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市場調查報告書

Frontier Pharma:前列腺癌症 - First-in-Class的革新認識和商業化

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

出版商 GBI Research 商品編碼 321539
出版日期 內容資訊 英文 91 Pages
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Frontier Pharma:前列腺癌症 - First-in-Class的革新認識和商業化 Frontier Pharma: Prostate Cancer - Identifying and Commercializing First-in-Class Innovation
出版日期: 2014年11月30日 內容資訊: 英文 91 Pages
簡介

前列腺癌症的開發平台,有484種產品正在開發,在製藥產業中最大。使用的作用機制範圍,與現有的市場形勢也比較的話,非常富有多樣性。

本報告提供前列腺癌症治療藥市場相關調查分析、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(技術創新)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
    • 流行病學
    • 病因
    • 疾病的症狀
    • 疾病的病理生理學
    • 疾病的症狀
    • 疾病的分期與診斷
    • 治療
  • 上市產品概要
    • 荷爾蒙療法
    • 化療
    • 治療疫苗
    • 標靶治療(第二世代抗雄激素)
    • 骨轉移的治療

第5章 開發中產品革新的評估

  • 前列腺癌症開發平台:各分子類型、階段、治療標靶
  • 前列腺癌症市場與開發平台計劃比較分佈:各治療標靶
  • 新分子標靶的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

  • 腫瘤學的信號傳達網路的複雜
  • 信號傳達途徑,成為疾病原因的變異,First-in-Class分子標靶整合
  • First-in-Class標靶矩陣的評估

第7章 First-in-Class標靶評估

  • MDM2
  • AKT1
  • p53
  • MAPK
  • 特異性蛋白質1
  • XIAP
  • HIF-1
  • GALECTIN-3
  • 攝護腺特異性抗原
  • 極光激酶

第8章 交易與策略性整合

  • 產業整體的First-in-Class交易
  • 許可交易
  • 共同開發交易
  • 不涉及許可/共同開發的First-in-Class計劃

第9章 附錄

圖表

目錄

Summary

Exceptionally Large and Innovative Pipeline

The prostate cancer pipeline is among the largest in the pharmaceutical industry with 484 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 174 first-in-class programs in the prostate cancer pipeline, acting on 122 first-in-class molecular targets. This accounts for some 36% 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 prostate 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 prostate 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 strongly associated with disease progression. 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 Deals Landscape with Numerous Investment Opportunities

Analysis has confirmed that 169 of the 174 first-in-class products have not been involved in a licensing or co-development deal. Although many act on targets that are not yet strongly substantiated in terms of their therapeutic potential in prostate cancer in clinical studies, there are many which are supported by promising in vivo and in vitro preclinical evidence, and as such are highly promising prostate cancer therapies. Indeed, breakthrough innovations are highly desirable as an investment option.

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.

Scope

The report analyzes innovation in prostate 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 prostate cancer, and pinpoints opportunities for in-licensing. The report covers and includes -

  • A brief introduction to prostate 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 prostate 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 prostate 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 prostate cancer, 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. Active Pipeline Reflects Large Market with Significant Unmet Needs
  • 2.2. Market Landscape to Grow in Diversity over Coming Decade
  • 2.3. Deals Landscape Presents Significant Investment Opportunities for First-in-Class Products

3. The Case for Innovation in Prostate Cancer

  • 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. 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. Disease Staging and Diagnosis
    • 4.1.6. Treatment
  • 4.2. Overview of Marketed Products
    • 4.2.1. Hormonal Therapies
    • 4.2.2. Chemotherapy
    • 4.2.3. Therapeutic Vaccines
    • 4.2.4. Targeted Therapies (Second Generation Anti-androgens)
    • 4.2.5. Bone Metastasis Treatments

5. Assessment of Pipeline Product Innovation

  • 5.1. Prostate Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
  • 5.2. Comparative Distribution of Programs between the Prostate Cancer 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 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 and Pipeline Program Evaluation

  • 7.1. Pipeline Programs Targeting Human Double Minute 2
    • 7.1.1. Overview of Pipeline Programs Targeting MDM2
  • 7.2. Pipeline Programs Targeting AKT1
    • 7.2.1. Overview of Pipeline Programs Targeting AKT1
  • 7.3. Pipeline Programs Targeting Tumor Protein p53
    • 7.3.1. Overview of Pipeline Programs Targeting p53
  • 7.4. Pipeline Programs Targeting Mitogen-Activated Protein Kinase
    • 7.4.1. Overview of Pipeline Programs Targeting MAPK
  • 7.5. Pipeline Programs Targeting Specificity Protein 1
    • 7.5.1. Overview of Pipeline Programs Targeting Specificity Protein 1
  • 7.6. Pipeline Programs Targeting X-linked Inhibitor of Apoptosis Protein
    • 7.6.1. Overview of Pipeline Programs Targeting X-linked Inhibitor of Apoptosis Protein
  • 7.7. Pipeline Programs Targeting Hypoxia-Inducible Factor 1
    • 7.7.1. Overview of Pipeline Programs Targeting Hypoxia-Inducible Factor 1
  • 7.8. Pipeline Programs Targeting Galectin-3
    • 7.8.1. Overview of Pipeline Programs Targeting Galectin-3
  • 7.9. Pipeline Programs Targeting Prostate Specific Membrane Antigen
    • 7.9.1. Overview of Pipeline Programs Targeting Prostate Specific Membrane Antigen
  • 7.10. Pipeline Programs Targeting Aurora Kinase
    • 7.10.1. Overview of Pipeline Programs Targeting Aurora Kinase
  • 7.11. Conclusion

