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Stakeholder Insight: Hepatitis in China - Liver Let Die?

Published by: Datamonitor

Published: Dec. 21, 2005 - 310 Pages


Table of Contents


TABLE OF CONTENTS

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

Abstract

Introduction
Hepatitis is a major health problem in China, which is home to one third of hepatitis B patients and one quarter of hepatitis C patients globally. HBV vaccination, together with HBV and HCV screening have helped to reduce transmission, but continued transmission from mother to child (for HBV) and transmission via blood transfusions (HCV) means that HBV and HCV are likely to remain a problem.

Scope
Analysis of the current dynamics of the Chinese hepatitis market through primary research data from 176 physicians, supported by key opinion leaders
Identification of drivers and resistors of the Chinese hepatitis market, and how the Chinese healthcare system impacts these market-shaping factors
Examination of key hepatitis drug regimens for hepatitis in China, and factors affecting prescription trends underlying these regimens
Assessment of the differences between China and the 7 major markets in terms of HBV and HCV transmission and diagnosis
Highlights
Datamonitor physician research indicated that HBV incidence is decreasing in China. In contrast to the seven major markets, where most patients acquire HBV sexually, perinatal transmission is the dominant HBV transmission route, which impacts on HBV disease progression and effectiveness of drug therapy.

Chinese physicians believe that HCV incidence may be increasing in China. Blood transfusion is though to be the dominant HCV transmission route in China, while in the seven major markets, HCV is mainly acquired through intravenous drug use.

Chinese physicians do not consider any HBV therapy a gold-standard, although lamivudine is the most prescribed first-line therapy, while adefovir is the most prescribed second-line therapy. While treatment choice is more limited for HCV, the Chinese HCV market is highly fragmented, with treatment differing significantly between regions.

Reasons to Purchase
Review the clinical and commercial factors shaping the uptake of hepatitis products in China, and the opportunities and threats facing the market
Gain insight into HBV and HCV prevalence, transmission and coinfection in China
Evaluate unmet needs in China's hepatitis market and capitalize on these opportunities to develop commercial strategies to increase market penetration


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