CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - China



Summary



GlobalData, the industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - China”. The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in China. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

China is the most populated country in the world. In 2012, its population was approximately 1.3 billion, approximately one fifth of the global population. Growth has however been effectively controlled and has slowed down due to the strict enforcement of family-planning and one-child policies. The decline in the size of the young working-age group and the growing elderly population are however matters of concern for policy planners. China’s pharmaceutical industry was estimated to be worth $287 billion in 2012. The market for western medicine was approximately $8.8 billion in 2007 and was estimated at $46.7 billion in 2012. The medical device market was worth approximately $20.1 billion in 2012 and is expected to reach approximately $53.5 billion by 2020 at a projected Compound Annual Growth Rate (CAGR) of 13.1%.

These positive trends can primarily be attributed to -
- Increasingly elderly population
- Widening healthcare insurance coverage
- Improved Intellectual Property Rights (IPR) environment



Scope


The report provides information on the healthcare, regulatory and reimbursement landscape in China, and includes -
- Overview of the pharmaceutical and medical devices markets, comprising market size, segmentation, and key drivers and barriers
- Profiles and SWOT analysis of the major players in the pharmaceutical market, of which the major Multinational Companies (MNCs) were GlaxoSmithKline (GSK), Pfizer, and AstraZeneca; and the major domestic players were Harbin Pharmaceutical Group and Tasly Pharmaceutical Group; and the medical device market, of which the major players were Siemens Healthcare, GE Healthcare, Fresenius Medical Care, GlaxoSmithKline, and Philips Healthcare
- Insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, regulatory agencies, and market authorization 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 Chinese 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 and medical devices market segments, and companies likely to impact the 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 most opportunities for consolidation, investments, and strategic partnerships
- Identify, understand and capitalize on the opportunities and challenges in China’s healthcare market

Table Of Contents

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 10
1.2 List of Figures 15
2 Introduction 19
2.1 Report Guidance 19
3 Overview of the Pharmaceutical and Medical Device Markets 20
3.1 Pharmaceutical Market 20
3.1.1 Market Overview 20
