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世界のがんワクチン市場とパイプラインの分析

Global Cancer Vaccines Market & Pipeline Analysis

発行 KuicK Research 商品コード 311929
出版日 ページ情報 英文 864 Pages
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世界のがんワクチン市場とパイプラインの分析 Global Cancer Vaccines Market & Pipeline Analysis
出版日: 2014年09月08日 ページ情報: 英文 864 Pages
概要

がんワクチンは、効果的な治療法が発見されていないさまざまなタイプのがんを治療することができる有力な選択肢として注目を集めています。がんワクチンは、人体に元々備わっている防衛機能を強化することでがん患者を治療する治療用ワクチンと、健康な人の体内でがんが成長するのを防ぐために使用される予防用ワクチンに大別することができます。現在製薬会社の主な収入源となっているのは、予防用ワクチンであり、治療用ワクチンの市場は手付かずの状態ですが、今後各国の監督機関が承認プロセスを迅速化し、製薬会社が研究開発投資を大幅に増強するようになれば、市場全体が急速に拡大する可能性もあります。誕生間もないがんワクチンは臨床試験の標準化が難しく、その有効性を定量化するための基準が不完全なうえ、従来の治療法とは作用機序が異なるため、化学療法や放射線療法、手術などに対応する標準を適用することもできませんが、すでに多くの研究者がこの問題に取り組んでおり、近い将来解決策は見つかると思われます。

当レポートは、世界のがんワクチン市場を詳細に分析し、今後の展望を示したもので、現在研究開発が進められている製品の情報、米食品医薬品局(FDA)の規制の枠組み、主要企業各社の概要や製品のパイプラインなども明らかにします。

第1章 イントロダクション

第2章 がんワクチンの作用機序と技術革新

  • イディオタイプがんワクチンの機序
  • 細胞がんワクチンの機序
  • ガングリオシド抗原をベースにしたがんワクチンの機序
  • ペプチドがんワクチンの機序
  • 腫瘍宿主相互作用がんワクチンの機序

第3章 がんワクチンのデリバリーに対応するアジュバントプラットフォーム

第4章 世界がんワクチン市場の概要

  • 現在の市場のシナリオ
  • 臨床パイプラインの概要

第5章 個別化医療に対応するがんワクチン:進歩と可能性

第6章 ヒトパピローマウィルス(HPV)ワクチン接種のための公的なプログラム

第7章 世界のがんワクチン市場の力学

  • 市場の成長に有利な条件
    • がんワクチンに対する需要の拡大
    • 各国政府による資金拠出と支援
    • がんワクチン開発のための革新的な技術
    • 個別化医療に対応するがんワクチンの需要
    • がんワクチン開発にとって追い風となる各種の人口統計
  • 解決すべき課題

第8章 がんワクチンの今後の見通し

第9章 世界的ながんワクチン臨床開発パイプラインの分析

  • 段階:未確認
  • 段階:研究
  • 段階:前臨床
  • 段階:臨床
  • 第I相
  • 第I/II相
  • 第II相
  • 第II/III相
  • 第III相
  • 段階:登録前
  • 段階:登録済み

第10章 上市されているがんワクチンの臨床所見

第11章 開発が中断または中止されたがんワクチンの臨床パイプライン

  • 開発状況についての報告なし
  • 中止
  • 中断

第12章 がんワクチン開発と上市についてのFDAの規制の枠組み

  • 臨床試験の早期段階と後期段階に共通する留意事項
    • 患者数
    • 免疫反応の監視
    • 効能の裏付けとなるバイオマーカー
    • 免疫反応を促進するために使用されるアジュバント
    • 多種抗原ワクチン
    • がんワクチンを最初に投与した直後の病状進行/再発
    • 併用療法と後続療法
  • 臨床試験早期段階の留意事項
    • 投薬の開始と投薬スケジュール
    • ブースター療法と維持療法
    • 用量増加
    • 開発早期段階でのシングルーアーム試験とランダム化第II相試験
  • 臨床試験後期段階の留意事項
    • 早期段階の臨床試験で得られた安全性プロフィール
    • 評価項目
    • 統計上の問題
    • 制御上の問題
    • 遅延型のワクチン効果
    • 自己ワクチンの試験
    • 承認手続きの加速に関する規制

第13章 競合環境:事業の概要と製品のパイプライン

  • Advaxis
  • Celldex Therapeutics
  • Dendreon Corporation
  • Galena Biopharma
  • ImmunoCellular Therapeutics
  • ImmunoGen
  • Inovio Pharmaceuticals
  • Merck
  • NeoStem Oncology
  • NewLink Genetics
  • Northwest Biotherapeutics
  • Novartis
  • Peregrine Pharmaceuticals
  • Roche
  • Seattle Genetics

