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Aug 16, 2010

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

Dallas, TX: ReportsandReports announce it will carry Forecast Insight: Hepatitis B - Baraclude and Viread set to thrive in the face of limited competition Market Research Report in its Store.

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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.


  • 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


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




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


Market overview

General characteristics



Healthcare spending and access


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


Journal papers


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



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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