Gene Therapy in Oncology: Innovation to Commercialization, Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions
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DelveInsight report “Gene Therapies in Oncology - Innovation to Commercialization: Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions, 2018” 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 inherent uniqueness and robustness. The Report also gives insights about the vectors usage in Gene therapy which are approximately 82% for viral vectors, 11% for the Non-Viral vectors and 7% for the Bacterial vectors.
The power of cell and gene therapies targeted for the life-threatening and high unmet need diseases have been the driving force behind academics, small biotech firms; and now large pharmaceutical companies which are also actively investing time and resources in this rapidly evolving area. The concept of human gene therapies had emerged in 1989, with the first approved human gene therapy trial of Rosenberg et al., which investigated the use of human tumor-infiltrating lymphocytes (TIL) modified genetically by introducing the gene coding for resistance to neomycin into TIL for patients with advanced melanoma. The discipline as a whole received a moderate push during the 1990’s until the elucidation of the human genome in 2003.There has been no looking back since then, and thereafter leading up to a stage where gene therapy is touted as the next big thing in the healthcare space; and is set to break the existing barriers and create new horizons.
Report Scope:
The report covers a descriptive account of Gene Therapy in oncology, inclusive of its historical timeline & its evolution over the years, types, and vectors along with the corresponding gene-transfer methods as well as delivery techniques, apart from advancements in technologies
Coverage of cancer gene therapy candidates under development worldwide, showcasing their relative positioning in global Oncology therapeutic space
Breakdown of Pipeline candidates across different phases, emerging trends and comparative analysis of the products with detailed clinical profiles, Targets, Designations, Technologies, Combination drugs along with product development activities
In-depth analysis of developmental gene therapy molecules based on cancer indication, types of vector, clinical staging and by geography
Comprehensive insight is provided into licensing & collaboration opportunities and funding details for emerging gene therapies
Matrix analysis, based on clinical and commercial scoring of promising therapies under late-stage development, to predict their regulatory success and subsequent market penetration
Mapping of Clinical trials based upon the trial design, targeted cancer indications and geography
A detailed review of the regulatory guidelines/framework for the approval of gene therapy across the 7MM [US, EU5 countries and Japan]
Additionally, an all-inclusive account of the currently marketed gene therapies in Oncology and their commercial impact in the market covered
The report provides an edge while formulating business strategies by enabling comprehensive understanding of the historical trends, present challenges and future developmental opportunities for Cancer Gene Therapy; which will help in prudently positioning in the market against competitors
DelveInsight report “Gene Therapies in Oncology - Innovation to Commercialization: Competitive Landscape, Technological Advancements, Market Opportunities & Future Directions, 2018” 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 inherent uniqueness and robustness. The Report also gives insights about the vectors usage in Gene therapy which are approximately 82% for viral vectors, 11% for the Non-Viral vectors and 7% for the Bacterial vectors.
The power of cell and gene therapies targeted for the life-threatening and high unmet need diseases have been the driving force behind academics, small biotech firms; and now large pharmaceutical companies which are also actively investing time and resources in this rapidly evolving area. The concept of human gene therapies had emerged in 1989, with the first approved human gene therapy trial of Rosenberg et al., which investigated the use of human tumor-infiltrating lymphocytes (TIL) modified genetically by introducing the gene coding for resistance to neomycin into TIL for patients with advanced melanoma. The discipline as a whole received a moderate push during the 1990’s until the elucidation of the human genome in 2003.There has been no looking back since then, and thereafter leading up to a stage where gene therapy is touted as the next big thing in the healthcare space; and is set to break the existing barriers and create new horizons.
