Ladies and gentlemen, thank you for standing by. We welcome you to the Jubilant Pharmova Virtual Meet. At this moment, all participants are in the listen-only mode. Later, we will conduct a question and answer session. At that time, you may raise your hand to ask a question. I now hand over the proceedings to Mr. Hemant Bakhru, Investors Relations at Jubilant Pharmova. Thank you, and over to you.
Thank you, Aditi. Good evening, everyone. Thank you for joining Jubilant Pharmova's analyst meet. I would like to remind you that some of the statements made on the call today could be forward-looking in nature, and a detailed disclaimer in this regard has been included in the presentation. On the call today, we have Mr. Shyam Bhartia, Chairman; Mr. Hari Bhartia, Co-Chairman and Managing Director; Mr. Arvind Chokhany, Group CFO; Mr. Pramod Yadav, CEO, Jubilant Pharma; Mr. Sergio Calvo, President, Radiopharmaceuticals; Mr. Chris Preti, President, Allergy and Respirology; Mr. Amit Arora, President, CMO; Mr. Gunjan Singh, Head, API Business; Mr. Terry Fullem, President, Jubilant Cadista; and Mr. Jasdeep, President, Generics and Non-U.S. Business. Finally, Mr. Christopher Krawtschuk, CFO, Jubilant Pharma; Mr. Marcel Velterop , President, Jubilant Biosys; Dr. Syed Kazmi, CEO, Jubilant Therapeutics; Mr. Arun Kumar Sharma, CFO, Jubilant Pharmova. I now invite Mr. Shyam Bhartia to share his comments.
Over to you, sir.
Thank you, Hemant. Good evening, everyone. A very warm welcome to the analyst meet of Jubilant Pharmova. On behalf of the Jubilant Pharmova family, I want to thank you for taking the time out to join us today and giving us the opportunity to explain our pharmaceutical business as well as respond to your questions. As you are aware, from February 1st, 2021, the entire chemical business of Jubilant Life Sciences, has been de-merged into Jubilant Ingrevia Limited, and the remaining pharmaceutical business continues to be part of Jubilant Pharmova Limited. Our journey of the pharmaceutical business started from the year 2003 onwards when we first acquired our API business in Nanjangud, Karnataka. Over the next six years, we continued to build the pharma business with a well-thought-through strategy of moving up the value chain while being closer to the customer.
We built dosage form facility in Roorkee and various R&D centers in India and acquired dosage form facility, Sterile and Non-Sterile Injectable CMO, Allergy Immunotherapy, and Radiopharmaceutical businesses in North America. Later, to complement our Radiopharma business, we acquired Radiopharmacy Network in 2017. As we saw an increasing opportunity in nuclear medicine, especially in theranostics and PET, we invested in SOFIE Biosciences in the year 2020 and are the largest shareholders. As a business conglomerate of 40 years of existence, Jubilant has built a leadership position in most of its businesses. We continue to maintain a majority market share in most of our products. In Radiopharmaceuticals, we are expanding our product pipeline with in-house research and development as well as entering into strategic partnerships. In Radiopharmacy business, we have begun to execute a detailed turnaround plan. CMO business is delivering strong growth, and we are further investing into growth CapEx.
Generics and API business continue to grow, and we are adding more capacities. R&D focus is more on complex generics. Contract Research and Development Services business continues to do well, and we are doubling our capacity in this business. Our Proprietary Novel Drug business, we are moving to clinical phase in one drug candidate and are evaluating funding through a private public equity raise during coming 18-24 months. Despite COVID-19-related lockdowns, we have been able to ensure continuity in most of our manufacturing operations across all business segments while at the same time ensuring safety of our employees.
I take this opportunity to thank all our employees who have worked tirelessly across all our plants and offices to ensure continuity in company's operation while continuing to serve our global customers. Jubilant Pharmova is ideally positioned to capitalize on its growth opportunities because of cost and market leadership in several products through integration and continuous improvement, timely delivery track record with full compliances, longstanding industry relationships and highly experienced management team with an excellent execution capability. I would now like to hand over to our Group CFO to share his perspective of the company. Thank you. Over to you, Arvind.
Thank you, Mr. Bhartia. A very good evening to everyone, and I invite all of you to today's Jubilant Pharmova's analyst meet. I hope all of you are very well, healthy and safe. As I would like to take you through the two or three slides to provide a broad overview on the business, I would like to start a little bit with the overview and if we can move to the next slide on the overview. Subsequent to the demerger of the chemical specialty chemicals business from Jubilant Life Sciences, Jubilant Pharmova Limited has three principal operating subsidiaries: Jubilant Pharma Limited, Jubilant Biosys and Jubilant Therapeutics, which are in the business of pharmaceuticals, contract drug discovery and in-house drug discovery respectively. The company's pharmaceutical business is diversified with presence in niche and high entry barrier businesses such as Radiopharma, allergy therapy and contract manufacturing business.
Our Contract Research and Development Services, that is CRDS, is a third-party drug discovery business and we have created strong chemistry and biology capabilities through our facilities in Noida and Bangalore. We are one of India's leading drug discovery players. In our proprietary business, we have some very promising and high potential assets in the areas of oncology and autoimmune disorders. The company's revenue is well spread across specialty pharma, CDMO and generics businesses, while the CRDS business is ramping up very well and we are doubling capacities in this business in view of the strong demand here. In terms of geography, as we can see in the pie, North America is our largest market which accounts for almost 4/5 of our top line. We are $820 million integrated global pharmaceutical and contract research company.
As you can see, we have 6 U.S. FDA-approved manufacturing facilities including four in North America and two in India, in addition to two world-class facilities for contract research. Employee strength is around 5,800 people, of which roughly 40% are based in North America. I would like to take you to the subsequent slide on the business overview. We can see that our pharmaceutical business has three main specialty lines in Specialty Pharma, CDMO and Generics. We can see from this slide that we have created strong leadership positions in various businesses which our businesses will explain in subsequent details. Radiopharma business is fully integrated from manufacturing to distribution through the radiopharmaceuticals and pharmacies respectively, in which we are ranked number three and two in the U.S.
In allergy business, we are number two player in the U.S. and sole supplier for venom products. CMO business, we have established strong relationships with leading specialty pharmaceutical companies. We're adding capacities in these businesses to meet strong demand. Generics business, we have manufacturing presence both in the U.S. and in India, we are leading player in several product categories. Solid dosage business is vertically integrated with our API business. Our Contract Research business is fully integrated with our discovery business. As I take you to the next slide, we will talk a little bit about the experience of the management team. As we can see that Jubilant Pharmova Limited is led by a very experienced management team and board with decades of experience in creating value in multiple businesses with strong corporate governance. Our three main business segments are led by experienced CEOs with domain knowledge over three decades.
At Jubilant, our vision is to attain global leadership position, continuously create growth opportunities and enhance return on capital for our stakeholders, and we'll see and examine that in more detail. With this, I would like to invite Pramod to elaborate on the pharmaceutical business in more detail. Over to you, Pramod. Thank you.
Thank you, Arvind. Very good evening to all. May I request next slide, please. I'm Pramod Yadav. I will introduce Jubilant Pharma business briefly and subsequently each businesses will be covered in detail by the respective business presidents. As Mr. Bhartia mentioned, we started building up Jubilant Pharma business in 2003. On the top portion of the slide you can see the timelines, the way we kept on building the businesses. You may see on the bottom left of the slide that our three business segments are Specialty, CDMO, the generics. may notice that while most of Indian pharma companies are focused on so-called the generic segments, we are very unique in that sense, where specialty and CDMO contributes 75%, the generics is balanced 25% in our portfolio.
This makes our majority of revenue coming in from segments which have higher growth potentials, more barrier to entry, and also sustainable margin on the long run. Few key business highlights on the right bottom of the slide. We have about 80% revenue coming from North America, six manufacturing sites, strong R&D capabilities, serving to more than 80 countries globally, long-term relationship with the who's who in pharma industry, very diversified business models with only 40% supplies coming from top 10 vendors, only 32% revenue from top 10 customers, and only 30% from top 10 products. Very diversified in all the aspects. 5,200 employees globally with 2,300 in North America. Last but not the least, highly qualified, dedicated, and experienced management team and the board. Next slide, please. Here you can see we have six manufacturing sites, two each in India, U.S., and Canada.
Since 80% of Jubilant Pharma's revenues come from the North America market, each site is inspected by FDA regularly, and you may see last inspection details on the bottom left of the slide. In addition to FDA sites, are also inspected by various other global regulatory authorities. To further explain Indian sites are at the Roorkee manufacturing generics, at the Nanjangud for the API, U.S. site in Salisbury is the generics, spokane CMO, as well as CMO for sterile injectables, as well as allergy immunotherapy. At Montreal, we have sterile and non-sterile injectables, ophthalmics, ointments, creams and the liquids, and also radiopharmaceuticals. In addition to this, what you don't see on this slide is that we have network of 48 radiopharmacies in 22 states in the U.S. Next slide, please.
Here on this slide, we are explaining you that in each of the businesses we are in, what are the key characteristics, what are the market dynamics, and how considerable headroom we have for growth in each of the business. I mentioned earlier, specialties are niche, U.S.-focused, high barrier to entry, and the businesses require front end. We have our own network of radiopharmacies and in both the Radiopharma as well as Allergy, we have our large front-end sales team. While most of these businesses are through long-term contracts, having complex supply chain and having limited players leading to concentrated market. The Radiopharmaceuticals currently are growing by about 6%-8%, and in fact, having potential to grow even at much, much higher rate, and Sergio will explain that. In CDMO business, that's operation-oriented, requiring cost and quality leaderships with agile R&D in API.
In the CMO business there's a lot of tailwinds currently due to shortage of sterile injectable capacity, and which got further fueled with the increasing vaccine demands with current ongoing pandemic situation. Has high entry barrier due to strict quality and the GMP requirements and also high capital cost. On quality, would like to highlight that we have very clean quality record and in Spokane our recent FDA inspection with the zero Form 483 observations. API also having tailwinds currently due to the disruptions in China and also favorable policy reforms like the Production Linked Incentive schemes in India. the generics, here also demand is shifting towards the complex APIs. Both these markets, CMO and the APIs, are also growing in the range of 6%-8%. Finally, generics, which requires ability to continuously identify niche products and then also launch them.
As of now, there is improved outlook in U.S. market and also non-U.S. market, which is stable with the de-risked growth opportunities. Overall generic market is also growing by 6%-7%. Next slide, please. While we operate in the diversified business segments, each of our business currently is at different stage of evolution. Let me explain that. In 3 of our businesses, which are Radiopharmaceuticals, Allergy, and CMO, we are sustaining momentum. We are maintaining the growth rate and also protecting margins and generating healthy cash flow. Like in Radiopharmaceuticals, we have the leadership in the profitable products like MAA-DTPA. We have highly advanced PET cardiac products like the RUBY-FILL, which continues to grow rapidly. In Allergy business, we have leveraged our strength of the allergy venom sole supply position, build higher market share in the U.S., and adding the capacities.
In CMO, we are not only sweating our existing assets to maximum, but also expanding Spokane sterile fill and finish capability, the capacities by 50%, and entering into niche, the ophthalmics in Montreal next year, which Amit will explain with the state-of-the-art preservative-free technologies. However, the API the generics are the businesses which we shall scale up by leveraging the leadership positions, by customer relationships, and by focusing more onto the research spent on complex or the difficult to enter segments. Unlike other businesses, the Radiopharmaceuticals business, however, is at a turnaround phase. For that, we have developed solid action plan comprising of commercial excellence, under which we will drive market share and growth, and operational excellence to drive efficiencies in operations as well as the procurement. Next slide, please.
If we look ahead in the market, markets are already in place for the sustainable and accelerated growth across each portfolio. Each of the business is at a different stage of evolution, as explained on the previous slide, we also at the same time have robust growth-oriented strategy in place for each of the business. The business presidents will be discussing same in details, let me explain in brief. In Radiopharmaceutical, we will continue to grow our RUBY-FILL, launch our NDA I-131 MIBG, which is having market potential of about $240 million. We have our own R&D pipeline of seven products, which we will launch over the next three to four years, having market potential of about $300 million. We are also working on growing theranostics and the new products under pipeline under various partnerships.
In Allergy, we are entering into partnerships with the distributors ex-U.S., and there we will grow the market rapidly. We are also exploring opportunities of launching the adjacent products in our allergy immunotherapy. In CMO, other than expansions already announced, we are also evaluating further expansions in sterile fill and finish capacity in Spokane, which will double the capacity from the current level, as well as Montreal, where we are increasing sterile fill and finish capabilities or the capacities by 150%, and also evaluating new ophthalmic line other than the one which is already as of now under commission. In API, while we continue to debottleneck existing Nanjangud site and improve assets throughput, we are also evaluating greenfield site to cater to increasing customer needs. the generics, we have 37 pending ANDAs for approval, which we will be launching post-approvals.
Various U.S. products we are extending to focused pharma emerging non-U.S. markets and our own front-end presence in some of the selected markets. In Radiopharmaceuticals, as explained earlier, we have the turnaround plan in place to eventually target the single-digit positive EBITDA margins. We have many fundamental capability investments already made in our network, which is predominantly being SPECT. We made strategic investment into SOFIE Biosciences, who has the complementary large PET network of 14 pharmacies. This will help us to target the large IDNs jointly, by which will be offered to our customers full basket of the products. We plan to expand our network by opening up more of the pharmacies in those metropolitan areas where currently we are not present. Next slide, please. With all these, the stage of evaluations where we are and in each of the businesses, we have a huge growth opportunity.
On this slide, let me explain you what are the five key differentiators we have for the Jubilant Pharmova business. While for each business we have focused growth strategy, we will sustain the outperformance in each of the businesses. The first key differentiator is the diversified portfolio. Whether it's the business segments or the customer base, the vendor base or the product range. Though we remain focused with the U.S.-centric front end, which drives innovation at the back and in the R&Ds. However, same gets supported by the robust operations we have in the low-cost economies of India. The second is scale and leadership in each of the businesses.
