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In Vitro Diagnostics (IVD) Market in China, 2021

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Description

As an in vitro diagnostics (IVD) market, China trails only the populous, developed economy markets of the United States, western European countries, and Japan. The country and its healthcare system are confronted by challenges shared by less developed countries, but also burdens common among developed middle-income and affluent countries such as diabetes, cardiovascular disease, and diseases of aging. China as an IVD market opportunity is defined by its standing next to other populous countries with demonstrated economic promise for over the past decade – Brazil, Russia and India (collectively with China referred to as the important, rapidly growing “BRIC” nations).

Scope and Methodology

This Kalorama Information report, In Vitro Diagnostic (IVD) Markets in China, 2021, is designed to provide the reader with an overview of the Chinese laboratory market and its influences.  The focus is on the IVD discipline including reagents, consumables, calibrators and controls of the following sub-segments:

  • Clinical Chemistry: routine lab testing; substrates, enzymes, homogeneous immunoassays, proteins, ISE (non-POC), HBA1c (non-POC), includes urinalysis and blood chemistry testing.
  • Immunoassays: hormones and thyroid function, tumor markers, allergy, anemia, neonatal tests, prenatal tests, interleukins, PCT, toxicology and common infectious diseases (HIV, hepatitis, influenza)
  • Microbiology and Molecular Testing: manual and automated tests, culture media (to be prepared or ready to use), latex tests, transport media, blood culture, sensitivity discs, Gram and other stains, MTB culture, Mycoplasma, Ureaplasma, nucleic acid testing.
  • Point-of-Care Testing: all POC tests for cardiology, toxicology, coagulation, diabetes, infectious diseases, including POC and non-POC blood gas and electrolytes, and glucose self-monitoring tests.
  • Histology/Cytology: PAP, HE, IHC, ISH, FISH, primary and secondary antibodies.

Included in the report are trends influencing the industry and country-level data including incidence of disease, life expectancy, population demographics, economic status, healthcare utilization and other market influences.

The information in the report was gathered using both primary and secondary research methods including more than a dozen major interviews completed during the period of June 2021 and September 2021.  These interviews were with government officials, medical device regulators, domestic distributors, and leading market participants in the global market.  In some cases, the use of a third-party interpreter service was used to complete the interview.   Secondary data included the use of government databases, company literature, medical journals and reports.

All market data pertains to the IVD market in China at the manufacturers’ level.  Market data is presented for the 2021 year with forecast data provided for 2026.  Compound annual growth rates (CAGRs) are provided for the 2021-2026 period.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  • INTRODUCTION
      • Figure 1-1: Market Drivers and Restraints: IVD Market in China
  • SCOPE AND METHODOLOGY
  • MAJOR FINDINGS OF THE REPORT
  • IVD MARKET IN CHINA
      • Figure 1-2: China IVD Market, 2021 and 2026 ($ millions)

CHAPTER TWO: CHINA IN CONTEXT

  • OVERVIEW
      • Figure 2-1: China IVD Market vs. China Medical Device Market, 2021-2026
      • Figure 2-2: China Market Dynamics
  • POPULATION TRENDS
      • Table 2-1: Total Midyear Population by Broad Age Group: China (million persons), 2010-2050
      • Figure 2-3: Total Midyear Population by Broad Age Group: China (million persons), 2010-2050
      • Figure 2-4: Total Number of Births in China by Year, 1990-2010 and Forecast 2020-2050
      • Figure 2-5: China Life Expectancy at Birth in Years, 2010-2050
      • Table 2-2: Elderly Dependency Ratio in China and Other Select Countries, 2010 and 2050
  • DISEASE DEMOGRAPHICS
    • Diabetes
      • Figure 2-6: Diabetes Prevalence, Top 10 Countries (number of adults age 20-79 years)
    • Cancer
      • Table 2-3: Top 5 Cancers Affecting Chinese Population (ranked by total number of cases), 2020
    • Cardiovascular Disease
  • INFECTIOUS DISEASE THREATS
    • Hepatitis
    • HIV/AIDS
    • Tuberculosis
    • COVID-19
    • Other Respiratory Diseases
  • CHINESE ECONOMY
      • Figure 2-7: China GDP, GDP (PPP) and Health Spending Growth (CAGR 2005-2010, CAGR 2010-2015, CAGR 2015-2020)
      • Figure 2-8: China GDP, GDP (PPP) and Health Spending, 1990-2020 (billions of $)

CHAPTER THREE: CLINICAL LABORATORY STRUCTURE IN CHINA

  • CLINICAL LABORATORY TESTS
    • Test Types
      • Table 3-1: Types of IVD and Clinical Laboratory Tests, 2021
    • Venues for Test Usage
      • Figure 3-1: Clinical Laboratory Service Market Distribution of Sales by Provider Type (China, United States, World), 2020
      • Hospitals
      • Figure 3-2: Utilization of Beds in Medical Institutions: China’s Average Length of Stay is Increasing Slightly, 1985-2018
      • Figure 3-3: China Health Care Institutions by Type (2005, 2010, 2015, 2018)
      • Figure 3-4: Number of Visits and Admissions to Hospital Institutions in China Annually, 2018
      • Private Laboratories
    • Urban vs. Rural IVD Market
      • Table 3-2: China In Vitro Diagnostic Reagent Sales by Urban/Rural Environment, 2021
      • Figure 3-5: Province-level Administrative Divisions of China
      • Table 3-3: Per Capita IVD Expenditures by China Province/Region, 2021
      • Figure 3-6: China IVD Market by Province/Region
  • CHINESE HEALTHCARE REFORM AND HOSPITAL INFRASTRUCTURE
      • Comprehensively deepen medical and health system reform
      • Improve the universal medical security system
      • Strengthen major critical disease prevention and control and basic public health service
      • Strengthen maternal and child healthcare and reproductive services
      • Improve the medical service system
      • Push for traditional Chinese medicine inheritance and development
      • Widely carry out public fitness campaigns
      • Ensure food and drug safety
  • CHINA REGULATION AND MEDICAL DEVICE POLICY CHALLENGES
    • Distribution in China
    • Medical Device Regulation Overview: China

