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市場調查報告書

Frontier Pharma:氣喘 - First-in-Class的革新認識和商業化

Frontier Pharma: Asthma - Identifying and Commercializing First-in-Class Innovation

出版商 GBI Research 商品編碼 331414
出版日期 內容資訊 英文 67 Pages
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Frontier Pharma:氣喘 - First-in-Class的革新認識和商業化 Frontier Pharma: Asthma - Identifying and Commercializing First-in-Class Innovation
出版日期: 2015年05月01日 內容資訊: 英文 67 Pages
簡介

氣喘治療藥的開發平台非常活躍,在全階段中有252產品正在開發。還有所使用的作用機制的範圍,與現有的市場情形比較,也富有多樣性。

本報告提供氣喘治療藥市場相關調查分析、革新案例、臨床與商業性情形、開發中產品的評估、計劃評估、最近的交易等相關的系統性資訊。

第1章 目錄

第2章 摘要整理

第3章 革新案例

  • 生技藥品的機會擴大
  • 分子標的多樣化
  • 創新的First-in-Class產品 (劃時代的醫藥品) 的開發現在也富有魅力
  • 法規、償付政策,對First-in-Class產品的革新有利
  • 持續性的革新
  • 報告指南

第4章 臨床、商業性情形

  • 疾病概要
  • 上市產品概要

第5章 開發中產品革新的評估

  • 氣喘治療藥開發平台:各階段、分子類型、治療標的
  • 氣喘治療藥市場與開發平台間的計劃比較分佈:各分子標靶
  • 新分子標的之First-in-Class開發平台計劃

第6章 信號 (信號傳達) 網路、疾病的因果關係、革新的調整

  • 氣喘的信號傳達網路的複雜度
  • 信號傳達途徑,成為疾病的原因的變異,First-in-Class分子標的整合
  • First-in-Class標的矩陣的評估

第7章 First-in-Class目標與開發平台計劃的評估

  • A4 水解酵素
  • P-選擇素
  • 脾臟蛋白酪氨酸激酶
  • 前列腺素 D2受體 2
  • OX40 配體
  • 白細胞介素 33
  • 白細胞介素 10
  • 肥胖幹細胞成長因素受體
  • Bradykinin B1受體
  • 結論

第8章 交易策略性與整合

  • 產業整體的First-in-Class交易
  • 許可證交易
  • 共同開發交易
  • 不參予許可證/共同開發交易的First-in-Class計劃

第9章 附錄

圖表

目錄
Product Code: GBIHC359MR

Executive Summary

Large and Innovative Pipeline

Analysis has confirmed the asthma pipeline to be highly active, with 252 products in active development across all stages. The range of mechanisms of action employed by these compounds is also highly diverse, especially in comparison to the existing market landscape. More pertinently, the degree and proportion of breakthrough innovations is significant. GBI Research analysis identified 59 first-in-class programs in the asthma pipeline, acting on 43 first-in-class molecular targets, accounting for 23% of all products with a disclosed molecular target and reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high clinical trial attrition rate, it is highly likely that many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.

Biologics Growing in Prominence in Asthma Treatment

While the current asthma market is almost exclusively dominated by small molecules, which account for approximately 99% (the exception being Xolair), the current asthma pipeline includes 64 biologics, accounting for 24%. Small molecules amount to 178 compounds, equating to 66%.

This highlights both the commercial and clinical appeal of developing drugs of this class, and follows trends seen in other therapy areas, particularly oncology. Xolair (omalizumab), a recombinant humanized anti-IgE monoclonal Antibody (mAb), was the first humanized therapeutic mAb to be indicated for asthma. It was approved by the FDA in 2003 as an add-on therapy for adults and adolescents aged 12 and over, with moderate-to-severe allergic asthma and symptoms not adequately controlled with Inhaled Corticosteroids (ICS).

