Opportunities in Chinese Cardiovascular Device Markets

Table of Contents

FORWARD

EXECUTIVE SUMMARY

Health Care System

Cardiovascular Disease Epidemiology

Cardiovascular Procedures

Product Markets

Suppliers

Summary Exhibit 1: Trend in China's Population, 2007-2025

Summary Exhibit 2: Trend in Cardiac Hospital Admissions, 1948-2006

Summary Exhibit 3: Outlays on Major Cardiovascular Conditions & Diabetes, 2003

Summary Exhibit 4: Trend in Performance of Selected Cardiovascular Procedures, 2005-2013

Summary Exhibit 5: Cardiovascular Products, Market Forecast, 2005-2013

1.0 ECONOMY, POLITICS & CULTURE

1.1 Contemporary Society—Demographics & Culture

1.2 Economy

1.2.1 Private and Public Enterprises

1.2.2 World Trade Organization Accession

1.2.3 Foreign Economic Relations

1.2.4 Foreign Investment

Exhibit 1-1: Geography of Chinese Provinces

Exhibit 1-2: Chinese Population and Economy, 2007

Exhibit 1-3: China's GDP Relative to Selected Industrialized Nations, 2007

Exhibit 1-4: Trend in China GDP, 1999-2007

Exhibit 1-5: Chinese Import-Export Growth: 1999-2007

Exhibit 1-6: China's SEZs and Special Administrative Regions

2.0 CHINA'S HEALTHCARE SYSTEM

2.1 Structure

2.1.1 Historical Overview

2.1.2 Public & Private Hospitals

2.1.3 Hospital Grades and Classes

2.1.4 Health Insurance & Healthcare Reform

2.1.4.1 Rural Healthcare Reform

2.1.4.2 Urban Healthcare Reform: Insurance and Drugs

2.2 Personnel

2.2.1 Physicians

2.2.2 Nursing

2.2.3 Hospital Management

2.3 Level of Services

2.3.1 Grade 3 Services

2.3.2 Grade 2 Services

2.3.3 Grade 1 Services

2.4 Cardiovascular Resources in China

2.4.1 Profiles of Major Cardiovascular Hospitals

2.4.1.1 Dalian University, First Affiliated Hospital

2.4.1.2 China PLA Hospital

2.4.1.3 Guangdong Provincial People's Hospital

2.4.1.4 Huashan Hospital

2.4.1.5 Peking Union Medical College Hospital

2.4.1.6 Peking University Third Hospital

2.4.1.7 Shanghai Chest Hospital

2.4.1.8 Shenyang Northern Hospital

2.4.1.9 Wuhan Asia Heart Hospital

2.4.1.10 Wuhan Union Hospital of China

2.4.1.11 Xi'an Jiaotong Hospital

2.4.1.12 Xi'an Xijing Hospital

2.4.1.13 XinHua Hospital

2.4.2 Profiles of Major Cardiovascular Physicians

2.4.2.1 CHEN Haozhu

2.4.2.2 GAO Changqing

2.4.2.3 GAO Run-Lin

2.4.2.4 GE Junbo

2.4.2.5 GU Dongfeng

2.4.2.6 HAN Qide

2.4.2.7 HAN Yaling

2.4.2.8 HU Dayi

2.4.2.9 HU Shengshou

2.4.2.10 WAN Feng

2.4.2.11 WU Yangfeng

2.4.2.12 XU Zhiwei

2.4.2.13 ZHANG Baoren

2.4.2.14 ZHANG Youn

2.4.2.15 ZHAO Qiang

2.4.2.16 ZHU Xiaodong

2.4.3 Collaborative Research Projects with West

2.4.3.1 The China-U.S. Collaborative Project for Neural Tube Defect

2.4.3.2 PRC-USA Collaborative Study

2.4.3.3 The Sino-MONICA Project

2.4.3.4 The George Institute, China

2.4.3.5 InterASIA

Exhibit 2-1: Comparison of China & U.S. Healthcare Spending, 2004

Exhibit 2-2: Chinese Hospitalization Expense Structure, 2002

Exhibit 2-3: Average Hospital Expenditures by Region, 2005

Exhibit 2-4: Strengths and Weaknesses of Public versus Private Hospitals in China

