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世界の遺伝子治療薬市場およびパイプライン分析

Global Gene Therapy Market & Pipeline Insight

発行 KuicK Research 商品コード 316744
出版日 ページ情報 英文 949 Pages
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世界の遺伝子治療薬市場およびパイプライン分析 Global Gene Therapy Market & Pipeline Insight
出版日: 2014年10月01日 ページ情報: 英文 949 Pages
概要

近年、遺伝子治療の分野では技術が大幅に進歩し、新薬の開発・治験が相次いでいます。様々な疾患向けに遺伝子治療薬が開発されていますが、とくにがん治療の分野では、放射線療法や化学療法と違い免疫系に悪影響を及ぼさない治療法として、高い注目を集めています。研究開発(R&D)面でのブレークスルーや継続的な市場成長に伴い、遺伝子治療薬の世界市場の規模は2020年には5億米ドルに達する、と期待されています。現段階では、Gendicine(中国)とRexin-G(フィリピン)の2製品が認可されています。また、多数の遺伝子治療薬が治験の第II〜III相に達していますが、開発資金の調達や治験患者の募集、遺伝子治療製品の利用に対する受容度などが今後の市場に(マイナスに)影響する可能性があります。治験中の遺伝子治療薬の大半は遺伝子疾患向けですが、研究者の関心はすでにがん治療薬としての利用・開発に向かっています。

当レポートでは、全世界の遺伝子治療薬市場の動向、およびパイプライ製品の開発状況について分析し、遺伝子治療の概要や重要性、市場促進・抑制要因や今後の課題、遺伝子治療薬の開発・販売のガイドライン、パイプライン製品の現在の開発状況、製品単位(計246製品)の詳細な開発状況、上市済みの遺伝子治療薬(計2製品)の販売状況といった情報をお届けいたします。

第1章 遺伝子療法の概要

  • 遺伝子療法の歴史
  • 遺伝子療法のベクター
    • ウイルスベクター
    • 非ウイルスベクター
  • 遺伝子療法のプロトコル

第2章 遺伝子治療の分類

  • 体細胞遺伝子治療
    • 体細胞遺伝子治療の技法
  • 生殖系細胞遺伝子治療
    • 生殖系細胞遺伝子治療の技法

第3章 遺伝子治療の機序

  • 遺伝子治療のアプローチ
  • 遺伝子操作の機序

第4章 世界の遺伝子治療市場の概況

  • 現在の市場シナリオ
  • 遺伝子治療の臨床パイプラインの概要
  • 遺伝子治療の新たな傾向

第5章 がん治療における遺伝子治療の重要性

第6章 がん治療への遺伝子治療の現在の適用状況

  • 現在利用可能ながん治療法
  • がん遺伝子治療へのアプローチ
  • がん治療で使用される遺伝子治療
  • がん患者への遺伝子の挿入方法
  • がん遺伝子治療に関する臨床的考察

第7章 世界の遺伝子治療市場のダイナミクス

  • 市場にプラスに働いている指標
    • 治療不可能だった疾患の治療
    • 検査技術
    • 医療費償還政策
    • がんの発症率の上昇
    • 投資増大
    • 生物情報学との一体化
  • 市場成長に際しての課題

第8章 遺伝子治療市場の今後の成長見通し

第9章 EMA(欧州医薬品庁)の遺伝子治療に関するガイドライン

  • 遺伝子導入ベクターの生殖系統への偶発的な移転に関する臨床データの欠如
  • 遺伝子治療薬の環境リスク評価に対する科学的要件
  • 先端治療向け医薬品に適用されるリスクベースのアプローチ
  • 遺伝子組み換え細胞を含む医薬品の品質・非臨床的/臨床的側面
  • 遺伝子治療薬を投与された患者のフォローアップ
  • 遺伝子治療薬の最初の臨床利用の前に必要な非臨床研究

第10章 FDA(米国食品医薬品局)の遺伝子治療に関するガイドライン

  • 細胞療法・遺伝子治療用製品の臨床前評価
  • 細胞療法・遺伝子治療用製品の力価試験
  • ヒト体細胞向け細胞治療・遺伝子治療
  • 遺伝子治療の治験:遅発性の有害現象に関する観察対象

第11章 遺伝子治療薬の臨床パイプライン:相(フェーズ)別・適応症別・国別・企業別

  • 不明
  • 研究段階
  • 前臨床段階
  • 臨床段階
  • 第I相
  • 第I/II相
  • 第II相
  • 第II/III相
  • 第III相
  • 認証前
  • 認証済み

第12章 上市済みの遺伝子治療薬:相別・適応症別・企業別・国別

  • Gendicine (Shenzhen SiBiono GeneTech)
  • Rexin-G (Epeius Biotechnologies)

