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Immuno-Oncology Strategic Insight - Multi-Indication And Market Size Analysis

Published: May 11, 2016 | Pages: 423 | Publisher: GlobalData | Industry: Pharmaceutical | Report Format: Electronic (PDF)

Immuno-Oncology Strategic Insight - Multi-Indication And Market Size Analysis

Summary

GlobalData estimates that the total IO market will be worth approximately $14 billion in 2019, rising to $34 billion by 2024 in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan). The main drivers of this growth will come from immune checkpoint inhibitors, which will have sales of approximately $10 billion in 2019, rising to $24 billion by 2024. The highest-selling IO drugs by 2024 will be Opdivo and Keytruda, both PD-1 inhibitors, with sales of approximately $10 billion and $7 billion, respectively. This is because these two drugs will be first-to-market in many indications, leapfrogging competition such as Roches atezolizumab and AstraZenecas durvalumab.

Highlights

Key Questions Answered

- Development of IO Products has increased significantly in the past three years. Which IO approaches will be the most commercially successful? Which early-stage IO approaches show the most promise?
- Novel combinations will differentiate late-to-market entrants. Which combinations are the most promising for each cancer type? What strategies are IO developers utilizing to differentiate themselves in this crowded market? What collaborations and deals are the most promising?
- NSCLC, melanoma, and myeloma will have the greatest contributions to the IO market in 2019 and 2024. Which diseases are going to be the biggest contributors to the IO market. Which IO product will be the most commercially successful in each disease? Which clinical and commercial strategies are IO developers pursuing in each disease?

Key Findings

- Opdivo will be the biggest selling IO drug by 2024, with approval forecast in seven indications
- Keytruda will be the second biggest selling IO drug by 2024, with approval forecast in eight indications
- NSCLC, melanoma, and myeloma will have the greatest contributions to the IO market in 2019 and 2024
- Novel combinations will allow late-to-market entrants such as durvalumab to achieve significant sales

Scope

- Overview of IO approaches, including checkpoint inhibitors, cell therapies, peptide vaccines, oncolytic viruses, bi-specific antibodies and CAR-T therapies.
- Revenue by indications for major IO products in 2019 and 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the IO therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global IO therapeutics market. Insightful review of the key industry drivers, restraints and challenges. This include analysis of novel combinations and the role of biomarkers such as PD-L1

Reasons to buy

The report will enable you to - 

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global multiple myeloma therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global multiple myeloma therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- 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 market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
  Table of Contents

1 Table of Contents 8
1.1 List of Tables 14
1.2 List of Figures 15

2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 22
2.3 Upcoming Related Reports 22

3 IO Development 23
3.1 History of IO Development 23
3.2 Recent Timeline of IO Approvals 25
3.3 IO Product Classification 28

4 Technology and Product Overview 29
4.1 Checkpoint Modulators 29
4.1.1 Mechanism of Action 29
4.1.2 Clinical Overview 30
4.1.3 Opdivo (Nivolumab) 31
4.1.4 Keytruda (Pembrolizumab) 43
4.1.5 Atezolizumab 53
4.1.6 Durvalumab and Tremelimumab 62
4.1.7 Avelumab 72
4.1.8 Yervoy (Ipilimumab) 79
4.2 Cellular Immunotherapies 85
4.2.1 Dendritic Cell Therapies 85
4.2.2 CAR-T Therapies 87
4.2.3 Sales Estimate 88
4.2.4 SWOT Analysis 90
4.3 Cancer Vaccines 90
4.3.1 NeuVax 91
4.3.2 HyperAcute-Pancreas 92
4.3.3 ProstVac 92
4.3.4 Vigil 93
4.3.5 Other Late-Stage Vaccines 93
4.3.6 Sales Estimate 93
4.3.7 SWOT Analysis 95
4.4 Oncolytic Viruses 95
4.4.1 Imlygic (Talimogene laherparepvec) 95
4.4.2 ProstAtak 97
4.4.3 Other Late-Stage Oncolytic Viruses 97
4.4.4 Estimated Sales 98
4.4.5 SWOT Analysis 99
4.5 Bispecific T-cell Engagers 99
4.5.1 Blincyto (Blinatumomab) 99
4.6 Other Late-Stage Immuno-oncology Products 102
4.6.1 Empliciti (Elotuzumab) 102