While Specialty business leadership in U.S. will continue to grow with in-house R&D as well as strategic partnerships, we will at the same time also grow our CMO, API, the generics by addition of more manufacturing capacities and focusing on rather more complex molecules. Third is the sustainable moats for high entry barrier in a few of the businesses, clubbed with the long-term contracts, which makes the entry barrier even more stronger. At the same time, various portfolio synergies help us to keep our cost in checks. Like the vertical integration we have in API the generics. we make energy and radiopharmaceutical products in our own sterile facilities. We are integrated in radiopharmaceuticals and the pharmacies. Fourth is strong mergers and acquisitions and the turnaround muscle and sustainable operations in long run.
Each of the business since we acquired, we invested in strategic growth CapEx, invested in human capital, we have grown the revenues and the margins multiple times. Let me give you examples. Like API, we have grown 7 x since we acquired it in the revenue. In the dosage form in U.S., we have grown 30 x. The Spokane business we have grown 3 x since the acquisition. The Montreal business we have grown 4 x since the acquisitions. This demonstrates our expertise in identifying and integrating the assets and then sweating the assets. We are in the process of doing something similar turnaround in Radiopharmacy business as of now, while we are also expanding our innovative pipelines through partnerships. Fifth one is, of course, the experience-proven management team.
While our each of business is focusing independently, headed by the respective presidents who are experienced leaders having deep insight of industry and proven track record for themselves. With this, I sum up overall Jubilant Pharma introduction, and I hand over to Sergio to walk you through Radiopharma business in detail.
Thank you, Pramod. Good evening to everyone. It's a pleasure to be here. I'm Sergio Calvo, President of the Radiopharmaceuticals Division. I'll be presenting Jubilant Radiopharma, which includes radiopharmacies and radiopharmaceuticals. I'll start with Radiopharmaceuticals with next slide, please. Next. Jubilant Radiopharma serves the nuclear medicine specialty. Nuclear medicine is a medical specialty that uses small amounts of radiation to diagnose and treat disease. It's widely used in the world with more than 40 million procedures in the world, half of them approximately in North America. Nuclear medicine as an imaging or diagnostic modality is similar to other diagnostic imaging tests like X-ray, CT, and MRI. The difference is that in nuclear medicine we inject the radiation into the patient, so it's a chemical process in which the radiopharmaceutical, which is the combination of the drug and the radioisotope, is metabolized by the body.
Which means we will take a picture of the physiology or the biochemistry of the patient, and the image is very rich in clinical information for the physicians. There are two types of imaging modalities in nuclear medicine, so-called SPECT imaging and PET imaging. The difference is the way the radioisotope decays, the type of radiation emitted, and the equipment that is used to photograph that radiation. There are many applications for SPECT, many others for PET, some of them overlap. PET is known to be a little more powerful in terms of image resolution, but SPECT has many merits and qualities as well. The fourth row of this slide, you see the most interesting area of nuclear medicine at the moment. Nuclear medicine can be used to treat disease. It has been used for many, many years, 80 years to be precise, in thyroid imaging, for example.
Most recently, we've been able to develop very specific peptides, very targeted peptides that carry radiation to the insides or boundaries of tumors to treat cancer in a very effective way and with low, in general, side effects for the patient. Nuclear therapies or radiopharmaceutical therapies are becoming one of the most powerful tools to treat cancer. The combination of imaging and therapy using the same molecule is something unique of nuclear medicine. This is being called theranostics. Theranostics is a term used in other contexts, but most prevalent in nuclear medicine today. We'll talk more about the potential of this combination in the subsequent slides. Next slide, please. The value chain of nuclear medicine is very complex. There are many players around the world. It starts with the production of the radioisotopes. Radioisotopes can be produced in nuclear reactors or particle accelerators.
This slide is showing a nuclear reactor chain. There are only a few of them in the world. They're expensive operations to run. From them, they go into so-called processors. Those companies that you see listed here, they purify the radioisotopes and make them ready for medical use. It goes to manufacturers of radiopharmaceuticals, companies that will combine them with the drugs to make radiopharmaceuticals. That's where we play. From this point, we move into the commercial or in-hospital radiopharmacy. That's where the individual patient doses are prepared. We also play a very important role in this field, as Pramod Yadav mentioned. We have a network of radiopharmacies. We are the only major player with a strong presence on both manufacturing and commercial radiopharmacy in North America. SOFIE Biosciences also has a presence on both sides, and they are one of our most important partners. Next slide.
Here we show our estimates based on reliable sources of the nuclear medicine market in the next 10 years. As of today, the market is about $5.5 billion. Primarily based on SPECT and PET imaging. Therapy is a meaningful contribution with about $1 billion. Therapy, as I mentioned before, is about to start growing much, much faster and could reach, according to the most optimistic or perhaps realistic estimates, up to $20 billion globally by the end of this decade. It is a huge opportunity. Mind you that a lot of it will be taken by Big Pharma. They are coming into this field because of its growth potential and their investment requirement. They are required to play. Novartis, Bayer, and many others are investing heavily.
There is a very important role for companies of all sizes, and I think ours is in a sweet spot to play here because most of the cancer treatments or many of the cancer treatments that will arise from this theranostics era will be niche applications. The big companies will not be able to cover them all, and we have a very important role to play. Next slide. This is a snapshot of the current split across companies globally and in the U.S. We believe our position in the world today is number five. We have a very strong presence in North America. Some of the companies listed here are present in more than one continent, like Curium, for example, or GE. We are number three in North America with about 12% market share, according to the latest estimates.
One interesting thing about nuclear medicine as a market is it's very fragmented. There are more than 80 companies playing today of reasonable size and about 100 companies developing nuclear medicine products, many of them trying to develop nuclear therapies, which are the highest potential, as you saw. Many of those companies will need partners to commercialize their products. Next slide. A few words about us. Our division is based in Canada. We are one of the most traditional vendors in this space. We were founded in 1955. Nuclear medicine predates that, but the invention of the SPECT imaging device, the gamma camera, was in 1953. Just to give you an idea of how early we were in this field. We have two pillars in our organization. One is quality. We are highly regulated, and we are known to be compliant with the most stringent quality principles.
The second one is our quest for innovation. We are number three in the U.S. We are leaders in some critical products such as lung imaging and therapeutic iodine. We are the innovation leader in cardiac PET. We'll talk about more later. We have avant-garde programs to treat diseases such as neuroblastoma. Next slide. This is a snapshot of our portfolio. I'll show a few key products in more detail. There are six SPECT products that are generic, one proprietary product in PET, RUBY-FILL, one commercial therapy, iodine-131, and one clinical program for MIBG for neuroblastoma, high potential, and it's going to play a major role for kids. Next slide. A few more details about some of our lead products. On the left side, you see our RUBY-FILL. This is a bedside generator of rubidium-82.
The short half-life of rubidium, only 75 seconds, makes it mandatory to have a generator very close to where the patient is. With rubidium-82, we're capable of creating a very powerful image of the heart. It's the most powerful test, non-invasive test for the heart. We can tell a physician the status of coronary artery disease, and most importantly, we provide very insightful guidance where to intervene if we're going to stent or not. It's a very powerful tool for interventional cardiology and clinical cardiologists. This is complementary to the role that nuclear medicine SPECT imaging plays in cardiology as well, which is widespread, and PET is becoming a more powerful, an evolutionary step in nuclear cardiology and growing fast in the United States, but still with a potential to grow much, much further and much, much further outside of the United States as well.
The second column shows how our traditional MAA and DTPA, we are leaders in these products as well, play a major role in diagnosing pulmonary emboli. 4 million people in the U.S. every year are suspected of having pulmonary emboli, we are the best test to diagnose pulmonary emboli with very, very low radiation exposure. Third column shows radioactive iodine for thyroid disease. This therapy was invented in 1941. It is a therapy that cures the patient. All the new sophisticated therapies that are existing now, they extend the life of the patient, for now. Hopefully, they will do more than that. iodine cures, we are the leaders in North America for this product. Next slide. Looking forward, we will not abandon our current position in any way, there are evolutionary steps that we are planning.
This slide is a summary showing that our current portfolio and strategy will be strengthened. We will continue to invest in SPECT generics. It's a high margin. It is a stable, profitable market. We will grow leaps and bounds our branded portfolio, RUBY-FILL for PET cardiac imaging, huge opportunity and a major role for us to play in cardiology. We are building an innovative pipeline that is going to be primarily focused on PET and even more specifically diagnostics, which, as I showed you, where the opportunity really is. Next slide. This slide represents our playfield. Today, we serve about a $400 million market size. Mind you that I'm here talking about the product specific segments, like what's the market size of MAA in North America, which is where we are.
When I add up the markets that we currently serve in the geography where we are currently really acting, it adds up to about $400 million. That's our playfield. By introducing new products by ourselves and with our partners, we're going to enlarge this playfield to more than $1 billion, more than $1.5 billion within the next five years. This is not accounting for any mergers or acquisitions that could take place during our history. This is only through planned initiatives that we have under execution at the moment. With further inroads into therapies, which are also in planning stage, we plan to expand our market potential to the range of $5 billion during the next decade. That's our goal, that's our aim, and I think it's our duty to actually play a major role in the expansion of nuclear therapies. Next slide.
Here I show a little more about the strategic pillars of our growth strategy. The first column shows expanding the core portfolio, how stable and strong the SPECT market is in the U.S. That's one of the things we are doing, expanding that portfolio. Second, play a major role expanding the cardiac PET market. It's an opportunity, and it's a social role that we can play making cardiology a better tool and more powerful for physicians around the world with RUBY-FILL. Third role, our ongoing MIBG program for neuroblastoma. About 800 children are diagnosed with neuroblastoma every year, and many of them could benefit from this treatment. We have a clinical program, two clinical trials, an expanded access program to provide this treatment to as many kids as we can, and hopefully, we will have a commercial product available within the next 2 years.
Fourth pillar, strategic partnerships. We have announced two already. I will detail a little more about them in the next two slides. Those are fundamental for us to expand even more our capabilities and be a more integrated company in the radiopharma space. Finally, we are very attentive and actively pursuing inorganic opportunities. As I said, there are about 100 companies developing nuclear medicine solutions around the world. Many of them would benefit from partnerships, and we are actively pursuing them. Next slide. Few words about SOFIE Biosciences. This partnership was announced in November 2020. This company is founded on innovation. They have a network of radiopharmacies in the U.S., and they were blessed with very fortunate strategic moves in the recent past. SOFIE has state-of-the-art CMO facility for therapeutic, which they planned way before this boom was starting to happen.
They also have manufacturing distribution agreement with Lantheus for the drug PYLARIFY, which was approved by the FDA just two weeks ago. This is a targeted PSMA agent for prostate cancer, which is one of the fastest-growing fields in PET in the world. SOFIE Biosciences will be part of it. SOFIE Biosciences also has an exclusive manufacturing distribution agreement for most geographies of the U.S. for the Life Molecular Imaging drug Neuraceq. This is an amyloid imaging tracer primarily for Alzheimer's disease. The drug has been approved for a while, but the road starts now because two weeks ago, the FDA approved lecanemab, Biogen's drug, first disease-modifying drug approved by the FDA for the treatment of Alzheimer's disease. The usage of this drug most likely will require an amyloid scan before the drug is approved. This market is about to grow very fast.
SOFIE has 70% of the rights of the family of FAP or FAP-targeted, or FAPI molecules developed by Heidelberg University. FAP is a miracle tracer for PET. It will be a revolution in many ways. It provides a very high signal-to-background ratio, high resolution, and has a very specific tracer for solid tumors. From a diagnostic perspective, it's going to be a revolution. From a workflow perspective, this tracer can be injected, and the patient can be imaged immediately. The conventional tracers like FDG requires the patient to rest for about one hour before the scan starts. It's also a workflow revolution for PET centers. FAPI molecules, because they're specific, they can be used for diagnostic and treatment.
There is studies already showing that when we combine FAPI molecules with treatment isotopes, we can use it to destroy the cancer or to tear down the cancer walls, the so-called stroma walls around the tumor. It's going to be a fantastic adjunct treatment for external radiotherapy, chemotherapy, and immunotherapy. SOFIE Biosciences and Jubilant are kind of made for each other. We have perfect synergies, complementary portfolios, complementary skills, and the only thing we have really in common, fully overlapping, is the quest for innovation. Next slide. We also announced in March 2021 a partnership with Isotopia Molecular Imaging. Based in Israel, this company is a world-class multidisciplinary team of scientists and nuclear sciences, radiochemistry, nuclear engineers, physicists and so on.
Two lead products of Isotopia are a PSMA agent, which can be prepared in just five minutes with gallium-68, and lutetium-177, a beta emitter used in therapies and one of the most important radioisotopes in the future of radiopharmaceutical therapies. There are also many synergies with Jubilant. Next slide summarizes. Next slide, please. Here I summarize the only two partnerships already announced. We have many others that we are considering. How we can become or how we are today and will be even more so integrated in the nuclear medicine space by combining our capabilities with those of our partners. This shows from the synthesis of API to the development of molecules, to radiolabeling, to manufacturing, and finally to distribution. We are the most integrated company in the radiopharmaceutical space. On the distribution side, I now will explain a little bit about our strategy on the Radiopharmacy division.
Next slide. Radiopharmacies are the final step of the value chain. That's where we prepare the individual doses for the patients. It's a very complex operation. There are many products involved. We have to be available 24/7 for our customers because most of them can do emergency services, and they require product pretty much anytime, scheduled or not. Usually, we cover a wide geography. For just for my handful of pharmacies for this continental size of the U.S., each of them cover a very large geography. It's a logistics challenge when we're dealing with a product that is decaying fast with radiation. Not an easy operation to manage, but a fascinating business. Next slide. Just like radiopharmaceuticals, radiopharmacies are in the context of nuclear medicine.
The aging population and high prevalence of disease increasing, prevalence of disease in the aging population, definitely they will increase demand for nuclear medicine procedures. Specifically, for the radiopharmacies, the increase of generics pipelines, the ones we are developing and others, usually makes their margins better. Profitability has a natural trend to increase. Their portfolio are increasing because of the development of new PET tracers, new therapies, new SPECT tracers as well, that are proprietary. The portfolio, which bring higher margins, are also increasing. It is a good time to be in this business. Next slide. Besides the high potential, it's not an easy business to get into. It's highly regulated. The supply chain is complex. To place radiopharmacies, it requires a lot of CapEx. Could be to the tune of $5 million, just to put a number, to set up a new radiopharmacy facility.
