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.
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The advancement of bioanalytical methods gave rise to a developing science with many promising potentials for future advancement. The primary benefit of bioanalysis for the Japanese pharmaceutical sector is the ability to quantify the drug and its metabolites.
A bioanalytical method is a combination of procedures used in the acquisition, processing, archival, and analysis of a biological matrix for a chemical molecule. The bioanalytical method validation (BMV) procedure evaluates a quantitative analytical method’s applicability for biochemical applications. Bioanalysis is the quantitative evaluation of biological molecules in biological systems, such as proteins, macromolecules, large-molecule drugs, and DNA. In addition, their xenobiotics and metabolites are in abnormal concentrations or locations. Its main emphasis is on evaluating the efficacy, toxicity, and safety of new pharmaceutical substances.
Factors Pushing the Global Market Growth
Increasing use of the quality-by-design methodology
Quality by Design (QbD) is a risk-based, methodical, proactive strategy for pharmaceutical development that emphasizes process and product knowledge and process control based on trustworthy quality and science risk management. QbD starts with predetermined targets. The pharmaceutical industry mainly relies on analytical Quality by Design to confirm the quality of the products. The outcome of QbD in bioanalytical testing is an understanding from product conception to commercial manufacturing, which makes it easy to identify the risk at the onset so that the procedure is more effective.
More people are choosing to outsource their analytical testing
Japan is one of the countries that have one of the most developed pharmaceutical industries. With the R&D of several drugs in Japan, the market for contract development manufacturing organizations is expanding. As a result, there is an increasing demand for outsourcing analytical testing, which will probably lead to market growth. Businesses can focus on their core competencies while outsourcing more difficult or boring tasks. Allowing firms to avoid building specialized buildings, hiring staff, etc., also lowers expenses.
The rise of infectious illness cases
Infectious disease cases are increasing, which is opening up a sizable window for market growth. Viral hemorrhagic fever, tick-borne infections, respiratory infections, and other significant new and re-emerging infections caused by mosquitoes are among the most common infectious diseases in Japan. Over the past 20 years, researchers have conducted considerable research on infectious diseases in Japan and discovered that the country is susceptible to a wide range of infectious diseases.
The difficulties of software validation and rising technological implementation costs, however, could impede industry expansion.
Syneos Health Inc., Charles River Laboratories Inc., Laboratory Corporation of America, and ICON Plc are a few of the leading companies in the Japanese bioanalytical testing service market. Through in-depth investigation, it was discovered that major players have used a variety of competitive techniques, like mergers and acquisitions, to control new markets. A number of leading businesses are also acquiring small and local brands in order to expand regionally.
Test Type Analysis
The cell-based assay segment recorded a share of 20% of the Japan bioanalytical testing industry in 2021. Cell-based assays are very quantitative and reductionist. Furthermore, it is possible to binding constants, measure rate constants, and the effect of cofactors on enzyme activity without interference from other biological factors by employing highly pure components and controlled environments. Contrarily, the serology, immunogenicity, and neutralizing antibodies segment are likely to record a CAGR of 13.5% over the prognosis period.
Molecule Type Analysis
The small molecule bioanalysis segment accounted for the share of 11.93% of the Japan industry in 2021, and the segment is likely to project the highest annual growth rate during 2022-2030. This is due to the advantages that small-molecule bioanalysis provides for modern drug discovery methods, such as selectivity, dynamics, sensitivity, range, and robustness.
The oncology segment maintained a share of 50% in 2021, and the segment will record the highest rate during 2022-2030. The global increase in cancer incidence and the expansion of oncology clinical trials are both responsible for this segment’s rise. Additionally, the market segment growth will be fueled by the aging population and dropping birthrate. Contrary, the gastroenterology segment revenue is likely to reach US$ 10 Mn by 2028.
The pharma and biotechnologies companies segment led the bioanalytical testing service industry, and the segment will project an opportunity of US$ 50 mn between 2022-2030. Contrarily, the contract research organizations segment will grow at the highest rate. This is a result of the nation’s growing number of contract development manufacturing companies.
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By Test Type Segment
- 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
- Pharmacokinetic Testing
By Molecule Type Segment
- Small Molecule Bioanalysis
- Large Molecule Bioanalysis
By Application Segment
- Infectious Diseases
By End-User Segment
- Pharma & Biotechnology Companies
- Contract Research Organizations
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