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市場調查報告書

全球基因治療藥市場及開發平台分析

Global Gene Therapy Market & Pipeline Insight

出版商 KuicK Research 商品編碼 316744
出版日期 內容資訊 英文 949 Pages
商品交期: 最快1-2個工作天內
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全球基因治療藥市場及開發平台分析 Global Gene Therapy Market & Pipeline Insight
出版日期: 2014年10月01日 內容資訊: 英文 949 Pages
簡介

近年來基因治療領域技術大幅進步,陸續有新藥開發、臨床實驗。雖然已開發了各種疾病用的基因治療藥,但由於它特別是在癌症治療領域上與放射線療法及化療不同,不會造成免疫系統的不良影響,而受到高度的注目。在研究開發(R&D)方面,隨著突破性及持續性市場成長,基因治療藥的全球市場規模可望將在2020年達到5億美金的規模。現階段Gendicine(中國)與Rexin-G(菲律賓)的二個產器通過認証。此外尚有許多基因治療藥已達到第Ⅱ∼Ⅲ的實驗階段,但開發資金的籌措及受驗患者的募集、利用基因治療產品的接受度,都有可能帶給今後市場負面影響。實驗中的基因治療藥大部分都是針對遺傳性疾病用,但研究人員的重點已經轉向癌症治療藥的開發上。

本報告提供全球基因治療藥市場趨勢,及開發平台產品的開發情形相關分析,提供基因治療概要和重要性,推動及阻礙市場要素和今後的課題,基因治療藥的開發·銷售指南,開發中產品的目前開發情形,產品單位(計246產品)的詳細開發情形,已上市的基因治療藥(計2產品)銷售情形的資訊,為您概述為以下內容。

第1章 遺傳基因療法概要

  • 遺傳基因療法的歷史
  • 遺傳基因療法的媒介
    • 病毒載體
    • 非病毒載體
  • 遺傳基因療法的Protocol

第2章 基因治療的分類

  • 體細胞基因治療
    • 體細胞基因治療的技術
  • 生殖系細胞基因治療
    • 生殖系細胞基因治療的技術

第3章 基因治療的機制

  • 基因治療的方法
  • 遺傳基因操作機制

第4章 全球基因治療市場概況

  • 目前市場方案
  • 基因治療的臨床實驗平台概要
  • 基因治療新的趨勢

第5章 癌症治療上基因治療的重要性

第6章 目前基因治療對癌症治療的適用情形

  • 目前可利用的癌症治療方法
  • 癌症基因治療的方法
  • 癌症治療所使用的基因治療
  • 癌症患者的遺傳基因插入法
  • 癌症基因治療相關臨床性考察

第7章 全球基因治療市場動態

  • 市場正面效能的指標
    • 治療不可能治療的疾病
    • 檢驗技術
    • 醫療費給付政策
    • 癌症發病率的上升
    • 投資增加
    • 與生物資訊學的一體化
  • 市場成長時的課題

第8章 基因治療市場今後的成長預測

第9章 EMA(歐洲藥品管理局)的基因治療相關指南

  • 缺乏基因轉移媒介的生殖系統偶發性轉移的相關臨床資料
  • 基因治療藥環境風險評估的科學性要件
  • 適用於尖端治療醫藥品的風險型方法
  • 包含基因重組細胞的醫藥品品質·非臨床性/臨床性方面
  • 追蹤接受基因治療藥施打患者
  • 在基因治療藥最初的臨床利用前所需的非臨床研究

第10章 FDA(美國食品藥物管理局)的基因治療相關指南

  • 細胞療法·基因治療用產品臨床前評估
  • 細胞療法·基因治療用產品的滴定率實驗
  • 人體細胞用細胞治療·基因治療
  • 基因治療臨床實驗:遲發性的有害現象相關觀察對象

第11章 按基因治療藥的臨床實驗平台:相(階段)·各適應症·各國·各企業

  • 不明
  • 研究階段
  • 前臨床階段
  • 臨床階段
  • 第一階段
  • 第I/II相
  • 第二階段
  • 第II/III相
  • 第三階段
  • 認證前
  • 已認證

第12章 已上市的基因治療藥:Phase別·各適應症·各企業·各國

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

第13章 實驗中斷·延期,開發平台上的基因治療藥

  • 未提交開發報告
  • 開發中斷
  • 開發延期

第14章 競爭情形

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

圖表一覽

目錄

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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