How Biopharma Navigates the 2026 Economic Shift

Key discussions expected to continue in biopharma from 2025 into 2026 center around shifting trends, such as reimagining supply chains to protect against global disruptions and how organizations plan to maintain a competitive advantage amid rising pressures. This industry outlook will address the accelerating role that AI and digital technologies will play, alongside strategies needed to boost and retain skilled talent.

The biopharmaceutical industry is currently navigating a period of profound transformation, characterized by a transition from the urgent demands of the post-pandemic era to a more calculated, technology-driven future (1). Despite various economic and political shifts, historical data spanning three decades suggest a fundamental resilience within the sector, according to Eric Langer, president and managing partner, BioPlan Associates.

As the industry moves toward 2026, however, it faces a complex intersection of geopolitical headwinds, a chronic talent shortage, and the rapid integration of AI into both R&D and manufacturing, Langer says. Understanding these trends is critical for stakeholders to maintain competitive advantage in a market where regulatory success no longer guarantees commercial viability, he explains.

How will geopolitical shifts and tariffs impact bioprocessing investment?

The economic climate for 2026 is heavily influenced by the 2025 US tariffs (2), which have introduced a period of investment caution, according to Langer. He notes that the industry’s response to these tariffs is marked by a lack of flexibility.

"The inability to predict and the requirement for more time, and the inability to create the flexibility to adjust, means people are just putting on [the] brakes," he observes. This uncertainty is compounded by potential legal shifts, such as a possible overturn of specific tariffs by the US Supreme Court (3), which forces companies to constantly re-evaluate their global supply chain strategies.

Despite this investment caution, the biopharma industry remains fundamentally healthy, Langer notes, saying, "the industry today is…very robust and strong based on what’s been experienced over the last number of decades."

Historically, such economic slowdowns do not indicate a permanent retreat but rather create pent-up demand that typically leads to accelerated growth once the political or economic climate stabilizes, Langer explains. This information is vital for the industry because it signals that although short-term capital expenditures may slow, the underlying requirement for innovation and capacity continues to build, Langer emphasizes.

Can AI and automation solve the complexity of analytical testing and documentation?

As biopharmaceutical products become more complex—particularly with the rise of recombinant proteins and advanced modalities—traditional manual processes are becoming a bottleneck (4). AI is rapidly moving from an experimental phase to being woven into the fabric of discovery, development, and commercial execution (5).

In the realm of analytical testing, automation is no longer optional, Langer stresses. The industry is targeting advances in analytical technologies to facilitate overall process development. “In our Annual Biopharma study (6), we’re seeing that better automation and monitoring are in high demand from end-users,” Langer says. “‘Automation: bioprocess control, monitoring’ is now reported by 38.8% [respondents] as a key innovation area being evaluated. This is up by more than double what it was in 2020 with 17.1% evaluating automation technologies. This is due partly to the expectation that automation can remove human errors in bioprocessing, and to meet hiring challenges that we have seen over the past 20 years in GMP [good manufacturing practice] operations.”

Digital integration and the implementation of miniaturized analytics are transforming biomanufacturing by enabling real-time quality assurance (7). These technologies are particularly critical for recombinant proteins, in which advanced liquid handling systems and automated chromatographic services are being used to shorten drug discovery timelines and improve precision.

Langer emphasizes that the most significant impact of AI in the near term may be in the "arcane" but essential world of documentation and quality management.

"Regulatory and documentation automation is most definitely on the books," Langer states, adding that AI can simplify labor-intensive tasks such as standard operating procedure (SOP) writing, deviation categorization, and SOP version tracking. The industry must determine whether it has the staff capable of "moving from, say, the manual batch release documentation to automation of batch release documentation," Langer adds.

This shift is essential for reducing human error and accelerating the release of critical therapies to market. Perhaps the most significant constraint on biopharmaceutical capacity is the ongoing difficulty in hiring and retaining skilled staff.

This is not a new problem, but it is intensifying as the industry grows faster than the workforce can be developed. Langer reports that "36% of the facilities out there are unable to hire their process development positions," and "28% can't hire the downstream production staff."

This problem is particularly acute in specialized areas such as cell and gene therapy and viral vector manufacturing, in which the required level of expertise often does not exist in the general workforce. Citing data from BioPlan Associates, Langer further highlights that, with only 28% of the global manufacturing staff residing in the United States, domestic policy and visa challenges are hindering access to the 72% of the workforce located internationally.

"Hiring difficulties are creating capacity constraints across the board and across regions," he warns.

To address this workforce skills gap, life sciences strategy consultant Janice MacLennan, senior strategy consultant to Big Pharma and founder and CEO of Nmblr, suggests a fundamental shift in how companies approach their workforce. She advocates for "redesigning the work before you actually redesign the workforce."

By focusing on where humans create the most value—such as judgment, creativity, and relationship building—technology can be positioned as an enabler rather than a threat, she states. MacLennan also promotes a "skills-based model" in which the focus is on portable capabilities rather than a traditional curriculum vitae (CV).

"What you're looking for is capability, not for a CV...it has less impact than what you're capable of achieving," MacLennan explains.

