2025 was a year of volatility for pharma and healthcare. In particular, the speed with which the administration of Donald Trump makes (and often then changes) consequential policy decisions has left industry stakeholders in the US and globally scrambling to fall in line. There are already clear winners and losers in the world’s biggest market, although these are subject to change in what remains a hugely changeable environment.
Across the Atlantic, Europe – for years the forgotten child of global pharma behind the US and China – is attempting to rejuvenate its R&D and manufacturing base. However, budget constraints and interminable policy deadlocks are still major barriers to its ambitions.
With the USA in a state of flux, China is continuing its remarkable rise to become the leading global innovation hub, shrugging off geopolitical tensions and welcoming in big new investments from the likes of AstraZeneca, Lilly, Takeda, and Sanofi. China accounted for 18 percent of all global licensing deals with multinational drug companies in the first half of 2025.
In the Middle East, Saudi Arabia is fleshing out its ambitions to become a regional innovation hub, while Africa is inching closer to a long-touted EMA-style transnational regulatory authority of its own – potentially increasing the speed and amount of access to medicines on the continent.
Globally, investor sentiment was up, and big M&A deals were back on the table. After a subdued 2024 in which regulatory and pricing pressures, especially in the US, spooked the market, 2025 saw several strategic, high-value deals for late-stage or differentiated assets, including J&J’s USD 14.6 billion acquisition of Intra-Cellular Therapies (neuroscience), Novartis picking up Avidity Therapeutics for USD 12 billion (neuromuscular disease), and Pfizer winning the bidding war for GLP-1/obesity player Metsera with a USD 4.9 billion bid.
Read on for our 10 picks of the game-changing events that defined the year.
‘Most Favoured Nation’ Pricing Gathers Steam
In the US, high drug prices have traditionally been the trade-off for globally leading levels of access to innovative new medicines (for those who can afford them). This dynamic has been shaken up in recent years, with the first-ever directly negotiated prices for drugs under the Biden administration’s Inflation Reduction Act.
Since taking office for a second time, President Trump has also targeted high US drug prices (as well as what he calls “freeloading” foreign countries which charge far less for the same medicines), calling for Americans to instead have access to the lowest ‘most-favored nation’ (MFN) price instead. This has been a long-term preoccupation of Trump, who attempted to install an MFN pricing framework during his first administration without success.
Rather than create a standardised industry-wide mandate on pricing, Trump has instead trusted his ability to strike deals with individual companies. Pricing agreements have already been agreed with the likes of Pfizer, AstraZeneca, Lilly, Novo Nordisk, EMD Serono, and most recently Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis and Sanofi.
These deals, the terms of which vary, have major implications in the US. The companies involved have agreed to lower prices in exchange for a range of benefits, including relief from tariffs and expanded access via government programs. Other countries are also watching closely – these types of deals could prompt companies to raise their prices outside of the US to avoid creating a low benchmark which the US would then use to set prices at home.
‘Build in America’: Pharma Falling in Line
Some of the pricing agreements explored above were conditional on another Trump hobbyhorse – manufacturing in America. The era of free trade and mass globalisation appears to have come to an end, with companies being cajoled to locate manufacturing within the US through the promise of reduced exposure to tariffs, better access to US government programmes, as well as state and local incentives like tax credits, training support, and grants.
While US manufacturing may be more costly than elsewhere, there are upsides to producing in, and for, the world’s largest market, worth USD 800 billion and accounting for over 40 percent of the total global market. These include greater supply security, shorter lead times, and more control over the entire manufacturing process.
Other historically strong regions for pharmaceutical manufacturing – notably Europe – are struggling to match the US offering. Indeed, AstraZeneca CEO Pascal Soriot recently told Le Monde that all new factories producing next generation medicines will be built in the US rather than Europe, suggesting that “The pharmaceutical industry in Europe will be reduced to a shadow of itself within 15 years.”
Regardless of whether through the stick or the carrot, in 2025, Big Pharma fell in line. Several companies announced multi-year, billions-of-dollars investments in US manufacturing and R&D, with some of the standout announcements included those from J&J (USD 55 billion), Roche (USD 50 billion), Lilly (USD 27 billion), Novartis (USD 23 billion), and Sanofi (20 billion), among others.
FDA Leadership in Turmoil
Staying in the US, pharma’s deals on pricing and manufacturing with the Trump administration risk being undermined by a regulatory agency in a state of turmoil. Increasingly, the Food and Drug Administration (FDA) seems to be selecting its leaders based more on ideological adherence to the ‘Make America Healthy Again’ doctrine of Secretary of Health and Human Services Robert F. Kennedy Jr and President Trump than on scientific suitability for their positions. This risks causing lasting damage to the world’s gold standard regulator.
Several long-serving leaders have retired or resigned from the FDA this year, including former Acting Commissioner and director of the Center for Drug Evaluation and Research Janet Woodcock , director of the Center for Biologics Evaluation and Research (CBER) Peter Marks, and director of the Oncology Centre of Excellence Richard Pazdur (all former PharmaBoardroom interviewees).
