China Pharmaceutical Guide – Annually updated and written by veteran industry executives, it is the most comprehensive and authoritative guide to the Chinese pharmaceutical industry and market available in English at discounted package prices.
TABLE OF CONTENTS
ABOUT THE AUTHOR .................................................................................................. 3
PREFACE ......................................................................................................................... 5
TABLE OF CONTENTS ................................................................................................. 9
LIST OF TABLES .......................................................................................................... 17
LIST OF CHARTS ......................................................................................................... 27
TABLE OF ABBREVIATIONS .................................................................................... 32
EXECUTIVE SUMMARY ............................................................................................ 34
PART I OVERVIEW OF THE CHINESE ECONOMY AND BUSINESS ............ 45
Chapter I-1 Introduction .................................................................................................... 47
1.1 Fast Economic Growth and Change .......................................................................................... 47
1.2 Integration into the World Economy .......................................................................................... 48
1.3 Economic Reform ...................................................................................................................... 49
1.4 WTO Entry Brought Further Reform and Regulatory Changes ................................................. 51
1.5 Rising R&D Investments and Patent Applications .................................................................... 53
1.6 Survey by AstraZeneca: China and India to Lead in Innovation in the Next Decade ................ 58
Chapter I-2 Demographic Trends ...................................................................................... 60
2.1 Land and People ........................................................................................................................ 60
2.2 Demographic Trends .................................................................................................................. 60
2.3 Conclusion – China Faces Daunting Demographic Challenges ................................................. 71
Chapter I-3 Contemporary Issues and Trends ................................................................. 74
3.1 Review of Chinese Economy in 2012 ........................................................................................ 74
3.2 Major International Trade Issues ............................................................................................... 76
3.3 Contemporary Social-Economic Issues and Challenges Facing China ...................................... 78
3.4 Outlook - The Chinese Economy Faces Mounting Uncertainties and Complex Challenges ..... 82
Chapter I-4 FOREIGN INVESTMENT: Structure, Trends & Outlook ........................ 89
4.1 Overview ................................................................................................................................... 90
4.2 Chinese Legal System ................................................................................................................ 91
4.3 Foreign Investment Regulatory Framework .............................................................................. 92
4.4 Major Tax Categories for FIEs and Foreigners ........................................................................ 101
4.5 Business Climate and Outlook – Surveys of Foreign Companies in China ............................. 104
PART II THE CHINESE PHARMACEUTICAL INDUSTRY AND MARKET 107
Chapter II-1 Introduction ................................................................................................. 109
1.1 Definitions and Coverage ........................................................................................................ 109
1.2 Segmentation of the Chinese Pharmaceutical Industry ............................................................ 110
1.3 A Brief History of the Modern Chinese Pharmaceutical Industry ........................................... 112
1.4 A Brief History of Drug Industry Administration and Regulation in China ............................ 113
1.5 Government Guidelines for Pharmaceutical Industry Development ........................................ 115
1.6 The Size of the Chinese Pharmaceutical Market ..................................................................... 123
Chapter II-2 The Pharmaceutical Industry .................................................................... 127
2.1 Overview of the Chinese Pharmaceutical Industry .................................................................. 127
2.2 The Pharmaceutical Manufacturing Sector .............................................................................. 134
2.3 The Biopharmaceutical Sector ................................................................................................. 142
2.4 The Pharmaceutical Distribution Sector .................................................................................. 156
2.5 The Human Vaccine Sector ...................................................................................................... 162
2.6 R&D of the Domestic Chinese Pharmaceutical Industry ......................................................... 170
2.7 Pharmaceutical R&D in China – Foreign Companies.............................................................. 176
2.8 Pharmaceutical Outsourcing Sector (R&D and Manufacturing) .............................................. 182
2.9 M&A and Consolidation in the Chinese Pharmaceutical Industry ........................................... 187
2.10 Leading Pharmaceutical Companies in China ....................................................................... 192
2.11 Leading Retail Pharmacy Chains in China ............................................................................. 199
Chapter II-3 Foreign Investment in the Pharma Industry ............................................ 203
3.1 Forms of Foreign Investment ................................................................................................... 203
3.2 Encouraged, Restricted and Banned Areas for Foreign Investment in the Pharmaceutical Industry...203
3.3 Growth of Foreign Investment ................................................................................................. 207
3.4 Contemporary Trend for Foreign Investment in the Pharmaceutical Industry ......................... 212
3.5 Increased Short Term Risks and Challenges for MNCs ........................................................... 219
3.6 Strategic considerations for MNCs .......................................................................................... 222
Chapter II-4 Intellectual Property Rights and Legal Issues .......................................... 225
4.1 Pharmaceutical Patent Protection ............................................................................................. 227
4.2 Administrative Protection of Pharmaceuticals (APP) .............................................................. 245
4.3 Data Exclusivity ....................................................................................................................... 251
4.4 Patent and Trademark Registration .......................................................................................... 253
4.5 Protecting and Policing IPRs in China ..................................................................................... 254
4.6 Patent and IP Strategies for China ............................................................................................ 256
4.7 Pharmaceutical Patent Litigation in China ............................................................................... 258
4.8 Counterfeit Drugs..................................................................................................................... 263
4.9 New Judicial Interpretation of Guidelines for Applying Criminal Law to Fake Drug and Inferior Drug...Cases 265
4.10 The PRC's New Tort Liability Law: What Can Pharmas Expect? ......................................... 270
4.11 Chinese Courts See Fast Growing Lawsuits over Food and Drug Safety .............................. 274
