Summary
We estimate 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 Roche’s atezolizumab and AstraZeneca’s 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.
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1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 IO Development
3.1 History of IO Development
3.2 Recent Timeline of IO Approvals
3.3 IO Product Classification
4 Technology and Product Overview
4.1 Checkpoint Modulators
4.1.1 Mechanism of Action
4.1.2 Clinical Overview
4.1.3 Opdivo (Nivolumab)
4.1.4 Keytruda (Pembrolizumab)
4.1.5 Atezolizumab
4.1.6 Durvalumab and Tremelimumab
4.1.7 Avelumab
4.1.8 Yervoy (Ipilimumab)
4.2 Cellular Immunotherapies
4.2.1 Dendritic Cell Therapies
4.2.2 CAR-T Therapies
4.2.3 Sales Estimate
4.2.4 SWOT Analysis
4.3 Cancer Vaccines
4.3.1 NeuVax
4.3.2 HyperAcute-Pancreas
4.3.3 ProstVac
4.3.4 Vigil
4.3.5 Other Late-Stage Vaccines
4.3.6 Sales Estimate
4.3.7 SWOT Analysis
4.4 Oncolytic Viruses
4.4.1 Imlygic (Talimogene laherparepvec)
4.4.2 ProstAtak
4.4.3 Other Late-Stage Oncolytic Viruses
4.4.4 Estimated Sales
4.4.5 SWOT Analysis
4.5 Bispecific T-cell Engagers
4.5.1 Blincyto (Blinatumomab)
4.6 Other Late-Stage Immuno-oncology Products
4.6.1 Empliciti (Elotuzumab)
5 Indication-Specific Analysis
5.1 Acute Leukemias
5.1.1 Disease Overview
5.1.2 Current Treatment Paradigm and Algorithm
5.1.3 IO Development
5.1.4 Non-Immunotherapy Threats
5.2 Bladder Cancer
5.2.1 Disease Overview
5.2.2 Current Treatment Paradigm and Algorithm
5.2.3 IO Development
5.2.4 Non-immunotherapy Threats
5.3 Breast Cancer
5.3.1 Disease Overview
5.3.2 Current Treatment Paradigm and Algorithm
5.3.3 IO Development
5.3.4 Non-immunotherapy Threats
5.4 Chronic Leukemias
5.4.1 Disease Overview
5.4.2 Current Treatment Paradigm and Algorithm
5.4.3 IO Development
5.4.4 Non-immunotherapy Threats
5.5 Colorectal Cancer
5.5.1 Disease Overview
5.5.2 Current Treatment Paradigm and Algorithm
5.5.3 IO Development
5.5.4 Non-immunotherapy Threats
5.6 Gastric and Gastroesophageal Junction Adenocarcinoma
5.6.1 Disease Overview
5.6.2 Current Treatment Paradigm and Algorithm
5.6.3 IO Development
5.6.4 Non-immunotherapy Threats
5.7 Glioblastoma
5.7.1 Disease Overview
5.7.2 Current Treatments
5.7.3 IO Development
5.7.4 Non-immunotherapy Treatments
5.8 Head and Neck Squamous Cell Carcinoma
5.8.1 Disease Overview
5.8.2 Current Treatments
5.8.3 IO Development
5.8.4 Non-immunotherapy Threats
5.9 Hepatocellular Carcinoma
5.9.1 Disease Overview
5.9.2 Current Treatments
5.9.3 IO Development
5.9.4 Non-immunotherapy Threats
5.10 Melanoma
5.10.1 Disease Overview
5.10.2 Current Treatment Paradigm and Algorithm
5.10.3 IO Development
5.10.4 Non-immunotherapy Treatments
5.11 Multiple Myeloma
5.11.1 Disease Overview
5.11.2 Current Treatment Paradigm and Algorithm
5.11.3 IO Development
5.11.4 Non-immunotherapy Threats
5.12 Non-Hodgkin’s Lymphoma
5.12.1 Disease Overview
5.12.2 Current Treatment Paradigm and Algorithm
5.12.3 IO Development
5.12.4 Non-immunotherapy Treatments
5.13 Non-small Cell Lung Cancer
5.13.1 Disease Overview
5.13.2 Current Treatments
5.13.3 IO Development
5.13.4 Non-immunotherapy Threats
5.14 Ovarian Cancer
5.14.1 Disease Overview
5.14.2 Current Treatments
5.14.3 IO Development
5.14.4 Non-immunotherapy Threats
5.15 Pancreatic Cancer
5.15.1 Disease Overview
