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市場調査レポート

肝臓がん:ファーストインクラス革新の識別・商業化

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

発行 GBI Research 商品コード 326290
出版日 ページ情報 英文 80 Pages
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肝臓がん:ファーストインクラス革新の識別・商業化 Frontier Pharma: Liver Cancer - Identifying and Commercializing First-in-Class Innovation
出版日: 2014年12月31日 ページ情報: 英文 80 Pages
概要

当レポートでは、肝臓がんにおけるファーストインクラス革新について調査し、症状、疫学、および薬物療法・治療アルゴリズムも含めた肝臓がんの概説、変化する分子標的情勢とパイプラインにおける特定の革新ポイント、開発段階、分子タイプおよび分子標的の分析によるファーストインクラス治療向けパイプラインの包括的レビュー、肝臓がんにおける特許動向・対応特許の分析、ファーストインクラス分子標的の特定と評価、および各種契約動向などをまとめ、お届けいたします。

第1章 目次

第2章 エグゼクティブサマリー

第3章 革新事例

  • 拡大する生物学的製剤の機会
  • 分子標的の多様化
  • 革新的ファーストインクラス製品の開発は依然として魅力的
  • 規制・医療費償還政策はファーストインクラス製品革新へ有利に働くよう変化
  • 革新の持続
  • GBI Research の調査ガイダンス

第4章 臨床・商業情勢

  • 疾病の概要
  • 症状
  • 疫学・病因
  • 病態生理学
    • 肝細胞がん
    • 胆管がん
    • 結論
  • 診断
    • 臨床所見
    • アルファフェトプロテイン (AFP)
    • 診断画像・スキャン
    • スクリーニング
    • 生検
    • 分類
  • 治療選択肢
  • 治療アルゴリズム
    • ファーストライン
  • 肝臓がん向け市販製品の概要
    • 分子タイプ・標的の分析
    • 肝臓がん市場における革新的製品
    • アンメットニーズ

第5章 パイプライン製品革新の評価

  • 肝臓がんパイプライン:分子タイプ、フェーズ、および治療標的別
  • 肝臓がんとパイプライン間のプログラム配分比較:対応治療標的別
  • 新規の分子標的をターゲットにしたファーストインクラスパイプラインプログラム

第6章 肝臓がん対応特許の分析

第7章 シグナル伝達ネットワーク、病気の原因、および革新の調整

  • がんにおけるシグナル伝達ネットワークの複雑さ
  • 突然変異を引き起こすシグナル経路疾患およびファーストインクラス分子標的の統合
  • ファーストインクラス標的のマトリクス評価

第8章 ファーストインクラス標的評価

  • ベータカテニンを標的にしたパイプラインプログラム
  • FGFR4 を標的にしたパイプラインプログラム
  • GPR55 を標的にしたパイプラインプログラム
  • タンパク質ジスルフィドイソメラーゼ (PDI) を標的にしたパイプラインプログラム
  • テロメラーゼを標的にしたパイプラインプログラム
  • デルタ様1ホモログ (DLK1) を標的にしたパイプラインプログラム
  • eIF5A を標的にしたパイプラインプログラム
  • FAK を標的にしたパイプラインプログラム
  • TGFベータ受容体を標的にしたパイプラインプログラム
  • 結論

第9章 契約・戦略的統合

  • 産業規模のファーストインクラス契約
  • 肝臓がんの契約情勢
  • ライセンシング契約
  • 競合開発契約
  • ライセンシングまたは共同開発契約に含まれていないファーストインクラスプログラム

第10章 付録

図表

目次

Executive Summary

Large and Diverse Pipeline

The liver cancer pipeline contains 238 products in active development, approximately 47% of which are first-in-class. The percentage of the pipeline devoted to innovative products is considerably larger than both the industry and oncology average, which is a promising sign for novel therapeutics reaching the liver cancer market.

