Protein Contract Manufacturing Market to Reach US$33.62bn

Visiongain has released its new Protein Contract Manufacturing Market Report 2026-2036, forecasting that the global market will reach US$33.62bn by 2036 from US$13.31bn in 2026.

The market is forecast to expand at a compound annual growth rate (CAGR) of 9.7% between 2026 and 2036, driven by the rising outsourcing of biologics development and manufacturing, expanding biosimilar pipelines, and sustained CDMO investment in large-scale, flexible production capacity.

Key Market Growth Drivers & Industry Transformations

Increasing Outsourcing of Protein Biologics Development and Manufacturing: Pharmaceutical and biotechnology companies are increasingly outsourcing protein development and manufacturing to reduce capital requirements, access specialised expertise and accommodate changing production needs. Lonza has reported that CDMO capacity continues to outpace capacity in customer-owned facilities, as both large and small biopharmaceutical companies increasingly rely on external manufacturing partners. Protein manufacturing outsourcing is increasingly becoming a long-term operating strategy rather than solely a temporary response to capacity shortages.

Expanding Pipeline of Monoclonal Antibodies and Recombinant Proteins: The expanding pipeline of monoclonal antibodies, fusion proteins, enzymes, hormones and other recombinant therapeutics is generating sustained demand for outsourced protein manufacturing. At the end of 2025, WuXi Biologics reported 945 integrated biologics projects, including 74 Phase III projects and 25 commercial manufacturing projects. Its late-stage and commercial manufacturing revenue increased by 26.4% to approximately RMB9.46bn (~US$1.3bn), supported by the progression of Phase II and Phase III programmes and the ramp-up of existing projects.

Growing Biosimilar Development and Commercialisation Activity: Increasing biosimilar development is strengthening demand for outsourced protein manufacturing. By October 2025, the US FDA had approved 76 biosimilars, with further approvals granted before the end of the year. Products approved during 2025 included biosimilars referencing denosumab, insulin aspart, omalizumab, bevacizumab, ustekinumab and aflibercept. As additional reference biologics lose exclusivity, pharmaceutical companies and specialist biosimilar developers are expected to use external manufacturers to access technical expertise, reduce fixed investment and secure clinical and commercial capacity.

Expansion of Flexible and Large-Scale Biologics Manufacturing Capacity: CDMO investment in large-scale, flexible and geographically distributed biologics facilities is increasing the availability of outsourced protein manufacturing capacity. Fujifilm is expanding its antibody drug-substance capacity in the United States and Denmark, targeting more than 750,000 litres of global production capacity by 2028. Its Holly Springs facility opened with eight 20,000-litre mammalian cell-culture bioreactors, providing 160,000 litres of large-scale drug-substance capacity. A further eight 20,000-litre bioreactors are planned as part of the facility’s second-phase expansion.

What This Means for the Protein Contract Manufacturing Market

The protein CDMO market is entering a period of sustained structural growth as biologics pipelines deepen, biosimilar competition intensifies, and pharmaceutical companies increasingly rely on external partners for both clinical and commercial-scale manufacturing. CDMOs that can offer integrated development-to-commercial services, regional manufacturing presence, and proven large-scale mammalian cell-culture capability are best positioned to capture long-term programme value over the next decade.

Scope of the Visiongain Report

The 350+ page report provides robust quantitative and qualitative analysis across all key facets of the global protein contract manufacturing market:

By Scale of Operation: Preclinical / Clinical; Commercial.

By Service: Protein Drug Substance Manufacturing; Protein Drug Product Manufacturing; Development and Analytical Services.

By Expression System: Mammalian; Microbial; Others.

By Protein Type: Monoclonal Antibodies and Antibody Fragments; Fusion Proteins; Enzymes; Hormones and Growth Factors; Cytokines and Interferons; Others.

By Therapeutic Area: Oncology; Autoimmune and Inflammatory Disorders; Metabolic Diseases; Cardiovascular Diseases; Infectious Diseases; Other Therapeutic Areas.

By End-users: Pharmaceutical Companies; Biotechnology Companies; Biosimilar Manufacturers; Academic and Research Institutions.

By Regional & Country Markets: North America, Europe, Asia Pacific, Latin America, and MEA.

Competitive Landscape

The competitive environment is characterised by large CDMOs competing across integrated biologics manufacturing capability, large-scale mammalian cell-culture capacity, biosimilar manufacturing expertise, and geographic manufacturing footprint. Companies profiled in the report include:

Abzena
3P BIOVIAN
AGC Biologics
Boehringer Ingelheim BioXcellence
Curia Global, Inc.
Cytovance Biologics
FUJIFILM Diosynth Biotechnologies
KBI Biopharma
Lonza Group AG
Catalent, Inc. (Novo Holdings)
ProBioGen AG
Rentschler Biopharma SE
Samsung Biologics Co., Ltd.
Syngene International Limited
Thermo Fisher Scientific Inc. (Patheon Pharma Services)
Wacker Biotech GmbH
WuXi Biologics

Recent Developments

1 Jul 2026 – Lonza expanded a long-term collaboration with a leading US biopharmaceutical company, adding two commercial biologics programmes and options for two more. Manufacturing will span Lonza’s US commercial-scale biologics facilities and European drug-substance and drug-product network. The combined contracts could generate a cumulative multi-billion CHF value.

30 Mar 2026 – WuXi Biologics highlighted its use of WuXiUP continuous bioprocessing platform and WuXiUI ultra-intensified fed-batch platform to improve manufacturing productivity. The company reported deploying single-use bioreactors of up to 5,000 litres and combining multiple units to support manufacturing scales of up to 16,000 litres.

7 Jan 2025 – ProBioGen expanded both protein and virus manufacturing at its Berlin headquarters, commissioning an additional 1,000L-scale GMP production line for proteins and completing construction of its virus manufacturing unit.

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About Visiongain

Established in 1998, Visiongain is an independent publisher of analyst-led market intelligence, delivering data-driven research, forecasts, and strategic insight across global industries and emerging markets. Visiongain supports evidence-based decision-making for investment, procurement, and long-term strategic planning.

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