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Report Overview

The United States CDMO market was valued at USD 86.11 Billion in 2025, driven by the rising prevalence of chronic diseases such as asthma and diabetes, and the growing demand for biologics and advanced therapeutics across the region. The market is anticipated to grow at a CAGR of 10.70% during the forecast period of 2026-2035, with the values likely to reach USD 237.97 Billion by 2035.

Key Market Trends and Insights

  • CMO leads the market share by service type, projected to grow at CAGR of 11.9% during 2025-2034.
  • In the United States, CROs are expected to attain a value of USD 37.47 billion by 2034. 
  • Oncological diseases lead the market segmentation by therapeutic area.
  • Based on end users, pharmaceutical and biopharmaceutical companies generate the highest revenue share.

Market Size and Forecast

  • Market Size (2025): USD 86.11 Billion
  • Projected Market Size (2035): USD 237.97 Billion 
  • CAGR (2026-2035): 10.70%
2025

Base Year

2019-2025

Historical Period

2026-2035

Forecast Period

  • As of 2022, an estimated 24.4 million people in the United States had been diagnosed with diabetes, highlighting a significant public health burden and emphasizing the need for improved prevention and management strategies.

  • Recent product approvals and innovative treatment solutions, such as advanced insulin delivery systems and digital monitoring tools, are significantly enhancing diabetes care and driving growth in therapeutic and management markets.

  • Strategic partnerships and acquisitions among major healthcare and technology firms are shaping the diabetes landscape, reflecting a strong trend toward integrated care solutions and expanding access to personalized treatment approaches.

Compound Annual Growth Rate

10.7%

Value in USD Billion

2026-2035


*this image is indicative*

United States Contract Development and Manufacturing Organization (CDMO) Market Overview

The CDMO market plays a crucial role in supporting the pharmaceutical and biotechnology sectors by offering integrated solutions that enhance efficiency and scalability. As companies increasingly rely on external partners to manage complex development and production processes, the market continues to expand. Growth is fueled by rising demand for biologics, advanced therapies, and flexible manufacturing capabilities. With strong regulatory alignment, modern infrastructure, and growing R&D investments, the market is projected to grow at a CAGR of 10.70% during 2026–2035.

United States Contract Development and Manufacturing Organization (CDMO) Market Growth Drivers

One of the key growth drivers is the increasing burden of chronic diseases, particularly respiratory illnesses like asthma. According to the 2024 Asthma Capitals Report, nearly 28 million Americans were living with asthma as of 2024, approximately 1 in 12 individuals. As a result, the need for efficient, scalable production of respiratory drugs and delivery devices is accelerating. CDMOs offer the necessary infrastructure, regulatory expertise, and flexibility to support pharmaceutical companies in developing and producing inhalation therapies and biologics. This persistent health burden underlines the role of CDMOs in supporting innovation and supply in the chronic disease treatment space, boosting market growth in the years ahead.

Another significant growth driver is the surge in biologics development and the strategic investments being made to meet this rising demand. For instance, in June 2025, Zydus Lifesciences Ltd. announced its entry into the global biologics CDMO business through the acquisition of Agenus Inc.’s manufacturing facilities in California. This move marks a notable shift, as international companies increasingly seek United States-based production to serve global biotech clients more efficiently. With cutting-edge capabilities in biologics development and manufacturing, Zydus’ investment strengthens the CDMO ecosystem in the United States. The deal highlights the country's position as a key hub for biologics and underscores the critical role of CDMOs in enabling innovation and ensuring rapid, compliant production pipelines.

United States Contract Development and Manufacturing Organization (CDMO) Market Trends

The market is witnessing several trends, including a surge in strategic acquisitions.

Surging Strategic Acquisitions Likely to Boost United States CDMO Market Value

A notable trend in the United States CDMO market is the rising number of strategic acquisitions, aimed at expanding capabilities and global reach. For instance, in December 2024, Arterex acquired Phoenix S.r.l., a leading Italian CDMO offering MDR-compliant design, assembly, and packaging services. This move strengthens Arterex’s position in regulated markets. Such strategic consolidations are expected to significantly enhance the market’s growth trajectory in the coming years.

