Global Bioanalytical Testing Services Market is estimated to be valued at USD 3.95 Bn in 2024, exhibiting a CAGR of 10% over the forecast period 2024-2031. Growing investment in pharmaceutical R&D and rising outsourcing of bioanalytical testing services by biotech and pharmaceutical companies are expected to drive the market growth during the forecast period. Furthermore, rapid evolution of large molecule therapeutics such as monoclonal antibodies and wave of patent expiries are also anticipated to boost demand for bioanalytical testing services.
Market Dynamics:
The market is expected to witness –growth due to increasing R&D investment in pharmaceutical and biotech industry and rising outsourcing of testing activities. Pharmaceutical and biotech companies are increasingly focusing on R&D and clinical trials to develop novel drug candidates. This has led to higher R&D expenditure globally, and this boosts demand for outsourced bioanalytical testing services from contract research organizations. There has been rising preference for outsourcing non-core testing activities as it helps companies focus on their core competencies and ensures timely delivery.
Increasing R&D expenditure and clinical trial activities can drive the bioanalytical testing services market growth
Rising expenditure on research and development activities by pharmaceutical and biotechnology companies can drive the market growth. As the drug development process becomes more complex with advanced molecular assays and analytics needed, there has been huge demand for sophisticated bioanalytical testing services. Many new drugs and therapies are in the clinical trial phase which requires robust bioanalysis to determine the drug's effects in the human body. The number of clinical trials being conducted globally has been growing steadily each year as R&D intensifies, thus, boosting demand for essential bioanalytical testing and sample analysis services.
Advancements in detection technologies and precision medicine can drive the market growth
With the emergence of precision medicine and personalized therapeutics, the development of advanced detection technologies for bioanalysis has become crucial. Technologies like mass spectrometry, liquid chromatography, and flow cytometry allow for highly sensitive quantitation of biomolecules down to picogram and femtogram levels. These are indispensable tools for bioanalysis in pre-clinical and clinical studies evaluating drug metabolism and pharmacokinetics. Rising focus on precision/individualized medicine and developing companion diagnostics has prompted drug developers and CROs to invest more in cutting-edge bioanalytical technologies.
Reduced costs and long development timelines can hamper the market growth
One major challenge faced by bioanalytical testing services market is need to reduce costs amid intense pricing pressures from pharmaceutical sponsors. Outsourcing to lower-cost regions is one-way providers are trying to tackle this issue. However, maintaining quality standards and turnaround times becomes difficult. Unexpected delays can result in penalties which further squeeze margins. Furthermore, the drug development process has became very lengthy with an average timeline of over 10 years. Any delays in bioanalysis can significantly delay product launches, thus, hampering the market growth.
Stringent regulatory guidelines hinders widespread adoption of bioanalytical testing services
Bioanalytical method validation and data generation have to strictly adhere to international regulatory guidelines set by entities like U.S FDA, EMA, and WHO. While regulations aim to ensure safety and efficacy, keeping up with continual changes and differing requirements across regions has become challenging. The approval processes have also gotten rigorous with agencies inspecting facilities for compliance. Meeting current good manufacturing practices (cGMP) adds to operating expenses. For some smaller labs and those in developing nations, it can be difficult to achieve full regulatory certification, limiting their potential in this market. Strict guidelines can hamper the market growth.
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Key Developments:
- In November 2023, Resolian uccessfully completed the acquisition of Denali Medpharma, a prominent bioanalytical contract research organization (CRO) based in China. This acquisition enabled Resolian to broaden its bioanalysis laboratory operations, spanning facilities in the U.S., UK, Australia, and China.
- In September 2023, Cerba HealthCare, clinical pathology laboratory finalized the acquisition of CIRION BioPharma Research, a Canada-based contract research laboratory, to bolster its bioanalytical capabilities and streamline the implementation of complex clinical trials
- In April 2023, Pace Analytical Services, a division of Pace® Science and Technology, providing local testing and analytical services announced the acquisition of Alpha Analytical, expanding its laboratory services across the Northeastern U.S. with over 39 locations
- In November 2021, Labcorp, global life sciences company inaugurated a new bioanalytical laboratory facility in Singapore, extending its central laboratory services and enhancing Singapore's biomedical ecosystem capabilities
- In November 2021, CURE Pharmaceutical Holding Corporation, pharmaceutical company obtained patent approval from the United States Patent and Trademark Office (USPTO) for its CUREfilm Blue Technology, an oral soluble film containing sildenafil citrate
- In June 2021, Charles River lab, a pharmaceutical company acquired Vigene Biosciences, a CDMO (contract development and manufacturing organization) providing viral vector-based gene delivery solutions, to strengthen its ability to support the clients with end-to-end cell and gene therapy support
- In October 2021, Syneos , biopharmaceutical solutions organization announced acquisition of RxDataScience, leading healthcare-focused data analytics, data management, and artificial intelligence (AI) company.
Key Players: Thermo Fisher Scientific Inc (PPD, Inc.), ICON Plc, Charles River Laboratories International, Covance, Inc., IQVIA, Syneos Health, SGS SA, Labcorp (Toxikon), Intertek Group Plc, Pace Analytical Services LLC, Pharmaceutical Product Development LLC, Laboratory Corporation of America Holdings, Toxikon Corporation,Wuxi Apptec Co. Ltd, Frontage Labs, Eurofins Scientific
