Demand for plasma-derived medicines continues to rise, bringing renewed attention to manufacturing capacity, supply resilience and the need for stronger plasma ecosystems. As Biotest enters its next phase of growth, CEO Jörg Schüttrumpf reflects on the company's strategic evolution, the opportunities created by its partnership with Grifols, and the role innovation and long-term investment will play in meeting growing patient needs worldwide.
How has your scientific and clinical background shaped your approach to leading Biotest?
I am a physician-scientist by training, specialising in transfusion medicine and haemostaseology, and my career has always been driven by the development of new therapies. My early research focused on gene therapy, coagulation factor engineering and experimental treatments for haemophilia, while my clinical work with patients with bleeding disorders also brought me into related fields such as immunology, intensive care and transplantation. I was fortunate to work at leading research and clinical institutions in both Germany and the United States, including the Children’s Hospital of Philadelphia, the Howard Hughes Medical Institute, the University of Pennsylvania, Goethe University Frankfurt and the German Red Cross Blood Donation Service. Although I originally intended to pursue an academic career, collaborating with industry made me realise how difficult it was to translate promising science into therapies that genuinely reach patients, and that ultimately led me to join Biotest in 2012.
When I joined Biotest, our research portfolio included monoclonal antibodies, recombinant proteins and plasma-derived therapies. We made a deliberate decision to focus our investment on Biotest’s core strength in plasma proteins, setting in motion a strategic shift that began around 2013 and laid the foundations for a next-generation portfolio centred on immunoglobulins, fibrinogen and trimodulin, supported by the Biotest Next Level programme and a major expansion of our manufacturing capabilities in Dreieich. After becoming Head of Research and Development in 2013 and joining the Executive Board as Chief Scientific Officer in 2022, I took on the role of Chief Scientific Innovation Officer at Grifols in 2023. That gave me the opportunity to continue advancing the Biotest portfolio while broadening my perspective across global research, development, manufacturing and commercialisation.
Returning to Biotest as CEO has given me the opportunity to complete the journey we began more than a decade ago by bringing these innovations to patients. Our immediate priority is to successfully commercialise the portfolio developed through Biotest Next Level. Three of the four main product families produced at our new Dreieich facility are already on the market, while trimodulin remains in Phase III clinical development. Seeing Yimmugo launch in the United States, followed by the approval and launch of our fibrinogen concentrate, PRUFIBRY/FESILTY, marks an important milestone, as they are the first products from the new facility to reach the US market. They represent the tangible outcome of a long-term strategy and investment programme, and with one key product still progressing through Phase III, we now have the opportunity to complete that transformation and position Biotest for its next phase of growth.
What defines Biotest today, and what is driving its next phase of growth?
Today, Biotest is a pharmaceutical company dedicated exclusively to plasma-derived medicines. Our operational footprint remains primarily European, with our headquarters, research and manufacturing facilities in Dreieich, proprietary plasma collection centres in Germany, Hungary and the Czech Republic, and subsidiaries across Central Europe. Through Grifols and our wider partner network, however, our products are marketed in more than 70 countries worldwide. We employ around 3,000 people and generated approximately EUR 650 million in revenue in 2025. At the same time, Biotest is a company with nearly 80 years of history, having evolved from blood-group serology and diagnostics into a specialist in plasma-derived therapies, with our non-core businesses gradually divested as we sharpened that strategic focus.
Although our directly owned operations are now concentrated in Europe, our reach extends far beyond it. Before becoming part of Grifols, Biotest had a much larger presence in the United States, including a plasma protein manufacturing facility in Boca Raton and an extensive plasma collection network, both of which had already been divested before the acquisition. Becoming part of Grifols has allowed us to retain Biotest’s scientific expertise, manufacturing base and identity while benefiting from a much broader international platform for plasma supply, manufacturing, market access and commercialisation.
That combination is what underpins our growth strategy. Biotest has always had a strong innovation and R&D DNA, and the next phase is about translating that innovation into commercial success through the products developed under Biotest Next Level. With Grifols as our strategic shareholder, we can scale much faster than we could independently by leveraging the strengths of both organisations across development, manufacturing and commercialisation, while maintaining Biotest’s specialist expertise. That gives us confidence in our ambition to return to profitability in 2027 and achieve annual revenues of at least EUR 1 billion over the medium term.
What was the rationale behind the Biotest Next Level investment, and why does Germany remain the right location for Biotest’s manufacturing operations?
Biotest Next Level was the result of a strategic decision we took more than a decade ago, when we recognised both the sustained growth of the plasma-derived medicines market and Biotest’s distinctive expertise in developing and manufacturing complex plasma proteins. Our objective was not only to expand manufacturing capacity, but also to broaden our portfolio and improve the number and yield of products obtained from each litre of plasma. We deliberately focused on plasma proteins that are difficult to replace through other technologies, particularly differentiated immunoglobulins containing immunoglobulin M (IgM) and immunoglobulin A (IgA), alongside products such as fibrinogen. These are therapies with long clinical lifecycles and enduring medical relevance, and they play to the strengths we have built over many years.
