With the Trump administration having begun its second term on January 20, 2025, and then Robert F. Kennedy Jr. stepping into the role of Health and Human Services Secretary, the US Food and Drug Administration (FDA) is undergoing seismic shifts. On March 28, Peter Marks, the agency’s top vaccine regulator and a key advocate for innovation in cell and gene therapies, was forced to resign. This followed the appointment of Marty Makary as the new FDA Commissioner and the announcement of 10,000 job cuts, plunging the agency into a period of profound uncertainty.
The fallout from Peter Marks’ departure and the sweeping 25% reduction in FDA headcount sent biotech stocks tumbling as markets opened on March 31, with vaccine manufacturers hit particularly hard. The turbulence was further compounded by Trump’s tariff announcements, which sparked a two-day selloff in the S&P 500, erasing $6.4 trillion in market value (The Wall Street Journal, 2025). Investor confidence in biotech deteriorated, and the sector continues to struggle amid heightened uncertainty.
The volatility hasn’t been confined to US markets — European biotech firms suffered just as much. This is unsurprising given the interconnected nature of global biotech markets and the US position as the world’s largest pharma player, representing more than 50% of the global pharma prescription market value compared to Europe’s 23% (European Federation of Pharmaceutical Industries and Associations, 2024). The critical question now is: Will Europe be able to capitalise on the regulatory uncertainty and potential withdrawal of US government funding in certain therapeutic areas? Or will structural challenges — such as fragmented regulatory frameworks, varying reimbursement systems across countries, and more conservative investment patterns — prevent European biotech from strengthening its global market position? To gain insights, we spoke with several Chief Medical Officers across Europe about both the challenges and emerging opportunities in this shifting landscape.
While we were finalising this article, the landscape continued to shift rapidly. Earlier this week, the White House announced a new most-favoured-nation drug pricing model, aiming to align US prescription drug prices with the lower rates paid in other countries. This significant policy shift will further intensify market volatility and accelerate the regulatory uncertainty our interviewees highlighted. And, a key theme of our findings is only reinforced by this most recent development: European biotechs must navigate an increasingly unpredictable US regulatory environment while seeking to strengthen their own position.
FDA Uncertainty and the Global Ripple Effects
The FDA has widely been regarded as a stable, science-driven regulatory body and a global leader in drug review and approvals, particularly in cell and gene therapy, where Peter Marks played a pivotal role in streamlining pathways for innovation. While the agency’s handling of COVID-19 vaccine approvals generated both praise and criticism — with some lauding its speed and others questioning aspects of its review process — the FDA’s overall approach to balancing scientific rigor with public health urgency influenced regulatory bodies worldwide. Its science-based framework shaped expectations for drug development and approval processes across the global biotech industry.
However, concerns about the FDA’s future effectiveness surfaced following the agency’s shakeup. “Overall, these changes are going to have a negative impact,” says Carlos Camozzi, a seasoned Chief Medical Officer, consultant, and expert in orphan diseases and cell and gene therapy. “The problem is that the FDA’s structure has been damaged. The FDA was fast, efficient, precise, and that is now gone — and it is not easily recovered.”
This sentiment about declining efficiency and the quality of regulatory reviews is echoed by Andrew Saunders, Chief Medical Officer at Captor Therapeutics. “I’ve felt with the FDA that their scientific and clinical reviewers have largely been on the ball: They ask very good questions and they allow innovative trial design. I am concerned from an early drug development point of view that with these changes, we are now going to get inappropriate questions as well as inappropriate mandatory requests built into trial designs that are too conservative and not relevant to the drug class.”
The prevailing belief in the biotech industry is that approval processes will become slower, with stricter safety requirements, and that the FDA will more aggressively scrutinise companies that gained approval through post-marketing commitments. Juan Carlos Jaramillo, Chief Medical Officer at Valneva, shares his perspective with WittKieffer: “There has always been a history of companies saying they will do post-marketing to show effectiveness — not just in vaccines, but in overall survival for oncology products. I think the FDA will now find more reasons to delay or not approve a product, and from an innovation perspective, this will have a ripple effect across Europe as we move ahead.”
Investor Trends: Funding Challenges and Market Volatility
The European biotech sector experienced significant shifts in recent years, with funding cycles, innovation trends, and market dynamics evolving in response to economic pressures and regulatory changes. We saw a sharp drop in biotech funding post-2021, and although investment levels stabilised in late 2024, M&A activity and the biotech IPO market remain weak. However, healthcare and biotech still count as the largest sector for venture funding in Europe, raising $4 billion in Q1 2025, which accounted for 32% of total venture capital investment (Crunchbase, 2025).
