Visiongain has published a new report entitled Biopharmaceuticals Contract Manufacturing Market Report 2025-2035(Including Impact of U.S. Trade Tariffs): Forecasts by Source (Mammalian, Non-mammalian), by Service ((Process Development (Downstream, Upstream), Fill & Finish Operations, Analytical & QC Studies, Packaging)), by Product ((Biologics (Monoclonal Antibodies, Recombinant Proteins, Vaccines, Others), Biosimilars)), by Company Size (Small, Mid-sized, Large), by Scale of Operations (Preclinical, Clinical), by Therapeutic Area (Therapeutic Area, Oncology, Autoimmune Diseases, Cardiovascular Diseases, Metabolic Diseases, Infectious Diseases, Neurology, Others) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies.

The global Biopharmaceuticals Contract Manufacturing market is estimated at US$18,679.5 million in 2025 and is projected to grow at a CAGR of 11.6% during the forecast period 2025-2035.

CDMO Partnerships Evolve into Strategic Pillars of Biopharma Growth and Resilience

The role of contract development and manufacturing organisations (CDMOs) is evolving from transactional service providers into strategic partners embedded within the long-term operating models of biopharmaceutical companies. While outsourcing was once primarily driven by the need to reduce capital expenditure, large sponsors are now deepening partnerships to secure specialised expertise in process development, regulatory navigation, and commercial-scale manufacturing. Multi-year agreements that guarantee priority access to capacity during periods of peak demand are becoming increasingly common, reflecting the growing importance of these alliances.

This shift is particularly pronounced in advanced modalities such as antibody–drug conjugates and autologous cell therapies, where in-house capabilities often fall short. CDMOs with the technical expertise, regulatory know-how, and global networks are being brought into programmes earlier in development, shaping downstream strategies and reducing risk at later stages. By embedding external partners at the outset, sponsors are creating a more resilient and scalable manufacturing ecosystem that can accelerate clinical progress and strengthen commercial readiness.

The focus is no longer on simply renting additional capacity. Sponsors now place value on co-developing flexible, future-proof manufacturing platforms. CDMOs that can deliver harmonised quality standards across regions, facilitate seamless technology transfer, and provide modular production systems are increasingly seen as long-term strategic allies. In a market where speed and specialisation determine competitive advantage, these partnerships are redefining how biologics and gene therapies are developed, scaled, and delivered.

How will this Report Benefit you?

Visiongain’s 373-page report provides 138 tables and 174 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the Biopharmaceuticals Contract Manufacturing market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Biopharmaceuticals Contract Manufacturing. Get financial analysis of the overall market and different segments including type, process, upstream, downstream, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing Biopharmaceuticals Contract Manufacturing market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Rising Demand for Biologics Accelerates Growth in Biopharmaceutical Contract Manufacturing

The rapid expansion of biologics is reshaping the pharmaceutical manufacturing landscape and driving sustained growth in biopharmaceutical contract manufacturing. Therapies such as monoclonal antibodies, vaccines, and cell and gene therapies now dominate pipelines for oncology, autoimmune disorders, and rare diseases. Their inherent complexity demands advanced facilities and deep regulatory expertise—capabilities that many pharmaceutical companies no longer maintain internally.

As a result, firms are increasingly relying on specialised contract manufacturing organisations (CMOs) equipped to handle the unique requirements of biologics production. These partners provide GMP-certified infrastructure, expertise in scaling novel modalities, and the technical know-how to manage the challenges of living cell–based systems. In a market where agility and speed to market are as critical as cost efficiency, CMOs deliver both the capacity and flexibility that sponsors require.

With biologics accounting for a growing share of global drug approvals and biosimilars gaining momentum as patents expire, demand for external manufacturing support will continue to accelerate. For CMOs with the right technical depth and compliance frameworks, this shift is fostering long-term strategic partnerships with leading pharmaceutical companies seeking to bring advanced therapies to market more quickly and reliably.

Technological Advancements Accelerate Biopharma’s Shift Toward Outsourced Manufacturing

Technological progress is reshaping pharmaceutical manufacturing and accelerating the trend toward outsourcing. Modern contract manufacturing organisations (CMOs) are deploying advanced tools such as continuous manufacturing, single-use systems, and digital production platforms to deliver greater speed, precision, and flexibility. For biopharma companies under pressure to reduce development timelines while safeguarding quality, these capabilities make outsourcing increasingly attractive.