The new manufacturing facility in Dreieich is a direct reflection of that strategy. It produces four core product families, two immunoglobulin preparations, fibrinogen and albumin, and has increased our installed plasma fractionation capacity from around 1.5 million to up to 3 million litres annually. It also provides additional headroom for future expansion as demand continues to grow, enabling us to make better use of our manufacturing platform, increase productivity and strengthen profitability over the long term. For us, expanding capacity has always gone hand in hand with building a differentiated portfolio that maximises the value of every litre of plasma.
Germany remains central to that strategy because our greatest asset is the expertise we have developed here, spanning science, engineering and highly specialised manufacturing. Those capabilities are not easily replicated and remain fundamental to our competitiveness. While operating in Germany comes with higher costs, it also reinforces the importance of investing in productivity, scale and advanced manufacturing. Combined with one of Europe’s strongest plasma collection infrastructures and a well-established scientific and industrial ecosystem, it provides the foundation on which we can continue to grow our plasma-derived medicines business and serve patients worldwide.
Where do you see the global plasma market heading, and how is Biotest positioning itself for the opportunities ahead?
For decades, the plasma market has been shaped by the United States, with its well-established commercial plasma collection system making it the world’s largest source of plasma-derived medicines. Access to the US market also depends on products manufactured from US plasma, creating a distinctive dynamic within the industry. Today, however, the focus is shifting towards greater self-sufficiency and regional supply, as more countries recognise the strategic importance of securing reliable access to plasma-derived therapies. China has long pursued that approach through a largely self-contained plasma system, and similar initiatives are now gaining momentum elsewhere. Grifols, for example, is supporting major plasma self-sufficiency programmes in Egypt and Canada, while Biotest has also contributed to comparable projects in the past. More broadly, the direction of travel is clear, with countries investing in domestic plasma collection and integrated national capabilities to strengthen supply resilience and reduce their reliance on imported, predominantly US-sourced plasma-derived medicines.
What policy and regulatory changes are needed to strengthen Europe’s plasma self-sufficiency?
The European framework is moving in the right direction. The new European Union Substances of Human Origin (SoHO) Regulation should provide a more harmonised framework for donor protection, plasma collection, oversight and supply continuity, and I see that greater consistency across Europe as a positive step. At the same time, I do not believe regulation alone will significantly increase plasma collection. Meeting the growing demand for plasma-derived medicines also requires dedicated plasmapheresis capacity, continued investment in collection infrastructure, donor recruitment and sustainable operating models. Experience shows that countries with well-established commercial or compensated collection systems, such as Germany, Austria, Czechia and Hungary, consistently achieve higher collection volumes, whereas many other European countries remain dependent on imported plasma or finished plasma-derived medicines. Germany is largely self-sufficient, although not at a level that allows it to export significant volumes, which highlights the wider opportunity to strengthen plasma collection across Europe.
There is growing recognition of that need, and initiatives such as France’s Ambition Plasma programme are encouraging, even if they are unlikely to deliver full self-sufficiency on their own. Before joining industry, I worked at the German Red Cross, where there was often concern that expanding plasma collection could come at the expense of whole-blood donation. In practice, however, countries that successfully operate both systems show that this does not have to be the case, provided there is a healthy donation ecosystem. Plasma donation requires a greater commitment from donors, and recognising that effort appropriately is, in my view, entirely justified. If Europe is serious about strengthening its long-term plasma self-sufficiency, it should remain open to the collection models that have already proved effective in countries with more established systems.
What gives you confidence in the future of plasma-derived medicines, and how do you hope Biotest will be recognised in the years ahead?
What gives me the greatest confidence is the growing medical need for our products. Although new therapies are emerging, the plasma-derived medicines market continues to grow steadily worldwide, driven by changing patterns of care as well as significant unmet need. Treatments such as CAR-T therapies, increasing numbers of transplant procedures and the wider use of immunosuppressive therapies are all contributing to a growing need for immunoglobulins, while many patients around the world still have little or no access to plasma-derived medicines. We therefore see opportunities for growth across both developed and developing healthcare systems, which gives me great confidence in the future of our industry.
Looking further ahead, I would like Biotest to be recognised not only for expanding access to plasma-derived medicines, but also for continuing to advance innovation in the field. I believe there are still several areas where immunoglobulins have significant therapeutic potential and where important medical needs remain. Neonatal sepsis is one example, where the underlying biology provides a strong rationale for investigating IgM-enriched therapies, although larger, well-controlled clinical trials are still needed. More broadly, immunoglobulins remain unique in their ability to address inflammation without suppressing the immune system, which means there is still considerable scientific and clinical work ahead, alongside the continued need to strengthen plasma collection and improve patient access to these medicines.
Ultimately, this is an industry built on collaboration. It depends on the commitment of millions of plasma donors, but equally on the support of regulators, reimbursement authorities and healthcare professionals who recognise the unique nature of plasma-derived medicines and help ensure that patients continue to receive them. That combination of scientific innovation and human commitment is what makes this field so rewarding, and it is what I hope will continue to define both Biotest and the broader plasma community in the years ahead.
