Healthcare, Regulatory and Reimbursement Landscape - China

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Jun 06, 2012, 09:15 ET

NEW YORK, June 6, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Healthcare, Regulatory and Reimbursement Landscape - China
http://www.reportlinker.com/p0829602/Healthcare-Regulatory-and-Reimbursement-Landscape---China.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Diagnostics

Summary

GlobalData, Industry analysis specialist, has released its new report, "Healthcare, Regulatory and Reimbursement Landscape - China". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape of China. The report identifies the key trends in the Chinese healthcare market, as well as insights on the demographics, the regulatory and reimbursement landscapes and healthcare infrastructure of China. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical devices market. This report 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 2010, the population of China was approximately 1.3 billion – approximately one-fifth of the global population. Population growth in China has been increasing with a slow growth rate due to the strict enforcement of the country's one-child policy. The decline in the population of the young working age group and increasing elderly population is a matter of concern for policy planners.

The pharmaceutical industry in China was estimated at $161.8 billion in 2010 and is expected to reach approximately $466 billion by 2020 with a projected CAGR of 10.3%. The western medicine market of China in 2009 was approximately $21 billion. The medical device market size was approximately $14.8 billion in 2010 and is expected to reach approximately $38.4 billion by 2020 with a projected CAGR of 10.1%.

This positive trend in the Chinese healthcare market can be attributed primarily to - - Increasing elderly population- Increasing healthcare insurance coverage- Favorable government funding for research and development- Government initiatives for the prevention and management of chronic diseases - Improved IPR environment- Reduced drug evaluation and registration process timelines

Scope

The report provides information on the healthcare, regulatory and reimbursement landscapes of China. The scope includes - - An overview of the Chinese pharmaceutical and medical devices market, including market size, market segmentation, key drivers and barriers for the market. - Profile and SWOT analyses of the major players in the pharmaceutical and medical devices market. Major players covered for the pharmaceutical market are the Yangtze River Pharmaceutical Group, Xiuzheng Pharmaceutical Group, Harbin Pharmaceutical Group, Noth China Pharmaceutical Group and the Tasly Group. Major players covered for the medical devices market are GlaxoSmithKline, Siemens Healthcare, GE Healthcare, Medtronic, F. Hoffmann-la Roche, and Philips Healthcare.- An insightful review on the reimbursement and regulatory landscapes. Analysis includes details of the healthcare reimbursement process, regulatory agencies and market authorization processes for new drugs and medical devices for China. - A detailed analysis of the political and economic environment of China including the economic indicators, demographics, healthcare infrastructure and healthcare expenditure. - An overview of the opportunities and challenges for growth that exist in the Chinese healthcare market.

Reasons to buy

This report provides comprehensive coverage of both the pharmaceutical and the medical devices market of China. The report will enhance your decision-making capability by allowing you to - - Develop business strategies by understanding the trends shaping and driving the healthcare market in China. - Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical and medical devices market segments, and the companies likely to impact the Chinese healthcare market in future. - Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. - Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships. - Identify, understand and capitalize on the opportunities and challenges in the healthcare market of China.