3.1.2 Pharmaceutical Imports and Exports 24
3.1.3 Supply Channels 25
3.1.4 Market Segments 27
3.1.5 Major Disease Areas 34
3.1.6 Major Players 39
3.2 Medical Device Market 82
3.2.1 Market Overview 82
3.2.2 Overview of Top Five Segments 84
3.2.3 Diagnostics Market 96
3.2.4 Major Players 98
3.3 Market Drivers and Barriers 132
3.3.1 Drivers 132
3.3.2 Barriers 134
4 Market Access 136
4.1 Reimbursement and Payer Landscape 136
4.1.1 Overview of Healthcare System 136
4.1.2 Reimbursement Process 137
4.1.3 Overview of Insurance Providers 142
4.1.4 Patient Share in Healthcare Spending 143
4.1.5 Healthcare Price Trends 144
4.1.6 Pricing Policies 145
4.2 Regulatory Landscape 146
4.2.1 Overview of Regulatory Agencies 146
4.2.2 New Drug Approval Process 148
4.2.3 Generic Drug Approval Process 150
4.2.4 New Medical Device Approval Process 150
4.2.5 Licensing Process for Pharmaceutical and Medical Device Manufacturing 156
4.2.6 Licensing Process for Pharmaceutical Exports and Imports 157
4.2.7 Intellectual Property Rights 158
4.2.8 Clinical Trial Regulations 160
4.2.9 Pharmaceutical Advertising Regulations 162
4.2.10 Pharmacy Regulations 163
4.2.11 Labeling and Packaging Regulations 164
5 Country Analysis 166
5.1 Political Environment 166
5.1.1 Political Structure 166
5.1.2 Analysis of Current Political Environment 167
5.1.3 Healthcare Policy Initiatives 168
5.2 Economic Landscape 170
5.3 Economic Indicators 173
5.3.1 Gross Domestic Product 173
5.3.2 Gross National Income 177
5.3.3 Inflation 178
5.3.4 Currency Exchange Rate 182
5.3.5 Foreign Direct Investment 183
5.3.6 Foreign Exchange Reserves 184
5.3.7 Trade Balance 185
5.3.8 Government Structural Balance 188
5.3.9 Government Gross Debt 190
5.3.10 Major Industries 191
5.4 Demographics 193
5.4.1 Population 193
5.4.2 Education and Literacy 209
5.4.3 Employment 211
5.4.4 Disease Burden 212
5.5 Healthcare Infrastructure 216
5.5.1 Healthcare Facilities 216
5.5.2 Healthcare Parameters 220
5.5.3 Environmental Health 222
5.5.4 Healthcare Personnel 230
5.6 Healthcare Expenditure 232
5.6.1 Overview 232
5.6.2 Major Components of Healthcare Spending 233
5.6.3 Public and Private Sector Share 235
5.7 Trade Associations and Trade Fairs 236
5.7.1 China Chamber of Commerce for Import and Export of Medicines and Health Products 236
5.7.2 China Healthcare Association 236
5.7.3 Shanghai Medical Instrument Trade Association 236
5.7.4 Chinese Hospital Association 236
5.7.5 China Pharmaceutical Industry Association 237
5.8 Trade Fairs 237
6 Opportunities and Challenges 239
6.1 Opportunities 239
6.2 Challenges 240
7 Appendix 242
7.1 Abbreviations 242
7.2 Bibliography 245
7.3 Methodology 255
7.3.1 Coverage 256
7.3.2 Secondary Research 256
7.3.3 Forecasting 257
7.3.4 Expert Panel Validation 257
7.4 Disclaimer 257

