Stakeholder Insight: Hepatitis in China
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Diseases pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Chinese Hepatitis B & C market - page 4
- China is undergoing an economic boom, generating 12% of global economic trade, and it is currently the leading recipient of foreign investment. Since 34% of the world's chronic hepatitis B patients and 24% of the world's chronic hepatitis C patients live in China, the Chinese hepatitis B (HBV) and C (HCV) markets have historically represented a significant growth opportunity, with a realistic current valuation of $1.0 billion (HBV) and $0.9 billion (HCV). However, the Chinese healthcare system has been ranked 144th out of 191 by the WHO, prompting it to be denounced as one of the most unfair systems in the world. These problems, together with the inability of many patients to afford these drugs and concerns over their efficacy in Asian patients, are retarding Western pharmaceutical penetration. - page 4
- Chinese physicians indicated that HBV incidence is decreasing and is set to continue to fall. In contrast to the seven major markets, where most patients acquire HBV sexually, the dominant route of HBV transmission in China is perinatal transmission, which increases the likelihood of becoming immune tolerant and impacts on HBV disease progression and the effectiveness of drug therapy. In China, physicians do not consider any of the currently available therapies a gold-standard, although lamivudine is the most prescribed first-line therapy, while adefovir is the most prescribed second-line therapy. - page 4
- Chinese physicians indicated that HCV incidence may be increasing. Blood transfusion is thought to be the dominant HCV transmission route in China, while in the seven major markets, HCV is mainly acquired through intravenous drug use. The Chinese HCV treatment market is highly fragmented, with treatment differing significantly between regions. For example, in Hong Kong, all HCV patients receive pegylated interferon/ribavirin combination therapy, currently considered the global standard of care. However, across mainland China, unmodified interferons are more commonly prescribed than pegylated interferons, and interferon monotherapy is more frequently used than interferon/ribavirin combination therapy. - page 4
- Due to the high cost of pharmaceuticals and the cost-conscious nature of the Chinese healthcare system, the hepatitis market faces a number of threats, including TCMs, generic drugs and counterfeit drugs. - page 5
- Similar to the seven major markets, efficacy is the most important factor driving HBV and HCV pharmaceutical prescription in China, with cost and reimbursement in second place. Interestingly, the side-effect profile ranked third in China, while this factor ranked second in the seven major markets. - page 5
- CHAPTER 2 COVERAGE - page 15
- Coverage of the Stakeholder Insight Survey - page 15
- CHAPTER 3 CHINA: AN OVERVIEW - page 16
- Overview of China - page 16
- Country profile - page 17
- Economy - page 17
- Shift from a centralized to a market economy - page 17
- Benefits from World Trade Organization (WTO) membership - page 19
- China: still a restricted society? - page 21
- Economy - page 17
- Healthcare in China - page 21
- The current scenario - page 21
- Symptoms of an ailing healthcare system - page 24
- The urban-rural divide - page 25
- Reforms on the horizon? - page 26
- Economic potential of the Chinese healthcare market - page 27
- Drug approval in China - page 28
- China's pharmaceuticals market - page 28
- China's biotechnology market - page 30
- International presence - page 31
- China as a foreign investment target - page 31
- Western pharmaceuticals in China - page 31
- The current scenario - page 21
- CHAPTER 4 ETIOLOGY & EPIDEMIOLOGY - page 33
- Overview of infectious diseases in China - page 33
- Infectious diseases in China - page 34
- Overview of infectious diseases in China - page 34
- Hepatitis in China - page 35
- Viral hepatitis: a brief introduction - page 35
- Disease definition and epidemiology - page 37
- HBV - page 37
