Bioanalysis is a branch of analytical chemistry that deals with biological samples for analysis of measurement of biological molecules, DNA, large molecules, and others. The U.S. FDA guidance in 2001 defined bioanalytical services as “quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine, tissue and skin samples.” The terms bioanalytical services and analytical services are usually used interchangeably in the health care industry; however, bioanalytical services are specifically applied to toxicology, pharmacology studies, bioequivalence studies, along with pharmacokinetic and bioavailability studies in animals of humans. Bioanalytical services are offered for every phase of drug development, from discovery to clinical development phases. Primary distinguishing parameter between analytical services and bioanalytical services is that bioanalytical services are employed to quantify the amount of drug present in a particular biological sample under study, whereas analytical services are used to evaluate qualitative parameters of the drug molecules. Various bioanalytical platforms are being used to perform these services ranging from LC/MS, gas chromatography, ligand binding assays, immunoassays, cell-based assays, and mass spectrometry among others.
There is an ever increasing demand for bioanalytical services in the pharmaceutical and biotechnology industry. Comparatively higher costs and longer time duration required to conduct bioanalytical services in-house is a major factor driving demand for bioanalytical services. This has led to pharmaceutical and biotechnology companies outsourcing bioanalytical services to companies specializing in the domain. Moreover, increase in incidence of chronic diseases and rise in economic cost burden of these diseases on health care systems across the world are propelling the need for new and personalized medicine and innovative drugs to be introduced in the market. This has led to increase in investment by biopharmaceutical companies in R&D and drug development, leading to higher demand for bioanalytical services in the global market. These factors combined with increasing number of players operating in the bioanalytical services market offering diversified and end-to-end portfolio of bioanalytical services fuel the growth of the global bioanalytical services market.
The global bioanalytical services market can be segmented based on test type, molecule type, service type, end-user, and region. In terms of test type, the global market can be classified into ADME (absorption, distribution, metabolism, and excretion), pharmacokinetic, pharmacodynamics, bioavailability, bioequivalence, and others. The ADME segment can be bifurcated into in vivo ADME and in vitro ADME. Based on molecule type, the global bioanalytical services market can be categorized into small molecules, large molecules, and vaccines. Based on service type, the global market can be divided into discovery bioanalysis services (non-GLP services), non-clinical bioanalysis services (GLP), and clinical bioanalysis services (GLP). In terms of end-user, the bioanalytical services market can be segmented into pharmaceutical companies, biotechnology companies, contract research organizations, and others.
In terms of geography, the global bioanalytical services market can be segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global market in 2017 and is projected to continue its dominance from 2018 to 2026. Higher demand for bioanalytical services in the U.S. owing to increase in focus of pharmaceutical companies on R&D and surge in demand for new and innovative drugs in the market. Europe accounted for the second largest share of the global market in 2017. The market in Asia Pacific is projected to expand at a higher CAGR from 2018 to 2026 owing to rise in shift of contract research organizations from countries in the West toward China, India, and other countries in Southeast Asia. A fast developing research and development infrastructure in the Middle East is also anticipated to drive demand for bioanalytical services in the region during the forecast period.
Key players operating in the global bioanalytical services market are ICON plc, Covance, Inc., Charles River Laboratories International, Inc., Bio-Rad Laboratories, Inc., Eurofins Scientific, and WuXi AppTec.
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