Hepatitis C Therapeutics Pipeline Insight and Therapeutic Assessment Reviewed in 2017

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, “Hepatitis C Therapeutics Pipeline Insight and Therapeutic” 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 patients 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 Gileads sofosbuvir/velpatasvir/voxilaprevir and AbbVies 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.

Scope

The hepatitis C Asia-Pacific market will be valued at $8.31 billion in 2023, growing from $5.38 billion in 2016 at a CAGR of 6.4%.
- How will pan-genotypic therapies such as glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir contribute to growth?
- What effect will the patent expiration of branded therapies have on market value?

The hepatitis C pipeline contains a range of molecule types and molecular targets, including those that are well established in hepatitis C, and novel target therapies.
- What are the common targets and mechanisms of action of pipeline therapies?
- Will the pipeline therapies fulfill the unmet needs of the hepatitis C market?
- What implications will the increased focus on pan-genotypic therapies have on the future of hepatitis C treatment?
Late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period.

- How have the late-stage therapies performed in clinical trials?
- How will the approval of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir, which hold a key advantage in terms of reducing the treatment duration, affect the competitive landscape, with no therapy currently available to address this unmet need?
The market forecasts indicate that China and Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.
- What will be the impact of available therapies with high cure rates on prevalence?
- How will the annual cost of therapy and market size vary between the five Asia-Pacific markets?
- Which countries are in the best situation currently for the eradication of HCV?

Various drivers and barriers will influence the hepatitis C market over the forecast period.
- What are the barriers that will limit the uptake of available and upcoming therapies in the assessed countries?
- Which factors are most likely to drive the market in these countries?
Licensing deals are the most common form of strategic alliance in hepatitis C, with total deal values ranging from under $10m to over $1.5 billion.
- How do deal frequency and value compare between target families and molecule types?
- What were the terms and conditions of key licensing deals?

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Reasons to buy

- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.

- Visualize the composition of the hepatitis C market in terms of dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
- Analyze the hepatitis C pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
- Understand the potential of late-stage therapies, with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.

- Predict hepatitis C market growth in the five Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
- Identify commercial opportunities in the hepatitis C deals landscape by analyzing trends in licensing and co-development deals.

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