Japan Bioanalytical Testing Services Market - Industry Dynamics, Market Size, And Opportunity Forecast To 2030

The development of 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: 

• The latest study published by Astute Analytica analyzes the Japan Bioanalytical Testing Services Market for the study period of 2017-2030; where the historical years are 2017-2020, the base year is 2021, and the forecast period is 2022-2030.
• The research report offers a detailed study of market determinants including market drivers, restraints, opportunities, and trends; along with an attractive presentation in the form of impact analysis to gain a simpler and easy comparison view of all market determinants.
• The research study is a compilation of 9 chapters distributed across 109 pages with 15 lists of tables and 31 lists of figures.
• The market is segmented based on test type, molecule type, application, and end-user.
• The market estimates are presented in terms of value (US$ Mn).
• Along with market estimations, the market study was conducted on the basis of various economic models such as PESTLE and Porter’s five force models.
• A detailed value chain analysis of the industry was conducted. It includes sample collection, sample preparation and raw materials used, sample analysis and validation, and end-user.
• The competitive dashboard section includes analysis on the basis of Concentration Ratio (CR), based on market size and market presence of key companies.

Key Takeaways from the Japan Bioanalytical Testing Services Market Report:

• Based on test type, the cell-based assays segment holds the highest share in the bioanalytical testing service market of Japan in 2021. Cell-based assays are highly quantitative and reductionist. Further, the use of highly purified components and controlled conditions allows the measurement of binding constants, rate constants, and the influence of cofactors such as phospholipids on enzyme function without interference from other cellular factors. However, the serology, immunogenicity, and neutralizing antibodies segment holds the highest growth rate over the forecast period.
• In terms of molecule type, the small molecule bioanalysis segment occupies the highest market share in 2021 and further registers the highest CAGR over the projection period. This is because of the advantages provided by small-molecule bioanalysis which include sensitivity, selectivity, dynamic range, and robustness, which are significant for modern drug development programs.
• Based on application, the oncology segment holds the highest share in the Japan Bioanalytical Testing Service Market in 2021 and records the highest CAGR over the forecast period 2022-2030. The growth of this segment is due to the increasing number of clinical trials conducted for oncology and the rising prevalence of cancer worldwide. Further, Japan’s aging population, combined with a diminishing number of children is further propelling the segmental growth.
• In terms of end-users, the pharma and biotechnologies companies segment holds the highest share in the bioanalytical testing service market of Japan in 2021. Further, the contract research organizations record the highest growth rate over the projection period. This is attributed to the growing contract development manufacturing organizations (CDMOs) in Japan.

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:

• Cell-based Assays
  • Bacterial cell-based assays
  • Viral cell-based assays
• Virology Testing
  • In Vitro Virology Testing
  • In Vivo Virology Testing
• Species-specific Viral PCR Assays
• Method Development Optimization and Validation
• Serology, Immunogenicity, and Neutralizing Antibodies
• Biomarker Assays
  • LBA/LC-MS/MS
• Pharmacokinetic Testing
• Others

By Molecule Type segment of Japan Bioanalytical Testing Services Market is sub-segmented into:

• Small Molecule Bioanalysis
• Large Molecule Bioanalysis
• Others

By Application segment of Japan Bioanalytical Testing Services Market is sub-segmented into:

• Oncology
• Neurology
• Infectious Diseases
• Gastroenterology
• Cardiology
• Others

By End User segment of Japan Bioanalytical Testing Services Market is sub-segmented into:

• Pharma & Biotechnology Companies
• Contract Research Organizations
• Others