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U.S. Biopharmaceuticals Contract Manufacturing Market Size, Share, & Trends Analysis Report By Source (Mammalian, Non-mammalian), By Service, By Products (Biologics, Biosimilars), By Type, By Scale Of Operation, By Therapeutic Area, And Segment Forecasts,

U.S. Biopharmaceuticals Contract Manufacturing Market Size, Share, & Trends Analysis Report By Source (Mammalian, Non-mammalian), By Service, By Products (Biologics, Biosimilars), By Type, By Scale Of Operation, By Therapeutic Area, And Segment Forecasts,

Published Date: May - 2025 | Publisher: MIR | No of Pages: 250 | Industry: healthcare | Format: Report available in PDF / Excel Format

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Market Size & Trends

The U.S. biopharmaceutical contract manufacturing industry was worth USD 10.67 billion in 2024 and is expected to register a CAGR of 10.6% during the period 2025-2030. As the biopharmaceutical sector continues to grow endlessly, businesses are always plagued by production problems due to the requirement for more expertise and advanced equipment while conducting in-house manufacturing.

The maturity of biotechnology and access to outside finance have led to the expansion of a number of early-stage bio/pharma firms. These firms are identified as core customers of CMOs, since these companies don't have the capability to establish strong manufacturing operations.

The biopharmaceutical contract manufacturing market is experiencing profitable growth due to increasing R&D expenditure for biologics development in combination with the availability of a high number of FDA-approved drugs in the nation. The U.S. has a large biopharmaceutical pipeline at different stages of development. Over 900 biological molecules are in clinical trials in the nation. Consistent growth in the number of new biological approvals in the nation is expected to increase revenue generation for the market.

Growing investment and adoption of cutting-edge manufacturing technologies among U.S. CMOs drive the market growth. Moreover, service provider service quality fuels the biopharma and CMO collaborations in the country. Growth of foreign CMOs and CROs into the country is anticipated to drive market growth.

Report Coverage & Deliverables

PDF report & online dashboard will help you understand

  • Competitive benchmarking
  • Historical data & forecasts
  • Company revenue shares
  • Regional opportunities
  • Latest trends & dynamics

Market Concentration & Characteristics

The growth stage of the market is medium and is increasing. Research and Development (R&D) by established market players to increase their stakes has led to a concentrated market. The driving forces are large pharmaceutical companies, biotech organizations, and contract manufacturers, who lead innovation through improving drug discovery, formulation, and manufacturing techniques. Their R&D spending results in the creation of innovative therapies and biologics, generating demand for specialized manufacturing services. Partnerships among these players drive technological innovation, enhance efficiency, and lower production costs.

The U.S. biopharmaceuticals contract manufacturing market is marked by a high rate of M&A activity by dominant players. This is attributed to the reasons including the growing emphasis on portfolio improvement and the necessity of consolidating in a fast-growing marketplace. The advancement of contract service providers is significantly driven by technological innovation and bioprocessing advancements, which assist in overcoming production challenges like the high cost of manufacture and changeover with each batch. Furthermore, the quick turnaround provided by one-time-use items with fewer linked activities, e.g., changeover and validation of cleaning, facilitated the growth of CMOs to a great extent. Market participants are pursuing several measures to expand their portfolios. In February 2022, Recipharm purchased Arranta Bio, an advanced therapy medicinal products provider, in order to enlarge its biologics capabilities in the U.S.

Market participants offer varied biopharmaceutical manufacturing services according to set Current Good Manufacturing Practice (cGMP) guidelines. The number of gene therapies moving from clinical trials to regulatory approval has grown, and the establishment of strong cell therapy manufacturing processes fuels market demand. Furthermore, increasing regulatory approvals for biologics and biosimilars are anticipated to fuel market demand.

The pharmaceutical sector is undergoing a transition towards small molecules to more intricate biopharmaceuticals. Additionally, patent losses of multiple drugs in the market drive the need for sophisticated therapeutics. Contract Manufacturing Organizations (CMOs) are working towards reducing capacity issues in biologics production, hence complementing biologics manufacturing growth.

