Report Overview

A spurring demand for efficacious biologics to treat various diseases and complex biopharma manufacturing processes are expected to boost the growth of United States CRDMO (Contract Research, Development, and Manufacturing Organization) Market during the forecast period between 2025 and 2031.

United States CRDMO Market – Industry Trends & Forecast Report, 2031

United States CRDMO (Contract Research, Development, and Manufacturing Organization) Market size was estimated at USD 42.72 billion in 2024. During the forecast period between 2025 and 2031, United States CRDMO Market size is projected to grow at a CAGR of 5.3% reaching a value of USD 61.33 billion by 2031. A prominent driver of United States CRDMO Market is the rising number of chronic diseases globally driven by growing elderly population, lifestyle changes, and economic development. Pharmaceutical companies are increasingly developing effective medical products to speed up treatment due to the increase in chronic diseases and the aging population.

Contract Research Development and Manufacturing Organization (CRDMO)– Overview

A CRDMO (Contract Research, Development, and Manufacturing Organization) is a specialized service provider in the pharmaceutical and biotechnology industries that offers integrated support across the entire drug development lifecycle. Unlike traditional models where companies might separately engage a CRO (Contract Research Organization) for early-stage research and clinical trials, and a CDMO (Contract Development and Manufacturing Organization) for later-stage development and manufacturing, a CRDMO combines these capabilities under one roof.

United States CRDMO Market

Growth Drivers

Rising Demand for Pharmaceutical and Biopharmaceutical Products

A rapid surge in the demand for biopharmaceuticals, including monoclonal antibodies, cell and gene therapies, and personalized medicines, is reshaping the drug development landscape. These advanced therapies require specialized expertise, sophisticated manufacturing capabilities, and strict regulatory compliance, all which CRDMOs are well-equipped to provide. Pharmaceutical companies are increasingly outsourcing drug development and manufacturing to CRDMOs to improve efficiency, reduce costs, and accelerate time-to-market. Outsourcing allows companies to focus on research and commercialization while leveraging the scale, regulatory knowledge, and technical capabilities of CRDMOs for production, formulation, Product, and quality assurance.

Challenges

Rising Competition and Market Saturation

United States CRDMO Market is experiencing intense rivalry not only from a growing number of domestic players but also from international CDMOs, especially as global pharmaceutical outsourcing expands and countries like India and China ramp up their capabilities. This increased competition makes it extremely difficult for companies to stand out based solely on traditional strengths such as technical infrastructure, regulatory compliance, or even professional expertise, as these have become standard across the industry.

Impact of Escalating Geopolitical Tensions on United States CRDMO Market

Escalating geopolitical, trade, and tariff tensions are reshaping United States CRDMO Market through being pushed to reduce their reliance on Chinese CDMOs for critical raw materials and manufacturing services. Legislative actions like the proposed BIOSECURE Act and the threat of higher tariffs on Chinese imports are prompting a strategic shift toward reshoring or diversifying supply chains, often favoring domestic or allied international partners such as those in South Korea and India. In the short term, these changes may lead to supply disruptions or drug shortages as new suppliers are qualified and integrated.

United States CRDMO Market

Segmental Coverage

United States CRDMO Market – By Service

By service, United States CRDMO Market is segmented into Early Phase Development Services, Clinical Research Services, Laboratory Services, Post-approval Services. The early phase development services segment focuses on activities, such as lead asset development, preclinical research, and preparation for investigational new drug (IND) applications. These services are crucial for accelerating timelines, managing costs, and mitigating risks, as they enable pharmaceutical companies to leverage CRDMO’s expertise, infrastructure, and regulatory support to move efficiently from discovery to clinical readiness.

United States CRDMO Market – By Product

Based on product, United States CRDMO Market is segmented into Small Molecules, Biologics, Cell & Gene Therapy, and Biosimilars & Antibody Drug Conjugates. Biologics are large, complex molecules derived from living organisms, such as proteins, antibodies, or hormones. They offer high target specificity and are especially valuable for treating complex or hard-to-treat diseases, but require injections, strict temperature control, and specialized manufacturing facilities, which increase costs and logistical challenges.

United States CRDMO Market - By Application

The application segmentation of United States CRDMO Market consists of Oncology, Infectious Diseases, Neurology, Immunology, Hematology, Vaccines, and Others. Oncology is the dominant segment, accounting for a significant market share, driven by the high incidence and prevalence of cancer, rapid innovation in targeted therapies, and significant R&D investments from pharmaceutical and biotechnology companies. The complexity of oncology drugs-such as biologics, monoclonal antibodies, and antibody drug conjugates-necessitates specialized expertise and infrastructure, making CRDMOs invaluable partners in developing and manufacturing these advanced treatments.

United States CRDMO Market – By End User

United States CRDMO Market by end user is segmented into Pharmaceutical & Biotech Companies, Medical Device Companies, Academic & Research Institutes, and other end users. Pharmaceutical and biotech companies represent the largest end-user segment, driving the majority of demand for outsourced research, development, and manufacturing services. These companies, ranging from emerging biotechnology companies to established pharmaceutical giants, turn to CRDMOs to streamline their drug development pipelines, reduce operational costs, and access specialized expertise and advanced technologies they may not possess in-house.

Competitive Landscape

Major players operating in the highly competitive United States CRDMO Market include Pfizer Centreone, Sai Life Sciences, Icosagen, WuXi Biologics, WuXi AppTec, Esco Aster, Jubilant Biosys, Syngene International, Chemveda, Ardena Holding, BioCentriq, Eurofins, and Jiangsu HUAYI Technology Co., Ltd. To further enhance their market share, these companies employ various strategies, including mergers and acquisitions, partnerships, joint ventures, license agreements, and new product launches.

Recent Developments

• In December 2024- BioCentriq, a leading cell therapy CDMO, signed a long-term lease agreement with National Business Parks for developing a cutting-edge manufacturing facility in Princeton, New Jersey.

Scope of the Report

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By Service

• Early Phase Development Services

• Clinical Research Services

• Laboratory Services

• Post-approval Services

By Product

• Small Molecules

• Biologics

• Cell & Gene Therapy

• Biosimilars

• Antibody Drug Conjugates

By Application

• Oncology

• Infectious Diseases

• Neurology

• Immunology

• Hematology

• Vaccine

• Others

By End User

• Pharmaceutical & Biotech Companies

• Medical Device Companies

• Academic & Research Institutes

• Others