U.S. Biopharmaceuticals Contract Manufacturing Market (2025 - 2030)

Market Size & Trends

The U.S. biopharmaceutical contract manufacturing market was valued at USD 10.67 billion in 2024 and is projected to grow a CAGR of 10.6% from 2025 to 2030. With the biopharmaceutical industry's perpetual expansion, companies constantly face production issues due to the need for more expertise and sophisticated equipment while practicing in-house manufacturing.

The maturity of biotechnology and the availability of external funding have resulted in the growth of several early-stage bio/pharma companies. These companies are recognized as core customers of CMOs, as these organizations lack the capabilities to develop robust manufacturing operations.

The biopharmaceutical contract manufacturing industry is witnessing lucrative growth owing to rising R&D spending for biologics development coupled with the presence of a large number of FDA-approved drugs in the country. The U.S. hosts a significant biopharmaceutical pipeline in various stages of development. More than 900 biological molecules are under clinical investigation in the country. Steady growth in the number of new biological approvals in the country is anticipated to boost revenue generation for the market.

Increasing adoption and investment in advanced manufacturing technologies by CMOs based in the U.S. propels the market growth. In addition, the quality of services offered by service providers drives the country's biopharma and CMO partnerships. The expansion of foreign CMOs and CROs into the country is expected to propel market growth.

Market Concentration & Characteristics

The market growth stage is medium, and the pace of growth is accelerating. Research and Development (R&D) by major market players to enhance their shares has resulted in a concentrated market. Key players, including large pharmaceutical companies, biotech firms, and contract manufacturers, drive innovation by advancing drug discovery, formulation, and production processes. Their R&D investments lead to the development of cutting-edge therapies and biologics, creating demand for specialized manufacturing services. Collaborations between these players foster technological advancements, improve efficiency, and reduce production costs.

The U.S. biopharmaceuticals contract manufacturing market is characterized by a high level of M&A activity from leading players. This is due to factors such as the increased focus on enhancing portfolios and the need to consolidate in a rapidly growing market. Technological advancements and innovations in bioprocessing play a pivotal role in the advancement of contract service providers by helping overcome manufacturing issues such as high production costs and the need for changeover with every batch. Moreover, the fast turnaround offered by single-use products with limited associated activities, such as changeover and cleaning validation, supported the growth of CMOs to a significant extent. Players in the market are undertaking multiple strategies to strengthen their portfolios. For instance, in February 2022, Recipharm acquired Arranta Bio, a provider of advanced therapy medicinal products, to expand its biologics offerings in the U.S.

Market players provide diverse biopharmaceutical production services following established Current Good Manufacturing Practice (cGMP) guidelines. The transition of gene therapies from clinical trials to regulatory approval has increased, and the development of robust cell therapy production methods drives market demand. In addition, rising regulatory approvals for biologics and biosimilars are expected to drive market demand.

The pharmaceutical industry is experiencing a shift from small molecules to more complex biopharmaceuticals. Moreover, the expiration of patents for several existing drugs fuels the demand for advanced therapeutics. Contract Manufacturing Organizations (CMOs) are focusing on mitigating capacity challenges in biologics production, thereby supporting the growth of biologics manufacturing.

Source Insights

The mammalian segment accounted for the largest market share of 55.2% in 2024.The growth is attributable to the higher cost of obtaining products from these sources. Companies that provide contract services using mammalian cell culture include AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals GmbH, and Catalent Pharma Solutions. Consequently, companies such as Lonza and Charles River Laboratories are making significant investments to expand their mammalian cell culture manufacturing facilities for biologics and biosimilar development.

The non-mammalian segment is projected to be the fastest-growing segment, with a CAGR of 12.7% from 2025 to 2030.Non-mammalian cell line E. coli is recognized as a widely adopted non-mammalian cell culture for biopharmaceutical production owing to its rapid access and cost-effective cultivation. The development of transgenic non-mammalian expression system is projected to an opportunity for market growth. Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion are a few companies working as CMOs using microbial cultures.

Service Insights

The process development segment dominated the biopharmaceuticals contract manufacturing industry in 2024 due tohigh capital expenditure in downstream processing. Downstream operations demand significant attention for final product recovery and purification steps to maintain product quality and prevent wastage. CMOs provide biopharma players with a wide array of services ranging from cell cultivation to the final packaging of the product.

The analytical & QC studies segment is set to grow at the fastest CAGR over the forecast period.Growing quality concerns and regulatory changes for biopharmaceutical development are expected to impel future growth opportunities for this segment. The analytical capabilities and expertise offered by the market players have a wide range of technologies & services to support the proper launch of products. These capabilities are implemented for Monoclonal Antibodies (mAbs), fusion proteins, chemically conjugated proteins, hormones, enzymes, and other biopharmaceuticals. Furthermore, entities offer validated analytical methods to assist the release of early phase clinical products.

Products Insights

The biologics segment held the largest revenue share in 2024. Contract manufacturers have played a vital role in the success of both biologics and biosimilars. This is mainly due to the significant commercial success of biologics, which is depicted through the presence of many FDA-approved biologics in the market. Among all the biologics, mAbs captured the largest share in 2023. The high capital required for constructing an MAb plant has accelerated the adoption of contract services for MAb production, thereby contributing to the major share of this segment.

