아시아태평양의 체외진단 시장 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, Asia-Pacific in-vitro diagnostics market size in 2026 is estimated at USD 27.01 billion, growing from 2025 value of USD 25.59 billion with 2031 projections showing USD 35.4 billion, growing at 5.54% CAGR over 2026-2031.

This report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, and More), Product (Instruments, Reagents, and More), Usability (Disposable IVD Devices, and Reusable IVD Devices), Application (Infectious Diseases, Diabetes, and More), End User (Diagnostic Laboratories, and More), and Country (China, Japan, and More). The Market Forecasts are Provided in Terms of Value (USD).

Asia Pacific In-Vitro Diagnostics Market Trends and Insights

Demographic ageing escalating demand for high-value diagnostics

Japan's 65+ cohort reached 29.1% in 2024 and China's elderly population is expanding 3.2% yearly, translating into higher volumes for oncology and cardiovascular assays. Health ministries are backing proactive detection to trim downstream treatment spending, with every USD 1 spent on early testing saving USD 3.4 in future care. Biomarkers such as pTau181 are entering routine workflows following the 2025 launch of Roche's Elecsys pTau181 assay. Specialized geriatric diagnostics-Alzheimer's, frailty panels, and cardio-renal markers-are beginning to form micro-segments that command premium pricing.

Government-mandated cancer & infectious-disease screening programs

China's Healthy China 2030 initiative directed USD 8.7 billion to cancer-screening infrastructure in 2024, while India lifted diagnostic allocations by 43% for 2024-2025. Standardized nationwide protocols favor automated, high-throughput platforms and incentivize firms aligned with priority diseases. bioMerieux now channels 75% of its global R&D budget to antimicrobial-resistance assays to meet these public-health agendas. Economic planners link screening coverage to labor-productivity gains, further embedding diagnostics in macro-development strategy.

Lengthy multi-agency regulatory approvals delaying product launches

Average clearance spans 18-24 months in Japan and 14-20 months in China, against 9-12 months for Western dossiers. Compliance outlays run 37% higher regionally, pushing smaller innovators to partner or concede share to multinationals that can field dedicated regulatory teams. ASEAN's harmonization roadmap shows progress, yet uneven national transposition slows benefits. Rapid-cycle technologies risk obsolescence before approval, compelling firms to sequence launches or adopt modular filings that can accommodate iterative upgrades.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of automated laboratory hubs into Tier-2/3 cities improving test accessibility
2. Localization incentives drawing IVD manufacturing CAPEX
3. Skills shortage in molecular and bio-informatics outside metropolitan laboratories

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Immunodiagnostics held 25.12% Asia-Pacific in-vitro diagnostics market share in 2025, reflecting entrenched use across infection control and chronic-disease monitoring. Molecular diagnostics is forecast for a 9.71% CAGR, dwarfing the broader 5.54% trend, and its Asia-Pacific in-vitro diagnostics market size contribution will climb steadily through 2031. Investment funnels into precision oncology and real-time pathogen surveillance, with PCR remaining the workhorse while next-generation sequencing moves downstream.

Point-of-care molecular platforms now deliver results in under an hour, vital for sepsis and respiratory triage. AI-augmented algorithms raise diagnostic accuracy by 28% when paired with molecular outputs. The COVID-19 infrastructure boom left a durable installed base, lowering entry barriers for broader assays. Suppliers that integrate multiplex capability, sample-to-answer simplicity, and cloud analytics are best placed to win micro-lab and emergency-department budgets.

Reagents and kits provided 59.65% of revenue in 2025 thanks to repeat-purchase economics inherent in testing workflows. Instruments remain critical, yet software and services will compound at 11.07% annually and account for a rising slice of Asia-Pacific in-vitro diagnostics market size. Laboratories demand cloud laboratory-information systems, middleware analytics, and AI-driven decision support to convert raw data into actionable care insights.

Roche's 2025 cobas roadmap embeds machine-learning modules that flag utilization gaps and recommend test panels, helping facilities balance cost and clinical yield. Subscription models tied to uptime guarantees and continuous algorithm upgrades broaden recurring revenue streams. Interoperability with electronic medical records and payer portals has become a key tender criterion, advantaging vendors that champion open-API strategies.