A clear trend has emerged: fewer companies are securing larger investments, with a growing preference for later-stage funding making access to capital more competitive than ever. However, recent regulatory uncertainty, tariff impacts, and institutional sell-offs intensified the pressure on the sector, leading to a 13% drop in the MSCI Europe Pharma & Biotech Index over the past month (MarketScreener, 2025-I). Unsurprisingly, preclinical biotech companies were affected the most.
Right now, there seems to be limited appetite for funding European biotech. Thomas Langenickel, Chief Medical Officer at Ethris, told WittKieffer: “IPOs are closed for the moment and VC funding is very challenging to come by, particularly from US-based VCs as they are reluctant to fund certain modalities. That has an impact that we are already seeing. We need to see how that develops in the future, but it is likely to affect biotech across the globe.”
Changing Biotech Strategies and Therapeutic Modalities
Given Robert F. Kennedy Jr.’s stance on vaccines, it’s unsurprising that vaccine biotech firms are among the hardest hit. In the US, the average domiciled vaccine biotech was worth $1.4 billion at the start of 2025; by the beginning of April, that number was $423 million (MarketScreener, 2025-II).
The resignation of Peter Marks, combined with Robert F. Kennedy Jr.’s scepticism towards vaccines, fuels concerns about vaccine misinformation, public trust, and the stability of international vaccine oversight — all of which could indirectly affect vaccine uptake and policy discussions in Europe.
A particular focus has been placed on mRNA vaccines, with Robert F. Kennedy Jr. claiming mRNA vaccines cause severe adverse effects, including neurodegenerative disease, and previously calling for the withdrawal of the COVID-19 vaccine authorisations made during the pandemic.
Could this scepticism impact vaccine and mRNA biotech investment in Europe? Thomas Langenickel believes more needs to be done to correct the public perception: “Certain therapeutic modalities like mRNA are particularly challenging as they are being viewed in the public domain as a kind of gene therapy. There is not enough knowledge out there about the modality itself, and there is a lot of misinformation. If we are thinking about prophylactic vaccines, for example, we might see a reduction in funding due to this. Europe receives a lot of money from the Biomedical Advanced Research and Development Authority (BARDA) and other government organisations; and right now, negotiations in grant funding have stopped.” This pause in US government funding represents a significant concern for European vaccine developers who historically relied on these transatlantic partnerships.
So, what is the most promising area for biotech in the near future? Andrew Saunders believes biologics, particularly antibody therapeutics, hold the strongest potential: “Antibody-drug conjugates (ADC) and drug conjugates are the most exciting. Of the ones being talked about, it has been delivering in a really impactful way with some of the agents, and I think it will continue to do so.”
The FDA is actively working to replace and reduce in vivo toxicology testing for certain drugs, including ADCs, which could streamline clinical trial entry in the US. However, Thomas Langenickel notes that international regulatory harmonisation remains a challenge: “We will need to see how that actually translates into changes in the ICH guidelines [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] that are still binding, which agencies like the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) are still following. Even if the FDA drops it, but EMA and PMDA do not, companies will still have to do it. Therefore, it may not be an advantage at all, so we need to see how it evolves.”
Europe’s Position — Can It Capitalise on US Uncertainty?
Europe boasts a thriving biotech ecosystem, with over 3,700 active companies and strong research institutions, especially in Germany, France, and the UK. Novo Nordisk is currently the 4th most valuable company in Europe, surpassing $380 billion in 2024 (FinanceCharts, 2025). Over the last two decades, innovative firms like BioNTech and argenx emerged, making a global impact in biotech.
While the US remains a dominant force, ongoing political and regulatory shifts, alongside recent tariffs and potential trade wars, raise the question of whether this presents an opportunity for Europe and the rest of the world. Notably, the US accounts for 26% of global GDP (down from 40% in 1960) compared to Europe’s 23% (International Monetary Fund, 2025).
One of Europe’s biggest hurdles remains the shortage of specialised biotech talent, particularly in executive leadership, R&D, and medical affairs, which has slowed progress and limited the sector’s potential. Historically, many skilled professionals migrated to the US for higher salaries and better career prospects, but could Europe now capitalise on the wave of layoffs in the US?
The shift may already be underway. Several European academic leaders noted an uptick in applications from US-based scientists in recent months, suggesting that talent migration patterns could be changing in response to the current climate.
European countries are actively establishing new initiatives to attract top scientific talent from around the world. For example, the Netherlands recently announced a dedicated fund aimed at accommodating exceptional international scientists. The initiative reflects a broader European trend, with countries like France, Germany, Spain, UK, and Belgium also launching similar efforts to position themselves as global hubs for innovation and academic excellence (Government of the Netherlands, 2025).
The regulatory landscape remains uncertain. The EMA has traditionally been viewed as more conservative than the FDA, and recent requests for joint regulatory revisions reflect an effort to expedite approvals. However, Juan Carlos Jaramillo warns that such changes could slow progress: “What you can see happening is that you have different views on specific areas, each agency has its own questions, and that creates further doubts — so there are more and more discussions back and forth… If we start to see a push from the US about being stricter on certain guidelines, then that will have a ripple effect on the rest of the agencies worldwide.”