Report Scope:
The report covers a descriptive account of Gene Therapy in oncology, inclusive of its historical timeline & its evolution over the years, types, and vectors along with the corresponding gene-transfer methods as well as delivery techniques, apart from advancements in technologies
Coverage of cancer gene therapy candidates under development worldwide, showcasing their relative positioning in global Oncology therapeutic space
Breakdown of Pipeline candidates across different phases, emerging trends and comparative analysis of the products with detailed clinical profiles, Targets, Designations, Technologies, Combination drugs along with product development activities
In-depth analysis of developmental gene therapy molecules based on cancer indication, types of vector, clinical staging and by geography
Comprehensive insight is provided into licensing & collaboration opportunities and funding details for emerging gene therapies
Matrix analysis, based on clinical and commercial scoring of promising therapies under late-stage development, to predict their regulatory success and subsequent market penetration
Mapping of Clinical trials based upon the trial design, targeted cancer indications and geography
A detailed review of the regulatory guidelines/framework for the approval of gene therapy across the 7MM [US, EU5 countries and Japan]
Additionally, an all-inclusive account of the currently marketed gene therapies in Oncology and their commercial impact in the market covered
The report provides an edge while formulating business strategies by enabling comprehensive understanding of the historical trends, present challenges and future developmental opportunities for Cancer Gene Therapy; which will help in prudently positioning in the market against competitors
1. REPORT INTRODUCTION
2. EXECUTIVE SUMMARY
3. GENE THERAPY IN ONCOLOGY OVERVIEW
4. GENE THERAPY IN ONCOLOGY INTRODUCTION
5. HISTORY- EVOLUTION OF GENE THERAPY OVER THE YEARS
6. GENE THERAPY IN ONCOLOGY ROLE
7. TYPES OF GENE THERAPY
8. GENE TRANSFER- TYPES OF VECTORS AND GENE DELIVERY METHODS
9. GENE THERAPY IN ONCOLOGY ADVANTAGES
10. KEY CHALLENGES IN DEVELOPMENT OF GENE THERAPY FOR ONCOLOGY
11. GENE EDITING IN GENE THERAPY
12. TYPES OF NUCLEASES
13. SAFETY AND ETHICAL CONCERNS
14. COMPANIES DEVELOPING GENE EDITING TECHNOLOGIES
15. REGULATORY GUIDELINES FOR GENE THERAPY PRODUCTS IN 7MM
16. GENERAL REGULATORY ENVIRONMENT
17. REGULATORY INCENTIVES AND SUPPORT
18. GENE THERAPY IN ONCOLOGY ANALYSIS –INNOVATION TO COMMERCIALIZATION
19. GENE THERAPY IN ONCOLOGY ANALYSIS BY TOTAL PRODUCTS
20. GENE THERAPY IN ONCOLOGY CLINICAL PIPELINE ANALYSIS BY REGION
21. GENE THERAPY IN ONCOLOGY PIPELINE ANALYSIS BY REGULATORY DESIGNATIONS
22. GENE THERAPY IN ONCOLOGY ANALYSIS BY COMPANIES COLLABORATIONS
23. GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE DEVELOPMENT
24. GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE -COMBINATION THERAPY
25. GENE THERAPY IN ONCOLOGY ANALYSIS BY ORIGINATOR
26. GENE THERAPY IN ONCOLOGY ANALYSIS BY PHARMACEUTICAL COMPANIES
27. GENE THERAPY IN ONCOLOGY ANALYSIS BY TECHNOLOGY
28. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY TARGETS
29. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY VECTORS
30. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY VIRAL VECTORS
31. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY NON-VIRAL VECTORS
32. MARKETED GENE THERAPIES
33. PROVENGE: DENDREON CORPORATION (ACQUIRED BY SAN POWER GROUP)
34. GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS SALES ANALYSIS
35. GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS-COMPARATIVE SALES
36. GENE THERAPIES IN PIPELINE
38. REIMBURSEMENT SCENARIO FOR CANCER GENE THERAPIES IN 7MM
39. THE UNITED STATES
40. EU-5 COUNTRIES
41. MARKET ACCESS AND REIMBURSEMENT SCENARIO FOR CANCER GENE THERAPY IN JAPAN
42. COST ANALYSIS OF GENE THERAPIES- CHALLENGES AND COUNTERMEASURES
43. HURDLES IN APPROVAL AND REVENUE GENERATION
45. EVIDENCE GENERATION
46. VALUATION AND PRICING
47. COMMERCIALISATION
48. GENE THERAPY IN ONCOLOGY FUTURE
49. DELVEINSIGHT COMPETITIVE MATRIX MODELING
50. MARKET DRIVERS
51. MARKET BARRIERS
52. APPENDIX
53. REPORT METHODOLOGY
54. DELVEINSIGHT COMPETITIVE MATRIX
55. DELVEINSIGHT CAPABILITIES
56. DISCLAIMER
57. ABOUT DELVEINSIGHT
2. EXECUTIVE SUMMARY
3. GENE THERAPY IN ONCOLOGY OVERVIEW
4. GENE THERAPY IN ONCOLOGY INTRODUCTION
5. HISTORY- EVOLUTION OF GENE THERAPY OVER THE YEARS
6. GENE THERAPY IN ONCOLOGY ROLE
7. TYPES OF GENE THERAPY
8. GENE TRANSFER- TYPES OF VECTORS AND GENE DELIVERY METHODS
9. GENE THERAPY IN ONCOLOGY ADVANTAGES
10. KEY CHALLENGES IN DEVELOPMENT OF GENE THERAPY FOR ONCOLOGY
11. GENE EDITING IN GENE THERAPY
12. TYPES OF NUCLEASES
13. SAFETY AND ETHICAL CONCERNS
14. COMPANIES DEVELOPING GENE EDITING TECHNOLOGIES
15. REGULATORY GUIDELINES FOR GENE THERAPY PRODUCTS IN 7MM
16. GENERAL REGULATORY ENVIRONMENT
17. REGULATORY INCENTIVES AND SUPPORT
18. GENE THERAPY IN ONCOLOGY ANALYSIS –INNOVATION TO COMMERCIALIZATION
19. GENE THERAPY IN ONCOLOGY ANALYSIS BY TOTAL PRODUCTS
20. GENE THERAPY IN ONCOLOGY CLINICAL PIPELINE ANALYSIS BY REGION
21. GENE THERAPY IN ONCOLOGY PIPELINE ANALYSIS BY REGULATORY DESIGNATIONS
22. GENE THERAPY IN ONCOLOGY ANALYSIS BY COMPANIES COLLABORATIONS
23. GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE DEVELOPMENT
24. GENE THERAPY IN ONCOLOGY ANALYSIS BY PRODUCT TYPE -COMBINATION THERAPY
25. GENE THERAPY IN ONCOLOGY ANALYSIS BY ORIGINATOR
26. GENE THERAPY IN ONCOLOGY ANALYSIS BY PHARMACEUTICAL COMPANIES
27. GENE THERAPY IN ONCOLOGY ANALYSIS BY TECHNOLOGY
28. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY TARGETS
29. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY VECTORS
30. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY VIRAL VECTORS
31. GENE THERAPY IN ONCOLOGY ANALYSIS BY GENE THERAPY NON-VIRAL VECTORS
32. MARKETED GENE THERAPIES
33. PROVENGE: DENDREON CORPORATION (ACQUIRED BY SAN POWER GROUP)
34. GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS SALES ANALYSIS
35. GENE THERAPY IN ONCOLOGY MARKETED PRODUCTS-COMPARATIVE SALES
36. GENE THERAPIES IN PIPELINE
38. REIMBURSEMENT SCENARIO FOR CANCER GENE THERAPIES IN 7MM
39. THE UNITED STATES
40. EU-5 COUNTRIES
41. MARKET ACCESS AND REIMBURSEMENT SCENARIO FOR CANCER GENE THERAPY IN JAPAN
42. COST ANALYSIS OF GENE THERAPIES- CHALLENGES AND COUNTERMEASURES
43. HURDLES IN APPROVAL AND REVENUE GENERATION
45. EVIDENCE GENERATION
46. VALUATION AND PRICING
47. COMMERCIALISATION
48. GENE THERAPY IN ONCOLOGY FUTURE
49. DELVEINSIGHT COMPETITIVE MATRIX MODELING
50. MARKET DRIVERS
51. MARKET BARRIERS
52. APPENDIX
53. REPORT METHODOLOGY
54. DELVEINSIGHT COMPETITIVE MATRIX
55. DELVEINSIGHT CAPABILITIES
56. DISCLAIMER
57. ABOUT DELVEINSIGHT
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
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
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
