Assay validation is a method to ensure that the proposed analytical methodology is accurate and safe. Assay validation services provide the complete documentation of analytical method to prove that the process can be commercialized. There are certain guidelines by the FDA and other government authority for a specific analytical methodology; the main purpose of assay validation services is to fulfill the drug development and production requirement by the regulatory authorities. Assay validation services is basically performed in three steps viz. assay optimization (pre-validation), assay qualification and final assay validation. During this entire process of assay validation services all the aspects of drug development and production is validated. Assay validation services can be performed via a different platform such as HPLC, LCMS, GCMS, IPC and others.
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The high focus of leading pharmaceutical and biotechnology companies for the research and development is the key factor propelling the growth of assay validation services market. Also, the rise in regulatory guidelines by the regulatory authorities in the developed countries will also upsurge the demand for assay validation services. Moreover, assay validation services provide a more efficient and quicker result to validate the specific analytical method which ultimately rising the demand for assay validation services. There are few drawbacks of assay validation such as it cannot determine the efficacy of large molecules in the active pharmaceutical ingredients. These drawbacks can be a major factor for the restraining the growth of assay validation services market.
The global assay validation services market is classified on the basis of test type, application, end user and region.
Based on test type, assay validation services market is segmented into the following:
- Bioanalytical Testing
- Stability Testing
- Raw Material Testing
- Batch Release Testing
- Microbial Testing
- Environmental Monitoring
- Physical Characterization
- Others
Based on application, assay validation services market is segmented into the following:
- Drug Development
- Forensic Testing
- Toxicity Screening
- Drug Screening
- Tissue Engineering
- Others
Based on end user, assay validation services market is segmented into the following:
- Biotechnology Companies
- Pharmaceutical Companies
- Food and Beverage Companies
- Forensic Laboratories
- Contract Research Organization
- Contract Manufacturing Organization
- Others
The continuous expansion in the intensive analysis and combined research expeditions is the primary factor responsible for the significant growth of assay validation services market. By service type, Bioanalytical testing segment is the dominating the assay validation services market in term of revenue which is then followed by stability testing segment. Batch release testing segment by service type for the assay validation services market is anticipated to grow at a greater pace than other segments. Based on application drug development and drug screening segment is expected to gain the majority of revenue share for assay validation services market. While the forensic testing segment is projected to grow at a faster rate among all the segment by application for assay validation services market. Among all end user, Pharmaceutical and biotechnology companies segment dominating the assay validation services market whereas the forensic laboratories segment will grow at the faster rate.
Asia-Pacific is the leading region for the assay validation services market owing to the rising number of research and development by biotechnology companies in India, Japan, and China. After Asia Pacific region assay validation services market is then followed by North America and Europe. The adoption is assay validation in the forensic laboratories in the U.S. is the key factor behind the growth of assay validation services market in North America. Also rising spending by key pharmaceutical companies in Europe for research and development is the major factor propelling the growth of assay validation services market in Europe region. On the other hand, there is a lack of pharmaceutical and biotechnology companies in Latin America and Middle East & Africa which is responsible for the sluggish growth of assay validation services market.
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Some of the key players found across the value chain of assay validation
- Services Merck KGaA
- MPI Research
- Intertek Group plc.
- Envigo
- Pace Analytical Services LLC
- Exova Group plc.
- Pharmaceutical Product Development LLC
- WuXi AppTec Group
- Charles River Laboratories Inc.
- SGS SA
- Laboratory Corporation of America Holdings
- Eurofins
- Toxikon Inc.
- Boston Analytical
- West Pharmaceutical Services
- STERIS
- Mount Sinai Services
- Lee Biosolutions Inc
- Spectro Analytical Labs Ltd. and others