Hepatitis B Virus | Niche & Rare Disease Landscape & Forecast | US/EU5 | 2017

The hepatitis B virus (HBV) therapy market is primarily defined by patients chronically infected with HBV who require lifelong treatment with a daily nucleoside analogue. Although the majority of HBV patients are well served with older, generically available agents such as Bristol-Myers Squibb’s Baraclude (entecavir, generics), new agents are needed that can reduce the long-term toxicities and adverse events that are generally associated with nucleoside reverse transcriptase inhibitors. The recent market launch of Gilead’s Vemlidy (tenofovir alafenamide) not only offers an additional treatment option for HBV patients, but it will be the primary growth driver in a market constrained by generic erosion. Furthermore, drug developers are recognizing the commercial opportunity in the HBV market and thus are focusing on developing agents with novel mechanisms of action in an effort to advance the standard of care in this space.

Questions Answered:

• How large is the diagnosed HBV population in the U.S. and EU5, and how will its size change over time?
• What is the current treatment landscape for chronic HBV infections, and how will it change in the next ten years?
• What is the market share of current agents in the U.S./EU5 HBV market?
• What do interviewed experts believe is the greatest unmet medical need in the treatment of chronic HBV infections?
• What are interviewed experts’ insights on emerging therapies? How will emerging therapies fit into future medical practice?

Scope

• Markets covered: United States, France, Germany, Italy, Spain, and the United Kingdom.
• Primary research: Six country-specific interviews with thought-leading gastroenterologists and hepatologists.
• Epidemiology: Diagnosed prevalence of HBV and drug-treated patients by country and segmented by HBeAg-seropositive and -negative status.
• Market forecast: Drug-level sales and patient share of key HBV therapies in 2016 and 2026.
• Emerging therapies: Phase II: 4 drugs. Coverage of select Phase I/II and I products.

Key companies: Bristol-Myers Squibb, GlaxoSmithKline, Roche, Gilead, Novartis, Spring Bank Pharmaceuticals, Inovio Pharmaceuticals, Ionis Pharmaceuticals, Alnylam Pharmaceuticals, Novira Therapeutics, Myr GmbH.

Key drugs: Entecavir (Baraclude, generics), lamivudine (Epivir-HBV, Zeffix, generics), pegylated interferon-α-2a (Pegasys), tenofovir alafenamide (Vemlidy), tenofovir disoproxil fumarate (Viread), SB-9200, GS-9620, INO-1800, IONIS-HBVRx, ALN-HBV, Myrcludex B, NVR-3778.