Exhibit 2-5: Chinese Public Hospital Grading System

Exhibit 2-6: Distribution of China's Hospitals by Grade and Class, 2003

Exhibit 2-7: A Comparison of Chinese Insurance Plans

Exhibit 2-8: Chinese Urban Health Insurance Participation, 2003

Exhibit 2-9: Comparison of Chinese & U.S. Healthcare Personnel

Exhibit 2-10: Comparison of Services Offered by Hospital Grade

Exhibit 2-11: Selected Leading Cardiovascular Hospitals in China, 2007

Exhibit 2-12: Selected Leading Cardiovascular Physicians in China

Exhibit 2-13: Sino-MONICA Project Publications

Exhibit 2-14: George Institute, China Projects

Exhibit 2-15: Clinical Articles Incorporating InterASIA Data

3.0 CARDIOVASCULAR DISEASE IN CHINA

3.1 Coronary Heart Disease

3.2 Heart Failure

3.3 Cardiac Arrhythmias

3.4 Heart Valve Disease

3.5 Hypertension

3.6 Congenital Heart Defects

3.7 Chronic Pulmonary Heart Disease

3.8 Cardiovascular Disease Risk Factors

3.9 Medical Expenditures on Cardiovascular Diseases

Exhibit 3-1: Prevalence of Selected Chronic Diseases in China, 2003

Exhibit 3-2: Changing Patterns of Heart Disease in China, 1948-2006

Exhibit 3-3: Overview of Major Cardiovascular Disorders in China

Exhibit 3-4: Coronary Heart Disease Mortality, 2000 and 2004

Exhibit 3-5: Sales of Major Cardiovascular Drugs, 2003

Exhibit 3-6: Comparison of Left and Right-Sided Heart Failure

Exhibit 3-7: Selected Types of Arrhythmias

Exhibit 3-8: Chambers and Valves of the Heart

Exhibit 3-9: Rheumatic Heart Disease Mortality, 2002

Exhibit 3-10: Prevalence of Hypertension Among Population 15+ Years, 1959-2002

Exhibit 3-11: Prevalence Rates of Hypertension by Sex and Age

Exhibit 3-12: Prevalence of Hypertension by Setting, 2002

Exhibit 3-13: Major Congenital Heart Defects

Exhibit 3-14: Share of Chinese Population Considered Overweight, 1980-1998

Exhibit 3-15: Adult and Youth Cigarette Smoking Rates in China

Exhibit 3-16: Cigarette Consumption by Nation, 2004

Exhibit 3-17: Per Capita Cigarette Consumption in Selected Nations, 2004

Exhibit 3-18: Expenditures on Major Cardiovascular Conditions and Diabetes, 2003

4.0 CARDIOVASCULAR PROCEDURES & PRODUCTS

4.1 Profiles of Surveyed Hospitals

4.1.1 Beijing Anzhen Hospital

4.1.2 Beijing FuWai Heart Hospital & Cardiovascular Institute

4.1.3 Shanghai Changhai Hospital

4.1.4 Shanghai Ruijin Hospital

4.1.5 Shanghai Zhongshan Hospital

4.2 National Cardiovascular Facilities and Personnel

4.3 National Cardiovascular Procedure Data

4.3.1 Coronary Revascularization

4.3.2 Percutaneous Coronary Interventions and Stenting

4.3.3 Cardiac Surgery

4.3.3.1 Coronary Artery Bypass Graft Surgery

4.3.3.2 Heart Valve Surgery

4.3.3.3 Repair of Congenital Defects

4.3.4 Arrhythmia Management

4.3.4.1 Pacemaker Implantations

4.3.4.2 Implantable Cardioverter Defibrillators

4.3.4.3 Radiofrequency Ablation

4.3.5 Aneurysm Repairs

4.4 Product Markets and Suppliers

4.4.1 Interventional Cardiology Products

4.4.1.1 Coronary Angioplasty Disposables

4.4.1.2 Coronary Stents

4.1.1.3 Percutaneous Defect Repair Products

4.4.2 Heart Surgery Products

4.4.2.1 Open Heart Surgery Disposables

4.4.2.2 Prosthetic Heart Valves

4.4.2.3 Endovascular Stent-Grafts

4.4.3 Arrhythmia Products

4.4.3.1 Pacemakers

4.4.3.2 Implantable Cardioverter Defibrillators (ICDs)

4.4.3.3 Electrophysiology Products

4.4.3.3.1 Capital Equipment

4.4.3.3.2 AF Catheters

4.4.3.3.3 Standard Diagnostic Catheters

4.4.3.3.4 Standard Ablation Catheters

4.4.3.3.5 Suppliers

Exhibit 4-1: Selected Comparative Data on Five Surveyed Hospitals

Exhibit 4-2: Cardiovascular Procedure Data for Beijing Anzhen Hospital, 2002-2007

Exhibit 4-3: Cardiovascular Procedure Data for FuWai Heart Hospital & Cardiovascular Institute, 2002-2007

Exhibit 4-4: Cardiovascular Procedure Data for Shanghai Changhai Hospital, 2002-2007

Exhibit 4-5: Cardiovascular Procedure Data for Shanghai Ruijin Hospital, 2002-2007

Exhibit 4-6: Cardiovascular Procedure Data for Shanghai Zhongshan Hospital, 2002-2007

