中国における肝炎治療の市場

Abstract

Overview

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

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Infectious Diseases pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the Chinese Hepatitis B & C market
    • 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.
    • 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.
    • 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.
    • 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.
    • 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.
• CHAPTER 2 COVERAGE
  • Coverage of the Stakeholder Insight Survey
• CHAPTER 3 CHINA: AN OVERVIEW
  • Overview of China
  • Country profile
    • Economy
      • Shift from a centralized to a market economy
      • Benefits from World Trade Organization (WTO) membership
    • China: still a restricted society?
  • Healthcare in China
    • The current scenario
      • Symptoms of an ailing healthcare system
      • The urban-rural divide
    • Reforms on the horizon?
    • Economic potential of the Chinese healthcare market
      • Drug approval in China
      • China's pharmaceuticals market
      • China's biotechnology market
    • International presence
      • China as a foreign investment target
      • Western pharmaceuticals in China
• CHAPTER 4 ETIOLOGY & EPIDEMIOLOGY
  • Overview of infectious diseases in China
  • Infectious diseases in China
    • Overview of infectious diseases in China
    • Hepatitis in China
  • Viral hepatitis: a brief introduction
  • Disease definition and epidemiology
    • HBV
      • Disease characteristics
      • HBV genotypes
      • Disease progression
      • Chronic hepatitis B serological markers
      • Complications and risk factors
      • Transmission
    • HCV
      • Basic virology and serology
      • Disease progression
      • Clinical manifestations
      • Risk factors
      • Transmission
    • Coinfection
      • Coinfection with HIV
      • HBV/HCV coinfection
      • Coinfection with other hepatitis viruses
    • Comorbidities
      • Liver fibrosis/cirrhosis
      • The high prevalence of hepatitis in China boosts prevalence of hepatocellular carcinoma (HCC)
      • Fatty liver (steatosis)
      • Transplant patients
    • HBV & HCV epidemiology
      • Global HBV & HCV epidemiology
      • China HBV & HCV epidemiology
• CHAPTER 5 DIAGNOSIS RATES AND PRESENTATION
  • Overview of diagnosis rates and presentation
  • Presentation and diagnosis rates
    • HBV diagnosis
      • Successful diagnosis rates
      • Markers used in HBV diagnosis & screening
    • HCV diagnosis
      • Successful diagnosis rates
      • Markers used in HCV diagnosis
  • Treatment rates
    • HBV treatment
    • HCV treatment
• CHAPTER 6 TREATMENT OPTIONS
  • Overview of treatment options
  • Treatment goals
  • HBV disease management
    • Criteria for initiation of treatment
    • HBV drug therapy
    • Treatment guidelines for HBV in Asia and China
    • HBV drugs
      • Immune modulators
      • Nucleoside analogues (nucleoside reverse transcriptase inhibitors; NRTIs)
      • Combination therapy
      • Maintenance therapy
    • HBV drugs in the pipeline
    • Actual prescription choices for HBV
      • Percentage of HBV patients on 1st line, 2nd line and 3rd line + in China
      • Choice of therapy for first-line HBV patients
      • Choice of therapy for second-line HBV patients
      • Treatment of HBV sub-populations
  • HCV disease management
    • Criteria for initiation of treatment
    • HCV drug therapy
    • Treatment guidelines for HCV in Asia and China
    • HCV drugs
      • Interferon monotherapy
      • Combination therapy
      • Genotype dependence on response rate
      • HCV drugs in the pipeline
    • The treatment of coinfected patients
    • Actual prescription choices for HCV
      • Percentage of HCV patients on 1st line, 2nd line and 3rd line+ in China
      • Choice of therapy for first- and second-line HBV patients
  • Vaccination
    • HBV vaccine
    • HBIG
  • Transplantation
  • Prevention
• CHAPTER 7 VALUING THE CHINESE HEPATITIS MARKET: THREATS, DRIVERS AND THE FUTURE
  • Overview of diagnosis rates and presentation
  • Threats to the Chinese pharmaceutical market
    • Traditional Chinese Medicine (TCM)
    • Counterfeit drugs and generics
      • Counterfeit drugs
      • Generics
  • Factors governing treatment choice
    • Prescription-governing factors
    • Genotyping
    • Type of physician
  • Estimating the value of the hepatitis market in China
    • HBV
      • HBV market valuation scenarios
    • HCV
      • HCV market valuation scenarios
    • The geography of hepatitis in China
  • Treating hepatitis in China: the future
    • The future of HBV in China
    • The future of HCV in China
• OPINION LEADER TRANSCRIPTS
  • Key opinion leader 1 - Mainland china opinion leader
  • Key opinion leader 2 - Mainland china opinion leader
  • Key opinion leader 3 - Mainland china opinion leader
  • Key opinion leader 4 - Hong Kong opinion leader
  • Key opinion leader 5 - Mainland China opinion leader
  • Key opinion leader 6 - Mainland China opinion leader
  • Key opinion leader 7 - Hong Kong opinion leader
• APPENDIX A
  • Bibliography
    • Journal articles
    • Conference presentations
    • Press releases
    • Organizations and websites
    • Datamonitor Reports
    • Miscellaneous
• APPENDIX B
  • Physician research methodology
    • Physician sample breakdown
      • Hong Kong
      • Beijing
    • Shanghai
      • Ghangzhou
      • Wuhan
• APPENDIX C
  • Questionnaire
  • About Datamonitor
    • About Datamonitor Healthcare
    • Datamonitor Healthcare's research and analysis methodologies
  • Disclaimer
  • List of Tables
    • Table 1: Main economic indicators for 7 of the world's largest economies (2003)
    • Table 2: Core Health indicators, 2003
    • Table 3: Selected Chinese national health accounts indicators, 2001
    • Table 4: HBV nomenclature: viral and host-derived serum markers
    • Table 5: Geographical distribution of HCV genotypes
    • Table 6: Percentage of patients with HBV/HCV coinfection
    • Table 7: Annual cases of liver cancer
    • Table 8: HBV prevalence worldwide and in China
    • Table 9: HCV prevalence worldwide and in China
    • Table 10: Most commonly used fibrosis staging systems
    • Table 11: Marketed HBV drugs
    • Table 12: HBV drugs: First launch vs China launch
    • Table 13: Interferons used for HCV monotherapy
    • Table 14: HCV combination therapy
    • Table 15: Identifying the number of patients on each type of HBV therapy
    • Table 16: Estimating the value of the HBV market in China
    • Table 17: Identifying the number of patients on each type of HCV therapy
    • Table 18: Estimating the value of the HCV market in China
    • Table 19: Hong Kong physician sample breakdown, 2005
    • Table 20: Beijing physician sample breakdown, 2005
    • Table 21: Shanghai physician sample breakdown, 2005
    • Table 22: Ghangzhou physician sample breakdown, 2005
    • Table 23: Wuhan physician sample breakdown, 2005
  • List of Figures
    • Figure 1: China's major trading partners, 2004
    • Figure 2: Total expenditure on health as percentage of GDP, 2001
    • Figure 3: The Chinese pharmaceutical industry revenues
    • Figure 4: Total pharmaceutical sales in China
    • Figure 5: Actual and predicted Chinese pharmaceutical market
    • Figure 6: Top five Western corporations in the Chinese healthcare market for the period March 2000-March 2001
    • Figure 7: HBV genotypes in China
    • Figure 8: HBV disease progression
    • Figure 9: Natural course of HBV infection
    • Figure 10: HBV virus variants and mutants
    • Figure 11: Factors influencing progression of CHB to cirrhosis
    • Figure 12: Key routes of HBV transmission and risk groups
    • Figure 13: HBV patients in China compared to the average 7 major markets, split by leading transmission type
    • Figure 14: HBV patients, split by leading transmission type, and region
    • Figure 15: HCV genotype prevalence in China
    • Figure 16: HCV disease progression
    • Figure 17: Natural course of HCV infection
    • Figure 18: Host factors influencing progression of chronic HCV to cirrhosis