図表リスト

目次

Cancer vaccines are a viable option for treating many types of cancers which in the present day do not have effective treatments. Therapeutic cancer vaccines and Prophylactic cancer vaccines are the two broad segments into which the cancer vaccines market is categorized. Therapeutic or Treatment vaccines are targeted at treating an existing cancer by strengthening the body's natural defences against the cancer and the Prophylactic or Preventive vaccines are used to prevent cancer from developing in healthy people. With the approval of the expensive prostate cancer vaccine, Provenge by Dendreon, the field of cancer vaccines has received an unprecedented boost. Consequently, many companies are expected to enter this emerging and highly profitable field of preventing, treating, and potentially curing cancer.

With the increasing focus of pharmaceutical companies in the cancer vaccine segment, the prophylactic vaccines segment grew substantially and currently is the largest source of revenue, with the therapeutic vaccines segment still remaining untapped. It is most likely that the regulatory authorities would in the near future quicken its approval process specifically for therapeutic vaccines. This coupled with a significant amount of investment for the research and development of these vaccines by the pharmaceutical companies would certainly push the overall cancer vaccines market onto a rapid growth trajectory.

The current market size of cancer vaccines category is many fold smaller than other cancer therapeutics categories. Due to nascent stages of industry-life cycle and late introduction in market has decreased their overall share. To tap this cancer market category, many global companies are actively investing in cancer vaccine development. The market penetration is expected to increase with the competition among various pharmaceutical companies to get a larger portion of this market category.

The capital investments in many sections are required for the development and introduction of new cancer vaccines in market. The present market has handful of cancer vaccines for preventive and therapeutic categories. The limited options to choose from these products have significantly limited the pharmaceutical companies' profit margins. On the other hand, many companies are developing cancer vaccine for both of these categories. The introduction of new products will also alleviate the financial burden from the patients.

The cancer vaccine pipeline is expected to increase at tremendous rates in coming years. As large numbers of cancer vaccines are entering in various phases of clinical trials, due to which cancer market will soon observe a boost. However, the novelty of cancer vaccines makes it difficult for the standardization of clinical trials, because the criterias required to quantify its effectiveness are not completely discovered, this cause loss of valuable time. Moreover, the present day methods are standardized for conventional cancer therapeutic methods like chemotherapy, radiotherapy and surgery, which are not applicable for cancer vaccines due to their different mode of actions. In near future, researchers will find the solution for this problem and it will decrease the winding time.

“Global Cancer Vaccines Market & Pipeline Analysis” Report Highlights:

  • Global Cancer Market Overview
  • Personalized Cancer Vaccines: Progress & Possibilities
  • Platforms for Cancer Vaccines Delivery
  • Cancer Vaccines: Mechanism & Innovations
  • Global Cancer Vaccines Clinical Pipeline by Phase, Indication, Company & Country
  • Global Cancer Vaccine Clinical Pipeline: 289 Vaccines
  • Marketed Cancer Vaccines: 12 Vaccines
  • Regulatory Framework for Cancer Vaccines Development & Marketing

Table of Contents

1. Introduction to Cancer Vaccines

2. Cancer Vaccines: Mechanism & Innovations

  • 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. Adjuvants Platforms for Cancer Vaccines Delivery

4. Global Cancer Vaccines Market Overview

  • 4.1. Current Market Scenario
  • 4.2. Clinical Pipeline Overview

5. Personalized Cancer Vaccines: Progress & Possibilities

6. Public HPV Cancer Vaccination Program

7. Global Cancer Vaccines Market Dynamics

  • 7.1. Favorable Market Parameters
    • 7.1.1. Increasing Demand for Cancer Vaccines
    • 7.1.2. Government Funding & Support
    • 7.1.3. Innovative Technologies for Cancer Vaccine Development
    • 7.1.4. On Demand Personalized Cancer Vaccines
    • 7.1.5. Myriad of Demographs for Cancer Vaccine Development
  • 7.2. Issues to be Resolved

8. Future Prospects of Cancer Vaccines

9. Global Cancer Vaccines Clinical Pipeline Insight by Phase, Indication, Company & Country

  • 9.1. Phase: Unknown
  • 9.2. Phase: Research
  • 9.3. Phase: Preclinical
  • 9.4. Phase: Clinical
  • 9.5. Phase-I
  • 9.6. Phase-I/II
  • 9.7. Phase-II
  • 9.8. Phase-II/III
  • 9.9. Phase-III
  • 9.10. Phase: Preregistration
  • 9.11. Phase: Registered

