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Global Hepatitis C Virus (HCV) Treatment Market Outlook to 2024

  • 26
  • |
  • Oct, 2018
  • |
  • Biopharmaceuticals
  • |
  • Pages
  • |
  • Global

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
 
HCV market was valued at $12.5bn in 2015 and is forecast to contract 4.1% CAGR between 2015 and 2024, reaching 2024 global sales of $8.2bn. The volume of HCV patients who will be treated over the next several years is expected to decline resulting in market contraction.
 
The World Health Organization (WHO) estimates that 185 million people globally are infected with Hepatitis C virus (HCV), with 3 to 4 million new infections each year. Roughly 75% of these cases fail to resolve acutely and evolve into a chronic state. Most estimates peg the number of patients with chronic hepatitis C infections at 3 million in the U.S. (1.0-1.8% of the population), although some recent estimates suggest that there could be as many as 8 million people (2.5% of the population). A slightly greater number of cases exists in Europe (7-12 million), with a large infected population in Asia (70 million+).  
 
 
Global HCV Patients Treated, 2015 - 2024 (in 1000’s)  
 
 
 
 
“Current Treatment algorithm”
 
Protease inhibitors were the first direct antiviral drugs on the market for HCV.  Vertex/J&J’s Incivek (telaprevir) and Merck’s Victrelis (boceprevir) were launched during 2011 and rapidly became part of the standard of care regimens.  
 
The approval of Gilead’s Sovaldi (sofosbuvir) in December 2013 was a watershed moment as it marked the availability of the first interferon-free regimens. The approval of Gilead’s Harvoni (sofosbuvir and ledispavir) in October 2014 brought the first FDA-approved interferon free regimen for genotype 1 HCV patients, the largest HCV population in the U.S.   
 
The approval of Gilead’s Epclusa (sofosbuvir/velpatasvir) in June 2016 further improved the standard of care in GT 2 and 3 patients.  Overall Gilead’s sofosbuvir based regimens appear to have a best-in-class profile, with the highest cure rates, shortest duration of therapy, fewest pills, and best safety/tolerability profile.   
 
J&J’s Olysio became the protease inhibitor of choice following its November 2013 FDA approval and launch, posting 2014 worldwide sales of $2.3bn as it was widely used in combination with Sovaldi (sofosbuvir) in an interferon-free regimen for GT 1 patients.  
 
“The Era of interferon-free regimens has arrived”
 
Following the approval of Gilead’s Harvoni in October 2014, AbbVie’s Viekira Pak in December 2014, and Merck’s Zepatier in January 2016, three FDA approved IFN–free regimens are available for genotype 1 patients.  These interferon-free regimens have revolutionized treatment, as they have high 95%+ cure rates, good safety and tolerability, with short (8-12 week) treatment times.   
 
“Innovations in HCV Treatment”
 
 
There are 5 key discovery programs that could disrupt the HCV landscape in the foreseeable future.  These include 1) Gilead's triplet at EASL, 2) Merck's nuke study, 3) Achillion's doublet nuke regimen, 4) Regulus' novel microRNA approach that could be used with pills, and 5) Abbvie/Enanta's next generation protease regimen.  
 
Merck’s Zepatier (elbasvir and grazoprevir) was approved by the FDA for the treatment of adult patients with HCV genotypes 1 and 4 in January 2016. Zepatier also produced strong Phase III data, with 95% SVR rates in most genotype 1 and 4 patient groups.
 
There are a number of other HCV candidates in development, including new regimens from Gilead, Abbvie, and Merck. J&J is also trying to develop an interferon free regimen.
 
“Gilead, Merck, Abbvie, GSK, Roche, Bristol Myers & J&J are some of the key players in HCV market"
 
Gilead and Bristol Myers led the HCV market with meaningful market share in 2015. We expect total sales to decline through 2024, though we anticipate Gilead will maintain majority share. We anticipate that Merck and AbbVie will gain share through the launch of their next-generation interferon-free regimens.
Merck and Roche lead the market for pegylated alpha-IFNs. We predict that the interferon market will continue to contract as the launch of direct antiviral combination regimens has the potential to eliminate the need for interferon. J&J and Bristol Myers could see their franchises sales to decline through 2024.
 
“Reimbursement insights”
 
HCV regimens are heavily discounted & rebated. Abbvie’s Viekira and Merck’s Zepatier have brought new competition to HCV, putting payors in a strong negotiating position leading to price declines. Moreover, contracts with payors that offer price discounts for the removal of restrictions on which HCV patients can be treated have pressured the average revenue per HCV patient.   Gilead reports that the standard 12 week Epclusa regimen will be priced at of $75K. Epclusa is priced for $84K per 12 week regimen and Harvoni at $94K per 12 week regimen.

