BIOANALYTICAL TESTING SERVICES MARKET ANALYSIS

Market Size and Trends

Global bioanalytical testing services market is estimated to be valued at USD 3.95 Bn in 2024 and is expected to reach USD 7.70 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 10% from 2024 to 2031.

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Global bioanalytical testing services market is expected to witness significant growth during the forecast period due to  rising investments in research and development by pharmaceutical and biotechnology companies. Growing demand for outsourcing analytical testing and rising emphasis on effective and faster drug development can boost demand for bioanalytical testing services. Expanding biologics and biosimilars pipeline can provide growth opportunities for service providers in the near future. Growing burden of chronic diseases worldwide escalates the drug development activities, thus, augmenting the need for timely and cost-effective bioanalytical testing services. However, challenges relating to accurate testing and maintenance of chain of custody can restrict the market growth over the forecast period.

Growing demand for monoclonal antibody-based drugs and recombinant proteins Global bioanalytical testing services market is witnessing significant growth due to increasing demand for monoclonal antibody-based drugs and recombinant proteins. Monoclonal antibodies have become one of the most important classes of therapeutic molecules, owing to their high efficacy and target specificity. A large number of monoclonal antibodies are presently in various stages of clinical development and many more are expected to be approved for marketing in the coming years. Their approvals will need exhaustive bioanalytical testing throughout the drug development and approval process. Recombinant proteins are also emerging as an important class of biotherapeutics for treatment of various diseases. Many promising proteins in pre-clinical and clinical testing pipelines of biotech firms will need extensive bioanalytical characterization and quantification as part of their development journey. For instance, in April 2024, according to the data published by Bioprocess International, recombinant antibody technology has revolutionized biologics production, thus, offering rapid, scalable, and cost-effective antibody generation while addressing ethical concerns associated with animal experimentation. This technology enables precise engineering of antibodies for optimal disease treatment, with advancements driven by decades of experience and increasingly sophisticated AI algorithms.

Market Concentration and Competitive Landscape

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Increasing research and development (R&D) activities

Rising demand for specific test types in R&D activities and increasing adoption of outsourcing laboratory testing services can drive the market growth. As companies expand their market presence by offering a diverse range of services and solutions, major players are pursuing various strategies such as mergers, acquisitions, and other developments. For instance, in August 2021, Eurofins Scientific, life sciences  entered into an agreement with Noritsu Koki Co. Ltd to acquire GeneTech Inc., a prominent Japan-based player in genetic analysis, thus, expanding Eurofins' testing portfolio in Japan.

Key Takeaways from Analyst:

Global bioanalytical testing services market is expected to witness growth steadily over the in the near future. Stringent regulatory guidelines for drug development along with a complex approval process boosts demand for outsourcing analytical testing for specialty contract research organizations.

 Rise of biologics and cell and gene therapies boosts the  need for sophisticated bioanalysis. However, high capital investment requirements to set up specialized bioanalytical facilities pose a challenge to new market players. North America currently dominates the market owing to presence of many pharmaceutical companies and strong regulatory environment mandating bioanalysis. However, Asia Pacific is expected to record highest growth due to increasing R&D expenditure, growing biopharma industry, and favorable government policies promoting clinical trials in the region. It provides lucrative outsourcing opportunities to Western biotechs seeking to reduce costs.

Larger players are focusing on strategic acquisitions of smaller bioanalytical CROs to expand into new therapies or geographic regions. There is also a trend of consolidation to offer integrated drug development services from preclinical to commercialization. To gain competitive edge, service providers are investing in advanced technologies like LC-MS/MS and immnoassays. Developing expertise in niche areas such as rare disease drugs, biosimilars, and personalized medicine can help CROs gain first.

Market Challenges: Challenges in the Development of Proper Analytical Techniques

Challenges in developing analytical techniques are expected to hamper the global bioanalytical testing services market growth. These techniques are integral to biotechnology and pharmaceutical manufacturing. However, the development of bioanalytical methods has become increasingly difficult due to rigorous requirements regarding method sensitivity, reliability, sample throughput, and analysis speed. Furthermore, the complex regulatory framework governing laboratory maintenance is expected to hinder the growth of the global bioanalytical testing services market. Each country has its own set of regulations pertaining to innovation, manufacturing, drug testing, marketing, and post-marketing studies. Consequently, stringent regulations concerning laboratory maintenance, validation, and pharmaceutical drug testing are projected to hamper the market growth.

