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市場調查報告書

Frontier Pharma:慢性阻塞性肺病 (COPD) - First-in-Class的革新認識和商業化

Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD) - Identifying and Commercializing First-in-Class Innovation

出版商 GBI Research 商品編碼 350753
出版日期 內容資訊 英文 53 Pages
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Frontier Pharma:慢性阻塞性肺病 (COPD) - First-in-Class的革新認識和商業化 Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD) - Identifying and Commercializing First-in-Class Innovation
出版日期: 2015年12月16日 內容資訊: 英文 53 Pages
簡介

慢性阻塞性肺病 (COPD) 治療藥的開發平台上有212個產品正在開發。

本報告提供慢性阻塞性肺病 (COPD) 治療藥市場相關調查分析,提供您革新案例,臨床·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 (劃時代醫藥品) 的開發現在也富有魅力
  • 法規·給付政策,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

  • 分子標的分析
  • 慢性阻塞性肺病 (COPD) 治療藥市場與開發平台間的計劃比較分佈:治療標的各系列
  • 新分子標的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

  • 慢性阻塞性肺病 (COPD) 的信號傳達網路之複雜
  • 信號傳達途徑和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標的評估

  • Toll樣受體3
  • AdenosineA (2B) 受體
  • 前列腺素D2受體2
  • P-Selectin
  • 巨噬細胞Metalloelastase
  • Rho相關蛋白質激酶1
  • 可溶性環氧樹脂水解酶
  • 血管工作性腸道胜肽受體家族
  • 結論

第8章 與交易策略性整合

  • 產業整體First-in-Class交易
  • 許可證交易
  • 共同開發交易
  • 許可證/共同開發交易無關的First-in-Class計劃

第9章 附錄

圖表

目錄
Product Code: GBIHC378MR

Executive Summary

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disorder associated with chronic inflammation of the airways and lungs. Persistent breathing difficulties and repeated exacerbations of COPD symptoms make the disease one of the leading causes of morbidity and the fifth-leading cause of death in the world. COPD is linked to cumulative exposure to risk factors, primarily tobacco smoke, but also environmental pollutants. The COPD marketed products landscape consists of pharmacological therapies aimed at managing the symptoms associated with COPD, although none of the available therapies have been shown to modify long-term disease progression.

The current COPD pipeline consists of 212 active products in development. Initial analysis revealed a small presence of first-in-class products, constituting 16.5% of the pipeline. In comparison to other indications, this is relatively low; however, there are some promising trends within COPD product development. The Preclinical Phase of development is the most active in terms of first-in-class products. This diminishes throughout clinical development, with only two such products being present in Phase III. However, if either of these products is approved, they would represent the first, first-in-class products to be approved for COPD since roflumilast, which was approved in 2011 by the FDA and in 2010 in the EU. Roflumilast was the first novel therapy for COPD in almost 20 years, which demonstrates the infrequency at which first-in-class products enter the COPD market. So to have two first-in-class products in Phase III and six in Phase II is a promising sign.

Scope

The COPD market has benefited from notable additions in recent years.

  • Which classes of drug dominate the market?
  • What additional benefits have newly approved therapies brought to market?
  • How do the leading marketed therapies compare clinically?

The pipeline contains a range of molecule types and molecular targets, including those that are well established in COPD and novel, first-in-class therapies.

  • Which molecular targets appear most frequently in the pipeline?
  • To what degree is the pipeline penetrated by first-in-class innovation?
  • Which target families consist of the most first-in-class products?

First-in-class products differ substantially in their clinical potential, based on their alignment to disease causing pathways.

  • How well are first-in-class targets aligned to known disease causing pathways?
  • Which targets are specifically found in early-stage development?
  • What is the industry-wide interest in these targets?
  • Which are the most promising first-in-class targets in early-stage development?

There have been 59 licensing deals and 41 co-development deals pertaining to COPD products since 2006.

  • Which territories show the most deal activity?
  • What were the trends in deal completion by product stage of development?
  • How many deals involved first-in-class products?
  • Which of the first-in-class products in development are not currently involved in a licensing or co-development deal, and therefore represent investment opportunities?

Reasons to buy

This report will allow you to -

  • Understand the current clinical and commercial landscape. It includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available at each stage of diagnosis.
  • Visualize the composition of the COPD market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
  • Analyze the COPD pipeline and stratify by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches to treating COPD.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.
  • Identify commercial opportunities in the COPD deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of COPD therapies that are not yet involved in deals and may be potential investment opportunities.