5.15.2 Current Treatments
5.15.3 IO Development
5.15.4 Non-immunotherapy Threats
5.16 Prostate Cancer
5.16.1 Disease Overview
5.16.2 Current Treatment Paradigm and Algorithm
5.16.3 IO Development
5.16.4 Non-immunotherapy Threats
5.17 Renal Cell Carcinoma
5.17.1 Disease Overview
5.17.2 Current Treatment Paradigm and Algorithm
5.17.3 IO Development
5.17.4 Non-immunotherapy Threats
6 Company Strategies
6.1 Combinations
6.1.1 Combination Type and Development Phase
6.1.2 Immunotherapy Combinations by Cancer Type
6.1.3 Immunotherapy Combinations by Approach
6.1.4 Immunotherapy Combinations by Target
6.1.5 Immunotherapy Combinations in Phase III Development (IO + IO)
6.1.6 Major IO Products in Combination Therapy
6.2 Biomarkers
6.2.1 Overview
6.2.2 PD-L1 Biomarker
6.2.3 Microsatellite Instability and Mutational Load
6.2.4 Human Leukocyte Antigen Alleles
6.3 Deals
7 Appendix
7.1 Bibliography
7.2 Abbreviations
7.3 IO Product and Trial Identification Methodology
7.3.1 Inclusion Criteria for IO Products
7.3.2 Exclusion Criteria for IO Products
7.3.3 Classification of IO Approach
7.3.4 List of Trials Involving IO Products
7.4 List of IO Drugs
7.5 Forecasting Methodology
7.5.1 Launch Dates
7.5.2 Sales Estimates
7.6 About the Authors
7.6.1 Lead Analyst
7.6.2 Analysts
7.6.3 Therapy Area Director
7.6.4 Global Director of Therapy Analysis and Epidemiology
7.6.5 Global Head of Healthcare
7.7 About us
7.8 Disclaimer
1.1 List of Tables
Table 1: Opdivo SWOT Analysis
Table 2: Keytruda SWOT Analysis
Table 3: Atezolizumab SWOT Analysis
Table 4: Durvalumab and Tremelimumab SWOT Analysis
Table 5: Avelumab SWOT Analysis
Table 6: Yervoy SWOT Analysis
Table 7: IO Cell Therapies SWOT Analysis
Table 8: Cancer Vaccines SWOT Analysis
Table 9: Oncolytic Viruses SWOT Analysis
Table 10: Approved IO Drugs and Combinations for Advanced Melanoma
Table 11: Approved BRAF/MEK-Targeting Drugs and Combinations for BRAF-Mutated Advanced Melanoma
Table 12: FIGO Guidelines: Staging Classification for Cancer of the Ovary, Fallopian Tube, and Peritoneum
Table 13: Treatment Guidelines for Ovarian Cancer in the 7MM
Table 14: IO + IO Combinations in Phase III Clinical Development
Table 15: PD-L1 Testing Criteria in NSCLC and Clinical Efficacy
Table 16: List of Immuno-oncology Drugs
1.2 List of Figures
Figure 1: Typical Kaplan-Meier Plot for Chemotherapy, Targeted Therapy, IO, and IO Combinations
Figure 2: Timeline of All IO Products Approved
Figure 3: Development of Opdivo Across Oncology Indications
Figure 4: Timeline of Approvals/Estimated Approvals for Opdivo
Figure 5: Overview of Selected Opdivo Late-Stage Trials
Figure 6: Opdivo Sales Estimate for 2019 and 2024
Figure 7: Development of Keytruda Across Oncology Indications
Figure 8: Timeline of Approvals/Estimated Approvals for Keytruda
Figure 9: Overview of Selected Keytruda Late-Stage Trials
Figure 10: Keytruda Sales Estimate for 2019 and 2024
Figure 11: Development of Atezolizumab Across Oncology Indications
Figure 12: Timeline of Approvals/Estimated Approvals for Atezolizumab
Figure 13: Overview of Selected Atezolizumab Late-Stage Trials
Figure 14: Atezolizumab Sales Estimate for 2019 and 2024
Figure 15: Development of Durvalumab Across Oncology Indications
Figure 16: Development of Tremelimumab Across Oncology Indications
