Outsourcing Hits Record Levels for All Bioprocess Platforms

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Outsourcing has hit record levels for all bioprocess platforms, with 82.6% of cell and gene therapy (CGT) companies now outsourcing at least some biologics manufacturing, 77.5% for mammalian, and 78.0% for microbial fermentation engaging in some outsourcing activity, up significantly during the past 10 years, according to BioPlan Associates (1). Nearly all of the 26 bioprocessing functions surveyed are outsourced by over half of respondents in BioPlan’s survey, underscoring a fundamental transformation in how the industry approaches operational execution.

This broad adoption is not happening in isolation. The global biomanufacturing landscape is being shaped by accelerating innovation in modalities like CGT, persistent capacity constraints, and rising demand for faster speed-to-market. As a result, contract development and manufacturing organizations (CDMOs) are no longer peripheral players, they are strategic partners embedded throughout the drug development lifecycle.

But while outsourcing itself is not new, how it is being leveraged is evolving rapidly. Companies are turning to CDMOs not just for execution, but also for regulatory expertise, digital infrastructure, and flexible capacity models that allow them to navigate growing therapeutic complexity and global uncertainty.

This article highlights the emerging contours of modern outsourcing: from analytical testing and fill/finish, to CGT, microbial and mammalian production, and global partner selection. The data reveal that outsourcing is not only increasing, but it is also diversifying, accelerating, and becoming more central to how biopharmaceuticals are developed and delivered.

Strategic outsourcing spanning entire lifecycle

Outsourcing in biopharmaceuticals has evolved far beyond simple cost-efficiency; it has become an essential strategy underpinning speed, scalability, and operational resilience. All 26 bioprocessing functions tracked in the survey were reported to be outsourced by more than 50% of respondents (1). This includes not only traditional areas like media preparation and packaging, but also high-complexity operations such as formulation, cell-line development, and even final product manufacturing.

This comprehensive adoption reflects two converging realities. First, the biopharmaceutical industry continues to expand its pipeline across modalities and geographies, putting pressure on internal capacity and specialized expertise. Second, today’s outsourcing partners, especially CDMOs, are offering far more than just hands and hardware. They bring with them advanced infrastructure, regulatory know-how, and the ability to rapidly mobilize resources across multiple products or sites.

The result is a highly collaborative ecosystem in which outsourcing has become the default mode for many critical bioprocessing activities. For emerging biotech firms, in particular, CDMO partnerships provide a fast track to commercialization without the delays or capital expenditure required to build internal capabilities. Even established pharma players are expanding outsourced functions to remain agile in the face of shifting global dynamics, such as supply chain disruptions, modality diversification, and regulatory tightening.

This shift is not uniform. Certain functions, like analytical testing, fill/finish, and CGT production, are clearly leading the outsourcing trend, each driven by unique sets of technical and strategic imperatives (Figure 1). But taken together, the data point to a decisive evolution: outsourcing is now a core competency of successful biomanufacturing, not an optional add-on.

Figure 1. Biomanufacturers outsourcing some activity today, 2025. Source: 22nd Annual Report on Biopharmaceutical Manufacturing, BioPlan Associates, Inc., April 2025, www.bioplanassociates.com

Analytical testing, fill/finish lead pack

Among the many bioprocessing functions now outsourced, analytical testing and fill/finish operations stand out as the most widely and consistently externalized. These functions are critical to ensuring product quality and timely release, requiring deep technical expertise, specialized infrastructure, and strict regulatory compliance, all of which CDMOs are increasingly equipped to deliver.

The report shows that 29.6% of biomanufacturers intend to increase analytical testing outsourcing within the next 24 months, highlighting the function’s growing strategic value (Figure 2). This includes a broad range of testing activities, from stability and sterility, to potency, identity, and residual impurity analytics. The continued rise in complexity of biologics, biosimilars, and CGTs is also fueling demand for sophisticated analytical capabilities that many smaller firms cannot cost-effectively maintain in-house.

Figure 2. Outsourcing activities projected to be done at ‘significantly higher levels’ in two years (2025). Source: 22nd Annual Report on Biopharmaceutical Manufacturing, BioPlan Associates, Inc., April 2025, www.bioplanassociates.com

Fill/finish, once viewed as a late-stage routine function, is now also commanding increased attention. The outsourcing market for fill/finish operations was estimated at $5.9 billion in 2024, with an expected compound annual growth rate of 8% over the next five years. Data suggest that approximately 71.7% of drug developers prefer to outsource fill/finish activities, particularly for biologics and injectable products (1). The rationale is clear: sterile fill/finish requires validated cleanrooms, highly trained staff, and specialized equipment that are prohibitively expensive to maintain for many drug sponsors.

Increased use of flexible single-use systems in fill/finish is also making it easier for CDMOs to accommodate multiple clients, formats, and batch sizes, further strengthening the case for outsourcing. And as biologic pipelines expand, outsourcing enables companies to avoid infrastructure bottlenecks while ensuring compliance with stringent current good manufacturing practice (CGMP) requirements.

Together, analytical testing and fill/finish illustrate how outsourcing is being driven by both necessity and opportunity. By tapping into CDMOs’ capabilities, drug developers can manage risk, ensure quality, and accelerate timelines, which are all essential outcomes in today’s high-stakes biopharma environment.