Xolair is also the only targeted therapy indicated for the treatment of a specific asthma phenotype. Its launch therefore addressed a significant unmet need for personalized therapy in asthma. Approximately 60% of asthmatics have allergic asthma, and may therefore benefit from Xolair treatment. However, only a minority of these patients has moderate-to-severe disease that is inadequately controlled with standard-of-care therapies, and is therefore eligible for treatment. Despite this, the drug has achieved blockbuster status, and although this can be attributed to a high Annual Cost of Therapy (ACoT), it is also reflective of how innovative drug development that targets unmet clinical needs can result in strong commercial outcomes. Indeed, drug developers are now looking to follow this example by developing highly specific biologics aimed at specific patient sub-types with the hope of benefiting previously underserved patients and generating strong revenues. Notable examples are mepolizumab, reslizumab, lebrikizumab and dupilumab, all of which target Interleukins (IL) heavily implicated in the inflammatory response.

A Deals Landscape with Numerous Investment Opportunities

Analysis has confirmed that 52 of the 59 first-in-class products have not been involved in a licensing or co-development deal. Although a number act on targets that are not yet strongly substantiated in terms of their therapeutic potential in asthma in clinical studies, many are supported by promising in vivo and in vitro preclinical evidence, and as such are highly promising asthma therapies. Indeed, breakthrough innovations are highly desirable as an investment option.

However, many deals involving first-in-class products were in early-stage development, whereas advance-in-class and addition-to-class product deals were typically made in late-stage development, indicating significant differentiation. These findings have significant strategic implications for both biotech companies seeking to out-license products and firms with an interest in in-licensing first-in-class products with strong clinical and commercial prospects.

Scope

The report analyzes innovation in asthma in the context of the overall pipeline and the current market landscape. In addition, it analyzes the deals landscape surrounding first-in-class products in asthma, and pinpoints opportunities for in-licensing. The report covers and includes -

  • A brief introduction to asthma, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
  • The changing molecular target landscape between market and pipeline and particular focal points of innovation in the pipeline
  • Comprehensive review of the pipeline for first-in-class therapies, analyzed by of stage of development, molecule type, and molecular target
  • Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets
  • Assessment of the licensing and co-development deal landscape for asthma therapies and benchmarking of deals involving first-in-class versus non-first-in-class-products

Reasons to buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to -

  • Understand the focal shifts in molecular targets in the asthma pipeline
  • Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Access a scientific and clinical analysis of first-in-class developmental programs for asthma, benchmarked against non-first-in-class targets
  • Access a list of the first-in-class therapies potentially open to deal-making opportunities

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Executive Summary

  • 2.1. Biologics Growing in Prominence in Asthma Treatment
  • 2.2. Market Landscape to Grow in Diversity over Coming Years
  • 2.3. Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products

3. The Case for Innovation in Asthma

  • 3.1. Growing Number of Opportunities for Biologic Products
  • 3.2. Diversification of Molecular Targets
  • 3.3. Innovative First-in-Class Product Developments Remain Attractive
  • 3.4. Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
  • 3.5. Sustained Innovation
  • 3.6. GBI Research Report Guidance

4. Clinical and Commercial Landscape

  • 4.1. Disease Overview
    • 4.1.1. Epidemiology
    • 4.1.2. Etiology
    • 4.1.3. Disease Pathophysiology
    • 4.1.4. Disease Symptoms
    • 4.1.5. Diagnosis
    • 4.1.6. Assessment of Disease Severity
    • 4.1.7. Treatment
    • 4.1.8. Treatment Algorithm
  • 4.2. Overview of Marketed Products
    • 4.2.1. Quick-Relief Medication
    • 4.2.2. ICSs for the Maintenance Treatment of Asthma
    • 4.2.3. ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma
    • 4.2.4. Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma
    • 4.2.5. Conclusion

5. Assessment of Pipeline Product Innovation

  • 5.1. Asthma Pipeline by Phase, Molecule Type and Therapeutic Target
  • 5.2. Comparative Distribution of Programs between the Asthma Market and Pipeline by Molecular Target
  • 5.3. First-in-Class Pipeline Programs Targeting Novel Molecule Targets

6. Signaling Network, Disease Causation and Innovation Alignment

  • 6.1. The Complexity of Signaling Networks in Asthma
  • 6.2. Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
  • 6.3. First-in-Class Target Matrix Assessment

