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乳癌ワクチンの世界市場と臨床パイプラインの将来展望

Global Breast Cancer Vaccine Market & Clinical Pipeline Outlook 2022

発行 KuicK Research 商品コード 408668
出版日 ページ情報 英文 190 Pages
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乳癌ワクチンの世界市場と臨床パイプラインの将来展望 Global Breast Cancer Vaccine Market & Clinical Pipeline Outlook 2022
出版日: 2016年12月14日 ページ情報: 英文 190 Pages
概要

当レポートでは、世界各国における乳癌ワクチンのパイプライン製品の開発・治験状況について分析し、乳癌ワクチンの作用機序や、患者数の動向見通し、現在までの治験シナリオと今後の見通し、治験の主な促進・抑制要因、主要なパイプライン製品の現在の治験状況、各段階における克服すべき課題、企業別の動向見通しなどについて調査・考察しております。

第1章 癌ワクチンとは何か?

第2章 癌ワクチンの作用機序

  • イディオタイプ癌ワクチンの作用機序
  • 細胞系癌ワクチンの作用機序
  • ガングリオシド抗原ベースの癌ワクチンの作用機序
  • ペプチド癌ワクチンの作用機序
  • 腫瘍宿主関係癌ワクチンの作用機序

第3章 乳癌ワクチンの作用機序

  • 免疫系を引き出すための基本戦略
    • 免疫抑制の克服
    • 免疫のチョークポイントの調整
  • 免疫原性と治療薬への反応
  • 乳癌治療用ワクチン

第4章 世界の乳癌発症件数

  • 米国
  • 欧州
  • アジア
  • 他の国々 (RoW)

第5章 世界の乳癌ワクチン市場:現在のシナリオ

  • まだ未開拓の市場機会
  • 世界の乳癌ワクチン:パイプラインの概要

第6章 個別化乳癌ワクチンのニーズ

第7章 世界の乳癌ワクチン市場のダイナミクス

  • 良好な市場指標
  • 実用化に際しての課題

第8章 世界の乳癌ワクチン市場の将来展望

第9章 乳癌ワクチンの開発・販売に関する、FDAのガイドライン

  • 治験の初期・後期段階における考慮事項
    • 患者人口
    • 免疫反応のモニタリング
    • 効能のエビデンスとしてのバイオマーカー
    • 免疫反応の刺激に使われるアジュバント
    • 多抗原ワクチン
    • 癌ワクチンの投与、即時または短期間で生じる病状進行・再発
    • 併用療法・付随療法
  • 治験の初期段階における考慮事項
    • 投与開始および投与スケジュール
    • 加速・維持療法
    • 投与回数の増加
    • 初期段階における、単一群/ランダム型の第II相治験
  • 治験の後期段階における考慮事項
    • 治験の初期段階の安全性プロファイル
    • エンドポイント
    • 統計上の問題
    • 管理上の課題
    • 遅効性のワクチン硬化
    • 自家製ワクチンの治験
    • 認証規制の加速化

第10章 世界の乳癌ワクチンの治験パイプライン:企業別・相 (フェーズ) 別

  • 前臨床
  • 第I相
  • 第I/II相
  • 第II相
  • 第II/III相
  • 第III相

第11章 乳癌ワクチンの中断・延期された治験パイプライン:企業別・相別

  • 延期
  • 報告なし
  • 中断

第12章 競争環境

  • Advaxis
  • AlphaVax
  • AVAX Technologies
  • Dendreon Corporation
  • Galena Biopharma
  • Generex Biotechnology
  • GlaxoSmithKline
  • Immune Design
  • Imugene
  • Immunovative Therapies
  • Immunovaccine
  • Inovio Pharmaceuticals
  • Merck
  • NewLink Genetics
  • Recombio
  • TapImmune
  • ViroMed

図表一覧

目次

“Global Breast Cancer Vaccine Market & Clinical Pipeline Outlook 2022” report analyzes ongoing clinical and non-clinical trends in the global breast cancer vaccine development market. Currently there is no single breast cancer vaccine commercially available in the market. This report analyzes the ongoing clinical trial of 36 breast cancer vaccines in clinical pipeline and gives comprehensive clinical insight on various parameters associated with the development of the vaccine. Most of the breast cancer vaccines in clinical trials are in preclinical phase followed by Phase-I trials. The advance stage of development of breast cancer vaccine in clinical trials across the globe is in Phase-III.