There are not newcomers seen in this space very frequently. We have a relatively stable competitive landscape. Next slide. This is the competitive landscape of radiopharmacies. We are the second largest network, and we serve a base of about 1,700 customers. On this list, you see Cardinal Health, which has PET and SPECT pharmacies. We have primarily SPECT pharmacies, and SOFIE Biosciences, shown at the bottom of this page, is primarily a PET radiopharmacy network. Combining the two networks, we can be much more comprehensive in our portfolio. The third one, PETNET Solutions, is only PET, RLS is only SPECT, and PharmaLogic is primarily SPECT. With the partnership with SOFIE, Jubilant and Cardinal Health are the only two truly players on both PET and SPECT. Next slide. Here we show the U.S. map. Blue dots are our radiopharmacies, 48 locations, 49 radiopharmacies.
We have here also shown the SOFIE PET pharmacies in red. Our key figures are shown here. We have about 760 employees. We serve 1,700 customers. About 3 million doses are delivered every year. That is not accounting for SOFIE, which would add another half a million to this number. Next slide. Radiopharmacies, in its future, we have a lot of key differentiators. The vertical integration with JDI brings safe supply chain. The partnership with SOFIE, possibility to provide a comprehensive portfolio, one-stop shop for customers. Number three, second-largest network, convenience geographically to serve customers, and we are planning to expand to about 20 new sites in the next five years. Early access to innovative products through the vertical integration with radiopharmaceuticals. Fifth, perhaps the most important, we have a strong track record of quality and good service. Next slide.
To close, I'll leave you with our strategic pillars for the Radiopharmacies vision. Driving operational efficiency to reduce costs, improve efficiencies, drive commercial excellence to increase our market share, and finally, drive network optimization and expansion to serve an even larger base of customers and seize opportunities in the U.S. I'll conclude by saying Jubilant Radiopharma is in a fascinating field of nuclear medicine, one of the fastest growing fields in medicine, and one of the best opportunities for our company. With this, I turn to Chris Preti to present the allergy business unit. Over to you, Chris.
Thank you, Sergio. Good evening, everyone. My name's Chris Pret i, I have the pleasure of actually representing the Allergy business unit as the President. What I'd like to do is first define what I mean by allergy immunotherapy. Specifically, this is all around treating the underlying cause of the disease, what's causing the reaction to the allergen, versus just suppressing the symptoms that are causing the reaction. In particular, if you look at the market itself under AIT, allergy immunotherapy, there's two main groups. The first group is what's called subcutaneous immunotherapy, otherwise known as SCIT. These are allergy shots. Worldwide, this is the most predominant form of allergy immunotherapy, SCIT. The other form, lesser, is called SLIT, sublingual immunotherapy, and this comes in the form of drops or tablets.
If you look specifically at the U.S. market, over 90% of the U.S. market is in the SCIT form or shots. Outside the U.S. is SLIT predominantly, or the tablets and the drops. Going one step further and looking at actually the SCIT marketplace, there's another category under the SCIT marketplace, which is venom immunotherapy, otherwise known as VIT, venom immunotherapy. Specifically, this is very important therapy for individuals who have anaphylaxis or a reaction to flying, stinging insects, such as bees, for example. The reason I highlight this is in 2018, following ALK-Abelló's exit from the U.S. market, Jubilant HollisterStier became the sole provider and supplier of VIT, venom immunotherapy, in the U.S. marketplace. Next slide, please.
If you look a little bit about my business, specifically, there's over 100 different allergenic extract products that we offer, SIX different insect products, and an exclusive array of skin diagnostic devices. We're the number two player in the allergenic skin U.S. marketplace, and there's a high barrier to entry because these are biologics that have been grandfathered in their biologic license application, or BLA, into the U.S. That's a high barrier to entry to competitor entrants.
The marketplace in the U.S. consists of two customer groups, allergists and ear, nose, and throat physicians, or ENTs. The products are sold under the HollisterStier name in the U.S. because that name goes back over 100 years in the allergist community. With that name comes a lot of equity and a lot of reliability in terms of quality for allergy treatment. We have a dedicated sales force in the U.S., and we have key distribution partnerships to allow us to actually introduce our products in Europe, Canada, and South Korea. Our products are manufactured at our Spokane facility, approved by the U.S. FDA and Health Canada. We're one of two suppliers with onshore manufacturing and the only manufacturer of venom in the U.S., which provides a potential strategic advantage, as I mentioned earlier. Next slide, please.
If you look at our categories of products, there's three major categories. On the left is our non-venom extracts. These are the 100 + different products that are produced in a unique acetone precipitate process using phenol-free excipients. What this means is at the end, the product that is produced is more potent and more robust, providing us an advantage in the marketplace. This provides an array of non-venom products, from dog to cat to mite to mold, to an array of pollen options for folks who suffer from allergens. Our in-house capabilities, we have small scale fills and also commercial scale lyophilization. In terms of the middle column, this is our venom products. This is our anchor to our business. One of the reasons why is in the U.S. alone, 16 million Americans are at risk of anaphylaxis reaction to a flying, stinging insect.
There's over 230,000 hospitalizations, ER visits every single year because of an anaphylaxis reaction to a flying, stinging insect, 60 deaths a year. That's why it's critical to have an option, venom immunotherapy or VIT, that's highly efficacious, this is, ours is, in 98% of the cases to provide this therapy and this significant benefit to patients. We cover the whole array of flying, stinging insects listed on this slide, from honeybees to hornets, to wasps, to yellow jackets, and mixed vespids. Then our third category on the right is our trading goods or our skin testing devices. Once again, these are unique in terms of the actual stainless steel tip used actually provides less or minimal trauma to the patient when testing for appropriate allergies. Next slide, please. In terms of key sources of differentiation, there's four main buckets.
The first, as I mentioned before, is we're the sole venom supplier in the U.S. marketplace. Customers like to buy the portfolio of products, having a portfolio of non-venom extracts plus venom allows us to uniquely differ our products and our offer to the customers. We also have the opportunity as the sole provider in the U.S. marketplace to double the opportunity, to double the amount of doses in the U.S. marketplace as it relates to venom immunotherapy. We're aggressively promoting through our Bee Aware campaign, this is a digital campaign to raise awareness around venom anaphylaxis and the importance of getting diagnosed and tested. Our second differentiator is these are biological products with very difficult-to-replicate supply chains. Over the years, many years, we have optimized the supply chain of this natural biological product.
We have optimized it such that we now have a consistent and reliable supply of these products. As I mentioned earlier, that coupled with the fact that these are grandfathered in biological license application products, it provides us a barrier to entry, a competitive advantage within the marketplace. The third differentiator is onshore manufacturing. Specifically, as I mentioned, we're the only venom provider in the U.S. marketplace, and we're investing in new capacities. Our capital is predominantly going towards increasing our capacity so that we can meet 100% increase in increasing demand in the U.S. and ex-U.S. as it relates to venom and non-venom extracts. Our last differentiator is branded differentiated portfolio. We have new offerings coming out of our R&D pipeline, specifically a dog and cat product, and we continue to leverage the HollisterStier name and the equity that brings with the allergist community. Next slide, please.
This is just a quick example of some of our aggressive Be Aware promotion and digital campaign that we're doing. This runs the array of resources, specifically patient testimonials as listed on the left, patient educational materials in the middle column, digital assets illuminating and highlighting the importance of getting diagnosed, how many individuals specifically suffer from venom anaphylaxis potentially, and the seriousness of this disease. On the right, resources for patients and individuals to look up and identify their local allergists to go in and engage with them about appropriate diagnosis and testing in the venom immunotherapy space. Next slide, please. To close, our strategy going forward. Next slide. Thank you. Our strategy going forward. Today, the health of the Allergy business unit is very strong. In the future, the health of the business will be even stronger.
We have a good future strong growth through two aspects, growing our venom and non-venom business in the U.S. and growing our ex-U.S. venom footprint and expanding our venom outside the U.S. There's three pillars that will support this growth and this strategy. The first on the left is leveraging existing capabilities. Specifically, this is around being the sole provider of venom and offering that portfolio of products, venom and non-venom, to the customers, doubling the amount of doses worldwide that we produce from approximately 500,000 to 1 million over the long-term horizon. Aggressively promoting our Be Aware campaign is also leveraging our existing resources. Finally, leveraging the HollisterStier brand name and the equity that provides to the allergy community. The middle pillar is all around enhancing our U.S. footprint and our portfolio.
Specifically, now that we've actually optimized our supply chain, we are changing the customer mindset from made to sell to made to stock, and giving the customer the reliability that we can supply the whole array of antigens and extracts that they're looking for. We're evolving our digital campaigns as well to make sure that we can engage with the customers where they want to engage with, and we're upgrading our capacities, as I mentioned earlier. Specifically, the majority of our capital plan over the next five years is to upgrade our facilities so that we can meet the increasing demands that the market will actually tell us over the next five years. The last pillar on the right is expanding target markets and portfolio. There's two elements of this.
One, the new launches that I mentioned, specifically coming out of our R&D portfolio, one for dog and one for cat, which will allow us to continue to differentiate in the marketplace. Two, ex-U.S. expansion, specifically within venom. If you look at the entire worldwide venom market, 98% of the market is comprised of two players, Jubilant HollisterStier and one other player. We will tap into that continued opportunity and that footprint ex-U.S. through strategic partnerships, as I mentioned before, through establishing our own presence through Jubilant in some of these local affiliates, and then through partnerships with local entities where that's required so that we can continue to grow our ex-U.S. venom footprint. I'll close by saying the health will continue to be strong, and we will continue to grow our business through U.S. expansion in venom and non-venom, and further venom expansion outside the U.S.
Now it's my pleasure to turn it over to my colleague, Amit Arora.
Good evening, everyone. It's a pleasure to meet all of you virtually. Thank you, Chris. If you can get to the next slide. The global CMO pharmaceutical industry has continued to grow. It's continued to grow in high single digits. Within that, if you really look at the injectable market, that is growing pretty much at the fastest pace as we know today. The sterile injectable demand continues to be strong because of rise in demand from new launches, including COVID. Over 70% of the molecules are what Jubilant can handle at both of their sites, Spokane and Montreal in Canada. The ophthalmic demand, another area where we have continued to focus on and invest, is growing significantly again because of the aging population.
Ability for us, it's about how the preservative-free market is growing, which prevents irritation to the eye and increases life of the product in the hands of the patient, where Europe is pretty much getting onto preservative-free, and U.S. will follow over the next two to three years, where we are investing in. Now, the trends in the CMO business, they're fairly strong, as you would have also seen with the COVID opportunities in the past where, in the last 18 months, where all these virtual companies have passed on their business to CMOs like us. The trends are also from the perspective of shortages in the injectable drugs and injectable capacities, where Jubilant is gaining because of that shortage in capacities.
The technical expertise in the drugs where we are a niche player and have very strong relationships with existing customers, which I will talk about on the next slide. Sterile injectable business, which is again at both our sites in Montreal and Spokane, accounts for over 80% of the revenues. Non-sterile products, which are majority of them in Montreal, account for 20% of our CMO revenue. In injections, we can handle vial sizes from 2 mL - 100 mL, and our batches can go as high as 2,000 liters. We have a very robust order book position as of today. As I mentioned about the partnerships, we serve seven of the top 20 pharmaceutical companies globally. Our relationships with almost all of them extend beyond five years, which has given us consistency in our operation and growth as well.
Our sites, Spokane, it manufactures clinical and commercial fill-and-finish batches for parenteral drugs. Montreal is a multi-dose form capability, which includes injectables, ampoules, solids, semi-solids, and liquid creams and lotions. A very strong inspection track record, as you would have heard Pramod mention earlier, that our last inspection with FDA resulted in zero 483s, and we are very proud of that inspection history with a lot of other regulators, including Russia, Korea, Japan, and ANVISA. Again, we spoke about investment earlier. Our $92 million investment will increase our capacity by 50% in Spokane. We have another preservative-free ophthalmic line coming up in Montreal, and we are pretty much one of the only CMOs who's investing in ophthalmics in North America. If we move on to the next one.
What I'm trying to do, again, you've seen some of the announcements we've made on our COVID-related products in the last some months. We've continued to look at expansion across the board. Other than the expansions already announced, we are looking at another brand-new line, high-speed isolator line at Spokane, which potentially will double our existing capacity to. We're also looking at expansion of our Montreal facility, where tripling the capacity on sterile fill-and-finish over the next four years, and have potential to increase our revenue significantly. As we leverage our existing assets and expand on the existing sites, that would also result in a margin expansion across both sites and the CMO business. We've continued to work on operational efficiencies, which I think, as most of you would be aware, is the core for a CMO. We continue to focus on our first time right.
We continue to focus on minimum deviations on the batch, increased product yields for our customers and patients, and very high capital efficiency through business excellence initiatives where we are invested on our sites. Our focus has always been with new lines coming in, new customers across all dosage forms. We continue to support our customers in new product launches and that's through the development phase, because then the opportunity comes in, we can track it. One of the opportunities which we publicly announced is obviously Gilead remdesivir, which we started manufacturing for Gilead from the development phase almost four to five years ago. As the opportunity came in, we really encashed on that for our site. We continue to focus on creating long-term, high-value contracts with large pharmaceutical companies to continue to grow.
Including COVID projects. All excluding, we continue to grow our business, grow our current products with existing customers and also getting new products starting from clinical phases in all dosage forms. Thank you with that. With that, I pass on to Terry. Sorry, API. Gunjan. Apologies.
Thanks, Amit. Good evening, everyone, once again. This is Gunjan Singh, and I am responsible for the API business at Jubilant. I will now take you through the business in the next few slides. Well, as you all know, API is in a very interesting phase currently, especially in the Indian context. Looking at this chart over here, if you see from a usage point of view, the API can be classified under two buckets, either it is outsourced or captive. At Jubilant, we play on both, but the dominant play is on the outsourced one. From a patent perspective, the below pie chart if you see, that classifies depending upon the patent, whether the API is for innovator or for generic. Here our dominant play is on the generic side.
Overall, long story short, it's close to around $48 billion worth of addressable market that is available to us from an API standpoint. Next slide, please. Regarding the highlights of our business. We are playing largely in the regulated market. More than 60% of the sales are coming from U.S., Europe, and Brazil market. Also, most of these relationships, as Amit just mentioned in his section, several of our relationships also extend beyond a decade or so. As I earlier mentioned, around 80% of our revenues are coming from third-party sales, which is non-captive usage of the API. Also, from a portfolio standpoint if you see, our dominant presence is in the lifestyle-related therapy. What this means for us is that it gives us a larger market size to address. At the same time, there's a consistent demand for these kind of products there.
