Please welcome to the stage Company Secretary Fiona Mead.
Good morning, everybody. I just wanted to give you a quick overview of today's agenda because we've got a very busy morning. You're going to have the opportunity to take a detailed look into our business and hear from our CEO, Paul McKenzie, our Chief Commercial Officer, Andy Schmeltz, our Chief Operating Officer, Mary Oates, and our new Chief Financial Officer, Ken Lim. And then lastly, I'll just draw your attention to the legal disclaimer, and then I will hand over to our CEO and Managing Director, Dr. Paul McKenzie.
Thank you, Fiona. Good morning, everyone. Thank you, Fiona. I hope everybody got to at least 3:00 A.M. sleeping. For those who are coming from Australia, I know I'm stuck on 3:00 A.M. since I came back last week, so always a tough one, but I hope everybody's as energized as I am for this day and session. I'm so incredibly proud of our manufacturing and plasma teams and the employees who make it happen every day, and I hope you'll enjoy meeting them. We're really trying to have you interact with the broader team. Mike Deem and Steve Marlow will host you, but they're very passionate about what they do, and I think you'll get a lot of energy from that as well. I know that you are all following us very closely, and I know that you're intimately aware of our recent history.
I would like to spend a few minutes talking about these from my perspective. The past year has brought unique challenges to the business, not only from within CSL, but also in the broader economic and geopolitical environment. Part of today's objectives is to provide you more color on these challenges and how we are responding, and also to address several concerns we've heard from our investors over the last few weeks and months. One of the concerns is CSL is not sufficiently focused on our shareholder, our shareholder value. While shareholder value has always been a focus for us, I must admit not all decisions along our journey the last five to 10 years have yielded the results that we wanted them to yield.
Let me assure you, this leadership team is keenly aware of the criticality of making decisions that keep shareholder returns at the forefront, and it's my commitment to you to continue to do that. We're also aware that we made some significant announcements, the breadth and depth of which has been unsettling to the market. "What happened to the old CSL?" I often heard. We'd like to take the opportunity today to walk you through the building blocks of our strategy, particularly for our foundational compound, IG, and explain why we are confident that these are the right approaches for CSL to deliver on our commitment to our patients and our shareholders. We also recognize that we have work to do to rebuild our credibility with the investment community and, importantly, all of you in this room.
For me, this starts with increased transparency, plain speech about our challenges, both internal and external, and most importantly, how we plan to deliver our shareholder returns. Why we believe our model is resilient and why we are confident in the vertically integrated IG franchise as well as its underlying market fundamentals. CSL is fortunate to be buoyed by a unique business model centered on our plasma collection network and our leading yield capabilities, which, as Mary will explain in greater detail later, are constantly evolving from both a technological and operational viewpoint. Under Mary's leadership, we are confident in our ability to deliver a level of excellence in IG manufacturing and purification that is second to none. And we believe our network strategy is the right one to deliver on our ambitions. The IG market is strong. Supply and demand are balanced.
Pricing is stable, and share trends are solid. The core market is growing at mid to high single digits. And within that market, we continue to leverage our scale to deliver revenues, margin expansion, and constant innovation across our portfolio. We are very aware of the concerns around the IG fundamentals, and we want to take the time today to walk through those, why there is strong reason to believe in that business today. Before we do, I'd like to make a few comments on the structure of the IG market. For any business to have success in the IG market requires a vast capital commitment to establish a large and effective plasma collection and manufacturing network. The investment continues as the business grows, evolves its products, and expands to meet the growing demand.
Then there is the considerable regulatory pathway to navigate, to bring products to patients, and to continually improve, to validate new facilities, and to conduct and improve operations. You're also faced with a high cash outlay, real intensity early on in your supply chain. Close to half of our operating costs are paid out at the time of donation. Then you have to navigate a long manufacturing cycle before achieving any sales, further adding to that cash intensity. Collectively, these factors tend to bring supply and demand inherently into balance. However, as I have mentioned, the sector is underpinned by considerable unmet need. If a company establishes itself within these guide rails, there is significant value potential. As a leader, this has been the advantage and will be the advantage for CSL for the past decades and for the decades to come.
Revenue growth and a focus on efficiency drives profitability, which in turn feeds our reinvestment into innovation and our commercial offerings. And the collective power of this ultimately underpins our strong shareholder returns. The first part of this market, first part of this framework, is about operating in markets which have unparalleled experience and where there is high unmet need. We are the market leader in IG, and we see strong, durable growth in demand for this critical first-line treatment. And as Andy will outline in detail later, we see opportunities to continue to grow beyond IG. The second element to our strategy is profitability. Cost leadership has been a competitive advantage of ours, and we have a strategy to ensure that continues. This is key to defending the leading market positions we hold. We break our cost initiatives into two broad categories: gross margin and operating cost.
On this slide, you'll see the levers that we've talked about many times for gross margin. These continue to be what we target for constant improvement in our margin journey. As the largest cost line within gross margin, any change in the cost per liter is the largest driver. We are very focused on reducing costs through yield initiatives and operational excellence across both our donor sites and our manufacturing plants. On the operating cost side, we are pursuing savings through the previously announced transformation program, targeting fixed R&D infrastructure, operations, commercial, and corporate cost duplication. The final third of this framework is all about capital allocation and the options we have with it. Ken is a bit passionate on this topic, so I'll make sure I let him talk in greater detail. But I want to be absolutely clear.
We take capital preservation very seriously, and going forward, disciplined value creation will sit and has sat at the core of every decision we make. We are fortunate to have a number of opportunities to which to allocate capital for growth. Our decisions for how to invest will be balanced against current and future market conditions. As you are aware, we've recently articulated a targeted program of transition, which will result in AUD 550 million of gross savings. These savings will provide us with the fuel to reinvest at high returns and expand margins within a disciplined allocation framework. That framework balances investment in our business and the future growth with shareholder returns and a continued strong balance sheet. As with many businesses coming out of COVID, the path back to a normalized environment certainly has not been linear. However, we have several proof points supporting a positive outlook.
The broader Behring portfolio will continue to be the basis of our commercial performance, and Andy will explain in detail the ways in which we are a leading player in this uniquely durable market. We expect to deliver mid-single-digit growth in the short term and long term at the corporate level, buoyed by IG, along with the growing range of other plasma-derived therapies and commercial portfolio. Our consistently growing portfolio is centered in attractive therapeutic areas with high and recurring patient impact. We believe there is reason to be excited about the strength of our base, as well as our global reach and industry-leading commercial operating scale. There is strong demand for our products across all three disease areas: primary immune deficiency, secondary immune deficiency, and CIDP.
Our product portfolio is positioned to keep us competitive in all of these, and our focus on innovative life cycle management will be a source of continued value. Competition in the space is healthy, but we also see a lot of opportunity to grow this market, and we are relentlessly focused on staying ahead. Andy will speak to all of these points. For fiscal year 2026, it is a fact that we are experiencing headwinds in two specific areas: flu and vaccination rates that Dave spoke to at length yesterday, and albumin demand and pricing in China. Dave went through our strategy to maximize our opportunities in flu, and today you will hear directly from Andy how we're addressing the challenge in China to recover growth and margin for albumin. Although a challenge, we see proof points that these headwinds can be overcome.
Maximizing shareholder value will continue to be the primary axis of how we manage our business and its strategy. We will address the topic of margin recovery and management of capital in both the short and midterm. Our scale, experience, and current effort to improve our manufacturing capabilities will continue to drive significant margin expansion. We are now operating with even more urgency and efficiency, as Mary will share in detail. Before I hand over to Andy and Mary, I want to confirm our confidence in the ability to deliver superior returns to our shareholders. These returns will be driven by a combination of our mid-single-digit revenue growth, stable free cash flow and earnings, and our dividend buyback policy. I also want to commit to ensuring that our investor community has the transparency to both the headwinds and the tailwinds that we experience.
