Bioanalytical Testing Services Market

Global Bioanalytical Testing Services Market Size (2024 to 2029)

The bioanalytical testing services market size is expected to grow at a CAGR of 9.12% from 2024 to 2029 and be worth USD 7448.38 million by 2029 from USD 4841.37 million in 2024.

MARKET DRIVERS

The growing prevalence of chronic diseases worldwide and the need for cost-effective alternatives to biologics have fuelled the need for biosimilars and this has created a need for robust bioanalytical testing services to ensure the safety, efficacy and comparability of biosimilar products and driving the bioanalytical testing services market growth. The expiration of patents and exclusivity terms for biologics has opened opportunities for the development of biosimilars and resulting in the growing demand for bioanalytical testing services and contributing to market growth.Stringent regulatory requirements, the growing need for compliance with safety and efficacy standards, the rising need for accurate and timely diagnostic testing increasing number of advancements in analytical technologies and methodologies that enable more precise and efficient testing and the growing outsourcing trend among pharmaceutical companies to reduce costs and focus on core competencies support the bioanalytical testing services market growth.The growing complexity of drug development and regulatory processes that require specialized expertise, the rapidly growing biopharmaceutical industry, increased investments in research and development activities, global increase in the number of clinical trials, increasing need for bioanalytical support, rising importance of personalized medicine and companion diagnostics, growing focus on quality control and assurance throughout the drug development lifecycle and increasing awareness about the importance of bioanalytical testing in ensuring drug safety and efficacy further drive the bioanalytical testing services market growth.

MARKET RESTRAINTS

The high cost of bioanalytical testing services that can limit accessibility for smaller pharmaceutical companies and research institutions, stringent regulatory requirements and evolving guidelines and resource investment and lack of standardized methodologies and reference materials majorly hamper the growth of the bioanalytical testing services market growth. Limited availability of skilled professionals with expertise in bioanalytical testing, leading to talent shortages and potential quality issues. Rapidly advancing technologies requiring continuous investment in equipment, infrastructure, and training to stay up to date and challenges in data interpretation and integration, especially in complex biomarker analysis and multi-analyte testing further inhibit the market’s growth rate.

REPORT COVERAGE

SEGMENTAL ANALYSIS

Global Bioanalytical Testing Services Market – By Molecule

Based on the molecule, the small molecule segment is expected to hold the leading share of the global market during the forecast period. Factors such as the growing demand for conventional drugs and the development of new small molecule-based therapies drive segmental growth. The versatility and wide applicability of small molecules boost the demand for bioanalytical testing services and boost segmental growth. Established regulatory frameworks for small molecule drugs and a growing market for generic drugs further promote the segment’s growth rate.The large molecule segment had a substantial share of the global market in 2022 and is estimated to grow at a healthy CAGR during the forecast period. The growing number of biologics in the pipeline, the increasing need for precise bioanalytical testing to assess their therapeutic effects and optimize patient outcomes, the rising number of developmental and commercialization activities of biosimilars and rigorous regulatory scrutiny contribute to the segmental growth.

Global Bioanalytical Testing Services Market – By Test

Based on the test, the bioavailability segment is predicted to account for the leading share of the global market during the forecast period. Regulatory compliance, formulation optimization, supporting the generic and biosimilar market, enabling personalized medicine approaches and meeting the demand for oral drug delivery majorly drive the growth of the bioavailability segment.

Global Bioanalytical Testing Services Market – By Workflow

Based on the workflow, the sample analysis segment is estimated to grow at a healthy CAGR during the forecast period owing to the growing demand for accurate and reliable analytical results, increasing number of advancements in analytical technologies and instruments, rising complexity of drug molecules and biomarkers requiring specialized analysis, regulatory requirements for comprehensive analysis and data generation and increasing research and development activities in pharmaceutical and biotechnology industries.