10. Marketed Cancer Vaccines Clinical Insight by Indication, Company & Country

11. Suspended & Discontinued Cancer Vaccines Clinical Pipeline by Phase, Indication, Company & Country

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

12. FDA Regulatory Framework for Cancer Vaccines Development & Marketing

  • 12.1. Considerations for both Early and Late Phase Clinical Trials
    • 12.1.1. Patient Population
    • 12.1.2. Monitoring the Immune Response
    • 12.1.3. Biomarkers as Evidence of Efficacy
    • 12.1.4. Adjuvants Used To Stimulate Immune Response
    • 12.1.5. Multi-Antigen Vaccines
    • 12.1.6. Disease Progression/Recurrence Immediately or Shortly After The Initial Administration Of Cancer Vaccines
    • 12.1.7. Concomitant & Subsequent Therapies
  • 12.2. Considerations for Early Phase Clinical Trials
    • 12.2.1. Starting Dose & Dosing Schedule
    • 12.2.2. Booster & Maintenance Therapy
    • 12.2.3. Dose Escalation
    • 12.2.4. Single Arm Versus Randomized Phase 2 Trials In Early Development
  • 12.3. Considerations for Late Phase Clinical Trials
    • 12.3.1. Safety Profile from Early Phase Clinical Trials
    • 12.3.2. Endpoints
    • 12.3.3. Statistical Issues
    • 12.3.4. Control Issues
    • 12.3.5. Delayed Vaccine Effect
    • 12.3.6. Autologous Vaccine Trials
    • 12.3.7. Accelerated Approval Regulations

13. Competitive Landscape: Business Overview & Product Pipeline

  • 13.1. Advaxis
  • 13.2. Celldex Therapeutics
  • 13.3. Dendreon Corporation
  • 13.4. Galena Biopharma
  • 13.5. ImmunoCellular Therapeutics
  • 13.6. ImmunoGen
  • 13.7. Inovio Pharmaceuticals
  • 13.8. Merck
  • 13.9. NeoStem Oncology
  • 13.10. NewLink Genetics
  • 13.11. Northwest Biotherapeutics
  • 13.12. Novartis
  • 13.13. Peregrine Pharmaceuticals
  • 13.14. Roche
  • 13.15. Seattle Genetics

List of Figures:

  • Figure 1-1: Categorization & Function of Cancer Vaccines
  • Figure 2-1: Classification of Different Types of Cancer vaccines
  • Figure 4-1: Global Cancer Vaccines Market (US$ Billion), 2014-2020
  • Figure 4-2: Global Cancer Vaccines Market by Region (%), 2014 & 2020
  • Figure 4-3: Examples of Commercially Available Cancer Vaccines
  • Figure 4-4: Global Cancer Vaccines Clinical Pipeline by Phase (%), 2014
  • Figure 4-5: Global Cancer Vaccines Clinical Pipeline by Phase (Number), 2014
  • Figure 4-6: No Development Reported in Cancer Vaccines Pipeline by Phase (%), 2014
  • Figure 4-7: No Development Reported in Cancer Vaccines Pipeline by Phase (Number), 2014
  • Figure 4-8: Discontinued Cancer Vaccines in Pipeline by Phase (%), 2014
  • Figure 4-9: Discontinued Cancer Vaccines in Pipeline by Phase (Number), 2014
  • Figure 4-10: Suspended Cancer Vaccines in Pipeline by Phase (%), 2014
  • Figure 4-11: Suspended Cancer Vaccines in Pipeline by Phase (Number), 2014
  • Figure 5-1: Overview of Personalized Cancer Vaccines Development
  • Figure 5-2: Methodology for the Development of Personalized Cancer Vaccine
  • Figure 5-3: Schematic Representation of Development of Skin Implant for Cancer Vaccine
  • Figure 6-1: Prophylactic Cancer Vaccines Available for Different Serotypes of HPV
  • Figure 7-1: Factors Responsible for High Demand of Cancer Vaccines
  • Figure 13-1: Advaxis Clinical Pipeline
  • Figure 13-2: Celldex Therapeutics Clinical Pipeline
  • Figure 13-3: Galena Biopharma Clinical Pipeline
  • Figure 13-4: ImmunoCellular Therapeutics Clinical Pipeline
  • Figure 13-5: ImmunoGen Clinical Pipeline
  • Figure 13-6: Inovio Pharmaceuticals Clinical Pipeline
  • Figure 13-7: NewLink Genetics Corporation Clinical Pipeline
  • Figure 13-8: Northwest Biotherapeutics Clinical Pipeline
  • Figure 13-9: Peregrine Pharmaceuticals Clinical Pipeline
  • Figure 13-10: Seattle Genetics Clinical Pipeline

List of Tables:

  • Table 5-1: Different Types of Biomarkers for Personalized Cancer Vaccine Development
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