We will work closely with all of you to provide clear guidance that we will deliver on. Rest assured that we have heard you. I have heard you, but I remain very optimistic about our future. My executive team is committed to this organization to drive it to the next level. The team is hyper-focused on taking decisive action, and we are making the necessary changes to address the challenges we face to reinforce the foundations for attractive, consistent future returns. Thank you for your time today, and it is my pleasure to now welcome Chief Commercial Officer Andy Schmeltz to the stage. Andy.
Thanks, Paul. Good morning, everyone. I'm very, very pleased to be with you here today. In my role as Chief Commercial Officer, I'm responsible for the CSL business, spanning commercial medical affairs across our Behring and Vifor portfolios, as well as our CSL Plasma collections unit.
As you'll see for yourselves throughout today's sessions, our deep understanding of rare diseases and our leading vertically integrated plasma collection, manufacturing, and commercialization capability are fundamental drivers of our growth strategy. Today, I'm joined by Dr. Mary Oates, CSL's new Chief Operating Officer, and together, we'll represent our flagship immunoglobulin franchise. I'll address plasma collection efficiency, as well as IG innovation and commercialization, and Mary will speak on manufacturing and operations efficiency. But before we get into it, let's start with a quick snapshot of our overall portfolio. In fiscal year 2025, the combined Behring and Vifor portfolio delivered AUD 13.4 billion in revenue and 6% growth on a constant currency basis. And as a reminder, this included a half-year impact of the U.S. IRA Medicare Part D reform, which impacted fiscal year 2025 growth in the combined portfolio by about 150 basis points.
While the combined legacy Behring and Vifor portfolio is diversified across several high-growth therapeutic areas, our predominant focus remains on treating rare diseases, where our medicines have a profound impact on the patients we serve. Our growth drivers, representing about 70% of our revenue, are anchored by immunoglobulin, representing 45% of the overall portfolio, as well as hemophilia, acute hemorrhagic control, hereditary angioedema, and rare nephrology, which collectively represent about 25% of the business, and these growth drivers represent attractive categories where we have leading medicines supported by active commercialization, product differentiation, and life cycle innovation efforts. These areas will contribute disproportionately to our revenue growth over the coming years. Our established core, representing about 30% of the overall portfolio, and including our iron and nephrology dialysis franchises, as well as albumin, are also critical components of the CSL business.
Today, Mary and I will focus on our IG franchise, and then later today, I'll come back to speak more about our growth drivers beyond IG and our established core portfolio. To begin, I want you to walk away from today's session with the following four key takeaways. One, there is strong IG market demand coupled with balanced supply. Two, we're relentlessly driving plasma supply chain efficiencies. Three, our transformative yield improvement initiatives are underway and are progressing. And four, we're driving CSL IG growth across indications and across presentations via innovation and commercial excellence. IG continues to be our flagship franchise, and we expect this to continue for the long term. Here's why. Plasma therapeutics have a long history of safety, efficacy, and benefits for many, many different patient populations. And across the horizontal line shown here, you can see IG is a polyclonal therapy with distinct characteristics.
IG cannot be replicated with existing technologies and does not rely on patents for exclusivity. IG has multiple mechanisms of action. It's used widely as a replacement for people who don't make enough IG, and it's also used widely for immunomodulation. And because of all this, it can be used across a variety of diseases. Plasma is also a tough business to operate at scale. And as we'll discuss later, we require an extensive fleet of plasma collection centers to acquire the plasma we need to make our medicines. And we also have a global network of sites to manufacture these medicines. As Paul mentioned, this is a cash-intensive and complex business. Let's talk about supply and demand. Today, I want to bring clarity to any concerns regarding the supply and demand dynamics of the IG market. Let's start with demand.
This chart depicts the historical monthly moving annual total demand growth rates over the past seven years from July 2018 through June 2025, and that's the latest month that we have data on. I'm sharing U.S. data because it's the most robust and timely, and it's representative of global trends. This chart illustrates the period prior to COVID, the pandemic-related disruption, and the subsequent growth stabilization. As you can see, market demand growth has recovered nicely post-COVID, driven by increasing diagnosis, treatment trends, and the inclusion of plasma-derived therapies in clinical guidelines. We've also highlighted the long-term trend from July 2018 through our latest data point that shows demand in the mid to high single-digit range. IG market demand is now steady and robust with consistent growth post-COVID, and we expect this to continue.
Despite the inherent cyclicality, the demand growth trend is clear and sustainable, and there are several proof points to support this view. Proof point number one, the global unmet need in total addressable market for IG is significant across core treated conditions. In primary immunodeficiency, or PID, a part of the body's immune system is missing or doesn't function correctly. Because of this, infections may be frequent, severe, long-lasting, hard to cure, even with antibiotics. There remains limited awareness among primary care providers, and it takes a significant amount of time to diagnose. In secondary immunodeficiency, or SID, the immune system is compromised due to environmental factors such as HIV, chemotherapy, severe burns, or malnutrition. There are low rates of IgG testing and a lack of aligned guidelines for treatment.
Chronic inflammatory demyelinating polyneuropathy, or CIDP, is a rare disorder of the nervous system in which the protective outer layer of nerves, called myelin, is attacked by the immune system. Over time, this may cause gradual weakness and loss of motor function. If CIDP isn't treated, it can cause permanent nerve damage. The diagnosis process is complex, and as a result, there are high misdiagnosis rates. And as the global IG market leader, CSL has purposeful efforts underway to address these diagnostic and treatment challenges. Let's now focus on proof point number two, the market growth trend for IG. Over the past four CSL fiscal years, through June of 2025, we've seen steady increases in diagnosis rates in IG use across core indications, as well as across presentations, meaning IV and subcutaneous presentations. Over this timeframe, the total IG market volume has increased at approximately 9% compound annual growth rate.
We're seeing growth due to more diagnoses and treatment initiations across core IG treated conditions. IG use in secondary immunodeficiency is growing fast due to greater use of new B-cell depleting therapies in blood cancers, which often require supplemental IG. IG use in CIDP is also growing due to increased awareness and new diagnosis activity, even with new modalities. That's a point I'm going to speak to in detail later. IG use in PID, primary immunodeficiency, has continued to increase in sync with improvement and recovery in new diagnoses. We also see balanced growth across the two presentations of IG, intravenous and subcutaneous formulations. While the subcutaneous presentation offers convenient advantages for patient flexibility, provider economics, especially in the U.S., reinforce the important continued role of IVIG.
Overall, we see these IG market demand growth trends continuing over the midterm, which bodes well for both CSL and the patients we serve. Now, let's revisit the chart I shared earlier, but now focus on supply. Again, the chart depicts historic moving annual total IG supply growth rates over the past seven years. As you can see, market supply growth has normalized post-COVID, with mid to high single-digit growth highlighted, which corresponds well with the demand I showed earlier. While the seven-year growth trend is interesting, CSL monitors demand trends very, very closely, and we project into the future so that we can hone our plasma and IG supply needs. So the most recent two-year supply trend is probably most relevant. Here, this data informs us that IG supply growth has normalized post-COVID and depicts relatively consistent and steady growth.
In a nutshell, IG demand is the best leading indicator for IG supply. Now, let me bring together supply and demand. Looking at the combined IG market graph, it's clear that the IG market is robust with a healthy supply and demand balance. And I do want to take this opportunity to remind everyone of some key features of the industry structure because it provides important context. Most industry players are now vertically integrated, similar to CSL. The production of IG therapies is capital-intensive, requiring large manufacturing facilities and significant investments in donor networks. The IG supply chain post-plasma collection involves 9-12 months for manufacturing, regulatory, and distribution cycle before sales can be realized. And this all requires high cash intensity, with a significant proportion of costs paid out at the time of plasma collection.
