Investigational New Drug CDMO Market To Reach $10.4 Billion By 2033

Investigational New Drug CDMO Market Growth & Trends

The global Investigational New Drug CDMO market size is estimated to reach USD 10.4 billion by 2033, registering a CAGR of 8.7% from 2026 to 2033, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 8.66% from 2025 to 2033. This is largely due to the increased R&D investments, along with stringent regulations pertaining to IND.

The U.S. FDA and the European Medicines Agency (EMA) are health authority bodies that regulate the use of investigational drugs in the U.S. and the European Union, respectively. In addition, investigational review boards (IRBs) in the U.S. and ethics committees (ECs) in the European Union must approve the use of drugs in humans.

It is the requirement of a federal law that a drug be the subject of an approved marketing application prior to it is distributed or transported across the state lines. Hence, sponsors aiming to conduct clinical studies that involve an IND should gain exemption from the FDA to permit the shipping of the investigational drug to clinical investigators in several states.

The COVID-19 pandemic has significantly impacted the global economy and has an ongoing impact on various industries. However, the market for IND CDMO has benefited from the pandemic. Prior to COVID-19, prospective sponsors demanded facility audits to ensure CDMOs had the required capacity, equipment, and personnel to undertake their projects. Nowadays, CDMOs should find new ways to attract new sponsors, such as through videos, virtual reality, and other technologies that allow sponsors to virtually experience the site.

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Investigational New Drug CDMO Market Report Highlights

• Based on service, the contract development segment led the market with the largest revenue share of 85.6% in 2025, attributed to the increasing number of biologics, cell therapies, gene therapies, and other advanced therapeutics entering preclinical and early clinical development.

• Based on end use, the pharmaceutical companies segment led the market with the largest revenue share of 70.3% in 2025, attributed to increasing investments in biologics and specialty drug development, rising numbers of investigational new drug applications, and growing outsourcing of IND-enabling activities to accelerate clinical development.

• North America dominated the investigational new drug CDMO market with the largest revenue share of 41.1% in 2025, supported by increasing biologics research, expanding clinical trial activity, and rising outsourcing of IND-enabling development and manufacturing services.

Investigational New Drug CDMO Market Segmentation

Grand View Research has segmented the global investigational new drug CDMO market based on service, end-use, and region:

Investigational New Drug CDMO Service Outlook (Revenue, USD Billion, 2021 - 2033)

• Contract Development

  • Small Molecule

    • Bioanalysis and DMPK Studies

    • Toxicology Testing

    • Pathology and Safety Pharmacology Studies

    • Drug Substance Development

      • Synthetic Route Development

      • Process Development

      • Form Selection Crystallization Process Development

      • Scale-up of Drug Substance

    • Formulation Development

      • Pre Formulation

      • Preclinical Formulation Selection

      • First In Man Formulation/ Process Development

    • Analytical & Quality Services

      • Analytical Method Development / Validation

      • Release Testing of Drug Substance and Drug Product

      • Formal Stability of Drug Substance and Drug Product

    • Process Optimization

      • Work Up Purification Steps

      • Telescoping & Process Refining

      • Initial Optimization

  • Large Molecule

    • Cell Line Development

    • Process Development

      • Upstream

        • Microbial

        • Mammalian

        • Others

      • Downstream

        • MABs

        • Recombinant Proteins

        • Others

• Contract Manufacturing

  • Small Molecule

    • Oral Solids

    • Semi-Solids

    • Liquids & Injectables

    • Others

  • Large Molecule

    • MABs

    • Recombinant Proteins

    • Others

Investigational New Drug CDMO End-use Outlook (Revenue, USD Billion, 2021 - 2033)

• Pharmaceutical Companies

• Biotech Companies

• Others

Investigational New Drug CDMO Regional Outlook (Revenue, USD Billion, 2021 - 2033)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • Thailand

  • South Korea

• Latin America

  • Brazil

  • Argentina

• Middle East & Africa

  • South Africa

  • UAE

  • Saudi Arabia

  • Kuwait

  • Qatar

  • Oman

List of Key Players in the Investigational New Drug CDMO Market 

• Catalent, Inc.

• Lonza

• Recipharm AB

• Siegfried Holding AG

• Patheon Inc.

• WuXi Biologics

• Eurofins CDMO Alphora

• Cambrex Corporation

• Charles River Laboratories International, Inc.

• FUJIFILM Diosynth Biotechnologies

• Syngene International

• Jubilant Pharmova

• Piramal Pharma Solutions

• Dr. Reddy’s CPS

• Dishman Carbogen Amcis Ltd.

• AGC Biologics

• KBI Biopharma