List of Tables


Table 1: Pharmaceutical Industry, China, Revenue ($bn), 2007-2012 22
Table 2: Pharmaceutical Market, China, Revenue ($bn), 2007-2012 22
Table 3: Pharmaceutical Market, China, Revenue ($bn), Forecast, 2013-2020 23
Table 4: Pharmaceutical Market, China, Imports and Exports ($bn), 2007-2012 24
Table 5: Pharmaceutical Market, China, Branded and Generic Drugs, Share by Hospital Type (%), 2008 28
Table 6: Pharmaceutical Market, China, Branded and Generic Drugs, Share by Disease Area (%), 2008 30
Table 7: Pharmaceutical Market, Global, Drugs Going Off-Patent, Revenue ($m), 2011-2015 31
Table 8: Pharmaceutical Market, China, OTC, Revenue ($bn), 2007-2012 33
Table 9: Pharmaceutical Market, China, Major OTC Pharmaceuticals, 2010 34
Table 10: Pharmaceutical Market, China, Anti-infective Drugs by Class (%), 2010 36
Table 11: GlaxoSmithKline, Global, Major Products, Revenue ($bn), 2012 40
Table 12: Late-stage Pipeline, GlaxoSmithKline, 2013 41
Table 13: Major Products, Pfizer, Global, Revenue ($bn), 2012 50
Table 14: Late-stage Pipeline, Pfizer, 2013 51
Table 15: Major Products, AstraZeneca, Global, Revenue ($bn), 2012 60
Table 16: Late-stage Pipeline, AstraZeneca, 2013 61
Table 17: Major Products, Harbin Pharmaceuticals Group, 2012 70
Table 18: Major Products, Tasly, 2012 76
Table 19: Medical Device Market, China, Revenue ($bn), 2007-2012 83
Table 20: Medical Device Market, China, Revenue ($bn), Forecast, 2013-2020 83
Table 21: Medical Device Market, China, Revenue by Segment ($bn), 2012 84
Table 22: Medical Device Market, China, Ophthalmic Devices, Revenue ($bn), 2007-2012 86
Table 23: Medical Device Market, China, Ophthalmic Devices, Sales Trend for Major Players* ($m), 2007-2011 87
Table 24: Medical Device Market, China, In Vitro Diagnostic Devices, Revenue ($bn), 2007-2012 89
Table 25: Medical Device Market, China, In Vitro Diagnostic Devices, Sales Trend for Major Players ($m), 2007-2011 89
Table 26: Medical Device Market, China, Diagnostic Imaging Devices, Revenue ($bn), 2007-2012 91
Table 27: Medical Device Market, China, Diagnostic Imaging Devices, Sales Trends for Major Players* ($m), 2007-2011 91
Table 28: Medical Device Market, China, Cardiovascular Devices, Revenue ($bn), 2007-2012 93
Table 29: Medical Device Market, China, Cardiovascular Devices, Sales Trend for Major Players ($m), 2007-2011 93
Table 30: Medical Device Market, China, Orthopedic Devices, Revenue ($bn), 2007-2012 95
Table 31: Medical Device Market, China, Orthopedic Devices, Sales Trend for Major Players ($m), 2007-2011 95
Table 32: Medical Device Market, China, Diagnostics Market, Revenue ($bn), 2007-2012 96
Table 33: Medical Device Market, China, Diagnostics Market, Revenue Forecast ($bn), 2013-2020 97
Table 34: Medical Device Market, China, Major Medical Device Companies, Revenue ($m), 2011 98
Table 35: Major Products, Siemens, Global, Revenue ($m), 2012 99
Table 36: Major Product Segments, Fresenius Medical, Global, Revenue ($bn), 2012 111
Table 37: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 119
Table 38: Major Products, Philips Healthcare, Global, Revenue ($bn), 2012 125
Table 39: Healthcare Spending, China, Patient Share (%), 2007-2012 143
Table 40: Healthcare Consumer Price Index, China, Annual Change (%), 2007-2012 144
Table 41: Economic Indicators, Gross Domestic Product per Capita ($’000), China, 2007-2012 174
Table 42: Economic Indicators, China, Gross Domestic Product per Capita ($’000), Forecast, 2013-2020 174
Table 43: Economic Indicators, China, Gross Domestic Product Annual Growth (%), 2007-2012 175
Table 44: Economic Indicators, China, Gross Domestic Product Annual Growth (%), Forecast, 2013-2020 176
Table 45: Economic Indicators, China, Gross National Income per Capita ($’000), 2007-2012 177
Table 46: Economic Indicators, China, Average Consumer Price Index, 2007-2012 179
Table 47: Economic Indicators, China, Average Consumer Price Index, Forecast, 2013-2020 179