4.12 Navigating Compliance Risks When Donating to and Sponsoring Medical Institutions in China
................................................................................................................................................. 275
4.13 In the Chase for Market Share, Pharmaceutical Companies Need Comprehensive Measures to Reduce Corruption Risk in China ............................................................................................ 277
Chapter II-5 The Ethical Pharmaceutical Market ......................................................... 282
5.1 Market Size .............................................................................................................................. 282
5.2 Growth Forecast and Future Outlook....................................................................................... 283
5.3 Special Characteristics of the Chinese Ethical Pharmaceutical Market ................................... 285
5.4 The Hospital Sector ................................................................................................................. 286
5.5 The Rise of Retail Pharmacy Sector ........................................................................................ 288
5.6 Ethical Pharmaceutical Market: Urban vs. Rural ..................................................................... 295
5.7 Rising Importance of the Primary Healthcare Drug Market .................................................... 297
5.8 TCMs Presents Challenge to MNC Growth in China .............................................................. 302
Chapter II-6 The Chinese Vaccine Market ..................................................................... 304
6.1 Market Landscape .................................................................................................................... 304
6.2 Snapshot of Hospital Vaccine Sales in 22 Chinese Cities Since 2006 ..................................... 306
6.3 Market Outlook of the Chinese Human Vaccine Market ......................................................... 309
6.4 Asia Pacific Vaccine Market Requires Flexible, Targeted Portfolios....................................... 309
Chapter II-7 The OTC Pharmaceutical Market ............................................................ 311
7.1 OTC Market Size ..................................................................................................................... 311
7.2 Regulatory Progress on OTC Drugs ........................................................................................ 314
7.3 Chinese OTC Drug Market Growth Bottlenecked by Various Challenges Despite Rising Trend of Self-medication ........................................................................................................................ 316
7.4 Enthusiastic Pharmaceutical Industry Seeks to Expand OTC Drug Sales ............................... 317
7.5 MNCs Strive for OTC Growth in China .................................................................................. 319
7.6 Pharma Companies Turn to Consumer Healthcare for Higher Return ..................................... 324
7.7 Healthcare Reform Casts Shadow on Future of the Retail Pharmacy Sector ........................... 325
7.8 Chinese Online Pharmacy Sales on the Rise Despite Uncertainties Ahead ............................. 325
7.9 SFDA Considers Ban of OTC Drug Ads on Mass Media ........................................................ 327
Chapter II-8 The Bulk Drug/API sector ......................................................................... 329
8.1 Overview ................................................................................................................................. 329
8.2 International Regulatory Compliance ...................................................................................... 330
8.3 Technological Strength ............................................................................................................ 333
8.4 Comparisons with India’s API industry ................................................................................... 333
8.5 Rising Power of China’s API Industry ..................................................................................... 336
8.6 Latest Trends and Challenges .................................................................................................. 338
8.7 Outlook of the API Industry and Market in China and Asia Pacific ........................................ 340
8.8 China Remains A Challenge to the USFDA Despite Opening Three Field Offices ................. 342
Chapter II-9 Pharmaceutical Import and Export .......................................................... 344
9.1 Overview ................................................................................................................................. 344
9.2 Custom Duties on Drug Import ................................................................................................ 346
9.3 Import of WMs and MHPs ...................................................................................................... 347
9.4 Export of MHPs and Western Medicines ................................................................................. 348
9.5 Trends and Outlook for Western Medicine Foreign Trade ....................................................... 352
9.6 China and India Seek to Join Hands for Supply to the Global Drug Market ........................... 352
9.7 China Increases its Activity in Regulated Markets .................................................................. 353
PART III PHARMACEUTICAL REGULATORY FRAMEWORK ................... 361
Chapter III-1 Overview ..................................................................................................... 363
1.1 Drug Regulation Statistics ....................................................................................................... 363
1.2 Overview of Drug Registration ................................................................................................ 364
1.3 Adverse Drug Reaction Surveillance and Reporting ............................................................... 371
1.4 Review of New Chinese Pharmaceutical/Healthcare Regulations in 2012 .............................. 372
1.5 Major Drug-related Regulations and Laws under Drafting Process ........................................ 374
1.6 Drug Regulatory Direction in 2013.......................................................................................... 376
1.7 New Policy for Reform of China’s Drug Registration Regime ................................................ 377
1.8 SFDA Issues Plan to Phase in Bioequivalence Study on Generic Drugs ................................. 380
1.9 Reorganization of the Chinese Healthcare Agencies ............................................................... 383
Chapter III-2 Important Laws and Regulations ............................................................. 384
2.1 The Drug Administration Law of the People's Republic of China ........................................... 384
2.2 Regulations for Implementation of the Drug Administration Law of the PRC ........................ 385
2.3 Major Regulations Governed under the Drug Administration Law (2001) .............................. 385
2.4 Other Drug Related Laws and Regulations .............................................................................. 388
Chapter III-3 Major Government Agencies in the Pharma Field ................................. 390
3.1 The China Food and Drug Administration (CFDA) ................................................................. 390
3.2 The Center for Drug Evaluation under the CFDA ................................................................... 398
3.3 National Development and Reform Commission (NDRC) ...................................................... 400
3.4 The National Health and Family Planning Commission (NHFPC) ......................................... 403
3.5 Ministry of Human Resources and Social Security ................................................................. 411
3.6 Ministry of Industry and Information Technology (MIIT) ....................................................... 412
3.7 Ministry of Commerce (MOFCOM or MOC) ......................................................................... 413
3.8 State-owned Assets Supervision and Administration Commission (SASAC) ......................... 414
3.9 State Administration of Traditional Chinese Medicine (SATCM) ........................................... 415
