The global bioanalytical testing services market size was estimated to be USD 4.27 billion in 2023 and is expected to reach at USD 10.73 billion by 2034 with a CAGR of 8.74% during the forecast period 2024-2034. Growing trend among major pharmaceutical companies to outsource their R&D activities, enabling them to concentrate on their core strengths, rising innovation and the development of new products, increasing emphasis on advancing bioanalytical technologies to improve testing capabilities, surge in the adoption of bioanalytical testing outsourcing services for drug development & the validation of assays, both at clinical & preclinical stages, by numerous biopharmaceutical companies, growing need for early detection & widespread screening, heightened utilization of bioanalytical testing services for point-of-care diagnostics, and rising introduction of advanced bioanalytical testing platforms are some of the key factors boosting the market growth.
Rising introduction of advanced bioanalytical testing platforms is predicted to boost the market growth during the forecast period. Bioanalytical testing methods are employed for the precise measurement of drugs or their metabolites in biological samples such as serum, blood, plasma, tissue, urine, and skin samples. These methods find applications in various areas, including bioavailability, pharmacology, bioequivalence, pharmacokinetics, and toxicology studies conducted in both human and animal subjects. Hence, market players are launching advanced platforms. For instance, in June 2023, ICON plc, a global leader in Contract Research Organizations (CRO) and healthcare intelligence, has unveiled its latest offering, the ICON Digital Platform. This platform enables the smooth integration of ICON's patient, site, and sponsor services while offering harmonized and customizable data delivery.
By molecule, small molecule was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to its crucial role in the development of generic versions of branded drugs. Bioanalytical testing plays a substantial role in demonstrating the ability to replicate generic drug release profiles, similar to those of branded drugs, contributing to the segment's growth. For instance, in August 2022, BioDuro Sundia has introduced DNA Encoded Compound Library (DEL) technology services in China, aiming to assist innovative pharmaceutical companies in the rapid discovery of small molecule drugs. Additionally, large molecule is predicted to grow at fastest CAGR during the forecast period owing to many of the outsourcing Contract Research Organizations (CROs) are embracing innovative approaches for quantifying pharmacokinetic (PK) parameters, and increasing introduction & adoption of advanced technology.
By workflow, sample analysis was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the rising adoption in drug development as it aids in identifying impurities, quantifying them, & assessing the stability of drug molecules and growing collaborations within market players. For instance, in June 2023, Syneos Health, a prominent player in biopharmaceutical solutions, has unveiled a patient-centered partnership with uMotif, a clinical trial solutions provider. This collaboration is designed to expedite clinical trials and introduce new therapies to patients through a comprehensive and efficient digital platform. This platform includes strong Electronic Patient-reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) capabilities. Additionally, sample preparation is predicted to grow at fastest CAGR during the forecast period. Sample preparation is a crucial analytical step involving extraction procedures to isolate the necessary components from the matrix. The process varies depending on factors like selectivity, convenience, speed, and extraction phase configurations. To meet the increasing need for automation, solvent reduction, and miniaturization, nontraditional extraction technologies are being introduced, enabling on-site, in situ, and in vivo applications. Effective sample preparation is essential for reducing matrix-related risks, assay variability, and ensuring cleaner samples. Consequently, maintaining sample integrity from collection to analysis is vital to overcome challenges and improve bioanalysis.
By test, bioavailability was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the rising demand for these services in the field of generic drug development, increasing consumer focus on self-care is driving the consumption of pharmaceutical products, and surge in investment by major market players. For instance, in October 2022, Thermo Fisher Scientific Inc.'s clinical research division, PPD, has disclosed its intention to invest more than USD 59 million in a significant expansion of its laboratory operations in Kentucky. This investment is geared towards aiding customers in delivering life-changing medications to patients. A substantial portion of this expansion involves increasing the testing capabilities and sample management services to support the development of new therapeutics. Additionally, bioequivalence is predicted to grow at fastest CAGR during the forecast period owing to the increasing availability of bioanalytical testing services to a wide range of end users. To address the increasing demand for pharmaceutical products, end-users are endorsing in-house testing and broadening testing capacities across different sites.
By therapeutic area, cancer was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the rising cancer cases, growing number of clinical trials conducted for cancer, increasing demand for personalized medicine, and surge in collaboration among market players. For instance, in June 2023, Forge Biologics, a prominent manufacturer of genetic medicines, has revealed its partnership with Labcorp. This strategic collaboration is centered around gene therapy development and manufacturing. Additionally, cardiology is predicted to grow at fastest CAGR during the forecast period owing to the growing prevalence of cardiovascular illness and increasing focus on the development of novel therapies.