Over the period of time, Jubilant has very successfully developed its own niche in some of the select geographies. Geographies such as Brazil, South Korea, Middle East. We have a very regional play as well, in terms of partnerships with the local regional dominant formulators there. Our facility at Nanjangud provides API globally and has been approved by FDA, PMDA, Japan, Korea, COFEPRIS, Mexico, and [GSA]. All the global certifications are available with the facility. As you can see over on the right side as well, this is the list of API where we have a dominant market position in terms of market share globally. Ranging from around 10%-20% and going as high as 50%-70% odd in select APIs. This kind of a dominant position also helps us in bucketing or basketing our APIs and further strengthening our customer relationships. Next slide, please.
We'll now talk quickly around our USPs, our key sources of differentiation. As I was saying in the previous slide, our leadership position in some of these products, especially the franchise products such as carbamazepine and oxcarbazepine, innovative, help us have a deeper share of the customer's wallet. Also, in addition to these niche APIs, we are also present across multiple product ranges, including products such as valsartan, azithromycin, irbesartan, and so on. Our R&D capabilities are really distinguished, and these help us in adding the complex APIs. Which is now currently as well and going forward as well will be the key thing in demand. We have invested a lot in terms of developing and strengthening our relationships with the customers, and several of our relationships extend beyond decades there.
We also know that in the generic industry, it's important that we always keep our costs under control. Our key focus has been on cost reduction through R&D and process chemistry. At the same time, doing more from less. That's through the water-making initiative that our Nanjangud facility. Additionally, we also are privileged to have our own forward integration with the use of API in captive formulation products through our dosage teams. Next slide, please. Coming to our strategy going forward. As a business, we have chosen these three key pillars in terms of charting out the future growth for us. The first pillar is around putting focus on more sustainability and more predictability. If you see on these pillars, if we analyze the new business, the new growth, there we want to have a more robust and agile portfolio.
At the same time, we are expecting close to around 20% of the revenue to come in from these select portfolio additions. At the same time, on the existing portfolio, we are going to focus on further de-risking and sustaining our cost leadership on the products. The second pillar for our strategy is to invest in growth. This typically involves investing in debottlenecking, investing in niche R&D investments, and also investing in new capabilities and capacities. We have recently initiated designing work for a greenfield product at our SEZ in Bharuch as part of our further capacity addition. The last pillar here is to invest in relationships. Basically, this means that expanding our entry further into the emerging markets and strengthening the position into U.S. and Europe markets. At the same time providing a more significant value proposition to our customers.
Last but not the least, strengthening the approach of the organization to be a more customer-centric organization so that we take this business to the next step. With this, I will hand over this to Jasdeep and Terry, my colleagues, who will explain about the dosage business.
Thank you, Gunjan Singh. I am Terry Fullem. I am the President of Jubilant Cadista, which is the U.S. Generics business for Jubilant. I will be speaking to our global dosages and formulations business. On the first slide, I am just going to go through the first few slides, just a brief overview of the market. I think many of you are familiar with our market, but I am not going to spend a lot of time on this. The global generics market in 2020 was INR 329 billion. That is expected to grow to about INR 475 billion-INR 500 billion by 2025. If you look at some of the trends that are going on, the volume in the generic segment is really driven by patent expiry of a number of molecules, and I will show that in a minute.
There's also, going along with that, increased affordability and access to pharmaceuticals with this shift. At the same time, going in parallel to that is a move towards complex generics. Next slide, please. This is a breakdown of the different types of markets and also where the industry expects them to go. The light blue is the generic portion of spend. I'm highlighting spend because scripts is slightly a different story. On a global basis, about a quarter of the spend is in Generics, and if you look at the developed markets down at the bottom, that's 16%. If you look at script volume, that's actually a very different story. In the U.S., for the generics make up about 10% of the spend, but make up 90% of the scripts. 90.
It's kind of flip-flopped the generics are low priced, but our innovative products are very high priced. If you look down the road to 2025, I expect the global generics to increase in terms of their proportion of spending from 26% to about 30%. That's really being driven by the developed markets. Next slide. This is a graph on the left-hand side of patent expiries and the dollar value of those expiries. Recently in 2020 and 2021, there's kind of been a low point in those expiries, INR 14 billion and INR 16 billion respectively. Going forward, that's going to ramp back up to even higher than it has been in the past. That's really what is going to be driving a lot of this generic growth.
In terms of the first few bullets I kind of already spoke to on the first slide, but some other trends that are going on is really a look at supply chain across the globe. In the U.S. specifically, there is a lot of attention on that, and it's being balanced with concern on pricing of pharmaceuticals and also quality. Those three things are being looked at all at the same time, and prior to COVID, there was already a concern with overseas or reliance on overseas manufacturing, and then COVID kind of exacerbated that concern. There are a lot of policies being proposed in the U.S. for onshoring at least some of the production that has gone overseas. Next slide. That's a little bit about the overview of the market. Now I'm going to talk a bit about our business.
On a global basis, we're a market leader in the U.S. in select products. On the right-hand side, you can see what those products are. We have capabilities in multiple dosage forms. We're vertically integrated with our API business. We also have our own in-house R&D for formulations. We cover broad therapeutic areas, including cardiovascular, central nervous system, gastrointestinal. We have manufacturing facilities approved by U.S. regulatory, U.K., Brazil, Japan, Australia, and South Africa. Our Roorkee, India site expansion was completed in FY 2020, and our Salisbury, Maryland, which is our U.S. site, is pretty much at the end of its expansion, which will increase our capacity by about 85% in that facility.
Our non-U.S. business supplies over 45 countries with 80% of the revenue coming from 10 countries and is really driven by distributor-led and B2B model, while retaining the marketing authorizations in most of those countries. In the U.K. In South Africa, we have recently started our own offices as a part of our long-term plan of going direct to market with our own sales team. This is a significant part of our growth strategy, at least in those markets. Another focus area for us in non-U.S. is branded generics. Jubilant branded products are sold currently in eight countries with a portfolio of 57 products. Next slide, please. In terms of our sources of differentiation, one is how we go about selecting products. We target areas that will be expected to have lower competition. That way, we can have better margins.
We take extra effort in identifying those markets. We believe we are able to do that better than our competition. Also, in terms of vertical integration, we definitely leverage that significantly. 60% of our revenues are supported by our own in-house API, which provides both supply security and also cost advantage. We have calibrated redundancy and manufacturing flexibility in our supply chain. What that means is, in certain products, we dual qualify the products in more than one manufacturing site, so that if there's an issue one place, we can ramp up in the other and respond more quickly. Also, this means dual sourcing a lot of our materials. We have multi-agency approved facilities, and we have durable B2B customer relationships, and seven customers account for about 70% of our FY 2020 revenue. Next slide, please.
In terms of our go-forward strategy, it's really three pillars. First is leveraging our R&D capabilities. We're looking to enter underserved markets through opportunity identification and do that rapidly. That's the key the generics business, is to be quick to respond when you see opportunities. At the same time, we're moving up the value chain to get into more difficult products, and we're doing that partly with our in-house capability, but also partnering where we don't have those capabilities. We are focusing on various delivery systems and dosage forms, and we're ensuring robust formulations in terms of our scale-up to support reliable supply. Often, you grow by your competitors not having good supply, and if you do have good supply, then you're able to fill that gap. In terms of sustainable manufacturing, it's really a balance.
The balance is between cost, supply reliability, and speed to market. To solely focus on any one of those would not be a winning strategy. The secret to success is really doing a good balance of those three to make sure that you do have a good cost position, but that you're able to respond to the market quickly and that you have reliable supply, which is extremely important to the customers. We mitigate our supplier concentration by having alternate sources of API. We file across multiple locations, as I mentioned before. We're exploring additional manufacturing sites, either through partnerships or inorganic growth. We ensure sustained compliance through global regulatory standards to have that consistent growth. Our last pillar is market expansion.
As I mentioned in some of the previous slides, even though U.S. is our biggest business, there's a lot of opportunity in the non-U.S. markets, and we expect to launch a number of products over the next few years, both in the U.S. but also in those non-U.S. markets. New products are expected to add a potential revenue of $300 million in the period of FY 2022 through FY 2026. We're also going to be shifting from a traditional B2B model to a B2C model in some of those key non-U.S. markets to leverage the growth potential there. With that, I am going to hand it over to Chris to walk through our financials. Thank you very much.
Good day, everybody. Christopher Krawtschuk, I'm CFO for Jubilant Pharma. Let me take you through our financial statements and our financial performance for fiscal year 2021. As you can see, we printed $782 million of revenue compared to $803 million, and EBITDA of $177 million to $11 million, respectively. Our revenues by segment were principally driven by specialty pharmaceuticals, of course, CDMO and our generic business as the folks just outlined. Our year-on-year performance as a result of these businesses were really reflective of the performance of our management team and the market conditions in fiscal year 2021, and of course, impacted by COVID-19. As you can see, due to the diversity of our businesses and our markets that we serve our customers in, we were able to seize opportunities in our CDMO business to help our patients and our customers navigate through, and yet still manage risk associated with COVID-19.
Our CDMO business performed extremely well in FY 2021, driven by strong performance and certain one-time take-or-pay contracts and strong performance in our generics business. Was partially offset by the performance of our Specialty Pharma business, which was mostly impacted by COVID-19. Was principally driven by what I would call patient behavior as well as HCP behavior. Principally in the area of lung perfusions, as a result of patients seeking what I would call less accurate kinds of treatments. Effectively happened early on in FY 2021. We see improvement in those COVID conditions today as the U.S. has been almost fully vaccinated, and patients and practitioners are seeking more accurate lung perfusions, lung scans, et cetera. Our specialty pharma business is recovering nicely in that regard, particularly in North America, as vaccines have rolled out.
Year-on-year, our profit after tax was effectively driven by changes in tax rates and driven by our changes in accounting associated with deductibility of goodwill. Aside from the financial performance of our business, let me turn it over to Marcel, who will talk a little bit about our Jubilant Biosys business.
Great. Thank you, Chris. Good evening, everyone. Can we have the next slide, please? It's my pleasure to introduce you to the industry of research as a service. This slide introduces you to what is a very attractive marketplace of global research outsourcing, both in the preclinical stage as well as in the clinical stage. Market has been growing consistently about 7% annually from a number of INR 25 billion so many years ago. We are exceeding INR 40 billion-INR 42 billion in the coming years. The market is continuing to grow. We see signs of that. If we look at the drivers of that growth, it is driven by the very high-cost escalation that society and industry has seen over the past few decades. You've all heard of the billion-dollar plus development cost of a new medicine, which includes all the failures, of course.
The industry has been looking for ways to trim costs to reduce that number and become more efficient. One of those ways was outsourcing their services, and that is notably taking place in the small molecule area, which is the area that Jubilant Biosys focuses on. Big pharma companies are focusing on their core competencies, development, and commercialization, and they are increasingly relying on virtual companies which have emerged. Those are the biotech companies that we read exciting stories about in the press, notably in the U.S., some in Europe and other geographies, who feed, who develop compounds, discover compounds, and license them out with sufficient clinical data. My colleague Syed will give you a lot more insights in the next presentation.
The other benefit of outsourcing is, of course, that rather than invest and maintain very advanced research laboratories, huge staffs, which are fixed costs in nature, you actually pay for research as you need it. As soon as you have candidates and you go to the clinic, you can convert your efforts from the research discovery phase to the development phase and move your finances with the phase of the compound. That has proven to be a very efficient methodology. Next slide, please. What does Jubilant Biosys do in this industry? On the left-hand side is the snapshots. We have capability and scientists, which provides new drug discovery services to those innovators in the U.S., Europe, and Asia Pacific, including Japan. Those are the markets where we see innovation taking place primarily. We can offer integrated drug discovery service.
That means we can offer a portfolio of services that combines leads to a new candidate, which can go to clinic, and that requires all of the services that I'll introduce a little bit later. We can do functional services, which is essentially a menu, and depending on the requirement of an innovator, we can offer chemistry, biology, or further testing of those compounds in live and cell-based systems. The business is driven by a number of long-term relationships which give stability and also give references to expand our business in the future. We have, in addition, engaged in several risk-share discovery projects where we sacrifice some top line in return for milestones and upsides in case programs reach successful next phases.
These services offered out of two locations in India, one in North India, Noida, Greater Noida, where primarily chemistry analytical services take place to make thousands and thousands of compounds that get tested. The ones that make it will then be scaled up in Jubilant Biosys infrastructure for phase I clinical trials. Our Bangalore site is where we have all preclinical services concentrated from biology, medicinal chemistry, et cetera, which are required to serve into an investigational new drug application. The site also houses the brand TrialStat, which is an electronic data capture system for clinical trials. Clinical trials are one of the most expensive parts of developing a new drug. In recent years, the automation and digitization has accelerated. Jubilant is playing its role by a startup, as we call it.
We're developing a software platform that we've rolled out in North America, and all of the services are being developed out of our Bangalore site. Related to that is a foray into digitization services that one can read about in the industry on a daily basis. Machine learning, artificial intelligence, we are making inroads in that to understand the domain, understand how it applies in drug discovery, and how it accelerates drug discovery in the next one or two years. Later this year, we hope to launch some services in this area that will improve the speed of the quality of what we're doing.
If we look on the right-hand side, in the discovery area, you'll see an array of services. I won't go into scientific detail of all of them. It gives you a snapshot of the breadth of capabilities required to both design a molecule, to test it, including animal testing, avoid toxicology effects. Then finally be able to come up with a compound that has the potential to go to human clinical trials. That is a rigor that we find in the drug hunting phase of where we are in this business, which is a very exciting business to be in. The business has been doing extremely well in the past couple of years. We have nearly grown 50% in three years, touching close to 20% year-over-year. We expect to see continued growth in FY 2022.
We will make some major investments that are introduced on the next slide, please. Our strategy is based on four key pillars. The most important one is expansion of capacity and capability in our two key locations in North India, Noida and Greater Noida, as well as Bangalore. The first addition will actually occur in the next quarter. That investment is approved. It is nearing completion. That will more than double our chemistry capability to synthesize complex molecules, which are then ready for the testing phase. In addition, we are in advanced stages of planning a complete new site that will replace our existing site in Bangalore on a much larger location where we can grow. That will also be more than doubling capacity if all is approved later in the year. You will be informed accordingly.