There is nothing necessarily untoward about late-career bureaucrats stepping back from intense leadership roles, but the churn elsewhere in the agency suggests that something deeper is afoot. Now under the purview of Commissioner Marty Makary, the FDA appointed George Tidmarsh as head of CDER in July 2025, but just four months later, he resigned amid allegations of abusing his authority. He was replaced by Pazdur, who lasted just four weeks before announcing his retirement.
Commissioner Makary, his boss RFK Jr, new CBER Head Vinay Prasad, and acting CDER head Tracy Beth Høeg are all linked by one thing: vaccine scepticism. FDA insiders have been scathing in their criticism of these appointments. Prasad has been condemned for claiming, without evidence, that ten children had died from taking the COVID-19 vaccine, while another anonymous agency source, reported by CBS news, described Høeg’s appointment as “an extinction level event. Tracy Beth Høeg has never supervised a drug review, never has conducted a clinical trial. She doesn’t understand laws and regulations.”
Peter Marks, forced out by Kennedy over disagreements on vaccines, added that “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”
The First Trillion Dollar Pharma Company
A historic moment occurred in November this year, when Eli Lilly’s market capitalisation briefly crossed the one trillion-dollar threshold. This represents the first entry by a pharma company into the trillion-dollar club – a rarified group predominantly populated by tech giants like Apple, Amazon, and Google – and an ambition that Lilly execs first spoke about in 2023.
Lilly’s dramatic ascent to the top of the pharma tree has been driven by enormous demand for its obesity and diabetes drugs (marketed as Zepbound and Mounjaro respectively), both of which contain the active ingredient tirzepatide. As BioPharmaDive reports, from January to September this year, combined sales of Zepbound and Mounjaro reached almost USD 19 billion, making tirzepatide the world’s bestselling drug.
Based out of Indianapolis and historically smaller than many of its peers, Lilly’s bet on diabetes/obesity seems to have paid off. While manufacturing bottlenecks to meet demand and reimbursement challenges still exist, with big recent investments announced (see above), an oral form of the drug set for launch in the next year, and potential for the approval of GLP-1 drugs like theirs for other conditions, Lilly (and its shareholders) have much to be optimistic about.
The Other Side of the GLP-1 Coin
Europe’s flagbearer in the weight loss drug revolution, and Lilly’s main competitor, is Novo Nordisk. The first company to bring a GLP-1 drug for weight loss to market in 2021, Copenhagen-headquartered Novo’s revenues soared, and it has sporadically been Europe’s most valuable company ever since. However, hampered by supply chain issues and with increasing competition from the likes of Lilly, Novo’s share price slumped in 2025 and the company moved on long-term CEO Lars Fruergaard Jørgensen – the FT Person of the Year as recently as 2023 – in May.
Jørgensen’s replacement, former international commercial lead Maziar Mike Doustdar, immediately announced 9,000 job cuts and a company-wide restructuring. Perhaps guilty of overextending its ambitions in the years leading up to 2025, Novo – under the commercially-minded Doustdar, who more than doubled international sales to approximately USD 17.6 billion in his previous role – will be hoping to strengthen its commercial execution in the coming years.
After all, Novo Nordisk’s competition is not just coming Lilly anymore. Many other companies – including Pfizer, Roche, and AbbVie have jumped on the weight loss bandwagon via big-money acquisitions in the past 12 months in the hope of grabbing a greater share of a booming market.
France – Global Leader in Universal Healthcare – Finally Passes Budget, But System Remains Under Strain
Just making it onto the 2025 list, on December 16th France’s parliament was finally able to pass a budget, bringing over 12 months of tense negotiation to a close. This period has seen off three prime ministers and marks a relative success for what is an extremely divided parliament.
This milestone is of great importance for France’s universal healthcare system as it secures healthcare funding for the coming year, albeit under tight fiscal constraints. Health insurance spending (ONDAM) will rise by around three percent, with EUR 850 million earmarked for hospitals and EUR 150 million for priority public health measures.
The social security deficit remains high at EUR 19.4 billion, despite new revenue from taxes on health insurers and increased patient co-payments. While the budget protects core services and avoids immediate cuts, it signals a continued emphasis on cost control over expansion, with measures like capped sick leave and expanded primary care networks introduced to manage rising demand without fuelling further deficits.
The full budget follows on from the Social Security & Healthcare Bill (PLFSS 2026) in October, which imposed EUR five billion in healthcare cuts, and which the industry warned would exacerbate already severe access to medicine issues in France.
EU Joint Clinical Assessments Begin in January: Teething Pains
In January 2025, an EU-wide legislative framework on joint clinical assessments (JCA) was implemented, designed to harmonise clinical evaluations across member states, reducing disparities in access and long delays to market. While the aims of the programme are laudable and necessary – given the fact that only 46 percent of EMA-approved medicines were available across Europe in 2024 and the average time-to-access was 578 days in 2024 – stakeholder feedback has thus far been mixed, to say the least.
