Immuno-Oncology Strategic Insight: Multi-Indication and Market Size Analysis

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 Roche's atezolizumab and AstraZeneca's durvalumab.

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

Key Highlights

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?

Companies mentioned

AbbVie

Aduro BioTech

Amgen

AstraZeneca

Bavarian Nordic

Bristol-Myers Squibb

Celldex Therapeutics

Galena Biopharma

Gradalis

ImmunoCellular Therapeutics

Incyte

Juno Therapeutics

Kite Pharma

Merck & Co.

Merck ...

AbbVie

Aduro BioTech

Amgen

AstraZeneca

Bavarian Nordic

Bristol-Myers Squibb

Celldex Therapeutics

Galena Biopharma

Gradalis

ImmunoCellular Therapeutics

Incyte

Juno Therapeutics

Kite Pharma

Merck & Co.

Merck KGaA

NewLink Genetics

Novartis

Ono Pharmaceutical

Pfizer

Roche

Valeant

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3IO Development

3.1History of IO Development

3.2Recent Timeline of ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3IO Development

3.1History of IO Development

3.2Recent Timeline of IO Approvals

3.3IO Product Classification

4Technology and Product Overview

4.1Checkpoint Modulators

4.1.1Mechanism of Action

4.1.2Clinical Overview

4.1.3Opdivo (Nivolumab)

4.1.4Keytruda (Pembrolizumab)

4.1.5Atezolizumab

4.1.6Durvalumab and Tremelimumab

4.1.7Avelumab

4.1.8Yervoy (Ipilimumab)

4.2Cellular Immunotherapies

4.2.1Dendritic Cell Therapies

4.2.2CAR-T Therapies

4.2.3Sales Estimate

4.2.4SWOT Analysis

4.3Cancer Vaccines

4.3.1NeuVax

4.3.2HyperAcute-Pancreas

4.3.3ProstVac

4.3.4Vigil

4.3.5Other Late-Stage Vaccines

4.3.6Sales Estimate

4.3.7SWOT Analysis

4.4Oncolytic Viruses

4.4.1Imlygic (Talimogene laherparepvec)

4.4.2ProstAtak

4.4.3Other Late-Stage Oncolytic Viruses

4.4.4Estimated Sales

4.4.5SWOT Analysis

4.5Bispecific T-cell Engagers

4.5.1Blincyto (Blinatumomab)

4.6Other Late-Stage Immuno-oncology Products

4.6.1Empliciti (Elotuzumab)

5Indication-Specific Analysis

5.1Acute Leukemias

5.1.1Disease Overview

5.1.2Current Treatment Paradigm and Algorithm

5.1.3IO Development

5.1.4Non-Immunotherapy Threats

5.2Bladder Cancer

5.2.1Disease Overview

5.2.2Current Treatment Paradigm and Algorithm

5.2.3IO Development

5.2.4Non-immunotherapy Threats

5.3Breast Cancer

5.3.1Disease Overview

5.3.2Current Treatment Paradigm and Algorithm

5.3.3IO Development

5.3.4Non-immunotherapy Threats

5.4Chronic Leukemias

5.4.1Disease Overview

5.4.2Current Treatment Paradigm and Algorithm

5.4.3IO Development

5.4.4Non-immunotherapy Threats

5.5Colorectal Cancer

5.5.1Disease Overview

5.5.2Current Treatment Paradigm and Algorithm

5.5.3IO Development

5.5.4Non-immunotherapy Threats

5.6Gastric and Gastroesophageal Junction Adenocarcinoma

5.6.1Disease Overview

5.6.2Current Treatment Paradigm and Algorithm

5.6.3IO Development

5.6.4Non-immunotherapy Threats

5.7Glioblastoma

5.7.1Disease Overview

5.7.2Current Treatments

5.7.3IO Development

5.7.4Non-immunotherapy Treatments

5.8Head and Neck Squamous Cell Carcinoma

5.8.1Disease Overview

5.8.2Current Treatments

5.8.3IO Development

5.8.4Non-immunotherapy Threats

5.9Hepatocellular Carcinoma

5.9.1Disease Overview

5.9.2Current Treatments

5.9.3IO Development

5.9.4Non-immunotherapy Threats

5.10Melanoma

5.10.1Disease Overview

5.10.2Current Treatment Paradigm and Algorithm

5.10.3IO Development

5.10.4Non-immunotherapy Treatments

5.11Multiple Myeloma

5.11.1Disease Overview

5.11.2Current Treatment Paradigm and Algorithm

5.11.3IO Development

5.11.4Non-immunotherapy Threats

5.12Non-Hodgkin’s Lymphoma

5.12.1Disease Overview

5.12.2Current Treatment Paradigm and Algorithm

5.12.3IO Development

5.12.4Non-immunotherapy Treatments

5.13Non-small Cell Lung Cancer

5.13.1Disease Overview

5.13.2Current Treatments

5.13.3IO Development

5.13.4Non-immunotherapy Threats

5.14Ovarian Cancer

5.14.1Disease Overview

5.14.2Current Treatments

5.14.3IO Development

5.14.4Non-immunotherapy Threats

5.15Pancreatic Cancer

5.15.1Disease Overview

5.15.2Current Treatments

5.15.3IO Development

5.15.4Non-immunotherapy Threats

5.16Prostate Cancer

5.16.1Disease Overview

5.16.2Current Treatment Paradigm and Algorithm

5.16.3IO Development

5.16.4Non-immunotherapy Threats

5.17Renal Cell Carcinoma

5.17.1Disease Overview

5.17.2Current Treatment Paradigm and Algorithm

5.17.3IO Development

5.17.4Non-immunotherapy Threats

6Company Strategies

6.1Combinations

6.1.1Combination Type and Development Phase

6.1.2Immunotherapy Combinations by Cancer Type

6.1.3Immunotherapy Combinations by Approach

6.1.4Immunotherapy Combinations by Target

6.1.5Immunotherapy Combinations in Phase III Development (IO + IO)

6.1.6Major IO Products in Combination Therapy

6.2Biomarkers

6.2.1Overview

6.2.2PD-L1 Biomarker

6.2.3Microsatellite Instability and Mutational Load

6.2.4Human Leukocyte Antigen Alleles

6.3Deals

7Appendix

7.1Bibliography

7.2Abbreviations

7.3IO Product and Trial Identification Methodology

7.3.1Inclusion Criteria for IO Products

7.3.2Exclusion Criteria for IO Products

7.3.3Classification of IO Approach

7.3.4List of Trials Involving IO Products

7.4List of IO Drugs

7.5Forecasting Methodology

7.5.1Launch Dates

7.5.2Sales Estimates

7.6About the Authors

7.6.1Lead Analyst

7.6.2Analysts

7.6.3Therapy Area Director

7.6.4Global Director of Therapy Analysis and Epidemiology

7.6.5Global Head of Healthcare

7.7About GlobalData

7.8Disclaimer

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 ...

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

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 ...

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

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