The global GMP testing service market is anticipated to grow at a CAGR of 6.7% during the forecast period (2024-2031). Testing of drug substances involves analysing active pharmaceutical ingredients (APIs) to assess their quality, purity, and potency. This includes using methods such as chromatography, spectroscopy, and mass spectrometry. Microbiological testing is important to ensure the sterility and safety of pharmaceutical products. Quality control testing is conducted to confirm the quality of the finished product, including content uniformity, dissolution testing, and impurity analysis. Stability studies assess the physical, chemical, and microbiological attributes of the product over time. Environmental monitoring ensures the cleanliness and control of the manufacturing environment. Raw material testing involves analysing the starting materials used in pharmaceutical manufacturing. Method validation ensures that the analytical methods used for testing are accurate, specific, and reliable. Furthermore, the market’s growth is attributed to increasing biologic complexity. Biologics tend to be complex molecules with distinct properties. To assure safety and efficacy, these compounds need to be verified through advanced and specialized procedures, including potency testing. For instance, in April 2023, Svar Life Science recently launched the expansion of its biologics testing capacity with a GMP certification. Svar’s QC laboratories have been audited and approved by a separate auditor (Swedish Medical Products Agency) to begin QC analysis in accordance with the appropriate GMP standards for biologic potency testing.
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Furthermore, the biopharmaceutical industry is experiencing significant expansion and innovation, particularly in the manufacture of monoclonal antibodies, bispecific antibodies, ADCs, and vaccines. These products require substantial safety and efficacy assessments, stimulating a need for GMP testing services. in December 2022, WuXi Biologics(“WuXiBio”) launched a new Biosafety Testing Center. It provides biosafety testing services to aid in the development of monoclonal antibodies, bispecific antibodies, ADCs, vaccinations, and other biological products.
Global GMP Testing Service Market Report Segment
By Service Type
- Packaging and Shelf-Life Testing
- Product Validation Testing
- Bioanalytical Services
- Others(Analytical Testing Services, and Validation Services)
By Service provider
- In-House Testing Facilities
- Outsourced facility
By End-User
- Pharmaceutical and Biopharmaceutical Companies
- Medical Device Companies
- Others(Contract Research Organizations (CROs), and Research and Academic Institutions)
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Global GMP Testing Service Market Report Segment by Region
North America
- United States
- Canada
Europe
- UK
- Germany
- Italy
- Spain
- France
- Rest of Europe
Asia-Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Rest of the World
- Latin America
- Middle East & Africa
Company Profiles
- Labcorp
- Merck KGaA
- Microchem Laboratories
- North American Science Associates, LLC
- Pace Analytical Services, LLC
- Sartorius
- SGS
- Sigma-Aldrich Co. LLC.
- Sotera Health Co.
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