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OpportunityAnalyzer: Immune Thrombocytopenia (ITP) - Opportunity Analysis and Forecasts to 2025

OpportunityAnalyzer: Immune Thrombocytopenia (ITP) - Opportunity Analysis and Forecasts to 2025

Summary

Immune Thrombocytopenia (ITP) is an autoimmune-related bleeding disorder characterized by a low platelet count. The exact cause of ITP is still unclear; however, the pathophysiology of the disease can be contributed by an increased destruction of platelets, a decreased production of platelets, or both. Therefore, there might be multiple causes and mechanisms that can contribute to the disease. ITP can affect patients at all ages, but pediatric patients are likely to recover spontaneously while adult patients have a higher chance to develop into a chronic condition.

It is estimated that the value of the ITP market in the 7MM in 2015 was $928M, including sales of the major branded and off-label drugs commonly prescribed for ITP patients across the 7MM. The US is the largest contributor to the 7MM, with $587M in 2015, representing 63.3% of the market share. The 5EU and Japan contributed $281M and $60M in 2015, respectively, to the major ITP markets.

ITP market to grow during in the first half of the forecast period (2015-2025); however, sales will start to decline in 2022 in the US and projects that total ITP sales in 2025 will grow to $985M at a modest overall Compound Annual Growth Rate (CAGR) of 0.6%.

Major drivers of the growth of the ITP market over the forecast period include the following -

  • Increasing uptake and market penetration of marketed brands, Amgen’s Nplate (romiplostim) and Novartis’ Promacta/Revolade (eltrombopag), in both adult and pediatric ITP populations.
  • Rising diagnosed prevalence of adult ITP, and hence a rising treated population.
  • Launch of Rigel Pharmaceuticals’ fostamatinib, which will offer a new mechanism of action (MOA) for ITP treatment.
Companies are looking into drugs with novel MOA, which may offer hope to improve response rate and safety. It is identified that two promising approaches: spleen tyrosine kinase (Syk) inhibitors, including the Phase III fostamatinib, and CD40/CD40 ligand antagonists. As Rigel has managed to complete two pivotal Phase III trials for fostamatinib, It is expected that the drugs offering new MOAs to be essential for companies to successfully develop new ITP therapies moving forward.

The report OpportunityAnalyzer: Immune Thrombocytopenia (ITP) - Opportunity Analysis and Forecasts to 2025, provides an overview of ITP, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

In particular, this report provides the following analysis -
  • Annualized ITP therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including pediatric, adult primary, and adult secondary), forecast from 2015 to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the ITP therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for ITP therapy. The most promising candidate in Phase III development is profiled.
  • Analysis of the current and future market competition in the global ITP therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Companies mentioned in this report: Amgen, Bristol-Myers Squibb, Eisai, Genosco, GlaxoSmithKline, Gliknik, Hansa, Hoffmann La-Roche, Immunomedics, Jiangsu Hengrui, Kyowa Hakko Kirin, Ligand Pharmaceuticals, Merck & Co., Momenta, Novartis, PBM Capital, Pfizer, Protalex, Rigel Pharmaceuticals, UCB Biopharma.