- Disease characteristics - page 37
- HBV genotypes - page 39
- Disease progression - page 40
- Chronic hepatitis B serological markers - page 45
- Complications and risk factors - page 46
- Transmission - page 48
- HCV - page 53
- Basic virology and serology - page 53
- Disease progression - page 56
- Clinical manifestations - page 59
- Risk factors - page 60
- Transmission - page 61
- Coinfection - page 68
- Coinfection with HIV - page 68
- HBV/HCV coinfection - page 71
- Coinfection with other hepatitis viruses - page 72
- Comorbidities - page 73
- Liver fibrosis/cirrhosis - page 73
- The high prevalence of hepatitis in China boosts prevalence of hepatocellular carcinoma (HCC) - page 74
- Fatty liver (steatosis) - page 76
- Transplant patients - page 77
- HBV & HCV epidemiology - page 77
- Global HBV & HCV epidemiology - page 77
- China HBV & HCV epidemiology - page 79
- HBV - page 37
- CHAPTER 5 DIAGNOSIS RATES AND PRESENTATION - page 91
- Overview of diagnosis rates and presentation - page 91
- Presentation and diagnosis rates - page 92
- HBV diagnosis - page 92
- Successful diagnosis rates - page 92
- Markers used in HBV diagnosis & screening - page 96
- HCV diagnosis - page 98
- Successful diagnosis rates - page 98
- Markers used in HCV diagnosis - page 100
- HBV diagnosis - page 92
- Treatment rates - page 103
- HBV treatment - page 103
- HCV treatment - page 105
- CHAPTER 6 TREATMENT OPTIONS - page 108
- Overview of treatment options - page 108
- Treatment goals - page 110
- HBV disease management - page 110
- Criteria for initiation of treatment - page 110
- HBV drug therapy - page 112
- Treatment guidelines for HBV in Asia and China - page 114
- HBV drugs - page 117
- Immune modulators - page 117
- Nucleoside analogues (nucleoside reverse transcriptase inhibitors; NRTIs) - page 123
- Combination therapy - page 129
- Maintenance therapy - page 131
- HBV drugs in the pipeline - page 132
- Actual prescription choices for HBV - page 134
- Percentage of HBV patients on 1st line, 2nd line and 3rd line + in China - page 134
- Choice of therapy for first-line HBV patients - page 135
- Choice of therapy for second-line HBV patients - page 137
- Treatment of HBV sub-populations - page 139
- HCV disease management - page 143
- Criteria for initiation of treatment - page 143
- HCV drug therapy - page 143
- Treatment guidelines for HCV in Asia and China - page 144
- HCV drugs - page 146
- Interferon monotherapy - page 146
- Combination therapy - page 147
- Genotype dependence on response rate - page 150
- HCV drugs in the pipeline - page 151
- The treatment of coinfected patients - page 153
- Actual prescription choices for HCV - page 153
- Percentage of HCV patients on 1st line, 2nd line and 3rd line+ in China - page 153
- Choice of therapy for first- and second-line HBV patients - page 155
- Vaccination - page 163
- HBV vaccine - page 163
- HBIG - page 166
- Transplantation - page 167
- Prevention - page 169
- CHAPTER 7 VALUING THE CHINESE HEPATITIS MARKET: THREATS, DRIVERS AND THE FUTURE - page 172
- Overview of diagnosis rates and presentation - page 172
- Threats to the Chinese pharmaceutical market - page 173
- Traditional Chinese Medicine (TCM) - page 174
- Counterfeit drugs and generics - page 177
- Counterfeit drugs - page 177
- Generics - page 178
- Factors governing treatment choice - page 179
- Prescription-governing factors - page 179
- Genotyping - page 183
- Type of physician - page 184
- Estimating the value of the hepatitis market in China - page 185
- HBV - page 187
- HBV market valuation scenarios - page 190
- HCV - page 191
- HCV market valuation scenarios - page 193
- The geography of hepatitis in China - page 195
- HBV - page 187
- Treating hepatitis in China: the future - page 196
- The future of HBV in China - page 196
- The future of HCV in China - page 197
- OPINION LEADER TRANSCRIPTS - page 200
- Key opinion leader 1 - Mainland china opinion leader - page 200
- Key opinion leader 2 - Mainland china opinion leader - page 209
- Key opinion leader 3 - Mainland china opinion leader - page 217
- Key opinion leader 4 - Hong Kong opinion leader - page 226