1 Table of Contents1 Table of Contents 51.1 List of Tables 71.2 List of Figures 92 Introduction 112.1 Report Guidance 113 Overview of the Pharmaceutical and Medical Devices Market 123.1 Pharmaceutical Market 123.1.1 Market Overview 123.1.2 Supply Channels 153.1.3 Market Segments 163.1.4 Major Disease Areas 213.1.5 Major Players 253.2 Medical Device Market 393.2.1 Market Overview 393.2.2 Overview of Top Five Segments 423.2.3 Major Players 533.3 Market Drivers and Barriers 713.3.1 Drivers 713.3.2 Barriers 724 Market Access 734.1 Reimbursement and Payer Landscape 734.1.1 Reimbursement Process 734.1.2 Overview of Insurance Providers 754.1.3 Patient Share in Healthcare Spending 764.1.4 Drug Price Trends 774.1.5 Pricing Policies 784.2 Regulatory Landscape 794.2.1 Overview of Regulatory Agencies 794.2.2 New Drug Approval Process 814.2.3 New Medical Device Approval Process 824.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 864.2.5 Licensing Process for Pharmaceutical Exports and Imports 864.2.6 Intellectual Property Rights 874.2.7 Clinical Trial Regulations 894.2.8 Pharmaceutical Advertising Regulations 904.2.9 Pharmacy Regulations 904.2.10 Labeling and Packaging Regulations 915 Country Analysis 925.1 Political Environment 925.1.1 Political Structure 925.1.2 Analysis of Current Political Environment 925.1.3 Policy Initiatives 945.2 Economic Landscape 965.3 Economic Indicators 985.3.1 Gross Domestic Product 985.3.2 Gross National Income 1025.3.3 Inflation 1045.3.4 Currency Exchange Rate 1075.3.5 Foreign Direct Investment 1085.3.6 Foreign Exchange Reserve 1095.3.7 Trade Balance 1105.3.8 Government Structural Balance 1135.3.9 Government Net Debt 1145.3.10 Major Industries 1155.4 Demographics 1165.4.1 Population 1165.4.2 Education and Literacy 1385.4.3 Employment 1405.4.4 Disease Burden 1425.5 Healthcare Infrastructure 1455.5.1 Healthcare Facilities 1455.5.2 Healthcare Parameters 1485.5.3 Healthcare Personnel 1595.6 Healthcare Expenditure 1615.6.1 Overview 1615.6.2 Major Components of Healthcare Spending 1645.6.3 Spending in Pharmaceutical R&D 1655.6.4 Share of Public and Private Sector 1675.7 Trade Associations and Trade Fairs 1695.8 Trade Fairs 1706 Opportunities and Challenges 1726.1 Opportunities 1726.2 Challenges 1727 Appendix 1747.1 Abbreviations 1747.2 Methodology 1777.2.1 Coverage 1777.2.2 Secondary Research 1787.2.3 Forecasting 1787.2.4 Primary Research 1787.2.5 Expert Panel Validation 1797.3 Contact Us 1797.4 Disclaimer 1797.5 Bibliography 179