Table 48: Economic Indicators, China, Average Consumer Price Annual Change (%), 2007-2012 180
Table 49: Economic Indicators, China, Average Consumer Price Annual Change (%), Forecast, 2013-2020 181
Table 50: Economic Indicators, China, Currency Exchange Rate (CNY/$), 2007-2012 182
Table 51: Economic Indicators, China, Foreign Direct Investment ($bn), 2007-2012 183
Table 52: Economic Indicators, China, Foreign Exchange Reserves ($tn), 2007-2012 185
Table 53: Economic Indicators, China, Imports of Goods and Services ($tn), 2007-2012 186
Table 54: Economic Indicators, China, Exports of Goods and Services ($tn), 2007-2012 188
Table 55: Economic Indicators, China, General Government Structural Balance ($bn), 2007-2012 189
Table 56: Economic Indicators, China, General Government Gross Debt ($bn), 2007-2012 190
Table 57: Economic Indicators, China, Major Industries, Production ($tn), 2012 192
Table 58: Demographics, China, Population (million), 2007-2012 194
Table 59: Demographics, China, Population Forecast (million), 2013-2020 194
Table 60: Demographics, China, Urban and Rural Population Share (%), 2007-2012 195
Table 61: Demographics, China, Urban and Rural Population Share Forecast (%), 2013-2020 196
Table 62: Demographics, China, Population Distribution by Age Group (%), 2007-2012 198
Table 63: Demographics, China, Population Distribution by Age Group Forecast (%), 2013-2020 198
Table 64: Demographics, China, Births (per 1,000 Population), 2007-2012 199
Table 65: Demographics, China, Mortality (per 1,000 Population), 2007-2012 200
Table 66: Demographics, China, Major Causes of Mortality (%), 2011 201
Table 67: Demographics, China, Children Table 68: Demographics, China, Immunization Rate in the 12-23 Month Age Group (%), 2007-2012 204
Table 69: Demographics, China, Main Causes of Male Mortality (%), 2011 205
Table 70: Demographics, China, Main Causes of Female Mortality (%), 2011 206
Table 71: Demographics, China, Gender Ratio (M/F), 2007-2012 207
Table 72: Demographics, China, Life Expectancy at Birth (Years), 2007-2012 209
Table 73: Demographics, China, Student Enrollment by Level of Education (million), 2012 210
Table 74: Demographics, China, Unemployment (%),2007-2012 211
Table 75: Demographics, China, Major Diseases, City Hospital Inpatients (%), 2011 213
Table 76: Demographics, China, Major Diseases, China, County Hospital Inpatients (%), 2011 214
Table 77: Demographics, China, Major Diseases, DALYs (per 100,000 Population), 2009 215
Table 78: Healthcare Infrastructure, China, Hospitals, 2007-2012 217
Table 79: Healthcare Infrastructure, China, Hospitals by Bed Size (%), 2011 218
Table 80: Healthcare Infrastructure, China, Hospitals Beds (million), 2007-2012 219
Table 81: Healthcare Infrastructure, China, Hospital Beds (per 1,000 Population), 2007-2012 221
Table 82: Healthcare Infrastructure, China, Physicians (per 1,000 Population), 2007-2012 222
Table 83: Environmental Health, China, Air Quality in Major Cities (%), 2011 223
Table 84: Environmental Health, China, CO2 Emissions (Million Tons), 2007-2012 224
Table 85: Environmental Health, China, PM10 Emissions (?g/m3), 2007-2012 225
Table 86: Environmental Health, China, Source of COD Discharge (%), 2011 227
Table 87: Environmental Health, China, Groundwater Quality in Cities (%), 2011 228
Table 88: Environmental Health, China, Industrial Solid Waste (Million Tons), 2007-2012 229
Table 89: Healthcare Personnel, China, Nurses (per 1,000 Population), 2007-2012 230
Table 90: Healthcare Personnel, China, Pharmacists (per 1,000 Population), 2007-2012 231
Table 91: Healthcare Expenditure, China, Healthcare Expenditure (% of GDP), 2007-2012 233
Table 92: Healthcare Expenditure, China, Pharmaceuticals (%), 2008 234
Table 93: Healthcare Expenditure, China, Public-Private Share (%), 2007-2012 235
Table 94: Major Healthcare Trade Fairs, China, 2013 237

