Bioanalytical Testing Services Market

Bioanalytical Testing Services Market Size

Bioanalytical Testing Services Market was valued at USD 3.8 billion in 2023 and is set to achieve over 8.6% CAGR from 2024 to 2032.

The growth of this market can be attributed to factors such as increasing volume of ongoing research activities & clinical trials and development of complex therapeutic modalities, such as gene therapies as well as biologics. Also, increased outsourcing laboratory testing services and growing development and approval of biopharmaceutical are expected to fuel the market growth. Also, outsourcing these services enable companies to access testing facilities in different geographical regions. This globalization of testing capabilities allows companies to expand their market reach, establish strategic partnerships, and leverage regional expertise and resources to support drug development activities in diverse markets, thereby augmenting the industry growth.

Bioanalytical testing services refer to a range of laboratory services that involve the analysis of biological samples such as blood, urine, tissue, etc. to quantify the concentration of drugs, metabolites, biomarkers, and other analytes in biological matrices. These services are commonly used in the pharmaceutical and biotechnology industries for various purposes, including drug development, pharmacokinetic studies, bioequivalence assessments, and in overall clinical trials.

Bioanalytical Testing Services Market Trends

• Rising advancements in bioanalytical technology such as mass spectrometry, chromatography, and immunoassays, are enhancing the sensitivity, accuracy, and throughput of bioanalytical testing services. These advancements enable faster turnaround time, improved data quality, and expanded capabilities in metabolite profiling, biomarker discovery, and pharmacokinetic studies.
  
• Further, pharmaceutical companies are increasingly adopting advanced bioanalytical technologies to accelerate the drug discovery and development process. High-throughput screening (HTS), lab-on-a-chip (LOC) devices, and biosensors facilitate the rapid screening of drug candidates, identification of novel targets, and assessment of drug efficacy and safety profiles.
  
• Thus, the abovementioned factors are escalating the growth of the market.
  

However, complex regulatory framework for maintaining laboratories may hamper the market growth to certain extent.

Bioanalytical Testing Services Market Analysis

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The global market based on molecule type is segmented into small and large. The small segment accounted for majority of market share of 56.1% in 2023 and is expected to dominate throughout the analysis period.

• The segmental growth is attributed to the advancements in medical science concerning small molecules and the growing demand to address unmet medical needs.
  
• Moreover, increasing number of generic drug approvals and patent expirations for branded small molecule drugs, there is a growing demand for bioequivalence studies. Bioanalytical testing services are essential for demonstrating the bioequivalence of generic drugs compared to their branded counterparts, ensuring comparable pharmacokinetic profiles and therapeutic efficacy, thereby augmenting the segmental growth.
  

Learn more about the key segments shaping this market

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The bioanalytical testing services based on animal type is classified into DMPK testing, biomarker testing, virology testing, serology testing, immunogenicity testing, and other test types. The virology testing segment has been further divided into in-vivo virology testing and in-vitro virology testing. The biomarker testing dominated the market and was valued at USD 2.2 billion by 2032.

• Biomarker testing plays a crucial role in the bioanalytical testing services across various industries, including pharmaceuticals, biotechnology, CRO, and academic research. Biomarkers are measurable indicators of biological processes, disease states, or responses to therapeutic interventions.
  
• Additionally, the segment growth is majorly attributed to early disease detection, accurate diagnosis, and prediction of disease progression that helps clinicians to make informed decisions about patient management and treatment. Thus, demand for biomarker testing is anticipated to grow in upcoming years.
  

Based on application, the bioanalytical testing services is divided into oncology, neurology, infectious diseases, gastroenterology, cardiology, and other applications. The oncology segment accounted for significant market position and is predicted to reach USD 1.8 billion by 2032.

• Bioanalytical testing services play a crucial role in oncology that help in supporting research, drug development, clinical trials, and patient care.
  
