NEWS: 公告在東京證券交易所JASDAQ標準市場新上市

表紙
市場調查報告書

腫瘤中的基因治療-專題調查

Gene Therapy in Oncology - Thematic Research

出版商 GlobalData 商品編碼 1014033
出版日期 內容資訊 英文 104 Pages
訂單完成後即時交付
價格
腫瘤中的基因治療-專題調查 Gene Therapy in Oncology - Thematic Research
出版日期: 2021年06月15日內容資訊: 英文 104 Pages
簡介

目前,在美國、法國、德國、意大利、西班牙、英國、日本和中國的八個主要醫藥市場中,針對癌症適應症上市的基因治療藥物只有三種,有溶血病毒和溶血病毒兩種產品。一種使用病毒載體進行基因治療的產品。

正在開發針對各種實體癌(包括黑色素瘤)的基因治療藥物。截至 2021 年 4 月,在 8 個主要市場有 252 個研究體內基因治療的臨床試驗和 81 個在研藥物。到 2027 年,構成體內基因治療類別的產品銷售額預計將超過 70 億美元。隨著 COVID-19 信使核糖核酸 (mRNA) 疫苗的成功,治療性寡核甘酸市場有望蓬勃發展,到 2027 年將達到 45 億美元。

本報告調查了八個主要國家的腫瘤基因治療,包括市場增長因素和障礙、機遇和挑戰、未滿足的需求、治療和技術分類、監管和市場准入細節、產品和它提供的信息,例如基因治療,包括公司簡介和研發策略。

目錄

目錄

第一章前言

  • 目錄
  • 縮寫
  • 相關報導

第 2 章執行摘要

  • 主要調查結果

第3章基因治療概述

  • 什麼是基因治療?
  • 八個主要市場的癌基因治療發展歷史
  • 主要 Twitter 聊天

第 4 章趨勢

  • 行業趨勢-基因治療載體
  • 行業趨勢-治療性寡核甘酸
  • 行業趨勢-基因組編輯
  • 行業趨勢-溶瘤病毒
  • 監管趨勢

第 5 章價值鏈

  • 基因治療價值鏈
  • 基因治療載體
  • 治療性寡核甘酸
  • 基因組編輯
  • 溶瘤病毒
  • 腫瘤臨床試驗中的基因治療

第 6 章商業產品

  • 八個主要市場的癌症基因治療產品上市
  • 8個主要市場的主要基因療法

第七章管道產品

  • 8個主要市場的基因治療管線產品
  • 基因治療管道候選者
  • 8 個主要市場的晚期基因治療候選者

第八章市場分析與交易

  • 按治療類別劃分的基因治療市場分析和預測
  • 腫瘤基因治療領域10大交易規模(2012-2021)
  • 腫瘤基因治療領域最新交易
  • 包括腫瘤基因治療資產在內的併購(2019-2021)
  • 包括腫瘤基因治療資產在內的併購(2014-2018)

第 9 章監管和市場准入

  • 臨床試驗中的基因治療
  • 法規-美國
  • 市場准入-美國
  • 監管-歐洲
  • 市場准入-歐洲
  • 美國和歐洲對基因治療的監管
  • 監管和市場准入-日本
  • 美國、歐盟和日本的搶先體驗計劃比較
  • 監管和市場准入-中國

第 10 章機遇、挑戰和未滿足的需求

  • 基因治療載體、病毒:機遇與挑戰
  • 基因治療載體,非病毒:機遇與挑戰
  • 治療性寡核甘酸:機遇與挑戰
  • 基因組編輯:機遇與挑戰
  • 溶瘤病毒:機遇與挑戰
  • 基因治療中臨床未滿足的需求:差距分析
  • 基因治療的商業未滿足需求:差距分析
  • 未滿足的需求:KOL 的觀點

第11章企業

  • 藥物開發記分卡-再生醫學
  • 目前的主要公司
    • Amgen
    • SiBiono
    • Sunway Biotech
  • 今後臨床強勁的企業
    • Candel
    • CG Oncology
    • Checkmate
    • Daiichi Sankyo
    • Ferring
    • FKD
    • Geron
    • Idera
    • Istari
    • VBL

第12章附錄

  • 參考文獻
  • 初步調查
  • 影響製藥行業的主要主題
  • 我們的專題調查方法
  • 關於作者
  • 聯繫我們
  • 免責聲明

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: GDHCHT281

Gene therapy describes the treatment of various cancers with the use of in vivo treatments: viral and non-viral gene therapy products, therapeutic oligonucleotides, oncolytic viruses and genome editing therapies. There are currently just 3 gene therapies marketed for oncology indications in the eight major pharmaceutical markets (8MM) (US, France, Germany, Italy, Spain, UK, Japan, and China). Oncolytic viruses lead the category with 2 products, followed by viral vector gene therapies with 1 approved drug.

Gene therapies are in development for melanoma and other various solid tumors. As of April 2021, there are 252 clinical trials investigating in vivo gene therapies across the 8MM with 81 drugs in development.

Sales of products that comprise the categories of in vivo gene therapy are forecast to reach over $7B by 2027. The therapeutic oligonucleotide market, which will be galvanized by the success of COVID-19 messenger ribonucleic acid (mRNA) vaccines, is forecast to reach $4.5B by 2027 globally.

Key Highlights

  • The main drivers of growth include significant industrial investment in the field, as well as regulatory bodies' recognition of gene therapy potential by creating specialized designations for gene therapy products.
  • The main barriers to growth include market access issues such as high cost of therapy/lack of reimbursement and lack of expertise as well as clinical issues such as safety concerns.
  • The most important unmet needs in the oncology gene therapy market include high cost of therapy, improving the safety of delivery systems and providing a valid treatment option to treat several cancer types.
  • The 8MM have set up programs to expedite gene therapy approvals, especially when they address an unmet need or are targeting orphan indications.

