. With regard to the margin improvement, we like to be very boringly consistent in a sense that SG&A as a percentage of sales every year should benefit the margin. As well on the gross margin, we have every year a job to do with the mix improvement and the procurement savings and the prices to make also some improvement there. I do not see it is a significant step up in one way or another.
Of course, you can argue that in the 2030s, particularly on the manufacturing, we will get some benefit. But also there, when we ramp up the sites, this benefit, when you come to a full leverage of the site and of sites, that will also take a little bit of time. When we start ramping up in 2029, it probably has some ramp across in 2029 and 2030, and we are not full in 2031 that will come in. But also then with scale, that will further multiply. That is where we are quite confident that the 25%-27% over a five-year period should at least hit 30% by 2035.
Rebecca?
Yeah, maybe adding, in terms of 2030- 2035, you saw the number.
Can you stand here? You can't see. Yeah, but I can. We can't see you. We can hear you.
Stand up. No. Listen, we go from 30 products in 2030 to 70, which means we're going to add 40 launches. Of course, not all the launches start by 2030, so you have a phasing up of those launches. We're seeing a huge LOE between 2030 and 2035 with, you know, the examples, KEYTRUDA and some of the bigger oncology launches, but also in immunology, and we will continuously look for partnered assets across this period. Fundamentally, the dynamics we monitor currently, right, and consistently, in a sense, if we would see that competitive landscape is changing, this would, of course, be in favor of what we currently think the growth rate and the ambition is going to be. We think conservatively in terms of pricing. So we believe we have strong plan in place, and we might see upsides depending on competitive landscape.
Thank you.
We'll take a few more, I think, before we close out. So, just one from the webcast. Joris has come back with, and this is definitely for you, Remco. You indicated that delivering the Bio 100 ambition requires additional investments in the range of $2 billion-$2.5 billion. Could you help us think about the expected timing and composition of that spend? Specifically, if I can say it, how should we think about the split between CapEx versus OpEx?
Remco.
Of course, we will not spend $2 billion-$2.5 billion in one single year. You can be assured of that. That will be equally spread over the coming five years. Most of that $2 billion-$2.5 billion, as I said before, is to be spent in development. About, let's say two-thirds of that and one-third is going in manufacturing. The manufacturing part clearly gets capitalized. On the development in the overall portfolio, there's also a part which gets capitalized, but that you have to see in the context that bio as part of the total R&D goes up, so relatively also our capitalization goes a bit up. You can't only link that to the $2 billion-$2.5 billion.
All right. Casey, I'm struggling to see at the top, so do you want to take a pic at the top?
Sure.
There you go. Simon.
Thanks so much. Simon Baker from Rothschild & Co Redburn. Two quick ones. I am conscious of the time. Can you just give us an update on where we are with interchangeability in the U.S.? How important is that to unlocking biosimilar penetration within the U.S., and how successful has it been ex-U.S. where it is more established? Then a quick one for Remco. Obviously, the COGS is sensitive to the proportion of group revenues which are biosimilars. But how sensitive is COGS to the mix within biosimilars beyond ownership? Are there any meaningful differences we should think about between therapeutic areas, between size? Are these smaller opportunities, lower gross margin, higher gross margin, about the same? Any sort of color you can give on the sensitivity of biosimilars themselves to the gross margin. Thanks so much.
Okay. Keren, do you want to have a go at something we have not talked about for a while, actually, interchangeability?
Indeed. I would say, generally speaking, that it is getting less and less important. I think the FDA recognized that it should not be a decision-maker for the physicians, and it is not part of the label anymore. Congress is working to change the legislation around it, so there is a lot of support. It did not happen yet, but we are optimistic. I would say from a commercial perspective, there are still people that believe that interchangeability is something different than what it is. The reality is just allowing the pharmacist to change the product, if the prescription does not say the specific biosimilar. So in medical benefit, we do not see an impact, and we never saw an impact.
I would say in pharmacy benefit, the perception is that there is a benefit, but we were very successful with adalimumab, and we got our interchangeability a year and a half after we have been in the market. So I would say it is something that people consider becoming less and less important. Honestly, the other attributes of the product, the patient service and everything around the product are much more critical other than interchangeable.
I would say rest of world irrelevant. Broader. I mean, it's not a conversation that we have anymore. Remco, have a stab at it.
Yeah. I approach it more from a margin perspective overall, and as I said before, biosimilars which we fully develop ourself have a gross margin which is higher than the average. If we partner, it is lower, but also we have lower costs because we don't develop and we share the profitability. If you think about the different biosimilars, the larger and the smaller one of the COGS per unit, I don't think that's the real driver of the gross margin. The driver is really the discount, and that depends on the competitive intensity. So we expect indeed that with smaller assets, we will have less competitive intensity, and we would have a higher margin, much less related to the COGS per unit.
Also, I think bear in mind, if you take a drug like Omnitrope, it's 20 years old. It behaves like an originator product. No one's likely to ever develop, I could be wrong, but I can't see anyone ever developing a biosimilar to a drug like Omnitrope. So in a sense, the terminal value on a product like that is very significant, and it's continuing. It's still one of our largest assets. It continues, and I could say the same with a number of other biologics. So in a sense, they don't decay in the same way that small molecules do. They have a longevity, and then it's much harder then for new competitors to come into those markets. So as we add more and more assets, you build this foundation of business that is highly accretive.