Scope
  • Overview of ITP, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized ITP therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including pediatric, adult primary, and adult secondary), forecast from 2015 to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the ITP therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for ITP therapy. The most promising candidate in Phase III development is profiled.
  • Analysis of the current and future market competition in the global ITP therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global ITP therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global ITP therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Phases and Severity of ITP
3.3 Symptoms
3.4 Prognosis
3.5 Quality of Life
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 US
4.3.2 5EU
4.3.3 Japan
4.4 Forecast Methodology
4.4.1 Sources Used Tables
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiological Forecast for ITP (2015-2025)
4.5.1 Diagnosed Prevalent Cases of ITP
4.5.2 Age-Specific Diagnosed Prevalent Cases of ITP
4.5.3 Sex-Specific Diagnosed Prevalent Cases of ITP
4.5.4 Age-Standardized Diagnosed Prevalence of ITP
4.5.5 Diagnosed Incident Cases of ITP
4.5.6 Age-Specific Diagnosed Incident Cases of ITP
4.5.7 Sex-Specific Diagnosed Incident Cases of ITP
4.5.8 Age-Standardized Diagnosed Incidence of ITP
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.2 Diagnosis and Treatment
5.2.1 Diagnosis
5.2.2 Treatment Guidelines and Leading Prescribed Drugs
5.3 Clinical Practice
5.3.1 Decision on the Initiation of Treatment
5.3.2 First-Line Treatment
5.3.3 Second-Line Therapy
5.4 Product Profiles - Thrombopoietin Receptor Agonists
5.4.1 Nplate (Romiplostim)
5.4.2 Promacta/Revolade (Eltrombopag)
6 Unmet Needs Assessment and Opportunity Analysis
6.1 Overview
6.2 Safer and More Efficacious First-Line Therapy
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 High Treatment Cost of Thrombopoietin Receptor Agonists
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Second-Line Therapeutic Options that Offer Long-Term Remission
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 New Treatment for Multiple Drug Refractory Patients
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Difficulties in Clinical Trial Patient Recruitment
6.6.1 Unmet Need
6.6.2 Gap Analysis
6.6.3 Opportunity
7 Research and Development Strategies
7.1 Overview
7.1.1 Enlarging Eligible Patient Pool Through Label Expansion to Pediatric Patients
7.1.2 Targeting New Mechanisms of Action to Increase Competitiveness
7.2 Clinical Trial Design
7.2.1 Historical Lack of Consistency in Patient Selection Criteria
7.2.2 Inconsistent Timeframe for Endpoint Measurement and Study Duration
7.2.3 Selection of Suitable Comparator
7.2.4 Other Clinical Trial Requirements
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development
8.2.1 Avatrombopag
8.2.2 Fostamatinib (R-788)
8.3 Innovative Early-Stage Approaches
8.3.1 Overview
8.3.2 CD40/CD40L Antagonists
8.3.3 Anti-CD20 Monoclonal Antibodies
8.3.4 Thrombopoietin Receptor Agonists
8.3.5 Syk Inhibitors
8.3.6 Other Approaches
8.4 Biosimilars
8.5 Other Drugs in Development
9 Pipeline Valuation Analysis
9.1 Clinical Benchmark of Key Pipeline Drugs
9.2 Commercial Benchmark of Key Pipeline Drugs
9.3 Competitive Assessment
9.4 Top-Line 10-Year Forecast
9.4.1 US
9.4.2 5EU
9.4.3 Japan
10 Appendix
10.1 Bibliography
10.2 Abbreviations
10.3 Methodology
10.4 Forecasting Methodology
10.4.1 Diagnosed Immune Thrombocytopenia Patients
10.4.2 Percent Drug-Treated Patients
10.4.3 Drugs Included in Each Therapeutic Class
10.4.4 Launch and Patent Expiry Dates
