Bioanalytical Testing Services Market - Size & Upcoming Industry Trends (2024-2032)

Bioanalytical Testing Services Market Synopsis:

Bioanalytical Testing Services Market Size Was Valued at USD 3.96 Billion in 2023, and is Projected to Reach USD 7.70 Billion by 2032, Growing at a CAGR of 10% From 2024-2032.

Bioanalytical testing services market includes a broad spectrum of analytical services which play a crucial role in drug development, trials and biopharmaceutical research. This should not be confused with a related market of assaying biological samples like blood, urine and tissue to measure biomarkers, drugs and other metabolites to support regulatory compliance or improve the drug development life cycle. These services are significant for pharmaceutics and biotechnology companies and academic institutions to focus on development in drug delivery, safety and efficacy.

Bioanalytical testing services market is a significant segment of the biopharmaceutical industry due to the escalating spending on drug discovery and development. Due to massive consumption of chronic diseases and the need for the use of efficient and accurate analytical tests for medical purposes, there is a great need for improved bioanalytical tests. The FDA and EMA are some of the regulatory agencies with strict requirements of the new drugs and this has helped to fuel the need for a full package of the bioanalytical services. These services encompass wide spectrum of testing – chromatographic methods, mass spectrometric,immunological, and+= maintains that bioanalytical data of drugs gets accorded highest standards that are governing requirements though drug approval.

The bioanalytical testing industry is also seeing a shift with the help of innovation and newer technologies. Enhancements in automation and new tools for data analysis improves efficiency in laboratory testing, giving the ability to monitor drug levels and biomarkers responses in real-time. Furthermore, tendencies of outsourcing bioanalytical testing service provide opportunities for pharmaceutical companies to concentrate on their strengths, as well as utilizing an extensive range of service specialists. This trend is further confirmed by the fact that new CROs are coming up in the market with full bioanalytical testing capabilities that encourage the interaction and innovation in the industry.

Bioanalytical Testing Services Market Trend Analysis:

Rise of Personalized Medicine

• Another trend that characterize the development of the bioanalytical testing services market is the usage of the strategies of personalized medicine, which means usage of the medicine with individual approach supported by the consideration of genetic peculiarities of the patient and his biomeric indicators. This shift has been occasioned by better understanding of disease processes and innovation in targeted therapies that depend on bioanalysis for effective assessment of patient response. While individualized medicine gets a foothold, the need for sophisticated services for testing complex biological materials and assessing the effectiveness of treatment will only grow. As we witnessed companies such as ARL and LabCorp ramp up their bioanalytical capabilities by integrating next-generation sequencing and liquid biopsy technologies, more firms are equally moving to acquire sophisticated technologies in a bid to actualise the use of bioanalytical technologies in developing sophisticated medicines and improving patient’s well-being.

Growth in Biopharmaceuticals

• The bioanalytical testing services are full of opportunities though the current market trends show that the market is likely to grow tremendously with more development in biopharmaceuticals and biologics. Currently, the biopharmaceutical industry is experienced a rebirth since various new product categories such as monoclonal antibodies, vaccines, and gene therapies are already and will be launched even more in the future, and all these will require bioanalytical testing as a result of which the volume of testing will grow. Such products have strict safety, efficacy and quality testing procedures, and thus they will require more bioanalytical services as they seek to obtain correct and reliable results. In addition, regulatory bodies are revising the regulations periodically and the pressure is therefore on pharmaceutical markets to pay for sound bioanalytical tests that help meet the regulation requirements and accelerate the process of approving drugs. It’s this landscape that has the potential to continue growing and therefore open many opportunities for bioanalytical testing service providers to be a crucial partner in the discovery of the new generation of therapeutics.

Bioanalytical Testing Services Market Segment Analysis:

Bioanalytical Testing Services Market is Segmented on the basis of Type, Application, and Region

By Type, small molecules segment is expected to dominate the market during the forecast period

• Small molecules segment is expected to be largest and fastest growing due to high utilization in various therapeutic areas followed with the highest share at 65.1%. These are also preferred because they have well defined targeting ability and structure thus; enabling systematic preclinical study and quantification during drug development phase. It is common knowledge that these pharmaceutical Pipeline Models value small molecules more than Biologics because they are easier to synthesize, more stable and cheaper to produce than Biologics. Unsurprisingly, the expanse of small molecules in modulating molecular targets is often appreciated because of the elements of precision and personalization, which are currently fashionable. The uptake of rigorous regulatory guidelines also encourages the need for sophisticated small molecule analysis to offer specialized bioanalytical testing service.