5 Indication-Specific Analysis 104
5.1 Acute Leukemias 104
5.1.1 Disease Overview 104
5.1.2 Current Treatment Paradigm and Algorithm 105
5.1.3 IO Development 107
5.1.4 Non-Immunotherapy Threats 114
5.2 Bladder Cancer 116
5.2.1 Disease Overview 116
5.2.2 Current Treatment Paradigm and Algorithm 117
5.2.3 IO Development 119
5.2.4 Non-immunotherapy Threats 127
5.3 Breast Cancer 129
5.3.1 Disease Overview 129
5.3.2 Current Treatment Paradigm and Algorithm 130
5.3.3 IO Development 134
5.3.4 Non-immunotherapy Threats 141
5.4 Chronic Leukemias 143
5.4.1 Disease Overview 143
5.4.2 Current Treatment Paradigm and Algorithm 144
5.4.3 IO Development 147
5.4.4 Non-immunotherapy Threats 152
5.5 Colorectal Cancer 154
5.5.1 Disease Overview 154
5.5.2 Current Treatment Paradigm and Algorithm 155
5.5.3 IO Development 156
5.5.4 Non-immunotherapy Threats 161
5.6 Gastric and Gastroesophageal Junction Adenocarcinoma 162
5.6.1 Disease Overview 162
5.6.2 Current Treatment Paradigm and Algorithm 163
5.6.3 IO Development 165
5.6.4 Non-immunotherapy Threats 171
5.7 Glioblastoma 172
5.7.1 Disease Overview 172
5.7.2 Current Treatments 173
5.7.3 IO Development 174
5.7.4 Non-immunotherapy Treatments 179
5.8 Head and Neck Squamous Cell Carcinoma 180
5.8.1 Disease Overview 180
5.8.2 Current Treatments 181
5.8.3 IO Development 183
5.8.4 Non-immunotherapy Threats 188
5.9 Hepatocellular Carcinoma 189
5.9.1 Disease Overview 189
5.9.2 Current Treatments 191
5.9.3 IO Development 192
5.9.4 Non-immunotherapy Threats 198
5.10 Melanoma 200
5.10.1 Disease Overview 200
5.10.2 Current Treatment Paradigm and Algorithm 201
5.10.3 IO Development 205
5.10.4 Non-immunotherapy Treatments 216
5.11 Multiple Myeloma 218
5.11.1 Disease Overview 218
5.11.2 Current Treatment Paradigm and Algorithm 218
5.11.3 IO Development 220
5.11.4 Non-immunotherapy Threats 225
5.12 Non-Hodgkins Lymphoma 226
5.12.1 Disease Overview 226
5.12.2 Current Treatment Paradigm and Algorithm 227
5.12.3 IO Development 229
5.12.4 Non-immunotherapy Treatments 236
5.13 Non-small Cell Lung Cancer 239
5.13.1 Disease Overview 239
5.13.2 Current Treatments 239
5.13.3 IO Development 241
5.13.4 Non-immunotherapy Threats 254
5.14 Ovarian Cancer 255
5.14.1 Disease Overview 255
5.14.2 Current Treatments 257
5.14.3 IO Development 260
5.14.4 Non-immunotherapy Threats 269
5.15 Pancreatic Cancer 271
5.15.1 Disease Overview 271
5.15.2 Current Treatments 272
5.15.3 IO Development 273
5.15.4 Non-immunotherapy Threats 278
5.16 Prostate Cancer 280
5.16.1 Disease Overview 280
5.16.2 Current Treatment Paradigm and Algorithm 281
5.16.3 IO Development 282
5.16.4 Non-immunotherapy Threats 289
5.17 Renal Cell Carcinoma 291
5.17.1 Disease Overview 291
5.17.2 Current Treatment Paradigm and Algorithm 291
5.17.3 IO Development 293
5.17.4 Non-immunotherapy Threats 303

