by The global pharmaceutical analytical testing market is primarily driven by rising number of biologics, biosimilars, and generics.Pharmaceutical analytical testing refers to various testing techniques done to check the quality, purity and composition of drugs, healthcare products and medicine. It involves testing various physical as well as chemical properties of drugs at different stages including development, manufacturing and production. The tests are done to ensure patient safety and compliance with regulatory guidelines.
The global pharmaceutical analytical testing Market is estimated to be valued at US$ 9 Bn in 2023 and is expected to exhibit a CAGR of 3.3% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Dynamics:
The pharmaceutical analytical testing market is witnessing significant growth owing to increasing number of biologics, biosimilars, and generics. Biologics and biosimilars require rigorous analytical testing during their development and production due to complex nature and sensitivity. Additionally, growing generics market has also triggered the need for analytical testing to prove equivalence to reference products.
The other major driver is stringent regulatory guidelines mandating quality control and assurance. Regulatory agencies like USFDA and EMA regularly update testing guidelines focusing on various parameters like process validation, impurity profiling and method development and validation. This widens the scope of analytical testing services and boosts market growth.
SWOT Analysis
Strength: The pharmaceutical analytical testing market offers lucrative growth opportunities as stringent regulatory guidelines mandate quality checks at various stages of drug development and manufacturing. Early identification of impurities helps reduce costs and ensures patient safety. Further, continuous technological advancement in analytical techniques allows for accurate and rapid testing of drugs.
Weakness: The setup and operation of analytical testing facilities involves substantial capital investments and skilled workforce requirements. Test method validations and instrument qualifications as per regulatory norms make the approval process lengthy and complex.
Opportunity: Growing generics market and patent cliff of major drugs boost the demand for bioequivalence and dissolution testing services. Rising focus on pharmacovigilance also drives the need for testing drugs post approval. Outsourcing of various analytical tests to specialized laboratories increases due to the complexity of methods and talent crunch.
Threats: Delayed approvals and unfavorable changes in regulations hinder market revenues. Stringent import-export controls impact the ease of doing business in certain markets. Intense competition among players limits pricing flexibility.
Key Takeaways
The Global Pharmaceutical Analytical Testing Market is expected to witness high growth driven by the patent expiration of biologics and the increasing generics market penetration. Analytical techniques such as UPLC, HPLC, and GC are widely used in pharmaceutical manufacturing and quality control processes, and continued adoption provides significant opportunities. The global Pharmaceutical Analytical Testing Market is estimated to be valued at US$ 6.4 billion in 2023 and is expected to exhibit a CAGR of 3.3% over the forecast period 2023-2030.
Regional analysis: North America dominates the global market attributed to well-established regulatory guidelines and a large number of pharmaceutical manufacturing facilities in the region. Asia Pacific is anticipated to register the fastest growth over the forecast period supported by outsourcing of various analytical tests to lower-cost destinations such as India and China.
Key players: Key players operating in the pharmaceutical analytical testing market are SGS SA, Eurofins Scientific, Merck KGaA, Charles River Laboratories International, Inc., and Intertek Group plc. Pharmaceutical companies are partnering with these contract testing service providers for stability testing, method validation, and release assays to meet evolving standards.
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Source: Coherent Market Insights, Public sources, Desk research
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