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市場調查報告書

主要已開發國家的C型肝炎治療藥市場:最近的認證和後期開發平台,轉換臨床、商業性形勢

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

出版商 GBI Research 商品編碼 295790
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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主要已開發國家的C型肝炎治療藥市場:最近的認證和後期開發平台,轉換臨床、商業性形勢 Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape
出版日期: 2014年01月31日 內容資訊: 英文
簡介

C型肝炎治療藥市場,由於許多的未治療患者與新的治療方法認證,預計從2012年的57億美元,擴大到2019年的186億美元規模,以年複合成長率18.5%成長。

本報告提供主要已開發國家的C型肝炎治療藥市場相關調查分析、市場概要、上市產品、開發平台分析、市場預測、最近的交易相關資訊等,為您概述為以下內容。

第1章 目錄

第2章 簡介

  • 症狀
  • 病因和危險因素
  • 病理學
  • 流行病學
  • 預測
  • 診斷和篩檢
  • 治療
  • 治療流程

第3章 上市產品

  • Ribavirin
  • Pegasys(Peginterferon alfa 2a),PegIntron(Peginterferon alfa 2b)
  • Incivek(telaprevir)
  • Victrelis(boceprevir)
  • Olysio(simeprevir)
  • Sovaldi(sofosbuvir)
  • 上市產品的熱圖

第4章 開發的平台

  • 開發平台全體
  • 作用機制
  • 臨床試驗
  • 開發平台的有潛力候補藥
    • Sovaldi plus Ledipasvir
    • Daclatasvir
    • Faldaprevir
    • Peginterferon lambda 1a
    • ABT-450
    • Vaniprevir
  • 開發中產品的熱圖與競爭企業矩陣
  • 結論

第5章 市場預測

  • 全球市場
  • 美國
  • 加拿大
  • 歐洲主要5個國家
  • 日本

第6章 推動市場要素與阻礙

  • 推動市場要素
  • 障礙

第7章 許可證與共同開發交易

  • 許可證交易
  • 共同開發交易

第8章 附錄

圖表

目錄
Product Code: GBIHC321MR

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.

Abstract

Due to a large untreated patient pool and the recent approval of new treatments, the hepatitis C market will more than treble from $5.7 billion in 2012 to $18.6 billion by 2019, at an impressive Compound Annual Growth Rate (CAGR) of 18.5%, forecasts business intelligence provider GBI Research.

The company's new report* states that the hepatitis C market will receive this major boost with the 2013 approval of Sovaldi, which has the potential to transform the treatment algorithm for hepatitis C. Due to the clinical potential of the drug, Sovaldi will be very expensive, reaching a cost of $86,000 annually and setting a high price benchmark for future drugs.

Dominic Trewartha, Analyst for GBI Research, says: "Sovaldi boasts excellent tolerability and a Sustained Virologic Response rate approaching 100%, without specificity to any genotype 1. In genotypes 2 and 3, Sovaldi is administered with ribavirin alone, alleviating the need for Pegasys or Pegintron and therefore reducing the rate of adverse events associated with these two therapies. As a result, many patients who have previously deferred treatment are expected to re-enter the market and use Sovaldi."

Additional drugs, such as Olysio, which was also approved in 2013, and daclatasvir are anticipated to compete with Sovaldi, although they are not proven to be as effective and can only be used in genotype 1 infections.

According to GBI Research, Sovaldi-ledipasvir and ABT-450 triple therapy will further advance the hepatitis C market and displace older drugs from 2015 onwards. This is due to the fact that these therapies can be used without peginterferon and have demonstrated 100% efficacy in genotype 1, with strong tolerability and low dosing.

"The late-stage pipeline for hepatitis C is exceptionally promising, and we expect new products to completely transform the clinical and commercial landscape during the forecast period," Trewartha concludes.

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

This report provides 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. It also gives a market forecast between 2012 and 2019.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

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 Tables

  • 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 Figures

  • 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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