The contrast between the market and pipeline is vast. Analysis showed that the market contains 70 products, the majority of which are generic formulations of chemotherapies that are not frequently used in treatment, particularly in advanced-stage patients. Nexavar (sorafenib) is the dominant therapeutic on the market, and is also the only targeted therapy that is in regular use for advanced-stage liver cancer patients. However, pipeline analysis revealed that targeted therapies aimed at the underlying oncogenic signaling pathways are under much greater focus in the pipeline than in the market. The success of targeted therapies across the oncology market as a whole implies that the diversity and innovation in the pipeline is a promising sign, with products currently in development having the potential to transform and improve the relatively open liver cancer market.

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

The liver cancer pipeline is showing signs of adapting to the increasing understanding of aberrant signaling pathways and causes of liver cancer. A large portion of pipeline products target components of known dysfunctional signaling pathways, such as Wnt/ß-catenin signaling, which is commonly mutated in liver cancer tumor samples. By aligning the treatment with specific disease-causing features, the damaging off-target cytotoxic effects of treatment can be reduced, resulting in safer and more efficacious therapies.

GBI Research's analysis identified substantial variation in the alignment of first-in-class products to underlying dysfunctional signaling at protein and genetic level. The first-in-class products were compared in an in-depth analysis using various parameters to measure the potential of each target, with the most promising targets being further substantiated by published clinical and scientific evidence. Results of the analysis suggested that first-in-class status is not a feature that, in its own right, will create a successful product. However, there are a large number of first-in-class products backed by clinical and Preclinical data that are exciting future prospects for the liver cancer market.

Analysis of Patent Data

The report features an analysis of granted patent applications in the liver cancer market, which was used as an indication of innovation at the earliest stage of product development. Patent analysis provides an insight into the pre-developmental landscape, and identifies long-term future trends within a disease market. In liver cancer, the trend in patent applications in terms of predominant molecular targets reflects the pipeline landscape, suggesting that liver cancer therapeutics will continue to target key oncogenic signaling pathways in the long term.

The frequency at which companies apply for patents within the market helps to identify companies that are trying to establish themselves or increase their liver cancer market share. This information identifies not only potential competitors, but also companies that may seek strategic partnerships to enter drug development.

First-in-Class Products in Licensing and Co-Development Deals

The deals landscape for liver cancer has been relatively active in recent years, with 62 licensing deals and 23 co-development deals between 2006 and 2014. However, the number pertaining to first-in-class products is very low.

A comparative analysis of the deals revealed that first-in-class products have the potential to command substantially higher deal values than non-first-in-class products, which is a reflection of their market potential and importance. A total of 68 first-in-class products that are currently in development have not yet been entered into a licensing or co-development deal. In a transforming market that will favor innovative, targeted therapies with a strong clinical record, there are numerous opportunities for strategic alliances to bolster a first-in-class portfolio or fund clinical development. Although not all are aligned to disease-causing signaling pathways, many are supported by robust scientific and clinical data, making them attractive prospects as both therapeutics and investment opportunities.

Scope

The report includes -

  • A brief introduction to liver cancer, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
  • Coverage of the changing molecular target landscape and particular points of innovation in the pipeline
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed by stage of development, molecule type and molecular target
  • Analysis of patent trends and patent families in liver cancer
  • 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 of novel molecular targets
  • Industry-wide analysis of first-in-class deals compared to non-first-in-class deals
  • An assessment of the licensing and co-development deal landscape for liver cancer therapies, and benchmarking of deals comparing first-in-class and non-first-in-class-products

Reasons to buy

  • The report will enable business development and enable marketing executives to strategize their product launches by allowing them to -
  • Understand the focal shifts in molecular targets in the liver cancer pipeline
  • Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Understand the patent trends in liver cancer and what this means for long-term innovation
  • Access a scientific and clinical analysis of first-in-class developmental programs for liver cancer, benchmarked against non-first-in-class targets
  • Assess the valuations of licensed and co-developed liver cancer treatments
  • Access a list of the first-in-class therapies potentially open to deal-making opportunities

Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 3
  • 1.2 List of Figures 3