Source Insights

The mammalian segment held the highest market share of 55.2% in 2024.The growth is due to the increased cost of acquiring products from these sources. Some of the companies that offer contract services utilizing mammalian cell culture include AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals GmbH, and Catalent Pharma Solutions. Therefore, organizations like Lonza and Charles River Laboratories are investing heavily to increase their mammalian cell culture production plants for biologics and biosimilar development.

The non-mammalian segment is expected to be the fastest-growing segment, with a CAGR of 12.7% during 2025-2030.Non-mammalian cell line E. coli is known as a widely used non-mammalian cell culture for biopharmaceutical manufacturing due to its easy access and low-cost cultivation. Transgenic non-mammalian expression system development is forecast to an opportunity for market expansion. Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion are some of the companies operating as CMOs with microbial cultures.

Products Insights

The biologics segment dominated the revenue share in 2024. Contract manufacturers have been crucial to the success of biologics and biosimilars. This is primarily attributed to the great commercial success of biologics, which is illustrated through the strong presence of numerous FDA-approved biologics in the marketplace. Out of all the biologics, mAbs recorded the highest percentage in 2023. High capital needed for the construction of an MAb plant has prompted rapid growth of contract services in producing MAb, thus boosting the share of this segment as the highest one.

The segment of biosimilars will be the one that grows most rapidly during the forecast period. The production of biosimilars has been recognized as one of the major business expansion strategies over biologics since investment in the production of biosimilars accelerates the market access of biopharmaceuticals. Additionally, biosimilars have also driven the biopharmaceutical CMO market due to cost-saving benefits. Therefore, low production costs, coupled with the increasing patent expiry of blockbuster biologics, has further fueled the demand for its manufacturing capacity, including outsourced capacity.

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.

Key U.S. Biopharmaceuticals Contract Manufacturing Companies

U.S. Biopharmaceuticals Contract Manufacturing Market Report Scope

Report Attribute

Details

Revenue forecast in 2030

USD 19.54 billion

Growth rate

CAGR of 10.6% from 2025 to 2035

Base year for estimation

2024

Historical data

2018 - 2023

Forecast period

2025 - 2035

Quantitative units

Revenue in USD million and CAGR from 2025 to 2035

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Source, service, products, type, scale of operation, therapeutic area

Country scope

U.S.

Key companies profiled

Lonza; WuXi Biologics; FUJIFILM Diosynth Biotechnologies; Boehringer Ingelheim International GmbH; Thermo Fisher Scientific Inc.; Samsung Biologics; AGC Biologics; Catalent, Inc; Rentschler Biopharma SE; and Eurofins Scientific

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

Pricing and purchase options

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U.S. Biopharmaceuticals Contract Manufacturing Market Report Segmentation

Source Outlook (Revenue, USD Million, 2018 - 2035)

    • Mammalian

    • Non-mammalian

  • Service Outlook (Revenue, USD Million, 2018 - 2035)

    • Process Development

      • Downstream

      • Upstream

    • Fill & Finish Operations

    • Analytical & QC Studies

    • Packaging & Labelling

    • Others

  • Products Outlook (Revenue, USD Million, 2018 - 2035)

    • Biologics

      • Monoclonal Antibodies (mAbs)

      • Recombinant Proteins

      • Vaccines

      • Antisense, RNAi, & Molecular Therapy

      • Others

    • Biosimilars

  • Type Outlook (Revenue, USD Million, 2018 - 2035)

    • Drug Substance

    • Finished Drug Product

  • Scale Of Operation Outlook (Revenue, USD Million, 2018 - 2035)

    • Clinical

    • Commercial

  • Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2035)

    • Oncology

    • Autoimmune Diseases

    • Infectious Diseases

    • Cardiovascular Diseases

    • Metabolic Diseases

    • Neurology

    • Others

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