6 Company Strategies 305
6.1 Combinations 305
6.1.1 Combination Type and Development Phase 305
6.1.2 Immunotherapy Combinations by Cancer Type 306
6.1.3 Immunotherapy Combinations by Approach 307
6.1.4 Immunotherapy Combinations by Target 308
6.1.5 Immunotherapy Combinations in Phase III Development (IO + IO) 309
6.1.6 Major IO Products in Combination Therapy 311
6.2 Biomarkers 317
6.2.1 Overview 317
6.2.2 PD-L1 Biomarker 318
6.2.3 Microsatellite Instability and Mutational Load 322
6.2.4 Human Leukocyte Antigen Alleles 323
6.3 Deals 324

7 Appendix 328
7.1 Bibliography 328
7.2 Abbreviations 382
7.3 IO Product and Trial Identification Methodology 392
7.3.1 Inclusion Criteria for IO Products 394
7.3.2 Exclusion Criteria for IO Products 394
7.3.3 Classification of IO Approach 395
7.3.4 List of Trials Involving IO Products 395
7.4 List of IO Drugs 397
7.5 Forecasting Methodology 416
7.5.1 Launch Dates 416
7.5.2 Sales Estimates 416
7.6 About the Authors 417
7.6.1 Lead Analyst 417
7.6.2 Analysts 417
7.6.3 Therapy Area Director 420
7.6.4 Global Director of Therapy Analysis and Epidemiology 420
7.6.5 Global Head of Healthcare 421
7.7 About GlobalData 422
7.8 Disclaimer 422
List of Tables

Table 1: Opdivo SWOT Analysis 43
Table 2: Keytruda SWOT Analysis 53
Table 3: Atezolizumab SWOT Analysis 62
Table 4: Durvalumab and Tremelimumab SWOT Analysis 72
Table 5: Avelumab SWOT Analysis 79
Table 6: Yervoy SWOT Analysis 84
Table 7: IO Cell Therapies SWOT Analysis 90
Table 8: Cancer Vaccines SWOT Analysis 95
Table 9: Oncolytic Viruses SWOT Analysis 99
Table 10: Approved IO Drugs and Combinations for Advanced Melanoma 203
Table 11: Approved BRAF/MEK-Targeting Drugs and Combinations for BRAF-Mutated Advanced Melanoma 204
Table 12: FIGO Guidelines: Staging Classification for Cancer of the Ovary, Fallopian Tube, and Peritoneum 257
Table 13: Treatment Guidelines for Ovarian Cancer in the 7MM 260
Table 14: IO + IO Combinations in Phase III Clinical Development 310
Table 15: PD-L1 Testing Criteria in NSCLC and Clinical Efficacy 320
Table 16: List of Immuno-oncology Drugs 397

 List of Figures

Figure 1: Typical Kaplan-Meier Plot for Chemotherapy, Targeted Therapy, IO, and IO Combinations 25
Figure 2: Timeline of All IO Products Approved 28
Figure 3: Development of Opdivo Across Oncology Indications 32
Figure 4: Timeline of Approvals/Estimated Approvals for Opdivo 33
Figure 5: Overview of Selected Opdivo Late-Stage Trials 34
Figure 6: Opdivo Sales Estimate for 2019 and 2024 42
Figure 7: Development of Keytruda Across Oncology Indications 44
Figure 8: Timeline of Approvals/Estimated Approvals for Keytruda 45
Figure 9: Overview of Selected Keytruda Late-Stage Trials 46
Figure 10: Keytruda Sales Estimate for 2019 and 2024 52
Figure 11: Development of Atezolizumab Across Oncology Indications 54
Figure 12: Timeline of Approvals/Estimated Approvals for Atezolizumab 55
Figure 13: Overview of Selected Atezolizumab Late-Stage Trials 56
Figure 14: Atezolizumab Sales Estimate for 2019 and 2024 61
Figure 15: Development of Durvalumab Across Oncology Indications 63
Figure 16: Development of Tremelimumab Across Oncology Indications 64
Figure 17: Timeline of Approvals/Estimated Approvals for Durvalumab (with Tremelimumab) 65
Figure 18: Overview of Selected Durvalumab Late-Stage Trials 65
Figure 19: Durvalumab Sales Estimate for 2019 and 2024 70
Figure 20: Tremelimumab Sales Estimate for 2019 and 2024 71
Figure 21: Development of Avelumab Across Oncology Indications 73
Figure 22: Timeline of Approvals/Estimated Approvals for Avelumab 74
Figure 23: Overview of Selected Avelumab Late-Stage Trials 74
Figure 24: Avelumab Sales Estimate for 2019 and 2024 78
Figure 25: Development of Yervoy Across Oncology Indications 80
Figure 26: Timeline of Approvals/Estimated Approvals for Yervoy 81
Figure 27: Overview of Selected Yervoy Late-Stage Trials 81
Figure 28: Yervoy Sales Estimate for 2019 and 2024 84
Figure 29: IO Cell Therapies Sales Estimate for 2019 and 2024 89
Figure 30: Cancer Vaccines Sales Estimate for 2019 and 2024 94
Figure 31: Oncolytic Virus Sales Estimate for 2019 and 2024 98
Figure 32: Bispecific T-Cell Engagers Sales Estimate for 2019 and 2024 101
Figure 33: Empliciti Sales Estimate for 2019 and 2024 103
Figure 34: Treatment Flow Chart for ALL Patients 106
Figure 35: Treatment Flow Chart for AML Patients 107
Figure 36: Overview of Main IO Approaches, Targets, and Trial Development in ALL Patients 108
Figure 37: Overview of Main IO Approaches, Targets, and Trial Development in AML Patients 109
Figure 38: Approval Timeline for IO Drugs in ALL Patients 111
Figure 39: An Overview of the Late-Stage Trials with IO Products in ALL Patients 111
Figure 40: An Overview of the Late-Stage Trials with IO Products in AML Patients 112
Figure 41: An Overview of the Early-Stage Trials with IO Products in ALL Patients 113
Figure 42: An Overview of the Early-Stage Trials with IO Products in AML Patients 113
Figure 43: Non-Immunotherapy Treatments in ALL Patients 115
Figure 44: Non-Immunotherapy Treatments in AML Patients 116
Figure 45: Treatment Flow Chart for Bladder Cancer Patients 118
Figure 46: Overview of Immuno-oncology Development in Bladder Cancer 120
Figure 47: Phase III Timeline in Bladder Cancer 124
Figure 48: Phase III Trials in Bladder Cancer 124
Figure 49: Overview of the Early-Stage IO Trials in Bladder Cancer Patients 126
Figure 50: Non-immunotherapy Threats in Bladder Cancer 129
Figure 51: Treatment Flow Chart for Stage 0-III Breast Cancer Patients 133
Figure 52: Treatment Flow Chart for Stage IV or Recurrent Breast Cancer Patients 134
Figure 53: Overview of IO Development in Breast Cancer 135