Chapter III-4 Pharmaceutical Industry Associations in China ..................................... 416
4.1 China Pharmaceutical Industry Association (CPIA) ................................................................ 416
4.2 China Biochemical Pharmaceutical Industry Association (CBPIA) ........................................ 417
4.3 China Chamber of Commerce of Medicine and Health Product Importers and Exporters (CCCMHPIE) .......................................................................................................................417
4.4 China Association of Pharmaceutical Commerce (CAPC) ...................................................... 417
4.5 R&D-based Pharmaceutical Association Committee (RDPAC) .............................................. 417
4.6 China Pharmaceutical Enterprises Association (CPEA) ........................................................... 418
4.7 China Pharmaceutical Packaging Association (CPPA) ............................................................ 418
4.8 China Pharmaceutical Industry Research and Development Association (CPIRDA) ............ 418
4.9 China Quality Association of Pharmaceuticals (CQAP) .......................................................... 418
4.10 China Medicinal Biotechnology Association (CMBA) .......................................................... 418
4.11 China Pharmaceutical Association of Plant Engineering (CPAPE) ........................................ 418
4.12 China Association of Pharmaceutical Equipment (CAPE) .................................................... 419
4.13 China Medical Pharmaceutical Material Association (CMPMA) .......................................... 419
4.14 China Association of Traditional Chinese Medicines (CATCM) ........................................... 419
4.15 China Healthcare Association (CHA) .................................................................................... 419
Chapter III-5 Drug Regulatory Framework in China ................................................... 420
5.1 Pharmaceutical Manufacturer Licensing ................................................................................. 420
5.2 Contract Manufacture/OEM .................................................................................................... 424
5.3 Pharmaceutical Manufacturing and GMP Certification ........................................................... 428
5.4 Regulation of Pharmaceutical Excipients ................................................................................ 433
5.5 Drug Labeling and Packaging .................................................................................................. 438
5.6 Pharmaceutical Distribution Licensing .................................................................................... 443
5.7 Provisions for Control of Drug Distribution ............................................................................ 446
5.8 Registration of Domestic/Imported Drug and Biological Products ......................................... 450
5.9 Drug Import Process ................................................................................................................ 471
5.10 Classified Control of Drug Products ...................................................................................... 474
5.11 Drug Advertising .................................................................................................................... 478
5.12 Drug Pricing and Price Control .............................................................................................. 484
5.13 Post-marketing Surveillance/ADR Reporting ........................................................................ 507
5.14 Counterfeit, Fake and Sub-standard Drugs ............................................................................ 516
5.15 Control of Narcotics and Psychotropic Drugs ....................................................................... 522
5.16 Internet Information Service and Sales of Drug Products ...................................................... 525
5.17 Drug Prescription/Surveillance of Rational Drug Use/Clinical Practices .............................. 527
5.18 GLP/Non-clinical Research and GCP/Clinical Research ....................................................... 541
5.19 The National Essential Drug System ..................................................................................... 544
5.20 Centralized Hospital Drug Purchase System ......................................................................... 547
5.21 Electronic Regulation of Drugs ............................................................................................. 556
5.22 Pharmaceutical Technology Transfer / Administrative Protection / IP .................................. 560
5.23 Drug Donation ....................................................................................................................... 564
5.24 International Regulatory Cooperation .................................................................................... 564
5.25 Others ..................................................................................................................................... 567
PART IV HEALTHCARE PROVISION AND FINANCING ............................... 571
Chapter IV-1 Overview ..................................................................................................... 573
1.1 Improving Healthcare Provision .............................................................................................. 573
1.2 Falling Death Rate and Rising Life Expectancy ...................................................................... 575
1.3 Composition of the Chinese Population................................................................................... 577
1.4 Economic Burden from Chronic Diseases May Slowdown China’s Growth........................... 579
1.5 2012 Annual Health and Family Planning Sector Development Report .................................. 580
1.6 MOH’s Health China 2020 Strategic Research Report ............................................................ 584
Chapter IV-2 Structure and Composition of Medical Provision ................................... 586
2.1 Composition of the Chinese Medical Sector ............................................................................ 586
2.2 Grade Structure of Chinese Medical Institutions ..................................................................... 589
2.3 Regional Distribution of Healthcare Resources ....................................................................... 590
2.4 Distribution of Healthcare Resources by Medical Specialty ................................................... 594
China Pharmaceutical Guide 2013 – Volume 1 (8th Edition)
2.5 Human Resources in China’s Healthcare Industry ................................................................... 595
2.6 China Seeks to Establish a General Practitioner System by 2020 ............................................ 597
2.7 MOH Encourages the Formation of Medical Service Consortiums ......................................... 598
Chapter IV-3 Healthcare Reform ..................................................................................... 600
3.1 A Review of China’s Healthcare System Reform in the Past Three Decades .......................... 600
3.2 Details of the Healthcare Reform Plan and Its Impacts on the Pharma Industry ..................... 602
3.3 Latest Developments - Healthcare Reform in Stalemate and Primarily Driven by Cost Containment 609
3.4 Planned Reform Initiatives in 2013 and Beyond ..................................................................... 612
3.5 Primary Healthcare Reform Areas Between 2011 and 2015 .................................................... 616
3.6 State Council Issues the Healthcare Reform Plan in the 12th FYP (2011-2015) ...................... 618
3.7 Future Path of Public Hospital Reform .................................................................................... 623
Chapter IV-4 Healthcare Financing and Insurance Programs ...................................... 626
4.1 Healthcare Financing in China ................................................................................................. 626
4.2 Urban Employee Basic Medical Insurance .............................................................................. 631
4.3 Urban Resident Basic Medical Insurance Program .................................................................. 632