For many sponsors, the cost and complexity of establishing such systems internally remain prohibitive, particularly for smaller biotech firms or companies managing diverse pipelines. CMOs that have already invested in advanced, automated platforms are now providing ready-to-use solutions, enabling clients to scale without the burden of high upfront capital expenditure. Outsourcing is therefore evolving from a cost-control measure into a strategic enabler of growth and efficiency.

Digitalisation is reinforcing this shift. With tools such as real-time analytics, electronic batch records, and AI-supported quality management, CMOs can offer enhanced compliance, transparency, and proactive risk management. Clients are no longer selecting partners solely for capacity—they are prioritising those that can combine scale with deep data visibility and operational intelligence. In this context, technology has become not just a manufacturing capability but a source of competitive advantage.

Where are the Market Opportunities?

Patent Expirations and Rising Biosimilar Demand Create High-Growth Opportunities for CMOs

The expiry of patents on high-value biologics is creating significant opportunities for the growth of biosimilars, and with it, expanding demand for contract manufacturing partners. Biosimilars involve highly complex production processes and require rigorous regulatory validation and comparability testing. For pharmaceutical companies—particularly those entering the space for the first time—experienced CMOs provide essential expertise in development, scale-up, and regulatory navigation.

CMOs with proven capabilities in biosimilar manufacturing are well positioned to lead this market. Their ability to deliver consistent, high-quality production while navigating global regulatory requirements makes them attractive strategic partners. This is particularly critical in emerging markets, where healthcare systems are adopting biosimilars to manage costs without compromising patient outcomes.

As biosimilars are set to capture a growing share of biologics revenues in therapeutic areas such as oncology, rheumatology, and endocrinology, CMOs can leverage this momentum to secure long-term commercial supply agreements. By offering integrated, end-to-end services—from cell line development through to packaging—CMOs can enhance their strategic relevance and strengthen differentiation in a rapidly expanding segment.

Advanced Manufacturing Capabilities Unlock Strategic Growth Opportunities for CMOs

Advanced manufacturing technologies including single-use bioreactors, modular cleanrooms, and continuous processing are increasingly becoming baseline requirements for winning biopharmaceutical contracts. Investment in these platforms enables CMOs to deliver greater consistency, faster batch release, and lower contamination risk, which are critical for biologics and personalised therapies.

Continuous manufacturing is especially relevant for high-volume products such as vaccines and biosimilars. Although uptake has been slow due to capital intensity and regulatory hurdles, early adopters are demonstrating clear advantages in efficiency and scalability. For sponsors with aggressive commercial timelines, these capabilities are emerging as key factors in partner selection.

CMOs that can align technical innovation with regulatory discipline and operational flexibility will be best positioned to capture future demand. The ability to support both small-scale personalised therapies and large-scale biologics production will define competitiveness and secure durable partnerships in a consolidating market.

Competitive Landscape

The major players operating in the biopharmaceuticals contract manufacturing market are AbbVie Inc., AGC Biologics, Avantor, Inc., Binex Co., Ltd., Boehringer Ingelheim International GmbH, Cambrex Corporation, Catalent, Inc., Curia Global, Inc., Cytiva, FUJIFILM Diosynth Biotechnologies, JRS PHARMA, Jubilant Pharma Limited, KBI Biopharma, Lonza, Pfizer CentreOne, ProBioGen AG, Rentschler Biopharma SE, Samsung Biologics, Sandoz Group AG, TOYOBO CO., LTD., Thermo Fisher Scientific Inc., and WuXi Biologics. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.

Recent Developments

• On 21^st July 2025, WuXi Biologics announced that five manufacturing facilities successfully passed the Pre-License Inspection (PLI) by the U.S. Food and Drug Administration (FDA), with no critical issues or data integrity findings. This achievement further affirms WuXi Biologics’ strong track record of regulatory compliance—a 100% success rate passing PLIs.
• On 7^th April 2025, AGC Biologics announced the expansion of its single-use technology network, adds 5,000 L vessels from Thermo Scientific to New Yokohama, Japan facility. The CDMO is introducing two 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.), which makes the site one of the most advanced in Japan for large-scale mammalian-based biologics production, with GMP operations beginning in 2027.
• On 23^rd October 2024, Avantor, Inc. expanded partnership with the National Institute for Bioprocessing Research and Training (NIBRT). The new collaboration will focus on addressing urgent bottlenecks in biopharma manufacturing, particularly in downstream optimization for monoclonal antibodies (mAbs), by providing cutting-edge equipment and specialized training.

Notes for Editors

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