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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

発行 GBI Research 商品コード 326290
出版日 ページ情報 英文 70 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: 2017年06月01日 ページ情報: 英文 70 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
  • 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
  • 疫学・病因
  • 病態生理学
  • リスク因子と共存症
  • 治療選択肢
  • 治療アルゴリズム
  • 肝臓がん向け市販製品の概要
    • 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
  • ファーストインクラス・パイプラインプログラム

第6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7章 ファーストインクラス標的評価

  • PIK3CA、PIK3CB、PIK3CGを標的にしたパイプラインプログラム
  • プロテインキナーゼCを標的にしたパイプラインプログラム
  • AKT1を標的にしたパイプラインプログラム
  • HER3/ERBB3を標的にしたパイプラインプログラム
  • ROR1を標的にしたパイプラインプログラム
  • PRKACAフュージョンを標的にしたパイプラインプログラム
  • Frizzled 2を標的にしたパイプラインプログラム
  • CDK1およびCDK2を標的にしたパイプラインプログラム
  • PTK2/FAKを標的にしたパイプラインプログラム
  • 結論

第8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9章 付録

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: GBIHC445MR

Executive Summary:

Liver plays various vital roles within the body, including the removal of toxins from the blood, the production of bile to help digest fat and substances to help blood clot, in addition to making, storing and releasing sugar for energy. Primary liver cancer is a cancer that originates in the liver. Several histological subtypes make up liver cancer. The primary subtype is hepatocellular carcinoma (HCC), which accounts for approximately 80-90% of all cases (Nordenstedt et al., 2010). Others include cholangiocarcinoma, hepatoblastoma and hemangiosarcoma (McGlynn and London, 2011). As subtypes other than HCC are significantly less common, a substantial portion of clinical and commercial focus revolves around HCC.

Globally, liver cancer is the sixth most common cancer, but its poor prognosis makes it the second leading cause of cancer-related death (Globocan, 2012). It poses a much greater burden in countries with developing economies than in developed nations such as the US; East Asia and Sub-Saharan Africa are territories of particularly high incidence.

Liver cancer market is segmented in terms of its needs, as early-stage patients have access to curative therapies such as surgical resection, and therefore have a relatively strong outlook. However, at the opposite end of the spectrum patients that are diagnosed in later stages, who represent the majority of the patient population, are not eligible for surgery and have several major needs that are unmet by the current market.

In stark contrast to the relatively limited market landscape, which contains just 86 products, the liver cancer pipeline is large, diverse and highly innovative. The pipeline has 423 products in active development, with diversity of both molecule type and mechanism of action. Of these, 122 are first-in-class, and act on 109 distinct first-in-class molecular targets. These products span a very wide range of molecular target types including cancer immunotherapies, receptor tyrosine kinases, targeted cytotoxic agents and kinase inhibitors, far exceeding the scope of products present in the chemotherapy-dominated market.

The report "Frontier Pharma: Liver Cancer - Identifying and Commercializing First-in-Class Innovation" provides a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.

Specifically, this report provides the following -

  • Visualize the composition of the liver cancer market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed.
  • Analyze the liver cancer pipeline and stratify by stage of development, molecule type and molecular target..
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary molecular target matrix, first-in-class products have been assessed and ranked according to clinical potential.
  • Identify commercial opportunities in the liver cancer deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.

Companies mentioned in this report: Bristol-Myers Squibbs, Novartis

Scope:

  • The 423 products in active development, of which 122 are first-in-class and therefore act on completely novel targets, far exceed the scope of the current market. How will pipeline innovation affect the future liver cancer market?
  • There are 109 distinct first-in-class molecular targets currently being studied. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?
  • The majority of first-in-class products in development are cancer immunotherapies. Which of these are the most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
  • A significant number of first-in-class products have been identified with some prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

Reasons to buy:

  • Understand the current clinical and commercial landscape. The report includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
  • Visualize the composition of the liver cancer 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 market.
  • Analyze the liver cancer pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating liver cancer subtypes such as hepatocellular carcinoma and cholangiocarcinoma.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary molecular target matrix, first-in-class products have been assessed and ranked according to clinical potential.
  • Identify commercial opportunities in the liver cancer deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.

Table of Contents

1. Table of Contents

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

2. Executive Summary

  • 2.1. High Unmet Need and a Limited Number of Marketed Options
  • 2.2. Large, Diverse and Highly Innovative Pipeline
  • 2.3. Active Deals Landscape Reflects the Dynamic Pipeline

3. The Case for Innovation

  • 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
  • 4.2. Symptoms
  • 4.3. Diagnosis
    • 4.3.1. Clinical Presentation
    • 4.3.2. Alpha-Fetoprotein
    • 4.3.3. Diagnostic Imaging and Scans
    • 4.3.4. Screening
    • 4.3.5. Biopsy
    • 4.3.6. Staging, Classification and Prognosis
  • 4.4. Epidemiology and Etiology
  • 4.5. Pathophysiology
  • 4.6. Risk Factors and Co-Morbidities
  • 4.7. Treatment Options
  • 4.8. Treatment Algorithm
  • 4.9. Overview of Marketed Products for Liver Cancer
    • 4.9.1. Innovative Products in the Liver Cancer Market
    • 4.9.2. Unmet Needs

5. Assessment of Pipeline Product Innovation

  • 5.1. Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
  • 5.2. Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family
  • 5.3. 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 Targeting PIK3CA, PIK3CB and PIK3CG
  • 7.2. Pipeline Programs Targeting Protein Kinase C Delta
  • 7.3. Pipeline Programs Targeting AKT1
  • 7.4. Pipeline Programs Targeting HER3/ERBB3
  • 7.5. Pipeline Programs Targeting ROR1
  • 7.6. Pipeline Programs Targeting PRKACA fusions
  • 7.7. Pipeline Programs Targeting Frizzled 2
  • 7.8. Pipeline Programs Targeting CDK1 and 2
  • 7.9. Pipeline Programs Targeting PTK2/FAK
  • 7.10. Conclusion