4.4 Work-related injury insurance Program ................................................................................... 634
4.5 Medical Assistance Program for Civil Servants ....................................................................... 634
4.6 New Rural Cooperative Medical Scheme (NRCMS)............................................................... 635
4.7 Major Medical Insurance Coverage for Urban and Rural Residents........................................ 637
4.8 Maternity Insurance ................................................................................................................. 639
4.9 Medical Assistance Program for the Poor ................................................................................ 641
4.10 Commercial Health Insurance ................................................................................................ 642
4.11 Universal Coverage of Chinese Population by Basic Medical Insurance .............................. 647
4.12 China's Health Protection Gap to Reach US$73B by 2020 .................................................... 648
Chapter IV-5 Drug Reimbursement ................................................................................ 651
5.1 Drug Reimbursement under BMI, WRI and MI Programs ...................................................... 651
5.2 A Summary of the MoHRSS Notice for Publication of the 2009 NDRL under BMI, WRI and MI Programs 652
5.3 Common Rules (凡例) of the 2009 NDRL under BMI, WRI and MI Programs ..................... 655
5.4 Drug Reimbursement under the New Rural Cooperative Medical System ............................. 658
5.5 The Proposed Negotiation Mechanism under the NDRL ........................................................ 659
5.6 Observations and Discussions on Drug Reimbursement in China ........................................... 660
Chapter IV-6 Measures of Medical Cost-containment ................................................... 662
6.1 Price Control ............................................................................................................................ 663
6.2 Centralized Hospital Drug Purchase Tenders ........................................................................... 666
6.3 The National Essential Drug System ....................................................................................... 670
6.4 Clinical Pathway/DRGs ........................................................................................................... 677
6.5 National Formulary and Clinical Guidelines ........................................................................... 678
6.6 Other Cost-containment Measures ........................................................................................... 679
6.7 China’s Universal BMI System Faces the Double-bladed Sword of Potential Deficits and 14
Copyright 2013 by W i CON International Group LLC
China Pharmaceutical Guide 2013 – Volume 1 (8th Edition)
Excessive Cost Containment ................................................................................................... 682
PART V DISEASE AND DRUG CONSUMPTION PATTERNS ......................... 687
Chapter V-1 Growth of Drug Consumption and Demand ............................................. 689
1.1 Sharp Growth in Drug Consumption and Healthcare Expenditures ........................................ 689
1.2 The State of Health of the Chinese Population ........................................................................ 693
1.3 Health Awareness and Literacy ................................................................................................ 694
1.4 Aging Population and Increased Demand on Healthcare In China .......................................... 695
1.5 Medical and Public Health Services ........................................................................................ 698
Chapter V-2 Popular Diseases and Morbidity ................................................................ 700
2.1 Leading Diseases in Recent Years ........................................................................................... 700
2.2 Leading Causes of Death ......................................................................................................... 704
2.3 An Extensive Overview of Chronic and Epidemic Diseases in China ..................................... 707
2.4 Recent Chinese Therapeutic Trends in Diabetes, Hepatitis B and Oncology .......................... 721
2.5 Prevalent Health Problems to Senior Citizens in China ........................................................... 732
2.6 Chinese in Good Health Longer Than People in Other G20 Countries ................................... 733
Chapter V-3 Hospital Attendance and Medical Expenses ............................................. 735
3.1 Composition of Medical Care System in China ....................................................................... 735
3.2 Hospital Attendance ................................................................................................................. 736
3.3 Healthcare Expenditures and Medical Expenses ..................................................................... 739
Chapter V-4 Hospital Drug Consumption Patterns ....................................................... 747
4.1 Market Trends of the Chinese Hospital Drug Market in 2012 ................................................. 747
4.2 Leading Drug Products in Urban Hospitals ............................................................................. 749
4.3 Leading Pharmaceutical Suppliers ........................................................................................... 756
4.4 Patterns of Hospital Drug Purchase by Therapeutic Classes ................................................... 758
4.5 MOH Data on Drug Expenditures at Medical Institutions ....................................................... 763
4.6 High Growth Market Segments ............................................................................................... 764
Chapter V-5 Retail Drug Consumption Patterns ........................................................... 772
5.1 Review of the Chinese Retail Pharmacy Market ..................................................................... 772
5.2 Patterns of Retail Pharmacy Sales of Medicine and Health Products ...................................... 773
5.3 Consumption Patterns of OTC Drug Products ......................................................................... 781
Chapter V-6 Consumption Patterns of Formulated Traditional Chinese Medicines .. 789
6.1 IMS Data .................................................................................................................................. 789
6.2 SMEI Data ............................................................................................................................... 791
Chapter V-7 Regional Drug Consumption Patterns ...................................................... 792
7.1 Gap Between Cities and Rural Areas ....................................................................................... 792
7.2 Regional Hospital Markets for Drug Products ......................................................................... 793
7.3 Regional Markets by Pharmaceutical Distributor Sales ........................................................... 805
7.4 Regional Retail Pharmacy Markets for Drug Products ............................................................ 805
7.5 Regional OTC Drug Markets ................................................................................................... 808
Chapter V-8 Market Shares of Local, JV and Imported Drugs .................................... 810
8.1 Hospital Market – Local vs. JV vs. Imported Drugs ................................................................ 810
8.2 Retail Pharmacy/OTC Market - Domestic Companies vs. JV/Foreign Players ....................... 815
8.3 Market Segmentation by New and Generic Drugs ................................................................... 818
8.4 Analysis of Leading MNCs and Their Drug Products in China ............................................... 819
8.5 Future Trends and Outlook ...................................................................................................... 820
LIST OF TABLES
Table 2.1 Overall Chinese Drug Market Size and Growth 2001-2015 .......................... 123
Table 2.2a Chinese Drug Market Size by Major Segments 2001-2015 ......................... 124
Table 2.2b Chinese Drug Market Size Projections by Major Segments 2013-2015 ...... 125
