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Report
Japan In Vitro Diagnostics Market Report and Forecast 2025-2034
Market Report I 2025-06-20 I 250 Pages I EMR Inc.
The Japan in vitro diagnostics market was valued at USD 3.97 Billion in 2024, driven by rising elderly population leading to greater diagnostic testing needs, and increasing demand for personalized medicine across the region. The market is anticipated to grow at a CAGR of 6.20% during the forecast period of 2025-2034, with the values likely to reach USD 7.24 Billion by 2034. The market benefits from advanced healthcare infrastructure and growing adoption of molecular diagnostics. Trends such as AI-integrated testing and home-based diagnostics are expected to accelerate growth during the forecast period.
Japan In Vitro Diagnostics Market Overview
In vitro diagnostics (IVD) are laboratory-based tests performed on biological samples such as blood, urine, or tissue to detect diseases, monitor health conditions, and guide treatment decisions. These diagnostics are vital in ensuring accurate, early diagnosis and personalized patient care. The in vitro diagnostics market in Japan is experiencing steady growth due to its aging population, rising chronic disease burden, and advancements in diagnostic technologies. Increased demand for point-of-care testing and government support further contribute to market expansion. The market is poised to grow at a CAGR of 6.20% during the forecast period of 2025-2034.
Japan In Vitro Diagnostics Market Growth Drivers
Innovative Diagnostic Launch to Augment Growth in In Vitro Diagnostics Market in Japan
A key growth driver in the market is the increasing emphasis on advanced diagnostic tools to combat antimicrobial resistance. In July 2024, Shionogi & Co., Ltd. announced the domestic launch of the "Shionogi MIC Dry Plate Cefiderocol," designed to assess bacterial susceptibility to Fetroja, a treatment for Gram-negative infections. This innovation supports more targeted antibiotic use and strengthens the nation's infectious disease diagnostics framework. Such advancements are expected to significantly propel market growth in the coming years.
Japan In Vitro Diagnostics Market Trends
The market is experiencing multiple trends, including an increase in regulatory approvals for novel cancer diagnostics, as well as a surge in innovation and strategic collaborations.
Regulatory Approvals Driving Innovation in Cancer Diagnostics and Boosting Market Value
The market is witnessing a rise in regulatory approvals for novel cancer diagnostics. In June 2023, Toray Industries received marketing approval from Japan's Ministry of Health, Labour and Welfare for "Toray APOA2-iTQ," the first in vitro diagnostic kit in Japan to measure two APOA2 isoforms for aiding in pancreatic cancer diagnosis. This approval highlights the country's support for innovative, early-stage diagnostic tools. Such regulatory advancements are expected to enhance clinical outcomes and significantly boost the market's growth potential.
Strategic Partnerships in Diagnostics to Meet Rising Japan In Vitro Diagnostics Market Demand
In August 2024, Hitachi High-Tech and Gencurix formed a strategic partnership to develop advanced cancer molecular diagnostic testing services in Japan. Combining Hitachi's expertise in in vitro diagnostic product manufacturing with Gencurix's biomarker discovery and digital technology, this collaboration aims to enhance personalized cancer diagnosis. This development aligns with the increasing demand for precise, biomarker-based diagnostics in oncology. The partnership is expected to drive innovation and elevate testing accuracy, supporting the market's expansion.
Japan In Vitro Diagnostics Market Segmentation
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Product & Services
- Reagents and Kits
- Instruments
- Software and Services
Market Breakup by Technology
- Immunodiagnostics
??- Enzyme-Linked Immunosorbent Assay (ELISA)
??- Enzyme-Linked Immunospot (ELISPOT)
??- Rapid Tests
??- Radioimmunoassay (RIA)
??- Western Blotting
??- Others
- Clinical Chemistry
??- Basic Metabolic Panels
??- Liver Panels
??- Renal Profiles
??- Lipid Profiles
??- Thyroid Function Panels
??- Electrolyte Panels
??- Specialty Chemical Tests
- Molecular Diagnostics
??- Polymerize Chain Reaction (PCR)
??- Isothermal Nucleic Acid Amplification Technology (INAAT)
??- Hybridization
??- DNA Diagnostics
??- Microarray
??- Others
- Hematology
- Microbiology
- Coagulation and Haemostasias
- Urinalysis
- Others
Market Breakup by Application
- Infectious Diseases
- Diabetes
- Oncology
- Cardiology
- Drug Testing/Pharmacogenomics
- HIV/AIDS
- Autoimmune Diseases
- Nephrology
- Others
Market Breakup by End User
- Hospitals
- Diagnostic Centers
- Point-of-Care Testing
- Academic Institutes
- Others
Japan In Vitro Diagnostics Market Share
Segmentation Based on Application to Witness Substantial Growth
Among various application areas driving the market, infectious diseases emerge as the dominant segment due to their profound public health impact and escalating demand for accurate diagnostic solutions. According to the Tuberculosis in Japan Annual Report 2022, in 2021, a total of 11,519 new tuberculosis (TB) cases were reported, corresponding to a notification rate of 9.2 per 100,000 population. Among these cases, 73.0% were pulmonary TB (PTB), while extrapulmonary TB (EPTB) accounted for 27.0%. This significant disease burden fuels market growth, supported by government initiatives and rising public awareness, positioning infectious diseases as a key revenue driver in the forecast period.