KEY QUESTIONS ANSWERED

  • What are the late-stage gene therapy pipeline agents in development for cancer? Which class of gene therapy drugs will have the highest peak sales, and why?
  • What are the current unmet needs that gene therapies can address in the treatment of cancer? What are the opportunities for R&D?
  • How is the field of gene therapy going to move forward? Which technologies are the most promising for combinations?
  • What is the regulatory landscape for gene therapies in the US, the 5EU, Japan and China?

Scope

  • Overview of gene therapy including classification of therapy and technologies, regulatory and market access details, product & company profiles.
  • Quotes from US- and 5EU-based key opinion leaders and researchers.
  • Key topics covered for gene therapy in oncology in the 8MM include trends, value chain, market analysis, opportunities, challenges and unmet needs and high-value deals.
  • Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising late-stage pipeline drugs for classes of gene therapy (Phase III and pre-registration).
  • Analysis of the key dynamics of the gene therapy market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies covered in detail to highlight business opportunities.

Reasons to Buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential.
  • Develop business strategies by understanding the trends shaping and driving the global oncology gene therapy market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global oncology gene therapy market in the future.
  • Design your development strategy through a review of potential novel targets or combinations across indications.
  • Understand the challenges and strategies impacting the development of oncology gene therapy agents in preclinical studies and clinical trials.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the classes of gene therapy and indications that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

Table of Contents

1. Preface

  • 1.1. Table of Contents
  • 1.2. Abbreviations
  • 1.3. Related Reports

2. Executive Summary

  • 2.1. Key Findings

3. Gene Therapy Overview

  • 3.1. What is Gene Therapy?
  • 3.2. History of Gene Therapy Development in Cancer in the 8MM
  • 3.3. Key Twitter Chat

4. Trends

  • 4.1. Industry Trends - Gene Therapy Vectors
  • 4.2. Industry Trends - Therapeutic Oligonucleotides
  • 4.3. Industry Trends - Genome Editing
  • 4.4. Industry Trends - Oncolytic Viruses
  • 4.5. Regulatory Trends

5. Value Chain

  • 5.1. Gene Therapy Value Chain
  • 5.2. Gene Therapy Vectors
  • 5.3. Therapeutic Oligonucleotides
  • 5.4. Genome Editing
  • 5.5. Oncolytic Viruses
  • 5.6. Gene Therapy in Oncology Clinical Trials

6. Marketed Products

  • 6.1. Marketed Gene Therapy Products for Cancer in the 8MM
  • 6.2. Leading Gene Therapy Treatments in The 8MM

7. Pipeline Products

  • 7.1. Gene Therapy Pipeline Products in the 8MM
  • 7.2. Gene Therapy Pipeline Candidates
  • 7.3. Late Stage Gene Therapy Candidates, 8MM

8. Market Analysis and Deals

  • 8.1. Gene Therapy Market Analysis and Forecast by Class of Therapy
  • 8.2. Top 10 Transaction Deals by Size during 2012-2021 in the Oncology Gene Therapy Space
  • 8.3. Latest Transaction Deals in the Oncology Gene Therapy Space
  • 8.4. Mergers and Acquisitions That Include Oncology Gene Therapy Assets: 2019 - 2021
  • 8.5. Mergers and Acquisitions That Include Oncology Gene Therapy Assets: 2014 - 2018

9. Regulatory and Market Access

  • 9.1. Gene Therapy in Clinical Trials
  • 9.2. Regulatory - US
  • 9.3. Market Access - US
  • 9.4. Regulatory - Europe
  • 9.5. Market Access - Europe
  • 9.6. Regulation of Gene Therapy in the US and Europe
  • 9.7. Regulatory and Market Access - Japan
  • 9.8. Comparison of Early Access Schemes in the US, EU, and Japan
  • 9.9. Regulatory and Market Access - China

10. Opportunities, Challenges, and Unmet Needs

  • 10.1. Gene Therapy Vectors, Viral - Opportunities & Challenges
  • 10.2. Gene Therapy Vectors, Non-viral - Opportunities & Challenges
  • 10.3. Therapuetic Oligonucleotides - Opportunities & Challenges
  • 10.4. Genome Editing - Opportunities & Challenges
  • 10.5. Oncolytic Viruses - Opportunities & Challenges
  • 10.6. Clinical Unmet Needs in Gene Therapy - Gap Analysis
  • 10.7. Commercial Unmet Needs in Gene Therapy - Gap Analysis
  • 10.8. Unmet Needs - KOLs Perspective

11. Companies

  • 11.1. Drug Development Scorecard - Regenerative Medicine
  • 11.2. Current Major Players
    • 11.2.1. Amgen
    • 11.2.2. SiBiono
    • 11.2.3. Sunway Biotech
  • 11.3. Future Players Based on Pipeline Strength
    • 11.3.1. Candel
    • 11.3.2. CG Oncology
    • 11.3.3. Checkmate
    • 11.3.4. Daiichi Sankyo
    • 11.3.5. Ferring
    • 11.3.6. FKD
    • 11.3.7. Geron
    • 11.3.8. Idera
    • 11.3.9. Istari
    • 11.3.10. VBL

12. Appendix

  • 12.1. Bibliography
  • 12.2. Primary Research
  • 12.3. Key Themes Impacting the Pharmaceutical Industry
  • 12.4. Our Thematic Research Methodology
  • 12.5. About the Authors
  • 12.6. Contact Us
  • 12.7. Disclaimer