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Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape

Published By :

GBI Research

Published Date : Jan 2014

Category :

Therapeutic Area

No. of Pages : 120


GBI Research, has released the pharma report – “Hepatitis C Therapeutics in Major Developed Markets to 2019 – Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape”. The current Hepatitis C treatment landscape consists of a combination of pegylated interferon, ribavirin and, in patients infected with genotype 1 hepatitis C, one of two direct-acting antiviral agents (DAAs). Products with these mechanisms of action have performed strongly in the commercial setting, with the market leader Incivek (a DAA) having reached blockbuster sales. However, these products are very poorly tolerated and only moderately efficacious. The approval of the DAA Sovaldi in December 2013 changed this, with a complete viral clearance being achieved in close to 100% of patients and a much improved adverse event profile compared to previous standards of therapy. In patients with genotype 2 and 3 hepatitis C, Sovaldi does not need to be administered with pegylated interferon. A number of products in the late-stage pipeline, which promise to be even more efficacious and safe are anticipated to enter the market over the forecast period, including several interferon-free therapies for genotype 1-infected patients. As a result of this, as well as an overall increase in the treated population, GBI Research believes the global market has the potential to grow to a value of $18.6 billion by 2019, more than tripling the 2012 market value of $5.8 billion.

Scope

  • A brief introduction to hepatitis C, including the disease’s pathogenesis, risk factors and diagnosis, and detailed analyses of disease epidemiology and treatment algorithms.
  • In-depth analysis of the major antiviral drugs used in the treatment of hepatitis C, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map that compares marketed drugs in terms of safety and efficacy.
  • A comprehensive review of the pipeline for hepatitis C therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline is analyzed by phase distribution, molecule type and molecular target.
  • In-depth clinical trial enrolment, trial duration and program failure rate analyses for each molecule type and mechanism of action. Additionally, clinical trial endpoints and certain selection criteria are analyzed in great depth. This section also includes an additional heat map regarding pipeline products, and a direct cross-analysis against currently marketed products.
  • Multi-scenario forecast data of the market to 2019, which takes into account the effects of the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets: US, Canada, Japan, Germany, UK, France, Italy and Spain.
  • Discussion of the drivers and barriers for market growth.
  • Analysis of licensing and co-development deals occurring in the hepatitis C market.

Reasons to Buy

  • Understand the different types of hepatitis C therapies and how treatment varies by genotype.
  • Understand the treatment algorithms and guidelines related to hepatitis C, how they are anticipated to change during the forecast period and where opportunities and unmet needs lie.
  • Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are most prominent.
  • Observe trends in clinical trial duration and size as clinical phase and molecule type varies. Use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for hepatitis C therapeutics.
  • Observe the shift in clinical trial endpoints with each clinical Phase, and use this data to potentially influence any future developmental programs. Additionally, understand the trends in enrolment by patient genotype.
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules and the points of opportunity which remain to be capitalized upon.
Table of Contents

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Signs and Symptoms
2.2 Etiology and Risk Factors
2.3 Pathophysiology
2.4 Epidemiology
2.4.1 US and Canada
2.4.2 Europe
2.4.3 Japan
2.4.4 Regional Prevalence of Hepatitis C Genotypes
2.5 Prognosis
2.6 Diagnosis and Screening
2.7 Treatment
2.8 Treatment Algorithms

3 Marketed Products
3.1 Ribavirin
3.2 Pegasys (Peginterferon alfa 2a) and PegIntron (Peginterferon alfa 2b) – Hoffmann La Roche and Merck & Co
3.2.1 Pegasys – Hoffmann La Roche
3.2.2 PegIntron – Merck & Co
3.3 Incivek (telaprevir) – Vertex Pharmaceuticals and Janssen-Cilag
3.4 Victrelis (boceprevir) – Merck & Co
3.5 Olysio (simeprevir) – Johnson and Johnson
3.6 Sovaldi (sofosbuvir) – Gilead Sciences
3.7 Heat Map for Marketed Products

4 Developmental Pipeline
4.1 Overall Pipeline
4.2 Mechanisms of Action
4.3 Clinical Trials
4.3.1 Clinical Trial Failure Rates
4.3.2 Clinical Trial Enrollment
4.3.3 Clinical Trial Duration
4.3.4 Clinical Trial Design
4.4 Promising Pipeline Drugs
4.4.1 Sovaldi plus Ledipasvir – Gilead Sciences
4.4.2 Daclatasvir – Bristol-Myers Squibb
4.4.3 Faldaprevir – Boehringer-Ingelheim
4.4.4 Peginterferon lambda 1a – Bristol-Myers Squibb
4.4.5 ABT-450 – AbbVie and Enanta
4.4.6 Vaniprevir – Merck & Co
4.5 Heat Map and Competitor Matrix for Pipeline Products
4.6 Conclusion