As we know very well, there's a long regulatory pathway for both new medicine, new product approvals, and new plant approvals. Overall, these factors make a sustained imbalance in supply unlikely, as CSL takes purposeful and active steps to judiciously anticipate and manage our cost structures. We're committed to continued CSL leadership and sustainable profitable growth in this growing IG category because of our vertically integrated approach spanning plasma collection, manufacturing and operations, and innovation and commercialization. These end-to-end capabilities, coupled with our long-standing history and established stakeholder relationships, serve as key differentiators for our company. We take considerable pride in these strengths. For the remainder of this session, we're going to focus on our tangible efforts to improve efficiency in plasma collection and operations, along with our strategies for growth through innovation and commercialization. We'll start first with plasma collection.
With plasma collection, we're leveraging innovation to optimize efficiency, applying it to our scale, and ensuring a reliable supply of plasma and ultimately IG. We're actively reducing plasma costs per liter, which increased significantly during the COVID pandemic. Big picture, our plasma strategy concentrates on optimizing plasma yields at the time of collection while maintaining consistent efficiency throughout the network. And we have several proof points to demonstrate our progress. Our individualized nomogram, iNomi, which has been approved by the FDA, has enabled about a 10% increase in average donor plasma volume, which is improving overall collection efficiency. Cost per liter has been reduced by about 15% since the COVID peak, and donor fees have been reduced by about 25% since the COVID peak, contributing to overall costs.
As we've previously disclosed over the past year, we decided to close 22 centers after conducting a strategic review that considered center-level cost per liter and volume data. This analysis enabled us to optimize our operational footprint, retaining the most efficient centers as depicted in the scatter plot chart over here. Despite these plasma collection efficiency gains, we are not yet satisfied. That's why we're continuing to innovate. We've been on a journey evolving our plasma collection capabilities into a more personalized, data-driven approach, enhancing donor attraction and retention while driving down costs. We've evolved our donor fee strategy, transitioning from fixed fees to an integrated and dynamic pricing model, which allows us to be agile and allows us to react to changes in market conditions.
Additionally, our advanced approach to managing the donor journey provides us with a significant competitive advantage, making it challenging for others in the industry to match our progress. Bottom line, our segment-led and data-driven strategies ensure we attract and retain the right donors at the right times and in the right locations, all supporting sustainable growth for IG supply. And while donor fees comprise the largest part of cost per liter, plasma center labor costs and improving many little things are also critically important to manage efficiently. Enhanced labor and staffing models ensure the right staff are present at the right time, optimizing center days and operating hours. Additionally, plasmapheresis recovery is critical to ensuring that every drop counts. 0.5%, that's right, 0.5% of improvement here translates into 100,000 liters of incremental plasma.
In the plasma business, every decimal point of improvement matters and really adds up, and that is the CSL mentality. Here we're leveraging operational excellence, innovation, and data-based insights, and as you can see from the slide, we've achieved significant year-on-year efficiency gains. Importantly, these operational gains not only improve profitability, but they also strengthen our competitive position in plasma collection and manufacturing, and that actually is a perfect segue for manufacturing and operations efficiency. So now I'll hand it over to Dr. Mary Oates, who will walk you through this next section. Mary.
Thanks, Andy. Thank you, Andy, and good morning, everyone. My name is Mary Oates, and I am the Chief Operating Officer of CSL. My role encompasses all aspects of product supply, as well as process and product development. Since we haven't met before, I'd like to tell you just a little bit about myself.
I have more than 30 years of experience in all elements of operations, having spent most of that at several large biopharmaceutical companies. More importantly, for the past 15-plus years, I've led multiple large-scale transformations that have had a direct positive net impact on the bottom line, and that is the frame of reference that I bring to the role that I have here today. My key priority at CSL is to drive excellence and operational performance, and in manufacturing, what that means is that we must supply quality product at the lowest possible cost. Now, our performance today in terms of quality and supply is strong. We can support revenue growth. That's why in this moment, my key focus is on extracting cost from the system, and we're doing that in two key ways. First, we have a disciplined and rigorous operational excellence program.
Secondly, our yield improvement program, Horizon One and Two, which I will talk about in some detail today, now has multiple proof points, providing confidence that we will deliver transformative results. First, I'd like to talk about operational excellence. In my experience, to deliver sustainable and significant savings through operational excellence requires three things. First, there must be a systematic network-wide end-to-end review of every opportunity to be both more efficient and effective. Secondly, there must be discipline and execution once those opportunities are identified to ensure that we capture the value. And thirdly, and equally importantly, there must be a passion for excellence in every colleague across our entire network. I know that this approach works because I've done it before successfully. And it is exactly what we are deploying in CSL today. So what are we doing? We are mapping every one of our activities.
We are making a determination as to whether external partners can do some of these activities more efficiently than we can. We are also, for those activities that are staying with us, we are removing non-value-added work. We're eliminating waste. We are focusing our colleagues on where we will deliver the greatest value for our patients and for our stakeholders. And we're pursuing higher levels of automation and digitization. Our colleagues see the value in what we're doing because their jobs will be easier and simpler. In fact, our shop floor colleagues are participating in rigorous continuous improvement loops where no idea is too small if it makes our operations more efficient. Now, let's turn to the results that all of these efforts are delivering. This slide depicts our annual addressable manufacturing expenses using fiscal year 2023 as the base.
You can see that as a result of our efforts in fiscal year 26, we are reducing these expenses by 15%. By fiscal year 28, we will reduce our addressable manufacturing expenses by more than 25%. None of this would be possible without our commitment to and our passion for excellence in all things. Now, I'd like to turn to our yield improvement programs, beginning with Horizon One. You all recall that Horizon One delivers yield improvements through incremental changes to the existing manufacturing process. We are implementing Horizon One across all of our IG modules, and it has already improved yield by more than 6%. As we deploy all of the changes across all of our modules, we will capture a 10% yield improvement, meaning that we will need 10% less plasma for the same demand profile.
Another significant benefit that we derive from Horizon One is that we have been able to keep up with the IG demand with limited capital investment. Now, I'll turn to Horizon Two. The criticality of Horizon Two for our business is clear. That's why, since I joined, I've spent a lot of time doing a deep dive into the program and ensuring that we have a solid and reliable plan that we can deliver. Horizon Two is a highly innovative, patented process that will be a game changer in IG manufacturing. And today, I have significant progress to share. First, we have a manufacturing process that we now know works at full scale and delivers the anticipated yield. Secondly, we have a regulatory pathway aligned with FDA.
What I'd like to do now is to talk in a bit more detail about each of these accomplishments, then go into detail about the next steps and conclude with the value that this will bring to our business. So let's go back to the point about the full-scale runs that we've done successfully. So for those of you who are familiar with our network, we have converted Broadmeadows Module Three to Horizon Two. We started full-scale runs in this facility in August of this year, and we now have multiple runs, as I said, at the anticipated yield. In terms of our agreement with FDA, this was a critical milestone in our ability to file the first submission for Horizon Two this fiscal year.
Specifically, we used advanced analytics and quality-by-design principles to generate vast amounts of data on both the existing process as well as the new Horizon Two process, and FDA has agreed that if the validation data that we'll be generating for Horizon Two is comparable to the data that we have for our existing process, then they will accept our file for submission. That enables us to make the first submission for Horizon Two for Privigen in this fiscal year. So what are we doing next? Now that we have these proof points, these two important proof points, a process that works at full scale, and a regulatory pathway that we believe is a model that can be used with global regulators, we're moving full speed ahead. We have started to convert Module Four in Broadmeadows to Horizon Two.
We anticipate that we'll be able to file from Broadmeadows in fiscal year 28, meaning that product will begin flowing from those modules in fiscal year 29. At the same time, we're identifying a U.S. facility where we will build two new IG modules. We anticipate that we'll be able to file for Hizintra and Privigen from these two new modules in fiscal year 29, meaning that product will begin flowing from them in fiscal year 30. Across the four modules that I've just described, our plan is that 40% of our IG production will be from Horizon Two by fiscal year 30, and 80% will be by Horizon Two in fiscal year 32. Now, I'd like to spend a few minutes and talk about what this means for plasma.