List of Figures

Figure 1: Pharmaceutical Industry, China, Revenue ($bn), 2007-2012 21
Figure 2: Pharmaceutical Market, China, Revenue ($bn), 2007-2012 22
Figure 3: Pharmaceutical Market, China, Revenue ($bn), Forecast, 2013-2020 23
Figure 4: Pharmaceutical Market, China Imports and Exports ($bn), 2007-2012 24
Figure 5: Pharmaceutical Market, China, Distribution Channel, 2013 26
Figure 6: Pharmaceutical Market, China, Branded and Generic Drugs, Share by Hospital Type (%), 2008 28
Figure 7: Pharmaceutical Market, China, Branded and Generic Drugs, Share by Disease Area (%), 2008 29
Figure 8: Pharmaceutical Market, China, OTC, Revenue ($bn), 2007-2012 33
Figure 9: Pharmaceutical Market, China, Anti-Infective Drugs by Class (%), 2010 35
Figure 10: Medical Device Market, China, Revenue ($bn), 2007-2012 82
Figure 11: Medical Device Market, China, Revenue ($bn), Forecast, 2013-2020 83
Figure 12: Medical Device Market, China, Revenue by Segment ($bn), 2012 84
Figure 13: Medical Device Market, China, Ophthalmic Devices, Revenue ($bn), 2007-2012 86
Figure 14: Medical Device Market, China, Ophthalmic Devices, Sales Trend for Major Players* ($m), 2007-2011 87
Figure 15: Medical Device Market, China, In Vitro Diagnostic Devices, Revenue ($bn), 2007-2012 88
Figure 16: Medical Device Market, China, In Vitro Diagnostic Devices, Sales Trend for Major Players* ($m), 2007-2011 89
Figure 17: Medical Device Market, China, Diagnostic Imaging Devices, Revenue ($bn), 2007-2012 90
Figure 18: Medical Device Market, China, Diagnostic Imaging Devices, Sales Trends for Major Players* ($m), 2007-2011 91
Figure 19: Medical Device Market, China, Cardiovascular Devices, Revenue ($bn), 2007-2012 92
Figure 20: Medical Device Market, China, Cardiovascular Devices, Sales Trend for Major Players* ($m), 2007-2011 93
Figure 21: Medical Device Market, China, Orthopedic Devices, Revenue ($bn), 2007-2012 94
Figure 22: Medical Device Market, China, Orthopedic Devices, Sales Trend for Major Players* ($m), 2007-2011 95
Figure 23: Medical Device Market, China, Diagnostics Market, Revenue ($bn), 2007-2012 96
Figure 24: Medical Device Market, China, Diagnostics Market, Revenue Forecast ($bn), 2013-2020 97
Figure 25: Medical Device Market, China, Major Medical Device Companies, Revenue ($m), 2011 98
Figure 26: Healthcare Market, China, Drivers and Barriers, 2013 135
Figure 27: Healthcare System, China, Key Influences in Reimbursement Procedure, 2013 138
Figure 28: Healthcare System, China, Pricing and Reimbursement Process, 2013 139
Figure 29: Healthcare System, China, Process for Setting a Price Higher than the Ceiling Price, 2013 141
Figure 30: Healthcare Spending, China, Patient Share (%), 2007-2012 143
Figure 31: Healthcare Consumer Price Index, China, Annual Change (%), 2007-2012 144
Figure 32: Healthcare System, China, SFDA Structure, 2013 147
Figure 33: Healthcare System, China, New Drug Approval Process, 2013 149
Figure 34: Healthcare System, China, New Medical Device Approval Process, 2013 152
Figure 35: Healthcare System, China, CCC Mark Certification Process for Medical Devices, 2013 155
Figure 36: Healthcare System, China, Clinical Trial Approval Process, 2013 161
Figure 37: Economic Indicators, China, Gross Domestic Product per Capita ($’000), 2007-2012 173
Figure 38: Economic Indicators, China, Gross Domestic Product per Capita ($’000), Forecast, 2013-2020 174
Figure 39: Economic Indicators, China, Gross Domestic Product Annual Growth (%), 2007-2012 175
Figure 40: Economic Indicators, China, Gross Domestic Product Annual Growth (%), Forecast, 2013-2020 176
Figure 41: Economic Indicators, China, Gross National Income per Capita ($’000), 2007-2012 177
Figure 42: Economic Indicators, China, Average Consumer Price Index, 2007-2012 178
Figure 43: Economic Indicators, China, Average Consumer Price Index, Forecast, 2013-2020 179
Figure 44: Economic Indicators, China, Average Consumer Price Annual Change (%), 2007-2012 180