• Also, bioanalytical testing services assess the pharmacodynamic effects of anticancer drugs on tumor cells, tumor microenvironment, and host immune response. Pharmacodynamics studies helps to understand drug mechanisms, evaluate drug efficacy, and optimize therapeutic interventions. Hence, the interplay of these factors collectively contributes to the expansion of this segment.
  

Based on end-use, the bioanalytical testing services market is segmented into pharmaceutical & biotechnology companies, contract research organizations, research & academic institutes, and other end-users. The pharmaceutical & biotechnology companies segment held a market share of 45.9% in 2023.

• Pharmaceutical & biotechnology companies are involved in development of cell & gene therapeutics, nanoparticles & polymers, and biologics. These large molecules needs advanced bioanalytical technologies for quality control, characterization, and regulatory approval. Therefore, large molecule bioanalysis plays crucial role in all phases of clinical trials.
  
• Pharmaceutical & biotechnology companies perform the clinical trials and rely on bioanalytical tools to generate and interpret the data. Subsequently, increasing the adoption of bioanalytical testing.
  

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North America bioanalytical testing services market accounted for USD 1.6 billion revenue in 2023 and is anticipated to grow at CAGR of 8.4% between 2024 and 2032.

• An important factor contributing to market expansion is the increasing investment in the research and development of new drugs by pharmaceutical and biotechnology industries. With increase in R&D activities, the demand for bioanalytical testing services is projected to increase in upcoming years. Additionally, pharmaceutical and biotechnology companies are focusing on expanding their capabilities in biologics development and partnering with CROs and CDMOs with expertise in biopharmaceutical analysis, thereby accelerating the market growth.
  
• Additionally, the presence of major market players is expected to propel the growth of the global market in the region.
  

Bioanalytical Testing Services Market Share

The bioanalytical testing services industry is characterized by the presence of several key players offering innovative solutions to healthcare providers. The strategic partnerships, mergers, and acquisitions are common strategies employed by players to expand their market presence, enhance their product portfolios, and gain a competitive advantage.

Bioanalytical Testing Services Market Companies

Prominent players operating in the bioanalytical testing services industry include:

• BioAgilytix
• Charles River Laboratories, Inc.
• Eurofins Scientific
• Frontage Labs
• ICON Plc
• Intertek Group Plc
• Labcorp Drug Development
• Pace Analytical Services LLC
• SGS Société Générale de Surveillance SA
• Syneos Health
• Thermo Fisher Scientific Inc.
• WuXi AppTec
  

Bioanalytical Testing Services Industry News:

• In May 2022, Eurofins Scientific acquired majority shares of Repertoire Genesis Inc, a unique TCR/BCR repertoire profiling platform. This acquisition expands Eurofins' healthcare service offerings globally and helps in strengthening its position in the bioanalytical market and enhancing its capabilities in immune-related translational research, biomarker development, diagnostics, and pharmaceutical advancements.
  
• In November 2021, Labcorp announced expansion of its drug development offering in Asia Pacific with launch of a new bioanalytical lab facility in Singapore. This expansion aims to enhance Singapore's biomedical ecosystem by providing critical bioanalytical testing services for the development of biologics and vaccines. The new lab helped company to support the development of small and large molecular entities with offering of good laboratory practice and good clinical practice compliant services. This has helped company to strengthen its global presence.
  

The bioanalytical testing services market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 - 2032 for the following segments:

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Market, By Molecule Type

• Small molecule
• Large molecule

Market, By Test Type

• DMPK testing
• Biomarker testing
• Virology testing
  • In-vivo virology testing
  • In-vitro virology testing 
• Serology testing
• Immunogenicity testing
• Other test types

Market, By Application

• Oncology
• Neurology
• Infectious diseases
• Gastroenterology
• Cardiology
• Other applications    

Market, By End-use

• Pharmaceutical & biotechnology companies
• Contract research organizations
• Research & academic institutes
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe 
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East and Africa