Figure 17: Timeline of Approvals/Estimated Approvals for Durvalumab (with Tremelimumab)
Figure 18: Overview of Selected Durvalumab Late-Stage Trials
Figure 19: Durvalumab Sales Estimate for 2019 and 2024
Figure 20: Tremelimumab Sales Estimate for 2019 and 2024
Figure 21: Development of Avelumab Across Oncology Indications
Figure 22: Timeline of Approvals/Estimated Approvals for Avelumab
Figure 23: Overview of Selected Avelumab Late-Stage Trials
Figure 24: Avelumab Sales Estimate for 2019 and 2024
Figure 25: Development of Yervoy Across Oncology Indications
Figure 26: Timeline of Approvals/Estimated Approvals for Yervoy
Figure 27: Overview of Selected Yervoy Late-Stage Trials
Figure 28: Yervoy Sales Estimate for 2019 and 2024
Figure 29: IO Cell Therapies Sales Estimate for 2019 and 2024
Figure 30: Cancer Vaccines Sales Estimate for 2019 and 2024
Figure 31: Oncolytic Virus Sales Estimate for 2019 and 2024
Figure 32: Bispecific T-Cell Engagers Sales Estimate for 2019 and 2024
Figure 33: Empliciti Sales Estimate for 2019 and 2024
Figure 34: Treatment Flow Chart for ALL Patients
Figure 35: Treatment Flow Chart for AML Patients
Figure 36: Overview of Main IO Approaches, Targets, and Trial Development in ALL Patients
Figure 37: Overview of Main IO Approaches, Targets, and Trial Development in AML Patients
Figure 38: Approval Timeline for IO Drugs in ALL Patients
Figure 39: An Overview of the Late-Stage Trials with IO Products in ALL Patients
Figure 40: An Overview of the Late-Stage Trials with IO Products in AML Patients
Figure 41: An Overview of the Early-Stage Trials with IO Products in ALL Patients
Figure 42: An Overview of the Early-Stage Trials with IO Products in AML Patients
Figure 43: Non-Immunotherapy Treatments in ALL Patients
Figure 44: Non-Immunotherapy Treatments in AML Patients
Figure 45: Treatment Flow Chart for Bladder Cancer Patients
Figure 46: Overview of Immuno-oncology Development in Bladder Cancer
Figure 47: Phase III Timeline in Bladder Cancer
Figure 48: Phase III Trials in Bladder Cancer
Figure 49: Overview of the Early-Stage IO Trials in Bladder Cancer Patients
Figure 50: Non-immunotherapy Threats in Bladder Cancer
Figure 51: Treatment Flow Chart for Stage 0-III Breast Cancer Patients
Figure 52: Treatment Flow Chart for Stage IV or Recurrent Breast Cancer Patients
Figure 53: Overview of IO Development in Breast Cancer
Figure 54: Current Phase III Timeline in Breast Cancer
Figure 55: Late-Stage Pivotal Trials in Breast Cancer Patients
Figure 56: Overview of the Early-Stage IO Trials in Breast Cancer Patients
Figure 57: Non-immunotherapy Threats in Breast Cancer
Figure 58: Treatment Flow Chart for CLL Patients
Figure 59: Treatment Flow Chart for CML Patients
Figure 60: Overview of Main IO Approaches, Targets, and Trial Development in CLL Patients
Figure 61: Overview of Main IO Approaches, Targets, and Trial Development in CML Patients
Figure 62: An Overview of the Late-Stage Trials with IO Products in CLL Patients
Figure 63: An Overview of the Late-Stage Trials with IO Products in CML Patients
Figure 64: An Overview of the Early-Stage Trials with IO Products in CLL Patients
Figure 65: An Overview of the Early-Stage Trials with IO Products in CML Patients
Figure 66: Non-immunotherapy Treatments in CLL Patients
Figure 67: Non-Immunotherapy Treatments in CML Patients