List of Tables

Table 1: Pharmaceutical Industry ($bn), China, 2005 - 2010 13Table 2: Pharmaceutical Industry ($bn), China, Forecast, 2011 - 2020 14Table 3: Branded and Generic Drugs, China, Market Share by Type of Hospital (%), 2008 16Table 4: Branded and Generic Drugs, China, Market Share by Disease Area (%), 2008 17Table 5: Average Price Ratio of Branded and Generic Drugs, China, 2008 18Table 6: Major OTC Pharmaceuticals, China, 2010 19Table 7: OTC Pharmaceutical Market ($bn), China, 2005 - 2010 20Table 8: Share of the Anti-infective Drugs by Class, EDL, China, 2010 22Table 9: Major Pharmaceutical Companies, China, Revenue ($bn), 2010 25Table 10: Major Products, Harbin Pharmaceuticals Group, 2011 26Table 11: Major Products, Tasly Group Co., Ltd., 2011 30Table 12: Major Products, Yangtze River Pharmaceutical Group, 2011 35Table 13: Major Products, Xiuzheng Pharmaceutical Group, 2011 37Table 14: Major Products, North China Pharmaceutical Group, 2011 38Table 15: Medical Device Market ($bn), China, 2005 - 2010 40Table 16: Medical Device Market ($bn), China, Forecast, 2011 - 2020 41Table 17: Medical Device Market, China, Segment Share (%), 2010 42Table 18: Ophthalmic Devices Market ($bn), China, 2005 - 2010 43Table 19: Sales Trends for Major Players*, Ophthalmic Devices, China, 2010 44Table 20: In Vitro Diagnostics Market ($bn), China, 2005 - 2010 45Table 21: Sales Trends for Major Players*, in Vitro Diagnostics, China, 2010 46Table 22: Diagnostic Imaging Market ($bn), China, 2005 - 2010 47Table 23: Sales Trends for Major Players*, Diagnostic Imaging, China, 2010 48Table 24: Cardiovascular Devices Market ($bn), China, 2005 - 2010 49Table 25: Sales Trends for Major Players*, Cardiovascular Devices, China, 2010 50Table 26: Diabetes Care Devices Market ($bn), China, 2005 - 2010 51Table 27: Sales Trends for Major Players*, Diabetes Care Devices, China, 2010 52Table 28: Major Medical Device Companies, China, Revenue ($m), 2010 53Table 29: Major Products, Siemens, Global, Revenue ($m), 2010 54Table 30: Late Stage Pipeline, GE Healthcare, 2011 57Table 31: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2010 61Table 32: Major Products, Medtronic, Global, Revenue ($m), 2011 63Table 33: Major Products, Roche, Global, Revenue ($m), 2010 67Table 34: Late Stage Pipeline, F. Hoffmann-La Roche Ltd., 2010 68Table 35: Out-of-Pocket Healthcare Expenditure, China, Share (%), 2005 - 2010 76Table 36: Change in Average Price of Drugs (%), China, 2005 - 2009 77Table 37: GDP ($bn), China, 2005 - 2010 98Table 38: GDP ($bn), China, 2011 - 2020 99Table 39: GDP, China, Annual Growth (%), 2005 - 2010 100Table 40: GDP, China, Annual Growth (%), Forecast, 2011 - 2020 101Table 41: GNI Per Capita ($), China, 2005 - 2010 102Table 42: GNI Per Capita ($), China, Forecast, 2011 - 2020 103Table 43: Average Consumer Price Index, China, 2005 - 2010 104Table 44: Average Consumer Price, China, Annual Change (%), 2005 - 2010 105Table 45: Average Consumer Price Index, China, Annual Change (%), Forecast, 2011 - 2020 106Table 46: Currency Exchange Rate (Yuan/$), China, 2005 - 2010 107Table 47: Foreign Direct Investment ($bn), China, 2005 - 2010 108Table 48: Foreign Exchange Reserves ($bn), China, 2005 - 2010 109Table 49: Trade Balance ($bn), China, 2005 - 2010 110Table 50: Total Imports Value ($bn), China, 2005 - 2010 111Table 51: Total Exports Value ($bn), China, 2005 - 2010 112Table 52: General Government Structural Balance ($bn), China, 2005 - 2010 113Table 53: Government Net Debt ($bn), China, 2005 - 2010 114Table 54: Major Industries, China, Revenue ($bn), 2009 115Table 55: Population (m), China, 2005 - 2010 116Table 56: Population (m), China, Forecast, 2011 - 2020 117Table 57: Urban and Rural Population, China, Share (%), 2005 - 2010 118Table 58: Urban and Rural Population, China, Share (%), Forecast, 2011 - 2020 119Table 59: Age Groups, Population Distribution (%), Country, 2005 - 2010 120Table 60: Age Groups, Population Distribution (%), China, Forecast, 2011 - 2020 121Table 61: Births (Per 1,000 Population), China, 2005 - 2010 122Table 62: Births (Per 1,000 Population), China, Forecast, 2011 - 2020 123Table 63: Mortality (Per 1,000 People), China, 2005 - 2010 124Table 64: Mortality (Per 1,000 Population), China, Forecast, 2011 - 2020 125Table 65: Major Causes of Mortality ('000s), China, 2008 126Table 66: Maternal Mortality Rate (Per 100,000 Live Births), China, 2005 - 2010 127Table 67: Maternal Mortality Rate (Per 100,000 Live Births), China, Forecast, 2011 - 2020 128Table 68: Children <5 Years Age, China, Mortality Rate (Per 1,000 Live Births), 2005 - 2010 129>Table 69: Children <5 Years Age, China, Mortality Rate (Per 1,000 Live Births), Forecast, 2011 - 2020 130>Table 70: Immunization Rate (%), China, 2000 - 2009 131Table 71: Major Causes of Male Mortality ('000s), China, 2008 132Table 72: Major Causes of Female Mortality ('000s), China, 2008 133Table 73: Gender Ratio (M/F), China, 2005 - 2010 134Table 74: Gender Ratio (M/F), China, Forecast, 2011 - 2020 135Table 75: Life Expectancy at Birth (Years), China, 2005 - 2010 136Table 76: Life Expectancy at Birth (Years), China, Forecast, 2011 - 2020 137Table 77: Levels of Education, China, Students Share (%), 2009 138Table 78: Literacy Rate (%), China, 2005 - 2010 139Table 79: Employees, China, Urban-Rural (m), 2005 - 2010 140Table 80: Unemployment Rate (%), China, 2005 - 2010 141Table 81: Major Diseases, China, Inpatients (%), City Hospitals, 2009 142Table 82: Major Diseases, China, Inpatients (%), County Hospitals, 2009 143Table 83: Major Diseases, China, DALYs (Per 100,000 Population), 2004 144Table 84: Public and Private Hospitals, China, 2010 - 2011 145Table 85: Hospitals by Standard of Care, China, Share (%), 2011 146Table 86: Hospital Beds by Type of Services, China, Share (%), 2009 147Table 87: Beds (Per 1,000 Population), China, 2005 - 2010 148Table 88: Beds (Per 1,000 People), China, 2011 - 2020 149Table 89: Hospital Beds (m), China, 2005 - 2010 150Table 90: Hospital Beds (m), China, Forecast, 2011 - 2020 151Table 91: Physicians (Per 1,000 Population), China, 2005 - 2010 152Table 92: Air Quality (%), Cities, China, 2006 and 2009 153Table 93: Major Air Pollutants (1,000 Tons), China, 2006 - 2009 154Table 94: TSP Levels (µg/m3) in Five Cities, China, 1998 and 2004 155Table 95: Water Quality (%), China, 2006 and 2009 156Table 96: Waste Water (bn Tons), COD and Ammonia (m Tons), China, Discharge, 2006 - 2009 157Table 97: Population on Improved Drinking Water and Sanitation Facilities (%), China, 1990 - 2008 158Table 98: Healthcare Personnel (m), China, 2009 159Table 99: Healthcare Personnel (Per 100,000 Population), China, 2005 - 2010 160Table 100: Healthcare Expenditure ($bn), China, 2005 - 2010 161Table 101: Healthcare Expenditure (% of GDP), China, 2005 - 2010 162Table 102: Healthcare Expenditure (% of GDP), China, Forecast, 2011 - 2020 163Table 103: Healthcare Expenditure, China, Pharmaceuticals Share (%), 2008 164Table 104: Pharmaceutical R&D Expenditure ($bn), China, 2005 - 2010 165Table 105: R&D Expenditure, China, Healthcare Share (%), 2009 166Table 106: Healthcare Expenditure, China, Share of Major Components (%), 2008 167Table 107: Healthcare Expenditure ($bn), China, 2005 - 2010 168Table 108: Major Healthcare Trade Fairs, China 170

