Pharmaceuticals are designed, developed, and primarily manufactured in laboratories. Pharmaceutical testing in labs is required in almost every stage of pharmaceutical research and development and production, from testing on raw materials, to quality control (QC) and dosage form of in-process material & finished products.
Pharmaceutical testing include determining the potency, efficacy, and proper use or dosage of a medical product, as well as measuring its accuracy and stability. A pharmaceutical testing laboratory can assist in testing the products to ensure that they are safe for everyone to use before releasing them to the market.
Method development, packaging materials testing, process development, and release testing are few of the various services that pharmaceutical testing laboratories provide to ensure the safety of medications.
Global Pharmaceutical Testing Services Market – Dynamics
The increasing number of drug approvals is expected to propel the global pharmaceutical testing services market growth over the forecast period. For instance, according to the U.S. Food and Drugs Administration (FDA) fact sheet, until November 2020, there are over 20,000 prescription drug products approved by the U.S. FDA for marketing.
Due to the COVID-19 pandemic, the U.S. regulatory authorities have released several new guidelines related to quality and manufacturing of drugs, this may help to boost the global pharmaceutical testing services market growth over the forecast period. For instance, on May 17, 2021, the U.S. Food and Drug Administration (FDA) posted a new guidance document titled ‘COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention’, to guide sponsors of pharmaceutical companies about the new procedure on drug evaluation and testing. These factors are expected to support the global pharmaceutical testing services market growth over the forecast period.
Global Pharmaceutical Testing Services Market – Regional Insights
Among regions, North America is estimated to account for the largest share in the global pharmaceutical testing services market over the forecast period, owing to the rising approvals for novel drugs and biological therapies. For instance, till June 2021, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 26 novel drugs for indications ranging from lung cancer, prostate cancer, and bipolar disorder to Alzheimer’s disease.
Furthermore, due to the opening of new collaboration centers, Asia Pacific may witness a lucrative growth in global pharmaceutical testing services market over the forecast period. For instance, on July 10, 2020, Merck, a leading science and technology company, opened its MLab Collaboration Center in Shanghai, China, the largest of the company's nine collaboration centers worldwide. M Lab Collaboration Center provides adaptable solutions and services to help biopharmaceutical and biologics companies to improve their processes from drug discovery to development & testing to manufacturing and helping to speed up the process of product market release. These factors are expected to support global pharmaceutical testing services market growth over the forecast period.
Global Pharmaceutical Testing Services Market – Taxonomy
By Product Type:
- Active Pharmaceutical Ingredients
- Raw Materials
- Finished Products
By Service Type:
- Bio-analytical Testing
- Cell based Assays
- Virology Testing
- Method Development & Validation
- Extractable & Leachable
- Process Impurity Method
- Raw Material Testing
- Heavy-metal Testing
- Stability Testing
- Drug Substance Stability Testing
- Microbial Testing
By End User
- Biotechnology Industries
- Biopharmaceutical and Pharmaceutical Companies
- North America
- Asia Pacific
- Latin America
- Middle East
Global Pharmaceutical Testing Services Market – Competitive landscape
Key players operating in the global pharmaceutical testing services market include Merck KGaA, Boston Analytical, West Pharmaceutical Services Inc., Exova Group PLC., Source BioScience , Pace Analytical Services, Inc., W.uXi AppTec, Toxikon, Eurofins Scientific, and West Pharmaceutical Services Inc.