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癌の遺伝子治療薬:競合環境・技術的発展動向・市場機会・将来の方向性

Gene Therapies in Oncology - Innovation to Commercialization: Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions

発行 DelveInsight Business Research LLP 商品コード 740511
出版日 ページ情報 英文 281 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=110.75円で換算しております。
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癌の遺伝子治療薬:競合環境・技術的発展動向・市場機会・将来の方向性 Gene Therapies in Oncology - Innovation to Commercialization: Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions
出版日: 2018年11月01日 ページ情報: 英文 281 Pages
担当者のコメント
注目のオンコロジー分野における遺伝子治療薬について、各社様の最新の取り組み、開発動向、薬剤プロファイル、法規制など、約300ページでまとめた内容になります。
概要

癌の遺伝子治療はゲノミクス研究の進歩から、将来の癌治療において確実視されている成長部門です。

当レポートでは、癌の遺伝子治療薬の市場を調査し、遺伝子治療の定義と概要、発展の経緯、遺伝子治療薬の各種タイプ、主要7カ国の法規制ガイドライン、償還環境、競合分析、市場成長への各種影響因子の分析、上市済み製品・パイプライン薬・主要企業のプロファイル、将来の展望などをまとめています。

レポート概要

エグゼクティブサマリー

癌の遺伝子治療:概要

  • イントロダクション:定義・背景
  • 遺伝子治療の発展の経緯
  • 癌の遺伝子治療の重要性
  • 遺伝子治療の各種タイプ
  • 遺伝子導入:ベクタータイプとデリバリー手法
  • 癌の遺伝子治療のメリット
  • 癌の遺伝子治療薬の開発における主な課題

遺伝子編集

  • ヌクレアーゼの各種タイプ
  • 安全性・倫理上の懸念
  • 遺伝子編集技術の開発事業者

主要7カ国の法規制ガイドライン

癌の遺伝子治療薬の分析:イノベーションから商業化へ

  • 癌の遺伝子治療薬の分析:全製品
  • 癌の遺伝子治療薬の臨床パイプライン分析
  • 癌の遺伝子治療薬の分析:提供企業別
  • 癌の遺伝子治療薬の分析:製品開発区分別
  • 癌の遺伝子治療薬の分析:製品タイプ別 - 併用療法
  • 癌の遺伝子治療薬の分析:オーガナイザー別
  • 癌の遺伝子治療薬の分析:医薬品企業別
  • 癌の遺伝子治療薬の分析:技術別
  • 癌の遺伝子治療薬の分析:標的別
  • 癌の遺伝子治療薬の分析:ベクター別、など

上市済み遺伝子治療薬

  • PROVENGE:DENDREON CORPORATION (SAN POWER GROUP)
  • IMLYGIC:AMGEN
  • ONCORINE:SHANGHAI SUNWAY BIOTECH
    • 薬剤の概要
    • 製品プロファイル
    • 作用機序
    • 法規制上のマイルストーン
    • 安全性・有効性
    • メリット・デメリット

上市済み製品の売上分析

遺伝子治療薬のパイプライン

  • ADVAXIS
    • Axalimogene filolisbac (ADXS11-001; AXAL)
  • ADVANTAGENE
    • ProsAtak
  • AMERICAN GENE TECHNOLOGIES
    • γδ T細胞療法
  • CELL MEDICA LTD
    • CMD-602
  • COLD GENESYS
    • CG0070
  • CELSION CORPORATION
    • GEN-1
  • GENELUX CORPORATION
    • GL-ONC1
  • IMMATICS
    • IMA201
    • IMA202
  • INOVIO PHARMACEUTICALS
    • INO-5401
  • MAXIVAX SA
    • MVX-ONCO-1
  • MORPHOGENESIS
    • IFx-Hu2.0
  • LOKON PHARMA AB
    • LOAd703
    • LOAd713
    • LOAd700
  • MARSALA BIOTECH
    • E10A
  • MOLOGEN AG
    • MGN1601
  • ONCOSEC MEDICAL INCORPORATED
    • TAVO (pIL-12)
  • OXFORD BIOMEDICA
    • OXB-302
  • PNP THERAPEUTICS
    • Ad/PNP・fludarabine monophosphate
  • SILLAJEN
    • Pexa-Vec
  • SYNERGENE THERAPEUTICS, INC.
    • SGT-53
  • TARGOVAX
    • ONCOS-102
  • TOCAGEN
    • Toca 511-FC
    • Toca 521
  • タカラバイオ
    • TBI-1301
    • TBI-1201
    • HF10
  • UNUM THERAPEUTICS
    • ACTR087
  • ZIOPHARM ONCOLOGY
    • Ad-RTS-hIL-12
  • VYRIAD
    • Voyager-V1
    • HPV関連腫瘍向けVSV
    • MV-NIS
  • CZ BIOMED
    • Brvlysis
    • Corvlysis
    • Hervlysis
    • Lurvlysis
    • Mervlysis
    • Ovarvlysis
    • Panrvlysis
    • Prorvlysis
  • BIONOXX
    • Oncolytic Poxvirus (VVtk-)
  • アステラス製薬
    • 腫瘍溶解性ウイルス研究プログラム
  • REPLIMMUNE
    • RP1
  • TURNSTONE BIOLOGICS
    • MG1-MAGEA3
  • MULTIVIR
    • Ad-IL24
    • Ad-p53