Complete Report Scope:

• By Test Type
  • Clinical Chemistry
  • Molecular Diagnostics
  • Immunodiagnostics
  • Hematology
  • Coagulation
  • Microbiology
  • Urinalysis
• By Product
  • Instruments
  • Reagents & Kits
  • Software & Services
• By Usability
  • Disposable IVD Devices
  • Reusable IVD Devices
• By Application
  • Infectious Diseases
  • Diabetes
  • Oncology
  • Cardiology
  • Autoimmune Diseases
  • Nephrology
  • Respiratory Diseases
  • Other Applications
• By End User
  • Diagnostic Laboratories
  • Hospitals & Clinics
  • Academic & Research Institutes
  • Home Care & Self-testing
• By Country
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia-Pacific

List of Companies Covered in this Report:

1. Abbott Laboratories
2. Roche
3. Danaher
4. Siemens Healthineers
5. Thermo Fisher Scientific
6. bioMerieux
7. Sysmex
8. QIAGEN
9. Beckton Dickinson
10. Bio-Rad Laboratories
11. Arkray
12. Tosoh
13. QuidelOrtho
14. Agilent Technologies
15. Mindray
16. Seegene
17. DiaSorin S.p.A. (Luminex)
18. Genrui Biotech Inc.
19. Werfen Life Diagnostic
20. Fujirebio Holdings Inc.
21. Meril Life Science

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Demographic Ageing Escalating Demand For High-Value Diagnostics
  • 4.2.2 Government-Mandated Cancer & Infectious-Disease Screening Programs
  • 4.2.3 Expansion Of Automated Laboratory Hubs Into Tier-2/3 Cities Improving Test Accessibility
  • 4.2.4 Localization Incentives Drawing IVD Manufacturing CAPEX
  • 4.2.5 Rising Diabetes & Metabolic-Syndrome Burden Sustaining Assay Volumes
• 4.3 Market Restraints
  • 4.3.1 Lengthy Multi-Agency Regulatory Approvals Delaying Product Launches
  • 4.3.2 Skills Shortage In Molecular And Bio-Informatics Outside Metropolitan Laboratories
  • 4.3.3 Quality Variability Of Ultra-Low-Cost Domestic Reagents Eroding Clinician Confidence
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Bargaining Power of Suppliers
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitute Products
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Test Type
  • 5.1.1 Clinical Chemistry
  • 5.1.2 Molecular Diagnostics
  • 5.1.3 Immunodiagnostics
  • 5.1.4 Hematology
  • 5.1.5 Coagulation
  • 5.1.6 Microbiology
  • 5.1.7 Urinalysis
• 5.2 By Product
  • 5.2.1 Instruments
  • 5.2.2 Reagents & Kits
  • 5.2.3 Software & Services
• 5.3 By Usability
  • 5.3.1 Disposable IVD Devices
  • 5.3.2 Reusable IVD Devices
• 5.4 By Application
  • 5.4.1 Infectious Diseases
  • 5.4.2 Diabetes
  • 5.4.3 Oncology
  • 5.4.4 Cardiology
  • 5.4.5 Autoimmune Diseases
  • 5.4.6 Nephrology
  • 5.4.7 Respiratory Diseases
  • 5.4.8 Other Applications
• 5.5 By End User
  • 5.5.1 Diagnostic Laboratories
  • 5.5.2 Hospitals & Clinics
  • 5.5.3 Academic & Research Institutes
  • 5.5.4 Home Care & Self-testing
• 5.6 By Country
  • 5.6.1 China
  • 5.6.2 Japan
  • 5.6.3 India
  • 5.6.4 Australia
  • 5.6.5 South Korea
  • 5.6.6 Rest of Asia-Pacific

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 F. Hoffmann-La Roche Ltd.
  • 6.3.3 Danaher Corporation
  • 6.3.4 Siemens Healthineers AG
  • 6.3.5 Thermo Fisher Scientific Inc.
  • 6.3.6 bioMerieux SA
  • 6.3.7 Sysmex Corporation
  • 6.3.8 QIAGEN N.V.
  • 6.3.9 Becton, Dickinson and Company
  • 6.3.10 Bio-Rad Laboratories, Inc.
  • 6.3.11 ARKRAY, Inc.
  • 6.3.12 Tosoh Corporation
  • 6.3.13 QuidelOrtho Corporation
  • 6.3.14 Agilent Technologies, Inc.
  • 6.3.15 Mindray Medical International Ltd.
  • 6.3.16 Seegene Inc.
  • 6.3.17 DiaSorin S.p.A. (Luminex)
  • 6.3.18 Genrui Biotech Inc.
  • 6.3.19 Werfen Life Diagnostic
  • 6.3.20 Fujirebio Holdings Inc.
  • 6.3.21 Meril Life Sciences Pvt. Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment