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市場調查報告書

乳癌 - 新類型的技術創新的識別與商品化

Frontier Pharma: Breast Cancer - Identifying and Commercializing First-in-Class Innovation

出版商 GBI Research 商品編碼 312871
出版日期 內容資訊 英文 116 Pages
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乳癌 - 新類型的技術創新的識別與商品化 Frontier Pharma: Breast Cancer - Identifying and Commercializing First-in-Class Innovation
出版日期: 2014年07月31日 內容資訊: 英文 116 Pages
簡介

乳癌開發平台在醫藥品產業中成為最大規模。此化合物的作用機制非常多樣化。現在乳癌開發平台有253個新類型計劃,176個新類型分子目標研究正在進行。

本報告提供乳癌的概要與新類型治療藥開發平台的總括檢討、乳癌治療的授權和共同開發趨勢等彙整資料。

第1章 目錄

第2章 摘要整理

第3章 乳癌市場上技術創新的案例

  • 生技藥品的機會增加
  • 分子目標的多樣化
  • 受關注的創新新類型產品開發
  • 臨床及商業性環境的變化對於以利基的患者和適應症為目標的產品變得更合乎理想
  • 持續的技術創新
  • 報告指南

第4章 臨床及商業性環境

  • 疾病概要
  • 症狀
  • 病因
  • 病理學
  • 診斷
  • 預後和分期
  • 乳癌治療的引進
  • 手術和放射治療
  • 乳癌用已上市產品概要
  • 治療指南
  • 乳癌市場目前未滿足需求

第5章 開發中產品技術創新評估

  • 各相、分子的種類、分子目標的乳癌開發平台
  • 新類型開發平台計劃

第6章 信號傳達網路,疾病的原因及技術創新的整備

第7章 新類型目標評估

第8章 交易與策略性考察

  • 授權契約
    • 分子的種類
    • 作用機制
  • 共同開發契約
    • 分子的種類
    • 作用機制
  • 與授權和共同開發無關的新類型分子

第9章 附錄

圖表

目錄

Summary

Exceptionally Large and Innovative Pipeline

The breast cancer pipeline is the largest in the pharmaceutical industry with 815 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 in this pipeline is exceptional; GBI Research analysis identified 253 first-in-class programs in the breast cancer pipeline, acting on 176 first-in-class molecular targets. This accounts for some 39% of all products with a disclosed molecular target and is reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high attrition rate in breast cancer, it is highly likely many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.

Alignment of First-in-Class Molecular Target with Disease Causation

One of the key trends in oncology and in breast cancer in particular over the last decade is the clinical and commercial impact of targeted therapies designed to target proteins in signaling pathways that are frequently mutated in a significant proportion of the patient population. By aligning the molecular targets for therapeutic intervention with disease causation and/or propagation, these therapies limit the systemic cytotoxic effects whilst inhibiting tumor-promoting signaling pathways. Such strategies thereby typically achieve superior efficacy and safety profiles.

Our proprietary analyses demonstrate significant levels of differentiation as to how well the first-in-class products and their respective molecular targets align to underlying gene and protein level mutations and dysfunction. More advanced analytics further substantiated these findings as strong levels of differentiation in the scientific and clinical rationale for first-in-class molecular targets emerged. Furthermore, clear frontrunners were identified by integrating analyses to assess the accessibility of molecular targets for therapeutic compounds, the size of the target patient population that would benefit from therapeutic intervention, and the expected positioning of the first-in-class products based on the molecular targets and mechanisms of action of currently marketed products.

These insights and a detailed review of the available evidence from scientific studies substantiate the perspective that first-in-class-product technology in its own right is not sufficient to offer a compelling scientific and clinical rationale. However, a range of products offer very significant scientific and clinical promise and could therefore result in a strong commercial proposition with the prospect of clinically and commercially transformative products in the future.

A Highly Active Deals Landscape with Numerous Investment Opportunities

The breast cancer deals landscape is highly dynamic, with both deal number and aggregate value exceeding industry benchmarks, reflecting the large and highly competitive marketed and pipeline product environments. Moreover, with 40 first-in-class products that are currently in development having been involved in a licensing or co-development deal, the capital being committed to breast cancer partnership deals is not limited to products with established mechanisms of action in the marketed product landscape. On the contrary, breakthrough innovations are highly desirable as an investment option. Analysis shows that the licensing deal values can exceed the mean and median deal values for licensing deals in Phase I, II and III, suggesting that premium deals can be achieved by smaller firms with the capacity to advance strong products to one of the clinical stages of development. However, most deals involving first-in-class products were either preclinical or Phase I development, whereas advance-in-class and addition-to-class product deals were typically made in Phases II and III, therefore showing 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.

With the remaining 213 first-in-class products that are currently in development having not yet been involved in a licensing or co-development deal, there are numerous opportunities for in-licensing or co-development in this indication, which already has a strong track record of breakthrough innovation yielding highly commercially and clinically successful therapies. Although many act on targets that are not yet strongly substantiated in terms of their therapeutic potential in breast cancer in clinical studies, there are many which are supported by very robust and promising in vivo and in vitro preclinical evidence, and as such are highly promising breast cancer therapies.

Scope

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

  • A brief introduction to breast cancer, including symptoms, pathophysiology, and 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 on the basis 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 breast cancer 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 -

  • Understanding of the focal shifts in molecular targets in the breast cancer pipeline.
  • Understanding of 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 breast cancer, benchmarked against non-first-in-class targets.
  • Assess the valuations of licensed and co-developed breast cancer treatments.
  • 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. Exceptionally Large and Innovative Pipeline
  • 2.2. Alignment of First-in-Class Molecular Target with Disease Causation
  • 2.3. A Highly Active Deals Landscape with Numerous Investment Opportunities

3. The Case for Innovation in the Breast Cancer Market

  • 3.1. Growing Opportunities for Biologic Products
  • 3.2. Diversification of Molecular Targets
  • 3.3. Innovative First-in-Class Product Developments Remain Attractive
  • 3.4. Changes in the Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications
  • 3.5. Sustained Innovation
  • 3.6. Report Guidance

4. Clinical and Commercial Landscape

  • 4.1. Disease Overview
  • 4.2. Disease Symptoms
  • 4.3. Etiology
  • 4.4. Pathophysiology
    • 4.4.1. Tumor Initiation, and Aberrant Cell Proliferation and Survival
    • 4.4.2. Tumor Metabolic Shift
    • 4.4.3. Tumor Progression, Microenvironment Alteration and Angiogenesis
    • 4.4.4. Cancer Stem Cells
  • 4.5. Diagnosis
  • 4.6. Prognosis and Disease Staging
    • 4.6.1. Classification
  • 4.7. Introduction to Breast Cancer Treatments
  • 4.8. Surgery and Radiation Therapy
  • 4.9. Overview of Marketed Products for Breast Cancer
    • 4.9.1. Chemotherapy
    • 4.9.2. Efficacy of Chemotherapy Regimens
    • 4.9.3. Hormonal Therapies
    • 4.9.4. Efficacy of Endocrine Therapies
    • 4.9.5. Targeted Therapies
    • 4.9.6. Efficacy of Targeted Therapies
  • 4.10. Treatment Guidelines
  • 4.11. Current Unmet Need in the Breast Cancer Market

5. Assessment of Pipeline Product Innovation

  • 5.1. Breast Cancer Pipeline by Phase, Molecule Type and Molecular Target
  • 5.2. First-in-Class Pipeline Programs

6. Signaling Network, Disease Causation and Innovation Alignment

  • 6.1. The complexity of signaling networks in oncology
  • 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 Evaluation

  • 7.1. Pipeline Programs which Target Protein Kinase C Delta
  • 7.2. Pipeline Programs which Target p53
  • 7.3. Pipeline Programs which Target FGFR4
  • 7.4. Pipeline Programs which Target Akt 1, 2 and 3
  • 7.5. Pipeline Programs which Target HER3
  • 7.6. Pipeline Programs which Target PI3K
  • 7.7. Pipeline Programs which Target Murine Double Minute 2
  • 7.8. Pipeline Programs which Target Growth factor receptor-bound protein 2
  • 7.9. Pipeline Programs which Target Notch-1
  • 7.10. Pipeline Programs which Target Signal Transducer and Activator of Transcription 3
  • 7.11. Pipeline Programs which Target Cluster of Differentiation 44
  • 7.12. Pipeline Programs which Target Protein Phosphatase 2A
  • 7.13. Pipeline Programs which Target Heat Shock Protein 90
  • 7.14. Pipeline Programs which Target Basigin (CD147)
  • 7.15. Pipeline Programs which Target Rho-associated, Coiled-coil-containing Protein Kinase 1
  • 7.16. Pipeline Programs which Target Creb
  • 7.17. Pipeline Programs which Target Cyclin-Dependent Kinase 4 and Cyclin-Dependent Kinase 6
  • 7.18. Pipeline Programs which Target Integrin αV
  • 7.19. Conclusion

8. Deals and Strategic Consolidations

  • 8.1. Licensing Deals
    • 8.1.1. Molecule Type
    • 8.1.2. Mechanism of Action
  • 8.2. Co-Development Deals
    • 8.2.1. Molecule Type
    • 8.2.2. Mechanism of Action
  • 8.3. First-In-Class Molecules not Involved in Licensing or Co-Development Deals

9. Appendix

  • 9.1. Abbreviations
  • 9.2. References
  • 9.3. References for Heat Map
  • 9.4. Contact Us
  • 9.5. Disclaimer

List of Tables

  • Table 1: TNM Staging, 2010-2013
  • Table 2: US, Disease Stage at Diagnosis and Five-year Relative Survival (%), 2013
  • Table 3: Key Meta-Analyses for Chemotherapy Regimens
  • Table 4: Key Meta-Analyses for Endocrine Therapies
  • Table 5: Key Meta-Analyses for Targeted Therapies
  • Table 6: References for Heat Map (Figure 2)

