Industry Background:
Bioanalytical testing services refers to analytical method used for the analysis of biological products for drug development, commercialization of drugs, and drug discovery at clinical or preclinical stage. The uses of this testing method are in bioavailability, pharmacology, studies of toxicology and various others to determine drug quantity while leaving out quality parameters. Considering the need for early disease detection amid rise in number of chronic diseases, bioanalysis becomes important which attracted huge investment in its developments of late. Further, Bioanalytical testing services market has high growth prospects owing to increasing number of patients with chronic diseases. For instance, according to World Health Organization (WHO) cancer is the second leading cause of death and led to 9.6 million deaths globally in 2018.
According to AMA, the market for Bioanalytical Testing Services is expected to register a CAGR of 12.61% during the forecast period to 2026. This growth is primarily driven by Growth in the Biopharmaceutical Industry and Increasing Adoption of Outsourcing R&D Activities by the Pharmaceutical Companies.
Globally, a noticeable market trend is evident Emphasizing On Liquid Chromatography-Mass Spectrometry [LC/MS/MS] Analytical Technique for Performing Bioanalytical Testing
. The Health Care Services sector in the North America region has been increasing at a sustainable rate and further growth is expected to be witnessed over the forecast period, owing to the robust investments and expansion in production facilities in the region. Major Players, such as Charles River Laboratories International Inc. (United States), BioReliance Corporation (United States), WuXi PharmaTech (Cayman) Inc. (China), Bioclin Research Laboratories (Ireland), Eurofins Scientific SE (Luxembourg), SGS (Switzerland), Merck Group (Germany), LabCorp (United States), PPD Inc. (United States), Bioanalytical Technologies Private Limited (India), Intertek Group Plc. (United Kingdom), PRA Health Sciences (United States) and Parexel International (United States) etc have either set up their manufacturing facilities or are planning to start new provision in the dominated region in the upcoming years.
Key Developments in the Market:
2nd November 2018, Eurofins Scientific SE a bioanalytical testing provider acquired Test America the environmental testing laboratory in the United States and EnvironeX Group Inc. engaged in laboratory analyses for the health and pharmaceutical sectors in Canada to expands its bioanalytical testing capabilities in the North American market.
In 2018 SGS SA, a biopharmaceutical analytical and bioanalytical contract solutions provider invested USD 3.94 million in a new two phase expansion project at its laboratory in Poitiers, France to expand their bioanalytical testing capabilities.
Regulatory Insights:
“In the FDA Guidance for Industry: Bioanalytical Method Validation, FDA clearly stated that: ‘the bioanalytical method for human BA, BE, PK, and drug interaction studies must meet the criteria in 21 CFR 320.29. The analytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. The SOPs also should include the record keeping, security and chain of sample custody (accountability systems that ensure integrity of test articles), sample preparation, and analytical tools such as methods, reagents, equipment, instrumentation, and SOPs for quality control and verification of results.”
Market Drivers
- Growth in the Biopharmaceutical Industry
- Increasing Adoption of Outsourcing R&D Activities by the Pharmaceutical Companies
Market Trend
- Emphasizing On Liquid Chromatography-Mass Spectrometry [LC/MS/MS] Analytical Technique for Performing Bioanalytical Testing
- Increasing Demand for Bioanalytical Testing For Large-Molecule Drugs
Restraints
- High Prize Associated With Bioanalytical Testing Services
- Lack of Skilled Professionals to Adopt New Technology
Opportunities
Advancement in the Combination Molecules, Identical Biological Drugs, and Innovative Medicines Owing to High Prevalence of Chronic Diseases and Increasing Demand for Outsourcing Services for Healthcare from Developing Economies
Challenges
Lack of Advance Healthcare Infrastructure in Emerging Countries
AMA Research follow a focused and realistic research framework that provides the ability to study the crucial market dynamics in several regions across the world. Moreover, an in-depth assessment is mostly conducted by our analysts on geographical regions to provide clients and businesses the opportunity to dominate in niche markets and expand in emerging markets across the globe. This market research study also showcase the spontaneously changing Players landscape impacting the growth of the market. Furthermore, our market researchers extensively analyse the products and services offered by multiple players competing to increase their market share and presence.
Customization in the Report
AMA Research features not only specific market forecasts, but also include significant value-added commentary on:
- Market Trends
- Technological Trends and Innovations
- Market Maturity Indicators
- Growth Drivers and Constraints
- New Entrants into the Market & Entry/Exit Barriers
- To Seize Powerful Market Opportunities
- Identify Key Business Segments, Market Proposition & Gap Analysis
Against this Challenging Backdrop, Bioanalytical Testing Services Study Sheds Light on
The Bioanalytical Testing Services Market status quo and key characteristics. To end this, Analyst at AMA organize and took survey of the Bioanalytical Testing Services industry Players. The resultant snapshot serves as a basis for understanding why and how the industry can be expected to change.
Where Bioanalytical Testing Services industry is heading and what are the top priorities. Insights are drawn from financial analysis, the survey and interviews with key executives and industry experts.
How every company in this diverse set of Players can best navigate the emerging competition landscape and follow a strategy that helps them position to hold value they currently claim, or capture the new addressable opportunity.