This slide, the dashed line, depicts the plasma that would be required in the absence of Horizon One and Horizon Two. The area under the curve shows the savings that will be generated in terms of plasma collection as a result of our yield improvement programs. As I mentioned, 6% today, increasing to 10% as we complete the rollout of Horizon One across the network and culminating in a 20% reduction by fiscal year 2032. In summary, the operational excellence work that I've described, as well as our yield improvement programs, are generating significant cost reductions across the totality of our operational network. I'd like to welcome Andy back to the stage. Thank you.
Well done. Thank you, Mary. So now let's transition to the third component of our integrated CSL plasma capability, and that's innovation and commercialization.
We're actively investing in innovation and commercialization to sustain and expand CSL IG leadership. Importantly, we're investing in IG to maintain our leadership now, today, and into the future. Privigen is the world's number one IVIG brand, recognized for its proven efficacy and safety across a broad range of indications, making it the standard of care in IG therapy. It's the first and only IVIG with proline stabilization designed to enhance tolerability for a wide spectrum of patients. Privigen's value proposition is supported by real-world evidence with more than 200 publications, and it's well accepted in global treatment guidelines, and we've translated that into consistent performance, where Privigen has earned a market-leading approximately 25% share in the growing global IVIG segment. Hizintra is the world's number one prescribed subcutaneous IG worldwide, trusted for its efficacy, safety, and convenient self-administration.
Hizintra is the only SCIG available in a prefilled syringe, making administration easier and more convenient for patients and reducing the burden of IV infusions, including peaks and troughs. Hizintra has the longest established SCIG IG profile and the most extensive real-world evidence, with approximately 265 publications reinforcing its safety and effectiveness. The global SCIG market volume continues to grow robustly, and Hizintra holds a market-leading 55% share. Now, let's look again at the total addressable market for IG. Returning to the same graphic that I shared earlier, let's now look at the treatment challenges and the expansion opportunities for both IG replacement and IG immunomodulation. Primary immunodeficiency and secondary immunodeficiency are diseases where the administration of Privigen and Hizintra replace IG in a person's body. For CIDP and other neurological conditions, these medicines function as immunomodulators.
All three of these core indications remain challenging to diagnose and to initiate IG treatment. And that said, as I shared earlier, IG use across all these diseases has been growing strongly in the high single digits and low double digits over the past four years, clearly a positive trend with momentum. And we see further opportunities both for patients and for CSL. As the global IG market leader, CSL has purposeful efforts underway to address these diagnosis and treatment challenges and to affirm the IG benefit-risk profile versus new modalities. Let's focus a bit on CIDP. Given the new entrants in the CIDP space, I want to speak specifically on FCRNs. IG will continue to be the first-line therapy in CIDP based on its well-characterized benefit-risk profile, proven long-term benefits, and cost-effectiveness versus newer modalities. On the left chart, depicted are the 60,000 diagnosed U.S.
CIDP patients, of which about 42,000 are on therapy, and most are well-controlled on IG. However, there's about 12,000 patients, or 30% of the total, that have relapsed or may be refractory to IG, and this represents the target segment for FCRNs. It's great for these patients to have more options. The middle chart depicts FCRN uptake. Over time, the active number of FCRN-treated patients is lower than the total number of treated patients. This is due to patient drop-offs in the 30% range based on this data. And then the third chart on the right indicates that roughly two-thirds of patients who stopped taking FCRNs subsequently use IVIG or subcutaneous IG, particularly among individuals who had previously experienced partial efficacy.
The data represented here gives us confidence that while new modalities certainly will play a role in benefiting a subset of CIDP patients, immunoglobulin therapies, and specifically Privigen and Hizintra, continue to be considered standard first-line treatments. While new modalities will provide a welcome alternative for the minority of patients who don't respond to IG therapy, we don't anticipate significant loss of market share, and we expect continued CSL IG growth in CIDP as diagnosis and treatment rates improve. Let's shift gears to CSL IG innovation enabled by data generation and lifecycle management. Over the past two years, we've made a very purposeful investment in our CSL medical affairs capabilities, recognizing the critical role medical plays in rare disease, engaging in scientific exchange with specialists, and generating data to affirm the benefit-risk of CSL medicines.
This has enabled a stronger partnership with our R&D and commercial teams on active lifecycle management, and we're accelerating our efforts to expand Hizentra's label for PID naive and for secondary immunodeficiency in the United States. And we're really encouraged by recent FDA interactions that will guide our U.S. secondary immunodeficiency development program. For Privigen, we're seeking a measles indication in the European Union and a label expansion in Japan. And we have work underway on a next-generation Hizentra offering with an ambition for both higher concentrations and a truly convenient delivery device. And we're also doubling down on differentiation via evidence generation to support and expand the use of our IG medicines, with a steady stream of publications in the works across core indications. For CIDP, we're evaluating the real-world effectiveness and safety of IG as treatment options evolve.
In secondary immunodeficiency, our focus is on outcomes and treating patterns in oncology, aiming to determine the best use of IG to prevent serious infections as B-cell depleting therapy use increases. In primary immunodeficiency, we're enhancing the patient experience with innovations like our prefilled syringe and alternatives to IV infusions. These activities collectively support our continued scientific leadership across IG indications. In short, we'll continue to pursue database innovation to reinforce the clinical value, the safety, and the convenience of our IG therapies, and ensure continued leadership in this space. Let's move on to IG commercialization, where we're pursuing a multi-pronged approach both to expand the overall IG market and to increase CSL market share. As the global IG market leader, we disproportionately gain with stronger market growth, and our efforts to grow the market are multifaceted. They include our first fully integrated consumer campaign in the U.S.
to drive primary immunodeficiency awareness and patient education. We're also leveraging artificial intelligence tools to increase PID diagnosis rates. Internationally, for secondary immunodeficiency, we're partnering with thought leaders to develop consensus guidelines to enable treatment pathways, both of which are so very important in the oncology space. Of course, growing the market in and of itself is insufficient, so we're equally laser-focused on securing CSL IG share at the same time. In the U.S., we've made purposeful decisions to expand our sales and account management teams in areas where we think we can make a strong impact, and we're accelerating the rollout of the Hizintra prefilled syringe, a more convenient offering for patients. Enhancing our international tender capabilities is also a top priority, and we're taking a purposeful and disciplined approach.
With more than 400 international IG tenders each year of all shapes and sizes, we operate purposefully to understand global and local market shifts and dynamic trends, leveraging data to improve forecasting accuracy, enabling faster, smarter decisions. Let me provide you with a little more color on our commercialization approach by sharing an example of Hizintra in the U.S. specifically. Hizintra was the first SCIG introduced in the U.S. market, and it continues to hold a leading position with a market share in the mid-50% range. But we're not sitting on our laurels. Our ambition is to grow within this category beyond our current base share, and we're doing this by pulling multiple levers concurrently. I want to touch on just three. In terms of market development, we're leveraging AI-powered solutions to improve diagnosis and patient preference.
In the coming year, we're deploying a test-and-learn approach to be applied to hone our database algorithms with consideration for full-scale implementation based on those outcomes. Second, patient activation. We're innovating in direct-to-patient promotion across connected social media, which is very unique in this space. And third, we're upping our game to ensure patient access to Hizintra through enhancing our presence and effectiveness in both clinics and hospital settings. Now, let's bring it all together. CSL projects continued high single-digit IG growth over the midterm through fiscal year 2028, and we look to expand our market-leading share by a point or two over this timeframe. As previously communicated in fiscal year 2026, we navigate the negative effects of losing the U.K. tender and the partial year impact of Medicare Part D. These factors are expected to result in mid-single-digit growth for our flagship franchise.