7. First-in-Class Target and Pipeline Program Evaluation

  • 7.1. Pipeline Programs Targeting Leukotriene A4 Hydrolase
  • 7.2. Pipeline Programs Targeting P-selectin
  • 7.3. Pipeline Programs Targeting Spleen Tyrosine Kinase
  • 7.4. Pipeline Programs Targeting Prostaglandin D2 Receptor 2
  • 7.5. Pipeline Programs Targeting OX40 Ligand
  • 7.6. Pipeline Programs Targeting Interleukin-33
  • 7.7. Pipeline Programs Targeting Interleukin-10
  • 7.8. Pipeline Programs Targeting Mast Stem Cell Growth Factor Receptor
  • 7.9. Pipeline Programs Targeting Bradykinin B1 Receptor
  • 7.10. Conclusion

8. Deals and Strategic Consolidations

  • 8.1. Industry-Wide First-in-Class Deals
  • 8.2. Licensing Deals
  • 8.3. Co-development Deals
  • 8.4. First-in-Class Programs not Involved in Licensing or Co-Development Deals

9. Appendix

  • 9.1. References
  • 9.2. Abbreviations
    • 9.2.1. Expert Panel Validation
  • 9.3. Contact Us
  • 9.4. Disclaimer

List of Tables

  • Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 0-4 Years of Age
  • Table 2: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 5-11 Years of Age
  • Table 3: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Youths ≥12 Years of Age and Adults
  • Table 4: Management of Chronic Asthma
  • Table 5: Management of Acute Asthma

List of Figures

  • Figure 1: Innovation Trends in Product Approvals
  • Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval
  • Figure 3: Asthma, Global Pipeline Overview
  • Figure 4: Asthma, Molecular Target Classes of Pipeline Products
  • Figure 5: Asthma, Molecular Targets
  • Figure 6: Asthma, Molecular Target Category Comparison, Pipeline and Marketed Products
  • Figure 7: Asthma, Comparative Pipeline
  • Figure 8: Asthma, First-in-Class Products in the Asthma Pipeline
  • Figure 9: Signaling Networks of Functional Families in Asthma - Part 1
  • Figure 10: Signaling Networks of Functional Families in Asthma - Part 2
  • Figure 11: First-in-Class Molecular Target Analysis Matrix
  • Figure 12: Leukotriene A4 Hydrolase as a Therapeutic Target
  • Figure 13: Pipeline Programs Targeting Leukotriene A4 Hydrolase
  • Figure 14: P-selectin as a Therapeutic Target
  • Figure 15: Pipeline Programs Targeting P-Selectin
  • Figure 16: Spleen Tyrosine Kinase as a Therapeutic Target
  • Figure 17: Pipeline Programs Targeting Spleen Tyrosine Kinase
  • Figure 18: Prostaglandin D2 Receptor 2 as a Therapeutic Target
  • Figure 19: Pipeline Programs Targeting Prostaglandin D2 Receptor 2
  • Figure 20: OX40 Ligand as a Therapeutic Target
  • Figure 21: Pipeline Programs Targeting OX40 Ligand
  • Figure 22: Interleukin-33 as a Therapeutic Target
  • Figure 23: Pipeline Programs Targeting Interleukin-33
  • Figure 24: Interleukin-10 as a Therapeutic Target
  • Figure 25: Pipeline Programs Targeting Interleukin-10
  • Figure 26: Mast stem Cell Growth Factor Receptor as a Therapeutic Target
  • Figure 27: Pipeline Programs Targeting Mast Stem Cell Growth Factor Receptor
  • Figure 28: Bradykinin B1 Receptor as a Therapeutic Target
  • Figure 29: Pipeline Programs Targeting Bradykinin B1 Receptor
  • Figure 30: Industry-Wide Deals by Stage of Development, 2006-2014
  • Figure 31: Industry-wide Deals by Stage of Development, 2006-2014
  • Figure 32: Asthma, Licensing Deals by Region, 2006-2015
  • Figure 33: Asthma, Licensing Deals, 2006-2015
  • Figure 34: Asthma, First-in-Class and Non-First-in-Class Comparison, 2006-2015
  • Figure 35: Asthma, Licensing Deals by Mechanism of Action, 2006-2015
  • Figure 36: Asthma, Co-development Deals by Region, 2006-2015
  • Figure 37: Asthma, Co-development Deals, 2006-2015
  • Figure 38: Asthma, Co-development Deals by Mechanism of Action, 2004-2015
  • Figure 39: Asthma, First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2015
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