Biopharmaceutical CDMO Market Size, Share, Growth and Industry Analysis, By Types (SMBs, Large Companies), By Applications (Cell and Gene Therapies, Antibodies, Vaccines, Other), Regional Insights and Forecast to 2035

Biopharmaceutical CDMO Market Size

The Global Biopharmaceutical CDMO Market size was USD aaa Billion in 2025 and is projected to reach USD 31.85 Billion in 2026 and USD 109.07 Billion by 2035, exhibiting a CAGR of 13.1% during the forecast period from 2026 to 2035. Around 60% of the market demand is attributed to biologics manufacturing, while 40% comes from cell and gene therapy outsourcing. Increased biologic approvals and an expanding pipeline of biosimilars have contributed to nearly 45% of new CDMO contracts globally.

The US Biopharmaceutical CDMO Market continues to dominate the global landscape, accounting for nearly 38% of the total market share. Around 50% of biologics under development in the country are outsourced to CDMOs for process optimization and manufacturing. The U.S. market growth is driven by advanced biologics production facilities, technological innovation, and the rising trend of flexible biomanufacturing solutions, which together make up over 55% of regional capacity expansion investments.

Key Findings

• Market Size: Valued at USD aaa Billion in 2025, projected to touch USD 31.85 Billion in 2026 and USD 109.07 Billion by 2035, at a CAGR of 13.1%.
• Growth Drivers: Over 60% rise in outsourcing demand and 45% increase in biologics production are boosting CDMO partnerships globally.
• Trends: Around 35% of CDMOs have adopted single-use bioreactors and 40% are focusing on advanced therapy manufacturing capabilities.
• Key Players: Samsung Biologics, Lonza, Catalent, FUJIFILM Diosynth Biotechnologies, Thermo Fisher Scientific & more.
• Regional Insights: North America holds 40% of the market driven by biologics innovation; Europe accounts for 25% with strong regulatory standards; Asia-Pacific commands 30% due to cost-efficient manufacturing; Middle East & Africa capture 5% amid rising healthcare investments.
• Challenges: Around 30% of CDMOs face skilled workforce shortages and 25% report capacity bottlenecks in biologics production lines.
• Industry Impact: Nearly 50% of new biopharma drugs depend on CDMO services, with 33% of market growth linked to innovation-based outsourcing.
• Recent Developments: Over 40% of CDMOs expanded facilities in 2025, while 28% introduced automation and AI-driven process platforms.

The Biopharmaceutical CDMO Market is evolving rapidly as the industry shifts toward advanced therapies, personalized medicines, and scalable biologic production. Approximately 55% of CDMOs are expanding cell and gene therapy capacity, while 47% are investing in sustainable biomanufacturing technologies. The growing collaboration between pharmaceutical giants and contract manufacturers continues to redefine outsourcing models, making the CDMO sector a critical pillar in global biopharma innovation.

Biopharmaceutical CDMO Market Trends

The market for biopharmaceutical contract development and manufacturing organizations (CDMOs) is expanding rapidly as outsourcing becomes a preferred strategy among biopharma companies. Manufacturing services accounted for over 60% of global biopharmaceutical CDMO activity, highlighting their dominant role in the value chain. North America represented nearly 36.7% of the market share, while the Asia-Pacific region demonstrated the fastest growth due to its cost-effective operations and rising biologics production capabilities. The biologics segment itself represented around 61% of the total CDMO market, with increasing adoption of mammalian cell-culture processes and microbial fermentation technologies. These figures show how CDMOs have become integral to drug development and biomanufacturing worldwide.

Biopharmaceutical CDMO Market Dynamics

OPPORTUNITY

Expanding biopharma pipelines

The rising number of biologics, biosimilars, and cell & gene therapies is driving demand for outsourcing development and production. Mammalian cell-culture systems accounted for about 63.4% of the biopharmaceutical contract manufacturing segment, while microbial fermentation technologies are also gaining traction. As more than 50% of emerging drugs rely on biologic platforms, CDMOs are becoming strategic partners for innovation and scalability.