5 Market Forecast to 2019
5.1 Global Market
5.1.1 Treatment Usage Patterns
5.1.2 Market Size
5.2 US
5.2.1 Treatment Usage Patterns
5.2.2 Market Size
5.3 Canada
5.3.1 Treatment Usage Patterns
5.3.2 Market Size
5.4 Top Five European Markets
5.4.1 Treatment Usage Patterns
5.4.2 Annual Cost of Therapy
5.4.3 Market Size
5.5 Japan
5.5.1 Treatment Usage Patterns
5.5.2 Market Size

6 Drivers and Barriers
6.1 Drivers
6.1.1 Approval of Sovaldi and Olysio in 2013
6.1.2 Large and Exceptionally Promising Late-Stage Pipeline
6.1.3 Favorable Pricing Structure in the US
6.1.4 Weak Exposure to Generics and Biosimilars during the Forecast Period
6.1.5 Increasing Volume of Treated Patients
6.1.6 Rapid Incorporation of Novel Products into Treatment Guidelines
6.2 Barriers
6.2.1 Low Rates of Diagnosis and Treatment in Certain Markets
6.2.2 Unfavorable Pricing Structures in the EU and Japan
6.2.3 Rapidly Increasing Competition in the Market

7 Licensing and Co-development deals
7.1 Licensing Deals
7.1.1 Vertex Pharma Enters into Licensing Agreement with Alios BioPharma for ALS-2200 and ALS-2158
7.1.2 Bristol-Myers Squibb Company Enters into Licensing Agreement with ZymoGenetics
7.1.3 Human Genome Sciences Enters Into Licensing Agreement With Novartis
7.1.4 Roche Signs Licensing Agreement With InterMune
7.1.5 Idenix Enters Into A Licensing Agreement With Novartis Pharma
7.1.6 Enanta Pharma Enters into Licensing Agreement with Novartis for Hepatitis C Program
7.1.7 Medivir Enters into Licensing Agreement with Tibotec
7.1.8 Metabasis Therapeutics Enters Into Collaboration And Licensing Agreement With Roche
7.1.9 Schering-Plough And PTC Therapeutics Enter Into A Collaboration And Licensing Agreement
7.1.10 Presidio Pharma Enters into Licensing Agreement with XTL BioPharma
7.2 Co-development Deals
7.2.1 Vertex Pharma Enters into Co-Development Agreement with Janssen Pharmaceutica
7.2.2 Abbott Labs Enters into Agreement with Enanta Pharma
7.2.3 Genelabs Enters into Collaboration with Novartis
7.2.4 Regulus Therapeutics Enters into an Agreement with GlaxoSmithKline
7.2.5 Tacere Therapeutics Enters into Agreement with Pfizer
7.2.6 Biota Holdings Enters into an Agreement with Boehringer Ingelheim

8 Appendix
8.1 Sources
8.2 Sources for Heat Maps
8.3 All Pipeline Products, by Stage of Development
8.3.1 Discovery
8.3.2 Preclinical and IND/CTA-filed
8.3.3 Phase I
8.3.4 Phase II
8.3.5 Phase III and Pre-registration
8.3.6 Undisclosed
8.4 Tabular Forecast Data
8.4.1 Global
8.4.2 US
8.4.3 Canada
8.4.4 UK
8.4.5 France
8.4.6 Germany
8.4.7 Italy
8.4.8 Spain
8.4.9 Japan
8.5 Market Definition
8.6 Abbreviations
8.7 Methodology
8.7.1 Coverage
8.7.2 Secondary Research
8.7.3 Primary Research
8.7.4 Therapeutic Landscape
8.7.5 Epidemiology-Based Forecasting
8.7.6 Market Size by Geography
8.7.7 Geographical Landscape
8.7.8 Pipeline Analysis
8.8 Contact Us
8.9 Disclaimer

List of Table

Table 1: Hepatitis C, Top Five European Countries, Disease Prevalence (%), 2011
Table 2: Hepatitis C, Top Five European Markets, Most Common Risk Factors for Infection (%), 2011
Table 3: Hepatitis C, Global, Estimated Distribution of Hepatitis C Genotypes (%), 2013
Table 4: Market for Hepatitis C, Sources for Heat Maps
Table 5: Hepatitis C Therapeutics, Global, All Pipeline Products (Discovery), 2013
Table 6: Hepatitis C Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013
Table 7: Hepatitis C, Global, All Pipeline Products (Phase I), 2013
Table 8: Hepatitis C Therapeutics, Global, All Pipeline Products (Phase II), 2013
Table 9: Hepatitis C Therapeutics, Global, All Pipeline Products (Phase III), 2013
Table 10: Hepatitis C Therapeutics, Global, All Pipeline Products (Undisclosed), 2013
Table 11: Market for Hepatitis C, Global, Forecast Data, 2012–2019
Table 12: Market for Hepatitis C, US, Forecast Data, 2012–2019
Table 13: Market for Hepatitis C, Canada, Forecast Data, 2012–2019
Table 14: Market for Hepatitis C, UK, Forecast Data, 2012–2019
Table 15: Market for Hepatitis C, France, Forecast Data, 2012–2019
Table 16: Market for Hepatitis C, Germany, Forecast Data, 2012–2019
Table 17: Market for Hepatitis C, Italy, Forecast Data, 2012–2019
Table 18: Market for Hepatitis C, Spain, Forecast Data, 2012–2019
Table 19: Market for Hepatitis C, Japan, Forecast Data, 2012–2019