But looking ahead at the subsequent years, we fully anticipate both robust IG market growth and strong CSL high single-digit growth. Looking at the chart on the right, our growth will come disproportionately from IG replacement indications, primary immunodeficiency, and secondary immunodeficiency, which will soon represent more than 50% of our business, given many of our medical and commercialization efforts just discussed. But we also will see continued growth in CIDP as well. And we anticipate consistent growth for both Hizentra and Privigen, with the mix continuing to shift towards SCIG and Hizentra, given U.S. price realization and patient preference. I hope by now these four key takeaways have resonated and are top of mind for you. One, there's strong IG market demand with balanced supply. Two, we're relentlessly driving plasma supply chain efficiencies. Three, transformative yield improvements that Mary spoke to are underway and progressing nicely.
And four, we're driving CSL IG growth across indications and across presentations via innovation and commercial excellence. Thank you for your time today. Great to be back with you following a well-deserved break for all of us, I think. So now let's discuss the rest of the CSL portfolio beyond IG. During this session, I'll cover our key franchises beyond IG and their important roles in our portfolio. As mentioned in the last session, our growth drivers currently account for about 70% of our business and are expected to contribute disproportionately to CSL performance over the next three years and beyond. Now we're going to turn our focus to the other growth drivers beyond IG: hemophilia, acute hemorrhagic control, hereditary angioedema, and non-dialysis nephrology, which collectively represent about 25% of the current business.
Additionally, we're going to review our established core portfolio representing 30% of our business, including albumin, iron, and nephrology dialysis medicines. Now, these established core foundational medicines are entrenched in treatment algorithms for the conditions they treat. They generate significant cash flow today and tomorrow with continued volume growth anticipated moving forward. As before, I want to start with the key points I want you to walk away with following this session. Number one, CSL has significant portfolio breadth and depth beyond IG. Two, we're focused on diseases with attractive growth prospects. And three, both our growth drivers and our established core will make important contributions over the coming years. So let's begin with our hemophilia portfolio. Our hemophilia portfolio includes treatments for hemophilia B, hemophilia A, and von Willebrand's disease.
With 50 years of experience in treating bleeding disorders and a range of product offerings, CSL has established clear leadership in the hemophilia category. We've purposefully expanded our offering in this space time and time again. At CSL, our hemophilia B treatments have progressed from factor therapy to recombinant technology and now to gene therapy, aiming to better meet patient needs and to move towards a functional cure. Today, we're going to double-click on Idelvion and HEMGENIX, which are two of our key medicines in this space. Hemophilia B is a rare, life-threatening condition in which blood doesn't clot in the typical way because it doesn't have enough of the factor IX blood clotting protein. Addressing unmet needs, especially infusion burden, durable protection, and inhibitor management, remain key drivers for growth and for patient outcomes.
The total addressable market includes approximately 4,000 to 5,000 hemophilia B sufferers currently on prophylactic therapy and eligible for Idelvion, as well as a few thousand more who may be candidates to switch from on-demand treatment to a prophylaxis regimen, and of these, an estimated 1,000 to 2,000 adult hemophilia B patients with moderate to severe conditions are likely good candidates for HEMGENIX gene therapy. Let's take a closer look at Idelvion, which continues to demonstrate leadership in the expanding hemophilia B category, and Idelvion is the standard of care for hemophilia B prophylactic therapy across all countries where it's available. Now, while new entrants may offer alternative solutions for certain patients and will pick up some share, the overall hemophilia B category is growing, and Idelvion's unique differentiators will enable sustained leadership over the coming years.
Notably, Idelvion offers full resolution in target joints and no thromboembolic events, both are clear benefits over the new subcutaneous treatments. Idelvion offers flexible dosing intervals of seven, 14, and 21 days, which provides best-in-class convenience. And Idelvion has 10 years of proven long-lasting bleed protection and is reinforced in World Federation of Hemophilia, CDC, and ISTH treatment guidelines. Given these strengths, Idelvion is well-positioned to remain the leading prophylaxis treatment as we continue to advance scientific leadership and to pursue geographic expansion with launching Idelvion in new countries. Now, let's take a closer look at HEMGENIX, which is the first and only gene therapy for hemophilia B, providing a transformative solution that enables patients to produce their own clotting factor. HEMGENIX is a one-time infusion that delivers functionally curative factor IX levels sustained over four years.
The long-term durability and safety of HEMGENIX are confirmed by five-year HOPE data with the results to be presented at the upcoming ASH scientific conference in early December. We're making steady progress here. We now have administered HEMGENIX to 70 patients. This means there are now 70 people who are essentially living with the hemophilia-free mindset, not having to worry about routine prophylaxis and regular needle pricks. Interest in HEMGENIX continues to grow among healthcare professionals and patients, with over 65 U.S. hemophilia treatment centers trained to administer HEMGENIX and major payers covering more than 80% of U.S. commercial health plan lives. International momentum is also building, with national reimbursement now granted in 10 markets and patients being infused across these countries.
It's very important to highlight that the global hemophilia B patient advocacy community remains very enthusiastic about gene therapies and their impact on improved quality of life. Of course, CSL is partnering with these organizations to promote education and access. We expect to continue making steady progress with Hemgenics as reimbursement and acceptance of gene therapy increases worldwide. Now, let's move on to acute hemorrhagic control. Acute hemorrhagic control, or AHC, encompasses our plasma-derived therapies that are primarily used to control bleeding during or after surgical procedures or for traumatic bleeding. CSL has over 30 years of proven efficacy and safety in AHC, offering Kcentra, Beriplex, RiaSTAP, Haemocomplettan for major bleeding and low fibrinogen levels. Our medicines are recognized for their rapid and effective action in urgent clinical scenarios, supported by well-established safety profiles and decades of real-world experience.
The AHC category is growing and is projected to grow at a 6% compound annual growth rate by fiscal year 2028, driven by a large and growing patient segment with uncontrolled bleeding. On the right of the chart, in the non-oral anticoagulant segment, there are 12 to 15 million AHC procedures annually, and we offer a full range of options to treat these patients. In the middle, in the oral anticoagulant market, that represents significant potential, with more than 25 million patients taking therapies such as Eliquis and Xarelto, and there are no medicines currently approved for these factor Xa inhibitors. That's why we're particularly excited about VMX-C001 from our new partnership with VarmX, which I'll speak to in a few minutes.
Stepping back, with Kcentra and Beriplex and Haemocomplettan and Riastap and the addition of VMX-C001, we'll be able to address the full spectrum of acute hemorrhagic control patient needs. Currently, CSL maintains about a 50% share in this category, primarily driven by Kcentra in the U.S. and Beriplex internationally, which are recognized as leading four-factor prothrombin complex concentrates, or four-factor PCCs. Now, these medicines deliver rapid management of acute bleeding by facilitating efficient thrombin formation. Kcentra holds the leading four-factor PCC share in the U.S., with 10 years of proven efficacy, safety, lower all-cause mortality risk, and established partnerships with thought leaders and healthcare professionals. And while a new competitor has impacted short-term prospects, we are supporting Kcentra's leadership through an expanded U.S. hospital sales force, through purposeful contracting, and in-process label expansions and real-world evidence. And Kcentra's U.S. share is stabilizing as a result of these efforts.
Ristap and Haemocomplettan are leading fibrinogen concentrates with over 30 years of safe, effective use and minimal thrombotic or infection risk. For Ristap, we anticipate U.S. FDA approval of an acquired fibrinogen deficiency label extension in the near future. So in summary, despite new entrants, we anticipate CSL will retain the growing global AHC category leadership over the coming years, supported by implementation of target lifecycle investments, including patient blood management. As you may recall from our last Capital Markets Day, patient blood management, or PBM, is about optimizing the management of a patient's blood before, during, and after surgery, reducing the need for blood transfusions and improving outcomes and efficiency across healthcare systems. Our medicines across this acute hemorrhagic control portfolio, along with iron, play essential and complementary roles in the patient blood management paradigm across the full surgical journey. So now let's speak to VMX-C001.