DRIVERS

Outsourcing shift by biopharma firms

A growing number of pharmaceutical and biotech companies are outsourcing manufacturing to focus on core research and innovation. Manufacturing services held about 42.5% of the market share, while process-development support is expanding quickly. Asia-Pacific CDMOs experienced a regional growth rate of approximately 11.6%, driven by investments in biologics capacity, automation, and quality compliance.

RESTRAINTS

"Regulatory complexity and regional variation"

The biopharmaceutical CDMO market faces major challenges from regulatory diversity across regions. Differing quality, GMP, and approval standards increase compliance costs and prolong project timelines. Over 40% of CDMOs report regulatory approval as their top operational bottleneck, emphasizing the need for harmonized global quality standards to streamline outsourcing partnerships.

CHALLENGE

"Capacity constraints and skilled workforce shortage"

The surge in biologics and advanced therapies has created capacity limitations across many CDMOs. Around 55% of service providers report production bottlenecks due to limited bioreactor availability and skilled staff shortages. The market’s fragmented nature, dominated by small and mid-sized CDMOs, further limits scalability, making workforce development and infrastructure investment critical for sustained growth.

Segmentation Analysis

The biopharmaceutical CDMO market can be broken down by company size and by application type, helping companies understand where outsourcing demand is strongest and which types of firms benefit most. The global biopharmaceutical CDMO market size was USD aaa billion in 2025 and is projected to reach USD 31.85 billion in 2026 and USD 109.07 billion by 2035, exhibiting a CAGR of 13.1% during the forecast period from 2026 to 2035.

By Type

SMBs (Small & Medium-sized Biopharma and Biotech Firms)

These smaller companies frequently outsource development and manufacturing to avoid heavy investment in infrastructure and to gain flexibility. They often represent innovative or niche biologic or cell/gene therapy programs and rely on CDMOs to scale quickly and cost-effectively.

SMBs segment size in 2026 is projected at USD 31.85 billion, representing approximately 29% of the total market. This segment is expected to grow at a CAGR of around 12% from 2026 to 2035, driven by the growth in biotech start-ups and increasing outsourcing of early-stage biologic development.

Large Companies (Established Pharma & Large Biopharma Firms)

Large pharmaceutical and biopharma companies tend to outsource to CDMOs for commercial scale manufacturing, global supply chain reach and risk mitigation. These firms represent the largest share of CDMO demand because of high volume biologics, biosimilars and multiple therapy pipelines.

The Large Companies segment size in 2026 is also based on the USD 31.85 billion figure and is projected to account for around 71% of the market. This segment is expected to grow at a CAGR of about 14% from 2026 to 2035, supported by large-scale biologics launches and global manufacturing outsourcing strategies.

Segmentation Analysis

The biopharmaceutical CDMO market’s segmentation by application reveals where outsourcing services are most needed and which technologies drive the greatest demand. The global biopharmaceutical CDMO market size was USD 31.85 billion in 2026 and is projected to reach USD 109.07 billion by 2035, exhibiting a CAGR of 13.1% during the forecast period from 2026 to 2035.

By Application

Cell and Gene Therapies

This application segment covers CAR-T, gene editing, viral vector manufacturing and cell culture services, all of which require highly specialised CDMO capabilities. The complexity, personalised nature and small-batch production drive demand for outsourcing among biotechs and pharma firms alike.

Cell and Gene Therapies segment size in 2026 is estimated at USD 31.85 billion, representing approximately 35% of the total market. This segment is expected to grow at a CAGR of around 15% from 2026 to 2035, supported by increasing uptake of advanced therapies and regulatory approvals.

Antibodies

The antibody application segment includes monoclonal antibodies, bispecifics and antibody-drug conjugates, which are major franchises for many biopharma companies. Outsourcing manufacturing and development of antibodies remains a central service for CDMOs because of volume, complexity and market demand.

Antibodies segment size in 2026 is projected at USD 31.85 billion, accounting for about 25% of the total market. It is expected to grow at a CAGR of roughly 12% through 2035, driven by expansion of biosimilars, new antibody formats and global distribution needs.

Vaccines

This segment involves outsourcing of vaccine development, formulation, fill-finish and large-scale production. With public health concerns, new infectious disease threats and demand for mass immunisation, CDMOs supporting vaccine manufacturing play a growing role in the value chain.

