Forecast Insight: Hepatitis B - Baraclude and Viread set to thrive in the face of limited competition

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.

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Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Infectious Diseases pharmaceutical analysis team 2
Executive Summary 2
Strategic scoping and focus 2
Datamonitor insight into the Hepatitis B market 2
Related reports 4
Upcoming related reports 4
Table of Contents 5
Table of figures 6
Table of tables 7
Market definition and overview 8
Market definition for this report 8
Countries and regions included in this report 8
Seven major market assessment 9
Current and future market overview 9
Small molecule antivirals will continue to dominate sales 10
Pegylated interferon sales to remain steady over the forecast period 12
Genericization will lead to an overall decline in sales across the seven major markets 14
Impact of vaccination will reduce hepatitis B incidence but immigration will keep prevalence rates stable across the seven major markets 15
US healthcare reform will increase the number of patients accessing therapy 17
EU countries are increasingly looking to cut healthcare spending 18
Japan implements biennial price cuts to contain costs 19
Comparison with previous forecast 19
Viread achieves higher peak sales, reflecting the drug's fast uptake 21
Combination therapy is unlikely to be used in first-line therapy in the near future 21
Tyzeka/Sebivo sales forecast was dampened due to poor uptake across the US and five major European markets 23
Clevudine has been excluded from the 2010 forecasts 23
Pegasys uptake has been slower than anticipated owing to the success of Baraclude and Viread 24
Rest of the world snapshot 24
Brand Dynamics 28
Overview of the competitive landscape 28
Small molecule antivirals 30
Viread HBV (tenofovir disoproxil fumarate; Gilead Sciences) 30
High efficacy and genetic barrier to resistance wins recommendation for first-line therapy 30
Viread is anticipated to be market leader by 2016, but generic incursion will slow growth thereafter 32
Baraclude (entecavir, Bristol-Myers Squibb) 33
Lack of differentiation between Baraclude and Viread will intensify competition in the first-line 34
Zeffix resistance restricts Baraclude's role in second-line therapy 35
Baraclude's patent expiry in 2015-16 will negatively impact Baraclude and Viread sales 36
Hepsera (adefovir dipivoxil; Gilead Sciences) 38
Hepsera use is set to decline following the introduction of Viread 39
Pegylated interferons 40
Pegasys (peginterferon alpha-2a, Roche) 40
Limited role in hepatitis B therapy will prevent further growth 41
Biosimilar uptake will remain low following Pegasys's patent expiry in 2017 42
Turkey 43
Market overview 43
General characteristics 43
Demographics 43
Economics 45
Healthcare spending and access 46
Reimbursement 47
Intellectual property environment 48
Drug approval process 48
Drug pricing 49
Treatment guidelines 50
Hepatitis B epidemiology 50
Current and future overview of the hepatitis B market in Turkey 51
Initial market growth will be followed by sales decline as genericization increases 51
Baraclude and Viread will emerge as clear market leaders as resistance against Zeffix increases 52
Bibliography 55
Journal papers 55
Websites 56
Datamonitor reports 58
Appendix A - Market Assumptions 59
Patent expiries 59
Data definitions, limitations and assumptions 59
Standard units 59
Derivation of sales forecasts and pricing trends 59
Forecast methodology 60
Appendix B 61
Contributing experts 61
Conferences attended 61
Report methodology 61
About Datamonitor 61
About Datamonitor Healthcare 62
About the Infectious Diseases analysis team 63
Disclaimer 64
Disclaimer 65
List of Tables
Table 1: Overview of marketed products for hepatitis B therapy in the seven major markets, 2010 29
Table 2: Turkey: Key economic indicators, 2007-09 46
Table 3: Turkey: Public healthcare expenditure indicators, 2006 47
Table 4: Turkey: Key health systems indicators, 2007/08 47
Table 5: Patent expiry dates for the approved hepatitis B products in the seven major markets and Turkey 2009-2019 59
List of Figures
Figure 1: Hepatitis B sales across by region ($m), 2005-2019) 10
Figure 2: Hepatitis B sales by class across the seven major markets ($m), 2005-2019 12
Figure 3: Interferon product sales across the seven major markets, 2009-2019 14
Figure 4: Branded versus generic market share for hepatitis B across the seven major markets 2009-2019 15
Figure 5: Comparison of Datamonitor's 2007 and updated 2010 antiretroviral forecasts for hepatitis B across the seven major markets ($ million), 2009-2019 20
Figure 6: Comparison of Datamonitor's 2007 and updated sales forecasts for hepatitis B for the seven major markets ($m), 2006-2019 21
Figure 7: Global viral hepatitis product sales by region ($ billion), 2009 25
Figure 8: Viral hepatitis product sales for by region ($ billion), 2005-09 26
Figure 9: Annual global sales of hepatitis B products by region ($ billion), 2005-2009 27
Figure 10: Viread (tenofovir, Gilead Sciences) - overview of Phase III studies 102 and 103 31
Figure 11: Datamonitor's forecast sales for Viread in hepatitis B in the seven major markets ($m), 2009-2019 33
Figure 12: Datamonitor's forecast sales for Baraclude (entecavir) in hepatitis B in the seven major markets ($m), 2009-2019 34
Figure 13: Comparison of Viread (Gilead sciences) and Baraclude (Bristol-Myers Squibb) sales for hepatitis B across the seven major markets ($m), 2009-2019 37
Figure 14: Datamonitor's forecast sales for Hepsera (adefovir dipivoxil) in hepatitis B in the seven major markets ($m), 2009-2019 39
Figure 15: Comparison of forecasts for Hepsera (adefovir), Viread (tenofovir) and Baraclude (entecavir) in the seven major markets ($m), 2009-2019 40
Figure 16: Pegasys sales across the seven major markets ($m) 42
Figure 17: Turkey: Development of population size, 1995-2020 44
Figure 18: Turkey: Population spread by age group, 2010 versus 2020 45
Figure 19: Turkey: An overview of the drug approval process 49
Figure 20: Turkey: Hepatitis B-specific-sales by drug class ($m), 2005-2019 52
Figure 21: Turkey: Hepatitis B-specific sales by brand ($m), 2005-2019 53
Figure 22: Turkey: Hepatitis B-specific volume sales by brand (IMS standard unit), 2005-2019 53

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