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암 유전자 치료제 : 경쟁 상황, 기술적 발전 동향, 시장 기회, 향후 방향성

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

리서치사 DelveInsight Business Research LLP
발행일 2018년 11월 상품 코드 740511
페이지 정보 영문 281 Pages
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US $ 3,750 ₩ 4,276,500 PDF by E-mail (Single User License)


암 유전자 치료제 : 경쟁 상황, 기술적 발전 동향, 시장 기회, 향후 방향성 Gene Therapies in Oncology - Innovation to Commercialization: Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions
발행일 : 2018년 11월 페이지 정보 : 영문 281 Pages

암 유전자 치료는 게노믹스 연구의 진보로 향후 암치료에서 확실시되고 있는 성장 부문입니다.

암 유전자 치료제(Gene Therapies in Oncology) 시장을 조사했으며, 유전자 치료의 정의와 개요, 발전 경위, 유전자 치료제의 각종 종류, 주요 7개국의 규제 가이드라인, 상환 환경, 경쟁 분석, 시장 성장에 대한 각종 영향요인, 출시 제품·파이프라인 의약품·주요 기업 개요, 향후 전망 등의 정보를 전해드립니다.

보고서 개요

주요 요약

암 유전자 치료 : 개요

  • 서론 : 정의와 배경
  • 유전자 치료의 발전 경위
  • 암 유전자 치료의 중요성
  • 유전자 치료의 각종 종류
  • 유전자 도입 : 벡터 타입과 딜리버리 방법
  • 암 유전자 치료의 이점
  • 암 유전자 치료제 개발의 주요 과제

유전자 편집

  • 뉴클레아제의 각종 종류
  • 안전성 및 윤리상 우려
  • 유전자 편집 기술 개발 사업자

주요 7개국의 규제 가이드라인

암 유전자 치료제 분석 : 혁신에서 상업화로

  • 암 유전자 치료제 분석 : 전체 제품
  • 암 유전자 치료제 임상 파이프라인 분석
  • 암 유전자 치료제 분석 : 제공 기업별
  • 암 유전자 치료제 분석 : 제품 개발 구분별
  • 암 유전자 치료제 분석 : 제품 종류별 - 병용요법
  • 암 유전자 치료제 분석 : 오리지네이터별
  • 암 유전자 치료제 분석 : 의약품 기업별
  • 암 유전자 치료제 분석 : 기술별
  • 암 유전자 치료제 분석 : 표적별
  • 암 유전자 치료제 분석 : 벡터별 등

출시 유전자 치료제

  • PROVENGE : DENDREON CORPORATION(SAN POWER GROUP)
  • IMLYGIC : AMGEN
  • ONCORINE : SHANGHAI SUNWAY BIOTECH
    • 약제 개요
    • 제품 프로파일
    • 작용기서
    • 규제상 마일스톤
    • 안전성 및 유효성
    • 장단점

출시 제품 매출 분석

유전자 치료제 파이프라인

  • ADVAXIS
    • Axalimogene filolisbac(ADXS11-001; AXAL)
  • ADVANTAGENE
    • ProsAtak
  • AMERICAN GENE TECHNOLOGIES
    • γδ T 세포 치료
  • 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
  • Takara Bio Inc.
    • TBI-1301
    • TBI-1201
    • HF10
  • UNUM THERAPEUTICS
    • ACTR087
  • ZIOPHARM ONCOLOGY
    • Ad-RTS-hIL-12
  • VYRIAD
    • Voyager-V1
    • HPV 관련 종양용 VSV
    • MV-NIS
  • CZ BIOMED
    • Brvlysis
    • Corvlysis
    • Hervlysis
    • Lurvlysis
    • Mervlysis
    • Ovarvlysis
    • Panrvlysis
    • Prorvlysis
  • BIONOXX
    • Oncolytic Poxvirus(VVtk-)
  • ASTELLAS
    • 항암 바이러스 연구 프로그램
  • REPLIMMUNE
    • RP1
  • TURNSTONE BIOLOGICS
    • MG1-MAGEA3
  • MULTIVIR
    • Ad-IL24
    • Ad-p53

상환 시나리오

비용 분석

승인 및 매출 생성 장벽

암 유전자 치료 전망

Delveinsight의 경쟁 매트릭스 모델링

시장 성장 촉진요인

시장 장벽

부록

KSM 18.11.13

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

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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