第13章 治験が中断・延期された、パイプライン上の遺伝子治療薬

  • 開発報告が出されていないもの
  • 開発が中断されたもの
  • 開発が延期されたもの

第14章 競合情勢

  • Advantagene
  • BioCancell
  • Celgene
  • Epeius Biotechnologies
  • GenVec
  • Genethon
  • Introgen Therapeutics
  • MultiVir
  • Shenzhen SiBiono GeneTech
  • Vical
  • ZIOPHARM Oncology

図表一覧

目次

There have been significant advancements in the area of gene therapy in terms of research of new drugs. Over the past 20 years, the gene therapy market has witnessed significant advances ranging from the stage of conception, to the current stage of clinical trials for various disease conditions. When compared to other conventional methods such as radiotherapy and chemotherapy, gene therapy enjoys a clear advantage mainly because this therapy does not inhibit the immune system. Also, there has been an increased use of innovative technologies, which has led to an expansion of the scope of gene therapy worldwide. With continuous growth in this market along with major research and developments breakthroughs, the global market opportunity for gene therapy is expected to reach USD 500 million by 2020.

There are only 2 gene therapies which have been approved till now. They are Gendicine and Rexin-G. While Gendicine is marketed in China, Rexin-G is marketed in Philippines. China, with its significant efforts in researching gene therapy has become the first country to approve gene therapy products across the globe in 2003. The growing need for developing an effective treatment for head-and-neck cancer, a condition more prevalent in China than in the west, sustained the interest among Chinese researchers in this area. The market for gene therapy is currently in the experimental stages. There has not been any success as yet in developing completely curative therapeutic drugs.

The growth of this market greatly depends on the regulatory approval of products which are currently in clinical trials. A major part of the gene therapy products for cancer and cardiovascular diseases are currently in Phase II and Phase III of clinical trials. Other factors impacting the gene therapy market are the cost of the treatment and the disease population under study. Additionally, funding and developments in research coupled with acceptance of gene therapy products to use in medicine are also expected to impact the market in the near future.

Although the initial studies of gene therapy were conducted mostly on monogenetic diseases, the focus of the scientists rapidly shifted towards cancer. This increasing popularity of cancer therapeutics as a major interest for gene therapy applications led to it accounting for dominant share in the overall clinical trials being conducted. The major reasons for cancer to become a preferred area of application for gene therapy are the significant unmet medical needs in cancer therapy, coupled with the large size of its market. Additionally, the ethical acceptance of gene therapy as a therapeutic solution also contributed to the shift of focus from monogenetic diseases to cancer.

“Global Gene Therapy Market & Pipeline Insight” Market Highlight:

  • Gene Therapy Market Overview
  • Significance of Gene Therapy in Cancer Therapeutics
  • Current Applications of Gene Therapy to Cancer Treatment
  • Gene Therapy Market Dynamics: Drivers, Challenges & Future Outlook
  • FDA & AMA Guidelines for Gene Therapy
  • Gene Therapy Pipeline by Phase, Indications, Country & Company
  • Gene Therapy Pipeline: 246 Drugs
  • Marketed Gene Therapy: 2 (Gendicine & Rexin-G)
  • Cancer Gene Therapy Pipeline: 69 Drugs

Table of Contents

1. Introduction to Gene Therapy

  • 1.1. History of Gene Therapy
  • 1.2. Vectors of Gene Therapy
    • 1.2.1. Viral Vectors
    • 1.2.2. Non-Viral Vectors
  • 1.3. Gene Therapy Protocol

2. Gene Therapy Classification

  • 2.1. Somatic Gene Therapy
    • 2.1.1. Technique of Somatic Gene Therapy
  • 2.2. Germline Cell Therapy
    • 2.2.1. Technique of Germiline Therapy

3. Mechanism of Gene Therapy

  • 3.1. Approach of Gene Therapy
  • 3.2. Mechanism of Genetic Manipulation

4. Global Gene Therapy Market Overview

  • 4.1. Current Market Scenario
  • 4.2. Gene Therapy Clinical Pipeline Overview
  • 4.3. Emerging Trends in Gene Therapy

5. Significance of Gene Therapy in Cancer Therapeutics

6. Current Applications of Gene Therapy to Cancer Treatment

  • 6.1. Cancer Treatments Currently Available
  • 6.2. Approaches to Cancer Gene Therapy
  • 6.3. Gene Therapy Used in Cancer Treatment
  • 6.4. Methods of Inserting Genes into Cancer Patients
  • 6.5. Cancer Gene Therapy Clinical Insight

7. Global Gene Therapy Market Dynamics

  • 7.1. Favorable Parameters
    • 7.1.1. Curing the Incurable Diseases
    • 7.1.2. Testing Technology
    • 7.1.3. Reimbursement Policy
    • 7.1.4. Rising Incidence of Cancer
    • 7.1.5. Increasing Investments
    • 7.1.6. Integration of Bioinformatics
  • 7.2. Growth Restraints

