By Allison Proffitt 

February 19, 2026 | Life sciences executives remain cautiously optimistic about 2026, but a striking geographic divide has emerged that reveals growing concerns about U.S. regulatory and pricing policies, according to Deloitte Consulting’s 2026 Life Sciences Executive Outlook. Andy Bolt, leader of the firm’s Life Sciences R&D Practice, presented the data earlier this month at the Clinical Trial Venture, Innovation, and Partnering event with SCOPE.  

A Tale of Two Markets 

The Deloitte survey of 280 C-suite executives across medtech and pharma—spanning the EU, U.S., and Asia—found that while overall confidence matches last year’s 75% positive or cautiously positive outlook, the distribution of sentiment tells a more complex story. 

The most striking finding from this year’s outlook is the sharp divergence between U.S. and international executives. While 90% of leaders outside of the U.S. expressed a positive outlook, only 60% of U.S. leaders shared that sentiment. The gap is even more pronounced in biopharma, where only 56% of U.S. executives reported positive expectations. 

“What’s interesting also is if you look at their responses around financial outlook, it also broke out along a similar plane,” Bolt explained. U.S. executives reported only 71% positive financial outlook compared to 90% among their international counterparts. 

The timing of the survey—conducted in August and September 2025, immediately following the distribution of Most Favored Nation (MFN) pricing letters to pharmaceutical companies—appears to have significantly influenced U.S. sentiment. “I would posit that the U.S. leaders are feeling more of the brunt of that simply because the amount of U.S. revenue that they have exposure to those MFN policies is much greater than the ex-U.S. companies,” Bolt noted. 

Unsurprisingly, executives expressed lowest confidence in factors beyond their control: national and global economic conditions. 

Regulatory and Policy Concerns Dominate 

When asked about trends shaping corporate strategies, regulatory and policy issues topped the list, with executives citing concerns ranging from the EU AI Act to China’s Volume-Based Procurement Program. Government agency restructuring—particularly within the FDA and HHS—concerned 39% of U.S. respondents, while economic policy changes including MFN pricing and tariffs registered at the same level. 

Global political tensions showed the biggest year-over-year increase in executive concern. “The rising tension between world superpowers is playing out in real time,” Bolt said, referencing recent comments from the World Economic Forum head at Davos describing this as the most complicated geopolitical time in many generations. 

AI Transformation Accelerates 

Perhaps the most dramatic shift in the survey year over year came in digital and AI priorities. The percentage of leaders citing accelerated digital transformation as having significant strategic impact jumped from 36% to 48%—driven by what Bolt described as “a significant proliferation of generative AI” in an increasingly dynamic landscape where “things just keep getting better and better and moving faster and faster.” 

The emergence of agentic AI has already captured executive attention, with 30% of leaders believing it will have significant impact despite its early stage. When asked about their top priorities, 78% of executives cited AI as both a cost and growth lever that will drive major organizational change. 

Companies are beginning to shift from experimentation to holistic transformation. “What I’m seeing and what my practice is seeing is companies starting to move from a lot of experimentation within each of the buckets, trying things out, to thinking more holistically about this,” Bolt explained. This means “thinking about being truly transformational and driving an end-to-end holistic transformation of their clinical development and regulatory operations.” 

Several companies are already securing significant budgets for platform-based AI approaches to enable digital data flow across clinical and regulatory operations, and Deloitte is working with multiple organizations on these initiatives. 

R&D Productivity: The Central Challenge 

To complement the executive surveys, Deloitte analyzed analyst calls with the top 10 biopharma companies, revealing that R&D productivity overwhelmingly dominates investor concerns. “Where’s the long-term growth going to come from?” Bolt asked.  

Deloitte’s 15-year tracking of internal rates of return on late-stage pipelines tells a sobering story: the IRR remains “pretty flat” in the low single digits. “As long as it takes $2 billion and 10 years to bring a product to market and companies continue to go after smaller and smaller specialty indications and rare diseases that have smaller peak sales, this will continue,” Bolt warned. 

The recent expansion into obesity markets and GLP-1 drugs provides some lift on peak sales (reflected in an increase from 4.3% to 5.9% IRR), but Bolt emphasized that “the costs and the cycle times of R&D are really where the significant opportunity exists for companies to really drive more R&D productivity.” 

R&D productivity topped cost management priorities at 41%—and notably, these responses came from C-suite executives across the board, not just R&D leaders. “AI is going to play a central role” in addressing this challenge, Bolt stated. 

On the R&D challenges front, 60% of executives cited regulatory complexity and data submission requirements, 52% pointed to high clinical development costs, and 46% discussed the need to modernize legacy R&D workflows and analysis. 

Bolt highlighted a potential paradox: while companies plan to expand into new therapeutic areas and modalities to drive growth—and continue using M&A to fill pipelines—these strategies “actually make addressing the key R&D challenges even harder” by introducing significant complexity into portfolios and operations. 

The AI Maturity Gap

Despite the enthusiasm surrounding AI, Bolt presented sobering data on actual implementation. Only 9% of executives reported significant ROI on AI investments. One in four claimed to be operating AI at scale across their enterprise—a figure Bolt admitted he finds “hard to believe.” 

“There’s a technology problem, building technology solutions is great, but this is where the rubber meets the road,” Bolt said. “I think that there’s a real adoption challenge within pharmaceutical companies.” 

The solution, according to Bolt, requires companies to articulate a clear vision of organizational transformation. “Until companies start addressing what the future of their organizations looks like, like how transformational it actually is going to be and the role of their employees in that new future, until they start providing that vision and really reimagining what they’re doing,” he said, “I think a lot of companies and players are going to be sitting on the sidelines waiting for some kind of mandate to work with these AI tools.” 

Key Takeaways 

Bolt summarized the year’s outlook with several key observations. First, confidence remains high despite the complicated geopolitical landscape. Second, R&D productivity continues to emerge as the number one priority, with AI serving as the primary lever that both R&D leaders and CEOs are “banking on to help bend that curve.” 

R&D consistently ranks as the top priority for AI investment, and executives are beginning to “think a little more boldly, less incrementally” about organizational transformation. However, Bolt emphasized that “technology alone is not going to solve this issue. And solving those adoption and scale problems is going to be absolutely critical.” 

In a final observation, Bolt noted an interesting pattern in the trends data: only one trend—regulatory and policy concerns—was held by more than 50% of executives. He offered two potential interpretations: either executives view the other challenges as “around the edges” and believe they can navigate them, or they fundamentally believe that “the products that they create and the impact it has on patients are really where they’re going to drive their futures and their success” regardless of other challenges.  

“While these [areas of concern—AI, supply chain, care models, and more—] are important,” Bolt concluded, “the real importance is on developing new products that really drive patient impact.”