CHAPTER FOUR: IVD MARKETS IN CHINA

  • MARKET INTRODUCTION AND SUMMARY
      • Table 4-1: China In Vitro Diagnostic Sales by Market Segment, 2021-2026 ($ millions)
      • Figure 4-1: China In Vitro Diagnostic Sales by Market Segment, 2021-2026 ($ millions)
      • Figure 4-2: China In Vitro Diagnostic Sales by Market Segment, 2021 Market Distribution (%)
  • CLINICAL CHEMISTRY
      • Figure 4-3: China – Clinical Chemistry IVD Market, 2021-2026
      • Types of Tests
      • Table 4-2: China – Clinical Chemistry IVD Market Distribution, 2021-2026 (%)
      • Figure 4-4: China – Clinical Chemistry IVD Market Value by Segment, 2021 vs. 2026
      • Clinical Chemistries
  • POINT-OF-CARE (POC) TESTING
      • Figure 4-5: China – Point-of-Care IVD Market, 2021-2026
      • Types of Tests
      • Table 4-3: China – Point-of-Care IVD Market Distribution, 2021-2026 (%)
      • Figure 4-6: China – Point-of-Care IVD Market Value by Segment, 2021 vs. 2026
  • IMMUNOASSAYS
      • Figure 4-7: China – Immunoassay IVD Market, 2021-2026
      • Types of Tests
      • Table 4-4: China – Immunoassay IVD Market Distribution, 2021-2026 (%)
      • Figure 4-8: China – Immunoassay IVD Market Value by Segment, 2021 vs. 2026
  • MOLECULAR ASSAYS
      • Figure 4-9: China – Molecular Assay IVD Market, 2021-2026
      • Types of Tests
      • Table 4-5: China – Molecular Assay IVD Market Distribution, 2021-2026 (%)
      • Figure 4-10: China – Molecular Assay IVD Market Value by Segment, 2021 vs. 2026
      • Tests for Infectious Disease
      • Table 4-6: HIV Statistics in China, 2020
      • Tests for Cancer
      • Tests for Genetic Diseases
      • Other Tests
  • HEMATOLOGY
      • Figure 4-11: China – Hematology IVD Market, 2021-2026
      • Types of Tests
  • COAGULATION
      • Figure 4-12: China – Coagulation IVD Market, 2021-2026
      • Types of Tests
  • MICROBIOLOGY
      • Table 4-7: China Infectious Disease Classification Tier
      • Figure 4-13: China – Microbiology IVD Market, 2021-2026
      • Types of Tests
      • Table 4-8: China – Microbiology IVD Market Distribution, 2021-2026 (%)
      • Figure 4-14: China – Microbiology IVD Market Value by Segment, 2021 vs. 2026
  • TESTS USED IN BLOOD BANKING
      • Figure 4-15: China – Blood Bank Test IVD Market, 2021-2026
      • Table 4-9: Prevalence of Transfusion-transmissible Infections in Blood Donations (Median, Interquartile range (IQR), by Income Group
      • Types of Tests
  • HISTOLOGY AND CYTOLOGY
      • Figure 4-16: China – Histology/Cytology IVD Market, 2021-2026
      • Types of Tests
      • Table 4-10: China – Histology/Cytology IVD Market Distribution, 2021-2026 (%)
      • Figure 4-17: China – Histology/Cytology IVD Market Value by Segment, 2021 vs. 2026
      • Pap Stains
      • Traditional Non-Pap Stains
      • Immunohistochemistry and In Situ Hybridization
      • Circulating Tumor Cells
  • PRENATAL AND GENETIC TEST SERVICES

CHAPTER FIVE: COMPANY ACTIVITY IN CHINA

  • CHINA IVD MARKET PARTICIPANT OVERVIEW
      • Figure 5-1: China Market Share, Major Global IVD Vendors, 2020 IVD Sales Distribution by Company
  • ABBOTT LABORATORIES
  • ARKRAY
  • BECTON, DICKINSON & CO.
  • BIOMÉRIEUX, INC.
  • BIO-RAD LABORATORIES, INC.
  • DANAHER CORP.
  • HOLOGIC, INC.
  • HORIBA MEDICAL
  • INSTRUMENTATION LABORATORY
  • LUMINEX CORPORATION
  • MINDRAY MEDICAL INTERNATIONAL, LTD.
  • MYRIAD GENETICS
  • ORTHO CLINICAL DIAGNOSTICS
  • PERKINELMER
  • QIAGEN N.V.
  • ROCHE
  • SIEMENS HEALTHINEERS
  • SYSMEX CORP.
  • THERMO FISHER SCIENTIFIC

APPENDIX: SOURCES OF INFORMATION

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