List of Figures

Figure 1: Pharmaceutical Industry ($bn), China, 2005 - 2010 13Figure 2: Pharmaceutical Industry ($bn), China, Forecast, 2011 - 2020 14Figure 3: Branded and Generic Drugs, China, Market Share by Type of Hospital (%), 2008 16Figure 4: Branded and Generic Drugs, China, Market Share by Disease Area (%), 2008 17Figure 5: OTC Pharmaceutical Market ($bn), China, 2005 - 2010 20Figure 6: Share of Anti-infective Drugs by Class, EDL, China, 2010 21Figure 7: Major Pharmaceutical Companies, China, Revenue ($bn), 2010 25Figure 8: Medical Device Market ($bn), China, 2005 - 2010 40Figure 9: Medical Device Market ($bn), China, Forecast, 2011 - 2020 41Figure 10: Medical Device Market, China, Segment Share (%), 2010 42Figure 11: Ophthalmic Devices Market ($bn), China, 2005 - 2010 43Figure 12: Sales Trends for Major Players*, Ophthalmic Devices, China, 2005 - 2010 44Figure 13: In Vitro Diagnostics Market ($bn), China, 2005 - 2010 45Figure 14: Sales Trends for Major Players*, in Vitro Diagnostics, China, 2005 - 2010 46Figure 15: Diagnostic Imaging Market ($bn), China, 2005 - 2010 47Figure 16: Sales Trends for Major Players*, Diagnostic Imaging, China, 2005 - 2010 48Figure 17: Cardiovascular Devices Market ($bn), China, 2005 - 2010 49Figure 18: Sales Trends for Major Players*, Cardiovascular Devices, China, 2005 - 2010 50Figure 19: Diabetes Care Devices Market ($bn), China, 2005 - 2010 51Figure 20: Sales Trends for Major Players*, Diabetes Care Devices, China, 2005 - 2010 52Figure 21: Major Medical Device Companies, China, Revenue ($m), 2010 53Figure 22: Drivers and Barriers, Healthcare Market, China, 2011 72Figure 23: Access, Reimbursement and Regulatory Environment, China 73Figure 24: Pricing and Reimbursement Process, China 74Figure 25: Process to Set Higher Price than Ceiling Price, China 75Figure 26: Out-of-Pocket Healthcare Expenditure, China, Share (%), 2005 - 2010 76Figure 27: Change in Average Price of Drugs (%), China, 2005 - 2009 77Figure 28: SFDA Organizational Chart, China 80Figure 29: New Drug Approval Process, China 81Figure 30: New Device Approval Process, China 83Figure 31: CCC Mark Certification Process, China 85Figure 32: Clinical Trial Regulation Process, China 89Figure 33: GDP ($bn), China, 2005 - 2010 98Figure 34: GDP ($bn), China, 2011 - 2020 99Figure 35: GDP, China, Annual Growth (%), 2005 - 2010 100Figure 36: GDP, China, Annual Growth (%), Forecast, 2011 - 2020 101Figure 37: GNI Per Capita ($), China, 2005 - 2010 102Figure 38: GNI Per Capita ($), China, Forecast, 2011 - 2020 103Figure 39: Average Consumer Price Index, China, 2005 - 2010 104Figure 40: Average Consumer Price, China, Annual Change (%), 2005 - 2010 105Figure 41: Average Consumer Price Index, China, Annual Change (%), Forecast, 2011 - 2020 106Figure 42: Currency Exchange Rate (Yuan/$), China, 2005 - 2010 107Figure 43: Foreign Direct Investment ($bn), China, 2005 - 2010 108Figure 44: Foreign Exchange Reserves ($bn), China, 2005 - 2010 109Figure 45: Trade Balance ($bn), China, 2005 - 2010 110Figure 46: Total Imports Value ($bn), China, 2005 - 2010 111Figure 47: Total Exports Value ($bn), China, 2005 - 2010 112Figure 48: General Government Structural Balance ($bn), China, 2005 - 2010 113Figure 49: Government Net Debt ($bn), China, 2005 - 2010 114Figure 50: Major Industries, China, Revenue ($bn), 2009 115Figure 51: Population (m), China, 2005 - 2010 116Figure 52: Population (m), China, Forecast, 2011 - 2020 117Figure 53: Urban and Rural Population, China, Share (%), 2005 - 2010 118Figure 54: Urban and Rural Population, China, Share (%), Forecast, 2011 - 2020 119Figure 55: Age Groups, Population Distribution (%), Country, 2005 - 2010 120Figure 56: Age Groups, Population Distribution (%), China, Forecast, 2011 - 2020 121Figure 57: Births (Per 1,000 Population), China, 2005 - 2010 122Figure 58: Births (Per 1,000 Population), China, Forecast, 2011 - 2020 123Figure 59: Mortality (Per 1,000 Population), China, 2005 - 2010 124Figure 60: Mortality (Per 1,000 Population), China, Forecast, 2011 - 2020 125Figure 61: Major Causes of Mortality ('000s), China, 2008 126Figure 62: Maternal Mortality Rate (Per 100,000 Live Births), China, 2005 - 2010 127Figure 63: Maternal Mortality Rate (Per 100,000 Live Births), China, Forecast, 2011 - 2020 128Figure 64: Children <5 Years Age, China, Mortality Rate (Per 1,000 Live Births), 2005 - 2010 129>Figure 65: Children <5 Years Age, China, Mortality Rate (Per 1,000 Live Births), Forecast, 2011 - 2020 130>Figure 66: Immunization Rate (%), China, 2000 - 2009 131Figure 67: Major Causes of Male Mortality ('000s), China, 2008 132Figure 68: Major Causes of Female Mortality ('000s), China, 2008 133Figure 69: Gender Ratio (M/F), China, 2005 - 2010 134Figure 70: Gender Ratio (M/F), China, Forecast, 2011 - 2020 135Figure 71: Life Expectancy at Birth (Years), China, 2005 - 2010 136Figure 72: Life Expectancy at Birth (Years), China, Forecast, 2011 - 2020 137Figure 73: Levels of Education, China, Students Share (%), 2009 138Figure 74: Literacy Rate (%), China, 2005 - 2010 139Figure 75: Employees, China, Urban-Rural (m), 2005 - 2010 140Figure 76: Unemployment Rate (%), China, 2005 - 2010 141Figure 77: Major Diseases, China, Inpatients (%), City Hospitals, 2009 142Figure 78: Major Diseases, China, Inpatients (%), County Hospitals, 2009 143Figure 79: Major Diseases, China, DALYs (Per 100,000 Population), 2004 144Figure 80: Public and Private Hospitals, China, 2010 - 2011 145Figure 81: Hospitals by Standard of Care, China, Share (%), 2011 146Figure 82: Hospital Beds by Type of Services, China, Share (%), 2009 147Figure 83: Beds (Per 1,000 Population), China, 2005 - 2010 148Figure 84: Beds (Per 1,000 People), China, 2011 - 2020 149Figure 85: Hospital Beds (m), China, 2005 - 2010 150Figure 86: Hospital Beds (m), China, Forecast, 2011 - 2020 151Figure 87: Physicians (Per 1,000 Population), China, 2005 - 2010 152Figure 88: Air Quality (%), Cities, China, 2006 and 2009 153Figure 89: Major Air Pollutants (1,000 Tons), China, 2006 - 2009 154Figure 90: TSP Levels (µg/m3) in Five Cities, China, 1998 and 2004 155Figure 91: Water Quality (%), China, 2006 and 2009 156Figure 92: Waste Water (bn Tons), COD and Ammonia (m Tons), China, Discharge, 2006 - 2009 157Figure 93: Population Using Improved Drinking Water and Sanitation Facilities (%), China, 1990 - 2008 158Figure 94: Healthcare Personnel (%), China, 2009 159Figure 95: Healthcare Personnel (Per 100,000 Population), China, 2005 - 2010 160Figure 96: Healthcare Expenditure ($bn), China, 2005 - 2010 161Figure 97: Healthcare Expenditure (% of GDP), China, 2005 - 2010 162Figure 98: Healthcare Expenditure (% of GDP), China, Forecast, 2011 - 2020 163Figure 99: Healthcare Expenditure, China, Pharmaceuticals Share (%), 2008 164Figure 100: Pharmaceutical R&D Expenditure ($bn), China, 2005 - 2010 165Figure 101: R&D Expenditure, China, Healthcare Share (%), 2009 166Figure 102: Healthcare Expenditure, China, Share of Major Components (%), 2008 167Figure 103: Healthcare Expenditure ($bn), China, 2005 - 2010 168Figure 104: Opportunities and Challenges, Healthcare Market, China, 2011 173