Bioprocessing and Capacity Trends: Growth Despite Continued Uncertainty

Key Takeaways

• The biopharmaceutical industry weathered significant uncertainty in 2025 and continues to do so in 2026. Despite numerous geopolitical challenges and evolving funding paradigms, industry fundamentals remain sound and growth continues.

• Large-scale changes in bioprocessing, including the growing adoption of single-use technologies across both clinical and commercial production, increasing use of modular manufacturing solutions, greater implementation of continuous processes, and automation and digitalization, are helping to boost bioprocessing efficiencies and product quality while reducing costs.

• Biopharma companies and contract development and manufacturing organizations (CDMOs) continue to expand capacity to meet the growing demand for biologics, including antibody-based treatments, peptide drugs, cell and gene therapies, nucleic-acid derived products, and more.

• The demand for skilled workers has been outpacing their availability for some time, and the situation is only expected to worsen, making implementation of advanced bioprocessing technologies imperative.

• With margins expected to remain under pressure in the near term and geopolitical instability anticipated to continue going forward, biopharma companies must adjust to operating in a constant state of uncertainty for the foreseeable future.

• Balance will be crucial across all aspects of biopharmaceutical operations, from wider geographic, technological, and financial considerations to more detailed aspects of bioprocessing and capacity choices.

The biopharmaceutical industry weathered significant uncertainty in 2025 and continues to do so in 2026. Despite numerous geopolitical challenges and evolving funding paradigms, industry fundamentals remain sound and growth continues. The demand for biologics is rising, largely driven by blockbuster drugs in the cardiometabolic and oncology spaces.^1–3 While specialty products including chimeric antigen receptor (CAR)-T cell therapies, small interfering RNA (siRNA) therapies, and gene therapies received significant attention from 2010–2020, since then drugs targeting unmet needs in large patient populations, most notably glucagon-like peptide-1 (GLP-1) receptor agonists for obesity, have dominated. Sales of this class of drugs alone reached $75 billion in 2025.⁴ Also in that year, the top 20 biopharma companies accounted for 90% of sales.³

Manufacturers must leverage innovative technologies across research and development (R&D), manufacturing, analytics, and compliance to increase efficiencies and compensate for ongoing talent shortages. Rising pricing pressures, molecule and process complexity, and expanding use of accelerated approval pathways are further driving the importance of advanced technologies in establishing competitive advantage.^1–3 Artificial intelligence (AI) algorithms, automation and digitalization solutions, process intensification strategies, including continuous processing, and quality-by-design approaches have become essential. Companies are also pursuing mergers, acquisitions, and alliances to gain access to new technologies, differentiated capacity, and diverse markets.

The value of the bioprocessing market is consequently rising at a compound annual growth rate of 11.4% from approximately $93 billion in 2025 to reach nearly $229 billion by 2033.⁵ Single-use technologies and modular processing systems lie at the heart of capacity expansions across modalities.

The value of the global biopharmaceutical industry, meanwhile, reached $232 billion in 2025, with 72 companies generating more than $500 million in sales.⁴ A total of $68.5 billion in funding ($20.6 billion in venture capital) was raised, an increase of 11% compared with 2024. Small companies alone raised $58.9 billion, or 86% of the total, with follow-on financing up 24% from 2024. At $1.65 trillion, the biotech market capitalization was also up dramatically (28.8%), and the average value of all deals reached the highest level in five years, with over half of them worth more than $5 billion. On the innovation front, 38% of new product launches in 2025 were first-in-class, enabled by the use of AI in drug discovery and driven in good measure by advances achieved by Chinese companies.

Boston Consulting Group predicts revenue at the top 16 biopharma companies it follows to rise at a compound annual growth rate (CAGR) of 4.3% through 2030.⁴ The growth and new product launches are expected to be sufficient to overcome significant patent losses over that period, and particularly in 2028. In addition to the cardiometabolic segment, oncology and immunology are anticipated to fuel growth in the biopharma market, with a significant portion of sales by 2030 coming from newer modalities, although biosimilar sales could impact growth in the immunology sector from 2030 onwards. The most successful companies are those with diverse portfolios and thus “lower product concentration risk.”

Although a conservative sector, success in the biopharmaceutical industry relies on constant innovation across all activities, from drug discovery and development through manufacturing and regulatory compliance. Advances in technology make it possible to turn innovative concepts into practical realities. Today they are helping manufacturers overcome two key challenges: increasing complexity and the growing need for true flexibility.⁶

In recent years, large-scale changes have centered around the growing adoption of single-use technologies across both clinical and commercial production, increasing use of modular manufacturing solutions to facilitate more rapid facility buildouts across different geographies, greater implementation of continuous processes, particularly perfusion for upstream processing, and automation and digitalization of R&D and clinical and commercial manufacturing operations.

