New York, United States, Oct. 03, 2024 (GLOBE NEWSWIRE) -- The pharmaceutical analytical testing market is witnessing substantial expansion due to the escalating complexity of medication development and the heightened demand for biologics and biosimilars. Biotechnology and personalized medicine progress requires advanced testing methodologies to guarantee the safety, efficacy, and regulatory adherence of novel therapeutics. Companies such as Charles River Laboratories and Labcorp Drug Development offer sophisticated bioanalytical testing and method development services essential for these intricate medicines.
Furthermore, rigorous regulatory standards and an increased emphasis on quality control in international pharmaceutical markets require extensive analytical testing. The involvement of prominent entities providing specialized services and the increasing trend of outsourcing to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), including ICON plc and Thermo Fisher Scientific (PPD), further facilitate market growth by enabling pharmaceutical companies to utilize advanced testing capabilities and optimize their drug development processes.
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Market Dynamics
Increasing Regulatory Stringency on Drug Quality Drives the Global Market
National governments and international health organizations enforce stricter controls on pharmaceutical corporations to guarantee medication safety, efficacy, and quality. The heightened regulatory scrutiny substantially elevates the demand for comprehensive analytical testing during the medication development and production phases. The European Medicines Agency mandates compliance with the European Pharmacopoeia, which encompasses comprehensive testing protocols for drug purity. The EMA's guidelines include extensive stability testing to confirm a drug's efficacy throughout its shelf life.
Similarly, the ICH Q1A guidelines established by the International Council for Harmonisation prescribe protocols for stability testing. These standards mandate that pharmaceuticals undergo accelerated stability testing to ensure they retain quality under diverse settings before market release. These regulatory mandates guarantee that pharmaceutical goods adhere to stringent criteria for safety, efficacy, and quality, safeguarding public health and bolstering the integrity of the pharmaceutical market.
Adoption of Automation and Artificial Intelligence (AI) in Testing Creates Tremendous Opportunities
Implementing automation and Artificial Intelligence (AI) in pharmaceutical analytical testing presents disruptive prospects for the market. Artificial intelligence tools and machine learning algorithms are progressively utilized to optimize workflows, reduce human errors, and expedite testing procedures. Automated systems can manage high-throughput operations such as data analysis, quality control, and predictive modeling, facilitating expedited and precise testing.
For example, Thermo Fisher Scientific utilizes AI to improve chromatographic separations, markedly decreasing the duration of drug formulation testing, particularly in extensive batch testing, where automation enhances efficiency and throughput. Furthermore, artificial intelligence is employed for predictive analytics in pharmaceutical development, discerning patterns within extensive datasets and enhancing testing methodologies. This accelerates the market entry of novel pharmaceuticals and improves accuracy in intricate testing situations.
Moreover, the amalgamation of AI and automation is anticipated to propel substantial progress, rendering analytical testing more economical and dependable throughout the pharmaceutical sector.
Regional Analysis
North America is the most significant global market shareholder and is anticipated to hold a 53.17% market share during the forecast period. North America possessed the predominant pharmaceutical analytical testing market share, influenced by various critical factors. This encompasses a strong pharmaceutical and biotechnology sector, significant investment in research and development, and rigorous regulatory standards that demand extensive analytical testing. Additionally, prominent analytical testing facilities and sophisticated healthcare infrastructure enhance the region's market supremacy.
The Asia Pacific region is anticipated to experience the highest compound annual growth rate in the pharmaceutical analytical testing market due to various factors. The swift expansion of the pharmaceutical and biotechnology industries, heightened investments in healthcare infrastructure, and escalating demand for superior testing services, propelled by the proliferation of clinical trials and drug development initiatives, underpin this rise. Conducive regulatory frameworks and the rising trend of outsourcing analytical testing to the region facilitate its swift market growth.
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Key Highlights
- By services, the global pharmaceutical analytical testing market is segmented into bioanalytical testing, method development & validation, stability testing, and other testing services. The bioanalytical testing segment dominates the global pharmaceutical analytical testing market primarily owing to its critical role in drug development and approval processes.
- Based on end-users, the global pharmaceutical analytical testing market is segmented into pharmaceutical companies, biopharmaceutical companies, and contract research organizations. Pharmaceutical companies' dominance in the pharmaceutical analytical testing market is reinforced by their reliance on outsourcing specialized services.
- North America is the most significant global market shareholder and is anticipated to hold a 53.17% market share during the forecast period.
Competitive Players
- Eurofins Scientific
- SGS SA
- Charles River Laboratories
- Thermo Fisher Scientific Inc. (PPD)
- Intertek Group plc
- Pace Analytical Services LLC
- WuXi AppTec
- Laboratory Corporation of America
- Almac Group
- Syneos Health
- ICON plc
- Exova Group plc
- Avomeen Analytical Services
- Element Materials Technology
- Toxikon Corporation.
Recent Developments
- In June 2024, Thermo Fisher Scientific Inc., a global leader in scientific services, announced the opening a new 72,500-square-foot clinical research laboratory at its GMP facility in Middleton, Wisconsin. This expansion enhances the site’s chemistry, manufacturing, and control (CMC) analytical capabilities, supporting its clinical development and laboratory services aimed at advancing health and aiding customers in delivering transformative medicines.
- In February 2024, ICON plc completed its acquisition of Clinical Research Management, Inc., expanding its market presence in government-sponsored research and enhancing its capabilities in vaccines and infectious diseases.
Market Segmentation
- By Services
- Bioanalytical Testing
- Clinical
- Non-clinical
- Method Development and Validation
- Extractable and Leachable
- Impurity Method
- Technical Consulting
- Others
- Stability Testing
- Drug Substance
- Stability Indicating Method Validation
- Accelerated Stability Testing
- Photostability Testing
- Others
- Others
- Bioanalytical Testing
- By End User
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Contract Research Organizations
- By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- Latin America
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