List of Figures

  • Figure 1: Marketed Product Overview
  • Figure 2: Heat Map for Targeted Therapies
  • Figure 3: Treatment Algorithm for Cancer Diagnosed at Stages I to III
  • Figure 4: Treatment Algorithm for Cancer Diagnosed at Stage IV
  • Figure 5: Developmental Pipeline Overview
  • Figure 6: Developmental Pipeline Molecular Target Categories
  • Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products
  • Figure 8: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
  • Figure 9: First-in-Class Products in the Breast Cancer Pipeline, Part 1
  • Figure 10: First-in-Class Products in the Breast Cancer Pipeline, Part 2
  • Figure 11: Signaling Network, Disease Causation and Innovation Alignment Analysis
  • Figure 12: First-in-Class Molecular Target Analysis Matrix
  • Figure 13: First-in-Class Target Analysis Matrix (Part 2)
  • Figure 14: Data and Evidence for Protein Kinase C Delta as a Therapeutic Target
  • Figure 15: Pipeline Programs Targeting Protein Kinase C Delta
  • Figure 16: Data and Evidence for p53 as a Therapeutic Target
  • Figure 17: Pipeline Programs Targeting p53
  • Figure 18: Data and Evidence for FGFR4 as a Therapeutic Target
  • Figure 19: Pipeline Programs Targeting FGFR4
  • Figure 20: Data and Evidence for Akt as a Therapeutic Target
  • Figure 21: Pipeline Programs Targeting Akt, 2014
  • Figure 22: Data and Evidence for HER3 as a Therapeutic Target
  • Figure 23: Pipeline Programs Targeting HER3
  • Figure 24: Data and Evidence for PI3K as a Therapeutic Target
  • Figure 25: Pipeline Programs Targeting PI3K
  • Figure 26: Data and Evidence for Murine Double Minute 2 as a Therapeutic Target
  • Figure 27: Pipeline Programs Targeting Murine Double Minute 2
  • Figure 28: Data and Evidence for Grb2 as a Therapeutic Target
  • Figure 29: Pipeline Programs Targeting Grb2
  • Figure 30: Data and Evidence for Notch-1 as a Therapeutic Target
  • Figure 31: Pipeline Programs Targeting Notch-1
  • Figure 32: Data and Evidence for Signal Transducer and Activator of Transcription 3 as a Therapeutic Target
  • Figure 33: Pipeline Programs Targeting Signal Transducer and Activator of Transcription 3
  • Figure 34: Data and Evidence for CD44 as a Therapeutic Target
  • Figure 35: Pipeline Programs Targeting CD44
  • Figure 36: Data and Evidence for Protein Phosphatase 2A as a Therapeutic Target
  • Figure 37: Pipeline Programs Targeting Protein Phosphatase 2A
  • Figure 38: Data and Evidence for Heat Shock Protein 90 as a Therapeutic Target
  • Figure 39: Pipeline Programs Targeting Heat Shock Protein 90
  • Figure 40: Data and Evidence for Basigin (CD147) as a Therapeutic Target
  • Figure 41: Pipeline Programs Targeting Basigin (CD147), 2014
  • Figure 42: Data and Evidence for Rho-Associated, Coiled coil-containing Protein Kinase 1 as a Therapeutic Target
  • Figure 43: Pipeline Programs Targeting Rho-Associated, Coiled coil-containing Protein Kinase 1
  • Figure 44: Data and Evidence for Creb as a Therapeutic Target
  • Figure 45: Pipeline Programs Targeting Creb
  • Figure 46: Data and Evidence for Cyclin Dependent Kinase 4/6 as a Therapeutic Target
  • Figure 47: Pipeline Programs Targeting Cyclin Dependent Kinase 4/6
  • Figure 48: Data and Evidence for Integrin αV as a Therapeutic Target
  • Figure 49: Pipeline Programs Targeting Integrin αV
  • Figure 50: Global, Licensing Deals, 2006-2014
  • Figure 51: Network of Licensing Deals, 2006-2014
  • Figure 52: Licensing Deals by Molecule Type, 2006-2014
  • Figure 53: Upfront Payments by Molecule Type, 2006-2014
  • Figure 54: Licensing Deals by Mechanism of Action, 2006-2014
  • Figure 55: Upfront Payments by Mechanism of Action, 2006-2014
  • Figure 56: Licensing Deals, 2006-2014
  • Figure 57: Licensing Deals (Part 2), 2006-2014
  • Figure 58: Co-Development Deals, 2006-2014
  • Figure 59: Network of Co-Development Deals, 2006-2014
  • Figure 60: Co-Development Deals by Molecule Type, 2006-2014
  • Figure 61: Upfront Payments by Molecule Type, 2006-2014
  • Figure 62: Co-Development Deals by Mechanism of Action, 2006-2014
  • Figure 63: Upfront Payments by Mechanism of Action, 2006-2014
  • Figure 64: Co-Development Deals, 2006-2014
  • Figure 65: First-in-Class Programs with no Prior Deal Involvement
  • Figure 66: First-in-Class Programs with no Prior Deal Involvement (Part 2)
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