Takeda’s (NYSE: TAK) (TSE:4502) plasma-derived therapies (PDT) business, led by Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit and chair of the Plasma Protein Therapeutics Association global executive board of directors, tackles complex logistical and economic challenges, collecting about 15 million liters of blood plasma annually from millions of donations and transforming it into medicines.
The PDT industry includes other major players such as CSL Behring, a division of CSL Limited (ASX:CSL), and Grifols (NASDAQ: GRFS) also working to meet the increasing demand for these life-saving treatments. In 2024, the global PDT market was valued between $21.54 billion and $28.12 billion, depending on the source, and is projected to reach between $43.91 billion and $46.7 billion by 2031, growing at a compound annual growth rate (CAGR) of approximately 6.3% to 7.1%. The industry relies heavily on plasma sourced from a handful of countries, particularly the U.S., creating supply-chain vulnerabilities that Takeda seeks to mitigate through policy, advocacy and diversification efforts. Looking ahead, Takeda aims to expand plasma availability, reduce complexity, and improve global patient access to its life-saving treatments. Addressing these challenges is critical, as PDT remains a significant part of Takeda’s business, accounting for ~21% of the company’s total revenue in 2023—approximately $5.98 billion of its $28.16 billion total.
Feiger: Let’s start with a higher-level overview of plasma-derived therapies. What goes into the development of a plasma-derived therapy?
Platford: I should start with the basics. Plasma is the yellow-straw-colored liquid that comprises about 50% of blood and has several vital functions, like fighting disease and clotting blood. It’s a scarce resource sourced only from healthy human donors mostly through a process called plasmapheresis: blood is taken from the donor, the plasma is extracted and the rest of the blood is returned. That enables plasma donors to donate more frequently than whole blood donation.
From that plasma we extract, or fractionate, various proteins and develop them into medicines often to replace different deficient proteins in patients suffering from rare and complex, chronic diseases. Too often these patients have no alternative treatments available to them, and it requires quite a bit of plasma to treat them. Typically, upwards of 130 donations per year to sustain just one patient’s treatment for a disease like primary immunodeficiency, almost a thousand for a disease like alpha-1 antitrypsin deficiency.
After fractionation, you go through a process of purification and viral inactivation. All told it can take between 9 and 12 months from plasma donation to the delivery of a therapeutic, and it’s a highly human-capital-intensive process. Takeda alone collects more than 15 million liters of plasma a year. We have 20,000 people working across our value chain.
Feiger: What is Takeda doing to ensure that healthcare stakeholders truly understand the importance of the plasma-collection process?
Platford: A lot of work goes into advocacy and policy-shaping, because only a handful of countries have in place the plasmapheresis infrastructure that’s needed to encourage source plasma donation. It’s the U.S. and four countries in Europe: Germany, Hungary, Czechia and Austria. These five countries represent about 90% of the world’s plasma, and the U.S. represents 70% of all plasma globally sourced. That, frankly, is an unfair dependence on a few countries to contribute to the global supply of plasma.
So working with patient groups to advocate for appropriate policy change and a legislative regulatory environment that enables countries to contribute to the global supply is important.
Feiger: What are the critical bottlenecks in the process to bring plasma-derived therapies to patients? What strategies or technologies has Takeda incorporated to drive efficiencies?
Platford: One of the things that is quite unique about the plasma industry is how intensely we work with a wide range of stakeholder groups. Usually, biopharma works with patients and physicians and healthcare providers; in our industry, we are engaging with the general public in large numbers through our efforts to secure donated plasma. We have more than 270 plasma donation centers around the U.S. and Europe, and we have millions of donors coming through our doors. So, we’re collecting an enormous amount of data – in a responsible manner, of course – that we can use to improve the donor experience. We’re leveraging AI to get much better at predicting how, for example, the average donor is going to respond to different movements in macroeconomic indicators, and what that means in terms of making sure we have continuity of supply of what is a scarce resource.
Feiger: Let’s talk about what I’ll call ‘supply chain resilience’. How do you ensure that Takeda maintains consistency amid such a complex and lengthy manufacturing process?
Platford: The scale of operations is surprising to anybody who visits one of our eight plasma manufacturing sites around the world. We invest a lot in process improvement, because in the fractionation process yield is very important. So the question becomes how much protein are we able to extract from each liter of plasma that we collect through the fractionation process? By tweaking the process, we’ve been able to improve the yield by 10 percent between 2019 and 2023. That’s big.
There are things that we’re doing around data and technology to automate processes that have typically been quite human-capital-intensive, like quality control. Typically, you’d have human eyes assessing each and every vial for particulates, but now you can supplement that by leveraging technology and AI. You can train AI to an incredibly high level of accuracy to do automated visual inspection. You can use technology to reduce the turnover time between batches.
Feiger: There are always going to be disruptions of some kind, with the pandemic and its supply-chain issues as a recent example. How do you future-proof plasma therapy operations to protect against those disruptions?
Platford: One of the things we’ve reflected on is how to diversify the sources of plasma supply.
The industry globally is too dependent on plasma sourced from the U.S., and I think we should all be uncomfortable with that. The good news is, since the pandemic, we have seen more interest from governments about supply-chain sovereignty – in vaccines, in plasma-derived therapies and in other critical areas where supplies could be scarce.
With a bit of time, we’ll get to a place where more countries are doing their own part. That doesn’t always mean the private sector collecting plasma; there are many different ways to achieve self-sufficiency through partnering and we’re open to all avenues.
Feiger: Earlier in the conversation you touched on patient access and advocacy. How do you engage with patient advocacy groups to ensure that your therapies are meeting real-world patient needs?
Platford: So this is a topic very close to my heart – and, I would say, to the hearts of most people working at Takeda. We have a decision-making framework called PTRB: patient, trust, reputation, business. No matter what we’re dealing with, first we always ask: (1) Is this good for the patient? (2) Is it going to reinforce trust in the company? (3) Is it going to bolster the reputation of Takeda and the broader industry? If you tick the first three boxes, likely it’s going to be good for long-term business growth.
We try to engage the patient as early as possible in the research and development process and define what meaningful efficacy and safety endpoints look like. I would also say that it is perhaps quite unique that we’re trying to get the patient more involved upstream with the plasma donor. We like to reinforce to donors the generosity of the gift that they’re giving and how it impacts patients’ lives. Whether it’s through posters or videos or learning sessions, we do everything we can to connect donors to patients so that they understand what patients are going through and why their gift of donation matters so much.
Feiger: What do you see as the biggest challenges and opportunities in the plasma business over the next decade?
Platford: There are significant unmet medical needs out there, so the demand for plasma-derived therapies will continue to increase. It’s been growing 10% and will probably continue to grow due to improvements in diagnosis for conditions like primary immunodeficiencies, better standards of care and new therapeutic applications for existing proteins. So there’s a lot of runway for growth. But it won’t be easy to meet those high unmet needs and ensure that there’s equitable access to these treatments globally. So we have to ask ourselves, what can we, as an industry and a healthcare community, do to make sure that more countries are doing their part to contribute to the global supply of plasma?
As that supply of plasma hopefully becomes less constrained, it should bring down some of the cost of sourcing plasma technology is a huge opportunity. The more we can streamline our operations and drive efficiency and productivity, the more we can bring down costs and use the savings to address affordability and access challenges.