Table 2.3a Chinese Drug Market Shares by Sub-segments 2003-2011 ......................... 125
Table 2.3b Chinese Drug Market Shares by Sub-segments 2012-2015 ......................... 126
Table 2.4 Number of Pharmaceutical Businesses in China Since 1997 ......................... 127
Table 2.5 Distribution of Pharma Industry Sales by Sectors and Ownership in 2009 ... 136
Table 2.6 Distribution of Pharma Industry Profits by Sectors and Ownership in 2009 . 136
Table 2.7 Biopharma Players in Top 100 Chinese Pharma Cos 2006-2011 ................... 143
Table 2.8 Chinese Foreign Trade of Biopharmaceutical Products 2007-2012 ............... 146
Table 2.9 Regional Export Markets for Biopharmaceuticals in 2012 ............................ 147
Table 2.10 Chinese Approvals for New Biological Formulations 2007-2011 ............... 148
Table 2.11 Chinese Approvals of Biological Products by TCs 2007-2011 .................... 148
Table 2.12 Review Outcome of Registration Applications for Biological Products in 2012.........149
Table 2.13 Regional Pharmaceutical Distributor Sales Structure 2012 ......................... 159
Table 2.14 Top 10 Chinese Pharma Distributors by Sales in 2012 ................................ 161
Table 2.15 Top 10 Chinese Retail Companies by Sales Revenues in 2012 ................... 161
Table 2.16 Vaccine Product Pipelines of Selected Chinese Biotech Companies ........... 164
Table 2.17 New Vaccine Products under Development by MNCs in China .................. 165
Table 2.18 R&D Centers of RDPAC Members in China ............................................... 178
Table 2.19 Top 20 Chinese Pharma Companies by Total Assets in 2012 ...................... 192
Table 2.20 Top 20 Chinese Pharma Companies by Revenues in 2012 (1) .................... 192
Table 2.21 Top 20 Chinese Pharma Companies by Net Profit in 2012 .......................... 193
Table 2.22 Top 20 Chinese Pharma Companies by Revenues in 2012 (2) .................... 194
Table 2.23 Top 20 Chinese Pharma Companies by Revenues in 2012 (3) .................... 195
Table 2.24 Revenue Size of the Top 100 Chinese Pharma Companies 2006-2012 ....... 196
Table 2.25 Segmentation of the Top 100 Chinese Pharma Companies by Sales 2009-2012
Table 2.26 Publicy-listed Firms in Top 100 Chinese Pharma Cos by Sales 2009-2012 197
Table 2.27 Subsectors of Top 100 Chinese Pharma Companies by Sales 2009-2012 ... 197
Table 2.28 Ownership Structure of Top 100 Chinese Pharma Cos by Sales 2009-12 ... 197
Table 2.29 Regional Distribution of Top 100 Chinese Pharma Cos by Sales 2012 ....... 198
Table 2.30 Analysis of Account Receivable Turnover of Top 100 Chinese Pharma Cos....199
Table 2.31 Top 20 Chinese Retail Pharmacy Chains 2011 ............................................ 199
Table 2.32 Top 10 Chinese Retail Pharmacy Chains by Overall Competitiveness in 2011......200
Table 2.33 # of Outlets Owned by the Top 100 Chains 2010-11 ................................... 201
Table 2.34 Top 10 Chinese Retail Pharmacy Chains by Outlet Growth in 2011 ........... 202
Table 2.35 First Ten Sino-Foreign Pharmaceutical Joint Ventures in China ................. 209
Table 2.36 Foreign Investment in the Chinese Pharmaceutical Industry in the 1990s .. 209
Table 2.37 Pharma Foreign Investments in China between 2000 and 2006 .................. 210
Table 2.38 Chinese OTC and RX Segmentation in the Retail Pharmacy Sector Since 2009........293
Table 2.39 Market Shares of 3T and Community Healthcare Markets Since 2003 ....... 298
Table 2.40 Coverage/ Financing of NRCMS 2008-2011 ............................................... 299
Table 2.41 # of Outpatient Visits and Inpatients by Medical Institution Types 2008-2011....299
Table 2.42 Chinese Vaccine Market 2006-2014 ............................................................ 305
Table 2.43 Market Shares of Chinese and Foreign Vaccines Companies by Volume .... 305
Table 2.44 Market Shares of Chinese and Foreign Vaccines Companies by Value ....... 305
Table 2.45 Top Ten Vaccines by Sales in Rep Hospitals of 22 Chinese Cities 2010 ..... 306
Table 2.46 Growth of Retail Pharmacies 2010-2012 (27 Major Cities) ........................ 311
Table 2.47 Top 10 Chinese OTC Marketers 2011 .......................................................... 320
Table 2.48 Growth of the Chinese API/Bulk Drug Sector 2002-2012 .......................... 329
Table 2.49 Leading API Export Products by China in 2012 .......................................... 330
Table 2.50 China-based Pharma Companies with U.S. DMFs ...................................... 331
Table 2.51 Summary of U.S. DMFs Filed Products Manufactured in China ................ 331
Table 2.52 Top 15 China-based DMF holders with Ten or More Active DMFs ............ 331
Table 2.53 Cost Comparisons: China vs. India vs. Europe vs. U.S. .............................. 336
Table 2.54 Chinese Foreign Trade of MHPs in 2012 ..................................................... 346
Table 2.55 Major Categories of Western Medicine Import Since 2003 ......................... 347
Table 2.56 Chinese Import of MHPs by Categories in 2012 ......................................... 347
Table 2.57 Regional Import Origins for WMs in 2012 .................................................. 347
Table 2.58 China’s Top 5 WM Import Origin Countries in 2012 .................................. 348
Table 2.59 Importers of Medicines and Health Products by Equity Type in 2012 ........ 348
Table 2.60 Top 10 Chinese Importers WMs in 2012 ...................................................... 348
Table 2.61 Chinese Export of MHPs by Categories in 2012 ......................................... 349
Table 2.62 Regional Export Markets for Chinese MHPs in 2012 .................................. 350
Table 2.63 Chinese Exporters of MHPs by Company Type in 2012 ............................. 350
Table 2.64 Regional Export Markets for Chinese WMs in 2012 ................................... 350
Table 2.65 Top 10 Exported Regions for Chinese WMs in 2012 ................................... 351
Table 2.66 Top 10 Chinese WM Exporters in 2012 ....................................................... 351
Table 3.1 Chinese Drug Approvals in 2012 ................................................................... 364
Table 3.2 Chinese Drug Approvals 2009-2012 .............................................................. 365
Table 3.3 Breakdown of Clinical Trial Approvals 2010-2012 ....................................... 365
Table 3.4 SFDA Accepted Applications for New Chemical Drug 2009-2012 ............... 365
Table 3.5 Review Outcome of Chemical Drug Registration Applications in 2012 ....... 366
Table 3.6 Chemical Drug Evaluation Wait-time by Registration Type in 2012 ............. 367
Table 3.7 Evaluation Timeframe for Clinical Trial Applications of Chemical Drug TCs 2012 ...367
Table 3.8 Review Outcome of TCM Registration Applications in 2012 ....................... 367
Table 3.9 Review Outcome of Registration Applications for Biological Products in 2012
........................................................................................................................................ 368
Table 3.10 Structure of Chinese Drug Approvals in 2011 ............................................. 368
Table 3.11 Composition of Chinese Drug Approvals 2009-2011 .................................. 368
Table 3.12 Domestic Approvals for New Chemical Drugs 2010-2011 ......................... 369
Table 3.13 Domestic Approvals for New TCMs in 2011 ............................................... 369
Table 3.14 Class 1.1 New Drug Approvals by the SFDA in 2011 ................................. 369
Table 3.15 SFDA Accepted Drug Registration Applications in 2011 ............................ 370
Table 3.16 SFDA Accepted Supplemental Applications 2010-2011 ............................. 370
Table 3.17 Number of Drug Applications Accepted by the SFDA 2005-2011 .............. 370
Table 3.18 Breakdown of Clinical Trial Approvals 2010-2011 ..................................... 371
Table 3.19 Quarterly Pharma-related Regulatory Introductions in China 2010-2012 ... 372
Table 3.20 New Pharma-related Regulations and Policies Issued in 2012 .................... 373
Table 3.21 Differential/Relative Ratios for Common Formulations of Chemical Drugs & Biologicals (Appendix I)..502
Table 3.22 Differential/Relative Ratios for Common Formulation of TCMs and Natural Drugs (Appendix II)........................503
Table 4.1 Improvement of Medical Provision in China ................................................. 573
Table 4.2 Comparisons of Healthcare Provision by China vs. Other Countries (1) ...... 574