Figure 54: Current Phase III Timeline in Breast Cancer 138
Figure 55: Late-Stage Pivotal Trials in Breast Cancer Patients 139
Figure 56: Overview of the Early-Stage IO Trials in Breast Cancer Patients 141
Figure 57: Non-immunotherapy Threats in Breast Cancer 143
Figure 58: Treatment Flow Chart for CLL Patients 146
Figure 59: Treatment Flow Chart for CML Patients 147
Figure 60: Overview of Main IO Approaches, Targets, and Trial Development in CLL Patients 148
Figure 61: Overview of Main IO Approaches, Targets, and Trial Development in CML Patients 149
Figure 62: An Overview of the Late-Stage Trials with IO Products in CLL Patients 150
Figure 63: An Overview of the Late-Stage Trials with IO Products in CML Patients 151
Figure 64: An Overview of the Early-Stage Trials with IO Products in CLL Patients 151
Figure 65: An Overview of the Early-Stage Trials with IO Products in CML Patients 152
Figure 66: Non-immunotherapy Treatments in CLL Patients 153
Figure 67: Non-Immunotherapy Treatments in CML Patients 154
Figure 68: Treatment Flow Chart for CRC Patients 156
Figure 69: Overview of Main IO Approaches, Targets, and Trial Development in CRC Patients 157
Figure 70: Current Phase III and Regulatory Approval Timeline in CRC 159
Figure 71: An Overview of the Late-Stage Trials with IO Products in CRC Patients 159
Figure 72: An Overview of the Early-Stage Trials with IO Products in CRC Patients 161
Figure 73: Non-immunotherapy Treatments in CRC Patients 162
Figure 74: Treatment Flow Chart for Advanced G/GEJAC Patients 165
Figure 75: Overview of IO Development in G/GEJAC 166
Figure 76: Current Phase III Timeline in G/GEJAC 168
Figure 77: Late-Stage Pivotal IO Trials in G/GEJAC Patients 168
Figure 78: Selected Early-Stage IO Trials in G/GEJAC Patients 170
Figure 79: Non-immunotherapy Threats in G/GEJAC 172
Figure 80: Treatment Flow Chart for GBM Patients 174
Figure 81: Overview of Immunotherapies in Glioblastoma 175
Figure 82: Current Phase III Timeline in GBM 177
Figure 83: Late-Stage Pivotal IO Trials in GBM Patients 177
Figure 84: Overview of Selected Trials in GBM Patients 179
Figure 85: Non-immunotherapy Treatments in GBM 180
Figure 86: Treatment Flow Chart for HNSCC Patients 182
Figure 87: Overview of IO Development in HNSCC 184
Figure 88: Current Phase III Timeline in HNSCC 186
Figure 89: Late-Stage Pivotal IO Trials in HNSCC Patients 186
Figure 90: Overview of Early-Stage IO Trials in HNSCC Patients 188
Figure 91: Non-immunotherapy Threats in HNSCC 189
Figure 92: HCC Treatment Regimen by BCLC Stage 192
Figure 93: Overview of Immuno-oncology Development in HCC 193
Figure 94: Phase III Timeline in HCC 195
Figure 95: Phase III Trials in HCC 195
Figure 96: Overview of the Early-Stage IO Trials in HCC Patients 198
Figure 97: Non-immunotherapy Threats in HCC 200
Figure 98: Current Flowchart for Melanoma 204
Figure 99: Overview of IO Development in Melanoma 206
Figure 100: Current Phase III Timeline in Melanoma 208
Figure 101: Late-Stage Pivotal IO Trials in Melanoma Patients 209
Figure 102: Immune Checkpoint Modulator Combinations in Early-Stage Development 215
Figure 103: Non-immunotherapy Threats in Melanoma 216
Figure 104: Treatment Flow Chart for Multiple Myeloma Patients 219
Figure 105: Overview of Immunotherapies in Multiple Myeloma 221
Figure 106: Current Phase III Timeline in Multiple Myeloma 222
Figure 107: Late-Stage Pivotal IO Trials in Multiple Myeloma Patients 223
Figure 108: Selected Early-Stage Pivotal IO Trials in Multiple Myeloma Patients 225
Figure 109: Non-immunotherapy Treatments in Multiple Myeloma 226
Figure 110: Treatment Algorithm for NHL Patients 229