List of Chart

Figure 1: Market for Hepatitis C, Global, Treatment Algorithm (Genotype 1, Triple Therapy with Incivek), 2013
Figure 2: Market for Hepatitis C, Global, Treatment Algorithm (Genotype 1, Triple Therapy with Victrelis), 2013
Figure 3: Market for Hepatitis C, Global, Treatment Algorithm (Genotypes 2 to 7), 2013
Figure 4: Market for Hepatitis C, Global, Sales of Pegasys and PegIntron ($m), 2002–2012
Figure 5: Market for Hepatitis C, Global, Heat Map for Marketed Products, 2013
Figure 6: Market for Hepatitis C, Global, Developmental Pipeline, 2013
Figure 7: Market for Hepatitis C, Global, Pipeline by Mechanism of Action and Molecule Type, 2013
Figure 8: Market for Hepatitis C, Global, Clinical Trial Failure Rate by Molecule Type, 2006–2013
Figure 9: Market for Hepatitis C, Global, Clinical Trial Failure Rates by Mechanism of Action, 2006–2013
Figure 10: Market for Hepatitis C, Global, Clinical Trial Enrollment by Molecule Type, 2006–2013
Figure 11: Market for Hepatitis C, Global, Clinical Trial Enrollment by Mechanism of Action, 2006–2013
Figure 12: Market for Hepatitis C, Clinical Trial Duration by Molecule Type, 2006–2013
Figure 13: Market for Hepatitis C, Global, Clinical Trial Duration by Mechanism of Action, 2006–2013
Figure 14: Market for Hepatitis C, Global, Frequency of Clinical Trial Primary Endpoints Per Clinical Trial, 2006–2013
Figure 15: Market for Hepatitis C, Global, Frequency of Clinical Trial Endpoints Primary within Clinical Development Programs, 2006–2013
Figure 16: Market for Hepatitis C, Global, Usage of HCV Genotypes as Clinical Trial Inclusion Criteria, 2006–2013
Figure 17: Market for Hepatitis C, Global, Sales Forecast for Sovaldi plus ledipasvir ($m), 2015–2019
Figure 18: Market for Hepatitis C, Global, Sales Forecast for daclatasvir (monotherapy) ($m), 2015–2019
Figure 19: Market for Hepatitis C, Global, Sales Forecast for daclatasvir plus asunaprevir plus BMS-791325 ($m), 2015–2019
Figure 20: Market for Hepatitis C, Global, Sales Forecast for faldaprevir ($m), 2015–2019
Figure 21: Market for Hepatitis C, Global, Sales Forecast for peginterferon lambda 1a ($m), 2015–2019
Figure 22: Market for Hepatitis C, Global, Sales Forecast for ABT-450 ($m), 2015–2019
Figure 23: Market for Hepatitis C, Global, Sales Forecast for ABT-450 plus ABT-333 plus ABT-267 ($m), 2015–2019
Figure 24: Market for Hepatitis C, Global, Sales Forecast for vaniprevir, 2015–2019
Figure 25: Market for Hepatitis C, Global, Heat Map for Pipeline Products, 2013
Figure 26: Market for Hepatitis C, Global, Competitor Matrix, 2013
Figure 27: Market for Hepatitis C, Global, Market Growth and Size, 2012–2019
Figure 28: Market for Hepatitis C, Global, Treatment Patterns, 2012–2019
Figure 29: Market for Hepatitis C, Global, Market Size ($bn), 2012–2019
Figure 30: Market for Hepatitis C, US, Treatment Usage Patterns, 2012–2019
Figure 31: Market for Hepatitis C, US, Market Size ($bn), 2012–2019
Figure 32: Market for Hepatitis C, Canada, Treatment Usage Patterns, 2012–2019
Figure 33: Market for Hepatitis C, Canada, Market Size ($m), 2012–2019
Figure 34: Market for Hepatitis C, Top Five European Markets, Treatment Patterns, 2012–2019
Figure 35: Market for Hepatitis C, Top Five European Markets, Annual Cost of Therapy ($), 2012–2019
Figure 36: Market for Hepatitis C, Top Five European Markets, Market Size ($m), 2012–2019
Figure 37: Market for Hepatitis C, Japan, Treatment Usage Patterns, 2012–2019
Figure 38: Market for Hepatitis C, Japan, Market Size ($m), 2012–2019
Figure 39: Market for Hepatitis C, Global, Network of Licensing Deals, 2006–2013
Figure 40: Market for Hepatitis C, Global, Licensing Deals by Year, 2006–2013
Figure 41: Market for Hepatitis C, Global, Licensing Deals, 2006–2013
Figure 42: Market for Hepatitis C, Global, Network of Co-Development Deals, 2006–2013
Figure 43: Market for Hepatitis C, Global, Co-Development Deals by Year, 2006–2013
Figure 44: GBI Research Market Forecasting Model

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