Figure 45: Economic Indicators, China, Average Consumer Price Annual Change (%), Forecast, 2013-2020 181
Figure 46: Economic Indicators, China, Currency Exchange Rate (CNY/$), 2007-2012 182
Figure 47: Economic Indicators, China, Foreign Direct Investment ($bn), 2007-2012 183
Figure 48: Economic Indicators, China, Foreign Exchange Reserves ($tn), 2007-2012 184
Figure 49: Economic Indicators, China, Imports of Goods and Services ($tn), 2007-2012 186
Figure 50: Economic Indicators, China, Exports of Goods and Services ($tn), 2007-2012 187
Figure 51: Economic Indicators, General Government Structural Balance ($bn), 2007-2012 189
Figure 52: Economic Indicators, China, General Government Gross Debt ($bn), 2007-2012 190
Figure 53: Economic Indicators, China, Major Industries, Production ($tn), 2012 192
Figure 54: Demographics, China, Population (million), 2007-2012 193
Figure 55: Demographics, China, Population Forecast (million), 2013-2020 194
Figure 56: Demographics, China, Urban and Rural Population Share (%), 2007-2012 195
Figure 57: Demographics, China, Urban and Rural Population Share Forecast (%), 2013-2020 196
Figure 58: Demographics, China, Population Distribution by Age Group (%), 2007-2012 197
Figure 59: Demographics, China, Population Distribution by Age Group Forecast (%), 2013-2020 198
Figure 60: Demographics, China, Births (per 1,000 Population), 2007-2012 199
Figure 61: Demographics, China, Mortality (per 1,000 Population), 2007-2012 200
Figure 62: Demographics, China, Major Causes of Mortality (%), 2011 201
Figure 63: Demographics, China, Children Figure 64: Demographics, China, Immunization Rate in the 12-23 Month Age Group (%), 2007-2012 203
Figure 65: Demographics, China, Main Causes of Male Mortality (%), 2011 204
Figure 66: Demographics, China, Main Causes of Female Mortality (%), 2011 205
Figure 67: Demographics, China, Gender Ratio (M/F), 2007-2012 207
Figure 68: Demographics, China, Life Expectancy at Birth (Years), 2007-2012 208
Figure 69: Demographics, China, Student Enrollment by Level of Education (million), 2012 210
Figure 70: Demographics, China, Unemployment (%), 2007-2012 211
Figure 71: Demographics, China, Major Diseases, City Hospital Inpatients (%), 2011 212
Figure 72: Demographics, China, Major Diseases, County Hospital Inpatients (%), 2011 213
Figure 73: Demographics, China, Major Diseases, DALYs (per 100,000 Population), 2009 215
Figure 74: Healthcare Infrastructure, China, Hospitals, 2007-2012 217
Figure 75: Healthcare Infrastructure, China, Hospitals by Number of Beds (%), 2011 218
Figure 76: Healthcare Infrastructure, China, Hospitals Beds (million), 2007-2012 219
Figure 77: Healthcare Infrastructure, China, Hospital Beds (per 1,000 Population), 2007-2012 220
Figure 78: Healthcare Infrastructure, China, Physicians (per 1,000 Population), 2007-2012 221
Figure 79: Environmental Health, China, Air Quality in Major Cities (%), 2011 223
Figure 80: Environmental Health, China, CO2 Emissions (Million Tons), 2007-2012 224
Figure 81: Environmental Health, China, PM10 Emissions (?g/m3), 2007-2012 225
Figure 82: Environmental Health, China, Source of Chemical Oxygen Discharge (%), 2011 227
Figure 83: Environmental Health, China, Groundwater Quality in Cities (%), 2011 228
Figure 84: Environmental Health, China, Industrial Solid Waste (Million Tons), 2007-2012 229
Figure 85: Healthcare Personnel, China, Nurses (per 1,000 Population), 2007-2012 230
Figure 86: Healthcare Personnel, China, Pharmacists (per 1,000 Population), 2007-2012 231
Figure 87: Healthcare Expenditure, China, Healthcare Expenditure (% of GDP), 2007-2012 232
Figure 88: Healthcare Expenditure, China, Pharmaceuticals (%), 2008 234
Figure 89: Healthcare Expenditure, China, Public-Private Share (%), 2007-2012 235
Figure 90: Opportunities and Challenges, Healthcare Market, China, 2013 241

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