Hepatitis B Virus (HBV) Treatment Market Size, Share and Growth, Regional Analysis and Forecast – 2024

Market Overview, Key in-line Products, Market Share Distribution, Competitive Dynamics, Regulatory Outlook, Pipeline Development, Growth Catalysts & Challenges, Leading Market & R&D Trends, Partnership & Deals Analyses, Global Sales forecast of in-line and pipeline products, Fast Growing Private Companies, Management Perspectives, Commentaries, Market Outlook & Summary Conclusions
 
Global HBV market was valued at $eri2.8bn in 2015 and is forecast to grow at a modest CAGR of 1.8% between 2015 and 2024, reaching 2024 sales of $3.3bn.
Globally, 350 million people are living with Chronic Hepatitis B (CHB) infection currently. CHB affects up to 2.2 million people in the U.S. Because of the high incidence and risk of liver injury, CHB is a major global health and economic burden. Every year, close to a million people die due to CHB infection related complications including cirrhosis and hepatocellular carcinoma.
Despite the large number of patients with CHB worldwide, the current commercial opportunity is modest since the market in the U.S. and Europe is small, and the available treatments remain suboptimal. Existing therapies can slow disease progression, but cannot cure the chronic infection.
 
“Current Treatment Algorithm”
Currently approved therapeutic agents for HBV include interferon (IFN)-α and nucleos(t)ide analogues (nukes). Nukes inhibit HBV viral replication by inhibiting the viral DNA polymerase, thereby inhibiting the production of new viruses. The choice of therapy is determined by the likelihood of response and patient tolerability.  
There are five oral HBV polymerase inhibitors approved for CHB treatment. Epivir (lamivudine, GSK, now generic), Baraclude (entecavir, Bristol Myers), and Tyzeka (telbivudine, Novartis) are nucleoside analogues; Hepsera (adefovir) and Viread (tenofovir disoproxil fumarate, Gilead) are nucleotide analogues.  
Because of significant resistance problems with Epivir, Hepsera, and Tyzeka, only Baraclude and Viread are recommended as frontline treatment for CHB. Nukes are orally administered and have milder side effects compared with PEG-IFN. Further, as nukes target the viral polymerase directly, they are more effective in suppressing HBV DNA than PEG-IFN as well.
Baraclude and Viread, are the top-selling nukes and have demonstrated long-term efficacy and safety with little or no resistance, compared with others in the class.
“Preventative Therapy: Vaccines Are Available for Hepatitis B Prevention”
Hepatitis B infection can be prevented by currently marketed vaccines, which have contributed to curbing incidence of HBV infections globally in the past decades. Vaccination is not a treatment for infection, though if administered immediately after birth, can be about 90% successful at preventing vertical transmission from an infected mother. Effective administration of hepatitis B vaccine has decreased HBV infection rates in various parts of the world and is an important public health effort in stabilizing prevalence of HBV infections.
 
 
HBV Market, By Geography, 2013 - 2024 (USD Million)  
 
 
 
The market for hepatitis vaccines is substantial. Optima Insights estimates significant sales contribution driven by adult HepB monovalent vaccines and Twinrix (a combined HepA/HepB vaccine), with the remainder of sales in the pediatric patient population.  
 
“Product Innovation”
 
A new hepatitis B vaccine from Dynavax is nearing potential approval by the end of 2016. Heplisav, Dynavax’s lead product, has demonstrated superior seroprotection to the current standard of care Engerix-B of GSK with only two injections over one-month duration. The safety profiles of the two vaccines appear comparable.  
 
Heplisav is shown to be over 90% effective in all subpopulations tested, including those who respond suboptimally to Engerix-B. We expect Heplisav to become the new standard of care in the United States upon approval.
 
Therapeutic vaccines aim to generate virus-specific cytotoxic T cells to eradicate HBV-infected cells. They generally should incorporate the core and surface antigens, and should include an immune boosting component so as to induce multispecific broadly cross-reactive T cells and neutralizing antibodies to overcome immune exhaustion.  
 
The ideal patients for therapeutic vaccines are those well suppressed on nuke therapy, and agents who can lower S antigen load should aid in the efficacy of the vaccines.
 
There are a number of HBV programs in clinical development. Gilead, Inovio, Roche, Altimune and Transgene are engaged in the development of therapeutic vaccines in HBV space. Many of the experimental therapies are still in early stage of development. and it is unclear if any have the potential to increase cure rates and revolutionize treatment.
 
“Bristol Myers, GSK, Merck, Gilead, Roche & Novartis are some of the key players in HBV market"
 
Bristol Myer’s Baraclude, GSK’s Epivir, Gilead’s Hepsera/Viread, and Novartis’ Tyzeka, Merck’s PEG-Intron and Roche’s Pegasys are currently the market leading treatments in HBV.
 
On the vaccine side, the current market leader is GSK, whose HBV vaccines in aggregate generate over $1bn of sales annually. Merck has the second largest share, generating about $250m of HBV sales annually.
 
In early November 2016, Gilead received FDA approval of Vemlidy (Tenofovir Alafenamide) for the Treatment of CHB. Vemlidy is a targeted prodrug of tenofovir, a life cycle management product following Viread, which is becoming generic at the end of 2017.