- Key opinion leader 5 - Mainland China opinion leader - page 240
- Key opinion leader 6 - Mainland China opinion leader - page 253
- Key opinion leader 7 - Hong Kong opinion leader - page 258
- APPENDIX A - page 272
- Bibliography - page 272
- Journal articles - page 272
- Conference presentations - page 280
- Press releases - page 281
- Organizations and websites - page 284
- Datamonitor Reports - page 285
- Miscellaneous - page 286
- Bibliography - page 272
- APPENDIX B - page 288
- Physician research methodology - page 288
- Physician sample breakdown - page 288
- Hong Kong - page 288
- Beijing - page 289
- Shanghai - page 289
- Ghangzhou - page 290
- Wuhan - page 290
- Physician sample breakdown - page 288
- Physician research methodology - page 288
- APPENDIX C - page 291
- Questionnaire - page 291
- About Datamonitor - page 309
- About Datamonitor Healthcare - page 309
- Datamonitor Healthcare's research and analysis methodologies - page 310
- Disclaimer - page 310
- List of Tables
- Table 1: Main economic indicators for 7 of the world's largest economies (2003) - page 19
- Table 2: Core Health indicators, 2003 - page 22
- Table 3: Selected Chinese national health accounts indicators, 2001 - page 23
- Table 4: HBV nomenclature: viral and host-derived serum markers - page 38
- Table 5: Geographical distribution of HCV genotypes - page 54
- Table 6: Percentage of patients with HBV/HCV coinfection - page 71
- Table 7: Annual cases of liver cancer - page 75
- Table 8: HBV prevalence worldwide and in China - page 82
- Table 9: HCV prevalence worldwide and in China - page 87
- Table 10: Most commonly used fibrosis staging systems - page 102
- Table 11: Marketed HBV drugs - page 113
- Table 12: HBV drugs: First launch vs China launch - page 114
- Table 13: Interferons used for HCV monotherapy - page 146
- Table 14: HCV combination therapy - page 148
- Table 15: Identifying the number of patients on each type of HBV therapy - page 188
- Table 16: Estimating the value of the HBV market in China - page 189
- Table 17: Identifying the number of patients on each type of HCV therapy - page 192
- Table 18: Estimating the value of the HCV market in China - page 193
- Table 19: Hong Kong physician sample breakdown, 2005 - page 288
- Table 20: Beijing physician sample breakdown, 2005 - page 289
- Table 21: Shanghai physician sample breakdown, 2005 - page 289
- Table 22: Ghangzhou physician sample breakdown, 2005 - page 290
- Table 23: Wuhan physician sample breakdown, 2005 - page 290
- List of Figures
- Figure 1: China's major trading partners, 2004 - page 20
- Figure 2: Total expenditure on health as percentage of GDP, 2001 - page 24
- Figure 3: The Chinese pharmaceutical industry revenues - page 29
- Figure 4: Total pharmaceutical sales in China - page 29
- Figure 5: Actual and predicted Chinese pharmaceutical market - page 30
- Figure 6: Top five Western corporations in the Chinese healthcare market for the period March 2000-March 2001 - page 32
- Figure 7: HBV genotypes in China - page 39
- Figure 8: HBV disease progression - page 42
- Figure 9: Natural course of HBV infection - page 43
- Figure 10: HBV virus variants and mutants - page 44
- Figure 11: Factors influencing progression of CHB to cirrhosis - page 47
- Figure 12: Key routes of HBV transmission and risk groups - page 49
- Figure 13: HBV patients in China compared to the average 7 major markets, split by leading transmission type - page 50
- Figure 14: HBV patients, split by leading transmission type, and region - page 52
- Figure 15: HCV genotype prevalence in China - page 55
- Figure 16: HCV disease progression - page 57
- Figure 17: Natural course of HCV infection - page 59
- Figure 18: Host factors influencing progression of chronic HCV to cirrhosis - page 61
- Figure 19: HCV patients in China compared to the average 7 major markets, split by leading transmission type - page 62
- Figure 20: HCV patients, split by leading transmission type and region - page 63
- Figure 21: Percentage of hepatitis patients coinfected with HIV - page 68
- Figure 22: Proportion of annual cases of liver cancer worldwide caused by HBV and HCV - page 75