Okay. Before we go to the last question and I hand over to Richard for final remarks, I would just encourage you to have a look at the slides in your goodie bags along with the chocolates because it is in the appendix. It does show the full range of assets we are looking to target, so there are comprehensive pipeline slides at the back, and also it shows a calendar of all of the events and the corporate access we are looking at over the next few weeks or so. Let us go with the last question. Let us go with that side. Right in the center. I think that is Urban, in the center.
Just make it difficult.
Yeah. Thank you very much, Urban Fritsche from ZKB. So question to Keren and Christophe and Peter, then the second one. So in the U.S., we have the favorable changing regulatory environment, but on the other hand, we have the very protective behavior of the originators. So a situation like HUMIRA, is that something which is still possible to some extent, at least in the U.S., or is that history?
Keren, go for it.
Well, I am very optimistic, and I do think that there is a lot of opportunity. I think it is clear that we are the solution for a lot of the challenges that we have in the healthcare system in the U.S. I think still more policy is required, and we are working hard to provide it, but things like biosimilar first and other ideas that we have in mind. We absolutely will continue to shape the market. I think also HUMIRA, it took time. More time than we want, but already 60% of the market. If you look without private label, 60% of the market is already biosimilar, so we are absolutely progressing.
You look at patent reform, you are seeing great work there. PBM reform. The FTC is looking at the behavior of a number of the originators in the marketplace. You are seeing a shift. When three biologics in the U.S. cost more than all of the generics and biosimilars, which supply 90% of the patients, something is wrong. I think there is a huge opportunity for that change. To be fair, the administration see the huge disparity. I think we are sitting on a position of opportunity with the pipeline that we have and the relationship with Keren and Timberhill. I think we are extremely optimistic.
Okay. Then maybe to Christophe and Peter. You mentioned you are the leader in biosimilars in Europe International. You are also the one to go after. In terms of competitors, what do you think? Where are competitors really picking at you? Where are they trying to pick up, and how do you defend yourself?
Yeah. Thank you. Thank you very much for the question. Indeed, we see and we have competition as well in Europe, and this has been the case forever. As I said before, Europe is a mix of different archetypes. We have tender, share of voice, and substitution. The one that is the easiest to go for price sake, is obviously the tender archetype. We see competition coming our way in this tender archetype, gaining share based on the volumes that they can gain. Our response is quite simple. The first thing is, as said, Europe is 40 countries. It is three archetypes. We have a model that is built to be successful in all three archetypes. When it comes to tender, obviously cost of goods are important, supply reliability are important.
And just to give you an example, aflibercept in the U.K., we were supposed to have many competitors. Today, we have 80% share, and we have been awarded as a backup supply, national supply in the U.K. by the NHS, right? So it shows that it is not only the price that matter. It goes way beyond the price, and we need to be good at all the different items rather than just the price.
Peter?
Maybe I think it is for international. So international, we have a very selective play, right? We think on which other markets we want to play in, where we have a good commercial presence, which is 20 direct markets, and then 30 markets where we have a distributor model. So in those 20 markets, which are very diverse among each other, I mentioned Australia, Japan, and Brazil as examples. We have really strong local customer intimacy and presence in order to be able to compete. The example I gave in Brazil with the PDP is an important one. We have that relationship, the experience, the portfolio, and the breadth of the portfolio to succeed in that. But that is only one side of the coin, right? I think for international, what is really important. So one side is the market share we are having and the competition.
The other side, which is really important, is the overall biosimilar acceptance. In internatio nal, we are still a bit behind Europe in terms of biosimilar acceptance, biosimilar penetration. But that is changing now rapidly. We see a real shift in the acceptance of biosimilars in large markets like Australia, Brazil, especially also Japan. Japan is the third-largest biologics market and has one of the lowest biosimilar penetrations today. This will change thanks to a new law that is being implemented, which will push double penetration over the next year. So I think apart from having a discussion on shares against competitors, it is also about really providing more access for patients and reaching more patients by better biosimilar penetration in international.
But also, I go back to page 33 on Rebecca's slide, the biosimilar void. I think there is two parts. Going back to what I just said, do you think a lot of the local competitors are going to develop a biosimilar to human growth hormone? No. So in a sense, there is an opportunity for that to continue to grow. You are sitting here with a huge number of assets coming off LOE. Of course, some of them will get competition, but do I expect them. So I think it is this unique combination, and I think then as we move perhaps to a close, it is a nice segue to say what is unique about Sandoz? We have had this global scale. We have pedigree in terms of delivery. We have consistently executed across that pipeline.
We're now sitting with a golden decade that the originator industry sees as this patent cliff, we see as our patent opportunity. We're investing, we're vertically integrated, and we have a commercial scale. I think in a sense, this is now an execution story. It's an incredibly exciting time. Hopefully, we've given you a flavor of what we want to do over the next few years. I'm incredibly proud of the colleagues, the team that are here, and the 23,000 people around the world. Thank you again for your questions. Happy to have a drink in the corner, no doubt we'll have continued the conversations. I'm here, the sort of management team are here, so happy to continue the conversation over a glass of wine or a cold beer. Remco team, Gilbert, our colleagues, thank you so much, and thank you all of you for your active participation and questions.