That site will also includes in the plans is a larger GMP pilot plant that will take us up to phase II clinical supplies. It will have an associated expanded process research and analytical research department for new chemical entities CDMO services. That combination of knowledge generation and pilot plans is required. Lastly, we are planning a globally compliant GLP tox lab, where animal studies take place to test compounds for final stages that will increase the number of therapeutic areas that we can offer to customers. That's the foundation of our business. The quality of our business is driven by operational efficiencies. We've been succeeding in a very efficient electronic lab notes book for 500- 600 scientists, which we've done recently that has tremendously improved productivity of the science that we deliver.
We are driving quality, data integrity assurance through a robust system of quality assurance and SOPs, which will lead to ISO certification that we are targeting by quarter one of next calendar year. Jubilant has huge experience with business excellence across all its businesses. We have recently applied that also in the research stage. We've seen amazing results, accelerating turnaround time of 30%-40% in the sweet spot of our business, which is delighting our customers very much and is underpinning the growth that we are seeing. Due to the complexity of the science, we are also focusing on high-end talents, PhDs, as well as global pedigree PhDs with postdocs. Business expansion occurs in the third pillar, new customer targets.
Because the top 50 pharma is increasingly focusing on other modalities, we see thousands of biotech companies emerge in U.S. and Europe, as well as Korea, Japan, Australia, et cetera. We're looking to geographically expand our customer base, and that has been working quite well. We are increasingly looking to close longer-term contracts, which is not typical for this business. Most of it is done relatively short-term focus, 6-12 months. In the past year, we've been able to close two to three year deals with several large VC companies in the U.S. Finally, technology development is critical as finding new drugs is increasingly difficult. Applying new technologies, the earlier-mentioned machine learning AI, which is going to deliver value for us in the coming year. The digital services we're offering, and we are expanding in clinical research through our TrialStat brand.
We are applying chemical technologies such as flow chemistry, which enable synthesis of highly complex entities that are difficult to make in regular setups. Finally, because the biology is increasingly complex, we are investing in new state-of-the-art instruments that give us a higher resolution to model exactly what the compounds that we are making are doing to a cell or an animal in order to select the right candidates. These are the four pillars of our business that has driven the growth rates that I've presented to you in the previous slide. With that, I'll hand over to my colleague and customer, Syed, in Jubilant Therapeutics.
Thank you, Marcel. Good evening, everyone. I'm Syed Kazmi, and I have the pleasure of representing Jubilant Pharmova's proprietary novel drug business, Jubilant Therapeutics, as President and CEO. Jubilant Therapeutics was born out of Jubilant Pharmova's drug discovery organization that Marcel just walked you through. We now have several first-in-class and best-in-class drug development candidates that are moving along very nicely in the area of oncology and autoimmune disorders that I'll walk you through very shortly. This slide, as you're well aware, really describes the multi-step process for novel drug discovery and development, starting from the target identification and validation, then through the process of discovering novel drug candidates and taking those through the preclinical exploratory and candidate selection phase.
On the right-hand side, as you are well aware, the clinical process then starts after investigational new drug applications are submitted to regulatory agencies, and first-in-human studies phase I would then be followed by the mid-stage and the pivotal trials before the drug can reach the market. This cartoon is essentially here to really give you a sense of where exactly Jubilant's proprietary drug development business, Jubilant Therapeutics, stands today. If I could draw your attention to the intersection of preclinical and clinical, we are very excited that we are really at the value inflection point of transforming Jubilant Therapeutics from preclinical to a clinical-stage company, which is really one of the most important milestone in the evolution of a novel drug development business, as you well know.
As I will describe to you later, our advanced program is going through the IND track studies with the IND filing later this year and starting the human studies in both solid tumors as well as blood cancers early next year. There are other programs right behind going through this journey of finalizing and optimizing and doing all the sophisticated animal-based studies to prepare these drug candidates for first-in-human studies. As we go through this journey for a biotech like Jubilant Therapeutics, there are two primary value creation opportunities for a novel proprietary drug business. The one is where you have these wonderful, exciting, first-in-class differentiated programs that can be partnered in a licensing or collaboration setting with large pharma companies. The second value creation opportunity is to access funding through private or public ways.
We will give you an introduction to both of these value creation opportunities for biotechs in general and for Jubilant Therapeutics in particular over the next two slides. Next slide, please. Biotech companies like Jubilant Therapeutics dominate the new drug pipeline with novel agents, as shown here in this summary. If you look at the top bar that represents unpartnered biotechs like Jubilant Therapeutics with first-in-class or best-in-class programs. At every stage of the drug development, these biotechs, which includes Jubilant Therapeutics, have more new drugs in pipeline compared to the large pharma companies that are shown in the bottom bar, the third bar there. The external innovation or partnering with biotech companies are becoming more commonplace for pharma companies to develop new drugs. As much as 2/3 of the pharma late-stage pipelines come from biotech companies like Jubilant Therapeutics and other peers.
Just to give you a sense, the recent data shows that over 1/3 of pharma investment, in this case, the precise number from the recent survey is about 36%, of total investment of big pharma is towards these deals to bring in novel candidates from innovative biotechs. Partnering pipeline programs with large pharma, other biotechs to innovative venture funds with the upfront milestones, royalties, and equity deals is really one of the, like I said before, a key value unlocking opportunity for Jubilant Therapeutics. In our case, we have pursued and will continue to do so, the partnering opportunities at the right value inflection point, which will be typically after IND filing or after having some clinical proof of concept data from our innovative programs to maximize the deal value.
Partnering, as you well know, we have already done with our two prior programs, one with a very top-notch VC company called Frazier, and with a company formed around Jubilant's asset called Lengo Therapeutics, and they've also partnered with Checkpoint Therapeutics before. Going forward, we will continue to explore these value creation opportunities for Jubilant Therapeutics pipeline as well at an appropriate value [inflection] point. Next slide, please. The second value creation opportunity for novel proprietary companies like Jubilant Therapeutics is driven by the fact that there is a lot of attention and demand for biotech companies to attract funding through private-public placement. If you look at the recent data, the biotech IPOs have really grown exponentially.
Also, if you look at the size and valuation of these biotech IPOs, they are all driven by, and especially last year, we have seen a lot of activity in both private placement and public market access for innovative biotechs. The key there is to have a differentiated product for unmet medical need, especially in oncology. Increasingly, these companies are going and accessing external funding now that starting from preclinical to phase I stage. This is a new trend because there is a lot of demand for innovation from investors and from large pharma companies. Over the last three years, we've actually seen a number of preclinical, where we sit right now or soon to be phase I company going public. Majority of these companies have oncology focus, which by the way, we play in the same sandbox.
More than 50% of the IPOs, just to give you an example, in 2020 and 2021 year to date, have lead assets in stages where we sit in today. It's really a matter of generating some proof of concept to give the best possible valuation, and go through some of the private public funding rounds. Last year alone, I think as many as 91 biotech companies went public with a total raise of about $16.5 billion. This year to date, it looks like it will be even better because already close to about 53 biotechs have gone public in the last 6 months with a total raise of $9 billion.
Similarly, Jubilant Therapeutics has an equally, if in some cases better, pipeline with novel targets and advanced preclinical programs with opportunity to raise capital through private placement or public markets over the next 18 - 24 months. Next slide gives you a snapshot of where we are and who we are in terms of our management, our collaborations, and our programs. We are advancing, as I said before, open and selective small molecule precision therapeutics in the area of oncology and autoimmune disease. The company was launched formally about 20 months ago in Bedminster, New Jersey, with discovery labs in India as well. We are now at the cusp of, like I said, transforming the company from preclinical to clinical over the next six to nine months.
We have assembled an excellent and experienced leadership team with both large pharma and biotech pedigree, experienced in bringing novel compounds from discovery to the clinic. We are very fortunate to be working with a number of top names in oncology and autoimmune therapeutics, the key opinion leaders, and our scientific advisory board from world-class institutions such as Memorial Sloan Kettering, Francis Crick Institute in the U.K., Dana-Farber Cancer Institute in Boston, and several others. In terms of our pipeline programs, just to give you a quick introduction, our first-in-class dual inhibitor of two validated oncology targets are now in the IND filing stage, with the filing completed hopefully later this year. As I said, this program is targeted for both solid tumors and heme malignancies.
Our second program is a differentiated modulator of a target that has been well-established to play a key role in a number of cancer types, but more particularly in brain cancers, especially glioblastoma, for which there is very little therapy available, and it's almost a death sentence. The survival is very limited. We have managed to develop molecules that can cross what is called a blood-brain barrier. Not every drug will be able to reach brain because nature has put in this mechanism to prevent some of these drugs to go through brain and have all kinds of deleterious side effects. You can still develop very targeted therapies that can pass through that blood-brain barrier and act on specific proteins or genes to modulate and treat some of these brain cancers.
Ours is a very differentiated best-in-class molecule that is targeted not only for glioblastoma but also for other brain cancer that are secondary to lung cancer, breast cancer, prostate cancer, and so on. Our third program is a first-in-class modulator in the autoimmune inflammation space. This program is also going through the critical IND track studies, and we hope to file an IND for this program as well as for PRMT5 program in first half of next year.
You can see that over the next 12-18 months, we are looking at three of our programs going through the IND filing process and getting ready for clinical studies, which is pretty remarkable if you look at the overall ecosystem of biotechs, because most of these companies with very good valuations usually have one such lead program in their pipeline, and we are fortunate to have three very novel and very selective precision therapeutic candidates that are going through the initial process of IND filing so human studies can begin. We have other programs behind these three, including a checkpoint inhibitor program, which is an oral therapy. As you know, checkpoint inhibitors like PD-1, PD-L1 have become the new standard of care.
It's probably the best thing that has happened to the field of oncology to the point where we are now talking significant clinical benefits from these novel pathways. These are all injectables. Our goal is to develop a small molecule that can be taken orally for long-term maintenance therapy. We have some undisclosed discovery stage programs against difficult to drug targets in the area of what we call oncogenes that are so critical for regulating a number of tumor progression. That's utilizing our state-of-the-art technology platform that is described in the next slide, please. This platform that we are leveraging from our sister company, it integrates computational chemistry, structural biology, and sophisticated methodologies to study protein-protein interactions to understand targets well so we can develop novel small molecule modulators. The goal is to really optimize these modulators with the best possible therapeutic index.
We do that for identifying novel hits and then subsequently optimize these hits into a potential clinical candidate, which then goes through a very sophisticated integrated translational assays to then be able to select and declare clinical candidates. From these efforts, as I mentioned before to you, there are three programs that emerged. I'm surprised to say, without going into too much scientific detail, that the first program, which is called LSD-1/HDAC6 dual inhibitor. You can think about these. These are two targets that belong to a class called epigenetics. These are not specific gene sequencing approaches, but these are the pathways and mechanism that influence gene expression. In this case, these two targets essentially either decrease or increase expression of a number of genes that are involved in cancer progression.
By interfering with this target in a selective fashion, you can interfere tumor growth and in some cases achieve what is called tumor regression without having to affect other pathways where these agents are also involved to a certain extent. The idea here is to develop a selective molecule that we have been able to do with the best possible therapeutic index. Then along with that, we have utilized AI-enabled algorithms in a strategic partnership to identify biomarkers that can be used for selecting patients that are going to respond best to our drug candidate, as well as tracking clinical activity during the trial process. Our second program, as I mentioned, is a differentiated program. As I will show you in a minute, this target has been subject to a lot of interest as one of the primary targets for brain metastasis, brain cancers.
We happen to have a very differentiated molecule with enhanced exposure in both brain as well as in plasma. It has potential for development across multiple tumor types and is going through the final process of lead optimization and the studies that will be needed for eventual IND filing. PAD4 is essentially an autoimmune target. You can think about autoimmune diseases like lupus or rheumatoid arthritis or psoriasis as diseases triggered by autoantigens in the body. Pathways like PAD4 interfere and stop the creation of those autoantigens and thereby treat or help reduce the implications of autoimmune diseases without the liability of immunosuppression. A number of autoimmune targets are out there, like Humiras of the world with TNF or JAK2. This is another target in autoimmune. These agents, while they prevent creation of these autoantigens, they also cause immunosuppression, and patients are more prone to infections.
This mechanism we have chosen, which has this very clever pathway to regulate autoantigens without the liability of causing immunosuppression. Again, like PRMT5, this program is moving along nicely towards IND-enabling studies. This pathway also plays a role in tumor metastasis, so we are looking at a dual track development for PAD4. Next slide, please. How do we compare to some of the other companies that are playing in this space and the indications that we are showing? Just to give you a quick sense. For our dual inhibitor program, as lead indications, we are looking at some leukemia subsets as well as a small cell lung cancer indication, which as you know is close to about 15% of the total lung cell population. There is really nothing other than chemotherapy that works in this disease.
Both these indications, as you see on the right column, are multi-billion-dollar indications. Our PAD4 on the autoimmune side is targeted for subsets of rheumatoid arthritis, some inflammatory gut indications, as well as oncology. As you can see, rheumatoid arthritis is a huge market. There are many agents, but there is still a need for agents that can give you that autoimmune effect without the liability of infection or immunosuppression. In our brain cancer program, as well as some of the lymphoma for PRMT5, these are again billion-dollar opportunities. We are playing in significant markets, and if these agents continue to show the differentiated profile, these will result, hopefully, and of course, as you know, drug development is driven by data, but hopefully in large value assets.
The companies, just to give you a reference point, for our dual inhibitor program, there are two companies, Oryzon and Imago, that are shown bottom right. These two companies have LSD-1 as program only. This is not a dual inhibitor. Their value is largely driven by LSD-1 inhibitor program. In one case, Oryzon, based largely on that one program, has a market cap of $235 million, and another private company just did a Series C with a pre-money of $180 million. The nearest surrogate for our PAD4 program is a company called Padlock, which was sold to BMS not too long ago in the discovery stage, even earlier than where we are today, for a deal value of up to $600 million, including upfront of $150 million.
