Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Molecule (Small, Large), By Test (Bioavailability, Bioequivalance), By Workflow (Sample Analysis, Sample Preparation), And Segment Forecasts, 2023 - 2030

Report Overview

The global bioanalytical testing services market size was estimated at USD 3,937.2 million in 2022 and is anticipated to register a compound annual growth rate (CAGR) of 8.7% from 2023 to 2030. The bioanalytical testing method is used for the quantitative determination of drugs or metabolites in biological matrices, such as serum, blood, plasma, tissue, urine, and skin samples. The applications of such methods are bioavailability, pharmacology, bioequivalence, pharmacokinetic, and toxicology studies conducted in humans and animals. Also, with the outbreak of the COVID-19 pandemic, the market has witnessed high demand in the year 2020.

Moreover, the increasing frequency of outsourcing R&D activities by the major pharmaceutical companies to focus on their core competencies is the vital impact rendering driver for this market. Furthermore, the economic efficiency offered by outsourcing rather than conducting an in-house study is expected to boost the demand over the forecast period. Innovation and new product development are expected to further boost the demand for these services. Competitive pressure and pricing concerns are driving companies to outsource such services. This, in turn, is expected to augment the overall market growth.

In addition, a growing focus on the development of advanced bioanalytical technologies for enhanced testing is expected to contribute to market growth. The development of biosimilars, combination products, and other innovative medicines has increased the demand for specific testing procedures. The coronavirus pandemic has resulted in disruptions in the supply chain of the overall pharmaceutical industry. However, the market for bioanalytical testing services responded well to the outbreak. The pandemic resulted in the expansion of R&D and manufacturing operations of key stakeholders leading to a surge in demand for these services.

Furthermore, several biopharmaceutical companies are using bioanalytical testing outsourcing services for drug development and validation of assays at both clinical and preclinical stages, thus supporting the growth of the market. The global transmission of coronavirus disease and the lack of effective treatments and vaccines are driving the need for early detection and widespread screening. This has also increased the usage of bioanalytical testing services for point-of-care diagnostic and minimizing the societal impact of the infection.

For instance, in January 2021, Eurofin’s bioanalytical services division announced the launch of a surrogate virus neutralization antibody assay against the COVID-19 virus. This assay is the first neutralizing antibody serology test authorized by the FDA as Emergency Use Authorization (EUA) for SARS-CoV-2-virus. Hence, such novel initiatives have led to the significant growth of the market during the year 2020. The market is further anticipated to witness lucrative growth over the forecast period owing to a significant surge in demand for such services post-pandemic.

Molecule Insights

On the basis of molecules, the global market has been segmented into small and large molecules. The small molecule segment accounted for the largest revenue share of 55.9% in 2022. Contract Research Organizations (CROs) provide various testing services for small molecules. For instance, Pacific BioLabs offers testing services, such as High-Performance Liquid Chromatography (HPLC) with different detectors, Mass Spectrometry LC-MS, LC-MS/MS, and TOFMS, Ultraviolet-Visible Spectroscopy (UV-Vis). These tests can help sponsors in developing and lot-release testing of small molecule products.

Moreover, generic and branded drug compounds are mostly small molecules. In addition, generic manufacturers have to conduct and submit bioanalytical testing results due to increasing patent expiration. This, in, turn, drives the adoption of bioanalytical testing for small molecules. On the other hand, the large molecule segment is expected to register CAGR of 9.2% over the analysis period. This is due to a rich pipeline of amino acid-based molecules or biologics. In addition, testing these molecules requires advanced analytical instruments, and infrastructure, which is available with bioanalytical services providers. Hence, outsourcing bioanalytical testing of these molecules is likely to be the prevailing trend over the forecast duration.

Pharmacokinetics (PK) is the branch of pharmacology related to the fate of a drug after administration. The majority of the outsourcing CROs are adopting novel methods for the quantification of PK parameters. For instance, SGS offers the Dry Blood Spot (DBS) technology, which provides plenty of advantages over traditional methods. The absence of post-collection processing, minimal sample requirements, convenient sample storage & shipment, and low biohazard risks are the benefits of the DBS method.Hence, the introduction and adoption of advanced technology pertaining to pharmacokinetics studies are anticipated to boost the segment growth.