By Application, pharmacokinetics segment expected to held the largest share

• pharmacokinetics segment is expected to dominate the bioanalytical testing services market, holding 45.20% of the whole market The analysis of the absorption, distribution, metabolism, and excretion of a drug candidate is significant in determining whether it can undergo further steps in drug development and eventual use. Pharmacokinetic studies also looking for important values such as bioavailability, half-life, therapeutic drug concentrations, and also reveal possibility for interaction if two drugs is coadministered early in the development of the drugs. The pharmacokinetic properties become more difficult to assess as pharmaceutical R&D of new molecular entities turns its attention to novel approaches and various formulations. Moreover, the rules and requirements to provide biosimilarity and therapeutic equivalency in today’s regulatory environment also require detailed pharmacokinetics assessment by employing the complicated analytical instruments and specific technical skills. This results in the escalation of outsourcing of pharmacokinetic bioanalytical requirements to well-equipped contract research organizations.

Bioanalytical Testing Services Market Regional Insights:

North America is Expected to Dominate the Market Over the Forecast period

• North America has accounted for 39.2% of bio analytical testing services market for long time due to highest number of pharma and biotechnology industries. The use of animals is more pronounced in developed countries such as U.S and Canada owing to the highly developed R&D skills in drug development. Clinical research organizations (CROs) and contract research laboratories have seen a large part of them originating from North America to provide services to local testing pharmaceutical companies. Higher health care costs and increased regulatory requirements committed by authority like USFDA has further encouraged outsourcing of bioanalytical testing in the area. Some large scale pharma organization prefer to deal with experienced testing service provider due to various reason as communication, project supervision & quality assurance.

Active Key Players in the Bioanalytical Testing Services Market:

• Bioanalytical Systems, Inc. (BASi) (United States)
• Celerion (United States)
• Charles River Laboratories (United State)
• Covance (a Labcorp company) (United States)
• Eurofins Scientific (Luxembourg)
• Intertek Group (United Kingdom)
• Labcorp Drug Development (Labcorp)( United States)
• Medpace (United States)
• PRA Health Sciences (acquired by ICON plc) (United States)
• Quotient Sciences (United States)
• Syneos Health (United States)
• WuXi AppTec (United States)
• Other Active Players

Chapter 1: Introduction
 1.1 Scope and Coverage

Chapter 2:Executive Summary

Chapter 3: Market Landscape
 3.1 Market Dynamics
  3.1.1 Drivers
  3.1.2 Restraints
  3.1.3 Opportunities
  3.1.4 Challenges
 3.2 Market Trend Analysis
 3.3 PESTLE Analysis
 3.4 Porter's Five Forces Analysis
 3.5 Industry Value Chain Analysis
 3.6 Ecosystem
 3.7 Regulatory Landscape
 3.8 Price Trend Analysis
 3.9 Patent Analysis
 3.10 Technology Evolution
 3.11 Investment Pockets
 3.12 Import-Export Analysis

Chapter 4: Bioanalytical Testing services Market by Type
 4.1 Bioanalytical Testing services Market Snapshot and Growth Engine
 4.2 Bioanalytical Testing services Market Overview
 4.3 Small Molecules
  4.3.1 Introduction and Market Overview
  4.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  4.3.3 Key Market Trends, Growth Factors and Opportunities
  4.3.4 Small Molecules: Geographic Segmentation Analysis
 4.4 Large Molecules
  4.4.1 Introduction and Market Overview
  4.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  4.4.3 Key Market Trends, Growth Factors and Opportunities
  4.4.4 Large Molecules: Geographic Segmentation Analysis

Chapter 5: Bioanalytical Testing services Market by Application
 5.1 Bioanalytical Testing services Market Snapshot and Growth Engine
 5.2 Bioanalytical Testing services Market Overview
 5.3 Bioavailability and Bioequivalence Studies
  5.3.1 Introduction and Market Overview
  5.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  5.3.3 Key Market Trends, Growth Factors and Opportunities
  5.3.4 Bioavailability and Bioequivalence Studies: Geographic Segmentation Analysis
 5.4 Pharmacokinetics
  5.4.1 Introduction and Market Overview
  5.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  5.4.3 Key Market Trends, Growth Factors and Opportunities
  5.4.4 Pharmacokinetics: Geographic Segmentation Analysis