REGIONAL ANALYSIS

Based on region, the North American region is anticipated to continue holding the leading position in the global market throughout the forecast period. The presence of well-developed healthcare infrastructure, including research facilities, pharmaceutical companies, and academic institutions in North America drive the bioanalytical testing services market in North America. Stringent regulatory frameworks, such as those by the FDA, increasing number of R&D activities by pharmaceutical, biotechnology companies and academic research institutes and emphasis on precision medicine and personalized therapies further boost the growth rate of the North American market. The presence of a robust biopharmaceutical sector in North America, rising need for biologics and biosimilars and technological advancements in analytical instruments, methodologies and automation in North America contribute to the regional market growth. The U.S. had approximately 60% of the North American market in 2022 followed by Canada in 2022. The growth of the U.S. market is majorly driven by factors such as the presence of major pharmaceutical and biotechnology companies, growing investments for R&D and the U.S. being the preferred destination for conducting clinical research studies.

Europe held a substantial share of the global market in 2022 and is predicted to grow at a healthy CAGR during the forecast period. The well-established regulatory agencies in Europe, such as the European Medicines Agency (EMA) with comprehensive guidelines for bioanalytical testing majorly drive the European market growth. The growing adoption of biosimilars, the rising outsourcing of bioanalytical testing services to specialized service providers and the increasing number of collaborations between pharmaceutical companies, contract research organizations (CROs), and academic institutions contribute to the European market growth. The presence of several major bioanalytical service providers and pharmaceutical companies and an increasing number of renowned academic and research institutions conducting cutting-edge bioanalytical research further propel the European market growth. Germany, France, and the UK held the major share of the European market in 2022.

APAC is the most lucrative regional market for bioanalytical testing services worldwide and is estimated to witness the highest CAGR among all the regions during the forecast period. Factors such as APAC being the preferred destination for clinical trials and contract research, the growing pharmaceutical and biotechnology sectors in the Asia-Pacific region and an increasing number of favorable policies and incentives to promote research and development activities from the governments of the Asia-pacific region majorly boost the APAC market growth. The growing healthcare expenditure in countries like China and India, emerging markets for generic drugs and the rising adoption of precision medicine approaches and targeted therapies in the APAC region further fuel the growth rate of the APAC market.

Latin America is a noteworthy regional market and is expected to hold a considerable share of the global market during the forecast period. The growing investments in healthcare infrastructure and research facilities, rapidly growing pharmaceutical and biotechnology industries, increasing emphasis on improving healthcare standards and regulatory frameworks and rising prevalence of chronic diseases drive the Latin American market growth. Brazil held the major share of the Latin American market in 2022. The growth of the Brazilian market is majorly driven by the well-established pharmaceutical industry and increasing investments in healthcare infrastructure.

MEA captured a moderate share of the global market in 2022 and is estimated to grow at a steady CAGR during the forecast period.

KEY PLAYERS IN THE GLOBAL BIOANALYTICAL TESTING SERVICES MARKET

Charles River Laboratories International, Inc., Laboratory Corporation of America Holdings (LabCorp), Eurofins Scientific SE, SGS SA, PPD, Inc., ICON plc, WuXi AppTec, Inc., Syneos Health, Inc., BioAgilytix Labs and Medpace Holdings, Inc. are some of the notable companies in the global bioanalytical testing services market.

DETAILED SEGMENTATION OF GLOBAL BIOANALYTICAL TESTING SERVICES MARKET INCLUDED IN THIS REPORT

This market research report on the global bioanalytical testing services market has been segmented and sub-segmented by molecule, test, workflow and region.

By Molecule

• Small Molecule
• Large Molecule
  • LC-MS Studies
  • Immunoassays
    • PK
    • ADA
    • Others
  • Others

By Test

• ADME
  • In-Vivo
  • In-Vitro
• PK
• PD
• Bioavailability
• Bioequivalence
• Others

By Workflow

• Sample Preparation
  • Protein Precipitation
  • Liquid-Liquid Extraction
  • Solid Phase Extraction
• Sample Analysis
  • Hyphenated technique
  • Chromatographic technique
  • Electrophoresis
  • Ligand Binding Assay
  • Mass Spectrometry
  • Nuclear Magnetic Resonance
• Other Workflow Processes

By Therapeutic Area

• Oncology
• Neurology
• Metabolic Disorders
• Hematology
• Immunology
• Orthopedics
• Others

By End-user

• Pharmaceutical and Biotechnology Companies
• Contract Development and Manufacturing Organization
• Contract Research Organization
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa