Report Scope:
This report on checkpoint inhibitors provides a detailed analysis of the market based on approved clinical and preclinical developmental candidates that target PD-1/PD-L1, CTLA-4, IDO-1, LAG-3, TIM-3 and CD47/SIRPa. The report analyzes the market trends, key medical needs and provides insights into recent advances in the modulation of checkpoint inhibition in the treatment of cancer through the development of fully human monoclonal antibodies, bispecific antibodies, fusion proteins and Chimeric Antigen Receptor (CAR) T cells.
Report Includes:
- 21 data tables and 43 additional tables
- An overview of the global market for checkpoint inhibitors
- Analyses of global market trends, with data from 2017 to 2018, and projections of compound annual growth rates (CAGRs) through 2023
- Discussion of the market landscape and innovative strategies, and the areas of unmet medical needs
- Information on the biomarker development, immune modulation, innovative delivery technologies, and the future landscape
- Market analysis for CP inhibitors, including PD-1/PD-L1 agents, CTLA-4 agents, TIM-3 agents, LAG-3 agents, IDO-1 agents, and SIRPa agents
- Comprehensive company profiles of major players in the industry, including Agenus, Inc., BeiGene, BIOCAD, Forty Seven, Inc., Seattle Genetics, Inc., Shanghai Cell Therapy, Tesaro, Inc. and Xencor
Summary
The treatment of cancer patients involves a multidisciplinary approach encompassing surgery, radiotherapy, and chemotherapy. Traditionally, patients with metastatic disease are treated with combination cytotoxic chemotherapy or targeted agents; although chemotherapy treatment has good response rates complete responses are rarely seen. During the last decade the field of immuno-oncology has rapidly advanced and a number of agents which modulate the immune system are beginning to emerge and change treatment paradigms. Two of the most prominent and promising class of drugs are the immune checkpoint inhibitors, that target the proteins found on T-lymphocytes or T cells such as
programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) pathways.
The immune checkpoint inhibitors are causing a stir amongst oncologist as they have been shown to be effective in the treatment of a variety of cancers, enhancing the immune response to detect and target cancer cells with a lower incidence of side effects compared to conventional chemotherapy and providing durable responses, lasting for many years. Five checkpoint inhibitors have received rapid approval from the U.S. Food and Drug Administration for cancer, including the PD-1 inhibitors Keytruda (pembrolizumab), and Opdivo (nivolumab), the PD-L1 inhibitors Tecentriq (atezoliumab), Bavencio (avelumab) and Imfinzi (durvalumab) and the CTLA-4 inhibitor Yervoy (ipilimumab). In 2011, Bristol
Myers Squibb's Yervoy a CTLA-4 inhibitor became one of the first checkpoint inhibitor to be approved in the treatment of metastatic melanoma, despite considerable safety and tolerability concerns. It took a further 3 years before the next checkpoint inhibitor Keytruda, a PD-1 inhibitor was approved for the treatment of advanced unresectable melanoma.
Since 2013, over REDACTED has been invested by pharma companies in acquisitions, equity offerings and venture capital and a further REDACTED has been transacted in the establishment of strategic partnerships associated with the development of checkpoint inhibitors. According to clincailtrial.org there are more than 230 clinical trials underway evaluating checkpoint inhibitors either as a monotherapy or in combination with chemotherapy or targeted therapies these encompass a wide variety of caner sub-types: including 117 Phase 1 trials, 112 Phase 2 trial and 9 Phase 3 studies. Several novel agents are in early stage clinical development that target novel pathways including the T cell
immunoglobulin and mucin containing protein 3 (TIM-3) and lymphocyte-activation gene 3 (LAG-3) protein inhibitors, CD-47/signal regulatory protein a (SIRPa) and immunometabolic enzymes Indoleamine 2,3-dioxygenase-1 (IDO-1) which utilize an array of innovative delivery technologies such as small molecule agents, monoclonal antibodies, bispecific antibodies and fusion proteins to target inhibit checkpoint proteins.
In 2017, checkpoint inhibitors generated sales of nearly REDACTED and by 2023 we forecast these agents will garner over REDACTED in revenues as marketed therapies gain regulatory approval in new indications and territories. In addition, novel classes if checkpoint inhibitors will enter the market, companies will identify clinically effective combinations and validate biomarkers and signatures that will enable them to help identify patients that are most likely to benefit from treatment. Personalized precision medicine will be a major driver for pharma to effectively deliver these innovative medicines and ensure they are accessible and available at sustainable prices to all those in need.
