China In-Vitro Diagnostics (IVD) Market Research Report 2022-2028: Impact of COVID-19, Size, Share, Regulations, Reimbursement, Major Deals, Key Players Analysis, Trends & Recent Developments –

DUBLIN–()–The “China In-Vitro Diagnostics (IVD) Market, Impact of COVID-19, Size, Share, Regulations, Reimbursement, Major Deals, Key Players Analysis, Trends & Recent Developments – Forecast to 2028” report has been added to’s offering.

China In-Vitro Diagnostics (IVD) market is predicted to reach US$ 21 Billion by 2028

China represents one of the largest clinical laboratory markets in the Asia-Pacific region, and the fastest growing among the top ten IVD country markets. Historically, large multinational companies have dominated IVD market in China; today, domestic companies such as Shanghai Kehua Bio-Engineering (KHB) being one of the largest – are now gaining market share.

China is a large and fast-growing in vitro diagnostics (IVD) market – in fact, only second to the United States in terms of value. China’s quickly aging population means the country is experiencing an explosion of chronic conditions such as diabetes, heart disease and cancer. All of these conditions can be diagnosed and monitored using IVD products.

Moreover, 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.

Impact of COVID-19 on China In-Vitro Diagnostics Market

The COVID-19 outbreak has become a global stress test. As the number of people infected with the virus continues to rise around the world, uncertainties about global economic growth increases.

The COVID-19 disease has infected around 486 Million people worldwide. Globally the death toll has reached 6,157,201 according to the latest statistics from the Worldometers (as of March 30, 2022). In China, COVID-19 disease has infected around 147,437 people (as of March 30, 2022), and the death toll has reached 4,638. The clouds of the new coronavirus threat loom over the world and continue to create havoc in the lives of millions of people.

Maximum testing and quick hospitalization are key components for flattening the curve. In this scenario, the in-vitro diagnostics forms the crux of increased testing. Manufacturers in the in-vitro diagnostic market are focusing on developing novel technologies for maximum testing within a minimum period.

For instance, in April 2021, Sysmex Corporation obtained in vitro diagnostic approval for the manufacturing and marketing of the DetectAmp SARS-CoV-2 RT-PCR Kit, a SARS coronavirus nucleic acid kit that detects the RNA of the novel coronavirus (SARS-CoV-2).

The novel coronavirus has accelerated the research and development activities in the in-vitro diagnostics market. Development and production in maximum numbers is the need of the hour. Therefore, quick approvals are proving to be the cherry on the cake for the growth of the in-vitro diagnostic market.

China IVD Market Segment Wise Analysis

  • Immunoassay captures maximum share of the China IVD market, being followed by Clinical Chemistry segment
  • Molecular Testing stands at the 3rd spot and its market share is expected to rise throughout the forecast period, due to steady demand of polymerase chain reaction (PCR) products in China IVD market
  • China SMBG market is dominated by foreign IVD companies such as Roche
  • Microbiology and Hematology segments are competing closely with each other to grab maximum share of the pie
  • Point of Care Testing accounts for least share of the China IVD market

China IVD Market Company Analysis

  • Roche captures maximum share of the China IVD market, followed by Sysmex Corporation.
  • Shanghai Kehua Bio-Engineering Co. Ltd. and Abbott Laboratories are the other top two players in the China IVD market.
  • Sysmex has built a robust infrastructure in China, working with more than 400 sales distributors to provide products and services throughout the country
  • In Abbott’s worldwide diagnostics business, sales growth over the last four years reflected the acquisition of Alere in October of 2017
  • In March 2022, Mindray, a global leading medical solution provider, has launched the new BC-700 Series, a revolutionary hematology analyzer series that incorporates both complete blood count (CBC) and erythrocyte sedimentation rate (ESR) tests
  • In February 2022, Sysmex Corporation formed a capital and business tie-up with KAINOS Laboratories, Inc. with a view toward strengthening capabilities to develop and produce diagnostic reagents in the immunochemistry field

Key Topics Covered:

