Asia Pacific In-Vitro Diagnostics Market Size and Share

Asia Pacific In-Vitro Diagnostics Market (2025 - 2030)
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Asia Pacific In-Vitro Diagnostics Market Analysis by Mordor Intelligence

The current Asia-Pacific in-vitro diagnostics market size stands at USD 25.59 billion in 2025 and is forecast to reach USD 33.76 billion by 2030, expanding at a 5.70% CAGR. Robust healthcare spending, wider diagnostic reach, and a mounting chronic-disease burden underpin this steady trajectory. Rising government screening mandates, ageing populations, and industry-friendly localization incentives are opening profitable niches, while precision-medicine technologies—especially molecular assays—are changing competitive rules. Multinational and regional manufacturers are accelerating factory builds and digital upgrades to secure regulatory clearance faster, capture growth in Tier-2/3 cities, and serve the increasing preference for self-testing. Competitive intensity remains moderate, yet price pressure and quality concerns around ultra-low-cost reagents continue to shape procurement choices.

Key Report Takeaways

  • By test type, immunodiagnostics led with 25.4% of Asia-Pacific in-vitro diagnostics market share in 2024; molecular diagnostics is projected to post the fastest 9.9% CAGR through 2030. 
  • By product, reagents and kits captured 60.2% of the Asia-Pacific in-vitro diagnostics market size in 2024, while software and services are advancing at an 11.4% CAGR between 2025 and 2030. 
  • By usability, reusable devices held 70.5% revenue share in 2024; disposable devices are forecast to expand at a 10.0% CAGR by 2030. 
  • By application, infectious-disease testing accounted for a 33.8% share of the Asia-Pacific in-vitro diagnostics market size in 2024, whereas oncology is growing at an 11.3% CAGR through 2030. 
  • By end user, diagnostic laboratories commanded 55.2% share in 2024 and home-care self-testing is expected to deliver a 12.4% CAGR over 2025-2030. 
  • By country, China dominated with 45.3% of regional revenue in 2024; India is on track for the strongest 12.0% CAGR to 2030. 

Segment Analysis

By Test Type: Molecular Diagnostics Redefining Clinical Practice

Immunodiagnostics held 25.4% Asia-Pacific in-vitro diagnostics market share in 2024, reflecting entrenched use across infection control and chronic-disease monitoring. Molecular diagnostics is forecast for a 9.9% CAGR, dwarfing the broader 5.70% trend, and its Asia-Pacific in-vitro diagnostics market size contribution will climb steadily through 2030. 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.

Asia Pacific In-Vitro Diagnostics Market: Market Share by Test Type
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By Product: Software Integration Driving Value Creation

Reagents and kits provided 60.2% of revenue in 2024 thanks to repeat-purchase economics inherent in testing workflows. Instruments remain critical, yet software and services will compound at 11.4% 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.

By Usability: Disposable Devices Expanding Access Points

Reusable analyzers dominated with 70.5% share in 2024, but disposable devices will outrun aggregate growth at a 10.0% CAGR. Microfluidic cartridges now host multiplex molecular and immunoassay chemistries, bringing lab-grade accuracy to physician offices, retail clinics, and homes. Reduced maintenance, no calibration flows, and biosafety convenience underpin clinical uptake. 

Infectious-disease screening benefits strongly; single-use molecular panels for influenza and RSV entered mainstream pediatric practice after pandemic-era evaluation. BioMérieux’s 2024 acquisition of SpinChip provides edge-printed microfluidic disposables capable of running enzyme assays in <15 minutes. Sustainable materials and smart-chip recycling solutions are emerging to counter environmental cost criticisms.

By Application: Oncology Driving Precision Medicine Adoption

Infectious-disease testing held 33.8% of 2024 revenue, yet oncology diagnostics will post an 11.3% CAGR to 2030, almost double the Asia-Pacific in-vitro diagnostics market growth pace. Liquid biopsy advances allow early relapse detection and therapy monitoring without invasive tissue sampling. Comprehensive genomic panels and companion diagnostics underpin personalized treatment, with breast, lung, and colorectal cancers the early beneficiaries. 

AI-assisted pattern recognition across imaging and molecular datasets yields 31% higher early-stage discovery rates. Payers gradually reimburse high-value genomics after cost-effectiveness evidence accumulates. Vendors offering end-to-end oncology solutions—from screening through minimal residual disease monitoring—will consolidate loyalty among leading cancer centers.

Asia Pacific In-Vitro Diagnostics Market: Market Share by Application
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By End User: Self-Testing Revolution Transforming Care Models

Diagnostic laboratories processed 55.2% of volumes in 2024, leveraging bulk purchasing and sophisticated robotics. Home-care and self-testing, however, will accelerate at 12.4% CAGR, unlocking new Asia-Pacific in-vitro diagnostics market potential. Smartphone-linked lateral-flow cassettes and Bluetooth glucose readers demonstrate how consumer electronics ecosystems absorb health functions. 

The FDA’s 2025 Home as a Health Care Hub guidance catalyzes device designs prioritizing intuitive app interfaces and remote physician oversight. Roche’s Accu-Chek SmartGuide pairs continuous glucose reading with AI-generated coaching, highlighting how hardware, software, and behavioral nudges interlock. National insurers explore reimbursements for validated self-tests that lower emergency visits and enable population-level surveillance.

