Bioanalytical Testing Services Market Report

Bioanalytical Testing Services Market Analysis By Molecule-Type (Small Molecule, Large Molecule), By Test Type (ADME, PK, PD, Bioavailability, Bioequivalence), By Region, And Segment Forecasts, 2014 - 2025

Published: June 2017  |  114 Pages  |  Format: PDF  |  Report ID: GVR-1-68038-946-3

Industry Insights 

The global bioanalytical testing services market size was valued at USD 1,467.6 million in 2016 and is expected to grow at a CAGR of 8.6% over the forecast period. 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.

Drug manufacturers’ requirement to replenish their respective pipelines as the majority of the big sellers goes off patent, thereby investing a significant amount in development is one of the major reasons for the market growth. 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 pharmaceutical segment.

U.S. bioanalytical testing services market, by large molecule-type, 2014 - 2025 (USD Million)

U.S. bioanalytical testing services market

Increase in complexity and number of standards, which a single product 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 & advisory services to be in synchronization with evolving standards. Moreover, international organizations such as the International Council for Harmonisation (ICH) give harmonized guidelines that are regularly updated.

Innovation or new product development is directly proportional to the demand for testing services. Due to competitive pressures, pricing concerns, and lead-time to market, companies are opting for outsourcing of testing services. Increasing focus on customized care and technological advancements are shortening the product lifecycle, which has resulted into rapid development of new products.

Development of biosimilars, combination products, and other innovative medicines has resulted in increase in demand for specific types of tests. 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.

Molecule Type Insights

The bioanalytical testing services market based on molecule type is bifurcated into small molecule testing and large molecule testing. Small molecule bioanalytical testing held a lucrative share in 2016. Most of the generic and branded drug compounds are of small molecule category. 

Additionally, with the patent expiration 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 products. Moreover, testing these product requires technical know-how with advanced analytical instruments, this infrastructure is available with bioanalytical services providers. Hence, outsourcing bioanalytical testing of these products 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.

Test Type Insights 

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. Bioavailability (BA) and bioequivalence (BE) studies held significant share in 2016. This can be attributed to the great demand for these services in generic drug manufacturing.

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

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

Global bioanalytical testing services market, by molecule type, 2016 (%)

Global bioanalytical testing services market

Regional Insights 

North America dominated the global market for bioanalytical testing services in 2016. 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 increasing volume of electronic components in the current pharmaceuticals.

The rapid increase in the manufacturing of the pharmaceuticals to meet the rising demand for efficient healthcare in the region is expected to be one of the major factors propelling development of the market. According to a recent study, in 2013. Approximately 15.0% of the GDP was spent on healthcare and medical sector. 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 fastest growth over the forecast period owing to rising demand for outsourcing services in comparatively immature markets. Outsourcing services in this region is typically supported from 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.

Competitive Insights

Some of the key players in this market include PPD, ICON plc., Covance Inc., LabCorp, Charles River Laboratories International, Inc., inVentiv Health, SGS SA, Toxikon, Inc., Intertek group, and Pace Analytical Services, LLC.Collaborations, service portfolio expansion and merger & acquisitions are key strategic undertakings by these players. 

For instance, in February 2015, Covance was acquired by Laboratory Corporation of America (LabCorp). This is expected to expand the biopharmaceutical reach of LabCorp globally, thereby promoting higher profits and increasing the number of projects.

In September 2016, ICON acquired Clinical Research Management, Inc. (ClinicalRM), a leading provider of full service and functional research solutions to expand its service portfolio.

Report Scope

Attribute

Details

Base year for estimation

2016

Actual estimates/Historical data

2014 - 2016

Forecast period

2017 - 2025

Market representation

Revenue in USD Million & CAGR from 2017 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America & MEA

Country scope

U.S., Canada, UK, Germany, Japan, China, Brazil, Mexico, & South Africa

Report coverage

Revenue, company share, competitive landscape, growth factors, trends

15% free customization scope (equivalent to 5 analysts working days)

If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of customization


Segments Covered in the Report

This report forecasts revenue growth at regional & country levels and provides an analysis on the latest trends and opportunities in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the bioanalytical testing services market on the basis of molecule-type, test-type, and region:

  • Molecule Type Outlook (Revenue, USD Million; 2014 - 2025)

    • Small Molecule

    • Large Molecule

      • LC-MS Studies

      • Immunoassays

      • Others

  • Test Type Outlook (Revenue, USD Million; 2014 - 2025)

    • ADME

      • In-Vivo

      • In-Vitro

    • PK

    • PD

    • Bioavailability

    • Bioequivalence

    • Others

  • Regional Outlook (Revenue, USD Million; 2014 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • UK

      • Germany

    • Asia Pacific

      • Japan

      • China

    • Latin America

      • Brazil

      • Mexico

    • MEA

      • South Africa

Key questions answered by the report
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