On the other hand, Juan Carlos Jaramillo discussed a recent meeting with regulatory bodies from India, Europe, Brazil, and Canada, pointing to potential shifts away from FDA influence: “I think that there will be more collaborations between these agencies, meaning they will push away from the FDA if these situations continue. They want to try and build up Europe to be the world leader for regulatory.”
This view is echoed by Carlos Camozzi, who sees a strategic pivot for Europe: “It is a wake-up call for Europe — they have to work in a different way, be open to other markets, and adapt to their requirements. For example, working with China, Japan, Southeast Asia, and India. India has been developing pharma and biotech impressively, and its cost is much lower. It is no longer just the US and Europe only.”
Securing funding for European biotech will be crucial for its future. Juan Carlos Jaramillo highlights growing support from HERA (Health and Emergency Preparedness and Response): “We are now seeing HERA picking up, and there is more investment in Europe and a push for innovation… I do think there is going to be a change moving ahead, and I think that Europe will get stronger because of this.”
Meanwhile, Carlos Camozzi notes a shift away from the traditional “build-to-sell” model, where biotech startups were often acquired by US companies after a few years: “We have been building companies based on innovation and creating introductions within groups to try to remain within the European continent. I don’t believe it will move back to the US as it was before. Having a US affiliate will also become less of a priority.” However, this European ambition faces significant funding challenges — venture capital investment in European biotech reached only $16 billion from 2017 to 2022, compared to $72 billion in the US during the same period (GlobalData, 2022). This capital gap extends to public markets, where Europe offers less liquidity and fewer specialised biotech investors, emphasising the need for deeper capital pools to support European biotech independence.
Conclusion
The European biotech sector is navigating a dynamic and evolving landscape, shaped by regulatory shifts, investment trends, and geopolitical uncertainties. While early-stage companies face funding challenges and market volatility persists, rising M&A activity suggests growing investor confidence for the remainder of 2025. The EMA’s push for regulatory revisions and strengthened global collaborations indicates Europe may assert greater independence in biotech regulation, potentially enhancing its global standing.
Innovation is advancing rapidly, with cutting-edge technologies such as proteomic scanning and low-cost gene sequencing revolutionising drug discovery. This “golden era” of biotech reflects decades of foundational investment now delivering breakthrough therapies. However, success hinges on bold leadership capable of adapting strategies, driving outcomes, and leveraging talent. Strong leadership and strategic investments in talent will define Europe’s ability to capitalise on this transformative moment.
Despite recent volatility, biotech has proven its resilience time and time again. The industry has weathered downturns before, only to emerge stronger, and there is every reason to believe this cycle will be no different.
Disclaimer
The views expressed by Chief Medical Officers interviewed for this article represent their personal opinions based on their expertise and market experience, and do not necessarily reflect the official positions of their affiliated organisations or employers.
Sources
Crunchbase (2025). Europe’s VC funding stayed flat in Q1, even as healthcare added a third.
European Federation of Pharmaceutical Industries and Associations (2024). The pharmaceutical industry in figures. Key data 2024.
FinanceCharts (2025). Biggest companies in Europe for Apr 2025.
GlobalData (2022). Europe’s innovator drug venture financing loses pace with the US while entering bear market, says GlobalData.
Government of the Netherlands (2025). Netherlands launches fund to accommodate excellent international scientists.
International Monetary Fund (2025). World Economic Outlook, April 2025.
MarketScreener (2025-I). MSCI Europe/pharma and biotech.
MarketScreener (2025-II). NASDAQ biotechnology.
The Wall Street Journal (2025). Trump’s tariffs wipe out over $6 trillion on Wall Street in epic two-day rout.
About Author
As a Consultant in WittKieffer’s global Life Sciences Practice, Eleanor (Elle) Mason excels at identifying and placing top-tier C-suite candidates for both public and pre-public companies in biotech, animal health, and the broader life sciences sector. Elle leverages her science background to understand each client’s unique needs in order to recruit leaders and executive teams that align with their immediate strategic needs and long-term commercial goals. Through her extensive background in recruitment within the life sciences, she has built a broad, multifaceted network of executive contacts. Elle can be reached at: [email protected].
About WittKieffer
WittKieffer is the premier executive search and leadership advisory firm developing impactful leadership teams for organisations that improve quality of life. We work exclusively with organisations in healthcare, science, and education — the Quality of Life Ecosystem — and provide essential knowledge, analysis, and perspective that produce effective leaders and inclusive cultures. Through our executive search, interim leadership, and leadership advisory solutions, we strengthen organisations that make the world better. WittKieffer is proud to be 100 percent employee-owned. Visit wittkieffer.com to learn more.