Leading Players in the Japan In Vitro Diagnostics Market
The key features of the market report comprise funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
F. Hoffmann-La Roche Ltd.
F. Hoffmann-La Roche Ltd., established in 1896 and is a global leader in diagnostic solutions. The company develops and manufactures in vitro diagnostic tests and instruments for diseases such as cancer, diabetes, and infectious conditions. Roche's advanced diagnostic systems and test strips are widely used in Japan, supporting effective disease detection and treatment within clinical and laboratory settings.
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories is a prominent player in the in vitro diagnostics market. The company offers the QXDx product family, featuring advanced Droplet Digital PCR (ddPCR) systems and assay kits. These tools provide ultrasensitive and precise quantification for diagnostic applications, including chronic myeloid leukemia monitoring, and are gaining regulatory approvals for clinical use.
bioMerieux SA
Established in 1963, bioMerieux SA develops innovative IVD solutions, including molecular biology, immunoassays, and microbiology products. bioMerieux actively supports compliance with the new In Vitro Diagnostic Regulations (IVDR), enhancing patient safety and product quality in the Japan IVD market.
Abbott
Abbott, headquartered in Abbott Park, Illinois, is a key player in the in vitro diagnostics market. The company introduced the ARCHITECT i1000SR, a high-productivity immunoassay analyzer designed to deliver rapid, accurate results. This advanced system supports improved laboratory workflow and enhances diagnostic efficiency, reinforcing Abbott's strong market presence.
Other key players in the market include Sysmex Corporation, Thermo Fisher Scientific Inc., QIAGEN, Quidel Corporation, and Danaher Corporation.
Key Questions Answered in the Japan In Vitro Diagnostics Market Report
- What was the Japan in vitro diagnostics market value in 2024?
- What is the Japan in vitro diagnostics market forecast outlook for 2025-2034?
- What major factors aid the Japan in vitro diagnostics market demand?
- How has the market performed so far, and how is it anticipated to perform in the coming years?
- What are the market's major drivers, opportunities, and restraints?
- What are the major trends in the Japan in vitro diagnostics market?
- Which product & services is expected to dominate the market segment?
- Which technology is projected to lead the market segment?
- Which application is anticipated to drive the market segment?
- Which end user is likely to dominate the market segment?
- Who are the key players involved in the Japan in vitro diagnostics market?
- What are the current unmet needs and challenges in the market?
- How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 In Vitro Diagnostics Market Overview
3.1 Asia Pacific In Vitro Diagnostics Market Overview
3.1.1 Asia Pacific In Vitro Diagnostics Market Historical Value (2018-2024)
3.1.2 Asia Pacific In Vitro Diagnostics Market Forecast Value (2025-2034)
3.2 Japan In Vitro Diagnostics Market Overview
3.2.1 Japan In Vitro Diagnostics Market Historical Value (2018-2024)
3.2.2 Japan In Vitro Diagnostics Market Forecast Value (2025-2034)
4 Japan In Vitro Diagnostics Market Landscape
4.1 Japan In Vitro Diagnostics Market: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Japan In Vitro Diagnostics Market: Product Landscape
4.2.1 Analysis By Product & Services
4.2.2 Analysis By Technology
4.2.3 Analysis By Application
5 Japan In Vitro Diagnostics Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.2.1 Strengths
5.2.2 Weaknesses
5.2.3 Opportunities
5.2.4 Threats
5.3 PESTEL Analysis
5.3.1 Political
5.3.2 Economic
5.3.3 Social
5.3.4 Technological
5.3.5 Legal
5.3.6 Environment
5.4 Porter's Five Forces Model
5.4.1 Bargaining Power of Suppliers
5.4.2 Bargaining Power of Buyers
5.4.3 Threat of New Entrants
5.4.4 Threat of Substitutes
