China In-vitro Diagnostics Market Size & Share Analysis - Growth Trends & Forecasts (2023 - 2028)

The Report Covers China In-vitro Diagnostics Companies and the Market is segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immunodiagnostics, Hematology, and Other Types), Product (Instrument, Reagent, and Other Products), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, and Other Applications), and End User (Diagnostic Laboratories, Hospitals and Clinics, and Other End Users). The Values are Provided in Terms of USD Million for above segments.

China In-vitro Diagnostics (IVD) Market Size

China In Vitro Diagnostics Market Summary
Study Period 2019-2027
Base Year For Estimation 2021
Forecast Data Period 2024 - 2028
Historical Data Period 2019 - 2020
CAGR 6.14 %
Market Concentration Medium

Major Players

China In Vitro Diagnostics Market Major Players

*Disclaimer: Major Players sorted in no particular order

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China In-vitro Diagnostics (IVD) Market Analysis

China's In Vitro Diagnostics Market size is expected to grow from USD 10,644.78 million in 2023 to USD 14,339.43 million by 2028, registering a CAGR of 6.14% during the forecast period (2023-2028).

The COVID-19 pandemic turned the spotlight on in vitro diagnostics since there was an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV2 virus infection among the global population. The outbreak of COVID-19 positively impacted the market, as in vitro diagnostics involved the testing of various biological samples. This aided in the diagnosis of infectious diseases such as COVID-19. Testing remained a crucial step in controlling the COVID-19 pandemic. For instance, according to the WHO, 102,762 COVID-19 cases were recorded as of March 2021, with 4,851 deaths in China. The increasing burden of the COVID-19 pandemic led to a high requirement for tests, which boosted the IVD market in the country. However, the stabilizing cases of COVID-19 in China were expected to stabilize the growth of the market. For instance, as per the National Health Commission (NHC), in December 2022, China reported 36,061 new COVID-19 infections, of which 4,150 were symptomatic and 31,911 were asymptomatic. Thus, the stabilizing cases of COVID-19 were expected to bring the growth of China's in vitro diagnostics market back to its pre-pandemic level.

In vitro diagnostics (IVDs) play an important role in detecting infectious diseases. A large number of molecular assays and immunoassays are being used for the detection of COVID-19. China represents one of the largest in vitro diagnostics markets in the Asia-Pacific region, and this trend is expected to continue over the forecast period. Due to an increase in the geriatric population and the high burden of chronic and infectious diseases, like diabetes, cancer, and COVID-19, the market studied is slated to show significant growth, as these chronic disorders can be diagnosed and monitored using IVD products.

In May 2021, the State Council issued a guideline to implement the country's Healthy China initiative to diminish the incidence of disability among elderly people aged between 65 and 74 years by 2022 by offering medical and health services. Such initiatives by the government are expected to boost market growth during the forecast period. But a lack of proper reimbursement and strict regulations could slow the growth of the market.

Also, the increasing number of product launches with advanced features is expected to drive the market. For instance, in March 2021, OpGen announced that it had received regulatory approval from the Chinese National Medical Products Administration for its Curetis Unyvero system as an in vitro diagnostics instrument system. This application was sent in 2019 and included the Unyvero A50 Analyzer, the Unyvero L4 Lysator, and the Unyvero C8 Cockpit.

Due to these and other factors, the in vitro diagnostic market in China is expected to grow over the next few years.

China In-vitro Diagnostics (IVD) Market Trends

Molecular Diagnostics Segment Dominates the Chinese In Vitro Diagnostics Market

In diagnostics research, one of the most valuable advancements has been in the form of molecular diagnostic tools. The polymerase chain reaction is at the forefront of molecular diagnostics. The real-time PCR products simultaneously detect viruses, bacteria, fungi, and parasites, allowing molecular laboratories to operate at lower costs and ensure better outcomes.

Molecular diagnostic tests look for specific sequences in DNA or RNA, such as single nucleotide polymorphisms (SNPs), deletions, rearrangements, insertions, and others, that may or may not be linked to a disease.