While the JCA could help less-resourced countries improve HTA quality and timelines, the potential improvement it offers to well-established HTA bodies like France’s HAS and Germany’s AMNOG is less clear. Moreover, the JCA does not address budget constraints, which remain a major barrier in several markets.
Writing in PharmaBoardroom earlier this year, Merck’s Lora Fleifel also notes that the process may also add complexity and burden to pharmaceutical companies, who now face parallel HTA and regulatory processes, higher resource demands during the scoping phase, and the need to coordinate global and local dossiers.
Only three JCAs were officially underway as of June, despite the EU aiming for up to 25 in the first year, and early experience reveals fragmented communication, operational challenges, and significant methodological uncertainties.
Saudi Arabia Dials in on Cell & Gene Therapies
Life sciences are a key pillar of Saudi Arabia’s attempts to diversify its economy away from fossil fuel under the ‘Vision 2030’ banner. In 2024, the Kingdom – by far the Middle East’s largest and wealthiest country, as well as the cultural centre of the Islamic world – launched its National Biotech Strategy, a broad-brushstrokes plan covering vaccines, genomics, biomanufacturing, and clinical research.
The strategy covers everything from biotech scale-up to regulatory fast-tracking, and the creation of biomedical clusters. Most boldly, it aims to position the country as a regional R&D hub by 2030 and a global centre by 2040.
This year, Saudi Arabia finally dialled in on the specifics of this strategy, explicitly targeting cell and gene therapies as its area of focus. There are good reasons for this choice, even beyond the dangers implicit in an emergent R&D player spreading its expertise and capacity too thinly across multiple fields.
Importantly, Saudi Arabia has a young population (with 70 percent of the country under 35) and a high prevalence of inherited genetic diseases (largely due to high consanguinity rates, studies suggest that over 50 percent of marriages in the country are between relatives). This creates a strong demand for cell and gene therapies domestically and, the Saudi authorities hope, makes the country a compelling option for rare disease and genetic therapy clinical trials.
To this end, Saudi Arabia launched its first gene & cell therapy manufacturing facility in October at King Faisal Specialist Hospital & Research Centre (KFSHRC). The facility aims to help localise the GMP-standard production of T‑cell, stem cell, and viral vector‑based therapies and save an estimated USD 2.13 billion through reducing the need to import these products by 2030.
The African Medicines Agency Finally has a Director: What Next for Access in Africa?
One decade in the making, in November this year, the African Medicines Agency was finally launched. Based in Rwanda and led by inaugural Director General Delese Mimi Darko – formerly the CEO of Ghana’s Food and Drugs Authority – the AMA aims to be an EMA-style organisation for Africa.
It is intended to harmonise medicines regulation across the continent, reduce duplication of national assessments and enable more efficient, consistent decision-making on quality, safety, and efficacy. Other stated goals include speeding up approval timelines and improving access, attracting more clinical research to Africa, reducing the circulation of substandard and falsified products, and stimulating local manufacturing.
These are all pressing issues. Africa accounts for over a quarter of the global disease burden, but only 1.1 percent of global clinical trials. More than 70 percent of drugs consumed on the continent are imported, and in around half of all African countries, no pharmaceutical production exists at all. Regulatory capacity also varies widely. This all means that pharma companies often choose to launch in Africa later than other markets, if at all; causes regulatory delays; and creates sensitivities to supply chain fluctuations (as seen during the COVID pandemic).
While a transformational idea, whether the AMA will be able to achieve these goals in practice is unclear. 16 countries – including major regional powers Nigeria and South Africa – have still not signed the AMA, while the practicalities of harmonising regulatory systems, financing, talent, and data infrastructure across a disparate continent will be extremely challenging.
Hong Kong Biotech Listings Rebound with Chinese Biotechs at the Forefront
Since allowing pre-revenue biotechs to go public in 2018, the Hong Kong Stock Exchange has become the premier listing vehicle for China’s wealth of life science start-ups. HKEX data shows that 73 biotech companies listed under the Chapter 18A mechanism between 2018 and H1 2025, collectively raising USD 16 billion in IPO proceeds, and positioning Hong Kong as the second largest biotech fundraising hub globally.
However, against a challenging global biotech market slump and rising US-China geopolitical tensions 2024 was a fallow year for biotechs on HKEX. This year, pre-revenue biotech listings, predominantly from mainland China, are already up with 14 pharma and medical device firms making use of the Chapter 18A mechanism up to the end of October, surpassing the full year 2024 total of 12.
Chinese biopharmaceutical innovation shows no sign of slowing down. The country is home to 29.5 percent of the global drug pipeline and 14.6 percent of all clinical trials (up from seven percent just four years ago), with Hong Kong hoping to continue providing access to global capital for its leading companies.