償還シナリオ

コスト分析

承認・収益生成の障壁

癌の遺伝子治療の展望

DELVEINSIGHTによる競合マトリクスモデリング

市場成長推進因子

市場の障壁

付録

図表

List of Tables

  • TABLE 1: GENE THERAPY IN ONCOLOGY ANALYSIS BY TOTAL PRODUCTS, 2018
  • TABLE 2: GENE THERAPY IN ONCOLOGY CLINICAL PIPELINE ANALYSIS BY REGION (N), 2018
  • TABLE 3: GENE THERAPY IN ONCOLOGY ANALYSIS BY REGULATORY DESIGNATIONS, 2018
  • TABLE 4: GENE THERAPY IN ONCOLOGY ANALYSIS BY COMPANY COLLABORATIONS, 2018
  • TABLE 5: GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE, 2018
  • TABLE 6: GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE - COMBINATION THERAPY , 2018
  • TABLE 7: GENE THERAPY IN ONCOLOGY ANALYSIS BY ORIGINATOR, 2018
  • TABLE 8: GENE THERAPY IN ONCOLOGY ANALYSIS BY PHARMACEUTICAL COMPANIES, 2018
  • TABLE 9: GENE THERAPY IN ONCOLOGY ANALYSIS BY TECHNOLOGY, 2018
  • TABLE 10: GENE THERAPY IN ONCOLOGY ANALYSIS BY TARGETS, 2018
  • TABLE 11: GENE THERAPY IN ONCOLOGY ANALYSIS BY VECTORS, 2018
  • TABLE 12: GENE THERAPY IN ONCOLOGY ANALYSIS BY VECTORS, PRODUCTS & COMPANIES, 2018
  • TABLE 13: GENE THERAPY IN ONCOLOGY ANALYSIS BY VIRAL VECTORS (PHASES), 2018
  • TABLE 14: GENE THERAPY IN ONCOLOGY ANALYSIS BY VIRAL VECTORS (TYPE), 2018
  • TABLE 15: GENE THERAPY IN ONCOLOGY ANALYSIS BY NON-VIRAL VECTORS (PHASES), 2018
  • TABLE 16: MARKETED GENE THERAPIES IN ONCOLOGY, 2018
  • TABLE 17: GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS SALES ANALYSIS (MILLION), 2018
  • TABLE 18: MARKET ACCESS STATUS OF EC-APPROVED CELLULAR & GENE THERAPIES AS OF MARCH 31, 2017
  • TABLE 19: DESCRIPTIONS OF PAYMENT MODELS FOR GENE THERAPIES
  • TABLE 20:TOP 10 EARLY MARKET WINNERS IN GENE THERAPIES ONCOLOGY BY RANK