- Figure 23: Worldwide prevalence of HBV - page 78
- Figure 24: Worldwide prevalence of HCV - page 78
- Figure 25: Chronic hepatitis B & C prevalence in China compared to the rest of the world - page 79
- Figure 26: Prevalence of HBV in China - page 81
- Figure 27: HBV patients, split by sex - page 84
- Figure 28: HBV patients, split by age and geography - page 85
- Figure 29: Chinese HCV patients, split by sex and geography - page 88
- Figure 30: Chinese HCV patients, split by age and geography - page 89
- Figure 31: HBV patients, split by successful diagnosis and geography - page 93
- Figure 32: HBV patients in Hong Kong and the average 7 major markets, split by successful diagnosis - page 95
- Figure 33: Markers used for HBV diagnosis - page 96
- Figure 34: HCV patients, split by successful diagnosis and geography - page 98
- Figure 35: HCV patients in Hong Kong and the average 7 major markets, split by successful diagnosis - page 99
- Figure 36: Markers used for HCV diagnosis - page 101
- Figure 37: HBV patients, split by treatment type received and geography in China - page 104
- Figure 38: HBV patients, split by treatment type received and geography in China - page 105
- Figure 39: HCV patients, split by treatment type received and geography in China - page 106
- Figure 40: HCV patients, split by treatment type received and geography in China - page 107
- Figure 41: Advantages and disadvantages associated with unmodified interferon therapy - page 118
- Figure 42: Advantages and disadvantages associated with pegylated interferon therapy - page 121
- Figure 43: Advantages and disadvantages associated with lamivudine therapy - page 124
- Figure 44: Advantages and disadvantages associated with adefovir dipivoxil therapy - page 127
- Figure 45: HBV pipeline, by phase of clinical development and drug class - page 132
- Figure 46: Proportion of patients on 1st line, 2nd line and 3rd line + in China, compared to the 7 major markets - page 134
- Figure 47: Proportion of patients being prescribed each listed HBV first-line therapy in China - page 136
- Figure 48: Proportion of patients being prescribed each listed HBV second-line therapy in China - page 138
- Figure 49: Incidence of coinfection among HBV patients in China, compared to the 7 major markets - page 142
- Figure 50: Improvements in sustained response following the evolution of HCV treatments - page 149
- Figure 51: HCV pipeline, by phase of clinical development and drug class - page 152
- Figure 52: Proportion of patients on 1st line, 2nd line and 3rd line + for HCV therapies in China, compared to the 7 major markets - page 154
- Figure 53: Proportion of patients being prescribed each listed HCV first-line therapy in China - page 155
- Figure 54: HCV patients prescribed interferon combination therapy, split by type of interferon therapy and line of treatment - page 156
- Figure 55: HCV patients prescribed first-line interferon monotherapy and combination therapies, split by type of interferon therapy, for the average of China - page 158
- Figure 56: Type of ribavirin prescribed for Chinese HCV patients on unpegylated interferons and pegylated interferons in first-line therapy - page 160
- Figure 57: Proportion of patients being prescribed each listed HCV second-line therapy in China - page 162
- Figure 58: Prevention strategies for HIV - page 170
- Figure 59: Leading TCM brands prescribed for HBV and HCV in China - page 176
- Figure 60: Generic penetration of 1st- and 2nd-line HBV therapies - page 178
- Figure 61: Factors influencing prescription choice for HBV - page 180
- Figure 62: Factors influencing prescription choice for HCV - page 182
- Figure 63: HBV patient treatment with pharmaceuticals by different physician types - page 184
- Figure 64: Percentage of HBV and HCV patients who receive pharmacological therapy - page 186
- Figure 65: The geography of hepatitis in China - page 195
- Figure 66: Future trends affecting HBV transmission - page 196
- Figure 67: Future trends affecting HCV transmission - page 198
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