U.S. Biologics Contract Development Market (2025 - 2033) Size, Share, & Trends Analysis Report By Source (Mammalian, Microbial), By Product Service (Cell-line Development, Process Development), By Indication, And Segment Forecasts

U.S. Biologics Contract Development Market Summary

The U.S. biologics contract development market size was estimated at USD 2.82 billion in 2024 and is projected to reach USD 4.48 billion by 2033, growing at a CAGR of 5.3% from 2025 to 2033. Factors such as growing M&A activities; increasing adoption of advanced technologies for biological production; investment, a favorable regulatory environment for clinical trials in developing countries, and a rise in outsourcing of R&D activities by pharma and biopharma companies are driving the market.

High upfront costs, regulatory burdens, and the need for speed-to-market have led many pharmaceutical and biotech firms to outsource development and manufacturing to Contract Development and Manufacturing Organization (CDMOs). Small and mid-sized biotech companies in the U.S. biologics contract development industry, in particular, rely mostly on CDMOs due to limited in-house capabilities.

Furthermore, the rising prevalence of chronic diseases, such as cardiovascular disorders, neurological disorders, and cancer, fuels the demand for novel biologic therapies. According to a report published by the CDC in February 2024, chronic diseases such as heart disease, diabetes, and obesity are a major health challenge in the U.S., affecting about 129 million people. Many Americans live with more than one chronic condition, which is putting heavy pressure on the healthcare system, as about 90% of the country’s USD 4.1 trillion annual healthcare spending goes toward managing these illnesses.

Source Insights

The mammalian segment accounted for the largest revenue share of 56.0% in 2024 and is expected to grow at the fastest CAGR over the forecast period. This is due to the use of mammalian cells for protein expression offers a major benefit by producing mammalian proteins with correct post-translational modifications that provide a native structure. Mammalian cell-derived proteins show better receptor binding, longer half-lives, and enhanced therapeutic performance in comparison to proteins made in non-mammalian systems. In addition, mammalian cells can host and replicate animal or human viruses, making them essential for Gene therapy vectors and Viral vaccines.

The microbial segment is projected to grow at a significant CAGR of 5.0% over the forecast period. Microbial expression systems remain highly demanded in the biopharmaceutical industry due to their cost-effectiveness, efficiency, and scalability - especially for biologics such as enzymes, insulin, and vaccines.

Product Service Insights

The process development segment held the largest revenue share in 2024 and is expected to grow at the fastest CAGR over the forecast period. The segment is primarily divided into upstream and downstream techniques. Upstream process development focuses on critical early-stage activities such as cell line selection, culture media optimization, bioreactor system configuration, etc. Curia Global, Inc. provides upstream services such as media and feed optimization, shaker flask-to-bioreactor adaptation, and use of high-throughput systems such as Ambr15. The platform has demonstrated a 2 to 8 fold increase in productivity over traditional systems.

The cell line development segment is expected to grow at a significant CAGR over the forecast period.  According to NCBI, cell lines are being rigorously used to test vaccine production, drug metabolism & cytotoxicity, gene function studies, generation of artificial tissues (e.g., artificial skin), antibody production, and synthesis of biological compounds. The usage of cell lines has revolutionized scientific research.

Indication Insights

The oncology segment held the largest revenue share in 2024. Factors such as the rising prevalence of cancer, high investment in the pipeline of oncology biologics, and accelerated approvals by the FDA for oncology drugs are driving the segment demand. According to a report published by the National Cancer Institute in May 2025, approximately 2.04 million new cancer cases are expected in the U.S. in 2025, resulting in about 618,000 deaths, reflecting the ongoing high burden of cancer.

The immunological disorders segment is anticipated to experience the fastest CAGR during the forecast period. Immunological diseases, caused by dysfunction of the immune system, include asthma, allergy, autoimmune diseases, and others. The country's increasing prevalence of immunological disorders is expected to drive the industry.

Key U.S. Biologics Contract Development Company Insights

Some key companies in the U.S. biologics contract development industry are WuXi Biologics, Abzena, and FUJIFILM Diosynth Biotechnologies.

• WuXi Biologics is a leading global CDMO offering end-to-end solutions for biologics discovery, development, and production. The company operates several facilities worldwide and is involved in expansions in the U.S. to meet increasing local demand.

Recent Developments

• In April 2025, Fujifilm Diosynth Biotechnologies signed a 10-year, over USD 3 billion manufacturing supply agreement with Regeneron to provide biologic medicines, that treats millions of patients globally.

• In April 2025, AGC Biologics launched a dedicated cell & gene therapy business division. It offers support and scientific ability, backed by manufacturing network in Milan, the U.S., and Japan. Furthermore, the company’s proprietary ProntoLVV and BravoAAV enable developers to control cost and enhance the speed to GMP practices.

U.S. Biologics Contract Development Market Report Scope

U.S. Biologics Contract Development Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. biologics contract development market report based on source, product service, and indication:

• Source Outlook (Revenue, USD Million, 2021 - 2033)

  • Mammalian

  • Microbial

  • Others

• Product Service Outlook (Revenue, USD Million, 2021 - 2033)

  • Cell Line Development

    • Microbial

    • Mammalian

    • Others

  • Process Development

    • Upstream

      • Microbial

      • Mammalian

      • Others

    • Downstream

      • Bioanalytical methods

        • Impurity, isolation, & identification

        • Physicochemical characterization

        • Pharmaceutical analysis

        • Others

      • Product

        • MABs

        • Recombinant proteins

        • Others

• Indication Outlook (Revenue, USD Million, 2021 - 2033)

  • Oncology

  • Immunological Disorders

  • Cardiovascular Disorders

  • Hematological Disorders

  • Others