Forecast Insight: Hepatitis B - Baraclude And Viread Set To Thrive In The Face Of Limited Competitio

Introduction

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 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

For more information please visit :

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