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
 
HCV market was valued at $12.5bn in 2015 and is forecast to contract 4.1% CAGR between 2015 and 2024, reaching 2024 global sales of $8.2bn. The volume of HCV patients who will be treated over the next several years is expected to decline resulting in market contraction.
 
The World Health Organization (WHO) estimates that 185 million people globally are infected with Hepatitis C virus (HCV), with 3 to 4 million new infections each year. Roughly 75% of these cases fail to resolve acutely and evolve into a chronic state. Most estimates peg the number of patients with chronic hepatitis C infections at 3 million in the U.S. (1.0-1.8% of the population), although some recent estimates suggest that there could be as many as 8 milllion people (2.5% of the population). A slightly greater number of cases exists in Europe (7-12 million), with a large infected population in Asia (70 million+).  
 
 
Global HCV Patients Treated, 2015 - 2024 (in 1000’s)  
 
 
 
 
“Current Treatment algorithm”
 
Protease inhibitors were the first direct antiviral drugs on the market for HCV.  Vertex/J&J’s Incivek (telaprevir) and Merck’s Victrelis (boceprevir) were launched during 2011 and rapidly became part of the standard of care regimens.  
 
The approval of Gilead’s Sovaldi (sofosbuvir) in December 2013 was a watershed moment as it marked the availability of the first interferon-free regimens. The approval of Gilead’s Harvoni (sofosbuvir and ledispavir) in October 2014 brought the first FDA-approved interferon free regimen for genotype 1 HCV patients, the largest HCV population in the U.S.   
 
The approval of Gilead’s Epclusa (sofosbuvir/velpatasvir) in June 2016 further improved the standard of care in GT 2 and 3 patients.  Overall Gilead’s sofosbuvir based regimens appear to have a best-in-class profile, with the highest cure rates, shortest duration of therapy, fewest pills, and best safety/tolerability profile.   
 
J&J’s Olysio became the protease inhibitor of choice following its November 2013 FDA approval and launch, posting 2014 worldwide sales of $2.3bn as it was widely used in combination with Sovaldi (sofosbuvir) in an interferon-free regimen for GT 1 patients.  
 
“The Era of interferon-free regimens has arrived”
 
Following the approval of Gilead’s Harvoni in October 2014, AbbVie’s Viekira Pak in December 2014, and Merck’s Zepatier in January 2016, three FDA approved IFN–free regimens are available for genotype 1 patients.  These interferon-free regimens have revolutionized treatment, as they have high 95%+ cure rates, good safety and tolerability, with short (8-12 week) treatment times.   
 
“Innovations in HCV Treatment”
 
 
There are 5 key discovery programs that could disrupt the HCV landscape in the foreseeable future.  These include 1) Gilead's triplet at EASL, 2) Merck's nuke study, 3) Achillion's doublet nuke regimen, 4) Regulus' novel microRNA approach that could be used with pills, and 5) Abbvie/Enanta's next generation protease regimen.  
 
Merck’s Zepatier (elbasvir and grazoprevir) was approved by the FDA for the treatment of adult patients with HCV genotypes 1 and 4 in January 2016. Zepatier also produced strong Phase III data, with 95% SVR rates in most genotype 1 and 4 patient groups.
 
There are a number of other HCV candidates in development, including new regimens from Gilead, Abbvie, and Merck. J&J is also trying to develop an interferon free regimen.
 
“Gilead, Merck, Abbvie, GSK, Roche, Bristol Myers & J&J are some of the key players in HCV market"
 
Gilead and Bristol Myers led the HCV market with meaningful market share in 2015. We expect total sales to decline through 2024, though we anticipate Gilead will maintain majority share. We anticipate that Merck and AbbVie will gain share through the launch of their next-generation interferon-free regimens.
Merck and Roche lead the market for pegylated alpha-IFNs. We predict that the interferon market will continue to contract as the launch of direct antiviral combination regimens has the potential to eliminate the need for interferon. J&J and Bristol Myers could see their franchises sales to decline through 2024.
 
“Reimbursement insights”
 
HCV regimens are heavily discounted & rebated. Abbvie’s Viekira and Merck’s Zepatier have brought new competition to HCV, putting payors in a strong negotiating position leading to price declines. Moreover, contracts with payors that offer price discounts for the removal of restrictions on which HCV patients can be treated have pressured the average revenue per HCV patient.   Gilead reports that the standard 12 week Epclusa regimen will be priced at of $75K. Epclusa is priced for $84K per 12 week regimen and Harvoni at $94K per 12 week regimen.


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