Single-use technologies prevent cross-contamination, allow for process changeovers and startups, and facilitate process scaling (both out and up). They, along with automation and digitalization, also enable continuous processing, which itself leads to more consistent and improved product quality and reduced costs.⁶ Automation reduces the need for manual interventions and thus risk of human errors and contamination. Solutions are available across upstream and downstream processing operations, analytics, and document preparation.¹ Digitalization supports effective data integration and analytics, predictive modeling, and real-time monitoring and control for improved performance and efficiency.⁷

Both biopharma companies and contract development and manufacturing organizations (CDMOs) have been and continue to expand capacity to meet the growing demand for biologic drugs, including antibody-based treatments, peptide drugs, cell and gene therapies, nucleic-acid derived products, and more. Much of the recently announced activity is taking place in the United States in response to U.S. administration policies (see below).

Staffing those new and expanded facilities will be a problem, however.¹ The demand for skilled workers has been outpacing their availability for some time, and the situation is only expected to worsen. With nearly three-quarters of skilled workers located outside the United States and domestic policies limiting access to them, the issue is of real concern and may represent the greatest hindrance to realizing proposed capacity expansions. Companies are turning to technology, including AI and machine learning (ML) to help fill the gap, saving human workers for those jobs that require talents not currently possessed by AI algorithms, such as judgment, creativity, and relationship building.

The complexity of bioprocessing today typically requires development of the workforce, which takes time, particularly when it comes to highly specialized, advanced treatments.

The talent challenge is just one indication of ongoing difficulties in the biopharma sector despite the steady growth taking place. In 2025, there were 220 fewer publicly traded biopharma companies compared with 2021. This decline is in part due to the correction that occurred following excessive investment during the pandemic.⁵ The continued consolidation, however, is a warning sign, particularly for smaller companies.

In fact, of companies with revenues less than $500 million, just 45% had two years’ worth of cash on hand at the end of 2025, with 33% having less than one year of cash in reserve.⁵ While the initial public offering (IPO) market was active early in 2026, investors appear to be more conservative, focusing on late-stage companies. Merger and acquisition (M&A) activity has also been limited, with fewer, higher-value deals focused on de-risked assets. The same is true for licensing deals.³ This risk aversion is viewed as a response to the high levels of uncertainty in the world today.⁵ It is also creating a longer path to exit for small pharma companies and the need for real cash flow management that allows generation of data that will attract investors. Developers are also switching their R&D efforts to lower-risk and/or only slightly innovative candidates, which, combined with reduced basic research funding (particularly in the United States), could lead to reduced development of truly novel treatments.³

Policies implemented by the Trump administration in the United States are affecting not only U.S. biomanufacturers but biopharmaceutical companies around the world, and thus the global industry.^3,5 Cuts to scientific funding are impacting the rate of innovation in the United States, which is falling behind that of other regions, most notably China (see below). Tariffs announced in 2025 raised concerns, but were followed by a Supreme Court ruling questioning their legality. The administration responded with 100% tariffs imposed using Section 232 of the Trade Expansion Act of 1962. The largest international pharma companies have announced significant capacity additions through both greenfield sites and expansions of existing facilities, as well as new pricing strategies to align with the administration’s most-favored-nation (MFN) pricing policy, to gain tariff rate reductions or exempt status for the first few years.

In addition to unilateral trade and tariff policies, other U.S. government actions with potential negative impacts include the passage of the BIOSECURE Act and the recently introduced Biotech Investment National Security Act (BINSA), which would expand screening of US pharmaceutical licensing deals, joint ventures, and equity investments with “covered foreign persons” in China.⁸

Modality diversity and complexity, combined with pricing challenges, have created a situation in which biopharma companies must begin to think about market access from the earliest phases of candidate development. It is no longer feasible to wait until close to market launch, as commercialization is no longer a guarantee that products will reach patients.

Along with focusing on first-in-class, highly differentiated products manufactured using cost-efficient bioprocesses, drug developers must build relationships with payers, engage with them, and factor their possible responses into development and marketing strategies when they reach phase II development, if not sooner.¹ Similarly, life cycle management should be included in development plans from the outset, including new formulations, delivery systems, combination therapies, and bioprocess improvements.

Many companies are starting to use AI to develop sales strategies that address MFN concerns and enable more effective outreach to targeted patient groups, largely by building stronger launches that recoup investments faster.³ Some firms are also flirting with direct-to-patient and direct-to-employer models to eliminate middlemen for products suited to this approach. These changing strategies must be linked back to production planning and bioprocess design, optimization, and scaling.