Checkpoint Inhibitors: Global Markets
Table of Contents
Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
Chapter 2 Summary and Highlights
Chapter 3 Immuno-Oncology Market and Checkpoint Market Statistics
Immuno-Oncology
Co-Stimulatory Immune Checkpoint Targets
Inhibitory Immune Checkpoint Targets
Immunometabolic Modulatory Targets
Unmet Medical Needs
New Biomarkers to Stratify Patients
Relapse/Refractory Patients
Treatment Efficacy and Tolerability
Innovative Strategies
Emerging New Checkpoint Inhibitors
New Combinations
Novel Targeted Approaches
Humanized Monoclonal Antibodies
Bispecific Agents
CAR-T Cells
Current Market Landscape
Marketed Checkpoint Inhibitors
Developmental Checkpoint Inhibitors
Chapter 4 PD-1/PD-L1 Agents
Introduction
Marketed
Pembrolizumab (Keytruda), Merck & Co.
Companion Diagnostic
Clinical Trial Program
Pembrolizumab Forecasts
Nivolumab (Opdivo), BMS
Companion Diagnostic
Clinical Trial Program
Nivolumab Forecasts
Atezolizumab (Tecentriq), Genentech
Companion Diagnostic
Clinical Trial Program
Atezolizumab Forecasts
Avelumab (Bavencio), Merck KGaA/Pfizer
Companion Diagnostic
Clinical Trial Program
Avelumab Forecasts
Durvalumab (Imfinzi), AstraZeneca
Companion Diagnostic
Clinical Trial Program
Durvalumab Forecasts
Cemiplimab (Libtayo), Regeneron/Sanofi
Clinical Programs Phase 3
Spartalizumab, Novartis
Tislelizumab, BeiGene
Clinical Programs Phase 2
INCMGA0012, Incyte/MacroGenics
LY3300054, Eli Lilly
Clinical Programs Phase 1
BI 754091, Boehringer Ingelheim
CA-170, Curis/Aurigene
CS1001, CStone Pharmaceuticals
FS118, Merck KGaA/F-Star
Preclinical Programs
aCD27xaPD-L1, Celldex
MEDI1109, AstraZeneca
XmAb20717 and XmAb23104, Xencor
Market Forecasts
Chapter 5 CTLA-4
Introduction
Marketed Drugs
Yervoy (ipilimumab), BMS
Clinical Programs Phase 3
Tremelimumab, Astra Zeneca
Clinical Programs Phase 1/2
Anti-CTLA-4/PD-1 Expressing MUC1-CAR-T, Shanghai Cell Therapy
Clinical Programs Phase 1
AGEN-1884, Agenus
BCD-145, Biocad
CS1002, CStone Pharmaceuticals
REGN4659, Regeneron Pharmaceuticals
Market Forecasts
Chapter 6 IDO-1
Introduction
IDO-1 Developmental Therapies
Clinical Programs Phase 3
Epacadostat, Incyte
Clinical Programs Phase 1
BMS 986205, Bristol-Myers Squibb
EOS200271, iTeos Therapeutics
Indoximod (NLG-001) and Navoximod (NLG 919, GDC-0919, R6078), NewLink Genetics
KHK2455, Kyowa Kirin
LY3381916, Eli Lilly
Preclinical Programs
Market Forecasts
Chapter 7 LAG-3
Introduction
LAG-3 Developmental Therapies
Clinical Programs Phase 2/3
Relatlimab (BMS-986016), BMS
Clinical Programs Phase 2
LAG525 (IMP701), Novartis/Immuntep (Prima BioMed)
Eftilagimod Alpha (IMP321), Immuntep (Prima BioMed)
BI 754111, Boehringer Ingelheim
FS118, Merck KGgaA/ F-star
Sym022, Shire/Symphogen A/S
TSR-033, Tesaro/Anaptys Bio
XmAb22841, Xencor
Preclinical Programs
INCAGN02385, Incyte/Agenus
Market Forecasts
Chapter 8 TIM-1,3
Introduction
TIM-1,3 Developmental Therapies
Clinical Programs Phase 2
Bavituximab, Merck Sharp & Dohme/Oncologie International
Clinical Programs Phase 1/2
CDX-014, Celldex Therapeutics/Seattle Genetics
MGB453 +/- Spartalizumab, Novartis
Clinical Programs Phase 1
LY3321367 +/- LY3300054, Eli Lilly
TSR-022 +/- TSR-042, Tesaro/AnaptysBio
Preclinical Programs
CA-327 (AUPM-327), Curis/Aurigene
ENUM005, Enumeral Biomedical
JNJ-64158120, Johnson & Johnson
LY3321367, Eli Lilly
STI-600, Sorrento Therapeutics
Sym016, Symphogen A/S
Market Forecasts
Chapter 9 CD47/SIRPa
Introduction
CD47-SIRPa Developmental Therapies
Clinical Phase 1/2
5F9, Forty Seven Inc
Clinical Programs Phase 1
ALX148, ALX Oncology
CC-90002, Celgene/InhibRx
SRF231, Surface Oncology
TTI-621, Trillium
TTI-622, Trillium
Preclinical Programs
OSE-172, Boeringher Ingelheim/ OSE Immunotherapeutics
INCAGN2390, Incyte/Agenus
Market Forecasts
Chapter 10 Company Profiles
ALX ONCOLOGY
AGENUS INC.