Table of Contents

1. Table of Contents

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

2. Executive Summary

  • 2.1. Unmet Needs Remain in COPD Market
  • 2.2. First-in-Class Innovation Beginning to Emerge in COPD
  • 2.3. COPD Lags Behind Asthma in First-in-Class Innovation

3. The Case for Innovation in COPD

  • 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. Symptoms
    • 4.1.3. Etiology
    • 4.1.4. Pathophysiology
    • 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. Molecule Type and Target Analysis
    • 4.2.2. Quick Relief Medication
    • 4.2.3. Bronchodilator and Inhaled Corticosteroid Combination Therapy
    • 4.2.4. Bronchodilator Monotherapy
    • 4.2.5. Bronchodilator Combination Therapy
    • 4.2.6. Alternative Therapy
    • 4.2.7. Conclusion
    • 4.2.8. Unmet Needs

5. Assessment of Pipeline Product Innovation

  • 5.1. Molecular Target Analysis
  • 5.2. Comparative Distribution of Programs between COPD Market and Pipeline by Therapeutic Target Family
  • 5.3. First-In-Class Pipeline Programs Targeting Novel Molecular Targets

6. Signaling Pathways, Disease Causation and Innovation Alignment

  • 6.1. The Complexity of Signaling Networks in COPD
  • 6.2. Signaling Pathways and First-in-Class Molecular Target Integration
  • 6.3. First-in-Class Target Matrix Assessment

7. First-in-Class Target Evaluation

  • 7.1. Pipeline Programs Targeting Toll-Like Receptor 3
  • 7.2. Pipeline Programs Targeting Adenosine A(2B) Receptor
  • 7.3. Pipeline Programs Targeting Prostaglandin D2 Receptor 2
  • 7.4. Pipeline Programs Targeting P-selectin
  • 7.5. Pipeline Programs Targeting Macrophage Metalloelastase
  • 7.6. Pipeline Programs Targeting Rho Associated Protein Kinase 1
  • 7.7. Pipeline Programs Targeting Soluble Epoxide Hydrolase
  • 7.8. Pipeline Programs Targeting Vasoactive Intestinal Peptide Receptor Family
  • 7.9. 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
  • 9.3. Research Methodology
  • 9.4. Secondary Research
    • 9.4.1. Marketed Product Heatmaps and Treatment Algorithm
    • 9.4.2. Pipeline Analysis
    • 9.4.3. First-in-Class Matrix Assessment
    • 9.4.4. First-in-Class Target Profiles
    • 9.4.5. Licensing and Co-Development Deals
  • 9.5. Contact Us
  • 9.6. Disclaimer

List of Tables

  • Table 1: COPD, Introduction, Disease Severity, 2015
  • Table 2: COPD, Introduction, Patient Risk Categories, 2015
  • Table 3: COPD, Introduction, Treatment Algorithm, 2015

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: COPD Market,Molecular Targets of Marketed Products, 2015
  • Figure 4: COPD Market, Global, Pipeline, 2015
  • Figure 5: COPD Market, Global, Pipeline, Molecular Target, 2015
  • Figure 6: COPD Market, Global, Pipeline, Molecular Target Tier 2, 2015
  • Figure 7: COPD, Molecular Target Category Comparison, Pipeline and Marketed Products, 2015
  • Figure 8: COPD, Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets, 2015
  • Figure 9: COPD, First-in-Class Pipeline Products, 2015
  • Figure 10: COPD, First-in-Class Molecular Target Analysis Matrix, 2015
  • Figure 11: COPD, Toll-Like Receptor 3 Profile
  • Figure 12: COPD, Products Targeting Toll-Like Receptor 3
  • Figure 13: COPD, Adenosine Receptor Profile
  • Figure 14: COPD, Products Targeting Adenosine Receptor
  • Figure 15: COPD, Prostaglandin d2 Receptor 2 Profile
  • Figure 16: COPD, Products Targeting Prostaglandin d2 Receptor 2
  • Figure 17: COPD, P-selectin Profile
  • Figure 18: COPD, Products Targeting P-selectin
  • Figure 19: COPD, Macrophage Metalloelastase Profile
  • Figure 20: COPD, Products Targeting Macrophage Metalloelastase
  • Figure 21: COPD, Rho Associated Protein Kinase 1 Profile
  • Figure 22: COPD, Products Targeting Rho Associated Protein Kinase 1 Profile
  • Figure 23: COPD, Soluble Epoxide Hydrolase Profile
  • Figure 24: COPD, Products Targeting Soluble Epoxide Hydrolase
  • Figure 25: COPD, Vasoactive Intestinal Peptide Receptor Family Profile
  • Figure 26: COPD, Products Targeting Vasoactive Intestinal Peptide Receptor Family
  • Figure 27: Industry-Wide Deals by Stage of Development, 2006-2015
  • Figure 28: Industry-wide Deals by Stage of Development, 2006-2015
  • Figure 29: COPD, Global, Licensing Deals by Region, 2006-2015
  • Figure 30: COPD Market, Global, Licensing Deals by Value, 2006-2015
  • Figure 31: COPD, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015
  • Figure 32: COPD, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015
  • Figure 33: COPD, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015
  • Figure 34: COPD, Global, Licensing Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006-2015
  • Figure 35: COPD, Global, Co-development Deals by Region, 2006-2015
  • Figure 36: COPD, Global, Co-development Deals by Value, 2006-2015
  • Figure 37: COPD, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015
  • Figure 38: COPD, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015
  • Figure 39: COPD, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015
  • Figure 40: COPD, Global, Co-development Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006-2015
  • Figure 41: COPD, Global, First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2015
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