The global chemistry, manufacturing and control services outsourcing market size is anticipated to reach USD 15.16 billion by 2030 and is projected to grow at a CAGR of 6.72% from 2024 to 2030, according to a new report by Grand View Research, Inc. Stringent regulatory requirements, increasing R&D investments, and growing need for cost-efficient manufacturing solutions are key factor driving market growth potential. Moreover, complexity of drug development, technological advancements in biologics and personalized medicine, and biopharmaceutical companies focusing on core competencies are another key factors positively impacting the market growth.

The incorporation of state-of-the-art technologies such as automation, artificial intelligence, continuous manufacturing, and digital analytics serves to enhance precision, reduce costs, and accelerate production capabilities. For instance, AI and machine learning applications in quality control and predictive maintenance are expected to reduce operational costs by 20-30%. AI and machine learning algorithms offers predictive analytics for process optimization, quality control, and troubleshooting, reducing time and cost in drug development. Automation in manufacturing processes, including robotics and continuous manufacturing, improves production efficiency, minimizes human error, and enhance product quality. In addition, advancements in digitalization, such as electronic lab notebooks (ELNs) and laboratory information management systems (LIMS), streamline data management and regulatory compliance, assisting seamless information flow and traceability. These advancements enable CMC service providers to offer enhanced quality and heightened reliability services compliant to complex demands of modern biopharmaceuticals including biologics and personalized medicines. The integration of advanced solutions is expected to further propel the market growth and competitiveness of the market.

 

Stringent regulatory scenario in several economies is anticipated to boost the global CMC services outsourcing market. Regulatory agencies, such as the U.S. FDA, the EU EMA, and several other national regulatory authorities enforce strict standards to ensure the safety, efficacy, and quality of pharmaceuticals and biologics. These stringent regulations require thorough documentation, comprehensive testing, and robust quality control throughout the drug development and manufacturing process. Pharmaceutical and biotechnology companies often encounter difficulties in keeping abreast of the evolving regulatory landscape and the associated compliance costs resulting in outsourcing of CMC services to specialized service providers. Moreover, market participants offer critical support in areas such as regulatory submissions, stability studies, analytical method validation, GMP compliance and several others, thereby propelling the industry growth potential.

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Chemistry, Manufacturing And Control Services Outsourcing Market Report Highlights

  • Based on type, the finished drug formulation segment led market with the largest revenue share of 43.77% in 2023.High revenue share is attributed to increasing demand for specialized expertise in formulation development, stringent regulatory requirements for finished drug products, the growing complexity of drug formulations, and the need for cost-effective manufacturing solutions

  • Based on service, the analytical testing segment is expected to grow at the fastest CAGR during the forecast period. Growing adoption of biologics and advanced therapeutics along with stringent regulatory guidelines requiring comprehensive analytical testing throughout drug development cycles are anticipated to boost segmental demand in the global market.

  • Based on end use, the pharmaceutical segment led the market with the largest revenue share of 40.56% in 2023. Several pharmaceutical companies outsourcing CMC services to focus on R&D activities such as drug discovery and clinical development, and cost affordability. Moreover, surge in outsourcing trends, evolving regulatory landscape and demand for specialized expertise among pharmaceutical companies are driving the segment growth potential

  • North America dominated the market with the largest revenue share of 47.3% in 2023. Several factors such as stringent regulatory requirements, technological advancements, significant R&D investment, and increasing demand for specialized services are key factors accelerating the regional market growth. In addition, strong presence of leading pharmaceutical and biotechnology companies and growing focus on development of advanced therapies further propels market expansion 

Chemistry, Manufacturing And Control Services Outsourcing Market Segmentation

Grand View Research has segmented the global chemistry, manufacturing and control services outsourcing market report based on type, service, end-use and region:

Chemistry, Manufacturing And Control Services Outsourcing Type Outlook (Revenue, USD Million, 2018 - 2030)

  • API
    • Small Molecule

    • Large Molecule

  • Finished Drug Formulation

    • Solid Dosage Forms

    • Semi-solid Dosage Forms

    • Liquid Dosage Forms

    • Others

  • Medical Device

Chemistry, Manufacturing And Control Services Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Manufacturing Services

    • Clinical Manufacturing

    • Drug Product Development and Manufacturing

    • Fill Finish Manufacturing

    • Others

  • Regulatory Services

    • Regulatory Consulting

    • Regulatory Submissions

    • Compliance Audits

    • Others

  • Analytical Testing

    • Stability Testing

    • Method Development and Validation

    • Quality Control (QC) Testing

    • Bioanalytical Testing

    • Others

  • Others

Chemistry, Manufacturing And Control Services Outsourcing End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical Companies

  • Biotechnological Companies

  • Medical Device Companies

  • Others

Chemistry, Manufacturing And Control Services Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

  • South Korea

    • Thailand

    • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

List of Key Players in the Chemistry, Manufacturing And Control Services Outsourcing Market

  • Thermo Fisher Scientific

  • ICON plc

  • Catalent, Inc.

  • Thermo Fisher Scientific Inc.

  • Recipharm AB

  • WuXi AppTec

  • Jubilant Life Sciences

  • Samsung Biologics

  • Boehringer Ingelheim BioXcellence

  • Evonik Industries AG

  • Allucent.

  • Ardena Holding NV.

  • Argonaut Manufacturing Services Inc.

  • Bachem

  • Siegfried Holding AG

  • AbbVie Inc.

  • Ajinomoto Bio-Pharma

  • CordenPharma

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About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.