Stakeholder Insight: Hepatitis in China - Liver Let Die?

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the Chinese Hepatitis B & C market 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. 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. 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. 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. 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. 5
CHAPTER 2 COVERAGE 15
Coverage of the Stakeholder Insight Survey 15
CHAPTER 3 CHINA: AN OVERVIEW 16
Overview of China 16
Country profile 17
Economy 17
Shift from a centralized to a market economy 17
Benefits from World Trade Organization (WTO) membership 19
China: still a restricted society? 21
Healthcare in China 21
The current scenario 21
Symptoms of an ailing healthcare system 24
The urban-rural divide 25
Reforms on the horizon? 26
Economic potential of the Chinese healthcare market 27
Drug approval in China 28
China’s pharmaceuticals market 28
China’s biotechnology market 30
International presence 31
China as a foreign investment target 31
Western pharmaceuticals in China 31
CHAPTER 4 ETIOLOGY & EPIDEMIOLOGY 33
Overview of infectious diseases in China 33
Infectious diseases in China 34
Overview of infectious diseases in China 34
Hepatitis in China 35
Viral hepatitis: a brief introduction 35
Disease definition and epidemiology 37
HBV 37
Disease characteristics 37
HBV genotypes 39
Disease progression 40
Chronic hepatitis B serological markers 45
Complications and risk factors 46
Transmission 48
HCV 53
Basic virology and serology 53
Disease progression 56
Clinical manifestations 59
Risk factors 60
Transmission 61
Coinfection 68
Coinfection with HIV 68
HBV/HCV coinfection 71
Coinfection with other hepatitis viruses 72
Comorbidities 73
Liver fibrosis/cirrhosis 73
The high prevalence of hepatitis in China boosts prevalence of hepatocellular carcinoma (HCC) 74
Fatty liver (steatosis) 76
Transplant patients 77
HBV & HCV epidemiology 77
Global HBV & HCV epidemiology 77
China HBV & HCV epidemiology 79
CHAPTER 5 DIAGNOSIS RATES AND PRESENTATION 91
Overview of diagnosis rates and presentation 91
Presentation and diagnosis rates 92
HBV diagnosis 92
Successful diagnosis rates 92
Markers used in HBV diagnosis & screening 96
HCV diagnosis 98
Successful diagnosis rates 98
Markers used in HCV diagnosis 100
Treatment rates 103
HBV treatment 103
HCV treatment 105
CHAPTER 6 TREATMENT OPTIONS 108
Overview of treatment options 108
Treatment goals 110
HBV disease management 110
Criteria for initiation of treatment 110
HBV drug therapy 112
Treatment guidelines for HBV in Asia and China 114
HBV drugs 117
Immune modulators 117
Nucleoside analogues (nucleoside reverse transcriptase inhibitors; NRTIs) 123
Combination therapy 129
Maintenance therapy 131
HBV drugs in the pipeline 132
Actual prescription choices for HBV 134
Percentage of HBV patients on 1st line, 2nd line and 3rd line + in China 134
Choice of therapy for first-line HBV patients 135
Choice of therapy for second-line HBV patients 137
Treatment of HBV sub-populations 139
HCV disease management 143
Criteria for initiation of treatment 143
HCV drug therapy 143
Treatment guidelines for HCV in Asia and China 144
HCV drugs 146
Interferon monotherapy 146
Combination therapy 147
Genotype dependence on response rate 150
HCV drugs in the pipeline 151
The treatment of coinfected patients 153
Actual prescription choices for HCV 153
Percentage of HCV patients on 1st line, 2nd line and 3rd line+ in China 153
Choice of therapy for first- and second-line HBV patients 155
Vaccination 163
HBV vaccine 163
HBIG 166
Transplantation 167
Prevention 169
CHAPTER 7 VALUING THE CHINESE HEPATITIS MARKET: THREATS, DRIVERS AND THE FUTURE 172
Overview of diagnosis rates and presentation 172
Threats to the Chinese pharmaceutical market 173
Traditional Chinese Medicine (TCM) 174
Counterfeit drugs and generics 177
Counterfeit drugs 177
Generics 178
Factors governing treatment choice 179
Prescription-governing factors 179
Genotyping 183
Type of physician 184
Estimating the value of the hepatitis market in China 185
HBV 187
HBV market valuation scenarios 190
HCV 191
HCV market valuation scenarios 193
The geography of hepatitis in China 195
Treating hepatitis in China: the future 196
The future of HBV in China 196
The future of HCV in China 197
OPINION LEADER TRANSCRIPTS 200
Key opinion leader 1 – Mainland china opinion leader 200
Key opinion leader 2 – Mainland china opinion leader 209
Key opinion leader 3 – Mainland china opinion leader 217
Key opinion leader 4 – Hong Kong opinion leader 226
Key opinion leader 5 – Mainland China opinion leader 240
Key opinion leader 6 – Mainland China opinion leader 253
Key opinion leader 7 – Hong Kong opinion leader 258
APPENDIX A 272
Bibliography 272
Journal articles 272
Conference presentations 280
Press releases 281
Organizations and websites 284
Datamonitor Reports 285
Miscellaneous 286
APPENDIX B 288
Physician research methodology 288
Physician sample breakdown 288
Hong Kong 288
Beijing 289
Shanghai 289
Ghangzhou 290
Wuhan 290
APPENDIX C 291
Questionnaire 291
About Datamonitor 309
About Datamonitor Healthcare 309
Datamonitor Healthcare’s research and analysis methodologies 310
Disclaimer 310