Table 4.3 Comparisons of Healthcare Provision by China vs. Other Countries (2) ...... 574
Table 4.4 Birth, Death and Population Natural Growth Rate ........................................ 575
Table 4.5 Rising Life Expectancy of the Chinese Population ....................................... 576
Table 4.6 Composition of the Chinese Population by Urban/Rural Division and Sex .. 577
Table 4.7 Composition of the Chinese Population by Age ............................................ 578
Table 4.8 Composition of the Chinese Population by Education .................................. 578
Table 4.9 Medical Institutions by Specialties and Affiliations ...................................... 587
Table 4.10 Inpatient Beds of Medical Institutions by Specialties and Affiliations ........ 588
Table 4.11 Medical Institutions by Ownership Type ..................................................... 589
Table 4.12 Inpatient Beds of Medical Institutions by Ownership Type ......................... 589
Table 4.13 Inpatient Beds of Medical Institutions by Hospital Grade ........................... 589
Table 4.14 Number of Medical Institutions by Grade in 2011 ...................................... 590
Table 4.15 Regional Population Distribution in China 1990-2010 ................................ 590
Table 4.16 Regional Distribution of Medical Institutions and Inpatient Beds in 2011 .. 591
Table 4.17 Regional Distribution of Healthcare Professionals in 2010 ......................... 593
Table 4.18 Distribution of Inpatient Beds by Medical Specialty 2005-2011 ................. 594
Table 4.19 Distribution of Physicians by Medical Specialty 2000-2011 ....................... 595
Table 4.20 Healthcare Personnel in China 1950-2012 ................................................... 596
Table 4.21 Distribution of Healthcare Professionals in Cities and Counties 1980-2012....... 596
Table 4.22 Makeup of Healthcare Expenditures in China between 1980 and 2012 ...... 629
Table 4.23 Overview of Medical Aid Coverage in Urban & Rural Areas ..................... 642
Table 4.24 Coverage of Chinese Population by Basic Medical Insurance (Mln) .......... 648
Table 4.25 Coverage and Finance of Urban BMI Programs .......................................... 648
Table 4.26 Coverage/ Finance of New Rural Cooperative Medical System (NRCMS) 648
Table 4.27 Summary of Drug Price Cuts in China 1997-2012 ...................................... 664
Table 4.28 Consumer and Retail Price Indexes for Medicines & Health Products ....... 666
Table 4.29 NEDL Product Definition Change: 2012 Ed. vs. 2009 Ed. .......................... 673
Table 4.30 NEDL Structural Changes: 2012 Ed. vs. 2009 Ed. ...................................... 673
Table 4.31 NEDL Changes by WM Therapeutic Classes: 2012 Ed. vs. 2009 Ed. ......... 673
Table 4.32 NEDL Changes by TCM Therapeutic Classes: 2012 Ed. vs. 2009 Ed. ........ 674
Tabel 4.33 112 Newly Added Drugs (Chemical Drugs and Biologicals) in NEDL 2012 Ed. ..... 674
Table 4.34 Chemical Drugs with Newly Added/Reduced Routes/Forms in NEDL 2012 Ed. ..... 676
Table 5.1 Growth of Drug Consumption in China 2001-2012 ....................................... 689
Table 5.2 Growth of Healthcare Expenditures in China 1980-2012 .............................. 689
Table 5.3 Rising Share of Per Capita Drug Expenditures in Healthcare ........................ 692
Table 5.4 Percentage of Population Living in Urban / Rural Environs .......................... 696
Table 5.5 Leading Diseases by Two-week Morbidity in 2003 ....................................... 701
Table 5.6 Leading Diseases by Two-week Morbidity in 2008 ....................................... 702
Table 5.7 Morbidity Rate of Chronic Diseases in 2003 and 2008 ................................. 702
Table 5.8 Trend of Leading 10 Diseases among Inpatients of Urban Hospitals 2000-2011.........703
Table 5.9 Leading 10 Diseases among Inpatients of County Level Hospitals 2000-2011............ 704
Table 5.10 Leading Causes of Death in Certain Regions of China in 2011 ................... 705
Table 5.11 Leading Causes of Death among Chinese Males in 2011 ............................ 705
Table 5.12 Leading Causes of Death among Chinese Females in 2011 ........................ 706
Table 5.13 Examples of Drugs Covered under 2009 NRDL ......................................... 727
Table 5.14 Drugs Covered under Pap Program in China 2011 ...................................... 728
Table 5.15 Composition of Medical Care Providers in China 1980-2012 ..................... 735
Table 5.16 Number of Outpatient Visits and Inpatients in Medical Institutions ............ 736
Table 5.17 Outpatient Visits and Inpatients by Medical Institution Type in 2012 ......... 737
Table 5.18 Number of Outpatient Visits and Inpatients by Medical Specialties in 2011.......737
Table 5.19 Number of Outpatients & Emergencies Visits by Medical Specialties
2010-2011 ...................................................................................................................... 738
Table 5.20 Average Days of Hospitalization 1985-2011 ............................................... 738
Table 5.21 Income & Expenditure of Hospitals in 2011 ................................................ 739
Table 5.22 Per Capita Outpatient Medical Expense in Public Hospitals ....................... 740
Table 5.23 Per Capita Inpatient Medical Expense in Public Hospitals .......................... 741
Table 5.24 Per Capita Outpatient Medical Expense in Health Sector General Hospitals............... 742
Table 5.25 Per Capita Inpatient Medical Expense in Health Sector General Hospitals 743
Table 5.26 Outpatient and Inpatient Healthcare Expenditures in China 2009-2012 ..... 744
Table 5.27 Quarterly Sales of Chinese Hospital Market 2011-2012 ............................. 747
Table 5.28 Quarterly Chinese Hospita Drug Sales of MNCs 2011-2012 ...................... 747
Table 5.29 Quarterly Chinese Hospita Drug Sales of Domestic Cos 2011-2012 .......... 748
Table 5.30 Value Segmentation of the Chinese Pharma Market by Hospital Type 2012............748
Table 5.31 Chinese Market Shares by Dosage Forms 2010-2011 ................................. 749
Table 5.32 Top 10 Drug Brands by Hospital Purchase Value in 2012 ........................... 749
Table 5.33 Top 10 MNC New Products by Hospital Purchase Value in 2012 ............... 750
Table 5.34 Top 20 Drug Products by Hospital Sales in Chinese Hospitals 2010-2011 . 751
Table 5.35 Top 10 Systemic Anti-infectives in Chinese Hospitals in 2011 ................... 751
Table 5.36 Top 10 Oncology & Immuno-Regulatory Agents in Chinese Hospitals in 2011
........................................................................................................................................ 752
Table 5.37 Top 10 Cardiovascular System Drugs in Chinese Hospitals in 2011 ........... 752
Table 5.38 Top 10 Digestive System Drugs in Chinese Hospitals in 2011 .................... 753
Table 5.39 Top 10 Blood & Blood-making System Drugs in Chinese Hospitals in 2011............. 753
Table 5.40 Top 10 Nervous System Drugs in Chinese Hospitals in 2011 ...................... 753
Table 5.41 Top 10 Musculo-Skeletal System Drugs Shares in Chinese Hospitals in 2011.............754
Table 5.42 Top 10 Respiratory System Drugs in Chinese Hospitals in 2011 ................. 754
Table 5.43 Top 10 Hormonal Drugs Systemic Drugs in Chinese Hospitals in 2011 ..... 755
Table 5.44 Top 10 Reproductive/Urinary System and Sex Hormones Drugs in Chinese
Hospitals in 2011 ............................................................................................................ 755
Table 5.45 Top 10 Hospital Drug Suppliers by Sales in 2012 ....................................... 756
Table 5.46 Top 30 Drug Suppliers by Value to Rep Chinese Hospitals in 2011 ............ 757
Table 5.47 Top Ten Therapeutic Classes in 2012 by Hospital Drug Purchases ............. 758
Table 5.48 Drug Consumption of Rep Chinese Hospitals by Major TCs 2009-2011 .... 759
Table 5.49 Drug Consumption Trends of Top 10 TCs in Rep Chinese Hospitals 1999-2011.......... 759
Table 5.50 Hospital Drug Consumption Pattern at ATC1 Level in 2005-2011 .............. 760
Table 5.51 Top 20 Therapeutic Subclasses (ATC2) by Hospital Drug Sales in 2011 .... 761
Table 5.52 Top 20 Therapeutic Subclasses (ATC2) by Hospital Sales Growth in 2011 761
Table 5.53 Changing Hospital Drug Consumption Patterns Since 2005 ....................... 762
Table 5.54 Max Retail Prices of Top 10 Traditional Oncology Drugs in China ............ 768
