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Introduction
In 2009, hepatitis B sales across the seven major markets totalled $954m, demonstrating a CAGR of 37.5% between 2005 and 2009. Datamonitor expects the market to grow to $1.2 billion by 2014. However, from 2015 to 2019, sales across the seven major markets will decline due to patent expiries of key drugs such as Baraclude and Viread, and reach approximately $893m by 2019.
Scope
- Analysis of the current hepatitis B market dynamics across the US, 5EU, Japan and Turkey, with a snapshot of the Rest of World countries
- Thorough assessment of key marketed products for hepatitis B therapy
- Detailed ten-year sales forecasts for marketed hepatitis B drugs in each of the seven major markets and Turkey
- Review of opinions of key hepatitis B opinion leaders on future market developments
Highlights
In 2009, small molecule antivirals dominated the hepatitis B market with sales of $954m. In comparison, sales of interferon products were low, accounting for only 3% of total hepatitis B sales in 2009. This low market share can be attributed to the high cost of interferon products, their restricted use and inconvenient mode of administration.
Market growth until 2014 will be driven by the strong uptake of newer hepatitis B antivirals such as Bristol-Myers Squibb's Baraclude (entecavir) and Gilead's Viread (tenofovir). Older products such as Gilead's Hepsera (adefovir) and GlaxoSmithKline's Zeffix (lamivudine) will be used less frequently owing to the increased risk of resistance.
In 2009, Baraclude was the best selling brand in terms of value in Turkey; however Zeffix dominated in terms of volume. The popularity of Zeffix can be explained by the stringent reimbursement policy in Turkey, which restricts the use of more expensive drugs such as the pegylated interferons, Baraclude and Viread to specific populations.
Reasons to Purchase
- Understand the changing market dynamics of hepatitis B drugs and success factors for leading brands.
- Assess the impact of events such as patent expiries on the overall hepatitis B market.
- Obtain full, country, class and product-specific forecasts of currently marketed drugs from 2009 to 2019 for all seven major markets and Turkey.
Table Of Contents
Overview
Catalyst
Summary
About Datamonitor healthcare
About the Infectious Diseases pharmaceutical analysis team
Executive Summary
Strategic scoping and focus
Datamonitor insight into the Hepatitis B market
Related reports
Upcoming related reports
Table of Contents
Table of figures
Table of tables
Market definition and overview
Market definition for this report
Countries and regions included in this report
Seven major market assessment
Current and future market overview
Small molecule antivirals will continue to dominate sales
Pegylated interferon sales to remain steady over the forecast period
Genericization will lead to an overall decline in sales across the seven major markets
Impact of vaccination will reduce hepatitis B incidence but immigration will keep prevalence rates stable across the seven major markets
US healthcare reform will increase the number of patients accessing therapy
EU countries are increasingly looking to cut healthcare spending
Japan implements biennial price cuts to contain costs
Comparison with previous forecast
Viread achieves higher peak sales, reflecting the drug's fast uptake
Combination therapy is unlikely to be used in first-line therapy in the near future
Tyzeka/Sebivo sales forecast was dampened due to poor uptake across the US and five major European markets
Clevudine has been excluded from the 2010 forecasts
Pegasys uptake has been slower than anticipated owing to the success of Baraclude and Viread
Rest of the world snapshot
Brand Dynamics
Overview of the competitive landscape
Small molecule antivirals
Viread HBV (tenofovir disoproxil fumarate; Gilead Sciences)
High efficacy and genetic barrier to resistance wins recommendation for first-line therapy
Viread is anticipated to be market leader by 2016, but generic incursion will slow growth thereafter