There are many companies that are working on PRMT5 program, but just to highlight a company called Prevail Therapeutics, which just went public. Now has a market cap of $1.5 billion, largely driven by this single program called [PR-001] and another company, Tango Therapeutics, just went through a SPAC merger with a value of close to $1 billion. This is just to give you a sandbox where we're playing and the potential value propositions down the road, depending, of course, on the success of our programs. Next slide, please. Just to summarize, as Jubilant Therapeutics, we are now transitioning to clinical stage, very exciting, and with great programs in early next year with our dual inhibitor program. Like I said, subsets of acute myelocytic leukemia, there are some, again, blood cancer types.
One in this case, it's called MPN, then the select solid tumors with the specific gene signatures. Next, we will be filing for NDA around the corner, in first half of next year. Like I mentioned before, in terms of value creation, we're looking at creating shareholder value in this business through pharma biotech partnership at an appropriate value reflection point and private public equity raise during the coming 18- 24 months. With that, now I invite Mr. Arun Sharma to give you an overview of Pharmova Financials. Over to you.
Good evening, everyone. I hope everyone is doing well and keeping safe. If you can see the slide, our results revenue for 2021 is INR 6,099 crore, up from INR 5,976 crore, which was reported in FY 2020. This revenue has been reported despite the challenges of COVID, which we faced in few of our businesses. Jubilant Pharmova has delivered a stable performance for this year despite these challenges and stoppage at one of our API plants at Pithampur. If you go by revenue segment, in 2021, you see 37.8% is contributed by our Specialty Pharma business. 33% is contributed by our CDMO business. Generics contributes 24.2%, and CRDS contributes 5% of our business.
The EBITDA margins has been slightly lower side because of COVID challenges this year. We reported INR 1,414 crore EBITDA this year in FY 2021 against INR 1,585 crore last year. PAT margins has been at almost at 10% at INR 574 crore. Again, it is little lower, INR 670 crore reported last year. Next slide, please. If you go to return on capital employed, our return on capital employed for FY 2021 was at 14.2%, which is quite comparable with all the major pharma companies. Leverage, if you see our leverage for this year is at 1.36 x. In leveraging, we have a focus on de-leveraging our company. Whatever free cash we have, we try to de-leverage our company.
This year, if you look at our financials, we have reduced our gross debt by almost INR 760 crore and our net debt by almost INR 2,019 crore on a constant currency basis. Sorry, INR 219 crore on a constant currency basis. Capital expenditure this year has been INR 276 crore, which is 4.5% of the sales. Working capital has been 86 days, down from 94 days. These have released much cash into our system to have the operations smoothly. Next slide, please. Coming on to the detailed P&L account. As you can see, pharmaceutical reported a total revenue of INR 5,790 crore in FY 2021. This is breakdown into Specialty Pharma, INR 2,303 crore. CDMO reported INR 2,010 crore.
Generics reported INR 1,476 crore. Contract Research and Development Services has been growing quite steadily over years and year and reported a revenue of INR 305 crore. Total revenue from our Pharmova business, which we call continuing business due to demerger in February, is INR 6,099 crore, 2% up as compared to last year. Coming on to EBITDA. Pharmaceutical EBITDA was at INR 1,386 crore, and Contract Research and Development Service EBITDA was INR 109 crore. Property, plant and equipment, we have booked some expenses here, so our reported EBITDA is INR 1,414 crore. After depreciation and amortization and finance cost of INR 184 crore, we reported profit before tax of INR 881 crore.
If you look at our finance cost, finance cost, we are always trying to optimize it so that we borrow at a much lower rate. This year in FY 2021, we have replaced our high-yield bond of 4.875% with a much lower cost of term loans, which has brought the reduction in the interest cost. After exceptional items of INR 21 crore, we have reported profit before tax of INR 871 crore and tax expenses of INR 297 crore, PAT reported is INR 574 crore. EPS is at 36.04 per share. Pharmaceutical EBITDA margins are 23.9%. Contract Research and Development Services reported EBITDA margins of 35.6%. Overall reported EBITDA margin is 23.2% for Jubilant Pharmova for FY 2021. With this, I come to an end of my financial presentation.
Hand over to Hemant for Q&A session.
Thank you very much. We will now begin the question and answer session. To ask question, please click raise hand in the webinar controls. Your name will be announced, your line will be unmuted. Kindly restrict your questions to two per participant at a time. Reminder, anyone who wishes to ask a question may click raise hand. First question is from Mr. Alankar Bode.
Hi. Thank you for the detailed presentation. Much appreciated. My first question is to the group CFO, Mr. Chokhany. You mentioned about continuously achieving ROC at least 10 percentage points higher than the cost of capital. Firstly, what would be your ROC target for the business over the next three to five years? Secondly, can you give an indicative number on the quantum of cumulative CapEx planned across different segments over the next few years?
Hi, Alankar. Presently we are at an ROC, as you know, around 17%. Our target is to maintain the ROC over a medium term. There may be certain short-term fluctuations because of some of the CapExes. We have given indicative three-year CapEx for different businesses that we have provided. We are being very mindful of these CapExes so that our ROC does not fluctuate in line with our investments. I would say that our objective is to maintain the ROC and not to cause too much volatility in our ROC from present levels, at the same time to ensure that we invest for the future. That's what I would respond to that, Alankar.
Thank you, sir.
You're welcome.
Further add that, as you know that 95% of our business is in Jubilant Pharma. Drug discovery is also about 95% exports to U.S. and Europe. The Jubilant Pharma business is a dollarized business. The cost of capital is also lower in dollars as compared to in rupees.
Hey. Hello, sir. My second question is to [Sergio]. Ex-MAA and DTPA, we have spoken about a 90% return to pre-COVID levels Radiopharmaceutical manufacturing business. These two products itself are amongst our top three products. Including them, the impact would be much higher. Even if I adjust for, say, the competition in MAA, when can we expect the Radiopharmaceutical manufacturing sales to return to pre-COVID levels?
From a market perspective, we expect the recovery to pre-COVID levels under the first semester of this fiscal year. However, it is important to notice that we have competition on MAA now, and the pre-COVID level coincide with the moment that we were without competition as well. We do not expect MAA sales to recover to our pre-COVID levels.
Sorry, Sergio, you mentioned recovery to pre-COVID, by when? I missed that.
First half of this fiscal year.
Okay.
Third quarter of the calendar year.
Understood. One final question, if I may. Again, it's a follow-up to Sergio. With all the legal issues behind, when can we expect RUBY-FILL sales to exceed that of Bracco's CardioGen-82?
The legal issues are getting very close to resolution. I don't think we will face any trouble on that side. RUBY-FILL was also impacted by COVID. Many PET centers that were supposed to invest in cardiac PET were delayed. The growth of the market is a progressive phenomenon in U.S., something that we drive, something that the market by itself organically grow. RUBY-FILL is growing at the moment, and we are actively working to grow it much further than today. Especially after COVID, things are getting back to normal. PET centers are resuming their projects to start cardiac PET programs. I would say that part of the business and its growth is already happening.
Very well. That is all from my side. Thank you and all the best.
Thank you. Next question is from Mr. Rakesh Jhunjhunwala. Sir, please unmute yourself and ask the question.
Thank you for the detailed presentation. What I would like to ask is, do you care for pediatric oncology dose of orphan drug? Am I right? You have an orphan drug that you are trying to apply for pediatric oncology.
Yes, sir.
Where is it progressed?
We have I-131 MIBG, which is for the neuroblastoma.
Yeah, at what stage is it now?
Yeah. It's phase II and phase III. Both the trials are going simultaneously.
If you're able to launch it, in what time period could be launched it?
Yeah. We expect the launch after phase II trial in early FY 2024. For phase II trial, we will get the permission to launch it after the first relapse. Simultaneously, phase III trial, which is going on, that is for its approval as a first-line therapy. That opens up the market even much more. That approval and launch, we are expecting in early FY 2025.
Early. Right. Second thing is you have now entered already for a business in Europe. Is that right? How significant can that be?
Yeah. In Europe, currently, we have entered for the product RUBY-FILL, which Sergio explained on his slides. It's for the PET cardiac product. Europe also, like U.S., has quite a large market, and it's totally untapped. In Europe, no one had the approval for this. Our competition, Bracco, had installed very limited sites under a special access program kind of thing in Europe, but not a fully approved product. Ours is a fully approved product, and the first one, and the market over there has to be developed, but the potential is huge.
Roughly, what is the size of the market?
Size of the market. Currently, you can say that since the product is not there, so the market is not there. The way we have the projections for the RUBY-FILL, we expect this product to deliver us close to $200 million revenue in the next few years.
Annual revenue?
Yeah.
Third thing, sir, is the CDMO business that you have in Bangalore, which has that 35% margin. I think INR 306 crore turnover you have in that, where you do drug development and research on contractual basis.
Yeah.
How scalable is that business and how much are we scaling? What kind of projection do you have for that? Or plans?
Rakeshji, this is Hari Bhartia.
Yeah.
What you are talking about is our discovery services business.
Yeah.
Where we do two things. We do integrated drug discovery, and we do chemistry service.
Right.
Things like DMPK.
Right.
I think Marcel, in his opening remarks, said that we have already almost doubling the capacity for the chemistry service. That is very scalable. With the chemistry service, we are going to add DMPK very soon.
What is DMPK?
It's an additional service that I can ask Marcel to explain that comes with chemistry. When customers who come to us for FTEs on chemistry also request DMPK services. Marcel, if you can explain that.
Yeah. It is a testing platform, Drug Metabolism Pharmacokinetics. Essentially, it tries to model what happens to the compound when it gets metabolized in an organism, whether a cell or an animal.
Yeah.
That is the first filter of drug discovery.
The other part I want to just add, Rakesh, that while chemistry service is scalable in terms of FTEs, and Marcel can give you the numbers that we are scaling up in our present expansion, the potential that we have is almost doubling. We also have potential to scale up our what we call CDMO, the scale-up business. That means in chemistry service, we do very early stage. In few grams, we produce compounds for our customers, but that has a potential into producing kilos for their preclinical requirement and clinical requirement for phase I and II.
Right.
We continue to look at expanding that. That's where we are working on how do we expand the capacity there so that we continue to serve customers who come to us at an early stage, and we continue to retain them for a later stage when they increase the quantity of compound that they require.
Am I right in assuming that this business is some part of what Syngene is doing with Biocon subsidiary? Is it similar?
Yes.
That is highly scalable. Syngene has got a very good profitability and a very good turnover. Can we also scale up this type of business?
Rakesh, we will also scale up. It was a very small business and we are scaling it up very fast. I'll tell you the differentiation that we have, Rakesh, is our integrated drug discovery
is a very differentiated. That means we actually discover the compound for biotechs and large pharma. We have done over 85 programs in the history of the company, which is very rare. Very few companies in the world are known for integrated drug discovery. We use computational chemistry and structure-based drug design to do that. It's a very unique differentiation.
Right.
We have a great science reputation. Now we are going into more in terms of areas which are expandable. Integrated drug discovery is difficult to scale up more than what we are doing. We'll continue to scale that up because there are other services that we are adding to that.
Right
which are high-end. We are now getting into areas which we will scale up much faster. That is the chemistry and the CDMO part.
How many people do you have in that business today?
Marcel.
What was the question? How much?
How many people do you have in that business today?
We have about 850 people, growing to 950 - 1,000 in the coming fiscal year.
Madhan, how many people would Syngene have?
Syngene has a few thousand, 3,000 - 4,000 people.
How can we be lower than the lady, sir? We have to beat her.
I can tell you we have some land in place, but the scalability of Syngene is also linked to huge infrastructure. You need a lot of research buildings.
Even on that area, they are every dime to dozen.
Hey, Rakesh, part of the Syngene business is also, I don't know whether you have studied that, it's also a CDMO business. No. We are gearing up for expansion.
Sir, t here's fantastic scope in that business.
That's right.
It's like a software service. I think we need to really scale up and invest money, even take some more risk if needed.
You are right.
[Biocon every dime a dozen, sir. Biocon every dime a dozen.]
Rakesh, we have a great team, and we have great scientific capability, very well known in the market. We have acquired 10 acres of land near the airport, where we are expanding in the future, in the next five years, our research park. Tomorrow, we are going to inaugurate a very large center in Greater Noida. Whenever you have time, we'd love for you to visit.
Your centers are Noida and Bangalore? Our centers are to Noida and Bangalore.
That's right.
Yeah.
Absolutely.
Okay, sir. I think there's great pleasure in that business.
We must expand it.
Best of luck for other endeavors. ES endeavors look forward to them. Best of luck. Thank you.
Thank you. Thank you, Rakesh.
Thank you. Next question is from Mr. Zafar Ahmadullah.
Thank you for the presentation. Just a couple of questions, please. The first one is on Radiopharma, where if I understand correctly, there are two parts to the business. On the Pharmacy business, we are losing money and are trying to turn around. Can you give us a bit of light on that? Maybe it would be helpful if you could split the numbers out so that, because at the moment our profits look less than they are because the losses of the pharmacy business are sort of coloring the numbers up. If you could maybe explain that, please.
In Jubilant Radiopharma business, we mentioned that the Radiopharmaceuticals and the Pharmacies business are integrated. It's a strategic acquisition for us because it helps us to take our all the products through the dispensing up to the nuclear imaging centers. The entire acquisition had been strategic because we have quite a strong R&D pipeline of the products, plus we are also bringing products through the partnership arrangements. If we have our own dispensing system, we have a better access and a wider access to our customer base. It will not be fair to treat these two of the businesses separately. However, when we internally analyze and look at standalone business, we know that in this business currently EBITDA is negative. I mentioned that we have a very robust turnaround plan for this.
We did a very detailed exercise. We will turn around this business on three aspects. One is the commercial excellence. We mentioned that we are growing our market share rapidly. The operational excellence, where we are bringing a lot of efficiencies into operations, into procurement. Third is overall network optimization. With that, we expect that we will be able to turn around the business in about two years timeframe. This business will remain very strategic and will continue to grow this business.
Okay, thanks. The second question is on the CDMO side. You mentioned that last year the margins were benefited from some one-off contracts in COVID, and I think because they were last made ones, they were very profitable. Roughly, can you give us some idea how much the base is inflated because of this, so that when we go into the current year, most of that will run off? I'm sure there'll be some spill over, but how much is left?
In our last quarterly call, we indicated that we have done five COVID-related deals. With that in FY 2021, we had generated about INR 535 crore revenue. With those five deals which we had, we are expecting another about INR 200+ crore revenue in FY 2022. However, please appreciate, currently the COVID market remains very volatile. Things continue to change every week, every month, and there's a possibility that the volumes can go up. Last week itself, we announced another sixth deal with Ocugen, who is trying to bring the Bharat Biotech product into the U.S. market. Things continue to evolve.