Figure 111: IO Approaches, Targets, and Clinical Trials in NHL Patients 231
Figure 112: Current Regulatory Approval Timeline in NHL 233
Figure 113: Late-Stage IO Trials in NHL Patients 233
Figure 114: Overview of Early-Stage IO Trials in NHL Patients 236
Figure 115: Non-immunotherapy Threats in NHL 238
Figure 116: Treatment Flow Chart for Stage III/IV NSCLC Patients 240
Figure 117: Overview of Main IO Approaches, Targets, and Trial Development in NSCLC Patients 242
Figure 118: Current Phase III Timeline in NSCLC 249
Figure 119: An Overview of the Late-Stage Trials with IO Products in NSCLC Patients 250
Figure 120: Overview of the Early-Stage IO Trials in NSCLC Patients 253
Figure 121: Non-immunotherapy Treatments in NSCLC 255
Figure 122: Top-Level Treatment Flow Chart for Ovarian Cancer Patients 259
Figure 123: Ovarian Cancer IO Products in Development by Therapeutic Approach 261
Figure 124: IO Products in Late-Stage Development for Ovarian CancerEstimated Approval Dates 263
Figure 125: IO Products in Late-Stage Development for Ovarian CancerPivotal Clinical Trials 264
Figure 126: IO Products in Early-Stage Development for Ovarian Cancer 268
Figure 127: Non-IO Therapies Recently Approved or in the Late-Stage Ovarian Cancer Pipeline 271
Figure 128: Treatment Flow Chart for Pancreatic Cancer Patients 273
Figure 129: Overview of Immunotherapies in Pancreatic Cancer 274
Figure 130: Estimated Approval Times for Immunotherapies in Pancreatic Cancer 276
Figure 131: Current Phase III Trials in Pancreatic Cancer 276
Figure 132: Selected Early-Phase IO Trials in Pancreatic Cancer 278
Figure 133: Non-immunotherapy Treatments in Pancreatic Cancer 279
Figure 134: Treatment Flow Chart for Prostate Cancer Patients 282
Figure 135: Overview of Main IO Approaches, Targets, and Trial Development in Prostate Cancer Patients 283
Figure 136: Current Phase III and Regulatory Approval Timeline in Prostate Cancer Patients 284
Figure 137: An Overview of the Late-Stage Trials with IO Products in Prostate Cancer Patients 285
Figure 138: An Overview of the Early-Stage IO Trials in Prostate Cancer Patients 289
Figure 139: Non-immunotherapy Treatments in Prostate Cancer Patients 290
Figure 140: Treatment Algorithm for Advanced RCC Patients 293
Figure 141: IO Approaches, Targets, and Clinical Trials in RCC Patients 295
Figure 142: Current Phase III and Regulatory Approval Timeline in RCC 298
Figure 143: Late-Stage IO Trials in RCC Patients 299
Figure 144: Early-Stage IO Trials in RCC Patients 302
Figure 145: Non-immunotherapy Threats in RCC 304
Figure 146: Clinical Development Activity by Combination Type and Development Phase 306
Figure 147: Clinical Development Activity by Combination and Cancer Type 307
Figure 148: Clinical Development Activity by Combination Type and Approach 308
Figure 149: Clinical Development Activity by Combination Type and Target 309
Figure 150: Select IO Products in Clinical Development by Combination Type 312
Figure 151: Select Keytruda IO Combinations in Clinical Development by Combination Type 313
Figure 152: Select Opdivo/Yervoy Combinations in Clinical Development by Combination Type 314
Figure 153: Select Durvalumab/Tremelimumab IO Combinations in Clinical Development by Combination Type 316
Figure 154: Select Atezolizumab IO Combinations in Clinical Development by Combination Type 317
Figure 155: Number of Trials Tagged for PD-L1 Biomarker Positivity 319
Figure 156: Number of Trials Tagged for HLA-A2/A1 Positivity 324
Figure 157: Number of Deals by IO Products 327 



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