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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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
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)
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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