“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.”
The article cited AMA's "Global Bioanalytical Testing Services Market Study" explored substantial growth in North America and of 12.61%. According to the report, Emphasizing On Liquid Chromatography-Mass Spectrometry [LC/MS/MS] Analytical Technique for Performing Bioanalytical Testing
is one of the primary growth factors for the market. Growth in the Biopharmaceutical Industry
is also expected to contribute significantly to the Bioanalytical Testing Services market. Overall, Oncology
applications of Bioanalytical Testing Services, and the growing awareness of them, is what makes this segment of the industry important to its overall growth. The End User , such as Biopharmaceutical Companies, is boosting the Bioanalytical Testing Services market. Additionally, the rising demand from SMEs and various industry verticals, macro-economic growth are the prime factors driving the growth of the market.The Molecule Type, such as Small Molecule, is boosting the Bioanalytical Testing Services market. Additionally, the rising demand from SMEs and various industry verticals, macro-economic growth are the prime factors driving the growth of the market.
AMAs Analyst on the Global Bioanalytical Testing Services market identified that the demand is rising in many different parts of the world as "Advancement in the Combination Molecules, Identical Biological Drugs, and Innovative Medicines Owing to High Prevalence of Chronic Diseases
". Furthermore, some recent industry insights like "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." is constantly making the industry dynamic.
The report provides an in-depth analysis and forecast about the industry covering the following key features: o Industry outlook including current and future market trends, drivers, restraints, and emerging technologies o Analyses the Global Bioanalytical Testing Services market according to Type, Application, and regions o Analyzes the top 10 players in terms of market reach, business strategy, and business focus o Provides stakeholders insights and key drivers & trends of the market
**The market is valued based on weighted average selling price (WASP) and includes any applicable taxes on manufacturers. All currency conversions used in the creation of this report have been calculated using constant annual average 2018 currency rates.
Market Size Estimation In market engineering method, both top-down and bottom-up approaches have been used, along with various data triangulation process, to predict and validate the market size of the Bioanalytical Testing Services market and other related sub-markets covered in the study.
o Key & emerging players in the market have been observed through secondary research. o The industrys supply chain and overall market size, in terms of value, have been derived through primary and secondary research processes. o All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Data Triangulation The overall Bioanalytical Testing Services market size is calculated using market estimation process, the Bioanalytical Testing Services market was further split into various segments and sub-segments. To complete the overall market engineering and arriving at the exact statistics for all segments and sub-segments, the market breakdown and data triangulation procedures have been utilized, wherever applicable. The data have been triangulated by studying various influencing factors and trends identified from both demand and supply sides of various applications involved in the study. Along with this, the Global Bioanalytical Testing Services market size has been validated using both top-down and bottom-up approaches.