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Cystic Fibrosis Therapeutics in Major Developed Markets to 2019 - CFTR Modulators Initiate Drive Towards Personalized Treatment and Market Growth

Published By :

GBI Research

Published Date : Feb 2014

Category :

Therapeutic Area

No. of Pages : 76 Pages


GBI Research has released its pharma report “Cystic Fibrosis Therapeutics in Major Developed Markets to 2019 - CFTR Modulators Initiate Drive Towards Personalized Treatment and Market Growth.” The value of the Cystic Fibrosis (CF) market is expected to increase significantly in value over the forecast period across the leading eight developed nations, from $695.6 million in 2012 to almost $4.5 billion in 2019. This equates to a Compound Annual Growth Rate (CAGR) of 30.4%. Novel treatments with disease-modifying mechanisms of action are the primary factor driving the growth of the value of the market. The positive impact of new market entrants will offset the effects of key patent losses during the forecast period. 

Cystic Fibrosis Transmembrane conductance Regulators (CFTR) modulators are the first type of CF therapy to treat the root cause of the disease rather than the symptoms, and as a result, they offer patients improved relief and quality of life. Kalydeco (ivacaftor), which has been marketed since 2012, was the first CFTR modulator to reach the market, and despite only treating a small proportion of the CF population, it had a large impact on the value of the market. This effect will be repeated on a larger scale when lumacaftor and Ataluren (PTC124) enter the market, as these treatments can be used for a much larger proportion of the CF population. Vertex Pharmaceuticals Inc. are the developers of Kalydeco, lumacaftor and other early phase CFTR modulators, and are therefore expected to play a key role in the development of the future CF market.

Scope

  • A disease introduction, which defines the disease, including symptoms, diagnosis and treatment.
  • An analysis of the CF marketed landscape, including a comparison of the efficacy and safety of the most prominent brands, as well as the unmet needs of CF treatment.
  • A detailed analysis of the CF pipeline, detailing, among other parameters, drug distribution by phase, molecule type and mechanism of action. The CF clinical trial landscape is then analyzed, with a particular emphasis on failure rates across different trial phases as well as the trends in clinical trial size and duration. This section also includes profiles and single product forecasts for the most promising pipeline drugs.
  • An epidemiological forecast of the major CF markets. The projected values include total and treated populations.
  • An in-depth forecasting model for the CF market, which considers the current marketed therapies, in addition to the potential entry of new products into the market. The model consists of a projected outcome, with high and low variance results, depending on the potential performance of pipeline therapies.
  • Analysis of strategic consolidations within the CF indication, including co-development and licensing agreements.
  • An overview of the drivers and barriers for the CF market is also included

Reasons to Buy

  • Understand the CF pipeline and the clinical needs it is addressing. In particular, the importance and benefits of CFTR modulators are highlighted and compared with symptomatic treatments.
  • Develop their knowledge of key products that may enter the market before 2019. Detailed profiles of these products are provided, with a focus on their clinical trial performance, as well as how they can be incorporated into the CF treatment plan and what competition they face.
  • Assess the risk associated with CF clinical trials compared with both industry and therapy area averages. In addition, in order to understand the trends in both trial size and duration according to mechanism of action or molecule type.
  • Identify patterns of growth in the CF market over the forecast period and understand the underlying causes, as well as observing the contributions made by each major market to this growth.
TABLE OF CONTENT

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

2 Introduction
2.1 Disease Introduction
2.2 Symptoms
2.3 Etiology
2.4 Pathophysiology
2.5 Diagnosis
2.6 Prognosis
2.7 Assessment of Disease Severity
2.8 Treatment

3 Marketed Products
3.1 Overview
3.2 Product Profiles
3.2.1 Pulmozyme (dornase alfa) – Genentech
3.2.2 Bronchitol (mannitol) – Pharmaxis
3.2.3 TOBI (tobramycin) – Novartis
3.2.4 TOBI Podhaler (tobramycin) – Novartis
3.2.5 Bramitob/Bethkis (tobramycin) – Chiesi Farmaceutici
3.2.6 Colobreathe (colistimethate sodium) – Forest Laboratories
3.2.7 Cayston (aztreonam) – Gilead Sciences
3.2.8 Kalydeco (ivacaftor) – Vertex Pharmaceuticals
3.2.9 Pancreatic Enzyme Replacement Therapies
3.2.10 Other Successful Products
3.3 Heat Map of Marketed Products
3.4 Conclusion

4 Developmental Pipeline
4.1 Overview
4.2 Mechanisms of Action in the Pipeline
4.3 Clinical Trials
4.3.1 Failure Rate
4.3.2 Clinical Trial Duration
4.3.3 Clinical Trial Size
4.4 Promising Pipeline Molecules
4.4.1 Lumacaftor (VX809) – Vertex Pharmaceuticals
4.4.2 Ataluren (PTC124) – PTC Therapeutics
4.4.3 Aeroquin (levofloxacin) – Aptalis Pharma
4.4.4 Arikace (amikacin liposomal) – Insmed
4.4.5 Other Promising Molecules
4.5 Heat Map of Pipeline Products
4.6 Conclusion

