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市場調査レポート

米国の癌ワクチン市場見通し 2020年

US Cancer Vaccine Market Outlook 2020

発行 KuicK Research 商品コード 302600
出版日 ページ情報 英文 420 Pages
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米国の癌ワクチン市場見通し 2020年 US Cancer Vaccine Market Outlook 2020
出版日: 2015年05月22日 ページ情報: 英文 420 Pages
概要

当レポートでは、米国における癌ワクチン市場の概要、癌の発症率、罹患率、癌ワクチンの価格と医療費償還政策、パイプライン動向とともに、参入する企業の競合環境をまとめています。

第1章 癌ワクチンのイントロダクション

第2章 癌ワクチンのメカニズム & イノベーション

  • イディオタイプ癌ワクチンのメカニズム
  • 細胞癌ワクチンのメカニズム
  • ガングリオシド抗原型ワクチンのメカニズム
  • ペプチド癌ワクチンのメカニズム
  • 腫瘍宿主相互作用癌ワクチンのメカニズム

第3章 癌ワクチンデリバリー向けのアジュバントプラットフォーム

第4章 米国の癌発症率と罹患率

  • 主な癌の発症率
  • 州別発症率
  • 性別発症率
  • 年齢グループ別発症率

第5章 米国の癌ワクチン市場見通し

  • 現在の市況
  • 癌ワクチンの臨床パイプライン分析
  • 価格 & 医療費償還政策

第6章 オーファンの地位にある癌ワクチン

第7章 癌研究の資金 & 補助金

第8章 米国の癌ワクチン市場ダイナミクス

  • 好ましい市場パラメーター
  • 市場課題

第9章 米国の癌ワクチン市場における将来の成長機会

第10章 米国の癌ワクチン臨床パイプライン:企業・適応症・相別

  • 研究
  • 前臨床
  • 臨床
  • 第1相
  • 第1相/第2相
  • 第2相
  • 第2相/第3相
  • 第3相
  • 登録済み

第11章 米国における上市済み癌ワクチンの臨床考察

  • 膀胱癌ワクチン:ID Biomedical (PACIS)
  • 膀胱癌ワクチン:Organon Teknika (OncoTICE)
  • HPV4価ワクチン (ヒトパピロマーウィルス4価ワクチン):Merck (Gardasil)
  • HPV2価ワクチン (ヒトパピロマーウィルス2価ワクチン):GlaxoSmithKline/MedImmune (Cervarix)
  • 前立腺癌:Dendreon Corporation (Provenge)

第12章 臨床パイプラインにおける中止 & 停止した癌ワクチン

  • 開発報告なし
  • 中止
  • 停止

第13章 癌ワクチン治験に対するFDA規制

  • 早期・後期段階治験の検討事項
  • 早期段階治験の検討事項
  • 後期段階治験の検討事項

第14章 競合情勢

  • Aduro BioTech
  • Advaxis
  • Antigen Express
  • Argos Therapeutics
  • Bavarian Nordic
  • Celldex Therapeutics
  • Cosmo Pharmaceuticals
  • Dendreon Corporation
  • Galena Biopharma
  • Generex Biotechnology
  • Gradalis
  • GSK
  • Merck
  • NewLink Genetics
  • Oxford BioMedica

図表

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目次

Escalating cancer incidences have made the investigators to come forth with therapeutics that could reduce high morbidity and mortality rates. Cancer segment has several products belonging to different categories having different pharmacological efficacy. So, it becomes imperative for investigators to develop products that have both high pharmacological and commercialization potential. Numerous cancer therapeutic is available in market but they have limited pharmacological efficacy and high unmet medical necessities prevails across the globe. Vaccination has been successfully employed to treat various infectious diseases and this idea has been extended to treat different malignancies. In past few decades, various malignancies have increased several folds in US due to which regulatory authorities are willing to accept cancer vaccines as a viable option. After hard work of several decades, investigators have been able to successfully market cancer vaccines in US market.

Cancer vaccines could be divided into to two broad categories of prophylactic (preventive) and therapeutic (treatment) segments. In US, cancer vaccines belong to both of these groups have been marketed in past few decades. Food and Drug Administration (FDA) is taking effective measures to offer better medical care to cancer patients. They are willing to try newer modalities due to which pharmaceutical companies are actively engaged for developing them for different malignancies. Due to this reason cancer vaccines got marketing approval in US and in clinical trials they have generated significant data. Increasing demand and higher acceptance rates among patients are expected to increase their sales due to which pharmaceutical companies are actively competing to generate more revenues from this segment. In future, number of clinical trials is expected to increase to develop cancer vaccines for different malignancies. Some of the products are different stages of clinical trials which are expected to be commercialized in US in coming years.