Figure 68: Treatment Flow Chart for CRC Patients
Figure 69: Overview of Main IO Approaches, Targets, and Trial Development in CRC Patients
Figure 70: Current Phase III and Regulatory Approval Timeline in CRC
Figure 71: An Overview of the Late-Stage Trials with IO Products in CRC Patients
Figure 72: An Overview of the Early-Stage Trials with IO Products in CRC Patients
Figure 73: Non-immunotherapy Treatments in CRC Patients
Figure 74: Treatment Flow Chart for Advanced G/GEJAC Patients
Figure 75: Overview of IO Development in G/GEJAC
Figure 76: Current Phase III Timeline in G/GEJAC
Figure 77: Late-Stage Pivotal IO Trials in G/GEJAC Patients
Figure 78: Selected Early-Stage IO Trials in G/GEJAC Patients
Figure 79: Non-immunotherapy Threats in G/GEJAC
Figure 80: Treatment Flow Chart for GBM Patients
Figure 81: Overview of Immunotherapies in Glioblastoma
Figure 82: Current Phase III Timeline in GBM
Figure 83: Late-Stage Pivotal IO Trials in GBM Patients
Figure 84: Overview of Selected Trials in GBM Patients
Figure 85: Non-immunotherapy Treatments in GBM
Figure 86: Treatment Flow Chart for HNSCC Patients
Figure 87: Overview of IO Development in HNSCC
Figure 88: Current Phase III Timeline in HNSCC
Figure 89: Late-Stage Pivotal IO Trials in HNSCC Patients
Figure 90: Overview of Early-Stage IO Trials in HNSCC Patients
Figure 91: Non-immunotherapy Threats in HNSCC
Figure 92: HCC Treatment Regimen by BCLC Stage
Figure 93: Overview of Immuno-oncology Development in HCC
Figure 94: Phase III Timeline in HCC
Figure 95: Phase III Trials in HCC
Figure 96: Overview of the Early-Stage IO Trials in HCC Patients
Figure 97: Non-immunotherapy Threats in HCC
Figure 98: Current Flowchart for Melanoma
Figure 99: Overview of IO Development in Melanoma
Figure 100: Current Phase III Timeline in Melanoma
Figure 101: Late-Stage Pivotal IO Trials in Melanoma Patients
Figure 102: Immune Checkpoint Modulator Combinations in Early-Stage Development
Figure 103: Non-immunotherapy Threats in Melanoma
Figure 104: Treatment Flow Chart for Multiple Myeloma Patients
Figure 105: Overview of Immunotherapies in Multiple Myeloma
Figure 106: Current Phase III Timeline in Multiple Myeloma
Figure 107: Late-Stage Pivotal IO Trials in Multiple Myeloma Patients
Figure 108: Selected Early-Stage Pivotal IO Trials in Multiple Myeloma Patients
Figure 109: Non-immunotherapy Treatments in Multiple Myeloma
Figure 110: Treatment Algorithm for NHL Patients
Figure 111: IO Approaches, Targets, and Clinical Trials in NHL Patients
Figure 112: Current Regulatory Approval Timeline in NHL
Figure 113: Late-Stage IO Trials in NHL Patients
Figure 114: Overview of Early-Stage IO Trials in NHL Patients
Figure 115: Non-immunotherapy Threats in NHL
Figure 116: Treatment Flow Chart for Stage III/IV NSCLC Patients
Figure 117: Overview of Main IO Approaches, Targets, and Trial Development in NSCLC Patients
Figure 118: Current Phase III Timeline in NSCLC
Figure 119: An Overview of the Late-Stage Trials with IO Products in NSCLC Patients
Figure 120: Overview of the Early-Stage IO Trials in NSCLC Patients
Figure 121: Non-immunotherapy Treatments in NSCLC
Figure 122: Top-Level Treatment Flow Chart for Ovarian Cancer Patients
Figure 123: Ovarian Cancer IO Products in Development by Therapeutic Approach
