This year has brought a range of challenges for biopharma companies and their leaders, including on-and-off tariff threats and President Donald Trump's arm-twisting around overseas drug spending. Now, new data show how many industry leaders are grappling with these issues and others.
On the occasion of life sciences supplier and partner Cytiva’s third global biopharma index, many of the more than 1,200 executives surveyed concurred that uncertain government policy and inconsistent regulatory approaches—both in the U.S. and abroad—are creating significant obstacles for the industry.
Effective policy and regulation are key to the biopharma industry’s success, setting the “rules of engagement” for investment, innovation and market access, Cytiva noted in the index, which it released Monday. But among the 1,250 industry executives Cytiva surveyed, many are grappling with “fragmented, unpredictable policy environments,” even in markets that have traditionally remained stable, according to the report.
Overall, 51% of the executives surveyed said government policy pertaining to biopharma is inconsistent, up from the 45% who held that view in 2023, when Cytiva last ran its global index. Further, half of those polled noted that current market conditions are making it more difficult to raise capital, up from 42% of executives who held that perspective two years back.
What’s more, some 25% of the executives polled suggested that policy and regulatory processes aren’t well aligned to cell and gene therapies in particular.
The issue isn’t restricted to emerging economies either, Cytiva said, noting that policy and regulatory concerns are mounting in developed countries, too, thanks to leadership changes, shifting political priorities and “reactive policymaking” that is hamstringing companies’ efforts to plan for the long term.
In the U.S., major healthcare policy changes taking place under the second Trump administration are certainly adding fuel to the fire, but the whiplash nature of American politics more broadly also deserves some of the blame, according to at least one of the executives who spoke to Cytiva.
“The U.S. remains one of the best places to practice science, but science requires consistency, in funding, in regulation, in support for talent,” Johannes Fruehauf, M.D., Ph.D., executive chairman of LabCentral, said in the report. “When those things change with every administration, it’s very hard to make long-term plans.”
With multiple major elections taking place in 2024—which introduced a wave of changes in areas like regulatory reviews, taxes and trade rules—the industry is now faced with a “patchwork of policies,” some of which are “encouraging,” while others are “contradictory,” according to Cytiva.
For example, some countries promote domestic R&D but then impose restrictive price controls on medicines or fail to offer appealing intellectual property protections. That take can be applied to the U.K., which has seen multiple large pharmaceutical companies pull back on or pause investments this year over similar issues, with Eli Lilly’s CEO David Ricks last month telling the Financial Times that the U.K. is “probably the worst country in Europe” with regards to drug pricing.
Tariffs are one leading culprit driving the sense of uncertainty in the industry. More than half of the survey respondents said they believe tariffs will increase in their country in the next year, and many of those same respondents voiced concerns over inconsistent policy.
Patchwork regulation
On the regulatory front, global drug reviewers are struggling to keep pace with innovation, especially in terms of emerging modalities like cell and gene therapy, mRNA platforms and platform-based drug delivery systems, the report continues.
“At the moment, we’re applying things that work for more traditional drugs in the approval process to cell and gene therapies,” Elektrofi’s chief operating officer, Joanne Beck, Ph.D., said in a statement. “We’re trying to fit a square peg into a round hole.”
Several countries are now actively working to reform their regulatory systems, although those efforts have been “uneven” to date, Cytiva said.
In the U.K., for example, the country’s Medicines and Healthcare products Regulatory Agency is establishing mutual recognition pathways with other, trusted international regulators, while changes to the Prescription Drug User Fee Act and the FDA’s type D meetings are aimed at improving early-stage developer guidance in the U.S., Cytiva explained.
Nevertheless, smaller companies in particular see regulatory approval processes as a “significant barrier,” according to the 2025 index.
The new report marks Cytiva’s third global biopharma index, following the publication of similar industry snapshots in 2023 and 2021. To develop the index, Cytiva interviewed 1,250 biopharma executives from 22 countries and asked them to rate six industry pillars on a 0 to 10 scale. Aside from government policy and regulation, those pillars were supply chain resilience, talent pool, R&D ecosystem, manufacturing agility and sustainability, with the final category newly added in the 2025 index.
The global average score for the 2025 report clocked in at 5.96, down from the 6.08 rating executives gave in 2023, signaling slippage across several key areas.
Cytiva noted that the overall decline reflects “mixed performance” across the six industry pillars, although the firm caveated that, while some areas are “struggling,” others “give reason to be optimistic.”
Aside from policy and regulatory uncertainty, the industry would do well to address persistent talent shortages, especially in advanced modalities, and shifting manufacturing priorities in a post-COVID pandemic world, Cytiva advised.
The report also ranks the 22 countries represented in terms of how well they’re doing on each of the categories. Switzerland held on to top billing, followed by the U.K., which shifted up one position from third in 2023 to second this year.
The U.S., meanwhile, fell three spots from second place to fifth, which Cytiva blamed in part on “regulatory uncertainty and policy disruption.”