    • Figure 19: HCV patients in China compared to the average 7 major markets, split by leading transmission type
    • Figure 20: HCV patients, split by leading transmission type and region
    • Figure 21: Percentage of hepatitis patients coinfected with HIV
    • Figure 22: Proportion of annual cases of liver cancer worldwide caused by HBV and HCV
    • Figure 23: Worldwide prevalence of HBV
    • Figure 24: Worldwide prevalence of HCV
    • Figure 25: Chronic hepatitis B & C prevalence in China compared to the rest of the world
    • Figure 26: Prevalence of HBV in China
    • Figure 27: HBV patients, split by sex
    • Figure 28: HBV patients, split by age and geography
    • Figure 29: Chinese HCV patients, split by sex and geography
    • Figure 30: Chinese HCV patients, split by age and geography
    • Figure 31: HBV patients, split by successful diagnosis and geography
    • Figure 32: HBV patients in Hong Kong and the average 7 major markets, split by successful diagnosis
    • Figure 33: Markers used for HBV diagnosis
    • Figure 34: HCV patients, split by successful diagnosis and geography
    • Figure 35: HCV patients in Hong Kong and the average 7 major markets, split by successful diagnosis
    • Figure 36: Markers used for HCV diagnosis
    • Figure 37: HBV patients, split by treatment type received and geography in China
    • Figure 38: HBV patients, split by treatment type received and geography in China
    • Figure 39: HCV patients, split by treatment type received and geography in China
    • Figure 40: HCV patients, split by treatment type received and geography in China
    • Figure 41: Advantages and disadvantages associated with unmodified interferon therapy
    • Figure 42: Advantages and disadvantages associated with pegylated interferon therapy
    • Figure 43: Advantages and disadvantages associated with lamivudine therapy
    • Figure 44: Advantages and disadvantages associated with adefovir dipivoxil therapy
    • Figure 45: HBV pipeline, by phase of clinical development and drug class
    • Figure 46: Proportion of patients on 1st line, 2nd line and 3rd line + in China, compared to the 7 major markets
    • Figure 47: Proportion of patients being prescribed each listed HBV first-line therapy in China
    • Figure 48: Proportion of patients being prescribed each listed HBV second-line therapy in China
    • Figure 49: Incidence of coinfection among HBV patients in China, compared to the 7 major markets
    • Figure 50: Improvements in sustained response following the evolution of HCV treatments
    • Figure 51: HCV pipeline, by phase of clinical development and drug class
    • Figure 52: Proportion of patients on 1st line, 2nd line and 3rd line + for HCV therapies in China, compared to the 7 major markets
    • Figure 53: Proportion of patients being prescribed each listed HCV first-line therapy in China
    • Figure 54: HCV patients prescribed interferon combination therapy, split by type of interferon therapy and line of treatment
    • Figure 55: HCV patients prescribed first-line interferon monotherapy and combination therapies, split by type of interferon therapy, for the average of China
    • Figure 56: Type of ribavirin prescribed for Chinese HCV patients on unpegylated interferons and pegylated interferons in first-line therapy
    • Figure 57: Proportion of patients being prescribed each listed HCV second-line therapy in China
    • Figure 58: Prevention strategies for HIV
    • Figure 59: Leading TCM brands prescribed for HBV and HCV in China
    • Figure 60: Generic penetration of 1st- and 2nd-line HBV therapies
    • Figure 61: Factors influencing prescription choice for HBV
    • Figure 62: Factors influencing prescription choice for HCV
    • Figure 63: HBV patient treatment with pharmaceuticals by different physician types
    • Figure 64: Percentage of HBV and HCV patients who receive pharmacological therapy
    • Figure 65: The geography of hepatitis in China
    • Figure 66: Future trends affecting HBV transmission
    • Figure 67: Future trends affecting HCV transmission