The global bioanalytical testing services market is estimated to be valued at USD 4.35 Bn in 2025 and is expected to reach USD 8.60 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 10.2% from 2025 to 2032.
The 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 increasing emphasis on effective and faster drug development can boost demand for bioanalytical testing services. Expanding the biologics and biosimilars pipeline can provide growth opportunities for service providers shortly. The 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 chain custody maintenance can restrict the market growth over the forecast period.
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AI algorithms can process large volumes of complex bioanalytical data quickly and accurately, reducing human error and improving the reliability of test results. For instance, Metropolis Healthcare Limited launched a novel allergy testing platform in May 2023, utilizing Component Resolved Diagnostics (CRD) powered by AI. This fourth-generation technology assists clinicians in diagnosing various allergies by detecting specific IgE antibodies against 295 different allergens through a simple blood test. The AI system provides insights into selecting and optimizing treatment courses for individual allergic diseases.
Among method types, the small molecules segment is estimated to dominate the bioanalytical testing services market growth due to their extensive use in various therapeutic areas, with the highest share of 65.6%. 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. For instance, in September 2024, Catalent’s Center of Excellence for Small Molecule Analytical Services was acquired by Pace® Life Sciences, thus expanding its capacity in the small molecule segment.
Among test types, the pharmacokinetics segment is estimated to account for the largest share of the bioanalytical testing services market, with 45.7.% 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 an increase in outsourcing of pharmacokinetic bioanalytical requirements to well-equipped contract research organizations. In February 2025, Silo Pharma, Inc. (Nasdaq: SILO) announced positive results from a study assessing the pharmacokinetics, safety, and tolerability of its novel SP-26 ketamine extended-release rods implanted subcutaneously. This is further positively influencing the bioanalytical testing services market forecast.
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North America has dominated the global bioanalytical testing services market with 39.7% for many years due to the strong presence of pharmaceutical and biotechnology companies in the region. Countries like the 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 the U.S. FDA have further promoted the outsourcing of bioanalytical testing in this region. Many big pharma companies prefer to associate with experienced testing service providers owing to the benefits of better communication, project supervision, and quality oversight. For instance, in August 2024, SGS introduced its specialized bioanalytical testing services in New Hampshire. It provides solutions to support discovery, clinical trials, pharmacokinetic bioanalysis, etc. This expansion strengthens SGS’s partnership with Agilex Biolabs.
The Asia Pacific region has emerged as the fastest-growing market for bioanalytical testing services globally. The presence of a low-cost skilled workforce and the development of new international standard laboratories in countries like China and India have 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. For instance, in September 2023, Labcorp expanded its bioanalytical operations in the Asia Pacific region. The company established a new laboratory in Singapore. This expansion aims to strengthen Labcorp’s presence in the global bioanalytical testing services market.
The 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 the 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 2025, 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.
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, a life sciences entered into an agreement with Noritsu Koki Co. Ltd to acquire GeneTech Inc. player in genetic analysis, thus expanding Eurofins' testing portfolio in Japan. This is further adding to the bioanalytical testing services market share.
| Report Coverage | Details | ||
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| Base Year: | 2024 | Market Size in 2025: | USD 4.35 Bn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 10.2% | 2032 Value Projection: | USD 8.60 Bn |
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| Companies covered: |
hermo 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 |
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*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.
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About Author
Vipul Patil is a dynamic management consultant with 6 years of dedicated experience in the pharmaceutical industry. Known for his analytical acumen and strategic insight, Vipul has successfully partnered with pharmaceutical companies to enhance operational efficiency, cross broader expansion, and navigate the complexities of distribution in markets with high revenue potential.
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