The conventional cancer treatment methods have proved their importance in last decade. They are widely accepted among patients and physicians (oncologists) because of familiarity and large amount of statistically significant data supporting their efficacy. Despite their benefits, they sometimes fall short in meeting the patient's personal requirements. For instance, efficacy is a major requirement, but different patients display different response to the same medication, this is attributed to their unique genetic makeup. To meet the individual's necessities, high efficacy and safety, concept of cancer vaccine was formulated.

The best part with cancer vaccines is that they are capable of inducing “memory effect” in the immune cells. As a result, even in the absence of cancer vaccine molecule in the body, immune cells maintain their ability to search and destroy cancer cells. These memory effects are engraved on lymphocytes which keep on producing antigen long after the introduction of the initiator molecule. Pharmaceuticals companies are investing heavily in R&D segment to discover more properties of cancer vaccines. The benefits offered by cancer vaccine have poised the market to increase several folds.

At present the breast cancer vaccines are in emerging stages and this market has yet to be tapped by pharmaceutical companies. They are diverging funds towards research and development segment for advances in innovative breast cancer vaccines which will generate large amount of revenues. In recent years significant progress has been made on technological and scientific levels but still no vaccine for the treatment of breast cancer has seen market introduction in any part of the globe.

The present therapeutics available in market for breast cancer shows modest results in majority of patients which offers unexplored marketing opportunities for better innovative products to enter in competition. It is expected that more oncologists will prescribe the innovative breast cancer vaccines to their patients due to greater therapeutic effects. The higher rates of prescription would lead to high degree of market penetration and increased market share. The revenues generated in this way will encourage the pharmaceutical companies to fund new projects for the development of better breast cancer vaccines.

The first commercially available breast cancer vaccine is expected to be available in the market in next 5-7 years. Clinical trials would be able to come with thoroughly checked version of products under investigation which would be able to provide higher levels of medical care to breast cancer patients. Most of the innovative products are at the advance stages of clinical trials which are supposed to clear the targeted end points. Market introduction of these new products are supposed to generate significant revenues for the pharmaceutical companies in coming years.

Table of Contents

1. What are Cancer Vaccines?

2. Mechanism of Cancer Vaccines

  • 2.1. Idiotype Cancer Vaccine Mechanism
  • 2.2. Cellular Cancer Vaccines Mechanism
  • 2.3. Ganglioside Antigens based Cancer Vaccines Mechanism
  • 2.4. Peptide Cancer Vaccine Mechanism
  • 2.5. Tumor Host Interaction Cancer Vaccine Mechanism

3. Mechanism of Breast Cancer Vaccine

  • 3.1. Principle Strategies for Eliciting Immune System
    • 3.1.1. Overcoming Immune Suppression
    • 3.1.2. Modulation of Immune Checkpoints
  • 3.2. Immunogenicity & Responses to Therapies
  • 3.3. Breast Cancer Therapeutic Vaccines

4. Global Breast Cancer Incidence

  • 4.1. US
  • 4.2. Europe
  • 4.3. Asia
  • 4.4. Rest of the World

5. Global Breast Cancer Vaccine Market Current Scenario

  • 5.1. Unexplored Opportunity
  • 5.2. Global Breast Cancer Vaccine Pipeline Overview