Market Opportunities: The outbreak of COVID-19 across the globe

The global outbreak of COVID-19 is expected to offer significant growth opportunities for participants in the bioanalytical testing services market. The pandemic has led to rise in demand for such services worldwide. For instance, in January 2021, Eurofins Bioanalytical Services, is a biologics- focused, global leader in bioanalytical solutions provider introduced surrogate virus neutralizing antibody detection assays targeting SARS-CoV-2 (the COVID-19 virus). This assay identifies the presence of neutralizing or blocking antibodies against the viru,s and is the first of its kind authorized by the U.S FDA under Emergency Use Authorization (EUA) for the SARS-CoV-2 virus. Moreover, increasing demand for biologics and biosimilars globally is expected to offer substantial growth prospects for players in the global bioanalytical testing services market. With rising demand for biologics and biosimilars, coupled with a growing emphasis on analytical testing for these products, there has been rising demand for bioanalytical testing services. For example, in January 2020, Celltrion biopharmaceutical company announced plans to invest USD 514 million in a biologic’s facility in Wuhan, China, aimed at developing and manufacturing biologics for the local market and providing contract services for emerging Chinese biotech companies.

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Insights, By Method Type:

Among method type, small molecules segment is estimated to dominate the bioanalytical testing services market due to their extensive use in various therapeutic areas with highest share 65.1%. These are preferred for their precise targeting capabilities and well-defined structures, thus, facilitating thorough preclinical evaluation and quantitative analysis during drug development. Most pharmaceutical pipelines prioritize small molecule therapies over biologics due to their manufacturing simplicity, stability, and cost-effectiveness. Small molecules offer specificity and versatility in modulating molecular targets, thus, aligning with the trend toward precision and personalized medicine. As regulatory standards tighten, the demand for comprehensive small molecule analysis increases, thus, driving the need for specialized bioanalytical testing services.

Insights, By Test Type:

Among test type, pharmacokinetics segment is estimated to account for the largest share of the bioanalytical testing services market with 45.20% Understanding a drug candidate's absorption, distribution, metabolism, and excretion through the body is crucial to assessing its viability for further development and clinical use. Pharmacokinetic studies elucidate critical parameters like bioavailability, half-life, therapeutic drug concentrations, and identify potential drug-drug interactions early on. As pharmaceutical R&D shifts focus towards exploring new modalities and complex formulations, evaluating pharmacokinetic properties becomes more challenging. At the same time, regulatory expectations of demonstrating biosimilarity and therapeutic equivalence necessitate sophisticated pharmacokinetic analysis using advanced analytical technologies and specialized technical expertise. This leads to increase in outsourcing of pharmacokinetic bioanalytical requirements to well-equipped contract research organizations. 

Regional Insights

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North America has dominated the global bioanalytical testing services market with 39.2% for many years due to strong presence of pharmaceutical and biotechnology companies in the region. Countries like U.S. and Canada have extensive R&D infrastructure and expertise for drug development. A large number of clinical research organizations (CROs) and contract research laboratories are headquartered in North America, thus, catering to the testing needs of local pharmaceutical firms. High healthcare expenditure and stringent regulatory guidelines enforced by authorities such as U.S. FDA have further promoted outsourcing of bioanalytical testing in this region. Many big pharma companies prefer associate with experienced testing service providers owing to benefits of better communication, project supervision and quality oversight.

Asia Pacific region has emerged as the fastest growing market for bioanalytical testing services globally. Presence of low-cost skilled workforce and development of new international standard laboratories in countries like China and India has attracted substantial outsourcing from western pharmaceutical companies. Several global CROs have also established sizable operations in major Asia Pacific markets to leverage cost benefits. Moreover, growing domestic pharmaceutical production in China, Japan and India along with increasing orientation towards R&D boosts demand for bioanalysis outsourcing in the region.

Market Report Scope

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.

*Definition: Bioanalytical Testing Services Bioanalytical testing, or bioanalysis, is the process of identifying and quantifying drugs and metabolites within various biological matrices, such as blood, plasma, serum, cerebrospinal fluid, saliva, and urine.

Market Segmentation

• Method Type Insights (Revenue, USD BN, 2019 - 2031)
  • Small Molecules
  • Large Molecules
•  Test Type Insights (Revenue, USD BN, 2019 - 2031)
  • Bioavailability and Bioequivalence Studies
  • Pharmacokinetics
  • Pharmacodynamics
  • Other Test Types
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
• • 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
  • SGS SA
  • Toxikon Corporation
  • Intertek Group PLC
  • Wuxi Apptec Co. Ltd
  • Frontage Labs
  • Eurofins Scientific