Okay, thanks. My last question is more a capital allocation question, so maybe from Mr. Bhartia can do it. It's related to Jubilant Therapeutics that obviously we have this interesting pipeline, but is Jubilant Pharma the correct vehicle basically to exploit this pipeline? The history of Indian pharma trying to do innovative products is unfortunately disappointing. Is our capital best employed at this scale in this area? Do we have a budget? How much we are ready to spend here? It's a bit of a gamble, of course. We all know that, and obviously if we get lucky, we can do very well. Is this the right vehicle, and does it not make sense to use other people's capital possibly to de-risk? How do you think about a sort of budget of how much money we want to put into this?
Zafar bhai, this is Hari Bhartia. Let me explain the reason for doing this in Pharmova. As you know, Jubilant Therapeutics is an independent company. It's not part of Pharma, but definitely part of Pharmova. Where do we get our strength from? I think the strength came because Jubilant Biosys has been doing this drug discovery for other companies and biotech, and they have created huge value through our research, and we continue to do that. We felt at a certain point that we should work also on our proprietary molecules. These are early stage, and I can tell you, Zafar bhai, this is the most efficient way to do drug discovery, to use the best of Indian talent, which we have, which we do it for others, to apply in therapeutics.
Even in the early stage, when we did develop some of the proprietary molecules, as you may have seen in our early announcements, we have already licensed a few and generated cash with that. I can assure you that this initiative is very capital efficient. I would say much more efficient than anywhere being done because we have used some of the out-licensing funds to use in this and some of our own funds. As going forward, Syed did explain that we will, in the next 18 months, raise private or public fund to take these programs to the clinical stage.
Okay. Thank you very much. Thank you.
Thank you. Next question is from Mr. Rahul Vira.
Hi. Good evening, gentlemen. Just a quick question for Pramod sir. Sir, we've added a couple of new CapEx beyond what we had discussed in the previous con call, especially with the ophthalmic lines and the Montreal expansion. What will be the cumulative CapEx over the next 3 years?
Rahul, this ophthalmic line in Montreal we had announced earlier also, that's under commissioning. We expect it to be commissioned in FY 2023. We announced our Spokane expansion, which is increasing capacity by about 50% at that site for investment of $92 million. These are the CapEx which are under implementation currently. In today's presentation, we also indicated that we are also evaluating on various other expansion programs, which includes another ophthalmic line in Montreal, which includes a Montreal expansion of sterile fill and finish, and also another prefill syringe flex line. This evaluation also includes another expansion in Spokane. In Spokane, we'll be able to double up the capacity from existing levels. Those are the various initiatives which currently we are evaluating.
Once we have done the basis of design, we will be able to know exactly how much is the requirement, and when the board approves for that investment, we will make the announcement for the investment as well.
Sure, sir. This is helpful. Thank you so much.
Thank you.
Thank you. Next question is from Mr. Tushar Manudhane.
Am I audible?
Yes, you can ask your question.
Thank you for the opportunity. Just first on the strategic level, why we have a CDMO as well. How do we put ourselves in front of the manager so that there's no conflict of interest for the product portfolio or even in terms of-
Sorry, I didn't get the question, Tushar.
Tushar, can you repeat your question?
At a strategic level, we have both CDMO as well as our own drug discovery. In the CDMO space, our experience has been that the innovators are quite sometimes taken advantage of interest in some place.
Tushar, your voice is not clear. Can you just keep the mic near you?
Better?
Your voice is Yeah.
Is it better now?
Yes.
I think, Tushar.
At a strategic level, just to like-
Yeah. Tushar, I got your question. You're probably talking about conflict of interest, isn't it?
Correct.
Yeah. Let me explain. Firstly, all the integrated drug discovery players globally do develop their own proprietary set of molecules. I can explain. Sometimes they do completely contract work. Sometimes they develop what they call early target ideas and take it forward to generate hit or lead. This they offer to their clients, which are large pharma companies, for out-licensing. When they out-license, they continue to do those services which are required to take this forward. Now, in case of Jubilant Therapeutics, it's just a separate entity which has taken early-stage risk, and our interest is never to really go into the market with the end product. Even while we are developing this, and we probably will take it to phase I or phase II, when the value inflection will be higher, this is still available to large pharma to buy.
As you know, 60%-70% of large pharma's portfolio, and now probably 80%, comes by in-licensing at different stages. Some could be preclinical, some could be phase I, phase II, or sometimes even in phase III, they are bringing in these products. What we are doing is we are playing a role like any other biotech which is developing a product and then hopefully offer it to larger pharmaceutical companies to take it to the market.
The next question was related to Jubilant Therapeutics, wherein as in we are not going to get into clinical trial phase II or phase III, then specific reason for raising the funds?
We will get into phase II if required. For phase I also, we need to raise funds. Phase II-A or II-B, we will look at that. Depending on if we find that the molecules we have a stronger interest, we may take it to phase II and then license it out. The opportunity exists. Let me tell you, these are all open things. The targets that Jubilant Therapeutics works on, Jubilant Biosys does not work it for any client. Because Jubilant Biosys does the work, we are very transparent. If we are working for a project for our clients, then they will not work it for Jubilant Therapeutics, because these are all target exclusivity. We already work for many pharmaceutical companies.
We make sure that when we work for one pharma in a particular target, we don't work for another pharmaceutical company on the same target. That's how we maintain sanctity and clarity, and that's how other CROs also do it.
Great. Thanks a lot for that clarity. Just on Jubilant Therapeutics again, in terms of while either through the fundraise or through out-licensing, but the overall investment that would be required over the next two to three years, whether we have it in-house or through external funding. Any ballpark number you would like to share?
I would not share you the full numbers, but I can tell you this is done very efficiently and done at a very low cost. All our early-stage programs, we have brought it, and I would say it's one of the most efficient way to do it. If the amount of money that we have spent on these, we can sell all these products immediately right now. I can tell you right now. It's important to sell or exit through IPO at the right time. That's where Syed, who's the CEO, he's progressing these molecules in a very effective manner, and we are hoping that when it goes into clinic and has a proof of concept, the value inflection is in multiples. If you study any of these biotechs globally, you will also get, I'm sure, the similar sense.
As far as early-stage investments, it is small part of our overall investments that we do in pharma or in our CRO, so we don't see a stress on that.
Thanks. Thanks a lot for clarification and wish you all luck on each segment. Thank you.
Thank you. Next question is from Mr. Vishal Manchanda.
Thanks for the opportunity. Am I audible, sir?
Yes.
Yeah. Question on the private equity fundraise. Would you be doing this at the parent level or would this be done at a subsidiary level?
This is Syed, a goal for therapeutics, right?
No, I don't think.
Oh, okay. Sorry.
Which level are you asking about private equity?
You're contemplating a private equity fundraise. Just wanted to check whether it would be done at the parent level or it would be done at the subsidiary level where the funding may be required.
No. Are you in reference to therapeutics you are asking or general you are asking for private equity fundraise?
Not specifically in reference to therapeutics.
Okay. No, at this moment, we are not considering a private equity fundraise either at the holding or at the subsidiary level.
Okay. A follow-up question.
See, what we have stated is that Jubilant Therapeutics we will raise funds from private or in next 15 - 18 months.
Okay. Would it be right to benchmark Jubilant Therapeutics to companies like Evotec or Galapagos?
No. What Galapagos and Evotec does is what Jubilant Biosys is doing to some extent. Of course, Jubilant Biosys has a large chemistry service, but the integrated drug discovery part is what Jubilant Biosys is doing. Yes, Galapagos to some extent has gone into both, into service and what Jubilant Therapeutics is doing. Yeah, it's a mixture.
Okay.
We can discuss this separately in a greater detail, minutely also, if you want.
Was Jubilant Therapeutics always a separate entity or it's a spin-off from Jubilant Biosys?
Some early stage work we did in Biosys, and then as and when we decided to progress the programs, then Therapeutics was formed.
Okay. A few questions on the Radiopharma business. Basically, the first one is on RUBY-FILL. Just wanted to understand what proposition that RUBY-FILL brings. Why would hospitals shift from CardioGen-82 to RUBY-FILL?
Yeah. I will let Sergio explain this.
Yeah. Thank you for the question. RUBY-FILL and CardioGen-82 both serve the same purpose. The difference is the way the infusion of rubidium happens, the algorithm of infusion. Our major advantage is on that point. We have others on the workflow side, and our image quality is also preserved for more weeks than our competitor. Those advantages are demonstrated by scientific investigation, clinical papers, and so on.
In addition to what Sergio said, our product is able to deliver the dose in a much more safer way. We are able to calibrate the dose with the weight of the patient and can actually deliver what the quantity is required. The controls are far, far superior, all done through the computer, and everything visible to the doctor on the screen.
Would that translate into better savings for hospitals since you are able to titrate the dose as per the patient weight?
It's more the safety of the patient.
I think they can take out more doses out of our generators.
Yeah. They'll be able to handle more patients for the same volume. Got it.
Our generator efficiency is much better in comparison to the competition, and our safety profile for the product is far, far better.
What I would also think about, there have been some details around volume expiry and time expiry. Does that also help a larger volume, larger expiry life? Is that also different for CardioGen-82 and RUBY-FILL?
I think you're talking about the expiration date of the generator.
Yeah.
This is, as Pramod mentioned, and Mr. Bhartia as well, what differentiates the generator is the fact that we can infuse a constant activity at the dose that is tailored to the patient, and we can provide better image qualities at lower doses, and even if the generator is approaching the end of its life cycle. The original systems, first generation such as Bracco, the image quality is better when you are in the beginning of the column life, in the beginning of the cycle. It tends to go down, to get worse towards the end, like in the last after three, four weeks, it's known that the image quality deteriorates. Our image quality is constant during the entire cycle of the generator. We can use five, six, and seven weeks cycles, we have that flexibility as well.
During the entire time, the reading physician will see a consistent image quality. It's very difficult for a cardiologist reading study to have in a certain week a better image and towards the end of the cycle, a bad image. It throws them off, and they don't know what they're looking at. It's very vital to have consistent image quality across the entire cycle of the generator.
Thanks. This is helpful. Just one more on DTPA. This product is approved for lung scans and also other scans like brain imaging and renal scans. As you said, this year the sales had declined because lung scans are not permitted with DTPA. Just a sense on what percentage of sales of DTPA would be coming from non-lung scans.
DTPA is used in lung scans more than 90%. There are alternatives to scan the kidneys and alternatives to scan the brain. The primary use of DTPA is so-called ventilation scan. It is used in combination with our product MAA. MAA looks at the perfusion and DTPA looks at the ventilation. The pulmonary emboli usually will impact the perfusion but will not impact the ventilation. The way pulmonary emboli is detected, the perfusion scan will be abnormal in a certain region, the ventilation scan will be normal, and this mismatch of the two is indicative of a pulmonary emboli. That is the largest application by far for DTPA today. Because the patient has to inhale, it has certain risks of contamination during the peak of the COVID crisis, many hospitals decided not to do the ventilation scans.
Some of them were doing only the perfusion scan and trying to figure it out without the very important support of the ventilation scan. This is now going back to normal because people in the U.S. are by and large vaccinated. Healthcare professionals are vaccinated, including technologists, and therefore the Society of Nuclear Medicine issued a new guidance saying that it is safe to go back to performing ventilation scans, and that's what we observe.
Great.
Thank you. As we are closer to the time, we will take last three questions. Next question is from Mr. Aditya Khemka.
Yeah. Thanks for the opportunity. Sir, on the API business in the Pharmova vertical, we have Nanjangud, which is under, I think, a warning letter from the U.S. FDA. Can you talk a bit about the capacity utilization currently at Nanjangud and how is the warning letter impacting us, and what is the status of resolution of the warning letter?
Nanjangud is not under warning letter, it's under OAI, Official Action Indicated.
Yeah.
When FDA inspected, all the observations which they made for the inspection, mostly, I think 90% of them were related to nitrosamine impurities. That was the issue industry was struggling that time. We very actively got engaged with the FDA. They didn't escalate it from official action to warning letter. We are one of the company where the official action indicator remains for that long. The reason for that is that though we have completed all the remediation activities, unfortunately, by the time we completed this, the COVID pandemic started and FDA stopped the inspections because their auditor didn't want to travel. When they just started doing it again, India hit the second wave. Now again, the FDA inspections are on hold. I am sure that the FDA is piling up the list of the pending inspections.
As soon as they start doing the inspection again, they should have the Nanjangud plant also on the priority, and they should inspect it. They also in between started doing the virtual inspections, but very selectively. The decision on that, or the prerogative of that is with the FDA, where they want to do virtual and where they want to do physical. We are waiting. That's the status of the FDA regulatory compliance.
In terms of capacity utilization you asked.
Yes.
Last year was during this COVID time, unfortunately, our plant was shut for about two and a half months. In the rest of the year, we had run the plant at full capacity. What I mean to say, full operating capacity. Hence the revenue for the business for FY 2021 were more or less at par with FY 2020, in spite of two and a half months closure. Currently, we continue to see the demand from the customer for our products, and there's a need for us to increase the capacity. We continue to do the debottlenecking of the various streams to increase the capacity, and we plan to debottleneck it by about more than 30% over the next two years. At the same time, Gunjan explained that we are also evaluating another greenfield site for the future expansions.
Got it, sir. That's very helpful. Can you also talk about how vertically integrated are we in our API manufacturing? How much of our raw material comes from China? How much of it is indigenous? Do we buy just the basic raw material from China, or do we also buy advanced intermediates?
Like any other API manufacturer in India, there was dependency on China, and there is dependency on China. That's how overall API industries in India and China got developed. With this geopolitical disturbance, we took very proactive approach, and we started looking at each and every KSM or advanced intermediate we were buying from China to have alternate source of that outside China, preferably in India. Some of the products are available, but not all. Those which are not available, we have taken up the projects in our own R&D to develop the technologies, and we are in the process of transferring such developed technologies to the other Indian sites who can make the similar KSM or the advanced intermediates, and then we start procuring them. We have a very structured plan in place to reduce dependency from the China, and that plan is working on track.
