중국의 체외진단 시장 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The China in vitro diagnostics (IVD) market stands at USD 18.65 billion in 2025 and is forecast to reach USD 23.81 billion by 2030, registering a 5.01% CAGR.

Demand is buoyed by a rapidly ageing population, the country's high chronic-disease burden, and steady policy support for primary-care diagnostics. Streamlined National Medical Products Administration (NMPA) pathways shorten review timelines for high-value tests, while volume-based procurement (VBP) anchors price transparency and encourages wider adoption in lower-tier settings. Local manufacturers leverage 20% procurement price advantages to capture share, and artificial-intelligence (AI) tools embedded in tier-2/3 hospitals slash turnaround times from 30 minutes to five. Concurrently, disposable platforms gain traction as infection-control protocols persist and point-of-care (POC) solutions penetrate rural clinics.

China In Vitro Diagnostics Market Trends and Insights

High Burden of Chronic & Infectious Diseases

Diabetes affects over 140 million adults, prompting sustained demand for glucose monitoring and HbA1c testing. HIV cases reached nearly 1.3 million by 2023, broadening screening beyond traditional risk groups. C-reactive protein testing shows 72.23% sensitivity for tuberculosis screening among HIV-infected persons, highlighting the need for multi-marker panels. Point-of-care HbA1c tests deliver cost-utility ratios of USD 500.06/QALY in cities and USD 185.10/QALY in rural areas, well within national willingness-to-pay thresholds. These factors collectively sustain molecular and immunoassay volumes, particularly in decentralised settings.

Ageing Population Accelerating Diagnostic Demand

China counts 310 million citizens aged 60 and above, intensifying utilisation of cardiovascular, oncology and cognitive assays. Coordination studies point to widening gaps between elderly demand and diagnostic capacity in secondary cities. Government spending is projected to hit CNY 205 trillion (USD 28.2 trillion) by 2030, with diagnostics earmarked for geriatric care. Health All-in-One Machines boosted patient visits 37.85% and clinic revenue 54.03% in Hainan's rural network. The demographic shift therefore underpins automated, multi-condition test platforms.

Uncertain Reimbursement for Novel Assays

Volume-based procurement favours established technologies, delaying payment codes for emerging molecular and AI-enabled tests. Diagnosis-Intervention Packet pilots in 71 cities underscore reimbursement evolution but also risk inequities across insurance schemes, slowing novel assay uptake.

Other drivers and restraints analyzed in the detailed report include:

1. Government Price-Volume Procurement (PVP) Expanding Access
2. Rapid Decentralisation to Point-of-Care Settings
3. Stringent NMPA Clinical-Trial Requirements

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

Segment Analysis

Molecular diagnostics held 39.37% share in 2024, anchoring the China in vitro diagnostics (IVD) market. Immunodiagnostics rises fastest at 5.84% CAGR to 2030, backed by automation and infection-surveillance requirements. BGI Genomics' legal success against Illumina and a 4% uptick in sequencing-device sales illustrate home-grown momentum. Clinical chemistry remains relevant through entrenched hospital networks, while rapid nucleic-acid methods and CRISPR detection bolster pandemic preparedness.

The China in vitro diagnostics (IVD) industry benefits from AI-enhanced test-menu optimisation in secondary hospitals, improving throughput. Microbiology enjoys renewed focus after COVID-19, with C-reactive protein tests expanding tuberculosis programmes. Urinalysis and niche panels gain share through integrated POC devices that lower handling errors. Advances in microfluidics and sample-to-answer cartridges keep molecular diagnostics at the innovation frontier.

Reagents and consumables generated 62.29% revenue in 2024 and remain the backbone of recurring income for the China in vitro diagnostics (IVD) market. Yet software and services post a 6.35% CAGR to 2030 as laboratories digitise. Mindray's purchases of HyTest and DiaSys reinforce vertical integration, while Chemclin's automated immunodetection systems marry local cost advantages with export-level quality.