Molecular diagnostics were mainly used to diagnose infectious diseases, and with the rising burden and increasing spread of the COVID-19 pandemic, the segment was at its peak in the country. To find viral RNAs that are very specific to the SARS-CoV-2 virus, which caused COVID-19, molecular diagnostic tests were used.

In addition, the rising burden of infectious disease can be attributed to the segment’s growth. For instance, according to the National Health Commission, nearly 1.71 million cases of infectious diseases were reported on the mainland. Approximately 288,739 cases were classified as Class B infectious diseases. Viral hepatitis, TB, syphilis, scarlet fever, and gonorrhea accounted for 94% of these cases. Thus, owing to the rising importance given by clinical laboratories to diagnose diseases in the early stages of development, collaboration with domestic manufacturers, and new product launches, the molecular diagnostics segment is expected to witness good growth over the forecast period in China.

China In Vitro Diagnostics Market: Number of Cases of Infectious Diseases, (in Million), China, 2021

Cancer/Oncology Segment Dominates the Chinese In Vitro Diagnostics Market

Cancer is the second-leading cause of mortality in China. Early detection of cancer and access to effective anti-cancer treatment can result in higher survival rates and a better quality of life. In vitro diagnostics (IVDs) are tests or medical devices that examine human body specimens and provide critical data for screening, diagnosis, and treatment.

The main things that are driving market segment growth in China are the rising number of people with cancer, the rising number of products being approved and put on the market, and the rising amount of money being invested.

According to the report titled "Cancer Statistics in China and the United States, 2022: Profiles, Trends, and Determinants," published in February 2022, compared to the 4,689,754 new cancer cases in China in 2020, the predicted number of new cancer cases for 2022 is 4,820,000. This increase in new cases will directly increase the demand for early diagnosis, thus helping the market grow during the study period. Also, as per the report titled "Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020," published in April 2021, China is expected to experience 6.85 million new cancer cases and 5.07 million deaths in 2040. So, over the next few years, the market will be driven by the rise in cancer cases in China.

Additionally, the growing number of product launches in the region and the high concentration of key players in China act as major factors in driving the market. For instance, in August 2022, the cervical cancer screening test GynTect will be available to physicians and patients in China, the world’s most populous country. In China, this is the first methylation test that has been approved for triage of HPV-positive cases.

Because of all of these factors, the market segment is expected to grow a lot in China over the next few years.

China In Vitro Diagnostics Market: Number of New Cancer Cases and Death (in Million), China, 2022

China In-vitro Diagnostics (IVD) Industry Overview

The Chinese in vitro diagnostic market is moderately competitive and consists of some major players. Many players in this market are trying to expand their product portfolios in order to increase their global market share. These companies focus on strategies such as mergers and acquisitions, collaborations, and new product developments. Key players in the Chinese in vitro diagnostics market are Abbott Laboratories, Shanghai Kehua Bio-Engineering Co., Ltd., Autobio Diagnostics Co., Mindray Medical International Limited, and Maccura Biotechnology, among others.

China In-vitro Diagnostics (IVD) Market Leaders

  1. Autobio Diagnostics

  2. Mindray Medical International Limited

  3. Shanghai Kehua Bio-Engineering Co. Ltd.

  4. Maccura Biotechnology

  5. Xiamen Boson Biotech

*Disclaimer: Major Players sorted in no particular order

China In Vitro Diagnostics Market Concentration
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China In-vitro Diagnostics (IVD) Market News

  • September 2022: AroCell planned to complete TPS CLIA registration in the Chinese market before the end of the year. AroCell expanded the collaboration in the Chinese market by including TPS CLIA on Fosun Diagnostics' fully automated system. Through this collaboration, AroCell's market coverage in the Chinese market for tumor markers was doubled.
  • August 2022: Dx&Vx signed a business agreement with Jointown Medical Devices Group, China's largest pharmaceutical and medical device distributor, to develop, supply, and distribute in vitro diagnostic medical devices.