Workflow Insights

In terms of workflow, the sample analysis segment dominated the market and accounted for the largest revenue share of more than 45.8% in 2022. Sample analysis plays an important role in the drug development and marketing stages. This workflow helps in the quantitation of impurities, assessing the stability of drug molecules, and identification of impurities present in the sample. Hence, the growing rate of drug development is one of the crucial factors boosting the demand for sample analysis, thus augmenting the segment’s share. Sample Preparation segment is expected to register CAGR of 8.9% over the forecast period. Sample preparation is an analytical step that contains extraction procedures to help extract the component required from the matrix.

The process varies based on the degree of selectivity, convenience, speed, and configurations of the extraction phase. Nontraditional extraction technologies are being introduced to address the growing demand for automation, reduction of solvent use, and miniaturization. These technologies result in on-site in situ and in vivo implementation. Proper sample preparation helps in minimizing the matrix risks, assay variability, and thus, provides cleaner samples. Therefore, the integrity of the samples must be aligned from the time of collection to the moment of analysis to avoid challenges and to enhance the bioanalysis.

Test Insights

On the basis of tests, the global market has been segmented into Absorption Distribution Metabolism Excretion (ADME), Pharmacokinetics (PK), Pharmacodynamics (PD), bioavailability, bioequivalence, and other test types. The bioavailability segment accounted for the highest share of more than 18.7% of the global revenue in 2022 owing to the high demand for such services in generic drug development. Furthermore, the growing consumer concern about self-care is boosting the consumption of pharmaceutical products. Bioequivalance segment is expected to register CAGR of 9.1% over the forecast period.

Therefore, to tackle the rising demand for pharmaceutical products, end users are promoting in-house tests and expanding testing capabilities in various locations. For instance, in December 2018, SGS, a biopharmaceutical analytical and bioanalytical contract solutions provider, invested USD 3.95 million for expanding its bioanalytical testing capabilities in Poitiers, France, through two projects. Therefore, the growing accessibility to bioanalytical testing through various end users is expected to drive the segment’s growth.

Regional Insights

On the basis of geographies, the market has been segmented into North America, Asia Pacific, Latin America, Europe, and Middle East & Africa. North America dominated the global market in 2022 and accounted for the largest revenue share of more than 46.2%. The regional market is estimated to expand further at a steady CAGR retaining the dominant position throughout the forecast period. This growth can be attributed to an increase in the number of pharmaceutical industries in countries, such as the U.S. and Canada. The strong presence of a number of major market players is another key factor expected to contribute to the growth of the regional market.

Europe is estimated to register the second-fastest CAGR from 2023 to 2030 while Asia Pacific is estimated to be the fastest-growing regional market and is expected to register CAGR of 9.1% over the forecast period. This growth is mainly credited to the rising demand for outsourcing services in comparatively immature markets. Outsourcing services in this region are typically supported by delivery centers in countries like China, Manila, and India. China, in particular, is gaining popularity as a delivery location for onshore and nearshore clients that are based out of Japan.

Key Companies & Market Share Insights

Collaborations, service portfolio expansion and mergers and acquisitions are key strategic undertakings by market players. The key companies are also expanding their position in the market by providing various types of services, assay validations, launching new methods for method development, and other laboratory solutions. Moreover, due to the COVID-19 pandemic, several companies are expanding their capability and capacity to provide testing services for new viral threats using advanced and rapid testing platforms. These expansions are estimated to have a positive impact on the market. In addition, in October 2021, SGS announced the expansion of its Glasgow biosafety testing facility.

The investment and expansion project began in March 2021 and was completed in September, adding 550m2 and 16 BSL-2 laboratories to their facility. In June 2021, Eurofins Scientific announced that its subsidiary Eurofins Clinical Testing U.S. Holdings, Inc. has entered into an agreement to acquire DNA Diagnostics Center (“DDC”), a leader in consumer genetic testing. In September 2017, Eurofins Scientific signed an agreement to acquire EAG Laboratories, a leading global scientific services company providing analytical testing and consulting solutions to a diverse and demanding set of end markets, from Odyssey Investment Partners. Some of the key players in the global bioanalytical testing services market are:

• PPD, Inc.