Drug manufacturers no longer look to China only to achieve cost efficiencies through outsourcing of bioprocessing services. China today is a leader in novel drug development, conducts more clinical trials than the United States and Europe, and accounts for half or more of licensing deal value and a quarter or more of deal volume.¹² In addition, many of the candidates in development are next-generation therapies leveraging novel technologies and not me-too products.⁵ Key advantages for Chinese companies include lower costs and more rapid development backed by a comprehensive and government-supported biopharma ecosystem.³ It is also worth noting that India is attracting investment as well and continues to be an attractive destination for outsourced manufacturing as drug companies seek to minimize and disperse “geopolitical and operational risk.”³

What do all of these trends and issues mean for the future of the biopharma sector and bioprocessing needs? With margins expected to remain under pressure in the near term and geopolitical instability anticipated to continue going forward, biopharma companies must adjust to operating in a constant state of uncertainty for the foreseeable future. They must make R&D manufacturing, technology, and marketing choices in the face of U.S. tariffs, shifting pricing policies, and defunding activities; ongoing wars; talent shortages; and declining public perception, among other challenges.³

Clearly the biopharma industry is able to achieve reasonable growth despite facing long periods of uncertainty. Past performance indicates strong fundamentals that should balance concerns over the likelihood of continued success. Balance will in fact be crucial across all aspects of biopharmaceutical operations, from wider geographic, technological, and financial considerations to more detailed aspects of bioprocessing and capacity choices.⁵

Candidate portfolios must be balanced to overcome patent expiries by incorporating the right mix of modalities that fit with bioprocessing capabilities and capacities and represent real-world commercial potential.^3,5 Internal and external innovation approaches must be balanced appropriately to ensure competitive advantage. Use of AI across R&D, bioprocessing, and regulatory compliance must be pursued in a balanced manner as well.

When it comes to bioprocessing, manufacturing locations and the balance of in-house and outsourced capacities must be selected carefully to maximize opportunities and meet evolving local and global expectations.^3,5 Modification of supply chains is needed to ensure flexibility, agility, and responsiveness. Scalability and cost of goods must be considered against commercial potential, particularly for precision medicines. Flexible manufacturing solutions will need to be combined with new commercialization strategies.

Innovative bioprocessing technologies will be essential to reducing the cost and complexity of many advanced therapies. Further progress towards Pharma 4.0 with greater automation, digitalization, and integration across upstream and downstream processing, fill/finish, and process and analytical development activities achieved through the wise use of AI, ML, and other advanced technologies will be necessary to improve productivity and efficiency and address labor shortages while also enhancing overall process performance.

One potential approach to achieving such a complex balancing act is through expansion of networks beyond outsourcing of basic development and manufacturing activities. Such an “asset light” or “Bioweave” model involves partnering and collaborating across not just bioprocessing, but “innovation, commercialization and operational domains.”¹¹ Such networks would include CDMOs, professional infrastructure and real-estate firms, a wide variety of suppliers and technology vendors, and various other players. By “yielding ownership and control of real estate assets, site services and manufacturing operations to a partnership network,” biopharma companies can enable “right-sizing of operations and continuity of supply,” and potentially “reduce fixed costs, free up capital, optimize site management responsibilities and overheads, and better monetize under-utilized manufacturing assets.”

Whatever strategy companies choose, achieving the right balance will help ensure minimization of risk and maximization of reward. Given the foundational health of the sector, that will position biopharma firms for success despite the current uncertainty. Those with balanced portfolios and bioprocessing capabilities and capacities will be prepared to leverage the pent-up demand created during this turbulent period and benefit from accelerated growth that should occur once stability returns.¹

1. Mirasol, Feliza. “How Biopharma Navigates the 2026 Economic Shift.” BioPharm International. 19 Jan. 2026.

2. Auerbach, Mike. “The Bioprocess Revolution: How Technology and Trends are Reshaping Pharmaceutical Manufacturing.” American Pharmaceutical Review. Innovations at Interphex 2025 Supplement: 13–15 (2025).

3. Alvarez, Daniel, et al. “Biopharma Trends 2026: Pressures Mount—Now and into the Future.” Boston Consulting Group. 8 Jan. 2026. BCG

4. “Large And Small-scale Bioprocessing Market (2026–2033).” Grand View Research. Jun. 2026.

5. Ramko, Rich, Ashwin Singhania, and Arda Ural. “EY Biotech Beyond Borders Report 2026.” EY. June 2026. 

6. “How can bioprocessing professionals evolve their manufacturing for greater flexibility and efficiency?” Thermo Fisher Scientific, Life in the Lab. 4 Mar. 2026.

7. Dell-Price, Olivia. “Intelligent automation: transforming bioprocessing through data-driven control.” BioIndustry Association Blog. 20 Nov. 2025.

8. “Congress Proposes Federal Oversight for US-China Drug Licensing Deals.” PharmaSource. 4 June 2026.

9. Helleckes, Laura Marie, et al. “Perspectives for artificial intelligence in bioprocess automation.” Current Opinion in Biotechnology. 97: 103392 (2026).

10. “Biopharma Industry Trends: Drug Innovation and Patent Risk in 2026.” Morningstar Insights. 3 Aug. 2026.

11. Zweig, Olaf, and Derron Stark. “Why biopharma needs asset-light manufacturing models now.” EY Insights. 4 June 2026.

12. Challener, Cynthia A. “Pharmaceutical Innovation in China Takes Center Stage.” Pharma’s Almanac. 25 Aug. 2026.