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IVD in China

  • June 2015
  • -
  • Kalorama Information
  • -
  • 264 pages

With a population of more than 1 billion, China is the world’s largest country and therefore also its single largest potential market for goods and services. In the past ten years, China has led all major world economies in the average rate of growth in real GDP, total health expenditures, and government health expenditures. As an in vitro diagnostics (IVD) market, China trails only the populous, developed markets of the United States, western European countries, and Japan. 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.

This report places China and its IVD market in context with the developing world in terms of diseases, economic and healthcare system development, and other key metrics related to health expenditures and diagnostics. 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 “BRIC� nations. China 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, obesity and diseases of aging.

Table Of Contents

IVD in China
ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Major Findings of the Report
China in Context – A Developing Economy with Developed World Problems
Demographic Aging
Disease Drivers
Infectious Disease Threats
Chinese Economy
IVD Market in the BRIC Countries
IVD Market in China
Chinese Healthcare Reform and Hospital Infrastructure
Market Barriers – Regulation, Policy and Distribution
Regulation and Policy Challenges for International Companies
Distribution in China
TWO: INTRODUCTION TO HEALTH CARE AND DIAGNOSTICS IN THE DEVELOPING WORLD – CHINA IN CONTEXT
Background
Population Trends and Disease Demographics
Obesity
Disease Trends
Diabetes
Cancer
Allergy and Asthma
Cardiovascular Disease
Emerging Viruses and Diseases
Antimicrobial Drug Resistance
Clinical Lab Tests
Types of Tests
Venues for Test Usage
Market Segment Opportunities
Point-of-Care (POC) Testing
Core Lab Tests
Molecular Assays
Hematology
Coagulation
Microbiology
Tests Used in Blood Banking
Histology and Cytology
The Future of Chinese Economic Growth
Strong Capital Markets and MandA Activity
Rising Standards of Living
Corruption and Bribery
BRIC Metrics – Chinese IVD Market in Context
Available Markets – Urban Populations in BRIC Countries
Paying for Healthcare – Government Expenditures and the Culture of Spending
Healthcare Capacities in BRIC Nations – A Work in Progress
IVD Spending
Will China Capture the IVD Industry?
THREE: CHINA IVD SWOT ANALYSIS
Introduction
Strengths – Conditions That Support Market Growth
Government Support of the Emerging Chinese Healthcare Market
Western-Style Pharmaceuticals
Thriving Biotech Industry
Contract Research and High Technology
Returning Scientists
Growing Hospital Sector
Expanding Clinical Labs
Weaknesses – Factors That Pose Barriers to Market Success and Entry
Traditional Chinese Medicine
Resource Constraints in Hospitals
Culture and Business Environment
Intellectual Property Issues
Quality and Safety Concerns
Healthcare Insurance
Regulation – Product Approval and Clinical Trials
Regulation – Healthcare Service Cost Controls
Distribution Challenges
Opportunities – Rural Healthcare and Technology Partnerships
Threats – Domestic Competition and Government Policy
Domestic Competition
Government Policy and Price Setting
FOUR: CHINA IVD MARKET SIZE
Introduction
The Market
Total Chinese IVD Market
Immunoassays
Clinical Chemistry
Hematology
Point of Care/OTC
Molecular
Urinalysis
Other IVD Tests
FIVE: INDUSTRY AND COMPANY ACTIVITY IN CHINA
Introduction
Market Leaders in China
International IVD Companies – Recent Activity
Abbott Laboratories
Affymetrix, Inc.
ALERE
Arkray
Axis-Shield, plc
Beckman Coulter, Inc./Danaher
Becton, Dickinson and Co.
Biohit Oy
bioMérieux, Inc.
Bio-RAD Laboratories, Inc
Danaher Corp.
Gen-Probe, Inc.
Hologic, Inc.
Horiba Medical
Instrumentation Laboratory
IRIS International, Inc.
Laboratory Corporation of America
Life Technologies Corporation
Luminex Corporation
MedMira
Myriad Genetics
Novartis Diagnostics
Ortho Clinical Diagnostics
PerkinElmer
Phadia AB
Promega Corporation
QIAGEN N.V.
Radiometer A/S
Roche
Siemens
SuperNova Diagnostics, Inc.
Sysmex Corp.
Thermo Fisher Scientific
Chinese IVD Companies – Recent Activity
Autobio Group
BioSino Bio-Technology and Science, Inc.
CapitalBio Corporation
Caretium Medical Instruments
Chemtron Biotech Co., Ltd.
China Health Labs and Diagnostics, Ltd.
Daan Gene Co., Ltd.
Shanghai Fosun Pharmaceutical Co. Ltd.
Hai Kang Life Corporation
Shanghai Kehua Bio-engineering
Beijing Leadman Biochemistry Co., Ltd.
Mindray Medical International, Ltd.


LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Exhibit 1-1: Global Map of China
Exhibit 1-2: Industrial Map of China
Table 1-1: BRIC IVD Markets by Country, 2014-2019
Table 1-2: IVD Sales in China by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2014
TWO: INTRODUCTION TO HEALTH CARE AND DIAGNOSTICS IN THE DEVELOPING WORLD – CHINA IN CONTEXT
Table 2-1: Elderly Support Ratio in China, Other BRIC and Selected Countries(2010/2050) (Niger, Uganda, Pakistan, India, Egypt, Guatemala, Morocco, Mexico,Brazil, China, Russia, United States, France, Japan, World)
Table 2-2: Selected Worldwide Disease Statistics, 2014
Exhibit 2-1: Diabetes Population by Country, 2015
Exhibit 2-2: Cancer Prevalance by Country, 2015 (Australia, Austria, Belgium,Canada, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, United States,China)
Exhibit 2-3: Cardiovascular Disease Death as a Percentage of Total Deaths, 2015
Table 2-3: Types of IVD and Clinical Laboratory Tests, 2015
Table 2-4: Clinical Lab Counts and Lab Automation Penetration in BRIC Countries
Exhibit 2-4: Chinese GDP per Capita by Province, 2012
Exhibit 2-5: Venture Capital Funding in China, 2006 - 2014
Table 2-6: Government and Total Health Expenditures in BRIC and Comparison Countries (United States, France, Germany, Italy, Japan, United Kingdom,Australia, Brazil, South Africa, Argentina, South Korea, Vietnam, Poland,Turkey, Mexico, Russia, Nigeria, China, Thailand, India, Indonesia)
Table 2-7: Growth Rates of Government and Total Healthcare Expenditures andReal GDP (BRIC and Comparison Countries; 2003-2013) (China, India, Nigeria,Argentina, Vietnam, Indonesia, Turkey, Russia, Poland, Thailand, Brazil, SouthKorea, South Africa, Australia, Mexico, United States, Germany, United Kingdom, France, Japan, Italy)
Table 2-8: Healthcare System Capacities – BRIC and Comparison Countries(Argentina, Australia, Brazil, China, France, Germany, India, Indonesia, Italy,Japan, South Korea, Mexico, Nigeria, Poland, Russia, South Africa, Thailand,
Turkey, United Kingdom, United States, Vietnam)
Table 2-9: Per Capita IVD Expenditures and IVD Markets by Country, 2014(United States, Japan, Germany, France, Italy, China, Spain, United Kingdom,Brazil, Russia, India)
Table 2-10: BRIC IVD Markets by Country, 2014-2019
Table 2-11: Selected Made-in-China Lab Supplies
THREE: CHINA IVD SWOT ANALYSIS
Exhibit 3-1: Chinese Hospitals by Tier
Exhibit 3-2: Hospital Count by Certification Status, 2014
Exhibit 3-3: Ethnolinguistic Map of China
Table 3-1: Out-Of-Pocket, Other Private and Government Healthcare Expenditures in BRIC and Comparison Countries (%) (South Africa, France, United Kingdom, United States, Germany, Thailand, Turkey, Japan, Australia, Italy, Poland, Argentina, Brazil, South Korea, China, Russia, Mexico, Indonesia, Vietnam, India, Nigeria)
Exhibit 3-4: Chinese Urban Healthcare Market by National Market Shares of Province/Direct-Controlled Municipality
Exhibit 3-5: Chinese Rural Healthcare Market by National Market Shares of Province/Direct-Controlled Municipality
FOUR: CHINA IVD MARKET SIZE
Exhibit 4-1: Global IVD and Clinical Lab Market, 2014 (United States, Western Europe, Japan, Eastern Europe, China, India, Russia, Brazil, Other)
Table 4-1: Total IVD Sales in China, 2014-2024
Exhibit 4-2: Total IVD Sales in China, 2014-2024
Table 4-2: IVD Sales in China by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2014 (%)
Exhibit 4-3: IVD Sales in China by Market Segment (Immunoassays,Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2014 (%)
Table 4-3: IVD Sales in China by Market Segment (Immunoassays,Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2019 (%)
Exhibit 4-4: IVD Sales in China by Market Segment (Immunoassays, Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2019 (%)
Table 4-4: IVD Sales in China by Market Segment (Immunoassays,Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2024 (%)
Exhibit 4-5: IVD Sales in China by Market Segment (Immunoassays,Clinical Chemistry, Hematology, POC/OTC, Molecular, Urinalysis, Other) in 2024 (%)
Table 4-5: Immunoassay Sales in China, 2014-2024
Exhibit 4-6: Immunoassay Sales in China, 2014-2024
Table 4-6: Clinical Chemistry Sales in China, 2014-2024
Exhibit 4-7: Clinical Chemistry Sales in China, 2014-2024
Table 4-7: Hematology Sales in China, 2014-2024
Exhibit 4-8: Hematology Sales in China, 2014-2024
Table 4-8: Point of Care/OTC Sales in China, 2014-2024
Exhibit 4-9: Point of Care/OTC Sales in China, 2014-2024
Exhibit 4-10: Selected Point of Care/OTC Products Sold in China
Table 4-9: Molecular Test Sales in China, 2014-2024
Exhibit 4-11: Molecular Test Sales in China, 2014-2024
Table 4-10: Urinalysis Test Sales in China, 2014-2024
Exhibit 4-12: Urinalysis Test Sales in China, 2014-2024
Table 4-11: Other IVD Test Sales in China, 2014-2024
Exhibit 4-13: Other IVD Test Sales in China, 2014-2024
FIVE: INDUSTRY AND COMPANY ACTIVITY IN CHINA
Table 5-1: Leading Global IVD Companies in China
Table 5-2: Leading Domestic IVD Companies in China
Table 5-3: Leading Chinese IVD Companies

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