10.4.5 General Pricing Assumptions
10.4.6 Individual Drug Assumptions
10.4.7 Generic Erosion
10.4.8 Pricing of Pipeline Agents
10.5 Primary Research - KOLs Interviewed for this Report
10.6 Primary Research - Prescriber Survey
10.7 About the Authors
10.7.1 Analyst
10.7.2 Therapy Area Directors
10.7.3 Epidemiologists
10.7.4 Epidemiology Reviewer
10.7.5 Director of Epidemiology
10.7.6 Global Director of Therapy Analysis and Epidemiology
10.8 About GlobalData
10.9 Disclaimer
1.1 List of Tables
Table 1: Secondary Causes of ITP
Table 2: Phases and Severity of ITP
Table 3: Symptoms of ITP
Table 4: Risk Factors and Comorbidities for ITP
Table 5: 7MM, Sources for Diagnosed Prevalence of Primary ITP
Table 6: 7MM, Sources for Diagnosed Prevalence of Secondary ITP
Table 7: 7MM, Sources for Diagnosed Incidence of Primary ITP
Table 8: 7MM, Sources for Diagnosed Incidence of Secondary ITP
Table 9: 7MM, Sources Not Used in the Epidemiological Analysis of ITP
Table 10: 7MM, Diagnosed Prevalent Cases of Primary ITP, All Ages, Men and Women, Select Years, 2015-2025
Table 11: 6MM, Diagnosed Prevalent Cases of Secondary ITP, All Ages, Men and Women, Select Years, 2015-2025
Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of Primary ITP, Men and Women, N (Row %), 2015
Table 13: 6MM, Age-Specific Diagnosed Prevalent Cases of Secondary ITP, Men and Women, N (Row %), 2015
Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of Primary ITP, All Ages, N (Row %), 2015
Table 15: 6MM, Sex-Specific Diagnosed Prevalent Cases of Secondary ITP, All Ages, N, 2015
Table 16: 7MM, Diagnosed Incident Cases of Primary ITP, All Ages, Men and Women, Select Years, 2015-2025
Table 17: 6MM, Diagnosed Incident Cases of Secondary ITP, All Ages, Men and Women, Select Years, 2015-2025
Table 18: 7MM, Age-Specific Diagnosed Incident Cases of Primary ITP, Men and Women, N (Row %), 2015
Table 19: 6MM, Age-Specific Diagnosed Incident Cases of Secondary ITP, Men and Women, N (Row %), 2015
Table 20: 7MM, Sex-Specific Diagnosed Incident Cases of Primary ITP, All Ages, N (Row %), 2015
Table 21: 6MM, Sex-Specific Diagnosed Incident Cases of Secondary ITP, All Ages, N (Row %), 2015
Table 22: Non-Immunologic Causes of Thrombocytopenia
Table 23: Clinical Guidelines for ITP
Table 24: Leading Treatments for ITP, 2016
Table 25: Corticosteroid Therapy for First-Line ITP Treatment
Table 26: Efficacy of Rituxan in the Second-Line Setting
Table 27: Other Second-Line Options for ITP Treatment
Table 28: Product Profile - Nplate
Table 29: Efficacy of Nplate in Pivotal Trials
Table 30: Long-Term Efficacy of Nplate in Open-Label Studies
Table 31: Efficacy of Nplate Compared with SOC in Non-Splenectomized Patients
Table 32: Efficacy of Nplate in the NCT01444417 Trial
Table 33: Summary of AEs from the Two Pivotal Trials of Nplate
Table 34: Summary of AEs in the NCT01444417 Trial
Table 35: Nplate SWOT Analysis, 2016
Table 36: Product Profile - Promacta
Table 37: Efficacy of Promacta in the NCT00102739 Trial
Table 38: Efficacy of Promacta in the RAISE Trial
Table 39: Efficacy of Promacta in the PETIT Trial
Table 40: Age-Stratified Efficacy of Promacta in the PETIT Trial
Table 41: Efficacy of Promacta in the PETIT2 Trial
Table 42: Age-Stratified Efficacy of Promacta in the PETIT2 Trial
Table 43: Summary of AEs from the Pivotal Trials of Promacta in Adults
Table 44: Summary of AEs from the Pivotal Trials of Promacta in Children
Table 45: Promacta SWOT Analysis, 2016
Table 46: Unmet Need and Opportunity in ITP, 2016
Table 47: Phase III Pipeline Clinical Trial Design for ITP
Table 48: Key Late-Stage Pipeline Agents for ITP, 2016
Table 49: Product Profile - Avatrombopag