8. Deals and Strategic Consolidations

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

9. Appendix

  • 9.1. References
  • 9.2. Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration Tables
  • 9.3. Abbreviations
  • 9.4. Expert Panel Validation
  • 9.5. Contact Us
  • 9.6. Disclaimer

List of Tables

  • Table 1: Prostate Cancer Risk Factors
  • Table 2: Prostate Cancer, Disease Stage Classification

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: Percentage of Men Diagnosed with Prostate Cancer in the US by Age (%), 2005-2009
  • Figure 4: Average Number of New Cases and Age-Specific Incidence Rates per 100,000 Population in the UK, 2008-2010
  • Figure 5: Prostate Cancer Treatment Algorithm (Stages I and II)
  • Figure 6: Prostate Cancer Treatment Algorithm (Stages III)
  • Figure 7: Prostate Cancer Treatment Algorithm (Stages IV)
  • Figure 8: Global Pipeline Overview
  • Figure 9: Molecular Target Classes of Pipeline Products
  • Figure 10 : Prostate Cancer, Molecular Targets
  • Figure 11: Molecular Target Category Comparison, Pipeline and Marketed Products
  • Figure 12: First-in-Class and Non-First-in-Class Pipeline Product Comparison
  • Figure 13: Prostate Cancer, First-in-Class Products in the Prostate Cancer Pipeline, Part 1
  • Figure 14: Prostate Cancer, First-in-Class Products in the Prostate Cancer Pipeline, Part 2
  • Figure 15: Prostate Cancer, First-in-Class Products in the Prostate Cancer Pipeline, Part 3
  • Figure 16: Prostate Cancer, First-in-Class Products in the Prostate Cancer Pipeline, Part 4
  • Figure 17: Signaling Networks of Functional Families in Prostate Cancer
  • Figure 18: First-in-Class Molecular Target Analysis Matrix (Part 1)
  • Figure 19: First-in-Class Molecular Target Analysis Matrix (Part 2)
  • Figure 20: First-in-Class Molecular Target Analysis Matrix (Part 3)
  • Figure 21: MDM2 as a Therapeutic Target
  • Figure 22: Pipeline Programs Targeting MDM2
  • Figure 23: AKT as a Therapeutic Target
  • Figure 24: Pipeline Programs Targeting AKT1
  • Figure 25: TP53 as a Therapeutic Target
  • Figure 26: Pipeline Programs Targeting p53
  • Figure 27: MAPK8 as a Therapeutic Target
  • Figure 28: Pipeline Programs Targeting MAPK
  • Figure 29: Sp1 as a Therapeutic Target
  • Figure 30: Pipeline Programs Targeting Specificity Protein 1
  • Figure 31: XIAP as a Therapeutic Target
  • Figure 32: Pipeline Programs Targeting X-linked Inhibitor or Apoptosis Protein
  • Figure 33: HIF1A as a Therapeutic Target
  • Figure 34: Pipeline Programs Targeting Hypoxia-Inducible Factor 1
  • Figure 35: Galectin-3 as a Therapeutic Target
  • Figure 36: Pipeline Programs Targeting Galectin-3
  • Figure 37: PSMA as a Therapeutic Target
  • Figure 38: Pipeline Programs Targeting PSMA
  • Figure 39: Aurora Kinase as a Therapeutic Target
  • Figure 40: Pipeline Programs Targeting Aurora Kinase
  • Figure 41: Industry-wide Deals by Stage of Development, 2006-2014
  • Figure 42: Industry-wide Deals by Stage of Development, 2006-2014
  • Figure 43: Licensing Deals by Region, 2006-2014
  • Figure 44: Licensing Deals, 2006-2014
  • Figure 45: First-in-Class and Non-First-in-Class Comparison, 2006-2014
  • Figure 46: Market for Prostate Cancer, Global, Licensing Deals by Mechanism of Action, 2006-2014
  • Figure 47: Co-development Deals by Region, 2006-2014
  • Figure 48: Co-development Deals, 2006-2014
  • Figure 49: Co-developments by Mechanism of Action, 2006-2014
  • Figure 50: First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2014 (Part 1)
  • Figure 51: First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2014 (Part 2)
  • Figure 52: First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2014 (Part 3)
  • Figure 53: Signaling Networks of Functional Families in Prostate Cancer, Table 1
  • Figure 54: Signaling Networks of Functional Families in Prostate Cancer, Table 2
  • Figure 55: Signaling Networks of Functional Families in Prostate Cancer, Table 3
  • Figure 56: Signaling Networks of Functional Families in Prostate Cancer, Table 4
  • Figure 57: Signaling Networks of Functional Families in Prostate Cancer, Table 5
  • Figure 58: Signaling Networks of Functional Families in Prostate Cancer, Table 6
  • Figure 59: Signaling Networks of Functional Families in Prostate Cancer, Table 7
  • Figure 60: Signaling Networks of Functional Families in Prostate Cancer, Table 8
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