5.4.5 Degree of Rivalry
5.5 Key Demand Indicators
5.6 Key Price Indicators
5.7 Industry Events, Initiatives, and Trends
5.8 Value Chain Analysis
6 Japan In Vitro Diagnostics Market Segmentation (218-2034)
6.1 Japan In Vitro Diagnostics Market (2018-2034) by Product & Services
6.1.1 Market Overview
6.1.2 Reagents and Kits
6.1.3 Instruments
6.1.4 Software and Services
6.2 Japan In Vitro Diagnostics Market (2018-2034) by Technology
6.2.1 Market Overview
6.2.2 Immunodiagnostics
6.2.2.1 Enzyme-Linked Immunosorbent Assay (ELISA)
6.2.2.2 Enzyme-Linked Immunospot (ELISPOT)
6.2.2.3 Rapid Tests
6.2.2.4 Radioimmunoassay (RIA)
6.2.2.5 Western Blotting
6.2.2.6 Others
6.2.3 Clinical Chemistry
6.2.3.1 Basic Metabolic Panels
6.2.3.2 Liver Panels
6.2.3.3 Renal Profiles
6.2.3.4 Lipid Profiles
6.2.3.5 Thyroid Function Panels
6.2.3.6 Electrolyte Panels
6.2.3.7 Specialty Chemical Tests
6.2.4 Molecular Diagnostics
6.2.4.1 Polymerize Chain Reaction (PCR)
6.2.4.2 Isothermal Nucleic Acid Amplification Technology (INAAT)
6.2.4.3 Hybridization
6.2.4.4 DNA Diagnostics
6.2.4.5 Microarray
6.2.4.6 Others
6.2.5 Hematology
6.2.6 Microbiology
6.2.7 Coagulation and Haemostasias
6.2.8 Urinalysis
6.2.9 Others
6.3 Japan In Vitro Diagnostics Market (2018-2034) by Application
6.3.1 Market Overview
6.3.2 Infectious Diseases
6.3.3 Diabetes
6.3.4 Oncology
6.3.5 Cardiology
6.3.6 Drug Testing/Pharmacogenomics
6.3.7 HIV/AIDS
6.3.8 Autoimmune Diseases
6.3.9 Nephrology
6.3.10 Others
6.4 Japan In Vitro Diagnostics Market (2018-2034) by End User
6.4.1 Market Overview
6.4.2 Hospitals
6.4.3 Diagnostic Centers
6.4.4 Point-of-Care Testing
6.4.5 Academic Institutes
6.4.6 Others
7 Regulatory Framework
8 Funding and Investment Analysis
8.1 Analysis by Funding Instances
8.2 Analysis by Type of Funding
8.3 Analysis by Funding Amount
8.4 Analysis by Leading Players
8.5 Analysis by Leading Investors
9 Strategic Initiatives
9.1 Analysis by Partnership Instances
9.2 Analysis by Type of Initiative
9.3 Analysis by Leading Players
9.4 Analysis by Geography
10 Supplier Landscape
10.1 Market Share Analysis (Top 5 Companies)
10.2 F. Hoffmann-La Roche Ltd.
10.2.1 Financial Analysis
10.2.2 Product Portfolio
10.2.3 Demographic Reach and Achievements
10.2.4 Company News and Developments
10.2.5 Certifications
10.3 Bio-Rad Laboratories, Inc.
10.3.1 Financial Analysis
10.3.2 Product Portfolio
10.3.3 Demographic Reach and Achievements
10.3.4 Company News and Developments
10.3.5 Certifications
10.4 bioMerieux SA
10.4.1 Financial Analysis
10.4.2 Product Portfolio
10.4.3 Demographic Reach and Achievements
10.4.4 Company News and Developments
10.4.5 Certifications
10.5 Sysmex Corporation
10.5.1 Financial Analysis
10.5.2 Product Portfolio
10.5.3 Demographic Reach and Achievements
10.5.4 Company News and Developments
10.5.5 Certifications
10.6 Abbott
10.6.1 Financial Analysis
10.6.2 Product Portfolio
10.6.3 Demographic Reach and Achievements
10.6.4 Company News and Developments
10.6.5 Certifications
10.7 Thermo Fisher Scientific Inc.
10.7.1 Financial Analysis
10.7.2 Product Portfolio
10.7.3 Demographic Reach and Achievements
10.7.4 Company News and Developments
10.7.5 Certifications
10.8 QIAGEN
10.8.1 Financial Analysis
10.8.2 Product Portfolio
10.8.3 Demographic Reach and Achievements
10.8.4 Company News and Developments
10.8.5 Certifications
10.9 Quidel Corporation
10.9.1 Financial Analysis
10.9.2 Product Portfolio
10.9.3 Demographic Reach and Achievements
10.9.4 Company News and Developments
10.9.5 Certifications
10.10 Danaher Corporation
10.10.1 Financial Analysis
10.10.2 Product Portfolio
10.10.3 Demographic Reach and Achievements
10.10.4 Company News and Developments
10.10.5 Certifications
11 Japan In Vitro Diagnostics Market - Distribution Model (Additional Insight)
11.1 Overview
11.2 Potential Distributors
11.3 Key Parameters for Distribution Partner Assessment
12 Key Opinion Leaders (KOL) Insights (Additional Insight)
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