Vaccines segment size in 2026 is estimated at USD 31.85 billion, representing around 20% of the total market. It is expected to grow at a CAGR of about 10% from 2026 to 2035, as vaccine pipelines expand and production capacity continues to shift to third-party providers.

Other Applications

This category covers recombinant proteins, biosimilars, cell culture derived enzymes and emerging biologic formats outside of the main three application types. These services often involve niche production, specialty manufacturing or novel modalities requiring flexible CDMO support.

Other Applications segment size in 2026 is projected at USD 31.85 billion, making up roughly 20% of the total market. The expected CAGR for this segment is around 11% from 2026 to 2035, propelled by diversification of biopharma portfolios and outsourcing of non-core therapeutic production.

Biopharmaceutical CDMO Market Regional Outlook

The global biopharmaceutical CDMO market size was USD aaa Billion in 2025 and is projected to reach USD 31.85 Billion in 2026 and USD 109.07 Billion by 2035, exhibiting a CAGR of 13.1% during the forecast period from 2026 to 2035. Regional analysis shows a clear distribution of market dominance, with North America leading and Asia-Pacific emerging as the fastest-growing region.

North America

North America remains the largest market for biopharmaceutical CDMOs due to its advanced biomanufacturing ecosystem and the strong presence of established biotech and pharmaceutical companies. The region’s mature regulatory environment, high R&D expenditure, and strong adoption of outsourcing for biologics and cell & gene therapies continue to fuel growth. Over 60% of large-scale biologics CDMO projects are currently based in North America, supported by extensive commercial manufacturing capacity.

North America held the largest share in the biopharmaceutical CDMO market, accounting for USD 12.74 Billion in 2026, representing 40% of the total market. This region’s growth is driven by an expanding biologics pipeline, continuous innovation in cell therapy manufacturing, and a high concentration of CDMO facilities in the U.S.

Europe

Europe stands as a strong contributor to the global biopharmaceutical CDMO landscape, backed by a well-established healthcare infrastructure, strict regulatory compliance, and rising collaborations between pharma companies and CDMOs. The region shows increasing demand for antibody production and biosimilar manufacturing, particularly in countries such as Germany, Switzerland, and the UK, which host leading contract manufacturing facilities.

Europe accounted for USD 7.96 Billion in 2026, representing 25% of the total biopharmaceutical CDMO market. The region’s steady expansion is driven by biologics development programs, vaccine production, and strong demand for high-quality manufacturing standards among European pharmaceutical firms.

Asia-Pacific

Asia-Pacific is the fastest-growing region in the biopharmaceutical CDMO market, driven by cost-efficient manufacturing, government initiatives to boost biotechnology, and rapid expansion of biopharma facilities in China, India, and South Korea. The region is witnessing a surge in biosimilar production, vaccine outsourcing, and adoption of single-use bioreactor systems by local CDMOs. Increasing investments by global CDMO players are further accelerating capacity expansion in this region.

Asia-Pacific held a market share of 30% in 2026, valued at approximately USD 9.55 Billion of the total biopharmaceutical CDMO market. This growth is attributed to strong demand for biomanufacturing services, the rise of regional biotech start-ups, and favorable government support for advanced biologics production.

Middle East & Africa

The Middle East & Africa region represents an emerging market for biopharmaceutical CDMO services. Although smaller in scale, the region is gradually developing local biopharma manufacturing capabilities with a focus on vaccines, biosimilars, and fill-finish operations. Investment in healthcare infrastructure and regional partnerships are creating new opportunities for international CDMOs looking to expand into underserved markets.

Middle East & Africa accounted for USD 1.59 Billion in 2026, representing 5% of the global biopharmaceutical CDMO market. Growth in this region is primarily supported by rising government investment in healthcare, technology transfer initiatives, and expanding access to advanced manufacturing technologies.

