Bioanalytical Testing Services Market Size, Share & Trends Report

Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Molecule Type (Small Molecule, Large Molecule), By Test Type (ADME, PK, PD, Bioavailability, Bioequivalence), By Workflow, By Region, And Segment Forecasts, 2021 - 2028

  • Published Date: Feb, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-1-68038-946-3
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 120

Report Overview

The global bioanalytical testing services market size was valued at USD 3.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.6% from 2021 to 2028. The increasing frequency of outsourcing R&D activities by the major pharmaceutical companies in order to focus on their core competencies is the vital impact rendering driver for this market over the forecast period. Furthermore, the economic efficiency offered for outsourcing rather than conducting an in-house study is expected to boost the demand over the forecast period.

U.S. bioanalytical testing services market size, by molecule type, 2016 - 2028 (USD Billion)

Drug manufacturers’ require to replenish their respective pipelines as the majority of the big sellers are going off-patent, thereby investing a significant amount in development. This, in turn, is driving the market for bioanalytical testing services. CROs diversified expertise as compared to pharma companies with respect to performing clinical trials in a wide array of geographies and development of drugs in specific therapeutic areas are few factors responsible for the growing demand for the CROs in the pharmaceutical segment.

Increase in complexity and number of standards, which a single Molecule may have to comply with, is driving substantial growth in the pharmaceutical analytical testing services outsourcing market. In addition, companies are required to stay abreast with regulatory updates and avail expertise and advisory services to be in synchronization with evolving standards. Moreover, international organizations such as the International Council for Harmonization (ICH) give harmonized guidelines that are regularly updated.

Development of biosimilars, combination molecules, and other innovative medicines has resulted in an increased demand for specific types of tests such as electrophoresis, electrochemical and titrimetric assays, and immunoassays. Moreover, when companies diversify their business to a new location, it is mandatory to follow local standards, which may require them to conduct specific types of tests.

The COVID-19 has led to terrific morbidity, mortality, and economic loss. The bioanalytical diagnostic technologies have played important role in the mitigation of the COVID-19 pandemic and will continue to be foundational in the prevention of the subsequent waves of this pandemic along with future infectious disease outbreaks. Bioanalytical testing helps in the early detection of COVID-19, with the help of various techniques as well as focus on the performance metrics. Owing to their applicability and high demand due to the pandemic, the bioanalytical testing outsourcing industry is expected to witness lucrative growth over the forecast period and continue activities as usual.

Molecule Type Insights

The small molecule segment dominated the market for bioanalytical testing services and accounted for the largest revenue share of 55.6% in 2020. Most of the generic and branded drug compounds are of the small molecule category. Additionally, with the patent expiration of many blockbuster drugs, generic manufacturers are required to conduct and submit bioanalytical testing results. These factors primarily governed the growth of the small molecule drug bioanalytical testing market.

On the contrary, large molecule bioanalytical testing services are anticipated to exhibit healthy growth over the forecast period. This can be attributed to a rich pipeline of biologics or amino acid-based molecules. Moreover, testing these molecules requires technical know-how with advanced analytical instruments, the infrastructure for 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.

Large molecules, also known as biologics, are based on proteins that have therapeutic effects. These large molecules are made up of several thousands of amino acids and can be heavy as 150kDa. The bioanalytical testing of large-molecule drugs is required throughout the development process (research to market). The pipeline for biologics is rich and the sale of biologics has increased exponentially over the years.

Workflow Insights

The sample analysis segment dominated the market for bioanalytical testing services and accounted for the largest revenue share of 45.9% in 2020. Sample analysis helps in determining the concentration of chemical elements or chemical compounds. Various techniques are used for sample analysis, varying from simple weighing techniques to advanced techniques by using specialized instruments. Sample analysis plays an important role in the drug development and marketing stages. This workflow helps in assessing the stability of drug molecules, quantitation of impurities, and identification of impurities present in the sample. Once the validation method has been appropriately verified, a bioanalytical analysis of the sample is performed. Sample analysis can enhance pharmacokinetic studies and an increase in their uptake is expected to impact the overall market growth.