8. Gene Therapy Market Future Growth Outlook

9. EMA Guidelines for Gene Therapy

  • 9.1. Non Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors
  • 9.2. Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products
  • 9.3. Risk Based Approach Applied to Advanced Therapy Medicinal Products
  • 9.4. Quality, Non Clinical & Clinical Aspects of Medicinal Products Containing Genetically Modified Cells
  • 9.5. Follow Up of Patients Administered with Gene Therapy Medicinal Products
  • 9.6. Non Clinical Studies Required Before First Clinical Use of Gene Therapy Medicinal Products

10. FDA Guidelines for Gene Therapy

  • 10.1. Preclinical Assessment of Investigational Cellular & Gene Therapy Products
  • 10.2. Potency Tests for Cellular & Gene Therapy Products
  • 10.3. Human Somatic Cell Therapy & Gene Therapy
  • 10.4. Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events

11. Gene Therapy Pipeline by Phase, Indications, Country & Company

  • 11.1. Unknown
  • 11.2. Research
  • 11.3. Preclinical
  • 11.4. Clinical
  • 11.5. Phase-I
  • 11.6. Phase-I/II
  • 11.7. Phase-II
  • 11.8. Phase-II/III
  • 11.9. Phase-III
  • 11.10. Preregistration
  • 11.11. Registered

12. Marketed Gene Therapies by Indications, Country & Company

  • 12.1. Gendicine (Shenzhen SiBiono GeneTech)
  • 12.2. Rexin-G (Epeius Biotechnologies)

13. Suspended & Discontinued Gene Therapy in Pipeline

  • 13.1. No Development Reported
  • 13.2. Discontinued
  • 13.3. Suspended

14. Competitive Landscape

  • 14.1. Advantagene
  • 14.2. BioCancell
  • 14.3. Celgene
  • 14.4. Epeius Biotechnologies
  • 14.5. GenVec
  • 14.6. Genethon
  • 14.7. Introgen Therapeutics
  • 14.8. MultiVir
  • 14.9. Shenzhen SiBiono GeneTech
  • 14.10. Vical
  • 14.11. ZIOPHARM Oncology

List of Figures:

  • Figure 1-1: Protocol for Human Gene Therapy Clinical Trials
  • Figure 2-1: Technique of Somatic Gene Therapy
  • Figure 2-2: Steps Involved in a Human Germline Gene Therapy Protocol
  • Figure 3-1: Genetic Modification of Organisms
  • Figure 4-1: Global Gene Therapy Market Opportunity (US$ Million), 2014-2020
  • Figure 4-2: Gene Therapy Clinical Pipeline by Phase (%), 2014
  • Figure 4-3: Gene Therapy Clinical Pipeline by Phase (Number), 2014
  • Figure 4-4: No Development Reported in Gene Therapy Clinical Pipeline by Phase (%), 2014
  • Figure 4-5: No Development Reported in Gene Therapy Clinical Pipeline by Phase (Number), 2014
  • Figure 4-6: Discontinued Gene Therapy Clinical Pipeline by Phase (%), 2014
  • Figure 4-7: Discontinued Gene Therapy Clinical Pipeline by Phase (Number), 2014
  • Figure 4-8: Suspended Gene Therapy Clinical Pipeline by Phase (%), 2014
  • Figure 4-9: Suspended Gene Therapy Clinical Pipeline by Phase (%), 2014
  • Figure 6-1: Cancer Gene Therapy Drug Clinical Pipeline by Phase (%), 2014
  • Figure 6-2: Cancer Gene Therapy Drug Clinical Pipeline by Phase (Number), 2014
  • Figure 6-3: Suspended Cancer Gene Therapy Drug by Phase (%), 2014
  • Figure 6-4: Suspended Cancer Gene Therapy Drug by Phase (Number), 2014
  • Figure 6-5: Discontinued Cancer Gene Therapy Drug by Phase (%), 2014
  • Figure 6-6: Discontinued Cancer Gene Therapy Drug by Phase (Number), 2014
  • Figure 6-7: No Development Reported Cancer Gene Therapy Drug by Phase (%), 2014
  • Figure 6-8: No Development Reported Cancer Gene Therapy Drug by Phase (Number), 2014
  • Figure 14-1: Advantagene Clinical Pipeline
  • Figure 14-2: Genethon Clinical Pipeline
  • Figure 14-3: MultiVir Clinical Pipeline
  • Figure 14-4: Vical Clinical Pipeline
  • Figure 14-5: ZIOPHARM Oncology Clinical Pipeline

List of Tables:

  • Table 1-1: Approved Current Clinical Gene Therapy Protocols
  • Table 9-1: Classification of Integrating & Non-Integrating Vectors Based on the Parental Virus/Plasmid Characteristics
  • Table 9-2: Risk factors of GT Medicinal Products to be Considered
  • Table 10-1: Challenges to Potency Assay Development for CGT Products
  • Table 10-2: Commonly Used Gene Therapy Vectors in Clinical Trials
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