Biopharmaceutical Contract Manufacturing Market Size, Share & Trends Analysis Report By Service (Process Development, Analytical & QC studies, Fill & Finish Operations, Packaging & Labelling, Others), By Source (Mammalian, Non-mammalian), By Drug Type (Biologics, Biosimilars), By Product Type (Drug Substance, Finished Drug Product), By Therapeutic Area (Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Diseases, Metabolic Diseases, Neurology, Others) and By Region (North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2026-2034

Biopharmaceutical Contract Manufacturing Market Trends

Shift toward small batch manufacturing for cell and gene therapies

Biopharmaceutical contract manufacturers are increasingly turning to small batch manufacturing to support cell and gene therapies, which demand patient-specific and highly controlled manufacturing. The US FDA disclosed that 50 cell and gene therapies were approved worldwide in 2025, thereby increasing the demand for flexible manufacturing. The top CDMOs have expanded their capacities of modular, single-use bioreactors with volumes below 2,000 liters to support autologous CAR-T therapies. As the small-batch manufacturing models decrease the failure rate of batches and the time to clinical supplies for advanced therapies. Therefore, all aforementioned factors support the adoption of a small-batch manufacturing process for cell and gene therapies.

Focus on process optimization for commercial biologics manufacturing

Contract manufacturers are increasingly working to optimize biopharmaceutical manufacturing processes to minimize long-term operational impact. This includes efforts to minimize water for injection use and optimize buffer recycling, without negatively impacting product quality. Data from CDMO sustainability reports indicate a measurable reduction in water and energy use per batch for commercial biologics. This trend reflects a shift toward sustainable, regulation-compliant manufacturing models that support extended commercial supply of biologics at scale.

Biopharmaceutical Contract Manufacturing Market Drivers

Rising outsourcing of biologics manufacturing to specialized CDMOs accelerates market growth

The growing outsourcing of biologics to contract development and manufacturing organizations is a major driving force in the biopharmaceutical contract manufacturing industry. The increasing dependence of biopharma companies on CDMOs to handle complex biologics manufacturing is fueled by the high capital expenditure involved and the need for advanced technology. The outsourcing trend allows biopharma companies to accelerate the scale-up process, have flexible manufacturing capacity, and accelerate product commercialization while innovators focus on R&D. Thus, growing R&D activities by biopharma companies fuel the need for experienced manufacturing partners in the regulated market.

Expanding biologics pipeline and strong clinical development activity support market expansion

The growing number of biologics pipelines and the rising number of clinical development projects are key drivers for the biopharmaceutical contract manufacturing market. Pharmaceutical and biotech companies are developing an increasing number of biologic projects from preclinical through clinical and commercial stages. Contract manufacturers possess expertise in process development, clinical trials, and product manufacturing. This allows companies to develop multiple projects in-house without overstretching their resources. With the increasing number of clinical projects worldwide, the trend of partnering with experienced contract manufacturers continues to gain momentum in the biopharmaceutical industry.

Market Restraints

Concerns over intellectual property protection restricts outsourcing and impact market growth

Issues associated with the protection of intellectual property rights are a major restraining factor in biopharmaceutical contract manufacturing. Biopharma companies are reluctant to outsource novel manufacturing processes due to the leakage of confidential information and loss of process novelty. Handling confidential information of various partners is always associated with a higher risk of breaches and misuse. This is more important for novel biologics and early-stage products, and as a result, some firms are preferring in-house manufacturing, thus hindering the adoption of contract manufacturing services.

Market Opportunities

Growing biosimilar approvals creates long-term manufacturing opportunities

One of the significant market opportunities is presented by the increasing number of approvals and launches of biosimilars. Best-selling biologic drugs have progressed to late-stage development and have received approvals in the US and Europe, thus increasing the demand for efficient large-scale production. Most biosimilar companies have partnered with experienced contract manufacturers to handle process optimization, scale-up, and commercial production. This has presented a significant opportunity for contract manufacturers to form volume-based partnerships in markets that aim to lower healthcare expenses through biosimilar adoption.

Technological Landscape

• Viral Vector Services offered by Thermo Fisher focuses on lentiviral vector (LVV) manufacturing, technology transfer, GMP drug substance manufacturing, and regulatory support during end-to-end manufacturing of viral vectors.
• High productivity and single-use technology: MaruX, developed by Fujifilm, provides a continuous manufacturing approach. This platform features 500 L single-use perfusion bioreactors capable of high-density cultures.
• Biobrain Automation Platform by Sartorius is a modular automation system for bioprocess control with cGMP-ready audit trails and batch reporting to support continuous and single-use workflows.

Regional Analysis

The biopharmaceutical contract manufacturing market in North America had a share of 36.94% in 2025. The growth is supported by the region’s strong biopharma infrastructure, investments in advanced therapeutic manufacturing, and localized production of biologics. Initiatives taken by the local manufacturers, such as Novartis planning a billion-dollar biologics and sterile fill-finish hub in North Carolina, expand domestic capacity and attract global sponsors, also supporting the regional market expansion.

The US accounted for the largest market share in North America in 2025 due to a high concentration of biologics developers and strong federal support for advanced therapy development. Companies such as Lonza, Catalent, and Samsung Biologics expanded US facilities, providing large-scale mammalian cell culture and viral vector manufacturing capabilities that drive the commercialization of complex biologics and gene therapies.