List of Key Biopharmaceutical CDMO Market Companies Profiled

Investment Analysis and Opportunities in Biopharmaceutical CDMO Market

The biopharmaceutical CDMO industry is seeing strong investment momentum as companies scale infrastructure and adopt digital biomanufacturing technologies. More than 60% of CDMOs report expanding their production capacity to meet biologics demand, while 45% are investing in cell and gene therapy capabilities. Strategic alliances between pharma companies and CDMOs have increased by over 35% in the past few years, reflecting a growing reliance on outsourcing models. Around 50% of all recent facility expansions are focused on single-use systems and automation upgrades. With sustainability becoming a strategic priority, about 40% of CDMOs are integrating energy-efficient systems and green production practices. These investments are positioning the sector for continued growth and faster innovation cycles.

New Products Development

Innovation in the biopharmaceutical CDMO market is accelerating as companies focus on new therapeutic modalities and advanced manufacturing solutions. Over 55% of CDMOs are developing new process platforms for mRNA and viral vector production. Approximately 30% of new product development pipelines involve biosimilars and recombinant proteins, showing diversification in service portfolios. Continuous manufacturing and AI-driven process analytics have been adopted by nearly 25% of top-tier CDMOs to improve efficiency and reduce time to market. In addition, more than 40% of ongoing product development projects are centered on personalized medicine and next-generation biologics. The shift toward integrated development and commercial manufacturing is reshaping CDMO service offerings, enhancing flexibility and global competitiveness.

Recent Developments

• Samsung Biologics: In 2025, Samsung Biologics announced the expansion of its fourth biomanufacturing plant, increasing its total production capacity by 30%. This development aims to strengthen global biologics supply and meet growing demand for monoclonal antibodies and cell-based therapies. The company also reported a 22% rise in contract projects compared to the previous year.
• Lonza: In 2025, Lonza introduced a new cell and gene therapy platform focused on accelerating clinical-scale viral vector manufacturing. This upgrade enhanced process efficiency by nearly 25% and reduced production lead times significantly. The company also reported a 20% increase in new CDMO partnerships within North America and Europe.
• Catalent: Catalent expanded its biologics segment with a 35% increase in capacity for fill-finish operations across its U.S. and European facilities in 2025. The move aligns with rising global demand for biologics, vaccines, and advanced therapies, with 18% more biologic projects added to its portfolio compared to the prior year.
• FUJIFILM Diosynth Biotechnologies: FUJIFILM Diosynth Biotechnologies enhanced its microbial and mammalian cell-culture capabilities by launching a new production suite in 2025. The upgrade added nearly 28% more manufacturing capacity, supporting recombinant protein and vaccine production, while improving overall project turnaround efficiency by about 15%.
• WuXi AppTec: WuXi AppTec reported a 40% increase in biopharma collaborations in 2025 after expanding its integrated service network for end-to-end biologics manufacturing. The company launched new modular biomanufacturing facilities, allowing faster scale-up of small-batch production for cell and gene therapy developers worldwide.

Report Coverage

The biopharmaceutical CDMO market report provides an in-depth overview of the industry’s structure, segmentation, regional performance, and competitive landscape. It analyzes the market by type, including SMBs and large companies, and by application across cell and gene therapies, antibodies, vaccines, and other biologics. The report highlights how 60% of the market is dominated by large enterprises, while smaller biotechs account for nearly 40% through outsourcing partnerships.

Regional insights indicate that North America contributes about 40% of the global share, followed by Europe with 25%, Asia-Pacific with 30%, and the Middle East & Africa with 5%. The analysis shows a clear shift in outsourcing activity toward Asia-Pacific due to lower manufacturing costs and expanding biologics infrastructure. The report also identifies manufacturing services as the leading segment, representing nearly 42% of total CDMO activity, with process development and analytical testing following closely.

Furthermore, the report covers strategic trends, including digital transformation, automation, and modular biomanufacturing, adopted by over 50% of leading CDMOs to enhance efficiency. It examines key company profiles such as Samsung Biologics, Lonza, and Catalent, which collectively hold over 30% of the market share. The coverage extends to investment flows, recent product innovations, and emerging opportunities in cell and gene therapy outsourcing. Around 45% of CDMOs are expanding capacity to meet rising biologics demand, while 35% are adopting continuous manufacturing and AI-driven process analytics to improve scalability. Overall, the report provides a comprehensive snapshot of the market’s operational, financial, and technological landscape, positioning it as a critical resource for stakeholders and investors.