List of Figures

  • FIGURE 1: GENE THERAPY IN ONCOLOGY ANALYSIS BY TOTAL PRODUCTS (N), 2018
  • FIGURE 2: GENE THERAPY IN ONCOLOGY CLINICAL PIPELINE ANALYSIS BY REGION (N), 2018
  • FIGURE 3: GENE THERAPY IN ONCOLOGY ANALYSIS BY REGULATORY DESIGNATIONS, 2018
  • FIGURE 4: GENE THERAPY IN ONCOLOGY ANALYSIS BY COMPANY COLLABORATIONS (%), 2018
  • FIGURE 5: GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE (%), 2018
  • FIGURE 6: GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE-COMBINATION THERAPY (N), 2018
  • FIGURE 7: GENE THERAPY IN ONCOLOGY ANALYSIS BY ORIGINATOR (%), 2018
  • FIGURE 8: GENE THERAPY IN ONCOLOGY ANALYSIS BY PHARMACEUTICAL COMPANIES (CLINICAL VS NON-CLINICAL), 2018
  • FIGURE 9: GENE THERAPY IN ONCOLOGY ANALYSIS BY TECHNOLOGY, 2018
  • FIGURE 10: GENE THERAPY IN ONCOLOGY ANALYSIS BY TARGETS, 2018
  • FIGURE 11: GENE THERAPY IN ONCOLOGY ANALYSIS BY VECTORS, 2018
  • FIGURE 12: GENE THERAPY IN ONCOLOGY ANALYSIS BY VIRAL VECTORS (PHASES), 2018
  • FIGURE 13: GENE THERAPY IN ONCOLOGY ANALYSIS BY VIRAL VECTORS (TYPE), 2018
  • FIGURE 14: GENE THERAPY IN ONCOLOGY ANALYSIS BY NON-VIRAL VECTORS (PHASES), 2018
  • FIGURE 15: MARKETED GENE THERAPIES IN ONCOLOGY, 2018
  • FIGURE 16: GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS SALES ANALYSIS, 2018
  • FIGURE 17: COMPETITIVE MATRIX FOR GENE THERAPY IN ONCOLOGY DISEASE
  • FIGURE 18: MARKET DRIVERS
  • FIGURE 19: MARKET BARRIERS
目次

Introduction

The Oncology market is the most lucrative in the overall therapeutic segment. Up to now, effective cancer medications have probably guaranteed the highest returns for pharmaceutical manufacturers. The market is poised to continue to show strong growth, with an incredible sales rate of oncological therapies, driven by components such as aging population and changes in lifestyle that predispose to diseases. Personalised medicines such as Immuno-checks, gene therapy and T cell therapy are the fastest growing segments within the oncology field and the growth is likely to continue.

Gene Therapy in Oncology is a growing segment in Oncology sector and hold huge promise for the future of cancer therapy. This is due to advances in genomics that add to this positive outlook for cancer patients and genetic modification methods, reinforcing this progress. All cancers represent a certain degree of genetic or hereditary link. As a result of this, small pharmaceutical companies with an emphasis on the improvement of particular, novel innovations may at first focus on a particular growth subtype, yet additionally represents a huge opportunity of being funded through partnership or being acquired by an active portfolio player.

The report “Gene Therapies in Oncology - Innovation to Commercialization: Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions” includes Comprehensive Insights on Cancer Gene Therapy by Market Trends, Competitive Landscape, Clinical Trials, Regulatory Considerations, Potential Geographies Licensing Opportunities, Top Cancer Indications, Vectors (Viral, Non-Viral, Engineered nucleases) and Advancements in Technology. It provides information across the entire gene therapy value chain covering gene therapy profiles core insights, pre-clinical data, clinical data, technology details, and funding and licensing opportunities. Using the propriety DelveInsight Competitive Matrix models, the report also provides the first in class market analytics providing predictive analysis of early market winners of the clinical therapies in a demographic presentation view.

It has covered ~50 gene therapies covering 34 Pharmaceutical companies. Studies have been performed for approximately 60+ specific indications under Oncology. The Companies are utilizing 26 different technology platforms which have own uniqueness and robustness. The Report is also giving insights about the vectors usage in Gene therapy which is approximately 82% for viral vectors, 11% for the Non-Viral vectors and 7% for the Bacterial vectors.

Table of Contents

REPORT INTRODUCTION

  • REPORT HIGHLIGHTS
  • REPORT SCOPE

EXECUTIVE SUMMARY

GENE THERAPY IN ONCOLOGY: OVERVIEW

  • INTRODUCTION- DEFINITION AND BACKGROUND
    • Gene Therapy and Patterns of Gene Expression
    • Gene Therapy and Molecular Medicine
  • HISTORY- EVOLUTION OF GENE THERAPY OVER THE YEARS
  • ROLE OF GENE THERAPY IN ONCOLOGY
    • Gene Therapy in Cancer Treatment
    • Genetic Basis of Carcinogenesis
    • Gene Therapy Approaches to Cancer Treatment
  • TYPES OF GENE THERAPY
    • 1. Somatic Gene Therapy:
    • 2. Germ Line Gene Therapy:
  • GENE TRANSFER- TYPES OF VECTORS AND GENE DELIVERY METHODS
    • Viral Vectors
    • Non-Viral Vectors
  • ADVANTAGES OF GENE THERAPY IN ONCOLOGY
  • KEY CHALLENGES IN DEVELOPMENT OF GENE THERAPY FOR ONCOLOGY