We're very excited about VMX-C001 via our recent collaboration with VarmX. This agent directly supports our strategy in hematology and bleeding disorders and targets a clear unmet need in a growing patient population. Globally, more than 20 million patients receive chronic anticoagulation therapy with factor Xa inhibitors, as I mentioned, and approximately 3% experience severe bleeding or require urgent surgical interventions each year. VMX-C001 is a potentially first-in-class recombinant factor X with a defined mechanism of action and an expected favorable safety profile, offering improved efficacy and ease of use compared to current standards of care. C001 is being developed to rapidly restore clotting in these emergency situations, offering a targeted approach to address significant unmet medical need, and this is a tangible example of our purposeful approach to enhancing our CSL pipeline, targeting novel modalities in our core therapeutic areas where we have the right to win.
The partnership draws on CSL's global expertise in hematology, our expertise in clinical development, and in commercialization, positioning the therapy for success and delivering meaningful impact for patients. With a clear unmet medical need and a well-defined patient population in a growing market, we believe VMX-C001 has blockbuster revenue potential. Okay, let's move on to hereditary angioedema. CSL has more than a four-decade legacy in hereditary angioedema, or HAE. Our portfolio is a key growth driver here for CSL now and going forward, with a focus on best-in-class efficacy, safety, and patient experience. The portfolio's growth is driven by both established therapies such as Berinert IV and Haegarda, as well as our newly launched best-in-category Andembry. The HAE market is growing, with long-term prophylaxis therapy anticipated to be used by about 55% of treated patients as more individuals transition from on-demand therapies.
HAE is a rare genetic disorder that can lead to severe pain and unpredictable episodes of swelling in various parts of the body. Swelling in the throat or airway may result in life-threatening breathing difficulties and despite advancements, a number of HAE patients continue to have breakthrough attacks that impact their mental health, daily functioning, and productivity, even when receiving current long-term prophylactic treatment. About 30% of patients on previously approved preventative therapies report at least one attack in the past month, and 52% experienced an attack within the past three months. These trends indicate a continued need for therapies that further improve disease management, tolerability, and convenience and CSL's HAE portfolio is designed to meet the full spectrum of patient needs. We have deep experience in HAE treatment with on-demand treatment, Berinert IV, and prophylaxis therapy Haegarda in the U.S., Berinert internationally.
Those medicines will continue to support patients who prefer replacement of natural C1 for its strong efficacy, safety profile, and track record, and Andembry is a transformative addition to the HAE treatment landscape, developed to meet the needs of people who continue to face unpredictable, painful, and sometimes life-threatening HAE attacks, or those that just seek a simpler, less burdensome treatment regimen. Andembry acts by inhibiting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, inhibiting the HAE cascade at the top to prevent HAE attacks. Andembry offers once-monthly dosing from the start for all patients and is delivered in 15 seconds or less via an autoinjector. These are key differentiators versus the current leading HAE prophylaxis agent. These are key differentiators, and we're purposely reinforcing these differences in our promotional efforts with healthcare professionals.
Andembry, much like the advancements in our hemophilia franchise, exemplifies our commitment to meeting emerging and unmet patient needs, thereby expanding CSL's portfolio to the benefit of patients. Bottom line, simplicity and sustained protection from attacks make Andembry a compelling choice for patients who are new to prophylactic treatment or those looking to switch to a more convenient and highly effective option. So Andembry is a medicine we know patients and their providers want, and we're thrilled, really thrilled with the early adoption during its first months of availability. As of October, more than 500 HAE patients across eight countries have received Andembry. Andembry is now approved in 29 countries where reimbursement negotiations are in process and is under regulatory review in 10 more countries, demonstrating rapid global expansion and strong regulatory progress.
Let me give you an example of just how differentiated this medicine, Andembry, is and what a genuine advance it represents for patients. IQWiG, which is the health technology assessment entity in Germany, gave Andembry a rating of considerable additional benefit at launch based on indirect comparative evidence, showing just so powerfully the significant benefit Andembry can provide to HAE patients, and this ruling is unprecedented because IQWiG typically requires head-to-head trials to support such a rating, so when the toughest market in the world, Germany, for HTA guidance and acceptance and reimbursement gives you this kind of endorsement, you know that you have something special. We also have multiple data generation initiatives underway to broaden the eligible patient base and maintain momentum for Andembry. The Andembry switch study is evaluating patient transitions from other therapies, and we have a real-world evidence study focused on economic outcomes.
Let me double-click on how we're really supporting launch momentum in the very important market of the U.S. One of our goals with the U.S. Andembry launch was to deliver a best-in-class experience for patients to match the transformational nature of this medicine. We know these patients from our history here with Haegarda. So we took a unique and creative approach to packaging, designing an experience for patients that's comparable to unboxing consumer electronics like a new laptop or a mobile phone. Equally important is ensuring we have strong engagement with providers across the spectrum. Our U.S. Medical Affairs team has engaged in more than 1,000 interactions with healthcare professionals since launch. And according to third-party data, we have the largest commercial presence in this category and are represented at nearly every point of care treating HAE patients. Finally, as with any product launch, achieving market access is critical.
And during the first 10 weeks post-launch, we're focused on formulary inclusions and have successfully secured approvals for more than 80% of prior authorizations. So here's the bottom line. Andembry is raising the bar for HAE prophylaxis, and we, CSL, have raised our bar in launch excellence. We're well-positioned to maintain and expand leadership in the global HAE market with strong growth expected over the coming three to five years. Okay, let's turn to non-dialysis nephrology. In non-dialysis nephrology, we're growing fast, driven by the launches of TAVNEOS and Filspari in international markets. Nephrology is poised to become an important growth contributor in our portfolio. People living with chronic kidney disease often face a long and uncertain journey with significant symptoms and complications that impact their daily lives and long-term outcomes.
Within this, rare nephrology conditions like IgA nephropathy and ANCA-associated vasculitis, or AAV, stand out for their severity, their complexity, and limited treatment options. IgA nephropathy is a rare kidney disease marked by poorly controlled proteinuria, risk of kidney failure, and reduced quality of life. AAV is a systemic autoimmune disease that targets small blood vessels, mainly affecting kidneys and lungs. If untreated, AAV can progress rapidly and become life-threatening, and many patients struggle to maintain remission and often relapse, and long-term steroid use can result in serious side effects. Against this backdrop, Filspari in IgA nephropathy and TAVNEOS in AAV are redefining the standards of care. This is a story of momentum and executional excellence. We're expanding adoption in international launch markets, securing reimbursement linked to compelling value propositions, and expanding our presence across geographies.
For Filspari, we're encouraged by strong launch trajectories in Germany, in Austria, Switzerland, and the U.K., while TAVNEOS usage is rising in new markets with growth over last year and rapid patient adoption. Both of these therapies address long-standing gaps in care with clear evidence of effectiveness and renal protection that's now shaping new clinical practice guidelines, and with more launches planned across Europe in fiscal year 2026, we continue to broaden the availability of our therapies to help more patients around the world. Now it's time to speak to our established core portfolio. Now that we've covered the CSL growth drivers beyond Ig, it's really important to touch on our established core portfolio, comprised of foundational medicines holding leadership positions in their respective fields, including albumin, iron, and dialysis nephrology medicines. Let me speak to albumin first.
CSL is the world's number one albumin specialist because of our state-of-the-art manufacturing network, our consistent supply, and industry-leading quality and safety measures. In fiscal year 2025, revenue from our albumin portfolio was $1.3 billion, up 7%, with China representing about 60% of the global business. However, it's become clear over the past few months that several healthcare cost control initiatives in China are constraining albumin usage and affecting the overall category, which will impact near-term growth, particularly in the first half of this fiscal year. Now, these include both the Chinese National Healthcare Security Administration's implementation of increased supervision and usage controls, and payment reforms, including the Diagnosis Related Group, DRG, and Diagnosis Intervention Packet, DIP, which both require hospitals to adopt cost control strategies. That said, we're actively responding to these challenges in China.