• ICON Plc

• Charles River Laboratories International

• Covance, Inc.

• IQVIA

• Syneos Health

• SGS SA

• Toxikon

• Intertek Group Plc

• Pace Analytical Services LLC

Recent Developments

• In June 2023, ICON plc, one of the world leaders in CRO and healthcare intelligence, announced the release of its new ICON Digital Platform. The platform facilitates seamless integration of ICON site, patient, site, and sponsor services along with harmonized and customizable data delivery. 

• In June 2023, Forge Biologics one of the leading manufacturers of genetic medicines, announced its collaboration with Labcorp. This strategic collaboration is focused on manufacturing and gene therapy development. 

• In June 2023, Syneos Health, one of the leading companies in biopharmaceutical solutions, announced a patient-centric partnership with uMotif, a clinical trial solutions organization. The collaboration is aimed at aiding the acceleration of clinical trials and introducing new therapies to patients via an end-to-end and more effective digital platform. This platform comprises robust Electronic Patient-reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) capabilities 

• In May 2023, Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), along with Charles River Laboratories International, Inc. announced an agreement for the implementation of RightSourceSM at Wheeler Bio’s current good manufacturing practice (CGMP) manufacturing facility of biologics in Oklahoma City. RightSource is a flexible, on-site biologics testing lab that is managed and operated by Charles River. It helps in making reliable and fast quality control more accessible to a wider range of companies.

• In May 2023, IQVIA a significant provider of advanced analytics, clinical research services, and technology solutions in the world, announced a strategic partnership RED, to battle against AIDS and the injustices that permit pandemics to thrive. This partnership supports laboratory system strengthening 

• In April 2023, Pace Analytical Services announced the acquisition of Alpha Analytical and expanded its laboratory services in the Northeast U.S. with over 39 Locations.

• In October 2022, Thermo Fisher Scientific Inc.’s clinical research division, PPD, announced its plans to invest over USD59 million to prominently expand the company’s laboratory operations in Kentucky. This investment is aimed at assisting customers deliver life-transforming medicines to patients. A major part of this expansion involves adding to the testing capacity and sample management of the business to support new therapeutics

• In September 2021, SGS announced the completion of the expansion of the company’s bioanalytical testing laboratory in France (Poitiers). This expansion is aimed at meeting the proliferating demand for bioanalytical testing services and support drug development of peptides, small molecules, biotherapeutics, and gene & cell therapies.

• In October 2021, SGS announced the expansion of its Glasgow biosafety testing facility. The investment and expansion project began in March 2021 and was completed in September, adding 550m2 and 16 BSL-2 laboratories to their facility.

• In June 2021, Eurofins Scientific announced that its subsidiary Eurofins Clinical Testing U.S. Holdings, Inc. has entered into an agreement to acquire DNA Diagnostics Center (“DDC”), a leader in consumer genetic testing.

Bioanalytical Testing Services Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global bioanalytical testing services market report on the basis of molecule, test, workflow, therapeutic area, end-user, region:

• Molecule Outlook (Revenue, USD Million, 2018 - 2030)

  • Small Molecule

  • Large Molecule

    • LC-MS Studies

    • Immunoassays

      • PK

      • ADA

      • Others

    • Others

• Test Outlook (Revenue, USD Million, 2018 - 2030)

  • ADME

    • In-Vivo

    • In-Vitro

  • PK

  • PD

  • Bioavailability

  • Bioequivalence

  • Others

• Workflow Outlook (Revenue, USD Million, 2018 - 2030)

  • 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 Work flow Processes

• Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Neurology

  • Metabolic Disorders

  • Hematology

  • Immunology

  • Orthopedics

  • Others

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical and Biotechnology Companies

  • Contract Development and Manufacturing Organization

  • Contract Research Organization

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

    • The Netherlands

    • Switzerland

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Indonesia

    • Malaysia

    • Singapore

    • South Korea

    • Thailand

    • Taiwan

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel