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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - China

Summary

GlobalData, the industry analysis specialist, has released its latest report, ‚ÄúCountryFocus: Healthcare, Regulatory and Reimbursement Landscape - China‚ÄĚ. The report is an essential source of information on and analysis of the healthcare, regulatory and reimbursement landscape in China. It identifies the key trends in the country‚Äôs healthcare market and provides insights into its demographic, regulatory, and reimbursement landscape and healthcare infrastructure.

The population of China in 2014 was approximately 1.37 billion, having grown at a Compound Annual Growth Rate (CAGR) of 0.5% from 2008. The country’s increasingly elderly population and a corresponding increase in the incidence of chronic diseases will help to boost the growth of the pharmaceutical industry, which was estimated to be worth $106.5 billion in 2008 and is projected to reach $1,637.3 billion by 2020, at a CAGR of 25.6%. Approximately 95% of China’s population has healthcare coverage. Improvements in drug safety and quality; a shorter drug registration timeline; the elimination of price caps by the government; a more transparent system for the approval of drugs and medical instruments; and an IPR regime are driving innovation in the pharmaceutical sector. These changes encourage foreign Multinational Companies (MNC) to invest in China. The Chinese medical device market is the second largest in Asia, valued at $27.7 billion in 2014 and projected to grow at a CAGR of 10.6% to an estimated $50.8 billion in 2020.

These growth trends can be primarily attributed to the following causes -

- Sedentary lifestyles leading to a high chronic disease burden.
- The accessibility of healthcare professionals in the remote areas of the county.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in China, and includes -
- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceutical market: GlaxoSmithKline, Pfizer, AstraZeneca, Harbin Pharmaceutical Group and Tianjin Tasly Pharmaceutical; and profiles and SWOT analyses of the major players in the medical device market: Siemens Healthcare, GE Healthcare, Philips, Medtronic and F. Hoffman La Roche
- Insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
- Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
- An overview of the opportunities for and challenges to growth in the healthcare market

Reasons to buy

This report will enhance your decision-making capability by allowing you to -
- Develop business strategies by understanding the trends shaping and driving China’s healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect China’s healthcare market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investment, and strategic partnerships
- Identify, understand, and capitalize on the opportunities and challenges in China’s healthcare market

Table Of Contents

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - China
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 11
1.2 List of Figures 15
2 Introduction 19
2.1 GlobalData Report Guidance 19
3 Overview of Pharmaceutical and Medical Device Markets 20
3.1 Pharmaceutical Market 20
3.1.1 Market Overview 20
3.1.2 Pharmaceutical Exports and Imports 24
3.1.3 Supply Channels 25
3.1.4 Market Segments 26
3.1.5 Overview of Top Five Disease Areas 27
3.1.6 Major Players 30
3.2 Medical Device Market 63
3.2.1 Market Overview 63
3.2.2 Overview of Top Five Segments 65
3.2.3 Diagnostic Market 81
3.2.4 Major Players 84
3.3 Market Drivers and Barriers 112
3.3.1 Drivers 112
3.3.2 Barriers 114
4 Market Access 115
4.1 Overview of the Healthcare System 115
4.2 Reimbursement and Payer Landscape 115
4.2.1 Reimbursement Process 115
4.2.2 Overview of Insurance Providers 117
4.2.3 Patient Share in Healthcare Spending 117
4.2.4 Prescription Drug Price Trend 119
4.2.5 Pricing Policies 120
4.3 Regulatory Landscape 120
4.3.1 Overview of Regulatory Agencies 120
4.3.2 Market Authorization Procedure for Pharmaceutical Products 122
4.3.3 Market Authorization Procedure for Medical Devices 125
4.3.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 129
4.3.5 Licensing Process for Pharmaceutical Exports and Imports 131
4.3.6 Intellectual Property Rights 132
4.3.7 Clinical Trial Regulations 134
4.3.8 Pharmaceutical Advertising Regulations 135
4.3.9 Pharmacy Regulations 136
4.3.10 Labeling and Packaging Regulations 137
5 Country Analysis 139
5.1 Political Environment 139
5.1.1 Political Structure 139
5.1.2 Analysis of the Current Political Environment 140
5.1.3 Healthcare Policy Initiatives 141
5.2 Economic Landscape 143
5.3 Economic Indicators 148
5.3.1 Gross Domestic Product 148
5.3.2 Gross National Income 151
5.3.3 Inflation 152
5.3.4 Currency Exchange Rate 155
5.3.5 Foreign Direct Investment 156
5.3.6 Foreign Exchange Reserves 157
5.3.7 Trade Balance 159
5.3.8 General Government Structural Balance 162
5.3.9 General Government Gross Debt 163
5.3.10 Major Industries 164
5.4 Demographics 166
5.4.1 Population 166
5.4.2 Education and Literacy Rate 181
5.4.3 Employment 183
5.4.4 Disease Burden 184
5.5 Healthcare Infrastructure 188
5.5.1 Hospitals 188
5.5.2 Healthcare Facilities 189
5.5.3 Healthcare Parameters 191
5.5.4 Environmental Health 193
5.5.5 Healthcare Personnel 197
5.6 Healthcare Expenditure 198
5.6.1 Overview 198
5.6.2 Public and Private Sector Share 200
5.7 Trade Associations 201
5.7.1 China Chamber of Commerce for Import and Export of Medicines and Health Products 201
5.7.2 China Healthcare Association 201
5.7.3 Shanghai Medical Instrument Trade Association 201
5.7.4 Chinese Hospital Association 201
5.7.5 China Pharmaceutical Industry Association 202
5.8 Trade Fairs 202
6 Opportunities and Challenges 203
6.1 Opportunities 203
6.2 Challenges 204
7 Appendix 206
7.1 Abbreviations 206
7.2 Bibliography 209
7.3 Research Methodology 219
7.3.1 Coverage 219
7.3.2 Secondary Research 220
7.3.3 Forecasts 220
7.3.4 Expert Panel 220
7.4 Disclaimer 221

1.1 List of Tables
Table 1: Pharmaceutical Market, China, Revenue ($bn), 2008-2014 22
Table 2: Pharmaceutical Market, China, Revenue Forecast ($bn), 2015-2020 23
Table 3: Pharmaceutical Market, China, Exports and Imports ($bn), 2008-2014 24
Table 4: GlaxoSmithKline, Global, Major Products, Revenue ($bn), 2014 31
Table 5: Late-stage Pipeline, GlaxoSmithKline, 2015 32
Table 6: Pharmaceutical Market, Pfizer, Global, Major Products, 2014 38
Table 7: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2015 39
Table 8: Major Products, AstraZeneca, Global, Revenue ($bn), 2014 46
Table 9: Late-stage Pipeline, AstraZeneca, 2015 47
Table 10: Major Products, Harbin Pharmaceuticals Group, 2015 54
Table 11: Major Products, Tasly, 2015 59
Table 12: Medical Device Market, China, Revenue ($bn), 2008-2014 64
Table 13: Medical Device Market, China, Revenue Forecast ($bn), 2014-2020 65
Table 14: Medical Device Market, China, Revenue by Segment, 2014 66
Table 15: Medical Device Market, China, Ophthalmic Devices Market, Revenue ($bn), 2008-2014 68
Table 16: Medical Device Market, China, Ophthalmic Devices Market, Market Share for Major Players, 2012 69
Table 17: Medical Device Market, China, Diagnostic Imaging Market, Revenue ($bn), 2008-2014 71
Table 18: Medical Device Market, China, Diagnostic Imaging Market, Market Share for Major Players, 2012 72
Table 19: Medical Device Market, China, In Vitro Diagnostic Market, Revenue ($bn), 2008-2014 74
Table 20: Medical Device Market, China, In Vitro Diagnostic Market, Market Share for Major Players, 2012 75
Table 21: Medical Device Market, China, Cardiovascular Device Market, Revenue ($bn), 2008-2014 77
Table 22: Medical Device Market, China, Cardiovascular Device Market, Market Share for Major Players, 2012 78
Table 23: Medical Device Market, China, Orthopedic Device Market, Revenue ($bn), 2008-2014 80
Table 24: Medical Device Market, China, Orthopedic Device Market, Market Share for Major Players, 2012 81
Table 25: Medical Device Market, China, Diagnostic Market, Revenue ($bn), 2008-2014 82
Table 26: Medical Device Market, China, Diagnostic Market, Revenue Forecast ($bn), 2015-2020 83
Table 27: Medical Device Market, China, Major Medical Device Companies, Revenue, 2012 84
Table 28: Medical Device Market, Major Products, Medtronic, 2014 101
Table 29: Healthcare Spending, China, Out-of-Pocket Expenditure (% of Total Healthcare Expenditure), 2008-2014 118
Table 30: Market Access, China, Healthcare Consumer Price Index, 2008-2014 119
Table 31: Economic Indicators, China, GDP per Capita ($), 2008-2014 148
Table 32: Economic Indicators, China, GDP per Capita Forecast ($), 2015-2020 149
Table 33: Economic Indicators, China, GDP Growth (%), 2008-2014 150
Table 34: Economic Indicators, China, GDP Annual Growth Forecast (%), 2015-2020 151
Table 35: Economic Indicators, China, Gross National Income per Capita ($), 2008-2014 152
Table 36: Economic Indicators, China, Average Consumer Price Index, 2008-2014 153
Table 37: Economic Indicators, China, Average Consumer Price Index Forecast, 2014-2020 154
Table 38: Economic Indicators, China, Average Consumer Price Change (%), 2008-2014 155
Table 39: Economic Indicators, China, Currency Exchange Rate (CNY/$), 2008-2014 156
Table 40: Economic Indicators, China, Foreign Direct Investment ($bn), 2008-2014 157
Table 41: Economic Indicators, China, Foreign Exchange Reserves ($tn), 2008-2014 158
Table 42: Economic Indicators, China, Trade Balance ($bn), 2008-2014 159
Table 43: Economic Indicators, China, Imports of Goods and Services ($tn), 2008-2014 160
Table 44: Economic Indicators, China, Exports of Goods and Services ($tn), 2008-2014 161
Table 45: Economic Indicators, China, Government Structural Balance ($bn), 2008-2014 162
Table 46: Economic Indicators, China, General Government Gross Debt ($tn), 2008-2014 163
Table 47: Economic Indicators, China, Major Industries, GDP by production ($tn), 2013 165
Table 48: Demographics, China, Population (billion), 2008-2014 167
Table 49: Demographics, China, Population Forecast (billion), 2015-2020 168
Table 50: Demographics, China, Population, Urban and Rural Population (%), 2008-2013 169
Table 51: Demographics, China Population Distribution by Age Group (%), 2008-2014 170
Table 52: Demographics, China, Population Distribution by Age Group Forecast (%), 2014-2020 171
Table 53: Demographics, China, Births (per 1,000 Population), 2008-2014 172
Table 54: Demographics, China, Mortality (per 1,000 Population), 2008-2014 173
Table 55: Demographics, China, Major Causes of Mortality (per 1,000 population), 2011 174
Table 56: Demographics, China, Children ?5 Years, Mortality Rate (per 1,000 Live Births), 2008-2014 175
Table 57: Demographics, China, Immunization (%), 2008-2014 176
Table 58: Demographics, China, Major Causes of Male Mortality (%), 2011 177
Table 59: Demographics, China, Major Causes of Female Mortality (%), 2011 178
Table 60: Demographics, China, Gender Ratio (Males per 100 Females), 2008-2014 179
Table 61: Demographics, China, Life Expectancy (Years), 2008-2014 181
Table 62: Demographics, China, Student Enrollment by Level of Education (million), 2014 182
Table 63: Demographics, China, Unemployment Rate in Urban Areas (%), 2008-2014 183
Table 64: Demographics, China, Major Diseases, City Hospital In-Patients (%), 2011 185
Table 65: Demographics, China, Major Diseases, Share of County Hospital In-Patients (%), 2011 186
Table 66: Demographics, China, Major Diseases, DALY (per 100,000 Population), 2009 187
Table 67: Healthcare Infrastructure, China, Hospitals, 2008-2014 189
Table 68: Healthcare Infrastructure, China, Hospitals by Bed Size (%), 2011 190
Table 69: Healthcare Infrastructure, China, Hospitals Beds (million), 2008-2014 191
Table 70: Healthcare Infrastructure, China, Hospital Beds (per 1,000 Population), 2008-2014 192
Table 71: Healthcare Infrastructure, China, Doctors (per 1,000 Population), 2008-2014 193
Table 72: Healthcare Infrastructure, China, CO2 Emissions (Metric Tons per Capita), 2008-2014 195
Table 73: Healthcare Infrastructure, China, PM10 Emissions (µg/m3), 2008-2014 196
Table 74: Healthcare Infrastructure, China, Nurses (per 1,000 Population), 2008-2014 198
Table 75: Healthcare Expenditure, China, Healthcare Expenditure (% of GDP), 2008-2014 199
Table 76: Healthcare Expenditure, China, Public-Private Share of Healthcare Expenditure (%), 2008-2014 200
Table 77: Trade Fairs, China, Major Healthcare Trade Fairs, 2015 202

1.2 List of Figures
Figure 1: Pharmaceutical Market, China, Revenue ($bn), 2008-2014 22
Figure 2: Pharmaceutical Market, China, Revenue Forecast ($bn), 2015-2020 23
Figure 3: Pharmaceutical Market, China, Exports and Imports ($bn), 2008-2014 24
Figure 4: Pharmaceutical Distribution Channels, China, 2015 25
Figure 5: Medical Device Market, China, Revenue ($bn), 2008-2014 64
Figure 6: Medical Device Market, China, Revenue Forecast ($bn), 2014-2020 65
Figure 7: Medical Device Market, China, Revenue by Segment ($bn), 2014 66
Figure 8: Medical Device Market, China, Ophthalmic Devices Market, Revenue ($bn), 2008-2014 68
Figure 9: Medical Device Market, China, Ophthalmic Devices Market, Market Share for Major Players (%), 2012 69
Figure 10: Medical Device Market, China, Diagnostic Imaging Market, Revenue ($bn), 2008-2014 71
Figure 11: Medical Device Market, China, Diagnostic Imaging Market, Market Share for Major Players (%), 2012 72
Figure 12: Medical Device Market, China, In Vitro Diagnostic Market, Revenue ($bn), 2008-2014 74
Figure 13: Medical Device Market, China, In Vitro Diagnostic Market, Market Share for Major Players (%), 2012 75
Figure 14: Medical Device Market, China, Cardiovascular Device Market, Revenue ($bn), 2008-2014 77
Figure 15: Medical Device Market, China, Cardiovascular Device Market, Market Share for Major Players (%), 2012 78
Figure 16: Medical Device Market, China, Orthopedic Device Market, Revenue ($bn), 2008-2014 80
Figure 17: Medical Device Market, China, Orthopedic Device Market, Market Share for Major Players (%), 2012 81
Figure 18: Medical Device Market, China, Diagnostic Market, Revenue ($bn), 2008-2014 82
Figure 19: Medical Device Market, China, Diagnostic Market, Revenue Forecast ($bn), 2015-2020 83
Figure 20: Medical Device Market, China, Major Medical Device Companies, Revenue ($m), 2012 84
Figure 21: Healthcare Market, China, Drivers and Barriers, 2014 114
Figure 22: Healthcare System, China, Key Influences in Reimbursement Procedure, 2013 116
Figure 23: Healthcare Spending, China, Out-of-Pocket Expenditure (% of Total Healthcare Expenditure), 2008-2014 118
Figure 24: Market Access, China, Healthcare Price Index, 2008-2014 119
Figure 25: Market Access, SFDA Structure, 2013 122
Figure 26: Healthcare System, China, New Drug Approval Process, 2013 124
Figure 27: Healthcare System, China, New Medical Device Approval Process, 2013 127
Figure 28: Economic Indicators, China, GDP per Capita ($), 2008-2014 148
Figure 29: Economic Indicators, China, GDP per Capita Forecast ($), 2015-2020 149
Figure 30: Economic Indicators, China, GDP Growth (%), 2008-2014 150
Figure 31: Economic Indicators, China, GDP Growth Forecast (%), 2015-2020 151
Figure 32: Economic Indicators, China Gross National Income per Capita ($), 2008-2014 152
Figure 33: Economic Indicators, China, Average Consumer Price Index, 2008-2014 153
Figure 34: Economic Indicators, China, Average Consumer Price Index Forecast, 2014-2020 154
Figure 35: Economic Indicators, China, Average Consumer Price Change (%), 2008-2014 155
Figure 36: Economic Indicators, China, Currency Exchange Rate (CNY/$), 2008-2014 156
Figure 37: Economic Indicators, China, Foreign Direct Investment ($bn), 2008-2014 157
Figure 38: Economic Indicators, China, Foreign Exchange Reserves ($tn), 2008-2014 158
Figure 39: Economic Indicators, China, Trade Balance ($bn), 2008-2014 159
Figure 40: Economic Indicators, China, Imports ($tn), 2008-2014 160
Figure 41: Economic Indicators, China, Exports ($tn), 2008-2014 161
Figure 42: Economic Indicators, China, Government Structural Balance ($bn), 2008-2014 162
Figure 43: Economic Indicators, China, General Government Gross Debt ($tn), 2008-2014 163
Figure 44: Economic Indicators, China, Major Industries, GDP by Production ($tn), 2013 165
Figure 45: Demographics, China, Population (billion), 2008-2014 167
Figure 46: Demographics, China, Population Forecast (bn), 2015-2020 168
Figure 47: Demographics, China, Population, Urban and Rural Population (%), 2008-2014 169
Figure 48: Demographics, China, Population Distribution by Age Group (%), 2008-2014 170
Figure 49: Demographics, China, Population Distribution by Age Group Forecast (%), 2015-2020 171
Figure 50: Demographics, China, Birth Rate (per 1,000 Population), 2008-2014 172
Figure 51: Demographics, China, Mortality (per 1,000 Population), 2008-2014 173
Figure 52: Demographics, China, Major Causes of Mortality (per 1,000 population), 2011 174
Figure 53: Demographics, China, Children ?5 Years, Mortality Rate (per 1,000 Live Births), 2008-2014 175
Figure 54: Demographics, China, Immunization (%), 2008-2014 176
Figure 55: Demographics, China, Main Causes of Male Mortality (%), 2011 177
Figure 56: Demographics, China, Major Causes of Female Mortality (%), 2011 178
Figure 57: Demographics, China, Gender Ratio (Males per 100 Females), 2008-2014 179
Figure 58: Demographics, China, Life Expectancy (Years), 2008-2014 180
Figure 59: Demographics, China, Student Enrollment by Level of Education (million), 2014 182
Figure 60: Demographics, China, Unemployment Rate in Urban Areas (%), 2008-2014 183
Figure 61: Demographics, China, Major Diseases, City Hospital In-Patients (%), 2011 184
Figure 62: Demographics, China, Major Diseases, Share of County Hospital In-Patients (%), 2011 185
Figure 63: Demographics, China, Major Diseases, DALY (per 100,000 Population), 2009 187
Figure 64: Healthcare Infrastructure, China, Hospitals, 2008-2014 189
Figure 65: Healthcare Infrastructure, China, Hospitals by Bed Number (%), 2011 190
Figure 66: Healthcare Infrastructure, China, Hospitals Beds (million), 2008-2014 191
Figure 67: Healthcare Infrastructure, China, Hospital Beds (per 1,000 Population), 2008-2014 192
Figure 68: Healthcare Infrastructure, China, Doctors (per 1,000 Population), 2008-2014 193
Figure 69: Healthcare Infrastructure, China, CO2 Emissions (Metric Tons per Capita), 2008-2014 195
Figure 70: Healthcare Infrastructure, China, PM10 Emissions (µg/m3), 2008-2014 196
Figure 71: Healthcare Infrastructure, China, Nurses (per 1,000 Population), 2008-2014 198
Figure 72: Healthcare Expenditure, China, Healthcare Expenditure (% of GDP), 2008-2014 199
Figure 73: Healthcare Expenditure, China, Public-Private Share of Healthcare Expenditure (%), 2008-2014 200
Figure 74: Healthcare Market, China, Opportunities and Challenges, 2014 205

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