What strategies will define competitive advantage and market access?

In 2026, the definition of winning in biopharma is shifting from regulatory approval to market access, MacLennan says. Patent cliffs and increasing pressure from biosimilars are intensifying margin pressures, making what she calls "defendable differentiation" a requirement for any R&D investment. MacLennan notes that companies must focus on assets that are first-to-market or best-in-class, often utilizing biomarkers for selective populations.

A critical component of this strategy is early engagement with payers, MacLennan adds. She explains that companies historically waited until they had regulatory approval to address market access; however, current trends show that cross-functional teams must build payer thinking into their strategy as early as Phase II development.

MacLennan highlights this forward movement, saying, "Winning is about getting access, so it’s a shift."

Furthermore, life cycle management now requires a 10-year horizon (8). Instead of waiting for a product to enter the market to think about its future, companies are now planning for new formulations, delivery systems, and combination therapies a decade in advance, according to MacLennan. She adds that long-term planning is essential for maintaining the value of an asset throughout its entire lifecycle in a highly competitive environment.

Which therapeutic areas are leading the next wave of innovation?

In looking ahead into 2026, MacLennan identifies two major frontiers: oncology and cardio-metabolic health. In oncology, for example, the exploration of novel modalities like bispecific antibodies is yielding remarkable data, she says. She points out that "even with bispecifics at the moment in cancer...the data that we are seeing are significantly different in terms of progression-free survival." These new modalities are proving more effective at targeting tumors and fighting treatment resistance (9).

Meanwhile, the cardio-metabolic space, which covers diabetes, heart health, and blood pressure, is evolving, MacLennan observes. "This is probably the first space which is really going to start acting like a consumer-driven market," observes MacLennan, noting that daily data from apps and wearable devices will allow for faster innovation and a more continuous model of care (10).

Regulatory bodies like FDA are also driving innovation by shaping how AI is used in manufacturing and encouraging a move away from animal models toward more human-centric preclinical models (11,12). This transition is expected to shorten development times and allow assets to reach first-in-human trials faster, MacLennan says.

The modernization mandate

As Langer and MacLennan demonstrate, the biopharma industry in 2026 is at a crossroads where manual tradition meets digital necessity. The reliance on manual batch release and traditional hiring models is no longer sustainable given the 36% vacancy rate in process development and the increasing complexity of new biologic modalities, they say.

From their perspective, the path forward requires a robust embrace of automation—not just in the production line, but in the analytical and documentation processes that ensure quality and compliance. As Langer observes, the biopharma industry has historically met its needs through innovation, and the current focus on continuous upstream automation reflects this.

"The industry is providing sufficient innovation necessary in these areas to meet the needs of the industry right now," he notes regarding the maturation of single-use technologies. By integrating AI-guided discovery, automated analytical testing, and a human-centric talent system, the industry can overcome current economic and workforce constraints to deliver the next generation of therapies.

References

1. L.E.K. Consulting. Looking Ahead in Biopharma: 2024. L.E.K. Insights 2024, 26 (1).
2. The White House. Fact Sheet: President Donald J. Trump Imposes Tariffs on Imports from Canada, Mexico and China. WhiteHouse.gov. Feb. 1, 2025.
3. Howe, A. How the Tariffs Could Be Refunded if the Court Sides Against Trump. SCOTUSblog. Dec. 18, 2025.
4. European Commission. New Technologies and Production Tools for Complex Protein Biologics. cordis.europa.eu. Oct. 31, 2015 (accessed Jan. 12, 2026).
5. Barbosu, S. Harnessing AI to Accelerate Innovation in the Biopharmaceutical Industry. ITIF.org. Nov. 15, 2024.
6. BioPlan Associates. 22nd Annual Report and Survey of Biopharmaceutical Manufacturing and Capacity. bioplanassociates.com. April 2025.
7. Mirasol, F. Miniaturized Analytics Are Transforming Aseptic Bioprocessing. BioPharm Int. 2025, 38 (8), 19–21.
8. Whittington, M. D.; Garrison, L. P.; O’Brien, J. M.; Campbell, J.D. How Time Is Accounted for When Modeling Pharmaceutical Impacts: Investment vs Assessment Perspectives. Health Affairs Scholar 2025, 3 (9), qxaf169. DOI: 10.1093/haschl/qxaf169
9. Guidi, L.; Etessami, J.; Valenza, C.; et al. Bispecific Antibodies in Hematologic and Solid Tumors: Current Landscape and Therapeutic Advances. Am Soc Clin Oncol Educ 2025, 45 (3), e473148. DOI: 10.1200/EDBK-25-4731
10. Izmailova, E. S.; Wagner, J. A.; Perakslis, E. D. Wearable Devices in Clinical Trials: Hype and Hypothesis. Clin. Pharmacol. Ther. 2018, 104 (1), 42–52. DOI: 10.1002/cpt.966
11. FDA. Draft Guidance for Industry, Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products (CBER, CDER, January 2025).

About the author

Feliza Mirasol is the science editor for BioPharm International®.