5 Market Forecast to 2019
5.1 Geographical Markets
5.1.1 Global Markets
5.1.2 North America
5.1.3 Top Five EU Countries
5.2 Drivers and Barriers
5.2.1 Drivers
5.2.2 Barriers

6 Strategic Consolidations
6.1 Major Co-Development Deals
6.2 Major Licensing Deals

7 Appendix
7.1 References
7.1.1 Marketed Product Heat Map References
7.1.2 Pipeline Product Heat Map References
7.2 Market Definition
7.3 Abbreviations
7.4 Methodology
7.5 Coverage
7.6 Secondary Research
7.7 Therapeutic Landscape
7.8 Epidemiology-Based Forecasting
7.9 Market Size by Geography
7.10 Geographical Landscape
7.11 Pipeline Analysis
7.12 Competitive Landscape
7.12.1 Expert Panel Validation
7.13 Contact Us
7.14 Disclaimer

List of Table


Table 1: Cystic Fibrosis Market, Global, Treatment Plan
Table 2: Cystic Fibrosis Market, Global, Pipeline, Preclinical
Table 3: Cystic Fibrosis Market, Global, Pipeline, Phase I
Table 4: Cystic Fibrosis Market, Global, Pipeline, Phase II
Table 5: Cystic Fibrosis Market, Global, Pipeline, Phase III
Table 6: Cystic Fibrosis Market, Global, Pipeline, Pre-Registration
Table 7: Cystic Fibrosis Market, Global, Pipeline, Undisclosed
Table 8: Cystic Fibrosis Market, Global, Market Forecast, 2012-2019
Table 9: Cystic Fibrosis Market, US, Market Forecast, 2012-2019
Table 10: Cystic Fibrosis Market, Canada, Market Forecast, 2012-2019
Table 11: Cystic Fibrosis Market, UK, Market Forecast, 2012-2019
Table 12: Cystic Fibrosis Market, France, Market Forecast, 2012-2019
Table 13: Cystic Fibrosis Market, Germany, Market Forecast, 2012-2019
Table 14: Cystic Fibrosis Market, Italy, Market Forecast, 2012-2019
Table 15: Cystic Fibrosis Market, Spain, Market Forecast, 2012-2019

List of Chart


Figure 1: Cystic Fibrosis Market, Global, Marketed, Heat Map
Figure 2: Cystic Fibrosis Market, Global, Pipeline Summary
Figure 3: Cystic Fibrosis Market, Global, Pipeline Mechanisms of Action
Figure 4: Cystic Fibrosis Market, Global, Clinical Trial Failure Rate
Figure 5: Cystic Fibrosis Market, Global, Pipeline Trial Duration
Figure 6: Cystic Fibrosis Market, Global, Pipeline, Trial Duration by Mechanism of Action
Figure 7: Cystic Fibrosis Market, Global, Pipeline Trial Size
Figure 8: Cystic Fibrosis Market, Global, Pipeline, Trial Size by Mechanism of Action
Figure 9: Cystic Fibrosis Market, Global, Pipeline, Promising Pipeline Products, Lumacaftor Forecast,
2015-2019
Figure 10: Cystic Fibrosis Market, Global, Pipeline, Promising Pipeline Products, Ataluren Forecast,
2016-2019
Figure 11: Cystic Fibrosis Market, Global, Pipeline Promising Pipeline Products, Aeroquin Forecast,
2014-2019
Figure 12: Cystic Fibrosis Market, Global, Pipeline, Promising Pipeline Products, Arikace Forecast,
2015-2019
Figure 13: Cystic Fibrosis Market, Global, Pipeline, Heat Map
Figure 14: Cystic Fibrosis Market, Global, Treatment Patterns, 2012–2019
Figure 15: Cystic Fibrosis Market, Global, Market Size, 2012–2019
Figure 16: Cystic Fibrosis Market, North America, Treatment Patterns, 2012–2019
Figure 17: Cystic Fibrosis Market, North America, Annual Cost of Treatment, 2012–2019
Figure 18: Cystic Fibrosis Market, North America, Market Size, 2012–2019
Figure 19: Cystic Fibrosis Market, Top Five EU Countries, Treatment Patterns, 2012–2019
Figure 20: Cystic Fibrosis Market, Top Five EU Countries, Annual Cost of Treatment, 2012–2019
Figure 21: Cystic Fibrosis Market, Top Five EU Countries, Market Size, 2012–2019
Figure 22: Cystic Fibrosis Market, Global, Major Co-developments by Region and Value, 2006–2013
Figure 23: Cystic Fibrosis Market, Global, Major Co-development Deals by Year, 2006–2013
Figure 24: Cystic Fibrosis Market, Global, Co-development Deals by Phase, 2006–2013
Figure 25: Cystic Fibrosis Market, Global, Licensing Deals by Region, 2006–2013
Figure 26: Cystic Fibrosis Market, Global, Licensing Deals by Year, 2006–2013
Figure 27: Cystic Fibrosis Market, Global, Licensing Deals by Phase, 2006–2013
Figure 28: Forecasting Model for Therapeutic Areas

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