ANAPTYS BIO
BEIGENE
BIOCAD
CSTONE PHARMACEUTICALS
CRESCENDO BIOLOGICS LTD.
F-STAR BIOTECHNOLOGY
FORTY SEVEN, INC.
IMMUTEP, LTD.
INHIBRX
MACROGENICS, INC.
OSE IMMUNOTHERAPEUTIC
REGENERON PHARMACEUTICALS, INC.
SEATTLE GENETICS, INC.
SORRENTO THERAPEUTICS, INC.
SHANGHAI CELL THERAPY
SYMPHOGEN A/S
SURFACE ONCOLOGY
TESARO, INC.
TRILLIUM THERAPEUTICS
XENCOR
Chapter 11 Appendix A: List of Abbreviations
Chapter 12 Appendix B: Glossary of Terms
Chapter 13 Appendix C: Sources
List of Tables
Summary Table : Global Market for Checkpoint Inhibitors, by Drug Class, Through 2023
Table 1 : Adverse Events Associated with Immune-Checkpoint Blockade
Table 2 : Global Market for Marketed Checkpoint Inhibitors, by Drug Target, Through 2023
Table 3 : Global Market for Developmental Checkpoint Inhibitors, by Drug Target, Through 2023
Table 4 : Comparison of PD-L1-PD-L2 ligands
Table 5 : Summary of Anti-PD-1/PD-L1 Therapies Approved Indications
Table 6 : PD-1/PD-L1 Agents in Development
Table 7 : Pembrolizumab Approved Indications
Table 8 : Global Market for Pembrolizumab, by Region, Through 2023
Table 9 : Global Market for Pembrolizumab, by Indication, Through 2023
Table 10 : Nivolumab Approved Indications
Table 11 : Global Market for Nivolumab, by Region, Through 2023
Table 12 : Global Market for Nivolumab, by Indication, Through 2023
Table 13 : Atezolizumab Approved Indications
Table 14 : Global Market for Atezolizumab, by Region, Through 2023
Table 15 : Global Market for Atezolizumab, by Indication, Through 2023
Table 16 : Avelumab Approved Indications
Table 17 : Global Market for Avelumab, by Region, Through 2023
Table 18 : Global Market for Avelumab, by Indication, Through 2023
Table 19 : Durvalumab Approved Indications
Table 20 : Global Market for Durvalumab, by Region, Through 2023
Table 21 : Global Market for Duvalumab, by Indication, Through 2023
Table 22 : Regeneron's NSCLC Development Program
Table 23 : Global Market for Cemiplimab, by Region, Through 2023
Table 24 : Global Market for Cemiplimab, by Indication, Through 2023
Table 25 : Clinical Trials Evaluating Tislelizumab
Table 26 : Clinical Trials Evaluating INCMGA00012
Table 27 : Global Market for anti-PD-1/PD-L1 Therapies, by Product, Through 2023
Table 28 : CTLA-4 Agents in Development
Table 29 : Global Market for Anti-CTLA-4 Therapies, by Product, Through 2023
Table 30 : Summary of Anti-IDO-1 Developmental Programs
Table 31 : Clinical Trials Evaluating Epacadostat
Table 32 : Clinical Trials Evaluating Navoximod (GDC-0919)
Table 33 : Global Market for anti-IDO-1 Therapies, by Product, Through 2023
Table 34 : Anti- LAG-3 Therapies in Development
Table 35 : Clinical Trials Evaluating Relatlimab
Table 36 : Clinical Trials Evaluating LAG525
Table 37 : Clinical Trials Evaluating IMP321
Table 38 : Clinical Trials Evaluating BI 754111
Table 39 : Clinical Trials Evaluating FS118
Table 40 : Clinical Trials Evaluating Sym022
Table 41 : Clinical Trials Evaluating TSR-033
Table 42 : Global Market for anti-LAG-3 Therapies, by Product, Through 2023
Table 43 : TIM-1,3 Agents in Development
Table 44 : Global Market for Anti-TIM-1,3 Therapies, by Product, Through 2023
Table 45 : T-Cell and Macrophages Characteristics
Table 46 : Clinical Trials Evaluating CD47-SIRPa Targeted Therapies
Table 47 : Clinical Trials Evaluating 5F9
Table 48 : Clinical Trials Evaluating ALX148
Table 49 : Clinical Trials Evaluating C-9002
Table 50 : Clinical Trials Evaluating C-9002