2 Executive Summary 4

  • 2.1 Unmet Needs and Limited Market Drive an Innovative Pipeline 4
  • 2.2 Targeted Therapies Segment to Expand over the Coming Decade 4
  • 2.3 Active Deals Landscape Reflects the Dynamic Pipeline 4

3 The Case for Innovation 5

  • 3.1 Growing Opportunities for Biologic Products 6
  • 3.2 Diversification of Molecular Targets 6
  • 3.3 Innovative First-in-class Product Developments Remain Attractive 6
  • 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
  • 3.5 Sustained Innovation 7
  • 3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9

  • 4.1 Disease Overview 9
  • 4.2 Symptoms 9
  • 4.3 Epidemiology and Etiology 9
  • 4.4 Pathophysiology 10
    • 4.4.1 Hepatocellular Carcinoma 11
    • 4.4.2 Cholangiocarcinoma 13
    • 4.4.3 Conclusion 14
  • 4.5 Diagnosis 14
    • 4.5.1 Clinical Presentation 14
    • 4.5.2 Alpha-Fetoprotein 14
    • 4.5.3 Diagnostic Imaging and Scans 14
    • 4.5.4 Screening 15
    • 4.5.5 Biopsy 15
    • 4.5.6 Classification 15
  • 4.6 Treatment Options 15
  • 4.7 Treatment Algorithm 15
    • 4.7.1 First Line 16
  • 4.8 Overview of Marketed Products for Liver Cancer 17
    • 4.8.1 Molecular Type and Target Analysis 17
    • 4.8.2 Innovative Products in the Liver Cancer Market 18
    • 4.8.3 Unmet Needs 19

5 Assessment of Pipeline Product Innovation 20

  • 5.1 Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target 20
  • 5.2 Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family 24
  • 5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 25

6 Liver Cancer Patent Family Analysis 29

7 Signaling Network, Disease Causation and Innovation Alignment 38

  • 7.1 The Complexity of Signaling Networks in Oncology 38
  • 7.2 Signaling Pathways Disease-Causing Mutations and First-in-Class Molecular Target Integration 39
  • 7.3 First-in-Class Target Matrix Assessment 42

8 First-in-Class Target Evaluation 48

  • 8.1 Pipeline Programs Targeting β-Catenin 48
  • 8.2 Pipeline Programs Targeting FGFR4 50
  • 8.3 Pipeline Programs Targeting GPR55 51
  • 8.4 Pipeline Programs Targeting Protein Disulfide Isomerase 53
  • 8.5 Pipeline Programs Targeting Telomerase 54
  • 8.6 Pipeline Programs Targeting Delta-Like 1 Homolog 56
  • 8.7 Pipeline Programs Targeting eIF5A 57
  • 8.8 Pipeline Programs Targeting FAK 59
  • 8.9 Pipeline Programs Targeting TGFβ Receptor 61
  • 8.10 Conclusion 63

9 Deals and Strategic Consolidations 64

  • 9.1 Industry-wide First-in-Class Deals 64
  • 9.2 Liver Cancer Deals Landscape 66
  • 9.3 Licensing Deals 66
    • 9.3.1 Molecule Types 69
    • 9.3.2 Mechanism of Action 70
  • 9.4 Co-Development Deals 71
    • 9.4.1 Molecule Types 73
    • 9.4.2 Mechanism of Action 74
  • 9.5 First-In-Class Programs Not Involved in Licensing or Co-Development Deals 74

10 Appendix 77

  • 10.1 References 77
  • 10.2 Abbreviations 79
  • 10.3 Contact Us 80
  • 10.4 Disclaimer 80

List of Tables

  • Table 1: Liver Cancer, Organizations Frequently Applying for Chemical Entity Patent Families, (2008-2012) 30