We've expanded our customer-facing footprint that's increasing CSL's presence in more hospitals, in more cities, and in more provinces, and we're strengthening strategic partnerships with local retail players. To require appropriate albumin usage that's in sync with these policies, CSL will continue to invest in on-label demand generation initiatives, as well as data generation via real-world evidence in the local Chinese population. We believe these measures will enable us to maintain and grow our albumin portfolio over time and to sustain our position as the albumin leader in serving the needs of patients in China. Let's move on to our iron portfolio. In fiscal year 2025, our iron portfolio contributed about $1 billion in revenue. In Europe, we're seeing strong resilience two years after the loss of exclusivity of Ferinject.
Despite multiple generics in key markets, we've retained strong market share, and we've remained competitive through disciplined execution and effective tendering. We're also expanding into high-potential markets like China and Canada, and in the U.S., the current business is stable, but we're working with our U.S. partners to plan for anticipated generic entries for Injectafer beginning in July of 2026, and for Venofer, the low-dose IV iron, generics have now entered the U.S. market, and price competition has begun. Despite these challenges, the iron business is highly resilient, and we're well-positioned for success through tendering, through portfolio management, and market expansion. Bottom line, we'll sustain iron leadership over the midterm, with volume continuing to grow in the face of increased pricing competition. Iron will continue to be an important component of CSL's established core, and it has a unique and differentiating role in our patient blood management offering.
So let's bring it all together. In conclusion, we're committed to driving robust, sustainable growth across our diverse and globally balanced portfolio that includes both growth drivers and an established core. Growth drivers representing 70% of the portfolio today, the established core representing about 30%. And that positions ourselves for continued success throughout the medium term. Our primary growth drivers, spanning Ig and beyond Ig medicines, are poised to deliver robust volume and differentiation-driven growth in the high single digits in revenue through fiscal year 2028, fueling our momentum and reinforcing our leadership across these critical therapeutic areas. And for our established core, we'll continue to predominantly deliver volume-driven growth while we navigate product-specific dynamics. This resilience highlights the enduring strengths of our broad and deep CSL portfolio.
All that said, all of us at CSL appreciate the critical role of Ig, our flagship franchise, representing 45% of the combined Behring and Vifor business that's so critical to our growth prospects. We project continued high single-digit growth of our Ig portfolio over the midterm through fiscal year 2028. The Ig market is growing, and we look to capitalize on that over this timeframe. Let me finish by reinforcing my three key takeaway messages from this session. One, CSL has a significant portfolio with breadth and depth beyond Ig. Two, we're focused in disease areas with attractive growth prospects. And three, both our growth drivers, led by Ig and beyond, and our established core medicines will make important contributions over the coming years. So with that, I'm going to hand things over to our Chief Financial Officer, Ken Lim. Thank you.
Thank you, Andy. Good morning, everyone. As Paul said, I'm new to my role as Chief Financial Officer. However, my association with CSL began in the early 2000s when I advised the company on a number of strategic initiatives, including the acquisition of Aventis Behring in 2004 that laid the foundations for what is today's CSL Behring. I joined CSL in 2013, and I've had the privilege of working in a number of roles across the company. Most recently, I was CSL's Chief Strategy Officer, and before that, I led finance and strategy for CSL Seqirus. I've seen a lot of change at CSL over the last 20 years, and one thing that has always stood out for me is the ability of our company to adapt, whether that be to take advantage of an emerging opportunity or navigate through some unexpected challenges.
I'm confident that the strategies that we have in place today are the right ones to generate attractive returns for our shareholders. As you've heard today, we have a market-leading Ig franchise delivering durable growth and many opportunities to expand our portfolio beyond Ig. Today, I'd like to give you some more detail on our approach to capital allocation. I'm committed to bringing rigor and discipline to our capital allocation decisions, to invest in future growth, and deliver returns for our shareholders. I'll provide further details on the transformation program that we announced in August. We're making good progress and continue to expect cost savings of up to $550 million by 2028. I'll also make some comments around the U.S. policy environment regarding tariffs and most-favored-nation pricing.
Our capital allocation framework and transformation program are key components of how we will generate returns for our shareholders through high single-digit earnings growth, together with dividends and share buybacks. One of my key priorities is to ensure we're rigorous and disciplined with how we make investment decisions and deploy capital. In summary, our capital allocation framework aims to reinvest in the business to drive growth while also maintaining a strong balance sheet, and importantly, given our strong free cash generation, we expect to be able to accomplish those two objectives while still generating excess cash that we will distribute to shareholders in the form of dividends and ongoing share buybacks. I'll elaborate on that in a little more detail. First, we see many opportunities to invest in our product portfolio.
As you've heard from Andy, that includes investment in our commercial and medical execution, ensuring strong market access and driving diagnosis and uptake of our medicines. In R&D, lifecycle management is a key component of our growth strategy, particularly in Ig. Lifecycle management can contribute significant value for CSL, given these initiatives are often faster to market and have higher probabilities of success, and we'll complement our LCM strategies with investment in new molecules, both through our own drug discovery efforts as well as external partnerships. External partnerships and business development will play an important role in how we expand our clinical portfolio, and I'll come back to describe our target portfolio profile and business development strategy a little later in my presentation.
Turning to operations, we will continue to invest to ensure we have the capacity to meet the strong demand that we see for our products over the longer term. That includes continually optimizing our network of plasma collection centers and industrializing our Horizon 2 technology. Any investment, whether that be into our product portfolio or into our operations, will be guided by strict criteria where we focus on generating value for our shareholders. As I mentioned, we will reinvest for growth while also maintaining a strong balance sheet. And for us, that means targeting a net debt-to-EBITDA ratio of 1.5-2 times. And finally, and to reiterate my earlier point, our strong cash generation allows us to achieve those objectives while still generating excess cash that we will return to shareholders through dividends and buybacks. So let me describe our target product portfolio in more detail.
Our strategy is to build a portfolio that will deliver growth over the near, medium, and long term. We've identified five therapeutic areas where we see significant growth opportunities for CSL. Each of these encompasses disease areas where we have strong scientific and commercial capabilities, and there remains significant unmet medical need. We have multiple levers to drive growth, firstly through a mix of lifecycle management and novel molecules, and secondly through a mix of internally sourced innovation and external partnerships. In order to realize these opportunities, we've strengthened the collaboration across key functions with the objective of accelerating how we source, develop, and commercialize our portfolio. I'd like to spend some time discussing how we assess investments into our product portfolio, whether that be through our internal R&D or business development. To qualify for investment, a candidate needs to demonstrate three things.
First, strong science that addresses a significant unmet need. Secondly, attractive commercial turns that are material to CSL. And finally, it must align with our core capabilities, giving us a credible right to win. As I mentioned previously, while we will continue to pursue our own internal innovation, we see many opportunities to insource external innovation. We have a clear framework that guides our business development activities, with our recent transaction with VarmX being a good example of what this looks like in practice. First, our preference is for partnership structures where each company contributes their own unique assets or capabilities. In the case of VarmX, our partner contributes a truly exciting first-in-class molecule that adds a blockbuster product to our hematology portfolio. We contribute our expertise in late-stage clinical studies, navigating the regulatory pathway to licensure, industrial scale, manufacturing, and commercialization.
We recognize that business development can be a competitive process, and we're going to make sure that we don't get ourselves into a bidding war, particularly with major pharma for assets. And as a result, our focus is on products with peak sales potential in the range of $500 million-$2 billion. Importantly, products of this scale would have a material impact on our top line, but are, in general, too small for major pharma. Finally, we'll look to structure deals in a way that shares risk and shares upside. That means milestone-based payments and potentially royalties to reflect how the product progresses through development and in the commercial markets. Importantly, we'll structure those payments so that we're happy to make them because they reflect successful outcomes.