Table 51 : Clinical Trials Evaluating TTI-621
Table 52 : Clinical Trials Evaluating TTI-622
Table 53 : Global Market for anti-CD47-SIRPa Therapies, by Product, Through 2023
Table 54 : Abbreviations Used in Checkpoint Inhibitors
Table 55 : Glossary of Terms
Table 56 : Checkpoint Inhibitors Sources
Table 57 : Chapter 2 Sources
Table 58 : Chapter 3 Sources
Table 59 : Chapter 4 Sources
Table 60 : Chapter 5 Sources
Table 61 : Chapter 6 Sources
Table 62 : Chapter 7 Sources
Table 63 : Chapter 8 Sources
List of Figures
Summary Figure : Global Market for Checkpoint Inhibitors, by Drug Class, 2017-2023
Figure 1 : Potential Targets for Checkpoint Inhibition in Clinical Evaluation
Figure 2 : Global Market for Marketed Checkpoint Inhibitors, by Drug Target, 2017-2023
Figure 3 : Global Market for Developmental Checkpoint Inhibitors, by Drug Target, 2017-2023
Figure 4 : Pembrolizumab Comprehensive Clinical Trial Programs, by Status
Figure 5 : Pembrolizumab Comprehensive Clinical Trial Programs, by Therapy
Figure 6 : Pembrolizumab Comprehensive Clinical Trial Programs, by Cancer Type
Figure 7 : Global Market for Pembrolizumab, by Region, 2017-2023
Figure 8 : Nivolumab Comprehensive Clinical Trial Programs, by Status
Figure 9 : Nivolumab Comprehensive Clinical Trial Programs, by Therapy
Figure 10 : Nivolumab Comprehensive Clinical Trial Programs, by Cancer Type
Figure 11 : Global Market for Nivolumab, by Region, 2017-2023
Figure 12 : Atezolizumab Comprehensive Clinical Trial Programs, by Status
Figure 13 : Atezolizumab Comprehensive Clinical Trial Programs, by Therapy
Figure 14 : Atezolizumab Comprehensive Clinical Trial Programs, by Cancer Type
Figure 15 : Global Market for Atezolizumab, by Region, 2017-2023
Figure 16 : Avelumab Comprehensive Clinical Trial Programs, by Status
Figure 17 : Avelumab Comprehensive Clinical Trial Programs, by Therapy
Figure 18 : Avelumab Comprehensive Clinical Trial Programs, by Cancer Type
Figure 19 : Global Market for Avelumab, by Region, 2017-2023
Figure 20 : Durvalumab Comprehensive Clinical Trial Programs, by Status
Figure 21 : Durvalumab Comprehensive Clinical Trial Programs, by Therapy
Figure 22 : Durvalumab Comprehensive Clinical Trial Programs, by Cancer Type
Figure 23 : Global Market for Durvalumab, by Region, 2017-2023
Figure 24 : Global Market for Cemiplimab, by Region, 2017-2023
Figure 25 : Global Market for anti-PD-1/PD-L1, by Product, 2017-2023
Figure 26 : Signaling Molecules Involved in CD28 and CTLA-4 Function
Figure 27 : Fab Fragment of ipilimumab (blue) Binding CTLA-4 (green)
Figure 28 : Global Market for Anti-CTLA-4 Therapies, by Product, 2017-2023
Figure 29 : Schematic of Mechanism of Action of IDO-1 Inhibition on Tryptophan (Trp) Catabolism in Cancer
Figure 30 : Structure of Epacadostat
Figure 31 : Structure of BMS-986205
Figure 32 : Structure of A) Inoximod and B) navoximod
Figure 33 : Global Market for anti-IDO-1 Therapies, by Product, 2017-2023
Figure 34 : Global Market for Anti-LAG3 Therapies, by Product, 2017-2023
Figure 35 : Schematic of Mechanism of Action of TIM-3 in T-Cell Activation and Synergistic Effect on PD-1 Inhibition
Figure 36 : Global Market for Anti-TIM-1,3 Therapies, by Product, 2017-2023
Figure 37 : Mechanism of Action of Anticd47/SIRPa Therapies
Figure 38 : Structure of ALX148
Figure 39 : Structure of TTI-621
Figure 40 : Structure of TTI-622
Figure 41 : Global Market for anti-CD47-SIRPa, by Product, 2017-2023
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