List of Figures

  • Figure 1: Innovation Trends in Product Approvals 5
  • Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval 7
  • Figure 3: Overview of Marketed Products 18
  • Figure 4: Overview of Pipeline Products 21
  • Figure 5: Breakdown of Pipeline Molecular Targets 23
  • Figure 6: Pipeline Molecular Targets by Stage of Development 24
  • Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products 25
  • Figure 8: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 26
  • Figure 9: List of First-in-Class Pipeline Products (Part 1) 27
  • Figure 10: List of First-in-Class Pipeline Products (Part 2) 28
  • Figure 11: Liver Cancer, US and EU, Patent Families Filed and Granted by Year, 2008-2012 29
  • Figure 12: Liver Cancer, US and EU, Granted Patent Families by Molecular Target, 2008-2012 31
  • Figure 13: Liver Cancer, US and EU, Granted Patent Families by Molecular Target Family, 2008-2012 32
  • Figure 14: Liver Cancer, US and EU, Molecular Targets Identified in Patents (Part 1), 2008-2012 34
  • Figure 15: Liver Cancer, US and EU, Molecular Targets Identified in Patents (Part 2), 2008-2012 35
  • Figure 16: Liver Cancer, US and EU, Molecular Targets Identified in Patents (Part 3), 2008-2012 36
  • Figure 17: Signaling Networks of Functional Families in Liver Cancer 41
  • Figure 18: Target Matrix Assessment (Part 1) 43
  • Figure 19: Target Matrix Assessment (Part 2) 44
  • Figure 20: Target Matrix Assessment (Part 3) 45
  • Figure 21: Target Matrix Assessment (Part 4) 46
  • Figure 22: Target Matrix Assessment (Part 5) 47
  • Figure 23: Data and Evidence for β-Catenin as a Therapeutic Target 49
  • Figure 24: Pipeline Products Targeting β-Catenin 50
  • Figure 25: Data and Evidence for FGFR4 as a Therapeutic Target 51
  • Figure 26: Pipeline Products Targeting FGFR4 51
  • Figure 27: Data and Evidence for GPR55 as a Therapeutic Target 52
  • Figure 28: Pipeline Products Targeting GPR55 53
  • Figure 29: Data and Evidence for PDI as a Therapeutic Target 54
  • Figure 30: Pipeline Products Targeting PDI 54
  • Figure 31: Data and Evidence for Telomerase as a Therapeutic Target 55
  • Figure 32: Pipeline Products Targeting Telomerase 55
  • Figure 33: Data and Evidence for DLK1 as a Therapeutic Target 57
  • Figure 34: Pipeline Products Targeting DLK1 57
  • Figure 35: Data and Evidence for eIF5A as a Therapeutic Target 58
  • Figure 36: Pipeline Products Targeting eIF5A 58
  • Figure 37: Data and Evidence for FAK as a Therapeutic Target 60
  • Figure 38: Pipeline Products Targeting FAK 60
  • Figure 39: Data and Evidence for TGFβR1 as a Therapeutic Target 62
  • Figure 40: Pipeline Products Targeting TGFβR1 62
  • Figure 41: Industry Wide Deals by Stage of Development, 2006-2014 64
  • Figure 42: Industry Licensing Deal Values by Stage of Development, 2006-2014 65
  • Figure 43: Licensing Agreements, 2006-2014 67
  • Figure 44: Licensing Agreements by Phase, 2006-2014 68
  • Figure 45: Licensing Agreements by Territory, 2006-2014 69
  • Figure 46: Licensing Agreements by Molecule Type, 2006-2014 70
  • Figure 47: Licensing Agreements by Molecular Target, 2006-2014 71
  • Figure 48: Co-development Agreements, 2006-2014 72
  • Figure 49: Co-development Agreements by Territory, 2006-2014 73
  • Figure 50: Co-development Agreements by Molecule Type, 2006-2014 73
  • Figure 51: Co-development Agreements by Molecular Target, 2006-2014 74
  • Figure 52: List of First-in-Class Pipeline Products Not Involved in Deals (Part 1) 75
  • Figure 53: List of First-in-Class Pipeline Products Not Involved in Deals (Part 2) 76
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