The biosimilars segment is expected to be the fastest-growing segment over the forecast period. Biosimilar production is considered one of the key strategies for business expansion compared to biologics because investment in biosimilar manufacturing helps expedite the market reach of biopharmaceuticals. Moreover, biosimilars have supported the biopharmaceutical CMO industry owing to cost-saving advantages. Hence, the low cost of production, along with the growing patent expiry of blockbuster biologics, has further boosted the demand for its manufacturing services, including outsourced services.

Type Insights

The drug substance segment accounted for the largest revenue share in 2024 due to the rising demand for biologic drugs requiring complex production processes. Manufacturers increasingly outsource drug substance production to specialized CMOs with the expertise and infrastructure to handle intricate processes. The growing need for high-quality Active Pharmaceutical Ingredients (APIs) and regulatory compliance also contributes to the dominance of this segment, as companies prioritize efficiency and cost-effectiveness in drug development and production.

The finished drug product segment is projected to be the fastest-growing segment from 2025 to 2030, attributed to increased demand for advanced drug delivery systems, particularly biologics and injectables. Companies are turning into contract manufacturers for specialized fill-finish services to ensure quality and compliance. Growing emphasis on patient-centric therapies, packaging innovations, and complex formulations drives this trend. In addition, advancements in manufacturing technologies will enable faster, more efficient production, positioning the finished drug product segment for significant growth in the coming years.

Scale Of Operation Insights

Thecommercial segment dominated the biopharmaceuticals contract manufacturing industry in 2024, owing to the high demand for large-scale production of approved drugs. Established biopharmaceutical companies prefer to outsource manufacturing to contract manufacturers who can handle the complexities of large volumes, stringent regulatory standards, and cost-efficient production. This trend has grown with the increasing number of biologics and biosimilars reaching the market, which require high-capacity, specialized manufacturing facilities to meet global demand. Furthermore, the need for consistent product quality further supports the dominance of the commercial segment.

The clinical segment is set to grow at the fastest CAGR over the forecast period,driven by the growing number of clinical trials and drug development activities. Contract manufacturers are increasingly offering services for early-phase production, catering to the need for small batches and customized processes. Rising investment in novel therapies, including gene and cell-based treatments, fuels demand. Moreover, flexibility in production, faster turnaround times, and specialized expertise make the clinical segment an attractive option for biopharmaceutical companies in early-stage development.

Therapeutic Area Insights

The oncology segment held the largest revenue share in 2024, attributed tothe increasing prevalence of cancer and the growing demand for targeted therapies. Biopharmaceutical companies are focusing on the development of novel biologics, such as monoclonal antibodies and immune-oncology treatments, which require specialized manufacturing processes. Contract manufacturers with expertise in biologics production and regulatory compliance are crucial for ensuring consistent quality and scalability of these complex therapies. The expansion of cancer-focused clinical trials has further solidified oncology's dominance in the biopharmaceuticals contract manufacturing industry.

The autoimmune diseases segment is expected to grow significantly over the forecast period, propelled by the rising incidence of autoimmune disorders and a growing need for innovative treatments. Biopharmaceutical companies are developing biologic therapies to target conditions such as rheumatoid arthritis, lupus, and multiple sclerosis. This shift toward specialized, biologic-based treatments drives demand for advanced manufacturing capabilities. With increasing investment in research and development, contract manufacturers specializing in autoimmune disease therapies are set for significant growth as more treatments reach clinical and commercial stages.

Key U.S. Biopharmaceuticals Contract Manufacturing Company Insights

Some of the key companies in the U.S. biopharmaceuticals contract manufacturing industry include Lonza; Boehringer Ingelheim International GmbH; Thermo Fisher Scientific Inc.; Samsung Biologics; and Eurofins Scientific.

• Thermo Fisher Scientific Inc. provides laboratory instruments, reagents, consumables, and software solutions to support research, drug development, and manufacturing across various industries, such as life sciences, biotechnology, pharmaceuticals, and healthcare.

• Eurofins Scientific offers comprehensive laboratory services, including testing and analysis across pharmaceuticals, food, environmental, and clinical sectors. It specializes in contract research, clinical trials, quality control, and regulatory support for life sciences industries.

Recent Developments

• In May 2023, Aurigene Pharmaceutical Services Limited, a biopharmaceutical CDMO, announced the construction of a state-of-the-art manufacturing and development facility at Genome Valley for therapeutic proteins, viral vectors, and antibodies.

• In April 2022, FUJIFILM Corporation acquired a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. This acquisition expanded its CDMO capability to produce cell therapies for clinical and commercial purposes.

• In April 2022, Lonza extended the capability of its Coccon platform used in the manufacturing of automated cell therapy. The new capabilities included integrated capabilities in cell separation, cell binding, and bead removal.

• In March 2022, Cambrex expanded its biopharmaceutical testing services business by adding 11 cGMP laboratories in its U.S. facility. The expansion included the addition of instruments for nanoparticle size analysis, qPCR, imaging, mass spectrometry, immunoblotting, and next-generation sequencing, among other applications.

• In February 2022, Thermo Fisher Scientific, Inc. invested USD 40 million to upgrade a bioprocessing manufacturing site in Millersburg, Pennsylvania, creating over 100 jobs.

U.S. Biopharmaceuticals Contract Manufacturing Market