The Pharmaceutical Analytical Testing Market is estimated to be valued at US$ 8356.52 Mn in 2023 and is expected to exhibit a CAGR of 8.2% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Overview:
Pharmaceutical analytical testing involves various quality control tests at each stage of drug development and manufacturing to ensure safety, efficacy, and potency of pharmaceutical products. It helps in drug substance identification, determining drug purity level, determination of drug content in formulations, and detection of potential impurities in drugs. With stringent regulations around quality and efficacy of pharmaceutical products, analytical testing plays a vital role in drug development and manufacturing.
Market key trends:
Regulatory compliance and increasing regulatory activity are among the major trends in the pharmaceutical analytical testing market. Stringent regulations worldwide toward quality and safety of drugs and drug products have necessitated rigorous analytical testing of pharmaceutical drugs at various stages. For instance, the U.S. FDA enforces its Current Good Manufacturing Practices (CGMP) regulations that require extensive quality testing protocols for pharmaceutical manufacturers. Additionally, the regulatory revisions are getting stricter with time requiring advanced analytical technologies and methods for drug quality testing. This has propelled the demand for analytical capabilities and related services among pharmaceutical companies.
Porter’s Analysis
Threat of new entrants: The pharmaceutical analytical testing market requires high capital investment and stringent regulations, lowering threats of new entrants.
Bargaining power of buyers: Buyers have moderate bargaining power due to the availability of substitutes and price sensitivity of pharmaceutical companies.
Bargaining power of suppliers: Suppliers have moderate bargaining power owing to differentiated products and services.
Threat of new substitutes: Threat of substitution is low as pharmaceutical analytical testing services have no close substitutes.
Competitive rivalry: Market is competitive due to presence of many global and regional players.
SWOT Analysis
Strength: Presence of sophisticated infrastructure and skilled workforce. Compliance with stringent regulations boosts credibility.
Weakness: High dependence on limited number of buyers increases pricing pressure. Initial investments and maintaining certifications increase costs.
Opportunity: Growth in generics and biosimilars market drives demand. Expanding biopharmaceutical industry in developing nations offers opportunities.
Threats: Stringent approval timelines increase pressure on service providers. Economic slowdowns negatively impact spend on R&D.
Key Takeaways
The Global Pharmaceutical Analytical Testing Market Size is expected to witness high growth, exhibiting a CAGR of 8.2% over the forecast period, due to increasing regulatory stringency worldwide. The FDA and EMA have considerably tightened norms for pharmaceutical quality control and assurance.
Regional analysis: North America dominates the global market currently, attributed to presence of a well-established pharmaceutical industry and stringent regulatory environment in the region. However, Asia Pacific is poised to be the fastest growing market due to increasing generic production, growing R&D investments, and favorable regulatory assistance in various countries.
Key players related content: Key players operating in the pharmaceutical analytical testing market include Steris PLC, West Pharmaceutical Services Inc., Boston Analytical, Intertek Pharmaceutical Services, Pace Analytical Services, Labcorp (Toxikon Inc.), SGS SA, Eurofins Scientific, and Laboratory Testing Inc., among others. These players have adopted different strategic approaches for gaining market share such as expanding service portfolios and geographical presence through mergers and acquisitions.