The development of the bioanalytical techniques brought a progressive discipline for which the future holds many exciting opportunities for further improvement. The main impact of bioanalysis in the pharmaceutical industry of Japan is to obtain a quantitative measure of the drug and its metabolites. The Japan Bioanalytical Testing Services Market is projected to make a forward leap in its revenue from US$ 63.5 Mn in 2021 to US$ 166.9 Mn by 2030. The market is registering a CAGR of 11.6% over the forecast period 2022-2030.
A bioanalytical method is a set of procedures involved in the collection, processing, storage, and analysis of a biological matrix for a chemical compound. Bioanalytical method validation (BMV) is the process used to establish that a quantitative analytical method is suitable for biochemical applications. Bioanalysis covers the quantitative measurement of xenobiotics of drugs such as their metabolites, and biological molecules in unnatural locations or concentrations and biotics like macromolecules, proteins, DNA, large molecule drugs, and metabolites in biological systems. It focuses on the evaluation of the safety, toxicity, and efficacy of new drug molecules.
The market is majorly driven by factors such as increasing preference for outsourcing analytical testing and rising adoption of the quality by design approach. Japan is one of the countries with a highly developed pharmaceutical industry. Along with the research and development of various drugs, the contract development manufacturing organization (CDMO) market is emerging in Japan. This is propelling the demand for outsourcing analytical testing, which in turn is expected to propel market growth. Outsourcing allows companies to focus on their core competencies and allows them to send out more complex activities, or more repetitive tasks. This provides cost savings by allowing companies to avoid building specialized facilities, hiring staff, etc. Further, Quality by Design (QbD) is a systematic risk-based, proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
Analytical Quality by Design (QbD) plays a key role in the pharmaceutical industry in ensuring product quality. The outcome of QbD in bioanalytical testing is the understanding from product development to commercial production, which helps in easily identifying the risk initially so that quality can be increased. Moreover, the growing prevalence of infectious diseases is providing a lucrative opportunity for market growth. However, the challenges of software validation and high technology implementation cost is hindering the market growth.
Key Insights of the Report:
Key Takeaways from the Japan Bioanalytical Testing Services Market Report:
Competitive Insights
The key players in the Japan Bioanalytical Testing Service Market are Syneos Health Inc., Laboratory Corporation of America, Charles River Laboratories Inc, ICON Plc, among others. Through extensive research, it is found that big players have adopted various competitive strategies such as mergers & acquisitions in order to have a grip of emerging market. Furthermore, leading companies are expanding their geographical boundaries by acquiring small brands and domestic companies.
Segmentation Overview
The following are the various segments of the Japan Bioanalytical Testing Services Market.
By Test Type segment of the Japan Bioanalytical Testing Services Market is sub-segmented into:
By Molecule Type segment of Japan Bioanalytical Testing Services Market is sub-segmented into:
By Application segment of Japan Bioanalytical Testing Services Market is sub-segmented into:
By End User segment of Japan Bioanalytical Testing Services Market is sub-segmented into:
The Japan Bioanalytical Testing Service Market was valued at US$ 63.5 Mn in 2021.
The main impact of bioanalysis in the pharmaceutical industry of Japan is to obtain a quantitative measure of the drug and its metabolites.
Bioanalysis is a quantitative measurement of a compound (drug) or its metabolite in biological fluids such as blood, plasma, serum, urine, or tissue extracts.
The Japan Bioanalytical Testing Service Market is projected to rise at a CAGR of 11.6% over the forecast period.
The market is majorly driven by factors such as increasing preference for outsourcing analytical testing and rising adoption of the quality by design approach.
The challenges of software validation and high technology implementation cost are hindering the market growth.
The growing prevalence of infectious diseases is providing a lucrative opportunity for market growth.
Cell-based assays dominates the market in 2021.
In terms of application, the oncology segment leads the bioanalytical testing service market in 2021.
Pharma and biotechnologies companies are the highest end-users in the Japan Bioanalytical Testing Service Market.
The key players in the Japan Bioanalytical Testing Service Market are Syneos Health Inc., Laboratory Corporation of America, Charles River Laboratories Inc, ICON Plc, among others.