Geography Analysis

China captured 45.3% of the Asia-Pacific in-vitro diagnostics market in 2024, anchored by vast population, hospital digitization, and strategic policy such as tender bundling for high-throughput systems. Despite near-term price caps that squeezed margins for multinationals, ongoing NMPA reforms promise streamlined pathways for localized production and innovative assays[3]National Medical Products Administration, “Medical Device Regulatory Update 2025,” nmpa.gov.cn. Rural diagnostics networks supported by 5G cloud links extend testing far beyond megacities. 

India is the growth pacesetter at a 12.0% CAGR. Government PLI incentives, rising insurance coverage, and public-private lab chains fuel double-digit revenue expansion. Immunology demand is set to double from INR 160 billion to INR 320 billion within the decade, signaling lucrative viral-hepatitis and auto-immune test segments. Urban dominance persists, but hub-and-spoke rollouts plus mobile vans gradually shrink rural diagnostic gaps. 

Japan and South Korea remain high-value markets thanks to affluent ageing demographics, automated mega-labs, and a culture of preventive screening. Australia’s strong evidence-based procurement sustains premium pricing for precision assays, while Indonesia, Thailand, and Vietnam climb from low bases with infrastructure upgrades and donor-backed disease programs. Hong Kong’s InnoLife Healthtech Hub positions the city as an R&D and finance gateway for regional genomics start-ups.

Competitive Landscape

Roughly 200 manufacturers vie for a share; the top 10 control a significant share, indicating moderate concentration. Abbott, Roche, and Siemens Healthineers leverage wide portfolios and service networks to lock multi-year reagent contracts. Mindray and Seegene exploit cost agility and local insight to penetrate mid-tier hospitals. Localization of manufacturing—e.g., Sysmex’s 2025 India plant—reduces tariffs and wins public tenders stipulating domestic value addition. 

Molecular and point-of-care segments see brisk product launches and smaller players introducing niche platforms, spurring faster turnover of technology cycles. Integration of software analytics into instruments adds new barriers to entry; vendors capable of combining assay chemistry with AI dashboards achieve sticky customer relationships. Partnerships between diagnostics firms and tele-health platforms signal future ecosystem plays where test results trigger automated care pathways. 

Regulatory navigation remains a differentiator. Advantaged firms pre-engage with agencies, leverage real-world evidence for conditional filings, and adopt modular submissions to shorten time-to-market. Pricing reform pressures compel innovation in value-based contracting, bundling reagents, service, and data analytics for outcome-linked payments, particularly in oncology and diabetes management.

Asia Pacific In-Vitro Diagnostics Industry Leaders

  1. Siemens Healthineers AG

  2. bioMérieux SA

  3. Thermo Fisher Scientific

  4. F Hoffmann-La Roche Ltd

  5. Abbott Laboratories

  6. *Disclaimer: Major Players sorted in no particular order
Asia Pacific In Vitro Diagnostics Market Concentration
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Recent Industry Developments

  • April 2025: Sysmex began full-scale operations at its new Indian plant and commenced manufacturing the XQ-Series automated hematology analyzer.
  • February 2025: Roche secured Japanese and Australian approval for its SBX sequencing technology, widening access to high-throughput genomic oncology testing.

Table of Contents for Asia Pacific In-Vitro Diagnostics Industry Report

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
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Asia Pacific In-Vitro Diagnostics Market Report Scope

As per the scope of the report, in vitro diagnostics involve medical devices and consumables that are utilized to perform in-vitro tests on various biological samples. They diagnose various medical conditions, such as diabetes and cancer. The Asia Pacific In-vitro Diagnostics Market is segmented by test type (clinical chemistry, molecular diagnostics, immunodiagnostics, hematology, and other test types), product (instruments, reagents, and other products), usability (disposable IVD devices and reusable IVD devices), application (infectious disease, diabetes, cancer/oncology, cardiology, autoimmune disease, nephrology, and other applications), end user (diagnostic laboratories, hospitals and clinics, and other end users), and Geography (China, Japan, India, Australia, South Korea, and rest of Asia-Pacific). The report offers values (in USD) for the above segments.

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
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
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Key Questions Answered in the Report

How large is the Asia-Pacific in-vitro diagnostics market in 2025?

The market is valued at USD 25.59 billion in 2025 and is forecast to reach USD 33.76 billion by 2030.

Which test type is expanding the fastest across Asia-Pacific?

Molecular diagnostics is growing at a 9.9% CAGR due to wider precision-oncology and infectious-disease use cases.

Why is India considered the most dynamic market within Asia-Pacific?

India's 12.0% CAGR stems from large infrastructure investments, supportive manufacturing incentives, and rising disease awareness.

How are regulations affecting product launch timelines?

Multi-agency approvals in Japan and China extend launch timelines to 14-24 months, increasing compliance costs and favoring firms with dedicated regulatory teams.

Which companies recently expanded manufacturing in the region?

Sysmex opened a new Indian plant in April 2025, and Roche gained approvals for its SBX sequencing system in Japan and Australia in February 2025.

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