8. Deals and Strategic Consolidations

  • 8.1. Industry-Wide First-in-Class Deals
  • 8.2. Liver Cancer Deals Landscape
  • 8.3. Licensing Deals
    • 8.3.1. Molecule Type
    • 8.3.2. Molecular Target
  • 8.4. Co-development Deals
    • 8.4.1. Molecule Type
    • 8.4.2. Molecular Target
  • 8.5. First-in-Class Programs Not Involved in Licensing or Co-development Deals

9. Appendix

  • 9.1. Abbreviations
  • 9.2. References
  • 9.3. Research Methodology
  • 9.4. Secondary Research
    • 9.4.1. Market Analysis
    • 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: Symptoms of Liver Cancer
  • Table 2: Tumor, Regional Lymph Node and Metastasis Staging
  • Table 3: Risk Factors and Comorbidities for Liver Cancer
  • Table 4: Liver Cancer, Key Features and Pipeline Activity of PIK3CA/PIK3CB/PIK3CG
  • Table 5: Liver Cancer Key Features and Pipeline Activity of PRCKD
  • Table 6: Liver Cancer, Key Features and Pipeline Activity of AKT1
  • Table 7: Liver Cancer, Key Features and Pipeline Activity of HER3
  • Table 8: Liver Cancer, Key Features and Pipeline Activity of ROR1
  • Table 9: Liver Cancer, Key Features and Pipeline Activity of PRKACA Fusions
  • Table 10: Liver Cancer, Key Features and Pipeline Activity of FZD2
  • Table 11: Liver Cancer, Key Features and Pipeline Activity of CDK1/2
  • Table 12: Liver Cancer, Key Features and Pipeline Activity of PTK2/FAK

List of Figures

  • Figure 1: Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2015
  • Figure 2: Sales Performance After Marketing Approval of First-in-Class and Non-First-in-Class Products, 2006-2013 ($m)
  • Figure 3: Liver Cancer, Marketed Product Overview, 2017
  • Figure 4: Liver Cancer, Pipeline Products by Therapy Area, 2017
  • Figure 5: Liver Cancer, Developmental Pipeline Overview, 2017
  • Figure 6: Liver Cancer, Developmental Pipeline Overview, 2017
  • Figure 7: Liver Cancer, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017
  • Figure 8: Liver Cancer Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2017
  • Figure 9: Liver Cancer Drug Market, Global, Distribution of First-in-Class Products in Pipeline by Molecular Target (%), 2017
  • Figure 10: Liver Cancer, Products in the Pipeline (Part 1), 2017
  • Figure 11: Liver Cancer, Products in the Pipeline Part 2, 2017
  • Figure 12: Liver Cancer, Products in the Pipeline Part 3, 2017
  • Figure 13: Liver Cancer, Products in the Pipeline Part 4, 2017
  • Figure 14: Liver Cancer, Products in the Pipeline Part 5, 2017
  • Figure 15: Liver Cancer, Products in the Pipeline Part 6, 2017
  • Figure 16: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 1 2017
  • Figure 17: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 2 2017
  • Figure 18: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 3 2017
  • Figure 19: Liver Cancer, PIK3CA/PIK3CB/PIK3CG Targeting Products, 2017
  • Figure 20: Liver Cancer, PRKCD Targeting Products
  • Figure 21: Liver Cancer, AKT1 Targeting Products, 2017
  • Figure 22: Liver Cancer, HER3 Targeting Products, 2017
  • Figure 23: Liver Cancer, ROR1 Targeting Products, 2017
  • Figure 24: Liver Cancer, PRKACA Fusion Targeting Products, 2017
  • Figure 25: Liver Cancer, FZD2 Targeting Products, 2017
  • Figure 26: Liver Cancer, CDK1/2 Targeting Products, 2017
  • Figure 27: Liver Cancer, PTK2/FAK Targeting Products, 2017
  • Figure 28: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014
  • Figure 29: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014
  • Figure 30: Liver Cancer, Global, Licensing Deals by Region and Value, 2006-Q1 2017
  • Figure 31: Liver Cancer, Global, Licensing Deals by Stage and Value, 2006-Q1 2017
  • Figure 32: Liver Cancer, Licensing Deals by Molecular Type, 2006-Q1 2017
  • Figure 33: Liver Cancer, Licensing Deals by Molecular Target, 2006-Q1 2017
  • Figure 34: Liver Cancer, Licensing Deals with Disclosed Values, 2006-Q1 2017
  • Figure 35: Liver Cancer Drug Market, Global, Co-development Deals by Region, Value and Year, 2006-Q1 2017
  • Figure 36: Liver Cancer, Co-development Deals by Stage and Value, 2006-Q1 2017
  • Figure 37: Liver Cancer, Co-development Deals by Molecule Type, 2006-Q1 2017
  • Figure 38: Liver Cancer, Co-development Deals by Molecular Target, 2006-Q1 2017
  • Figure 39: Liver Cancer, Co-development Deals with Disclosed Values, 2006-Q1 2017
  • Figure 40: Liver Cancer Market, Global, Pipeline Programs in Active Development Involved in Previous Deals, 2017
  • Figure 41: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 1)
  • Figure 42: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 2)
  • Figure 43: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 3)
  • Figure 44: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 4)
  • Figure 45: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 5)
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