United States Contract Development and Manufacturing Organization (CDMO) Market Share

Oncology to Lead the Segmentation Based on Therapeutic Areas

The CDMO market serves a wide range of therapeutic areas, including oncological diseases, metabolic disorders, neurological disorders, respiratory diseases, cardiovascular diseases, infectious diseases, and others. Oncology is expected to lead the market, driven by rising cancer incidence, robust R&D investments, and government reimbursement policies. According to Rebecca L. Siegel, MPH et al., 2025, 2,041,910 new cancer cases are projected in 2025 in the United States, underscoring sustained demand for oncology-focused CDMO services.

United States Contract Development and Manufacturing Organization (CDMO) Market Analysis by Region

The report covers the United States regions, including New England, the Mideast, the Great Lakes, the Plains, the Southeast, the Southwest, the Rocky Mountain, and the Far West. Among these, the Far West, especially California and Washington, is expected to demonstrate significant growth. This region benefits from high levels of pharmaceutical and biotech activity, extensive clinical trial pipelines, and major CDMO facility investments. As operators expand manufacturing capabilities and leverage innovation hubs, regional growth momentum is anticipated to remain strong.

Leading Players in the United States Contract Development and Manufacturing Organization (CDMO) Market

The United States CDMO market research report by Expert Market Research provides an in-depth analysis of the competitive landscape, offering key insights into patent filings, grants, funding trends, investments, and strategic initiatives by major players. It tracks recent investments, mergers, acquisitions, and partnerships that showcase the market's growth trajectory. Additionally, the report details strategic activities by leading companies, including regional expansions, adoption of new technologies, and efforts to enhance capacity, helping stakeholders better understand the market dynamics and positions of key industry players. Some of the leading players are as follows:

Vetter Pharma-Fertigung GmbH & Co. KG

Vetter is a leading global CDMO specializing in aseptic fill-and-finish services, offering end-to-end solutions from clinical development to commercial production. The company generates good sales through its sterile injectable manufacturing capabilities. With a strong presence in the United States, Vetter supports pharmaceutical clients through advanced drug product development, aseptic filling, device assembly, analytical services, and regulatory compliance assistance.

Recipharm AB

Recipharm offers end-to-end CDMO services spanning oral solids, sterile fill-finish, and biologics. In October 2024, through a strategic alliance with Exela Pharma Sciences in North Carolina, they now have capacity for over 100 million vials and pre-filled syringes annually, including biologics, ADCs, GLP‑1 drugs, and vaccines. They also deployed a new modular Grade A sterile filling line in Germany, supporting syringes, vials, and PFS, helping biotech clients from development to clinical production

Patheon (Thermo Fisher Scientific Inc.)

Under Thermo Fisher, Patheon provides comprehensive CDMO services across the United States, including small-molecule APIs, biologics, viral vectors, and clinic-to-commercial fill-finish (vials, ampoules, PFS). Its robust capabilities in both oral solids and sterile injectables support major pharma and biotech clients such as Amgen, Novartis, and Merck. On-site product listings showcase services for cGMP plasmids and viral vectors, emphasizing flexibility across development stages

Pfizer Inc.

Pfizer Inc., through its specialized CDMO division Pfizer CentreOne, plays a significant role in the United States CDMO market. Leveraging Pfizer’s advanced global manufacturing network, the company offers comprehensive development and commercial manufacturing services for oral solids, sterile injectables, biologics, and small molecule APIs. With integrated regulatory support and end-to-end lifecycle services, Pfizer CentreOne enables pharmaceutical and biotech partners to bring high-quality therapies to market efficiently.

*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*

Other key players in the market include Boehringer Ingelheim, Famar SA, Lonza Group, Novotech Pty Ltd., WuXi AppTec, Fareva SA, FUJIFILM Diosynth Biotechnologies, Nipro Pharma Corporation, B. Braun SE, and WuXi Biologics.