Baraclude (entecavir, Bristol-Myers Squibb)
Lack of differentiation between Baraclude and Viread will intensify competition in the first-line
Zeffix resistance restricts Baraclude's role in second-line therapy
Baraclude's patent expiry in 2015-16 will negatively impact Baraclude and Viread sales
Hepsera (adefovir dipivoxil; Gilead Sciences)
Hepsera use is set to decline following the introduction of Viread
Pegylated interferons
Pegasys (peginterferon alpha-2a, Roche)
Limited role in hepatitis B therapy will prevent further growth
Biosimilar uptake will remain low following Pegasys's patent expiry in 2017
Turkey
Market overview
General characteristics
Demographics
Economics
Healthcare spending and access
Reimbursement
Intellectual property environment
Drug approval process
Drug pricing
Treatment guidelines
Hepatitis B epidemiology
Current and future overview of the hepatitis B market in Turkey
Initial market growth will be followed by sales decline as genericization increases
Baraclude and Viread will emerge as clear market leaders as resistance against Zeffix increases
Bibliography
Journal papers
Websites
Datamonitor reports
Appendix A - Market Assumptions
Patent expiries
Data definitions, limitations and assumptions
Standard units
Derivation of sales forecasts and pricing trends
Forecast methodology
Appendix B
Contributing experts
Conferences attended
Report methodology
About Datamonitor
About Datamonitor Healthcare
About the Infectious Diseases analysis team
Disclaimer
Disclaimer
List of Tables
Table 1: Overview of marketed products for hepatitis B therapy in the seven major markets, 2010
Table 2: Turkey: Key economic indicators, 2007-09
Table 3: Turkey: Public healthcare expenditure indicators, 2006
Table 4: Turkey: Key health systems indicators, 2007/08
Table 5: Patent expiry dates for the approved hepatitis B products in the seven major markets and Turkey 2009-2019
List of Figures
Figure 1: Hepatitis B sales across by region ($m), 2005-2019)
Figure 2: Hepatitis B sales by class across the seven major markets ($m), 2005-2019
Figure 3: Interferon product sales across the seven major markets, 2009-2019
Figure 4: Branded versus generic market share for hepatitis B across the seven major markets 2009-2019
Figure 5: Comparison of Datamonitor's 2007 and updated 2010 antiretroviral forecasts for hepatitis B across the seven major markets ($ million), 2009-2019
Figure 6: Comparison of Datamonitor's 2007 and updated sales forecasts for hepatitis B for the seven major markets ($m), 2006-2019
Figure 7: Global viral hepatitis product sales by region ($ billion), 2009
Figure 8: Viral hepatitis product sales for by region ($ billion), 2005-09
Figure 9: Annual global sales of hepatitis B products by region ($ billion), 2005-2009
Figure 10: Viread (tenofovir, Gilead Sciences) - overview of Phase III studies 102 and 103
Figure 11: Datamonitor's forecast sales for Viread in hepatitis B in the seven major markets ($m), 2009-2019
Figure 12: Datamonitor's forecast sales for Baraclude (entecavir) in hepatitis B in the seven major markets ($m), 2009-2019
Figure 13: Comparison of Viread (Gilead sciences) and Baraclude (Bristol-Myers Squibb) sales for hepatitis B across the seven major markets ($m), 2009-2019
Figure 14: Datamonitor's forecast sales for Hepsera (adefovir dipivoxil) in hepatitis B in the seven major markets ($m), 2009-2019
Figure 15: Comparison of forecasts for Hepsera (adefovir), Viread (tenofovir) and Baraclude (entecavir) in the seven major markets ($m), 2009-2019
Figure 16: Pegasys sales across the seven major markets ($m)
Figure 17: Turkey: Development of population size, 1995-2020
Figure 18: Turkey: Population spread by age group, 2010 versus 2020
Figure 19: Turkey: An overview of the drug approval process
Figure 20: Turkey: Hepatitis B-specific-sales by drug class ($m), 2005-2019
Figure 21: Turkey: Hepatitis B-specific sales by brand ($m), 2005-2019
Figure 22: Turkey: Hepatitis B-specific volume sales by brand (IMS standard unit), 2005-2019
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