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 provide 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 Type Insights

The Bioavailability (BA) segment dominated the market for bioanalytical testing services and held the largest revenue share of 18.6% in 2020. This can be attributed to the great demand for these services in generic drug manufacturing. The bioanalytical testing services market based on test type is segmented into Absorption Distribution Metabolism Excretion (ADME), Pharmacokinetics (PK), Pharmacodynamics (PD), bioavailability, bioequivalence, and other tests such as electrophoresis, electrochemical and titrimetric assays, and immunoassays.

Global bioanalytical testing services market share, by test type, 2020 (%)

Pharmacokinetics (PK) is the branch of pharmacology related to the fate of drug after administration. Dose, dosing interval, peak plasma concertation (Cmax), and time to reach peak plasma concentration (tmax), volume of distribution, elimination half-life, and elimination rate constant is vital and commonly measured PK parameters. Companies are using advanced methods for the determination of PK parameters.

For instance, Dry Blood Spot (DBS) technology offered by SGS has plenty of advantages over traditional methods. Minimal sample requirements, absence of post-collection processing, convenient sample shipment and storage, and low biohazard risks are the benefits of DBS method.

Regional Insights

North America dominated the market for bioanalytical testing services and accounted for the largest revenue share of 50.9% in 2020. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end pharmaceuticals. Consequently, original equipment manufacturers are increasingly moving toward electronics manufacturing service providers to efficiently handle the increasing volume of electronic components in the current pharmaceuticals.

The rapid increase in the manufacturing of pharmaceuticals to meet the rising demand for efficient healthcare in the region is expected to be one of the major factors propelling the development of the market. According to a recent study, in 2019, approximately 10% of the GDP was spent on the healthcare and medical sector. The pharmaceutical outsourcing market is anticipated to grow further due to the increasing government support to curb the healthcare expenses in the region. 

Asia Pacific is anticipated to witness the fastest growth over the forecast period owing to rising demand for outsourcing services in comparatively immature markets. Outsourcing services in this region are typically supported by delivery centers in China, Manila, and India. China is gaining popularity as a delivery location for onshore clients 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 these 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.

For example, SGS SA announced that its Center of Excellence for Biosafety laboratory offers GMP compliant vaccine testing solutions for coronavirus in February 2020. Due to this Covid-19 pandemic, the bio-safety laboratory expanded its 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. Some of the prominent players in the bioanalytical testing services market include:

  • PPD

  • ICON plc

  • Covance Inc.

  • LabCorp

  • Charles River Laboratories International, Inc.

  • inVentiv Health

  • SGS SA

  • Toxikon, Inc.

  • Intertek group

  • Pace Analytical Services, LLC

Bioanalytical Testing Services Market Report Scope

Report Attribute

Details

Market size value in 2021

USD 3.5 billion

Revenue forecast in 2028

USD 6.3 billion

Growth rate

CAGR of 8.6% from 2021 to 2028

Base year for estimation

2020

Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units                          

Revenue in USD Million and CAGR from 2021 to 2028

Report coverage

Revenue forecast, competitive landscape, growth factors and trends

Segments covered

Molecule type, test type, workflow, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; U.K.; Germany; France; Italy; Spain; China; Japan; India; Australia; South Korea; Mexico; Brazil; Argentina; South Africa; Saudi Arabia; UAE

Key companies profiled

PPD; ICON plc; Covance Inc.; LabCorp; Charles River Laboratories International, Inc.; inVentiv Health; SGS SA; Toxikon, Inc.; Intertek group; Pace Analytical Services, LLC

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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 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global bioanalytical testing services market report on the basis of molecule type, test type, and region:

  • Molecule Type Outlook (Revenue, USD Million, 2016 - 2028)

    • Small Molecule

    • Large Molecule

      • LC-MS Studies

      • Immunoassays

        • PK

        • ADA

        • Others

      • Others

  • Test Type Outlook (Revenue, USD Million, 2016 - 2028)

    • ADME

      • In-Vivo

      • In-Vitro

    • PK

    • PD

    • Bioavailability

    • Bioequivalence

    • Others

  • Workflow Outlook (Revenue, USD Million, 2016 - 2028)

    • 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 Processes

  • Regional Outlook (Revenue, USD Million, 2016 - 2028)

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • MEA

      • South Africa

      • Saudi Arabia

      • UAE

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