Chapter 6: Bioanalytical Testing services Market by End User
 6.1 Bioanalytical Testing services Market Snapshot and Growth Engine
 6.2 Bioanalytical Testing services Market Overview
 6.3 North America
  6.3.1 Introduction and Market Overview
  6.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.3.3 Key Market Trends, Growth Factors and Opportunities
  6.3.4 North America: Geographic Segmentation Analysis
 6.4 Europe
  6.4.1 Introduction and Market Overview
  6.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.4.3 Key Market Trends, Growth Factors and Opportunities
  6.4.4 Europe: Geographic Segmentation Analysis
 6.5 Asia Pacific
  6.5.1 Introduction and Market Overview
  6.5.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.5.3 Key Market Trends, Growth Factors and Opportunities
  6.5.4 Asia Pacific: Geographic Segmentation Analysis
 6.6 Latin America
  6.6.1 Introduction and Market Overview
  6.6.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.6.3 Key Market Trends, Growth Factors and Opportunities
  6.6.4 Latin America: Geographic Segmentation Analysis
 6.7 Middle East
  6.7.1 Introduction and Market Overview
  6.7.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.7.3 Key Market Trends, Growth Factors and Opportunities
  6.7.4 Middle East: Geographic Segmentation Analysis
 6.8 Africa
  6.8.1 Introduction and Market Overview
  6.8.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.8.3 Key Market Trends, Growth Factors and Opportunities
  6.8.4 Africa: Geographic Segmentation Analysis

Chapter 7: Company Profiles and Competitive Analysis
 7.1 Competitive Landscape
  7.1.1 Competitive Benchmarking
  7.1.2 Bioanalytical Testing services Market Share by Manufacturer (2023)
  7.1.3 Industry BCG Matrix
  7.1.4 Heat Map Analysis
  7.1.5 Mergers and Acquisitions  
 7.2 BIOANALYTICAL SYSTEMS INC. (BASI) (UNITED STATES)
  7.2.1 Company Overview
  7.2.2 Key Executives
  7.2.3 Company Snapshot
  7.2.4 Role of the Company in the Market
  7.2.5 Sustainability and Social Responsibility
  7.2.6 Operating Business Segments
  7.2.7 Product Portfolio
  7.2.8 Business Performance
  7.2.9 Key Strategic Moves and Recent Developments
  7.2.10 SWOT Analysis
 7.3 CELERION (UNITED STATES)
 7.4 CHARLES RIVER LABORATORIES (UNITED STATES)
 7.5 COVANCE (A LABCORP COMPANY) (UNITED STATES)
 7.6 EUROFINS SCIENTIFIC (LUXEMBOURG)
 7.7 INTERTEK GROUP (UNITED KINGDOM)
 7.8 LABCORP DRUG DEVELOPMENT (LABCORP) (UNITED STATES)
 7.9 MEDPACE (UNITED STATES)
 7.10 PRA HEALTH SCIENCES (ACQUIRED BY ICON PLC) (UNITED STATES)
 7.11 QUOTIENT SCIENCES (UNITED STATES)
 7.12 SYNEOS HEALTH (UNITED STATES)
 7.13 WUXI APPTEC (UNITED STATES)
 7.14 OTHER ACTIVE PLAYERS

Chapter 8: Global Bioanalytical Testing services Market By Region
 8.1 Overview
 8.2. North America Bioanalytical Testing services Market
  8.2.1 Key Market Trends, Growth Factors and Opportunities
  8.2.2 Top Key Companies
  8.2.3 Historic and Forecasted Market Size by Segments
  8.2.4 Historic and Forecasted Market Size By Type
  8.2.4.1 Small Molecules
  8.2.4.2 Large Molecules
  8.2.5 Historic and Forecasted Market Size By Application
  8.2.5.1 Bioavailability and Bioequivalence Studies
  8.2.5.2 Pharmacokinetics
  8.2.6 Historic and Forecasted Market Size By End User
  8.2.6.1 North America
  8.2.6.2 Europe
  8.2.6.3 Asia Pacific
  8.2.6.4 Latin America
  8.2.6.5 Middle East
  8.2.6.6 Africa
  8.2.7 Historic and Forecast Market Size by Country
  8.2.7.1 US
  8.2.7.2 Canada
  8.2.7.3 Mexico
 8.3. Eastern Europe Bioanalytical Testing services Market
  8.3.1 Key Market Trends, Growth Factors and Opportunities
  8.3.2 Top Key Companies
  8.3.3 Historic and Forecasted Market Size by Segments
  8.3.4 Historic and Forecasted Market Size By Type
  8.3.4.1 Small Molecules
  8.3.4.2 Large Molecules
  8.3.5 Historic and Forecasted Market Size By Application
  8.3.5.1 Bioavailability and Bioequivalence Studies
  8.3.5.2 Pharmacokinetics
  8.3.6 Historic and Forecasted Market Size By End User
  8.3.6.1 North America
  8.3.6.2 Europe
  8.3.6.3 Asia Pacific
  8.3.6.4 Latin America
  8.3.6.5 Middle East
  8.3.6.6 Africa
  8.3.7 Historic and Forecast Market Size by Country
  8.3.7.1 Russia
  8.3.7.2 Bulgaria
  8.3.7.3 The Czech Republic
  8.3.7.4 Hungary
  8.3.7.5 Poland
  8.3.7.6 Romania
  8.3.7.7 Rest of Eastern Europe
 8.4. Western Europe Bioanalytical Testing services Market
  8.4.1 Key Market Trends, Growth Factors and Opportunities
  8.4.2 Top Key Companies
  8.4.3 Historic and Forecasted Market Size by Segments
  8.4.4 Historic and Forecasted Market Size By Type
  8.4.4.1 Small Molecules
  8.4.4.2 Large Molecules
  8.4.5 Historic and Forecasted Market Size By Application
  8.4.5.1 Bioavailability and Bioequivalence Studies
  8.4.5.2 Pharmacokinetics
  8.4.6 Historic and Forecasted Market Size By End User
  8.4.6.1 North America
  8.4.6.2 Europe
  8.4.6.3 Asia Pacific
  8.4.6.4 Latin America
  8.4.6.5 Middle East
  8.4.6.6 Africa
  8.4.7 Historic and Forecast Market Size by Country
  8.4.7.1 Germany
  8.4.7.2 UK
  8.4.7.3 France
  8.4.7.4 The Netherlands
  8.4.7.5 Italy
  8.4.7.6 Spain
  8.4.7.7 Rest of Western Europe
 8.5. Asia Pacific Bioanalytical Testing services Market
  8.5.1 Key Market Trends, Growth Factors and Opportunities
  8.5.2 Top Key Companies
  8.5.3 Historic and Forecasted Market Size by Segments
  8.5.4 Historic and Forecasted Market Size By Type
  8.5.4.1 Small Molecules
  8.5.4.2 Large Molecules
  8.5.5 Historic and Forecasted Market Size By Application
  8.5.5.1 Bioavailability and Bioequivalence Studies
  8.5.5.2 Pharmacokinetics
  8.5.6 Historic and Forecasted Market Size By End User
  8.5.6.1 North America
  8.5.6.2 Europe
  8.5.6.3 Asia Pacific
  8.5.6.4 Latin America
  8.5.6.5 Middle East
  8.5.6.6 Africa
  8.5.7 Historic and Forecast Market Size by Country
  8.5.7.1 China
  8.5.7.2 India
  8.5.7.3 Japan
  8.5.7.4 South Korea
  8.5.7.5 Malaysia
  8.5.7.6 Thailand
  8.5.7.7 Vietnam
  8.5.7.8 The Philippines
  8.5.7.9 Australia
  8.5.7.10 New Zealand
  8.5.7.11 Rest of APAC
 8.6. Middle East & Africa Bioanalytical Testing services Market
  8.6.1 Key Market Trends, Growth Factors and Opportunities
  8.6.2 Top Key Companies
  8.6.3 Historic and Forecasted Market Size by Segments
  8.6.4 Historic and Forecasted Market Size By Type
  8.6.4.1 Small Molecules
  8.6.4.2 Large Molecules
  8.6.5 Historic and Forecasted Market Size By Application
  8.6.5.1 Bioavailability and Bioequivalence Studies
  8.6.5.2 Pharmacokinetics
  8.6.6 Historic and Forecasted Market Size By End User
  8.6.6.1 North America
  8.6.6.2 Europe
  8.6.6.3 Asia Pacific
  8.6.6.4 Latin America
  8.6.6.5 Middle East
  8.6.6.6 Africa
  8.6.7 Historic and Forecast Market Size by Country
  8.6.7.1 Turkiye
  8.6.7.2 Bahrain
  8.6.7.3 Kuwait
  8.6.7.4 Saudi Arabia
  8.6.7.5 Qatar
  8.6.7.6 UAE
  8.6.7.7 Israel
  8.6.7.8 South Africa
 8.7. South America Bioanalytical Testing services Market
  8.7.1 Key Market Trends, Growth Factors and Opportunities
  8.7.2 Top Key Companies
  8.7.3 Historic and Forecasted Market Size by Segments
  8.7.4 Historic and Forecasted Market Size By Type
  8.7.4.1 Small Molecules
  8.7.4.2 Large Molecules
  8.7.5 Historic and Forecasted Market Size By Application
  8.7.5.1 Bioavailability and Bioequivalence Studies
  8.7.5.2 Pharmacokinetics
  8.7.6 Historic and Forecasted Market Size By End User
  8.7.6.1 North America
  8.7.6.2 Europe
  8.7.6.3 Asia Pacific
  8.7.6.4 Latin America
  8.7.6.5 Middle East
  8.7.6.6 Africa
  8.7.7 Historic and Forecast Market Size by Country
  8.7.7.1 Brazil
  8.7.7.2 Argentina
  8.7.7.3 Rest of SA

Chapter 9 Analyst Viewpoint and Conclusion
9.1 Recommendations and Concluding Analysis
9.2 Potential Market Strategies

Chapter 10 Research Methodology
10.1 Research Process
10.2 Primary Research
10.3 Secondary Research