Table 5.55 Growth of Retail Pharmacies 2010-2012 (27 Major Cities) ........................ 773
Table 5.56 Chinese Retail Pharmacy Market Segmentation by Major Categories Since
2009 ................................................................................................................................ 774
Table 5.57 Retail Rx Drug Market Segmentation 2010-2011 ........................................ 774
Table 5.58 Chinese Retail Market for Western Medicines by TCs 2008-2011 .............. 775
Table 5.59 Top 10 Cold Drugs by Chinese Retail Sales in 2011 ................................... 776
Table 5.60 Top 10 Antibiotics Drugs Shares by Chinese Retail Sales in 2011 .............. 776
Table 5.61 Top 10 Vitamin Products by Chinese Retail Sales in 2011 .......................... 777
Table 5.62 Top 10 Gastrointestinal Drugs by Chinese Retail Sales in 2011 .................. 777
Table 5.63 Top 10 Cardio-/Cerebro-vascular Drugs by Chinese Retail Sales in 2011 .. 778
Table 5.64 Top 10 Cough Drugs by Chinese Retail Sales in 2011 ................................ 778
Table 5.65 Top 10 Skin Disease Drugs by Chinese Retail Sales in 2011 ...................... 779
Table 5.66 Top 10 Anti-hypertension Drugs by Chinese Retail Sales in 2011 .............. 779
Table 5.67 Top 10 Gynecological Drugs by Chinese Retail Sales in 2011 .................... 780
Table 5.68 Top 10 Throat Medicines by Chinese Retail Sales in 2011 ......................... 780
Table 5.69 Composition of OTC Drug Sales in Retail Pharmacies in 2012 .................. 781
Table 5.70 Chinese Retail Pharmacy OTC Sales Growth by TCs in 2012 .................... 781
Table 5.71 Chinese OTC Drug Market by TCs 2008-2012 (US$ mln at MSP) ............ 782
Table 5.72 Chinese OTC Drug Market Growth by TCs 2009-2012 (%) ....................... 782
Table 5.73 Retail OTC Drug Market Segmentation by TCs 2010-2011 ........................ 783
Table 5.74 Top 20 Products (OTC Drugs+Health Foods) of Retail Pharmacies in 2012.............. 784
Table 5.75 China’s Top 20 OTC Drug Companies in 2013 ........................................... 785
Table 5.76 China’s Top 5 OTC Chemical Drug Brands in 2013 ................................... 786
Table 5.77 Top Players in Retail Rx Drug Market 2010-2011 ....................................... 787
Table 5.78 Top Players in Retail OTC Drug Market 2010-2011 ................................... 788
Table 5.79 Composition of Chinese Pharma Market 2012: TCMs vs. WMs ................ 789
Table 5.80 Hospital Market Share of Formulated TCMs by TCs 2012 ......................... 789
Table 5.81 Market Share of Formulated TCMs by Hospital Tier 2012 ......................... 790
Table 5.82 Formulated TCMs under NRDL 2000 Ed. & 2009 Ed. ............................... 790
Table 5.83 Share of Formulated TCMs in Total NRDL Reimbursement 2010 ............. 790
Table 5.84 Share of NEDL FTCMs in Overall Chinese FTCM Sales Value by TCs in 2012............. 790
Table 5.85 Changing Hospital TCM Drug Consumption Patterns Since 2005 .............. 791
Table 5.86 Hospital Drug Markets of Key Chinese Cities/Regions 2009-2011............. 795
Table 5.87 Structure of Shanghai Hospital Drug Sales by Hospitals Tier in 2012 ........ 795
Table 5.88 Regional Hospital Drug Consumption Growth Trend 2009-2011................ 796
Table 5.89 Drug Consumptions in 260 Chinese Rep Hospitals of Six Chinese Cities
2008-11 ........................................................................................................................... 797
Table 5.90 Top Suppliers by Hospital Drug Sales in Six Yangtze River-Vicinity Cities 2011....... 797
Table 5.91 Leading Suppliers by Drug Sales in 119 Shanghai Rep Hospitals 2011 ...... 797
Table 5.92 Leading Suppliers by Drug Sales in 26 Hangzhou Rep Hospitals 2011 ...... 798
Table 5.93 Leading Suppliers by Drug Sales in 32 Wuhan Rep Hospitals 2011 ........... 798
Table 5.94 Leading Suppliers by Drug Sales in 34 Chongqing Rep Hospitals 2011 ..... 799
Table 5.95 Leading Suppliers by Drug Sales in 33 Nanjing Rep Hospitals 2011 .......... 799
Table 5.96 Leading Suppliers by Drug Sales in 16 Chengdu Rep Hospitals 2011 ........ 800
Table 5.97 No.1 Drug by Sales in 260 Rep Hospitals in Six Cities of Yangtze River
Vicinity 2011 .................................................................................................................. 801
Table 5.98 Top 20 Drugs by Sales Value in 119 Shanghai Rep Hospitals 2011 ............ 801
Table 5.99 Top 20 Drugs by Sales Value in 26 Hangzhou Rep Hospitals 2011 ............. 802
Table 5.100 Top 20 Drugs by Sales Value in 33 Nanjing Rep Hospitals 2011 .............. 802
Table 5.101 Top 20 Drugs by Sales Value in 32 Wuhan Rep Hospitals 2011 ................ 803
Table 5.102 Top 20 Drugs by Sales Value in 16 Chengdu Rep Hospitals 2011 ............. 804
Table 5.103 Top 20 Drugs by Sales Value in 34 Chongqing Rep Hospitals 2011 ......... 804
Table 5.104 Tiered Composition of the Chinese Retail Pharmacy Sector in 2011(1) .... 806
Table 5.105 Tiered Composition of the Chinese Retail Pharmacy Sector in 2011(2) .... 806
Table 5.106 Tiered Composition of the Chinese Retail Pharmacy Sector in 2011(3) .... 806
Table 5.107 Regional Distribution of Chinese Retail Pharmacy Outlets 1H/2011 ........ 808
Table 5.108 Chinese Retail OTC Drug Consumption Value by City Tier 2012 ............ 809
Table 5.109 Market Share of Imported Drugs in Ten Major Chinese Cities in 2Q, 1995...............811
Table 5.110 Hospital Market Shares of Local, JV and Imported Drugs 2006-2012 ...... 812
Table 5.111 Market Shares in 260 Rep Hospitals of Yangtze River-Vicinity Cities 2008-11...........814
Table 5.112 Shares of Local & JV/Foreign Companies in Retail Drug Sales 2004-06 . 815
Table 5.113 Retail Pharmacy Market Shares of FIEs and Local Cos 2011 ................... 816
Table 5.114 Shares of Domestics and MNCs in Retail Prescription Drug Sales by TCs
2012................................................................................................................................ 817
Table 5.115 Shares of Innovative Drugs, Generics and TCMs in China 2012 (1) ........ 818
Table 5.116 Shares of Innovative Drugs, Generics and TCMs in China 2012 (2) ........ 819
Table 5.117 Top 10 MNC Companies by Hospital Drug Sales in 2012 ........................ 819
LIST OF CHARTS
Chart 2.1 Overall Chinese Drug Market Size and Growth 2001-2015 .......................... 124
Chart 2.2 Gross Output Value of Chinese Pharmaceutical Industry 2006-2013 ............ 128
Chart 2.3 Composition of Chinese Pharmaceutical Industry by Output Value .............. 128
Chart 2.4 Gross Output Value of Six Chinese Pharma Sub-sectors in 2012 .................. 129
Chart 2.5 Sales Revenues of Chinese Pharmaceutical Industry 2006-2012 .................. 129
Chart 2.6 Composition of Chinese Pharmaceutical Industry by Revenues.................... 130
Chart 2.7 Sales Revenues of Six Chinese Pharma Sub-sectors 2012 ............................. 130
Chart 2.8 COGS/Revenue Ratio of Chinese Pharmaceutical Industry 2006-2012 ........ 131
Chart 2.9 COGS/Revenue Ratio of Six Chinese Pharma Sub-sectors 2012 .................. 131
Chart 2.10 Net Profit of Chinese Pharmaceutical Industry 2006-2012.......................... 132
Chart 2.11 Composition of Chinese Pharmaceutical Industry by Net Profits 2012 ....... 132
Chart 2.12 Net Profit Growth of Six Chinese Pharma Sub-sectors in 2012 .................. 133
Chart 2.13 Sales Margin Trend of the Chinese Pharma Industry 1997-2012 ................ 133
Chart 2.14 Sales Margins of Six Chinese Pharma Sub-sectors 2012 ............................. 134
Chart 2.15 Distribution of Pharma Industry Sales by Ownership Types in 2009 .......... 136
Chart 2.16 Distribution of Pharma Industry Profits by Ownership Types in 2009 ........ 137
Chart 2.17 Gross Output Value of Chinese Biopharma Industry 2006-2012 ................. 144
Chart 2.18 Revenues of Chinese Biopharma Industry 2006-2012 ................................. 145
Chart 2.19 Net Profit of Chinese Biopharma Industry 2006-2012 ................................ 145
Chart 2.20 Foreign Trade of Chinese Biopharmaceutical Industry 2005-2012 ............. 146
Chart 2.21 China’s Biopharmaceutical Drug Import Origin Countries in 2012 ............ 147
Chart 2.22a Profit Margins of the Chinese Pharma Distribution Sector Since 2002 ..... 157
Chart 2.22b Chinese Pharma Distributor Sales by Product Categories in 2012 ............ 157
Chart 2.22c Chinese Retail Pharmacy Market Segmentation in 2012 ........................... 158
Chart 2.22d Distribution of Pharma Industry Sales by Ownership in 2012 ................... 158