By end-user, pharmaceutical and biotechnology companies was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the growing emphasis on creating new drugs for various diseases has led to an increased outsourcing of early-phase development, clinical, & laboratory testing services by pharmaceutical companies and rising partnerships between key market players. For instance, in May 2023, Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), has partnered with Charles River Laboratories International, Inc. to implement RightSource at Wheeler Bio's current good manufacturing practice (CGMP) biologics manufacturing facility in Oklahoma City. RightSource is a flexible, on-site biologics testing lab managed and operated by Charles River, offering more accessible and expedited quality control services to a broader spectrum of companies. Additionally, contract research organizations is predicted to grow at fastest CAGR during the forecast period owing to the surge in research & development activities and growing investment by major market players.
North America region is anticipated for the highest revenue share during the forecast period owing to the strong presence of a number of major market players, growing demand for personalised medicine, surge in number of clinical trials, rising drug approvals, and increasing acquisitions within market players. For instance, in March 2023, Pace Analytical Services has confirmed its acquisition of Alpha Analytical, thereby broadening its laboratory services presence in the Northeastern United States with a network of more than 39 locations. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the rising demand for outsourcing services in relatively underdeveloped markets, increasing focus on analytical testing of biologics & biosimilars by market players, and growing regulatory approvals. For instance, in July 2022, Pace Analytical Services, a division of Pace and a leading provider of in-lab, mobile, and emergency onsite specialty-contaminant and regulatory testing and analysis services, in collaboration with partner Shimadzu Scientific Instruments, Inc., has revealed that the Environmental Protection Agency (EPA) has granted approval for Pace Analytical Method PAM-16130-SSI. This method is designed for the detection of Dioxins and Dibenzofurans using state-of-the-art Gas Chromatography Mass Spectrometry (GC-MS/MS).
PK
Others
Rising introduction of advanced bioanalytical testing platforms is predicted to boost the market growth during the forecast period. Bioanalytical testing methods are employed for the precise measurement of drugs or their metabolites in biological samples such as serum, blood, plasma, tissue, urine, and skin samples. These methods find applications in various areas, including bioavailability, pharmacology, bioequivalence, pharmacokinetics, and toxicology studies conducted in both human and animal subjects. Hence, market players are launching advanced platforms. For instance, in June 2023, ICON plc, a global leader in Contract Research Organizations (CRO) and healthcare intelligence, has unveiled its latest offering, the ICON Digital Platform. This platform enables the smooth integration of ICON's patient, site, and sponsor services while offering harmonized and customizable data delivery.
By molecule, small molecule was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to its crucial role in the development of generic versions of branded drugs. Bioanalytical testing plays a substantial role in demonstrating the ability to replicate generic drug release profiles, similar to those of branded drugs, contributing to the segment's growth. For instance, in August 2022, BioDuro Sundia has introduced DNA Encoded Compound Library (DEL) technology services in China, aiming to assist innovative pharmaceutical companies in the rapid discovery of small molecule drugs. Additionally, large molecule is predicted to grow at fastest CAGR during the forecast period owing to many of the outsourcing Contract Research Organizations (CROs) are embracing innovative approaches for quantifying pharmacokinetic (PK) parameters, and increasing introduction & adoption of advanced technology.
By workflow, sample analysis was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the rising adoption in drug development as it aids in identifying impurities, quantifying them, & assessing the stability of drug molecules and growing collaborations within market players. For instance, in June 2023, Syneos Health, a prominent player in biopharmaceutical solutions, has unveiled a patient-centered partnership with uMotif, a clinical trial solutions provider. This collaboration is designed to expedite clinical trials and introduce new therapies to patients through a comprehensive and efficient digital platform. This platform includes strong Electronic Patient-reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) capabilities. Additionally, sample preparation is predicted to grow at fastest CAGR during the forecast period. Sample preparation is a crucial analytical step involving extraction procedures to isolate the necessary components from the matrix. The process varies depending on factors like selectivity, convenience, speed, and extraction phase configurations. To meet the increasing need for automation, solvent reduction, and miniaturization, nontraditional extraction technologies are being introduced, enabling on-site, in situ, and in vivo applications. Effective sample preparation is essential for reducing matrix-related risks, assay variability, and ensuring cleaner samples. Consequently, maintaining sample integrity from collection to analysis is vital to overcome challenges and improve bioanalysis.
By test, bioavailability was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the rising demand for these services in the field of generic drug development, increasing consumer focus on self-care is driving the consumption of pharmaceutical products, and surge in investment by major market players. For instance, in October 2022, Thermo Fisher Scientific Inc.'s clinical research division, PPD, has disclosed its intention to invest more than USD 59 million in a significant expansion of its laboratory operations in Kentucky. This investment is geared towards aiding customers in delivering life-changing medications to patients. A substantial portion of this expansion involves increasing the testing capabilities and sample management services to support the development of new therapeutics. Additionally, bioequivalence is predicted to grow at fastest CAGR during the forecast period owing to the increasing availability of bioanalytical testing services to a wide range of end users. To address the increasing demand for pharmaceutical products, end-users are endorsing in-house testing and broadening testing capacities across different sites.