Advanced modalities, CGT push boundaries

Outsourcing is no longer limited to traditional biologics. It has become foundational to how the industry is navigating the complex terrain of CGTs and other emerging modalities. These therapies demand highly specialized capabilities, closed-system processing, viral vector manufacturing, aseptic isolation, and robust regulatory support, making in-house development prohibitively difficult for most companies.

A quarter of industry respondents (24%) said they plan to increase outsourcing of CGT production, while 19.2% plan to expand CGT-related R&D outsourcing. These are not marginal changes—they indicate a substantial and growing reliance on external partners to bring novel therapies to market.

CDMOs have responded by investing heavily in purpose-built CGT infrastructure. This includes cleanroom suites equipped with validated isolators, automated cell-processing platforms, and modular vector production lines. These investments are not just about capacity; they are about speed. In a therapeutic space where development windows are compressed and patient demand is urgent, CDMOs offer the ability to accelerate timelines without compromising compliance.

Equally important is the regulatory expertise that CDMOs bring. Navigating the evolving frameworks around advanced therapy medicinal products, GMP for autologous therapies, and regional chemistry, manufacturing, and controls expectations requires a depth of knowledge that many emerging biotech companies lack. Strategic outsourcing ensures that this knowledge is built into the development process from the outset.

This shift is mirrored in BioPlan’s data on in-house versus outsourced CGT production. Only 17.4% of respondents keep 100% of their CGT manufacturing in-house as of 2025, down significantly from 30.4% in 2024 (Figure 3). This trend confirms that outsourcing is no longer an adjunct, but rather the default approach for most CGT developers.

Figure 3. Biopharmaceutical manufacturing facilities outsourcing no production (2006–2025). Source: 22nd Annual Report on Biopharmaceutical Manufacturing, BioPlan Associates, Inc., April 2025, www.bioplanassociates.com

As pipelines expand to include messenger RNA, clustered regularly interspaced short palindromic repeats (CRISPR)-based products, and personalized cell therapies, outsourcing models will continue to evolve. But the direction is clear: For next-generation therapies, CDMOs are no longer just service providers, they are strategic enablers of innovation.

Strategic partnerships and the road ahead

As outsourcing becomes more entrenched in the biomanufacturing ecosystem, companies are shifting how they choose and work with external partners. No longer is cost the primary driver; quality now dominates vendor selection criteria. According to BioPlan’s report, 87.3% of respondents cite compliance with quality standards as the top factor when selecting outsourcing partners. This underscores the growing emphasis on long-term strategic alignment over short-term cost savings.

Budget forecasts reinforce this shift. Following recent downturns in capital allocation, outsourcing budgets are rebounding. In 2025, the average projected increase in outsourcing budgets is 11.0%, up from 8.5% in 2024. This uptick reflects renewed confidence in CDMOs as innovation partners rather than mere execution arms.

Another key trend is the increasing diversification of outsourcing destinations. While traditional hubs like the United States and Western Europe remain strong, new regions are rising. Japan, the United Kingdom, and Canada continue to be favored destinations, but Asia is also gaining ground thanks to improving biomanufacturing capabilities, legislative support, and lower costs. This broadening global footprint allows biopharma companies to optimize for speed, cost, regulatory alignment, and market access.

At the same time, the types of outsourcing relationships are becoming more sophisticated. Beyond conventional CDMO models, new formats like hybrid CDMOs and integrated development and manufacturing organizations are gaining traction, offering end-to-end solutions from discovery to commercial production. These models allow therapeutic developers to maintain knowledge continuity across development stages, reduce technology transfer friction, and integrate artificial intelligence-enabled tools and predictive analytics.

In this evolving landscape, success hinges not just on choosing the right partner, but on forging a collaborative, tech-enabled partnership that adapts as pipelines and priorities shift. Outsourcing is no longer a tactical decision, it’s a strategic pillar in delivering complex therapies to market, faster and more efficiently.

Outsourcing as a strategic imperative

The outsourcing landscape in biopharmaceutical manufacturing is undergoing a fundamental transformation. Once a tool for tactical efficiency, it has evolved into a strategic imperative, especially as advanced modalities, compressed timelines, and global supply challenges reshape the industry. Outsourcing is no longer limited to non-core functions. It touches everything from analytical testing and fill/finish to gene therapy production and regulatory compliance.

As companies navigate increasing complexity and pressure to accelerate development, CDMOs are stepping up, not just as vendors, but as innovation partners. With rising budgets, evolving partnership models, and a sharp focus on quality and speed, the future of outsourcing is smarter, more global, and more essential than ever.

Reference

1. BioPlan Associates. 22nd Annual Report on Biopharmaceutical Manufacturing, BioPlan Associates, April 2025.

About the author

Yasmin Timol is project manager and market researcher at BioPlan Associates.

Article details

BioPharm International®
Vol. 38, No. 6
July/August 2025
Pages: 22–25

Citation

When referring to this article, please cite it as Timol, Y. Outsourcing Hits Record Levels for All Bioprocess Platforms. BioPharm International 2025 38 (6).