United States Contract Development and Manufacturing Organization (CDMO) Market Segmentation

The market report offers a detailed analysis of the market based on the following segments:

Market Breakup by Service Type

  • Contract Manufacturing Organization
    • Active Pharmaceutical Ingredient (API) Manufacturing
      • Small Molecule
      • Large Molecule
      • High Potency (HPAPI)
    • Finished Formulation (FDF) Development and Manufacturing
      • Solid Dose Formulation
      • Liquid Dose Formulation
      • Injectable Dose Formulation
    • Secondary Packaging Services
    • Others
  • Contract Research Organization
    • Pre-Clinical
    • Phase I
    • Phase II
    • Phase III
    • Phase IV

Market Breakup by Therapeutic Area

  • Oncological Diseases
  • Metabolic Disorders
  • Neurological Disorders
  • Respiratory Diseases
  • Cardiovascular Diseases
  • Infectious Diseases
  • Others

Market Breakup by End User

  • Pharmaceutical and Biopharmaceutical Companies
  • Medical Devices Companies
  • Others

Market Breakup by Region

  • New England
  • Mideast
  • Great Lakes
  • Plains
  • Southeast
  • Southwest
  • Rocky Mountain
  • Far West

Key Questions Answered in the United States Contract Development and Manufacturing Organization (CDMO) Market Report

  • What was the United States CDMO market value in 2025?
  • What is the United States CDMO market forecast outlook for 2026-2035?
  • What are the major factors aiding the United States CDMO market demand?
  • How has the market performed so far, and how is it anticipated to perform in the coming years?
  • What are the market's major drivers, opportunities, and restraints?
  • What are the major United States CDMO market trends?
  • Which service type is expected to dominate the market segment?
  • Which therapeutic area is projected to lead the market segment?
  • Which end user is likely to dominate the market segment?
  • Who are the key players involved in the United States CDMO market?
  • What are the current unmet needs and challenges in the market?
  • How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?

Key Benefits for Stakeholders

  • Expert Market Research's report provides a detailed quantitative analysis of various market segments, historical and current trends, forecasts, and dynamics within the United States CDMO market from 2018 to 2034.
  • The report offers up-to-date information on key market drivers, challenges, and opportunities in the global healthcare interoperability solutions sector.
  • The report uses Porter's five forces analysis to assess the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitutes, helping stakeholders evaluate the level of competition and market attractiveness.
  • The competitive landscape section allows stakeholders to understand the competitive environment and provides insights into the current positions of key players in the market.

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

REPORT FEATURES DETAILS
Base Year 2025
Historical Period 2019-2025
Forecast Period 2026-2035
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Service Type
  • Therapeutic Area
  • End User
  • Region
Breakup by Service Type
  • Contract Manufacturing Organization
  • Contract Research Organization
Breakup by Therapeutic Area
  • Oncological Diseases
  • Metabolic Disorders
  • Neurological Disorders
  • Respiratory Diseases
  • Cardiovascular Diseases
  • Infectious Diseases
  • Others
Breakup by End User
  • Pharmaceutical and Biopharmaceutical Companies
  • Medical Devices Companies
  • Others
Breakup by Region
  • New England
  • Mideast
  • Great Lakes
  • Plains
  • Southeast
  • Southwest
  • Rocky Mountain
  • Far West
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • PESTEL Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Company News and Developments
    • Certifications
Companies Covered
  • Vetter Pharma-Fertigung GmbH & Co. KG
  • Recipharm AB
  • Boehringer Ingelheim
  • Patheon Pharma Services (Thermo Fisher Scientific Inc.)
  • Pfizer Inc.
  • Famar SA
  • Lonza Group
  • Novotech Pty Ltd
  • WuXi AppTec
  • Fareva SA
  • FUJIFILM Diosynth Biotechnologies
  • Nipro Pharma Corporation
  • B. Braun SE
  • WuXi Biologics

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