Gene Therapy in Oncology
Unlike conventional treatments such as chemotherapy, gene therapy combines reduced treatment duration (one time treatment in some cases) with higher chances of cure in oncology. This novel therapeutic approach requires direct delivery of genetic material to the patient or in vitro genetic modification of patient cells and subsequent delivery to the patient, which is an uncharted territory in oncology and will necessitate the implementation of new regulatory guidelines and restructuring of the existing treatment algorithms in various oncology indications. In this report, GlobalData provides an overview of the current competitive landscape of gene therapies in multiple oncology indications, the regulatory framework concerning their clinical development and commercialization in the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China). In addition, the report covers in detail the late stage clinical development of cancer gene therapies in the 8MM, providing key opinion leader (KOL) insight on the impact of cancer gene therapies in various treatment paradigms in the oncology space as well as payer perspective on the cost and reimbursement of novel cancer gene therapies.
- GlobalDatas Gene Therapy in Oncology combines KOL and payer insight with in-house analyst expertise and research to provide an insight-rich look at cancer gene therapies in the 8MM. Components of the report include -
- Overview of Cancer Gene Therapy: What are the gene transfer methods and strategies used in oncology.
- Cancer Gene Therapy in the 8MM: What is the regulatory framework concerning development and approval of cancer gene therapies in the 8MM and what are the currently marketed gene therapies in the oncology space in the 8MM.
- Clinical Development of Gene Therapies in Oncology: What are the late stage pipeline cancer gene therapies.
- Clinical Trial Mapping and Design: How are gene therapies positioned in the oncology space: what are the oncology indications they are targeting and which other therapeutic agents are they being evaluated in combination with.
- Market Outlook for Cancer Gene Therapies in Oncology: When are cancer gene therapies expected to be marketed for various oncology indications, what are some of the most promising candidates, and what are some challenges that cancer gene therapies are expected to face following their launch.
- Reimbursement of Gene Therapies in Oncology: What are the challenges associated with reimbursement of novel cancer therapies and some strategies to contain the cost of cancer gene therapies.
Reasons to buy
- Develop business strategies by understanding the trends shaping and driving the gene therapy in the oncology space in the 8MM.
- Formulate effective sales and marketing strategies by understanding the current competitive landscape and by analyzing the portfolios of various competitors.
- Identify areas of unmet need within the cancer gene therapy market to help drive research and development towards future market opportunities.
- Gain insights to help plan and design your clinical trials.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
- Identify key pricing and reimbursement strategies.
Table of Contents
1.1 Table of Contents 2
1.2 Abbreviations 4
1.3 Related Reports 9
1.4 Upcoming Related Reports 10
2. Executive Summary 11
2.1 Key Findings 12
2.2 KOL Insight on Cancer Gene Therapy Competitive Landscape 13
3. Overview - Cancer Gene Therapy 14
3.1 What is Gene Therapy? 16
3.2 Gene Transfer Methods and Vectors Used for Gene Therapy 24
3.3 Viral Vectors 25
3.4 Non-Viral Vectors 31
3.5 Gene Therapy Strategies Employed in Oncology 38
3.6 Sources 56
4. Cancer Gene Therapy in the 8MM 58
4.1 Global Regulatory Agencies Definitions of Gene Therapy 59
4.2 Cancer Gene Therapy in the US 60
4.3 Cancer Gene Therapy in the EU 61
4.4 Cancer Gene Therapy in Japan 62
4.5 Cancer Gene Therapy in China 64
4.6 Timeline of Clinical Development in Gene Therapy in the 8MM 65
4.7 Currently Marketed Gene Therapies in Oncology 73
4.8 Sources 80
5. Pipeline Assessment in the 8MM 82
5.1 Cancer Gene Therapy Pipeline in the 8MM 83
5.2 Pipeline Products - Phase III 85
5.3 Pipeline Products - Phase II 86
5.4 Mologens Lefitolimod 91
5.5 Ideras IMO-2125 92
5.6 Gerons Imetelstat 93
5.7 Oncotelics Trabedersen 94
5.8 VBL Therapeutics VB-111 95
5.9 Sillajens JX-594 97
5.10 Tocagens Toca 511 98
5.11 Advantagenes ProstAtak 100
5.12 MarsalaBiotechs E-10A 101
5.13 Advaxis AXAL 102
5.14 Sources 109
6. Clinical Trials Mapping and Design 110
6.1 Clinical Trial Mapping of Late Stage Gene Therapy Pipeline 112
6.2 Clinical Trial Mapping by Tumor Type 114
6.3 Clinical Trial Duration by Indication 116
6.4 Combination Partner by Therapy Area 122
6.5 Ongoing Clinical Trials of Cancer Gene Therapy Pipeline 123
6.6 Summary 126
7. Payer Perspective on Cancer Gene Therapies 127
7.1 Current Oncology Space 129
7.2 Challenges Associated with Reimbursement of Novel Cancer Therapies 130
7.3 Strategies to Tackle the Cost of Cancer Gene Therapies 131
7.4 A Novel Mechanism to Cover the Cost of Cancer Gene Therapies 132
8. Market Outlook 133
8.1 Phase III Cancer Gene Therapy Pipeline 135
8.2 Key Launch Dates for Phase III and II Cancer Gene Therapy Pipeline 137
9. Appendix 138
9.1 Methodology 139
9.2 Primary Research 140
9.3 About the Authors 141
9.4 About GlobalData 143
9.5 Contact Us 144
9.6 Disclaimer 145
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