Cancer vaccines for malignancies developed as a result of infectious agents has gained acceptance in past few years and success of HPV vaccines in encourages pharmaceutical companies to invest significantly in this segment. Moreover, FDA has already approved hepatitis B vaccine for hepatic carcinoma but cure for hepatitis C remains elusive. This segment may develop a whole new segment of cancer vaccines and time will tell about success of these measures. In future, it may happen that cancer vaccines for various malignancies caused by infectious agents will become easily available in US. Main emphasis is being given on Kaposi's sarcoma which is Human Immunodeficiency Virus (HIV) associated malignancy. Till date no effective treatment for Kaposi's sarcoma is available but by activating patients' immune system with the help of cancer vaccines it could be treated. In recent years, investigators have been able to find putative link between H. pylori and gastric cancer. These indices have less frequency but these cases are increasing and there are no competitive products in US market as a result of which significant opportunity to churn significant revenues exists for pharmaceutical companies.

US is expected to become one of the largest market for cancer vaccines due to amenable regulatory rules for newly developed medicinal products. FDA is known to provide early marketing approval to products if breakthrough is produced at early stages of clinical trials. This will allow the cancer patients use cancer vaccine for their treatment without waiting for long time. Recently, US has agreed to introduce lung cancer vaccine developed in Cuba to be used in clinical trials for checking its safety and efficacy. If this lung cancer vaccine proves its worth in clinical trials performed in US, then it will get marketing approval. Due to increasing cancer incidences, it has become necessary to take such steps which will help the large population base suffering from different malignancies. Hopefully, pharmaceutical companies will try to take introduce their cancer vaccines as soon as possible in US to occupy major market shares due to which more cancer patients will get highly effective cancer vaccines.

"US Cancer Vaccine Market Outlook 2020" Report Highlight:

  • US Cancer Vaccine Market Analysis
  • Cancer Vaccine with Orphan Status
  • US Cancer Vaccine Clinical Pipeline by Company, Indication & Phase
  • US Cancer Vaccine Clinical Pipeline: 187 Vaccines
  • Clinical Insight of Marketed Cancer Vaccines in US
  • Marketed Cancer Vaccine in US: 5 Vaccines
  • FDA Regulations for Clinical Trials of Cancer Vaccines

Clinical Insight of Marketed Cancer Vaccines in US

  • Bladder Cancer Vaccine - ID Biomedical (PACIS®)
  • Bladder Cancer Vaccine - Organon Teknika (OncoTICE)
  • Human Papillomavirus Vaccine Quadrivalent - Merck (Gardasil®)
  • Human Papillomavirus Vaccine Recombinant Bivalent - GlaxoSmithKlinee (Cervarix®)
  • Prostate Cancer - Dendreon Corporation (Provenge®)

Table of Contents

1. Introduction to Cancer Vaccine

2. Cancer Vaccine 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 Vaccine Delivery

4. US Cancer Incidence & Prevalence

  • 4.1. Leading Cancer Incidence
  • 4.2. Incidence by State
  • 4.3. Incidence by Gender
  • 4.4. Incidence by Age Group

5. US Cancer Vaccine Market Analysis

  • 5.1. Current Market Scenario
  • 5.2. Cancer Vaccine Clinical Pipeline Analysis
  • 5.3. Pricing & Reimbursement Policy

6. Cancer Vaccine with Orphan Status

7. Cancer Research Funding & Grants

8. US Cancer Vaccine Market Dynamics

  • 8.1. Favorable Market Parameters
  • 8.2. Market Challenges

9. US Cancer Vaccine Market Future Growth Opportunities

10. US Cancer Vaccine Clinical Pipeline by Company, Indication & Phase

  • 10.1. Research
  • 10.2. Preclinical
  • 10.3. Clinical
  • 10.4. Phase-I
  • 10.5. Phase-I/II
  • 10.6. Phase-II
  • 10.7. Phase-II/III
  • 10.8. Phase-III
  • 10.9. Registered

11. Clinical Insight of Marketed Cancer Vaccines in US

  • 11.1. Bladder Cancer Vaccine - ID Biomedical (PACIS®)
  • 11.2. Bladder Cancer Vaccine - Organon Teknika (OncoTICE)
  • 11.3. Human Papillomavirus Vaccine Quadrivalent - Merck (Gardasil®)
  • 11.4. Human Papillomavirus Vaccine Recombinant Bivalent - GlaxoSmithKline/MedImmune (Cervarix®)
  • 11.5. Prostate Cancer - Dendreon Corporation (Provenge®)