GENE EDITING IN GENE THERAPY

  • TYPES OF NUCLEASES
    • Mega-nucleases
    • Zinc finger nucleases
    • Transcription Activator-Like Effector Nucleases (TALEN)
    • Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)
  • SAFETY AND ETHICAL CONCERNS
  • COMPANIES DEVELOPING GENE EDITING TECHNOLOGIES

REGULATORY GUIDELINES FOR GENE THERAPY PRODUCTS IN 7MM

  • GENERAL REGULATORY ENVIRONMENT
    • The United States Regulatory Guidelines
    • The EU5 Countries Regulatory Guidelines
    • Japan Regulatory Guidelines
  • GUIDANCE'S ON DEVELOPMENT PROCESS
    • Pre-Clinical and Clinical Development
    • Product Quality
    • Pre-Clinical Assessment
    • Clinical Development
    • Shedding
    • Delayed Adverse Effects
  • REGULATORY INCENTIVES AND SUPPORT

GENE THERAPY IN ONCOLOGY ANALYSIS -INNOVATION TO COMMERCIALIZATION

  • GENE THERAPY IN ONCOLOGY ANALYSIS BY TOTAL PRODUCTS
  • GENE THERAPY IN ONCOLOGY CLINICAL PIPELINE ANALYSIS BY REGION
  • GENE THERAPY IN ONCOLOGY PIPELINE ANALYSIS BY REGULATORY DESIGNATIONS
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY COMPANIES COLLABORATIONS
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE DEVELOPMENT
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE -COMBINATION THERAPY
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY ORIGINATOR
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY PHARMACEUTICAL COMPANIES
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY TECHNOLOGY
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY TARGETS
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY VECTORS
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY VIRAL VECTORS
    • Gene Therapy Viral Vectors Analysis by Phases
    • Gene Therapy Viral Vectors Analysis by Viral Vector Type
  • GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY NON-VIRAL VECTORS
    • Gene Therapy Non-Viral Vectors Analysis by Phases

MARKETED GENE THERAPIES

  • PROVENGE: DENDREON CORPORATION (ACQUIRED BY SAN POWER GROUP)
    • Drug Description
    • Product Profile
    • Mechanism of Action
    • Regulatory Milestones
    • Advantages & Disadvantages
    • Clinical Studies
    • Other Clinical trial description, 2018
  • IMLYGIC: AMGEN
    • Drug Description
    • Product Profile
    • Mechanism of Action
    • Regulatory Milestones
    • Advantages & Disadvantages
    • Safety and Efficacy
    • Other Clinical trial description, 2018
  • ONCORINE: SHANGHAI SUNWAY BIOTECH
    • Drug Description
    • Product Profile
    • Mechanism of Action
    • Regulatory Milestones
    • Safety and Efficacy
    • Advantages & Disadvantages

GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS SALES ANALYSIS

  • GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS-COMPARATIVE SALES

GENE THERAPIES IN PIPELINE

  • ADVAXIS
    • Description
    • Technology
    • Research and Development
    • Axalimogene filolisbac (ADXS11-001; AXAL): Advaxis
    • Product Development Activities
  • ADVANTAGENE
    • Description
    • Technology
    • ProsAtak: Advantagene
    • Product Development Activities
  • AMERICAN GENE TECHNOLOGIES
    • Company Description
    • Company Technology
    • γδ T cell Therapies: American Gene Technologies
  • CELL MEDICA LTD
    • Description
    • Technology
    • Other Developmental Activities
    • CMD-602: Cell Medica
  • COLD GENESYS
    • Description
    • Future Milestones
    • CG0070: Cold Genesys
  • CELSION CORPORATION
    • Description
    • Technology
    • Other Developmental Activities
    • GEN-1: Celsion Corporation
  • GENELUX CORPORATION
    • Description
    • Technology Description
    • GL-ONC1: Genelux Corporation
  • IMMATICS
    • Description
    • Technology Description
    • Other Development Activities
    • IMA201: Immatics
    • IMA202: Immatics US, Inc
  • INOVIO PHARMACEUTICALS
    • Description
    • Technology
    • INO-5401: Inovio Pharmaceuticals, Inc.
  • MAXIVAX SA
    • Description
    • Technology
    • MVX-ONCO-1: MaxiVAX SA
  • MORPHOGENESIS
    • Description
    • Other Development Activities
    • IFx-Hu2.0: Morphogenesis
  • LOKON PHARMA AB
    • Description
    • Technology
    • LOAd703: Lokon Pharma AB
    • LOAd713: Lokon Pharma
    • LOAd700: Lokon Pharma
  • MARSALA BIOTECH
    • Description
    • Technology
    • E10A: Marsala Biotech
  • MOLOGEN AG
    • Description
    • Technology
    • MGN1601: Mologen AG
  • ONCOSEC MEDICAL INCORPORATED
    • Description
    • Collaboration
    • Technology Description
    • TAVO (pIL-12): OncoSec Medical
  • OXFORD BIOMEDICA
    • Description
    • Technology
    • OXB-302: Oxford BioMedica
  • PNP THERAPEUTICS
    • Description
    • Technology
    • Ad/PNP and fludarabine monophosphate: PNP Therapeutics, Inc.
  • SILLAJEN
    • Description
    • Technology
    • Pexa-Vec: SillaJen
  • SYNERGENE THERAPEUTICS, INC.
    • Description
    • SGT-53: SynerGene Therapeutics, Inc.
  • TARGOVAX
    • Description
    • Technology
  • ONCOS-102: TARGOVAX
  • TOCAGEN
    • Description
    • Toca 511-FC: Tocagen
    • Toca 521: Tocagen
  • TAKARA BIO, INC
    • Description
    • TBI-1301: Takara Bio, Inc
    • TBI-1201: Takara Bio, Inc.
    • HF10: Takara Bio, Inc.
  • UNUM THERAPEUTICS
    • Description
    • Technology
    • Other Developmental Activities
    • ACTR087: Unum Therapeutics
  • ZIOPHARM ONCOLOGY
    • Description
    • Ad-RTS-hIL-12: Ziopharm Oncology
  • VYRIAD
    • Description
    • Technology
    • Voyager-V1: Vyriad
    • VSV for HPV associated cancers: Vyriad
    • MV-NIS: Vyriad
  • CZ BIOMED
    • Description
    • Technology
    • Brvlysis: CZ Biomed
    • Corvlysis: CZ Biomed
    • Hervlysis: CZ Biomed
    • Lurvlysis: CZ Biomed
    • Mervlysis: CZ Biomed
    • Ovarvlysis: CZ Biomed
    • Panrvlysis: CZ Biomed
    • Prorvlysis: CZ Biomed
  • BIONOXX
    • Oncolytic Poxvirus (VVtk-): Bionoxx
  • ASTELLAS
    • Description
    • Oncolytic Virus Research Programme: Astellas
  • REPLIMMUNE
    • Description
    • RP1: Replimmune
  • TURNSTONE BIOLOGICS
    • Description
    • MG1-MAGEA3: Turnstone Biologics
  • MULTIVIR
    • Description
    • Ad-IL24: Multivir
    • Ad-p53: MultiVir

REIMBURSEMENT SCENARIO FOR CANCER GENE THERAPIES IN 7MM

  • THE UNITED STATES
    • Provenge Reimbursement Scenario in the US
    • Imlygic Reimbursement Scenario in the US
  • EU-5 COUNTRIES
    • Provenge Reimbursement Scenario in the EU5 countries
    • Imlygic Reimbursement Scenario in the EU5 countries
  • MARKET ACCESS AND REIMBURSEMENT SCENARIO FOR CANCER GENE THERAPY IN JAPAN
    • Key Opinion Leaders (KOL) - Views

COST ANALYSIS OF GENE THERAPIES- CHALLENGES AND COUNTERMEASURES

HURDLES IN APPROVAL AND REVENUE GENERATION

  • REIMBURSEMENTS
  • EVIDENCE GENERATION
  • VALUATION AND PRICING
  • COMMERCIALIZATION

FUTURE OF GENE THERAPY IN ONCOLOGY

DELVEINSIGHT COMPETITIVE MATRIX MODELING

  • Top 10 Early Market Winners in Gene Therapies Oncology

MARKET DRIVERS

MARKET BARRIERS

APPENDIX

  • REPORT METHODOLOGY
    • Coverage
  • DELVEINSIGHT COMPETITIVE MATRIX
    • Technical Description
  • DELVEINSIGHT CAPABILITIES
  • DISCLAIMER
  • ABOUT DELVEINSIGHT
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