Figure 124: IO Products in Late-Stage Development for Ovarian Cancer—Estimated Approval Dates
Figure 125: IO Products in Late-Stage Development for Ovarian Cancer—Pivotal Clinical Trials
Figure 126: IO Products in Early-Stage Development for Ovarian Cancer
Figure 127: Non-IO Therapies Recently Approved or in the Late-Stage Ovarian Cancer Pipeline
Figure 128: Treatment Flow Chart for Pancreatic Cancer Patients
Figure 129: Overview of Immunotherapies in Pancreatic Cancer
Figure 130: Estimated Approval Times for Immunotherapies in Pancreatic Cancer
Figure 131: Current Phase III Trials in Pancreatic Cancer
Figure 132: Selected Early-Phase IO Trials in Pancreatic Cancer
Figure 133: Non-immunotherapy Treatments in Pancreatic Cancer
Figure 134: Treatment Flow Chart for Prostate Cancer Patients
Figure 135: Overview of Main IO Approaches, Targets, and Trial Development in Prostate Cancer Patients
Figure 136: Current Phase III and Regulatory Approval Timeline in Prostate Cancer Patients
Figure 137: An Overview of the Late-Stage Trials with IO Products in Prostate Cancer Patients
Figure 138: An Overview of the Early-Stage IO Trials in Prostate Cancer Patients
Figure 139: Non-immunotherapy Treatments in Prostate Cancer Patients
Figure 140: Treatment Algorithm for Advanced RCC Patients
Figure 141: IO Approaches, Targets, and Clinical Trials in RCC Patients
Figure 142: Current Phase III and Regulatory Approval Timeline in RCC
Figure 143: Late-Stage IO Trials in RCC Patients
Figure 144: Early-Stage IO Trials in RCC Patients
Figure 145: Non-immunotherapy Threats in RCC
Figure 146: Clinical Development Activity by Combination Type and Development Phase
Figure 147: Clinical Development Activity by Combination and Cancer Type
Figure 148: Clinical Development Activity by Combination Type and Approach
Figure 149: Clinical Development Activity by Combination Type and Target
Figure 150: Select IO Products in Clinical Development by Combination Type
Figure 151: Select Keytruda IO Combinations in Clinical Development by Combination Type
Figure 152: Select Opdivo/Yervoy Combinations in Clinical Development by Combination Type
Figure 153: Select Durvalumab/Tremelimumab IO Combinations in Clinical Development by Combination Type
Figure 154: Select Atezolizumab IO Combinations in Clinical Development by Combination Type
Figure 155: Number of Trials Tagged for PD-L1 Biomarker Positivity
Figure 156: Number of Trials Tagged for HLA-A2/A1 Positivity
Figure 157: Number of Deals by IO Products
1.1 List of Tables
Table 1: Opdivo SWOT Analysis
Table 2: Keytruda SWOT Analysis
Table 3: Atezolizumab SWOT Analysis
Table 4: Durvalumab and Tremelimumab SWOT Analysis
Table 5: Avelumab SWOT Analysis
Table 6: Yervoy SWOT Analysis
Table 7: IO Cell Therapies SWOT Analysis
Table 8: Cancer Vaccines SWOT Analysis
Table 9: Oncolytic Viruses SWOT Analysis
Table 10: Approved IO Drugs and Combinations for Advanced Melanoma
Table 11: Approved BRAF/MEK-Targeting Drugs and Combinations for BRAF-Mutated Advanced Melanoma
Table 12: FIGO Guidelines: Staging Classification for Cancer of the Ovary, Fallopian Tube, and Peritoneum
Table 13: Treatment Guidelines for Ovarian Cancer in the 7MM
Table 14: IO + IO Combinations in Phase III Clinical Development
Table 15: PD-L1 Testing Criteria in NSCLC and Clinical Efficacy
Table 16: List of Immuno-oncology Drugs