By therapeutic area, cancer was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the rising cancer cases, growing number of clinical trials conducted for cancer, increasing demand for personalized medicine, and surge in collaboration among market players. For instance, in June 2023, Forge Biologics, a prominent manufacturer of genetic medicines, has revealed its partnership with Labcorp. This strategic collaboration is centered around gene therapy development and manufacturing. Additionally, cardiology is predicted to grow at fastest CAGR during the forecast period owing to the growing prevalence of cardiovascular illness and increasing focus on the development of novel therapies.
By end-user, pharmaceutical and biotechnology companies was the highest revenue-grossing segment in the global bioanalytical testing services market in 2023 owing to the growing emphasis on creating new drugs for various diseases has led to an increased outsourcing of early-phase development, clinical, & laboratory testing services by pharmaceutical companies and rising partnerships between key market players. For instance, in May 2023, Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), has partnered with Charles River Laboratories International, Inc. to implement RightSource at Wheeler Bio's current good manufacturing practice (CGMP) biologics manufacturing facility in Oklahoma City. RightSource is a flexible, on-site biologics testing lab managed and operated by Charles River, offering more accessible and expedited quality control services to a broader spectrum of companies. Additionally, contract research organizations is predicted to grow at fastest CAGR during the forecast period owing to the surge in research & development activities and growing investment by major market players.
North America region is anticipated for the highest revenue share during the forecast period owing to the strong presence of a number of major market players, growing demand for personalised medicine, surge in number of clinical trials, rising drug approvals, and increasing acquisitions within market players. For instance, in March 2023, Pace Analytical Services has confirmed its acquisition of Alpha Analytical, thereby broadening its laboratory services presence in the Northeastern United States with a network of more than 39 locations. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the rising demand for outsourcing services in relatively underdeveloped markets, increasing focus on analytical testing of biologics & biosimilars by market players, and growing regulatory approvals. For instance, in July 2022, Pace Analytical Services, a division of Pace and a leading provider of in-lab, mobile, and emergency onsite specialty-contaminant and regulatory testing and analysis services, in collaboration with partner Shimadzu Scientific Instruments, Inc., has revealed that the Environmental Protection Agency (EPA) has granted approval for Pace Analytical Method PAM-16130-SSI. This method is designed for the detection of Dioxins and Dibenzofurans using state-of-the-art Gas Chromatography Mass Spectrometry (GC-MS/MS).
Segmentation: Bioanalytical Testing Services Market Report 2023 - 2034
Bioanalytical Testing Services Market Analysis & Forecast by Molecule 2023 - 2034 (Revenue USD Bn)
- Small Molecule
- Large Molecule
- Immunoassays
PK
Others
- LC-MS Studies
- Others
Bioanalytical Testing Services Market Analysis & Forecast by Workflow 2023 - 2034 (Revenue USD Bn)
- Sample Analysis
- Electrophoresis
- Mass Spectrometry
- Ligand Binding Assay
- Hyphenated Technique
- Chromatographic Technique
- Nuclear Magnetic Resonance
- Sample Preparation
- Protein Precipitation
- Solid Phase Extraction
- Liquid-Liquid Extraction
- Other
Bioanalytical Testing Services Market Analysis & Forecast by Test 2023 - 2034 (Revenue USD Bn)
- Absorption Distribution Metabolism Excretion (ADME)
- In-Vitro
- In-Vivo
- Pharmacodynamics (PD)
- Pharmacokinetics (PK)
- Bioequivalence
- Bioavailability
- Others
Bioanalytical Testing Services Market Analysis & Forecast by Therapeutic Area 2023 - 2034 (Revenue USD Bn)
- Cardiology
- Immunology
- Neurology
- Orthopedics
- Oncology
- Gastroenterology
- Haematology
- Others
Bioanalytical Testing Services Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Bn)
- Contract Development & Manufacturing Organization
- Pharmaceutical & Biotechnology Companies
- Contract Research Organization
- Others
Bioanalytical Testing Services Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Bioanalytical Testing Services Market: Molecule Estimates & Trend Analysis
8. Bioanalytical Testing Services Market: Workflow Estimates & Trend Analysis
9. Bioanalytical Testing Services Market: Test Estimates & Trend Analysis
10. Bioanalytical Testing Services Market: Therapeutic Area Estimates & Trend Analysis
11. Bioanalytical Testing Services Market: End-user Estimates & Trend Analysis
12. Regional Market Analysis
13. North America Bioanalytical Testing Services Market
14. Europe Global Bioanalytical Testing Services Market
15. Asia Pacific Global Bioanalytical Testing Services Market
16. Latin America Global Bioanalytical Testing Services Market
17. MEA Global Bioanalytical Testing Services Market
18. Competitor Analysis
19. Company Profiles
Companies Mentioned
- Pace Analytical Services LLC
- SGS SA
- Intertek Group Plc
- PPD Inc.
- ICON Plc
- Syneos Health
- IQVIA
- Covance Inc.
- Toxikon
- Charles River Laboratories International
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | January 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 4.27 Billion |
| Forecasted Market Value ( USD | $ 10.73 Billion |
| Compound Annual Growth Rate | 8.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