Got it. I have one last question. On the Radiopharmaceutical business side, while I listen to all the commentary that you guys give, and it sounds very encouraging, but my understanding and my previous reading was that this is a market where the volumes are actually stagnant to maybe declining in low single digits, the MAA and DTPA market. Therefore, all the revenue growth that we have seen in the past five or six years in the segment has largely been driven by price increases. Hearing you guys out today, has something changed there? Has there been volume growth in overall MAA and DTPA as a market? I'm not talking about your segment, your revenue. I'm talking about overall MAA market and DTPA market.
I thought these were slightly outdated sort of products in the Radiopharma business, and there have been newer technologies which have come in, and therefore, the preference of doctors towards these technologies is actually going down. Please correct me if I'm wrong?
I will set the base, then I will request Sergio to add on. The way the nuclear medicine market got developed initially is mostly focused on the diagnostic treatments through SPECT. Over the last few years, from the SPECT, the technology started moving towards PET because PET gives you much more sharper image. Then in between came the time where from the diagnostic industry started moving on to the therapeutic side. Now the latest buzzword in the Radiopharma is the theranostic, where the same drug substance you attach with the different isotopes. One isotope helps you to get the diagnosis treatment, and the other isotope helps you to give the therapeutic treatment for that. Overall, currently in the industry, when we mention that volumes are flat, that reference is mostly to the existing generic product being used for the diagnostic treatment through SPECT modality.
However, even in the diagnosis, the PET is growing by about 6%-8% and the huge growth that Sergio was showing on his graph will come from therapeutic and theranostic molecules, where all the development has started happening only from the last about five to eight years. The number of large pharma company, number of research institutes who are working on it, there's a huge potential and expectation is that by 2030 it can grow up to INR 20 billion market size just on the theranostic side. While PET will continue to grow, SPECT probably will remain flat. However, in SPECT, the price increases will continue to happen. You would like to add anything, Sergio, on this?
You've covered very well, Pramod. I could illustrate just giving the three milestones that happened in the therapeutic side just for illustration purposes, call a commentary to complement what Pramod said. In 2013, Bayer launched a drug called Xofigo. It's an alpha therapy for bone metastasis for mainly prostate cancer. It was a game changer, but it was relatively mild impact in the patient survival. It was a change in direction for nuclear medicine. The first inflection point. The other one happened in 2018 with the approval of a drug called LUTATHERA, which was developed by a company called AAA. This company was acquired by Novartis soon after the launch, the approval by the FDA for $4 billion. That was another inflection point. Most academic centers in the U.S. are currently offering LUTATHERA for the treatment of neuroendocrine tumors.
Just a week ago, Novartis announced the conclusion of the trial that is experimenting with PSMA treatment for metastatic, castration-resistant prostate cancer, with very favorable results. That is a result of the acquisition of a company called Endocyte, which we also know, two years ago for $2 billion. That's going to be yet another inflection point. First large, huge application, prostate cancer in therapeutics. This trend is not going to change, as Pramod said. We have many other drugs in the pipeline, prostate neuroendocrine tumors, and a whole family of products based on FAPI, which I mentioned in my presentation. I'm sorry, do you have a follow-up question?
Yeah, I do have a follow-up there. I am so sorry to interrupt you. Just to understand this better, PET is obviously the more modern technology, sharper images. SPECT is the older technology. How is SPECT priced compared to a SPECT scan typically in the U.S.? Could you give us ballpark figures to what the pricing difference between the two scans are?
There's a wide range. I would like to just rectify something. Indeed, the PET image quality is better in most cases, but by and large, SPECT and PET are complementary. SPECT is used in many different organs, and PET is used primarily in oncology, growing in cardiology, as I mentioned, and growing now in neurology as well. SPECT is more general purpose, but they are complementary, and I believe they will remain, both modalities will continue to exist. PET is growing much faster because, number one, the growth in amyloid, prostate, cardiac PET, and as therapies grow, PET will be the preferred, perhaps not the only one, but the preferred imaging modality that will enable the therapies. As theranostic grows, PET will grow with it.
I understand.
Having said that, our existing products volume, as Pramod said, is not likely to grow. We have in pipeline five or six products. Some of the products are SPECT products, which will add the overall sales increase in our SPECT products through new product introductions.
I understand. That's very helpful. Thank you, gentlemen.
Thank you. Next question is from Mr. Rahul Vira.
Hi, sir. Since, sir, we have been discussing so much about the growth of the PET scan, are we going to increase our stake in SOFIE Biosciences?
We are already there in PET scan through rubidium generator. Rubidium generator is a PET scanning, uses PET camera for scanning. We are already there in one of the heart imaging in PET scan. Sergio can add to it what other things in PET we are doing.
The partnership with SOFIE is one of the ways we are going to reinforce our position in PET. It's not the only initiative. The partnership with Isotopia will give us access to PET tracers as well. Our research and development capabilities, our labeling capabilities, are also suitable for the development of PET tracers. It's an area we are investing in ourselves. To the question of whether we intensify the relationship with SOFIE, absolutely. I think we are finding more synergies by the day and cooperating more and more, finding many areas that could be done as a partnership. This may lead to higher stakes or not. That's an intense discussion, and I don't think we are ready to announce anything like that.
Sure. This time we recorded some kind of a licensing revenue in SOFIE Biosciences. Is that correct?
Because of the 25% stake, what we have, so equivalent equity basis, we have recognized the revenue. SOFIE had outlicensed their FAPI for the therapeutic application to Novartis. Against that out licensing, they have got the milestone payments. Many more milestone payments are expected, they will continue to be recognized as they come in. SOFIE has retained the rights for the diagnostic application. While Novartis will take approval for the therapeutic, along with therapeutic, SOFIE's diagnostic will be used for the diagnosis and both the SOFIE diagnosis and the Novartis therapeutics will continue to get approved for the many applications into the many geographies, the market will continue to grow.
Sure. This is very helpful. Thank you so much, sir.
Thank you.
Thank you.
If I could just add to what Pramod said. We don't record revenue for SOFIE. We actually account for them under what's called equity method investment, and we pick up our share of SOFIE's profit and loss in our financial statements commensurate with our voting interest in the company, which is 25%. You'll see that on our press release.
Sure. Thank you.
Of course.
Thank you. Next question is from Mr. Sayan Mukherjee.
Yeah. Are you able to hear me?
Yes, go ahead.
Yeah. Thank you. My question is on the CMO business. If I look at the history, there has been some issues with FDA in the past. The revenues were quite muted or stagnant, I would say, and we see an improved growth because of COVID and now substantial capacity expansion that you talked about. I'm wondering what has changed in the contract manufacturing business that it seems that you are in a stronger growth trajectory. We also talked about the order book, and the second question is, if you can throw some light on the profitability and margin of that business.
Sayan on the first question, let me answer this way, that we made this announcement of the new line now, and we are saying that this will be up and running in calendar year 2024. That's the timeframe it takes to implement any of the expansion in CMO business. If you look at the expansion also for this 50% capacity increase is to the tune of $92 million. This business is capital-intensive. This business has a huge compliance regulation. You are right in saying that in the past we had some issues, but that's a history. That was many years ago. Since then, our quality record is very clean. FDA pays extra attention to the cGMP compliances on sterile injectables because any misadventure there could be lethal.
Many CMOs in the past have gone through these quality issues, and hence it becomes difficult to make such an investment over a long run and then get into quality issue and not utilize the investment. This has resulted in industry shying away from the investments, and that had led to the demand-supply gap. Over the last four to five years, three to four years, the market had been tight, and that had been helping us to renew our each contracts at better terms whenever that contract came for the renewal. That also made us think how we can sweat the assets to its maximum, and hence we debottlenecked our existing lines to about 30%-35%, which came very handy when this additional demand of the COVID came because we were able to use our expanded capacity, debottlenecked capacity for these COVID contracts at a much higher margin.
The market remains tight and the additional vaccine demand of the COVID has further added to that tightness. Industry today requires investments. We being one of the pioneer and we being one of the large player in this industry in North America, we are also taking lead to make these investments and meet our customers' demands.
Okay. Sir, anything on profitability margin you would like to share?
You can very well imagine yourself that if the market is tight, so of course, the contracts will be done with the good margins and the profitability. The margins have been good in this business and especially, the COVID deals had even higher margins.
I see. Okay. Overall, you think it is above the company average margin for Pharmova or the CMO business?
The margins in all our Specialty businesses are good.
Okay.
Radiopharma margins are good, in allergy margins are good, in CMO the margins are good. That's why over the last few years, our focus has been to move more and more towards the Specialty. That's what I mentioned in my first slide that we are a little different Indian pharma company who has so much of focus on Specialties. We also have the API the generics as our continuing cash cows, and we also continue to build those businesses.
Okay. Just a question on Specialty. Actually what worries us is also competition like what happened in Radiopharma. We have seen competition in MAA. There were some issues with the Radiopharmacy business also. In allergy extract, you have the venoms where there is no competition at this point. It seems that this business, you keep taking price increases, so that helps your profitability. I'm just wondering about risk from competition and sudden drop in margin. Anything that you can help us understand, elaborate, how should we think about the overall profitability and margin of the Specialty business, given all this risk?
Yes. I will say that we should not be worried for the competition. We should look at the business in the long run. In a long run, all these businesses have entry to barriers. In the long run, all these businesses have sustainable margins. In the long run, all these businesses have high growth potential. In individual products, time to time, there will be competition. Time to time, the competition will be going out. There could be 100% sole supply situation. There could be little blip here and there, quarter- on- quarter. We should not be worried on that, as long as strategically we are committed that this is a business which has a huge potential at a good margins and on sustainable business.
Sir, on M&A, Pramod, you did mention you look at M&A. What are the top one or two areas or gaps that is your priority when you are looking at M&A across all your businesses at this point in time?
Sergio, in his presentation, used the word that the Radiopharma is a fascinating world. When it's a fascinating world, we cannot have each and every competency, each and every technology, each and every aspect of the science within the company. There are n number of industries, research institutes who are working on these innovative platforms. There's always opportunity for us to look at them and tap into those innovations when they are at the various stages of the development. We continue to look at that.
It's based on the partnership side, not on the acquisitions.
Okay. It looks like Specialty and Radiopharma seem to be a key focus area compared to, let's say, API or generics, which you can possibly achieve what you want to achieve organically. That would be a right assessment to make?
In the API the generics also, there are the opportunities. We have very good quality products, and we mentioned that we are shifting our focus from the vanilla products to the complex generics in both the businesses. They will also bring the additional revenue at a higher margins. We have the capacity. We have scope to debottleneck the capacity, and at the same time, we also continue to grow those businesses, and we will expand the capacity as per the requirement. We understand this business and both these businesses bring consistent cash flow and healthy cash flow.
Sir, in this complex generics, you are looking at other formulations like injectables, et cetera, because currently the presence is largely in oral solids?
Yeah. Currently the presence is into the oral solids, but we are looking at the different forms of the deliverance. Like even we made this announcement that we have developed the sublingual remdesivir, and we had said that our product is equivalent in pharmacokinetics to the injectable product. That's a different delivery system. Like this, we are also working on the other delivery system. It will be premature for me to talk about that at this stage, but you will continue to see the activities happening on that front.
Okay. Sir, the last thing, sir, I was expecting, sir, you will give some growth guidance, if not short-term, long-term, five-year growth guidance. Can you give some colors, sir? Can you quantify with all the measures that you're taking, what's the kind of growth expectation we should have?
[Preti].
Would you like to take that, Chris?
The growth expectations for the pharmaceutical business will continue as we execute our strategy. To guide you as it relates to where we see each of those businesses, we're happy to do that, but we provide guidance on a total company basis, not on a individual basis. You can hear that our expectations as it relates to pharma Specialty business will continue to grow as Pramod cited in the first slide of our presentation. He kind of went through each of the businesses, where they're going to grow, what percentage, and how they're going to grow commensurate with the overall market capture. We're happy to go through that again.
As I would say, we're going to default to you on total company. I think Pramod went through where we're going to sit and how we best strategic position our business in the various markets we operate in.
Overall, like FY 2021, we were impacted because of COVID. There could be a little bit impact of competition here and there. The way we have explained you about our businesses and the way we have strategies in place, what I can definitely assure you is that our businesses will continue to deliver very healthy growth. Our businesses will continue to improve their margins. Our businesses will continue to deliver a higher rate of return on capital employed.
Okay, sir. Thanks a lot, sir, and all the best.
Just maybe complementing what Pramod said here, certainly as Pramod talked about our growth, we're absolutely investing in growth capital to fuel our future growth of the company. You've heard some announcements that we've made, but we're making strategic investments in every one of our pharmaceutical businesses as it relates to fueling growth for our future success.
Great. Thanks, Chris.
Yep, of course.
Thank you. Now the last question is from Mr. Alankar.
Hi, sir. Thank you for the follow-up. Sir, two questions. Firstly, are you satisfied with the outcome of the UT inspection which happened in March?
We are still awaiting the FDA's final outcome on that, which is expected any time. FDA generally takes about 90 days after the inspection. FDA had a few observations, and we have already given the robust CAPA on that corrective and the preventive action plan on that. We expect that should be acceptable to the FDA. It will not be appropriate on my part to make the judgment what FDA will be deciding.
Sure, sir. Do we have any plans, because we will complete the expansion of Salisbury soon. Do we have any plans to transfer some of these 37 filings to Salisbury?
In Salisbury, we just expanded the capacity. Terry mentioned that it's almost coming to the fag end of its commissioning. He also touched upon that we have many products for which we have dual site approvals in place, and we are also working for the other products where the dual site approval is needed. That strategy will be depending upon product to product. As of now, we expect that the FDA inspection outcome should be favorable. We are waiting for that outcome.
Understood, sir. My last question is on MAA. Do we expect to hold on to the current market share and expect pricing to sustain? Is there a possibility of changes as and when more contracts come up for renewals?
This business is traditionally done through long-term contracts. When the competition came in, we ended up negotiating the contracts within the purview of what the contract was allowing, and we mentioned that whenever there will be any generic player, 20%- 30% market share goes to the new player, and that's natural, and that's what has happened here also. With that remaining market share, we have contracts in place.
Understood, sir. We are confident of protecting our current 70%-80% market share.
Absolutely.
Okay. Great, sir. Thank you and all the best.
Thank you.
Thank you. Ladies and gentlemen, on behalf of Jubilant Pharmova Limited, that concludes this session. Thank you for joining us, and you may now disconnect.