China In-vitro Diagnostics (IVD) Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 High Burden of Chronic Diseases and Infectious Diseases

      2. 4.2.2 Increasing Use of Point-of-Care (POC) Diagnostics Spurring the IVD Market

      3. 4.2.3 Increasing Awareness and Acceptance of Personalized Medicine

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Proper Reimbursement

      2. 4.3.2 Stringent Regulatory Framework

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Test Type

      1. 5.1.1 Clinical Chemistry

      2. 5.1.2 Molecular Diagnostics

      3. 5.1.3 Immunodiagnostics

      4. 5.1.4 Hematology

      5. 5.1.5 Other Types

    2. 5.2 By Product

      1. 5.2.1 Instrument

      2. 5.2.2 Reagent

      3. 5.2.3 Other Products

    3. 5.3 By Usability

      1. 5.3.1 Disposable IVD Devices

      2. 5.3.2 Reusable IVD Devices

    4. 5.4 By Application

      1. 5.4.1 Infectious Disease

      2. 5.4.2 Diabetes

      3. 5.4.3 Cancer/Oncology

      4. 5.4.4 Cardiology

      5. 5.4.5 Autoimmune Disease

      6. 5.4.6 Nephrology

      7. 5.4.7 Other Applications

    5. 5.5 By End-User

      1. 5.5.1 Diagnostic Laboratories

      2. 5.5.2 Hospitals and Clinics

      3. 5.5.3 Other End-Users

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Autobio Diagnostics Co.

      2. 6.1.2 F. Hoffmann-La Roche AG

      3. 6.1.3 Becton Dickinson & Company

      4. 6.1.4 Shanghai Kehua Bio-Engineering Co. Ltd

      5. 6.1.5 Abbott Laboratories

      6. 6.1.6 Thermofisher Scientific Inc.

      7. 6.1.7 QIAGEN NV

      8. 6.1.8 Xiamen Boson Biotech Co. Ltd

      9. 6.1.9 Maccura Biotechnology Co. Ltd

      10. 6.1.10 BGI Group

      11. 6.1.11 BioMerieux SA

      12. 6.1.12 Bio-Rad Laboratories Inc.

      13. 6.1.13 Danaher Corporation

      14. 6.1.14 Arkray Inc.

      15. 6.1.15 Mindray Medical International Limited

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers Business Overview, Financials, Products and Strategies, and Recent Developments.
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China In-vitro Diagnostics (IVD) Industry Segmentation

As per the scope of this report, in vitro diagnostics involves medical devices and consumables that are utilized to perform in vitro tests on various biological samples. They are used to diagnose various medical conditions, such as chronic diseases. The China in vitro diagnostics market is segmented by test type (clinical chemistry, molecular diagnostics, immunodiagnostics, hematology, and other 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), and end user (diagnostic laboratories, hospitals, and clinics, and other end users). The report offers the value in USD million for the above segments.

By Test Type
Clinical Chemistry
Molecular Diagnostics
Immunodiagnostics
Hematology
Other Types
By Product
Instrument
Reagent
Other Products
By Usability
Disposable IVD Devices
Reusable IVD Devices
By Application
Infectious Disease
Diabetes
Cancer/Oncology
Cardiology
Autoimmune Disease
Nephrology
Other Applications
By End-User
Diagnostic Laboratories
Hospitals and Clinics
Other End-Users
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China In-vitro Diagnostics (IVD) Market Research FAQs

The China In Vitro Diagnostics Market is studied from 2019 - 2027.

The China In Vitro Diagnostics Market is growing at a CAGR of 6.14% over the next 5 years.

Autobio Diagnostics, Mindray Medical International Limited, Shanghai Kehua Bio-Engineering Co. Ltd., Maccura Biotechnology, Xiamen Boson Biotech are the major companies operating in China In Vitro Diagnostics Market.

China In-vitro Diagnostics Industry Report

Statistics for the 2023 China In-vitro Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. China In-vitro Diagnostics analysis includes a market forecast outlook to 2028 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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