6. Need for Personalized Breast Cancer Vaccines

7. Global Breast Cancer Vaccine Market Dynamics

  • 7.1. Favorable Parameters
  • 7.2. Commercialization Challenges

8. Global Breast Cancer Vaccine Market Future Prospects

9. FDA Guideline for the Development & Marketing of Cancer Vaccines

  • 9.1. Considerations for Both Early and Late Phase Clinical Trials
    • 9.1.1. Patient Population
    • 9.1.2. Monitoring The Immune Response
    • 9.1.3. Biomarkers As Evidence Of Efficacy
    • 9.1.4. Adjuvants Used To Stimulate Immune Response
    • 9.1.5. Multi-Antigen Vaccines
    • 9.1.6. Disease Progression/Recurrence Immediately Or Shortly After The Initial Administration Of Cancer Vaccines
    • 9.1.7. Concomitant And Subsequent Therapies
  • 9.2. Considerations for Early Phase Clinical Trials
    • 9.2.1. Starting Dose And Dosing Schedule
    • 9.2.2. Booster And Maintenance Therapy
    • 9.2.3. Dose Escalation
    • 9.2.4. Single-Arm Versus Randomized Phase 2 Trials In Early Development
  • 9.3. Considerations For Late Phase Clinical Trials
    • 9.3.1. Safety Profile From Early Phase Clinical Trials
    • 9.3.2. Endpoints
    • 9.3.3. Statistical Issues
    • 9.3.4. Control Issues
    • 9.3.5. Delayed Vaccine Effect
    • 9.3.6. Autologous Vaccine Trials
    • 9.3.7. Accelerated Approval Regulations

10. Global Breast Cancer Vaccine Clinical Pipeline by Company & Phase

  • 10.1. Preclinical
  • 10.2. Phase-I
  • 10.3. Phase-I/II
  • 10.4. Phase-II
  • 10.5. Phase-II/III
  • 10.6. Phase-III

11. Discontinued & Suspended Breast Cancer Vaccine in Clinical Pipeline by Company & Phase

  • 11.1. Suspended
  • 11.2. No Development Reported
  • 11.3. Discontinued

12. Competitive Landscape

  • 12.1. Advaxis
  • 12.2. AlphaVax
  • 12.3. AVAX Technologies
  • 12.4. Dendreon Corporation
  • 12.5. Galena Biopharma
  • 12.6. Generex Biotechnology
  • 12.7. GlaxoSmithKline
  • 12.8. Immune Design
  • 12.9. Imugene
  • 12.10. Immunovative Therapies
  • 12.11. Immunovaccine
  • 12.12. Inovio Pharmaceuticals
  • 12.13. Merck
  • 12.14. NewLink Genetics
  • 12.15. Recombio
  • 12.16. TapImmune
  • 12.17. ViroMed

List of Figures

  • Figure 1-1: Categorization & Function of Cancer Vaccines
  • Figure 2-1: Classification of Different Types of Cancer vaccines
  • Figure 3-1: Development of a Cellular Immune Response against TAA
  • Figure 4-1: US -Number of New Cases & Deaths of Breast Cancer, 2016
  • Figure 5-1: Global Breast Cancer Vaccine Pipeline by Phase (%), 2016 till 2022
  • Figure 5-2: Global Breast Cancer Vaccine Pipeline by Phase (Numbers), 2016 till 2022
  • Figure 5-3: Global Breast Cancer Vaccine Pipeline by Phase (%), 2016 till 2022
  • Figure 5-4: Global Breast Cancer Vaccine Pipeline by Phase (Numbers), 2016 till 2022
  • Figure 6-1: Overview of Personalized Cancer Vaccines Development
  • Figure 6-2: Methodology for the Development of Personalized Cancer Vaccine
  • Figure 6-3: Schematic Representation of Development of Skin Implant for Cancer Vaccine
  • Figure 7-1: Favorable Parameters for Breast Cancer Vaccine Development
  • Figure 7-2: Challenges for Breast Cancer Vaccine Market
  • Figure 12-1: Advaxis Clinical Pipeline
  • Figure 12-2: AlphaVax Clinical Pipeline Overview
  • Figure 12-3: Galena Biopharma Clinical Pipeline Overview
  • Figure 12-4: Generex Biotechnology Clinical Pipeline Overview
  • Figure 12-5: Immune Design Clinical Pipeline Overview
  • Figure 12-6: Imugene Clinical Pipeline Overview
  • Figure 12-7: Immunovaccine Clinical Pipeline Overview
  • Figure 12-8: Inovio Pharmaceuticals Clinical Pipeline
  • Figure 12-9: NewLink Genetics Corporation Clinical Pipeline
  • Figure 12-10: TapImmune Clinical Pipeline Overview
  • Figure 12-11: ViroMed Clinical Pipeline Overview
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