Table 50: Efficacy of Avatrombopag in the Amendment 02 Trial
Table 51: Efficacy of Avatrombopag in the NCT00441090 Trial
Table 52: Summary of AEs from Two Phase II Trials of Avatrombopag
Table 53: Avatrombopag SWOT Analysis, 2016
Table 54: Product Profile - Fostamatinib
Table 55: Efficacy of Fostamatinib in ITP
Table 56: Safety of Fostamatinib in ITP
Table 57: Fostamatinib SWOT Analysis, 2016
Table 58: Early-Stage Clinical and Preclinical ITP Pipeline
Table 59: Discontinued or Inactive ITP Pipeline
Table 60: Clinical Benchmark of Key Pipeline Drugs - ITP
Table 61: Commercial Benchmark of Key Pipeline Drugs - ITP
Table 62: Top-Line Sales Forecasts ($M) for ITP, 2015-2025
Table 63: Key Events Impacting Sales for ITP, 2015-2025
Table 64: ITP Market - Global Drivers and Barriers, 2015‒2025
Table 65: Key Historical and Projected Launch Dates for ITP Therapeutics
Table 66: Key Historical and Projected Patent Expiry Dates for ITP Therapeutics
Table 67: Average Adult Body Weight and Surface Area Across the 7MM
Table 68: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Diagnosed Prevalence Rate for ITP in the 7MM for All Ages, Men and Women, Cases per 100,000 Population, 2015
Figure 2: Diagnosed Incidence Rate for ITP in the 7MM for All Ages, Men and Women, Cases per 100,000 Population, 2015
Figure 3: Case Flow Map
Figure 4: 7MM, Diagnosed Prevalent Cases of Primary ITP Cases, All Ages, Men and Women, N, Select Years, 2015-2025
Figure 5: 6MM, Diagnosed Prevalent Cases of Secondary ITP Cases, All Ages, Men and Women, N, Select Years, 2015-2025
Figure 6: 7MM, Age-Specific Diagnosed Prevalent Cases of Primary ITP, Men and Women, N, 2015
Figure 7: 6MM, Age-Specific Diagnosed Prevalent Cases of Secondary ITP, Men and Women, N, 2015
Figure 8: 7MM, Sex-Specific Diagnosed Prevalent Cases of Primary ITP, All Ages, N, 2015
Figure 9: 6MM, Sex-Specific Diagnosed Prevalent Cases of Secondary ITP, All Ages, N, 2015
Figure 10: 7MM, Age-Standardized Diagnosed Prevalence of Primary ITP, All Ages, Cases per 100,000 population, 2015
Figure 11: 6MM, Age-Standardized Diagnosed Prevalence of Secondary ITP, All Ages, Cases per 100,000 population, 2015
Figure 12: 7MM, Diagnosed Incident Cases of Primary ITP, All Ages, Men and Women, N, Select Years, 2015-2025
Figure 13: 6MM, Diagnosed Incident Cases of Secondary ITP, All Ages, Men and Women, N, Select Years, 2015-2025
Figure 14: 7MM, Age-Specific Diagnosed Incident Cases of Primary ITP, Men and Women, N, 2015
Figure 15: 6MM, Age-Specific Diagnosed Incident Cases of Secondary ITP, Men and Women, N, 2015
Figure 16: 7MM, Sex-Specific Diagnosed Incident Cases of Primary ITP, All Ages, N, 2015
Figure 17: 6MM, Sex-Specific Diagnosed Incident Cases of Secondary ITP, All Ages, N, 2015
Figure 18: 7MM, Age-Standardized Diagnosed Incidence of Primary ITP, All Ages, Cases per 100,000 Population, 2015
Figure 19: 6MM, Age-Standardized Diagnosed Incidence of Secondary ITP, All Ages, Cases per 100,000 Population, 2015
Figure 20: Nplate’s Development in ITP
Figure 21: Development of Promacta in ITP
Figure 22: ITP - Phase III Pipeline, 2016
Figure 23: Avatrombopag’s Development in ITP
Figure 24: Fostamatinib’s Development in ITP
Figure 25: Competitive Assessment of Pipeline Agents in ITP, 2015-2025
Figure 26: Top-Line Sales for ITP by Region, 2015 and 2025
Figure 27: Top-Line Sales for ITP by Region, 2015-2025
Figure 28: Global Sales for ITP by Drug Class, 2015 and 2025
Figure 29: Sales for ITP by Drug Class in the US, 2015 and 2025
Figure 30: Sales for ITP by Drug Class in the 5EU, 2015 and 2025
Figure 31: Sales for ITP by Drug Class in the Japan, 2015 and 2025

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