As I mentioned earlier, CSL's approach to capital allocation starts with our strong cash generation, and strengthening that cash generation frees up resources that can be reinvested into growth and driving shareholder returns. At our full-year results announcement, we provided an overview of our transformation program. This includes a range of initiatives that are designed to remove unproductive costs while also improving the efficiency of our decision-making. I'd like to summarize the four key pillars. Starting with R&D, we're implementing a range of initiatives that will enhance efficiency through consolidating our physical sites, refocusing our efforts in research, and enhancing the speed at which drug candidates progress from the bench to the clinic and to the market. And importantly, by removing unproductive fixed overhead, we increase the proportion of our R&D spend that drives growth.
Turning to operations, you've heard about the great progress that we've made in improving collection efficiency in our plasma centers and manufacturing yield in our facilities. And this allowed us to take the decision earlier this year to close 22 of our underperforming plasma collection centers. As you heard from Mary, we continue to see opportunities to take cost out of our manufacturing activities through a relentless focus on continuous improvement. On the commercial side, we've recognized that there are many similarities and therefore synergies between Behring and Vifor. Both are largely focused on rare diseases with similar go-to-market models. And given the similarities of these businesses, maintaining two business units is highly inefficient, for example, because of duplicated leadership teams, support functions, and IT systems.
By bringing these businesses together, we've been able to simplify our operating model with a greater focus on above-market, so with a greater focus on market-facing activities and removing duplication in above-market activities. In our corporate functions, we've completed a thorough review, identifying opportunities to streamline our corporate activities and reduce head office costs. Let me talk about the phasing of the cost savings. They start with approximately AUD 100 million in fiscal 2026, growing to around AUD 400 million in fiscal 2027, and then up to AUD 550 million in fiscal 2028. On the right is the breakdown of the savings by the categories that I mentioned on the previous slide. As you can see, R&D and operations each contribute about 35% of the savings. 20% are from removing commercial duplication, and the remaining 10% is from our corporate functions.
These are real savings that create optionality for CSL in the form of resources that we can redeploy towards generating top-line growth while also delivering margin expansion and operating leverage. Turning to our capital expenditure, following a period of significant capacity expansion, we now will invest it, and as a result, our CapEx has been declining in recent years. Our guidance for fiscal 2026, as you know, is for CapEx to be around $800 million, plus or minus $100 million. Going forward, our next exciting major capital initiative will be in the U.S., where we will be expanding our Horizon 2 capacity. And this is expected to represent an investment of around $1.5 billion, including both drug substance and additional filling capacity, with that spend spread between fiscal 2026 and fiscal 2030.
Outside of Horizon 2, our remaining CapEx in the near term will be consistent with the guidance that we've given for fiscal 2026. Tariffs and MFN. You'll be aware of the uncertain policy environment in the U.S. And to remind everyone, today's CSL products are not subject to tariffs. We'll continue to monitor the policy environment very closely and remain flexible to adapt as needed. And as we previously guided, we do not expect any material impact from tariffs or MFN in fiscal 2026. Paul started to discuss this earlier in his comments. There are a number of features of our U.S. operations that are relevant to tariffs and MFN. All of the plasma that we sell in the U.S., all the plasma products that we sell in the U.S., is sourced from U.S. plasma. So those products are regarded as having a U.S. country of origin.
Our supply chain is already heavily weighted to the U.S., including several in-flight capital projects, as well as our plans to invest further in Horizon 2 capacity. On most favored nations, as Paul mentioned as well, we're closely watching developments with the voluntary MFN agreements that some companies have struck, and we'll continue to assess the opportunity and our portfolio in this context. And of course, we'll keep you updated if our assessment changes based upon the evolving policy landscape. To finish up, I'd like to draw together some key messages you've heard today, particularly in relation to how we will deliver growth and returns for our shareholders. As we stated at the annual general meeting, in fiscal 2026, we expect constant currency revenue growth of 2%-3% and constant currency NPADA growth of 4%-7%.
Fiscal 26 is a year of significant change and transition, with a number of factors to consider. The majority of the business is tracking to plan, in some cases ahead of plan. But we are cycling the impact of some tender losses and the Medicare Part D reforms. And we're also working through the issues that have been highlighted already in relation to U.S. influenza vaccination rates and demand for albumin in China, with those two issues particularly affecting the first-half result for this financial year. I'd like to briefly comment on the choice between NPAT and NPATA for measuring our performance and let you know that in the interest of simplicity in our reporting, that from fiscal 27 onwards, we will be returning to NPAT as our key earnings metric.
Turning now to our outlook for fiscal 2027 and fiscal 2028, our revenue outlook is for mid-single-digit growth for the group, with IG growing at high single digits. In relation to Seqirus, we've looked at a number of scenarios, including downside scenarios, and are comfortable that we can accommodate those within the mid-single-digit revenue outlook for the group. With our focus on efficiencies, we'll drive gross margin expansion and operating leverage that will translate to high single-digit NPAT growth for shareholders. And in addition, we will, as I've said before, commit to returning our excess cash to shareholders in the form of dividends and a multi-year share buyback program. So that concludes my presentation. Yes, we have some challenges, but we're committed to working through them, and we also have many opportunities across our franchise to drive growth.
It's my privilege to take on this role as Chief Financial Officer, and I look forward to continuing to engage with all of you as we deliver upon our strategy. Thanks very much.
Thanks, Andy. Thanks, Ken, so first off, thanks again for all the effort and coming out. We know many of you have come a far distance, and we appreciate that opportunity to spend more time with you. I want to leave you with a few key thoughts that you heard and summarize. We have a long history of delivery, and we take great pride in this legacy, and we look at what made us great then and how we can leverage that moving forward into the future. We absolutely operate in attractive markets, ones that are large and growing with significant demand, unmet demand for the diseases we serve. We have leading positions in these markets.
In IG, we are the market leader. The growth profile is attractive and durable, and both of those are really important in our vocabulary. We are different. IG is different than other pharma products in terms of an LOE and where you get advantage by life cycle management approaches. I hope you heard that our scale and operations do drive unique competitive advantage, and that's one of the things we'll continue to invest behind in both science, engineering, and capital discipline, capital allocation, and our mindset of last-leader economics. I can assure you, is everywhere throughout the culture of the company. We've actually created a refreshed last-leader economics course, and we allow and we voluntold everyone to make sure they understand last-leader economics because it's incredibly important for all of us that last-leader economics.
There's not a group that does not look at the last-leader economics video, I will assure you. And beyond IG, we have an innovative portfolio of products, growth products, and we have a track record of leveraging our franchise to add new products. We have people that come to us because we're good in HAA, because we're good in hematology. And looking forward to fiscal year 2027 and 2028, I just want to reiterate what our guidance is and what it isn't. So our guidance is mid-single-digit revenue with IG growing above this level. So IG is the foundational part of that mid-digit revenue. Scale and operational initiatives will drive the leverage on our P&L. And you've heard many of those proof points over the day today. And our transformation program will enhance and, more importantly, establish the foundations to future growth.
And that's really about simplicity, speed, and urgency to be successful. CSL will become stronger, will become faster, and we will better serve our patients and their physicians, and from that, our shareholders. This will all be managed, as Ken said, with a disciplined capital allocation framework that balances investment in the business and future growth with shareholder returns, with a strong balance sheet. I get up every day focused on the future of this company, and I believe very passionately in the strategy we've laid out for this company moving forward. I've never been afraid of a challenge. I was number six or seven, so I had lots of challenges growing up. I've never been afraid of a challenge. And it's always my personal belief that adversity brings opportunity. It forces you to think differently, to change, to innovate.
Really, you got to learn from the past, but you also have to test the beliefs of the past and make sure that they apply. It's critically important to build that resiliency into the overall company to be successful. I'm committed to the journey. My team's committed to the journey. We have a unique heritage we're extremely proud of, and I'm also very proud of the 29,000 people we have in our organization who bring it every day for the benefit of patients and shareholders. I want to thank everybody for their time. I wish you safe travels. Thanks, everybody. Appreciate the time.