1. Executive Summary

2. Impact of COVID-19 on China IVD Market

3. China IVD Market and Market Share Analysis (2010 – 2028)

3.1 China IVD Market and Forecast

3.2 China IVD Market Share and Forecast

3.3 China IVD Company Share and Forecast

4. China IVD – Segments Wise Market and Forecast (2010 – 2028)

4.1 China Clinical Chemistry Market and Forecast

4.2 China Immunoassay Market and Forecast

4.3 China Hematology Market and Forecast

4.4 China Coagulation Market and Forecast

4.5 China Microbiology Market and Forecast

4.6 China Molecular Testing Market and Forecast

4.7 China Self-Monitoring of Blood Glucose (SMBG) Market and Forecast

4.8 China Point of Care Testing (POCT) Market and Forecast

5. Development Environment of Chinese IVD Industry

5.1 State Healthcare Reforms

5.2 State Citizen-Benefiting Policies

5.3 Requirements of Hospital Upgrading

5.4 Healthy China 2030

6. Profile of In-vitro Diagnostic Reagents Registration Control

6.1 Classification of In-vitro Diagnostic Reagents in China

6.1.1 Class III: Highest Risk

6.1.2 Class II: Medium Risk

6.1.3 Class I: Lower Risk

6.2 Regulatory History in China IVD Market

6.3 Regulatory Status in China IVD Market

6.3.1 Blood Screening Reagents – Drug Administration

6.3.2 Varieties of Blood Screening Reagents

6.3.3 Blood Screening Reagent Test

6.3.4 Nucleic Acid Detection Kits for Blood Screening

6.3.5 Radioactive reagents – Drug Administration

6.3.6 Diagnostic Reagents – Medical Devices Management

6.4 Regulatory Trend in China IVD Market

6.4.1 Blood Screening Reagents Belonging

6.4.2 Quality Improvement

6.4.3 Pre-Evaluation of Registration Standards

7. Registration for In Vitro Diagnostic Reagents in China

7.1 Registration and Filing

7.2 Filing Obligation for Clinical Trials

7.3 Clinical Trial Institutions

7.4 Elimination of IVD Loophole for Research

7.5 Change of Manufacturing Address

7.6 Change of Main Supplier of An Antigen or Antibody

7.7 China In Vitro Diagnostics Registration Update

7.7.1 IVD Product Registration in China

7.7.2 China IVD Type Testing Process

7.7.3 Clinical Trials for IVD Products in China

8. Reimbursement of IVD Products in China

9. China IVD Market – Key Players Sales Analysis (2010 – 2027)

9.1 Roche Diagnostics

9.2 Abbott Laboratories

9.3 Sysmex Corporation

9.4 Mindray Medical International Limited

9.5 Shanghai Kehua Bio-Engineering Co. Ltd.

9.6 Bio-Rad Laboratories, Inc

9.7 Danaher Corporation

9.8 Biomerieux

10. Profiles of Select Private Clinical Labs and Diagnostic Services Companies

10.1 Dian Diagnostics Group Co. Ltd. (Formerly Zhejiang Di’an Diagnostics Technology Co., Ltd.)

10.2 ADICON Clinical Laboratories (Privately held)

10.3 Guangzhou KingMed Diagnostics Center Co. Ltd.

10.4 Kindstar Global (Privately held)

10.5 BGI-Shenzhen

10.6 OriGene Technologies

11. IVD Market – Recent Developments

12. IVD Market – Major Deals

12.1 2022

12.2 2021

12.3 2020

12.4 2019

12.5 2018

12.6 2017

12.7 2016

13. China IVD Market – Driving Factors

13.1 Government Efforts to Regulate Laboratory testing

13.2 Healthy China 2030 Initiatives to Fuel China IVD Market

13.3 Increasing Number of Private Hospitals & Independent Testing Laboratories

13.4 Chinese Government Policies Encourage Investment in IVD

13.5 Technology Advancement Spurring the IVD Market

13.6 High Prevalence of Chronic and Infectious Diseases

14. China IVD Market – Challenges

14.1 Lack of Expertise in Advanced Technology in the Local Companies

14.2 Price Pressures Limits Participation of Multinational IVD Companies in China IVD Market

14.3 Reimbursement Rates of Different Products Varies in Different Provinces

14.4 Operational Barriers Faced in Conducting Diagnostic Tests

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