Asia Pacific

The Asia Pacific biopharmaceutical contract manufacturingmarket is expected to register a CAGR of 13.11% from 2026 to 2034. This growth is augmented by rising biopharmaceutical R&D investment in China, Japan, and India and the growing prevalence of chronic diseases, which drives the demand for biologics and biosimilars. The increasing demand for low-cost biosimilars supports the market growth in the Asia Pacific region.

China leads the Asia Pacific market with a CAGR of 11.91% during the forecast period. Significant government and private investment in biotech infrastructure, expansion of CDMO facilities, and increasing domestic demand for vaccines collectively increased the demand for biologics, which, in turn, boosted contract manufacturing from established service providers.

Europe

The Europe biopharmaceutical contract manufacturing market is experiencing strong growth due to manufacturing collaborations within the EU’s Innovative Health Initiative, which promotes joint development projects and common quality standards. The region is also characterized by academic industry bioprocess consortia in regions such as Belgium and the Netherlands, which are promoting innovation in cell therapy and advanced vaccine production, supporting market growth.

Germany is expected to dominate the European market due to its established biotech ecosystem, manufacturing infrastructure, and robust regulatory system. CDMOs such as Boehringer Ingelheim and Rentschler Biopharma have large-scale mammalian and microbial production facilities in Germany that cater to high-volume biologics, gene therapy, and vaccine production for the domestic as well as international markets.

Latin America

The Latin American market is growing steadily due to increasing government efforts to promote local biopharmaceutical production, rising prevalence of cancer and autoimmune diseases, and collaborations with global CDMOs. Companies such as Eurofarma and Cristália are investing in GMP-compliant facilities, which will enable the local production of monoclonal antibodies and recombinant proteins in this region.

The Brazil biopharmaceutical contract manufacturing market is expanding rapidly due to local vaccine self-sufficiency initiatives driving the need for outsourced biologics production, as well as new regulatory modernization efforts accelerating biologics approvals. Brazil’s ANVISA also supports risk-based review strategies for complex biologics, which has motivated CDMOs and developers to accelerate tech transfer and localization initiatives.

Middle East and Africa

The Middle East and Africa biopharmaceutical contract manufacturing market growth is propelled by the establishment of regional biologic hubs, government-supported technology transfer initiatives, and the presence of niche biologics manufacturing facilities. The UAE’s Dubai Science Park biomanufacturing facilities offer GMP-compliant processes for regional vaccine and gene therapy supply. These factors collectively boost market growth in this region.

The South African market is supported by region-wide health security initiatives that accelerate toward Vision 2030. Companies in this region are also focusing on upgrading their existing manufacturing capabilities. For instance, Afrigen is part of the WHO/Medicines Patent Pool mRNA Technology Transfer Program, a global initiative to build locally owned mRNA vaccine production capabilities in low- and middle-income countries. The company upgraded its stance with a technical mRNA vaccine production for Rift Valley fever, showcasing scalable local mRNA biologics capabilities. This is in line with long-term plans to develop commercially viable GMP vaccine and therapeutic manufacturing.

Service Insights

The process development segment accounted for the largest biopharmaceutical contract manufacturing market share of 38.74% in 2025, as CDMOs leverage proprietary platform-based formulation solutions and integrate regulatory-ready design from the outset. For example, Samsung Biologics’ S-HiCon platform allows rapid optimization of high-concentration biologics, minimizing rework and increasing regulatory compliance.

The analytical & QC studies segment is estimated to register a notable CAGR of 11.69% during the forecast period. This growth is fueled by rising adoption of advanced analytics and digital QC systems by CDMOs. Contract manufacturers integrate automated data integrity and multi-attribute method (MAM) platforms, which increase regulatory confidence and outsourcing demand for specialized analytics.

Source Insights

The mammalian segment dominated the market in 2025 due to its widespread use in producing complex biologics such as monoclonal antibodies and recombinant proteins that require human-like post-translational modifications. The high clinical success rate and regulatory familiarity further support its adoption within the market.

The non-mammalian segment is projected to register the fastest CAGR of 12.03% during the forecast timeframe, as biopharma companies increasingly adopt microbial and yeast expression systems for rapid production of enzymes, vaccines, and plasmid DNA. CDMOs such as AGC Biologics and Fujifilm Diosynth expanded E. coli and yeast platforms to support mRNA vaccine development, which, in turn, drives demand for non-mammalian sources.

Drug Type Insights

The biologics segment accounted for the largest market share in 2025 due to increasing monoclonal antibody and recombinant protein pipelines for oncology, immunology, and rare disease indications, and the expansion of manufacturing facilities for biologics production.

The biosimilars segment is projected to grow at a CAGR of 12.25% during the forecast period. This growth is due to increasing patent expirations of branded biologics and strong adoption by healthcare systems with low budgets. For example, companies such as Celltrion and Amgen have advanced biosimilars into commercial stages, which accelerates outsourcing demand.

Therapeutic Area Insights

The oncology segment dominated the market in 2025, accounting for 33.16% market share, due to the rising prevalence of cancer. The expansion of monoclonal antibody and targeted therapy pipelines is also driving high manufacturing demand. Thus, high cancer prevalence and strong uptake of biologics for its treatment are expected to propel the biopharmaceutical contract manufacturing market through the forecast period.

The autoimmune diseases segment is projected to grow at a CAGR of 12.42% during the forecast period. This growth is augmented by the rising prevalence of conditions such as rheumatoid arthritis and multiple sclerosis and the increasing development of targeted biologics. The emergence of next-generation biologics, such as bispecific antibodies and Fc-engineered proteins for autoimmune disease management, also supports segment growth.