Chart 2.22e Distribution of Pharma Industry Profit by Ownership in 2012 .................. 159
Chart 2.23 R&D Centers of RDPAC Members by Research Stage in China ................ 179
Chart 2.24 R&D Centers of RDPAC Members by Function in China .......................... 180
Chart 2.25 Locations of R&D Centers of RDPAC Members in China .......................... 180
Chart 2.26 Chinese Market Access by New Drugs - 1 Year After Launch .................... 181
Chart 2.27 Chinese Market Access by New Drugs - 2 Years after Launch ................... 182
Chart 2.28 Revenues of Top 100 Chinese Pharmaceutical Companies Since 2005 ...... 196
Chart 2.29 Number of Chinese Retail Pharmacy Chains 2006-2011 ............................ 200
Chart 2.30 # of Chinese Retail Pharmacy Stores 2006-2011 ......................................... 201
Chart 2.31 Compulsory license application process ...................................................... 241
Chart 2.32 Application Procedures of APP .................................................................... 247
Chart 2.33 Flowchart – Revocation Procedures of APP ................................................ 248
Chart 2.34 Re-examination Procedures of APP ............................................................. 249
Chart 2.35 Infringement Settlement Procedures of APP ............................................... 250
Chart 2.36 Chinese Hospital Market Growth 2007-2012 .............................................. 282
Chart 2.37 Number of Chinese Retail Pharmacy Stores 2006-2011 .............................. 289
Chart 2.38 Structure of Retail Pharmacy Outlets Since 2006 ........................................ 289
Chart 2.39 Number of Chinese Retail Pharmacy Chains Since 2006 ............................ 290
Chart 2.40 Number of Outlets Owned by Chinese Retail Pharmacy Chains Since 2006............... 290
Chart 2.41 Number of Independent Chinese Retail Pharmacy Stores Since 2006 ........ 291
Chart 2.42 Growth of Chinese Retail Pharmacy Sales Since 2000 ............................... 291
Chart 2.43 Shares of Medical Institutions and Retail Channels in Drug Sales Since 2001................. 292
Chart 2.44 Composition of Outpatient Visits by Provider Types in 2011 ...................... 300
Chart 2.45 Composition of Inpatients by Provider Types in 2011 ................................. 300
Chart 2.46 Drug Consumption by THCs and CHCs in China 2008-2011 ..................... 301
Chart 2.47 Estimated Drug Consumption by Chinese Primary Medical Sector 2008-2011................ 302
Chart 2.48 Vaccine Sales in Representative Hospitals of 22 Chinese Cities 2005-2010....................307
Chart 2.49 Prophylactic Vaccine Sales in Rep Hospitals of 22 Chinese Cities 2006-2010.................307
Chart 2.50 Therapeutic Vaccine Sales in Rep Hospitals of 22 Chinese Cities 2006-2010.................308
Chart 2.51 Rabies Vaccine Sales in Rep Hospitals of 22 Chinese Cities 2006-2010 .... 308
Chart 2.52 Chinese OTC Drug Market Size 2000-2011 ................................................ 313
Chart 2.53 Size of Chinese OTC Drug Sales Channels 2007-2011 ............................... 313
Chart 2.54 Growth of Chinese OTC Drug Market 2008-2012 ...................................... 319
Chart 2.55 Chinese Online Retail (B2C) Drug Sales 2011-2015E ................................ 326
Chart 2.56 Regulatory Filings by Chinese Companies in EU and U.S. ......................... 332
Chart 2.57 US DMF Filings vs. US FDA Inspections in China ..................................... 332
Chart 2.58 API Manufacturer Ratings: China vs. India vs. Italy ................................... 334
Chart 2.59 US DMF Filings: China vs. India vs. Italy ................................................... 335
Chart 2.60 COS Filings: China vs. India vs. Italy .......................................................... 335
Chart 2.61 US FDA Inspections: China vs. India vs. Italy ............................................. 336
Chart 2.62 Progression of Chinese API Manufacturer Ratings: 2005 vs. 2011 ............. 337
Chart 2.63 Chinese Foreign Trade of MHPs 2008-2012 ................................................ 345
Chart 2.64 Export Value of Medicines and Health Products in China Since 2001 ........ 349
Chart 2.65 Chinese API Group Manufacturer Ratings ................................................... 354
Chart 2.66 Progression of Chinese API Group Manufacturer Rations: 2005 vs. 2011 .. 355
Chart 2.67 Regulatory Filings by Chinese Groups ........................................................ 356
Chart 2.68 Regulated Market Activity Deals: API and Intermediates ........................... 356
Chart 2.69 Regulated Market Activity Deals: FDF & Development Agreements ......... 357
Chart 2.70 Eight Chinese Groups Hold A Combined 28 ANDAs with Final FDA Approval............358
Chart 2.71 Follow-on Biologic Development among Chinese Groups ......................... 359
Chart 3.1 SFDA Accepted Drug Registration Applications in 2009-2012 ..................... 364
Chart 3.2 Chemical Drug Registration Applications Accepted by the SFDA in 2012 ... 366
Chart 3.3 Administrative Structure of Food and Drug Regulation in China .................. 393
Chart 3.4 Application and Approval Procedures for Clinical Trials .............................. 455
Chart 3.5 Application and Approval Procedure for Imported Drugs (1) ....................... 459
Chart 3.6 Application and Approval Procedure for Imported Drugs (2) ....................... 459
Chart 3.7 Supplemental Application and Approval Procedure for Imported Drugs (1) 460
Chart 3.8 Supplemental Application and Approval Procedure for Imported Drugs (2) 460
Chart 4.1 Healthcare Spending by Funding Source 1980-2011 ..................................... 631
Chart 5.1 Growth of Healthcare Expenditures in China Since 2000 ............................. 690
Chart 5.2 Growth of Per Capita Healthcare Expenditures in China Since 1990 ........... 691
Chart 5.3 Composition of Healthcare Expenditures in China Since 2000 ..................... 692
Chart 5.4 BMI by Total Adults in Each Geography ....................................................... 724
Chart 5.5 Pre-Diabetes and Type 2 Diabetes in Each Geography ................................. 725
Chart 5.6 Attitudes among Type 2 Diabetes Patients (% agree/strongly agree) ............ 726
Chart 5.7 Hospital Drug Purchases by Representative Chinese Hospitals 2004-2011 .. 748
Chart 5.8 Market Shares of Top Drug Products by Hospital Sales in 2011 ................... 750
Chart 5.9 # of Drug Products Purchased by Chinese Rep Hospitals 2005-2011 ........... 756
Chart 5.10 Sales Value of Oncology Drugs in Chinese Rep Hospitals (22 Cities) 2007-1H/2012 ..... 765
Chart 5.11 Leading Traditional Oncology Drugs in Chinese Rep Hospitals (22 Cities) 1H/2012.......766
Chart 5.12 Oncology Drug Sales by TCs in Chinese Rep Hospitals (22 Cities) 1H/2012....... 767
Chart 5.13 Changing Oncology Drug Consumption Structure in 2006-1H/2012 ...................... 767
Chart 5.14 Diabetes Drugs Sales in Chinese Rep Hospitals (22 Cities) 2005-2011 ............. 770
Chart 5.15 Diabetes Drug Sales in Chinese Rep Hospitals (22 Cities) by TCs in 2011 ..........771
Chart 5.16 Chinese Retail Pharmacy Market Segmentation Since 2004 .................................... 775
Chart 5.17 Chinese Hospital Drug Consumption by City Tier 2008-2012 .................................. 794
Chart 5.18 Chinese Hospital Drug Sales Growth by City Tier 2009-2012 .................................. 794
Chart 5.19 Regional Retail Pharmacy Markets in China 2011 ...................................................... 807
Chart 5.20 Provincial Retail Pharmacy Markets in China 2011 ..................................................... 807
Chart 5.21 Chinese OTC Drug Consumption Value by City Tier and Sales Channel 2012......808
Chart 5.22 Chinese Retail OTC Drug Consumption Value by Cities 2012 ..................................809
Chart 5.23 Chinese Hospital Drug Consumption by City Tier and Supplier Origin 2012.......... 812
Chart 5.24 Hospital Drug Sales Growth Contribution by City Tier and Supplier Origin 2012 ....813
Chart 5.25 Shares of MNCs and Domestics in Chinese Prescription Drug Sales 2012 . .........817
Contact us at the Consulting WP office nearest to you or submit a business inquiry online.
Subscribe to Our Newsletter
Published On : December 2019
$ 3600
Published On : November 2019
$ 3600
Published On : October 2019
$ 2950
Published On : October 2019
$ 2950
Published On : October 2019
$ 2950