Exhibit 4-7: Estimated Cardiovascular Personnel and Facilities in China, 2007

Exhibit 4-8: Coronary Revascularization by Type, 2005-2013

Exhibit 4-9: PCI and Coronary Stenting, 2005-2013

Exhibit 4-10: Geographic Distribution of Cardiac Surgery in China, 2007

Exhibit 4-11: Cardiac & Aortic Surgeries by Major Type, 2005-2013

Exhibit 4-12: CABG Surgery by Approach, 2005-2013

Exhibit 4-13: Heart Valve Surgery by Position, 2005-2013

Exhibit 4-14: Heart Valve Surgery by Prosthesis Type, 2005-2013

Exhibit 4-15: Congenital Defect Repairs by Type, 2005-2013

Exhibit 4-16: Pacemaker Implantations, 2005-2013

Exhibit 4-17: Trend in ICDs Implanted by Type, 1997-2007

Exhibit 4-18: ICD Implantations, 2005-2013

Exhibit 4-19: Radiofrequency Catheter Ablations by Major Type, 2005-2013

Exhibit 4-20: Atrial Fibrillation Patients by Type and Etiology

Exhibit 4-21: Aortic Aneurysm Repairs, 2005-2013

Exhibit 4-22: Cardiovascular Products, Market Forecast, 2005-2013

Exhibit 4-23: PCI Disposables, Market Forecast, 2005-2013

Exhibit 4-24: Coronary Stents, Market Forecast, 2005-2013

Exhibit 4-25: Drug-Eluting Coronary Stents, Estimated Supplier Shares, 2006-2007

Exhibit 4-26: Percutaneous Congenital Defect Repair Products, Market Forecast, 2005-2013

Exhibit 4-27: Open Heart Surgery Disposables, Market Forecast, 2005-2013

Exhibit 4-28: Cardiopulmonary Bypass Disposables, Estimated Supplier Shares, 2007

Exhibit 4-29: Prosthetic Valves and Repair Products, Market Forecast, 2005-2013

Exhibit 4-30: Heart Valve Products, Estimated Supplier Shares, 2007

Exhibit 4-31: Endovascular Aneurysm Stent-Grafts, Market Forecast, 2005-2013

Exhibit 4-32: Endovascular Stent-Grafts, Estimated Supplier Shares, 2007

Exhibit 4-33: Pacemakers by Major Type, Market Forecast, 2005-2013

Exhibit 4-34: Pacemakers, Estimated Supplier Shares, 2007

Exhibit 4-35: ICDs, Market Forecast, 2005-2013

Exhibit 4-36: ICDs, Estimated Supplier Shares, 2007

Exhibit 4-37: Electrophysiology Products, Market Forecast, 2007-2013

Exhibit 4-38: Electrophysiology Capital Equipment, Market Forecast, 2005-2013

Exhibit 4-39: Atrial Fibrillation (AF) Catheters, Market Forecast, 2005-2013

Exhibit 4-40: Standard Diagnostic Catheters, Market Forecast, 2005-2013

Exhibit 4-41: Standard (Simple) Ablation Catheters, Market Forecast, 2005-2013

5.0 CHINA MEDICAL PRODUCTS INDUSTRY

5.1 Regulatory Issues

5.1.1 State Food & Drug Administration

5.1.1.1 Medical Device Classifications

5.1.1.2 SFDA Registration and Approval Procedures

5.1.1.3 Agents: Registration & After-Sales

5.1.1.4 SFDA Developments

5.1.2 Quality Supervision, Inspection and Quarantine

5.1.3 Ministry of Health & State-Owned Hospitals

5.2 Importing Medical Devices

5.2.1 Product Distribution

5.2.2 Distribution Services

5.2.3 Multi-Tiered Distribution

5.2.4 Potential Distributor Difficulties

5.2.5 Representative Offices

5.3 Product Manufacturing

5.3.1 Distributors versus Manufacturing

5.3.2 Product Manufacturing Options

5.3.2.1 Wholly Owned Foreign Enterprises

5.3.2.2 Joint Ventures

5.3.2.3 Outsourced Manufacturing

5.3.3 Geography of Medical Products Industry and Markets

5.4 Major Chinese Cardiovascular Device Companies

5.4.1 Beijing Lepu Medical

5.4.2 Dong Guan Ke Wei Medical Instrument Co

5.4.3 JW Medical Systems

5.4.4 Lifetech (Shenzhen) Scientific

5.4.5 Microport Medical (Shanghai)

5.4.6 Tianjin Plastic Research Institute

Exhibit 5-1: Sample SFDA Registration Certificate

Exhibit 5-2: Medical Device Classifications

Exhibit 5-3: Guidelines and Procedures for SFDA Registration Requests

Exhibit 5-4: Accredited Medical Device Quality Supervision and Inspection Centers (MDQSIC)

Exhibit 5-5: Medical Devices Requiring CCC Certification and Sample Mark

Exhibit 5-6: CCC Mark Application Process

Exhibit 5-7: Select Chinese Medical Products Distributors

Exhibit 5-8: Potential Benefits and Dangers Associated with Chinese Distributors

Exhibit 5-9: Distributorship vs. Manufacturing Facility, Medical Products Sector

Exhibit 5-10: Chinese Manufacturing Options for Foreign Companies

Exhibit 5-11: Comparison of Foreign Direct Investment Options in China

Exhibit 5-12: Geography of China’s Medical Industry and Markets

Exhibit 5-13: Selected Chinese Suppliers of Cardiovascular Devices, 2008