12. Discontinued & Suspended Cancer Vaccine in Clinical Pipeline

  • 12.1. No Development Reported
  • 12.2. Discontinued
  • 12.3. Suspended

13. FDA Regulations for Clinical Trials of Cancer Vaccines

  • 13.1. Considerations for both Early and Late Phase Clinical Trials
    • 13.1.1. Patient Population
    • 13.1.2. Monitoring the Immune Response
    • 13.1.3. Biomarkers as Evidence of Efficacy
    • 13.1.4. Adjuvants Used To Stimulate Immune Response
    • 13.1.5. Multi-Antigen Vaccines
    • 13.1.6. Disease Progression/Recurrence Immediately or Shortly After the Initial Administration of Cancer Vaccines
    • 13.1.7. Concomitant & Subsequent Therapies
  • 13.2. Considerations for Early Phase Clinical Trials
    • 13.2.1. Starting Dose & Dosing Schedule
    • 13.2.2. Booster & Maintenance Therapy
    • 13.2.3. Dose Escalation
    • 13.2.4. Single-Arm versus Randomized Phase 2 Trials In Early Development
  • 13.3. Considerations for Late Phase Clinical Trials
    • 13.3.1. Safety Profile from Early Phase Clinical Trials
    • 13.3.2. Endpoints
    • 13.3.3. Statistical Issues
    • 13.3.4. Control Issues
    • 13.3.5. Delayed Vaccine Effect
    • 13.3.6. Autologous Vaccine Trials
    • 13.3.7. Accelerated Approval Regulations

14. Competitive Landscape

  • 14.1. Aduro BioTech
  • 14.2. Advaxis
  • 14.3. Antigen Express
  • 14.4. Argos Therapeutics
  • 14.5. Bavarian Nordic
  • 14.6. Celldex Therapeutics
  • 14.7. Cosmo Pharmaceuticals
  • 14.8. Dendreon Corporation
  • 14.9. Galena Biopharma
  • 14.10. Generex Biotechnology
  • 14.11. Gradalis
  • 14.12. GSK
  • 14.13. Merck
  • 14.14. NewLink Genetics
  • 14.15. Oxford BioMedica

List of Figures

  • Figure 1-1: Categorization & Function of Cancer Vaccines
  • Figure 2-1: Classification of Different Types of Cancer vaccines
  • Figure 5-1: US Cancer Vaccine Market (US$ Billion), 2014-2020
  • Figure 5-2: US Share in Global Cancer Vaccines Market (%), 2014 & 2020
  • Figure 5-3: US Vaccine Markey by Therapeutic & Prophylactic Vaccines, 2014 & 2020
  • Figure 5-4: US Prophylactic Cancer Vaccines Market, (US$ Billion), 2014-2020
  • Figure 5-5: US Therapeutic Cancer Vaccines Market, (US$ Billion), 2014-2020
  • Figure 5-6: US Cancer Vaccine Pipeline by Phase (%), 2015
  • Figure 5-7: US Cancer Vaccine Pipeline by Phase (Number), 2015
  • Figure 5-8: No Development Reported US Cancer Vaccine Pipeline by Phase (%), 2015
  • Figure 5-9: No Development Reported US Cancer Vaccine Pipeline by Phase (Number), 2015
  • Figure 5-10: Discontinued US Cancer Vaccine Pipeline by Phase (%), 2015
  • Figure 5-11: Discontinued US Cancer Vaccine Pipeline by Phase (Number), 2015
  • Figure 5-12: Suspended US Cancer Vaccine Pipeline by Phase (%), 2015
  • Figure 5-13: Suspended US Cancer Vaccine Pipeline by Phase (Number), 2015
  • Figure 14-1: Advaxis Clinical Pipeline
  • Figure 14-2: Argos Therapeutics Clinical Pipeline
  • Figure 14-3: Cosmo Pharmaceuticals Clinical Pipeline
  • Figure 14-4: Gradalis Clinical Pipeline
  • Figure 14-5: NewLink Genetics Clinical Pipeline

List of Tables

  • Table 4-1: Estimated Number of New Cases for Selected Cancers by State, 2015
  • Table 4-2: Estimated Number of Deaths for Selected Cancers by State, 2015
  • Table 4-3: Estimated Number of New Cancer Cases and Deaths by Gender, 2015
  • Table 4-4: Estimated New Cancer Cases by Age (Years), 2015
  • Table 4-5: Estimated Cancer Deaths by Age (Years), 2015
  • Table 6-1: US Orphan Designated Cancer Vaccines
  • Table 7-1: Spending on Cancer Research (US$ Million), 2010-2012
  • Table 7-2: Grants for Cancer Research (US$), 2013
  • Table 7-3: Grants for Cancer Research by States (US$), 2013
  • Table 7-4: Cancer Funding by Area of Research (US$)
  • Table 14-1: Aduro BioTech Cancer Vaccine Pipeline
  • Table 14-2: Aduro BioTech Cancer Immunotherapies
  • Table 14-3: Antigen Express Cancer Vaccine Pipeline
  • Table 14-4: Bavarian Nordic Cancer Vaccine Pipeline
  • Table 14-5: Celldex Therapeutics Cancer Vaccine Pipeline
  • Table 14-6: Dendreon Corporation Cancer Vaccine Pipeline
  • Table 14-7: Galena Biopharma Cancer Vaccine Pipeline
  • Table 14-8: GSK Cancer Vaccine Pipeline
  • Table 14-9: Merck Cancer Vaccine Pipeline
  • Table 14-10: Oxford BioMedica Cancer Vaccine Pipeline
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