The global bioanalytical testing services market size was valued at USD 2.67 billion in 2018 and is expected to register a CAGR of 7.5% over the forecast period. Increasing frequency of outsourcing R&D activities by the major pharmaceutical companies to focus on their core competencies is the vital impact rendering driver. Furthermore, the economic efficiency offered for outsourcing rather than conducting an in-house study is expected to further boost the demand.
Majority of big sellers are going off patent, which is anticipated to drive investments from drug manufacturers to replenish their respective pipelines. This is one of the major reasons for the growth of the market bioanalytical testing services. Contract Research Organizations (CROs) diversify 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 their growing demand from pharmaceutical segment.
Increase in complexity and number of standards 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 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.
On the basis of molecule type, the bioanalytical testing services market is bifurcated into small molecule and large molecule. The small molecule segment held a lucrative market share in 2018. Most of the generic and branded drug compounds are belong to 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 segment in the forthcoming years.
On the other hand, large molecule segment is 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. This infrastructure is available with bioanalytical services providers. Hence, outsourcing bioanalytical testing of these molecules is likely to be the prevailing trend over the forecast period.
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.
Based on test type, the market is segmented into Absorption Distribution Metabolism Excretion (ADME), Pharmacokinetics (PK), Pharmacodynamics (PD), bioavailability, bioequivalence, and others. Bioavailability (BA) and Bioequivalence (BE) studies held significant market share in 2018, 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 Concentration (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 and storage, and low biohazard risks are the benefits of DBS method.
North America led the global market for bioanalytical testing services in 2018. 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 (OEMs) are rapidly moving toward electronics manufacturing service providers to efficiently handle increasing volume of electronic components in the current pharmaceuticals.
The rapid increase in pharmaceutical manufacturing to meet the rising demand for efficient healthcare is expected to be one of the major factors propelling development of the market in North America. According to a recent study, in 2013, approximately 15.0% of the GDP was spent on healthcare and medical sector. The regional pharmaceutical outsourcing market is anticipated to grow further due to the increasing government support to curb healthcare expenses.
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 the delivery centers in China, Manila, and India. China is gaining popularity as a delivery location for onshore clients and nearshore clients based out of Japan.
Some of the key market players 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 expansions, and merger and acquisitions are the key strategic undertakings by these players.
For instance, in February 2015, Laboratory Corporation of America (LabCorp) acquired Covance. This transaction is expected to expand the biopharmaceutical reach of LabCorp globally, thereby promoting higher profits and number of projects. In another similar transaction, 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.
Base year for estimation
Actual estimates/Historical data
2014 - 2017
2019 - 2026
Revenue in USD Million and CAGR from 2019 to 2026
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Spain, China, Japan, India, Australia, South Korea, Mexico, Brazil, Argentina, South Africa, Saudi Arabia, UAE
Revenue forecast, competitive landscape, growth factors and trends
15% free customization scope (equivalent to 5 analyst working days)
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2014 to 2026. 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, 2014 - 2026)
Test Type Outlook (Revenue, USD Million, 2014 - 2026)
Regional Outlook (Revenue, USD Million, 2014 - 2026)
b. The global bioanalytical testing services market size was estimated at USD 2.9 billion in 2019 and is expected to reach USD 3.2 billion in 2020.
b. The global bioanalytical testing services market is expected to grow at a compound annual growth rate of 7.5% from 2019 to 2026 to reach USD 4.8 billion by 2026.
b. North America dominated the bioanalytical testing services market with a share of 54.0% in 2019. This is attributable to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end pharmaceuticals.
b. Some key players operating in the bioanalytical testing services market include PPD; ICON plc; Covance Inc.; LabCorp; Charles River Laboratories International, Inc.; inVentiv Health; SGS SA; Toxikon, Inc.; and Intertek group.
b. Key factors that are driving the market growth include increasing frequency of outsourcing R&D activities by the major pharmaceutical companies to focus on their core competencies.
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Multiple therapeutic regimens are being followed across the globe in attempts to come up with a reliable treatment for Covid-19. One line of treatment includes the use of hydroxychloroquine, while a second treatment line focuses to use antiviral drugs used in the disease management of HIV. Both these approaches have surged demand from advanced antivirals and antimalarial drugs. This impacts the drug manufacturers as an off label indication for these drug classes has to be worked upon. At the moment, the WHO has not prescribed any of these approaches, neither they have commented if one is better than the other. The report will account for Covid19 as a key market contributor.