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China Pharmaceutical Guide Volume 1 (8th Edition)

Category : Pharmaceuticals  | Published Date : Jan-2013 | Pages : 1300
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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.

  • Hundreds of pages of new data, information, analysis and case studies. 
  • Thorough summaries and analysis of the latest healthcare reform, drug pricing & reimbursement and hospital tender purchase policies. 
  • Comprehensive industry, market and international trade data as well as health statistics are updated with the 2012 (full year) and early 2013 figures. 
  • Expanded coverage on the primary healthcare sector, the OTC and consumer healthcare sector, high growth market segments, key regional hospital markets, the pharmaceutical distribution sector and online retail pharmacy segment. 
  • Added coverage of the Chinese biosimilar market prospects and regulatory outlook. 
  • Updated coverage of emerging legal issues (including FCPA/compliance and liability issues) and drug-related IP and trademark concerns. 
  • Comprehensive top line data, research findings and observations from our 
  • collaborative partners such as IMS Health, Kantar Health, Nicholas Hall, ZS Associates and RDPAC. 
  •  All regulatory changes in 2012/2013 are updated to present a clear and most up-to-date picture of the Chinese drug regulatory framework with summaries and analysis of all drug regulations in effect by mid-2013. 
  • Focused coverage of China’s deepening reform of its drug registration and evaluation regime, new policies to support drug innovation and high clinical value generics, and its initiative to re-evaluate all generic drugs with bioequivalence studies. 
  • An updated section covering proposed new drug-related laws and regulations under drafting process with previews of the draft versions. 
  • Extensive review and analysis of China’s drug registration applications and approvals as well as Chinese drug innovation trends in recent years. 
  • Comprehensive review of Sino-foreign M&A, joint venture, strategic alliance, licensing, research partnerships, co-marketing, and new drug research events in 2012 and early 2013. 
  • New and expanded coverage on MNC strategies in China with healthcare reform in the backdrop, intellectual property/patent law amendments, data exclusivity, patent litigation, drug regulations, pharma marketing and distribution strategies, drug consumption patterns, the Chinese R&D and outsourcing sector, clinical studies/practices, healthcare reform, community healthcare sector, essential drug policy, regional drug consumption patterns, and the vaccine and API sectors. 
  • Numerous new case studies are added to the 2013 Edition. 
  • Comprehensive revision of the China operation profiles of MNCs to reflect their latest performance, business deals, legal disputes and outlook.

 

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  26
     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 
      
     

 

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