Hepatitis C Therapeutics in Asia-Pacific Markets to 2023

Hepatitis C Therapeutics in Asia-Pacific Markets to 2023-Presence of Outstanding Direct-Acting Antivirals and Late-Stage Pipeline to Transform the Clinical and Commercial Landscape

Summary

Hepatitis C is a blood-borne liver disease caused by the hepatitis C virus (HCV), which can lead to acute and chronic hepatitis infection. According to the World Health Organization (WHO), in 2015 there were 1.75 million new HCV infections globally, and approximately 399,000 people die each year from hepatitis C, mostly due to cirrhosis and hepatocellular carcinoma. The APAC region has diverse HCV epidemiology, with prevalence ranging from 0.1% to 4.7%, and a unique genotype (GT) distribution. Acute HCV infection is usually asymptomatic, and 15-45% of people spontaneously clear the virus within six months of infection without any treatment, while the remaining 55-85% develop chronic HCV infection.

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The hepatitis C market is currently dominated by high-performance regimens comprising new-generation DAAs. The treatment algorithms have shifted away rapidly from interferon-based therapies, and towards interferon-free DAA combination therapies that can cure most patients in as little as eight to 12 weeks, without ribavirin. In the highly competitive hepatitis C treatment landscape, where new combination therapies match each other closely in terms of safety and efficacy, one key differential is patient segment coverage. A number of factors that have conventionally been used to predict treatment outcome, including HCV genotypes, previous treatment history, and a patient's liver and kidney conditions, are also used to define target patient populations for new therapies.

The late-stage hepatitis C pipeline is predominantly composed of DAA regimens targeting HCV NS5A, NS5B polymerase, and NS3/4A protease. The most advanced of the promising pipeline agents are Gilead's sofosbuvir/velpatasvir/voxilaprevir and AbbVie's glecaprevir/pibrentasvir, which have been studied in Phase III clinical trials. Due to the highly effective late-stage pipeline drugs and marketed products, developers of HCV NS5A, NS5B polymerase and NS3/4A protease in earlier stages of clinical development are not aiming to dominate the market, but rather to earn a place as a 'me too' product.

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List of Tables
Table 1: Hepatitis C Therapeutics Market, Risk Factors for Fibrosis Progression, 2016 20
Table 2: Hepatitis C Therapeutics Market, Global, Characteristics of DAAs, 2016 22
Table 3: Hepatitis C Therapeutics Market, APAC, Categories of Approved DAA Therapies in Hepatitis C, 2016 25
Table 4: Hepatitis C Therapeutics Market, Australia, GESA Hepatitis C Treatment Guidelines, 2016 26
Table 5: Hepatitis C Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006-2016 106
Table 6: Hepatitis C Therapeutics Market, Global, Co-development Deals Valued Above $5m, 2006-2016 113
Table 7: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 114
Table 8: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017 117
Table 9: Hepatitis C Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2017 119
Table 10: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 119
Table 11: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 120
Table 12: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 121
Table 13: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017 121

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Table 14: Hepatitis C Therapeutics Market, APAC, Market Forecast, 2016-2023 121
Table 15: Hepatitis C Therapeutics Market, India, Market Forecast, 2016-2023 122
Table 16: Hepatitis C Therapeutics Market, China, Market Forecast, 2016-2023 122
Table 17: Hepatitis C Therapeutics Market, Australia, Market Forecast, 2016-2023 122
Table 18: Hepatitis C Therapeutics Market, South Korea, Market Forecast, 2016-2023 123
Table 19: Hepatitis C Therapeutics Market, Japan, Market Forecast, 2016-2023 123

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