Laboratory-information management systems, AI analytics and cloud dashboards transform workflows, and blockchain tools address data-security mandates under the Personal Information Protection Law. Instrument makers pivot to subscription models bundling hardware, software and consumables, cushioning VBP price pressure. The China in vitro diagnostics (IVD) industry thereby transitions from product-centric to platform-centric value creation.

The China In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Microbiology, and More), Product (Instrument, Reagents & Consumables, and More), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cardiology, and More), and End-User (Hospitals & Clinics, and More). The Market Forecasts are Provided in Terms of Value (USD).

List of Companies Covered in this Report:

1. Roche
2. Mindray
3. Abbott Laboratories
4. Danaher Corp. (Cepheid, Beckman Coulter)
5. Thermo Fisher Scientific
6. BGI Genomics Co. Ltd
7. BD (Becton, Dickinson & Co.)
8. bioMerieux
9. Bio-Rad Laboratories
10. Siemens Healthineers
11. Autobio Diagnostics Co. Ltd
12. Wondfo Biotech Co. Ltd
13. Sansure Biotech Inc.
14. DaAn Gene Co. Ltd
15. Agilent Technologies
16. Maccura Biotechnology
17. Getein Biotech Inc.
18. Arkray
19. Zhongshan Bio-Tech Co. Ltd
20. Shanghai Kehua Bio-Engineering

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 High Burden Of Chronic & Infectious Diseases
  • 4.2.2 Ageing Population Accelerating Diagnostic Demand
  • 4.2.3 Government Price-Volume Procurement (PVP) Expanding Access
  • 4.2.4 Rapid Decentralisation To Point-Of-Care Settings
  • 4.2.5 AI-Assisted Test-Menu Optimisation In Tier-2/3 Hospitals
• 4.3 Market Restraints
  • 4.3.1 Uncertain Reimbursement For Novel Assays
  • 4.3.2 Stringent NMPA Clinical-Trial Requirements
  • 4.3.3 Data-Privacy Compliance Costs (PIPL, CSL)
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 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
  • 5.1.8 Others
• 5.2 By Product
  • 5.2.1 Instruments
  • 5.2.2 Reagents & Consumables
  • 5.2.3 Software & Services
• 5.3 By Usability
  • 5.3.1 Disposable IVD Devices
  • 5.3.2 Re-usable IVD Devices
• 5.4 By Application
  • 5.4.1 Infectious Disease
  • 5.4.2 Diabetes
  • 5.4.3 Oncology
  • 5.4.4 Cardiology
  • 5.4.5 Auto-immune Disorders
  • 5.4.6 Nephrology
  • 5.4.7 Pregnancy & Women's Health
  • 5.4.8 Others
• 5.5 By End-user
  • 5.5.1 Independent Clinical Laboratories
  • 5.5.2 Hospitals & Clinics
  • 5.5.3 Academic / Research Institutes

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 F. Hoffmann-La Roche AG
  • 6.3.2 Shenzhen Mindray Bio-Medical Electronics Co. Ltd
  • 6.3.3 Abbott Laboratories
  • 6.3.4 Danaher Corp. (Cepheid, Beckman Coulter)
  • 6.3.5 Thermo Fisher Scientific Inc.
  • 6.3.6 BGI Genomics Co. Ltd
  • 6.3.7 BD (Becton, Dickinson & Co.)
  • 6.3.8 BioMerieux SA
  • 6.3.9 Bio-Rad Laboratories Inc.
  • 6.3.10 Siemens Healthineers AG
  • 6.3.11 Autobio Diagnostics Co. Ltd
  • 6.3.12 Wondfo Biotech Co. Ltd
  • 6.3.13 Sansure Biotech Inc.
  • 6.3.14 DaAn Gene Co. Ltd
  • 6.3.15 Agilent Technologies Inc.
  • 6.3.16 Maccura Biotechnology Co. Ltd
  • 6.3.17 Getein Biotech Inc.
  • 6.3.18 Arkray Inc.
  • 6.3.19 Zhongshan Bio-Tech Co. Ltd
  • 6.3.20 Shanghai Kehua Bio-Engineering Co. Ltd

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment