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Global Immune Checkpoint Inhibitors Biomarkers & Clinical Trials Insight 2028

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    Drug Pipelines

  • 900 Pages
  • March 2022
  • Region: Global
  • Kuick Research
  • ID: 4117867
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Global Immune Checkpoint Inhibitors Biomarkers and Clinical Trials Insight 2028 Report Highlights

  • Global Immune Checkpoint Inhibitors Market Opportunity: > USD 30 Billion
  • Immune Checkpoint Inhibitors Clinical Trials Insight: CTLA-4, LAG3, PD-1/PD-L1, TIGIT Inhibitors
  • Immune Checkpoint Inhibitors Clinical Trials Insight: > 300 Drugs In Trials
  • Biomarkers Insight By Immune Checkpoint Inhibitors Classification
  • Insight On  Biomarkers Sourced From Trials By Drugs and Indication
  • Biomarker Name and Function Insight By Immune Checkpoint Inhibitor Drug

Biomarker Insight Based on Drugs in Multiple Trials Phase and Multiple Indication


Cancer biomarker is a traceable substance or molecules which indicate the presence of cancerous cells. The prevention of cancer by diagnosing and analyzing various cancer biomarkers using different diagnostic techniques is a profound approach to obtain rapid results for treatment. There are various types of biomarkers such as proteins, peptides, antibodies, and nucleic acids. The presence of these biomarkers in tissues, urine, serum, blood, and other body fluids indicate an abnormal process or a disease. Various such biomarkers for cancer indications have been studied and are used as biomarkers for diagnostics, prognostics, personalized medicines, and surrogate endpoints. The identification of different types of biomarkers is an integral part of various industries such as healthcare and pharmaceuticals. 

Among all targeted approaches, immune checkpoint inhibitors have gained the maximum interest in the market. To date, several immune checkpoint inhibitors have entered the market and various others are present in clinical development, thus driving this sector during the forecast period. However, these immune checkpoint inhibitors are shown to be effective in about 20%-30% of the cancer patients. Therefore, there is unmet need to develop and validate accurate biomarkers to assist immune checkpoint therapy in cancer patients.

Currently, the FDA has approved three predictive biomarkers for immune checkpoint inhibitor therapy in cancer patients including programmed cell death ligand-1 (PD-L1); microsatellite instability (MSI), and tumor mutational burden (TMB). Apart from this, several others are present in clinical development. The report provides comprehensive analysis on the ongoing clinical trials related to biomarker for approved immune checkpoint inhibitors as well as inhibitors which are under clinical trials. Furthermore, the role of biomarker in different therapeutic conditions is also mentioned in the report.

Many pharmaceutical companies are actively investing in research and development of novel biomarkers for the diagnosis and treatment of cancer. Many potential candidates are in their end stage of development and are projected to give a tremendous boost to the market after their launch. Recently in 2022, Personalis announced a strategic alliance with the Moores Cancer Center at University of California San Diego Health, a National Cancer Institute-designated Comprehensive Cancer Center, to support clinical diagnostic testing in patients with advanced solid tumors and hematological malignancies. The collaboration will bring Personalis’ leading comprehensive genomic tumor profiling test to UC San Diego health care professionals and their cancer patients to help guide FDA-approved therapy decisions, as well as clinical trial treatment options.

The US will continue to dominate the global market in terms of biomarker research and Immune checkpoint inhibitor sales during the forecast period driven by several factors including higher adoption of advanced technologies like next generation sequencing, and the increasing number of research studies establishing the role of biomarkers in drug discovery and development, and cancer diagnosis. Additionally, rising prevalence of cancer in the region and surge in awareness among population regarding the availability of biomarkers will also aid in the growth of market. Furthermore, rapid approval of diagnostic tests in the region will also propel the growth of the market. For instance in 2022, Oxford BioDynamics announced the US launch of its checkpoint inhibitor test (EpiSwitch CIRT) for cancer.

The global immune checkpoint inhibitor biomarkers market is expected to witness a significant growth during the forecast period due to increase in prevalence of various types of cancers such as breast, prostate, and lung cancer. In addition, surge in importance of biological and targeted drug therapies, technological advancements, accuracy, and reliability of cancer biomarkers also contribute toward the growth of the market. Moreover, increase in investments from governments and public and private sector toward research and development for cancer diagnostics have a positive impact on the market. The key players in the market include Roche, Abbott, Thermo Fisher Scientific, Centogene, Myriad, and others.

Table of Contents

1. Global Immune Checkpoint Inhibitor Market Overview
1.1 Current Market Scenario
1.2 Future Market Opportunity
2. CTLA4 Protein Inhibitors Biomarkers and Clinical Trials Insight By Company, Indication and Phase
2.1 Research
2.2 Preclinical
2.3 Phase-I
2.4 Phase-I/II
2.5 Phase-II
2.6 Phase-III
2.7 Preregistration
3. Marketed CTLA-4 Inhibitors Drugs Biomarkers Insight
4. Global LAG3 Inhibitors Clinical Pipeline By Company, Indication and Phase
4.1 Research
4.2 Preclinical
4.3 Phase-I
4.4 Phase-I/II
4.5 Phase-II
4.6 Phase-II/III
4.7 Phase-III
4.8 Preregistration
5. PD-1/PD-L1 Inhibitors Biomarkers and Clinical Trials Insight By Company, Indication and Phase
5.1 Research
5.2 Preclinical
5.3 Phase-I
5.4 Phase-I/II
5.5 Phase-II
5.6 Phase-II/III
5.7 Phase-III
5.8 Preregistration
5.9 Registered
6. Marketed PD-1/PD-L1 Inhibitors Drugs Biomarkers Insight
7. TIGIT Protein Inhibitors Biomarkers and Clinical Trials Insight By Company, Indication and Phase
7.1 Research
7.2 Preclinical
7.3 Phase-I
7.4 Phase-I/II
7.5 Phase-II
7.6 Phase-III
8. PD-1/PD-L1 Immune Checkpoint Inhibitor - Availability, Patent, Price and Dosage Analysis
8.1 Pembrolizumab (Keytruda )
8.2 Nivolumab (Opdivo)
8.3 Durvalumab (Imfinzi)
8.4 Avelumab (Bavencio)
8.5 Atezolizumab (Tecentriq)
8.6 Cemiplimab (Libtayo)
8.7 Dostarlimab (Jemperli)
8.8 Toripalimab (Tuoyi)
8.9 Sintilimab (Tyvyt)
8.10 Camrelizumab (AiRuiKa)
8.11 Tislelizumab (Baize’an)
8.12 Envafolimab (Enweida)
8.13 Sugemalimab (Cejemly)
8.14 Zimberelimab
8.15 Penpulimab
9. CTLA-4 Immune Checkpoint Inhibitor - Availability, Patent, Price and Dosage Analysis
9.1 Ipilimumab (Yervoy)
10. Global Immune Checkpoint Inhibitors Sales Insights 2028
10.1 Keytruda
10.2 Yervoy
10.3 Opdivo
10.4 Imfinzi
10.5 Tecentriq
10.6 Libtayo
10.7 Jemperli
10.8 Bavencio
10.9 Tyvyt
11. Competitive Landscape
11.1 Amgen
11.2 AstraZeneca
11.3 Bristol Myers Squibb
11.4 F-Star Therapeutics
11.5 GlaxoSmithKline
11.6 Immutep
11.7 Innovent
11.8 Macrogenics
11.9 Merck
11.10 Nanobiotix
11.11 Novartis
11.12 Ono Pharmaceutical
11.13 Pfizer
11.14 Roche
11.15 Shanghai Junshi Biosciences


List of Figures


Figure 1-1: Global – Immune Checkpoint Inhibitors Market Size (US$ Billion), 2020 and 2021
Figure 1-2: Global – Immune Checkpoint Inhibitors Market by Region (US$ Billion), 2021
Figure 1-3: Global – Immune Checkpoint Inhibitors Market by Region (%), 2021
Figure 1-4: Global – Immune Checkpoint Inhibitors Market by Product (US$ Billion), 2021
Figure 1-5: Global – Immune Checkpoint Inhibitors Market by Product (%), 2021
Figure 1-6: Global – Immune Checkpoint Inhibitors Market Opportunity (US$ Billion), 2022 - 2028
Figure 1-7: US – Immune Checkpoint Inhibitors Market Opportunity (US$ Billion), 2022 - 2028
Figure 8-1: Keytruda – Approval Year by Region
Figure 8-2: Keytruda – FDA Approval Year by Indication
Figure 8-3: Keytruda – Patent Expiration Year by Region
Figure 8-4: US - Price for 4ml, 8ml Supply and Price Per ml of Keytruda Intravenous Injection (US$), February’2022
Figure 8-5: UK - Price for 4ml and Price Per ml of Keytruda 100mg Intravenous Injection (GBP/US$), February’2022
Figure 8-6: Keytruda – Duration of Single Treatment Cycle and Full Treatment of Melanoma and Other Cancers (Weeks), February’2022
Figure 8-7: Keytruda - Cost of Single and Full Treatment using Solution of Injection (US$), February’2022
Figure 8-8: Opdivo – Approval Year by Region
Figure 8-9: Opdivo – FDA Approval by Indication
Figure 8-10: Opdivo - Patent Expiration Year by Region
Figure 8-11: US - Price for 4ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (US$), February’2022
Figure 8-12: US - Price for 10 ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (US$), February’2022
Figure 8-13: US - Price for 12 ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (US$), February’2022
Figure 8-14: US - Price for 24 ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (US$), February’2022
Figure 8-15: UK - Price for 4 ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (GBP/US$), February’2022
Figure 8-16: UK - Price for 10ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (GBP/US$), February’2022
Figure 8-17: UK - Price for 24ml Supply and Price Per ml of Opdivo 10mg/ml Intravenous Injection (GBP/US$), February’2022
Figure 8-18: Opdivo Monotherapy Therapy - Single Treatment Cycle and Full Treatment Average Cost (US$), February’2022
Figure 8-19: Imfinzi – FDA Approval Year by Indication
Figure 8-20: Imfinzi – Approval Year by Region
Figure 8-21: Imfinzi – FDA Approval and Patent Expiration Year
Figure 8-22: US– Price for a Supply of 2.4ml and Price Per ml of Imfinzi Solution for Injection (US$), February’2022
Figure 8-23: US – Price for a Supply of 10 ml and Price Per ml of Imfinzi Solution for Injection (US$), February’2022
Figure 8-24: UK– Price for a Supply of 2.4ml and Price Per ml of Imfinzi Solution for Injection (GBP/US$), February’2022
Figure 8-25: UK– Price for a Supply of 10ml and Price Per ml of Imfinzi Solution for Injection (GBP/US$), February’2022
Figure 8-26: Imfinzi - Average Cost of Single Treatment Cycle and Full Treatment of NSCLC (US$), February’2022
Figure 8-27: Bavencio – FDA Approval Year by Indication
Figure 8-28: Bavencio - Price for 10ml Supply and Price Per ml of 20mg/ml Intravenous Injection (US$), February’2022
Figure 8-29: UK– Price for a Supply of 10ml and Price Per ml of Bavencio Solution for Injection (GBP/US$), February’2022
Figure 8-30: Bavencio - Average Cost of Single Treatment Cycle and Annual Treatment (US$), February’2022
Figure 8-31: Tecentriq – Approval Year by Region
Figure 8-32: Tecentriq – FDA Approval Year by Indication
Figure 8-33: US- Price for 14ml Supply and Price Per ml of Tecentriq 840mg/14ml Intravenous Injection (US$), February’2022
Figure 8-34: US - Price for 20ml Supply and Price Per ml of Tecentriq 1200mg/20ml Intravenous Injection (US$), February’2022
Figure 8-35: UK– Price for a Supply of 20ml and Price Per ml of Tecentriq Solution for Injection (GBP/US$), February’2022
Figure 8-36: UK– Price for a Supply of 14ml and Price Per ml of Tecentriq Solution for Injection (GBP/US$), February’2022
Figure 8-37: Tecentriq - Average Cost of Single Treatment Cycle and Annual Treatment using 840mg/2 Week Dose (US$), February’2022
Figure 8-38: Tecentriq - Average Cost of Single Treatment Cycle and Annual Treatment using 1200mg/3 Week Dose (US$), February’2022
Figure 8-39: Tecentriq - Average Cost of Single Treatment Cycle and Annual Treatment using 1680mg/4 Week Dose (US$), February’2022
Figure 8-40: Libtayo – Approval Year by Region
Figure 8-41: Libtayo – FDA Approval Year by Indication
Figure 8-42: US– Price for a Supply of 7ml and Price Per ml of Libtayo Solution for Injection (US$), February’2022
Figure 8-43: UK– Price for a Supply of 7ml and Price Per ml of Libtayo Solution for Injection (GBP/US$), February’2022
Figure 8-44: Libtayo – Cost of Single Treatment Cycle and Annual Treatment Cost (US$), February’2022
Figure 8-45: US– Price for a Supply of 10ml and Price Per ml of Jemperli Solution for Injection (US$), February’2022
Figure 8-46: UK– Price for a Supply of 10ml and Price Per ml of Jemperli Solution for Injection (GBP/US$), February’2022
Figure 8-47: Jemperli - Average Dose of Initial 4 Cycles and Subsequent Cycles (mg)
Figure 8-48: Jemperli - Average Cost of Initial 4 Cycles and Subsequent Cycles (US$), February’2022
Figure 8-49: Tuoyi – NMPA Approval by Indication
Figure 8-50: China– Price for a Supply of 2ml and Price Per ml of Tuoyi Solution for Injection (Yuan/US$), February’2022
Figure 8-51: China– Price for a Supply of 2.5ml and Price Per ml of Tuoyi Solution for Injection (Yuan/US$), February’2022
Figure 8-52: China– Price for a Supply of 6ml and Price Per ml of Tuoyi Solution for Injection (Yuan/US$), February’2022
Figure 8-53: Tyvyt – NMPA Approval by Indication
Figure 8-54: China– Price for Vial of AiRuiKa (Yuan/US$), February’2022
Figure 8-55: Tislelizumab – NMPA Approval by Indication
Figure 8-56: China– Price for Vial of Penpulimab (Yuan/US$), February’2022
Figure 9-1: Yervoy – Approval Year by Region
Figure 9-2: Yervoy – FDA Approval Year by Indication
Figure 9-3: Yervoy – US and Europe Exclusivity Expiration Year
Figure 9-4: US - Price for 10ml Supply and Price Per ml of Yervoy 5mg/ml Intravenous Injection (US$), February’2022
Figure 9-5: US – Price for 40ml Supply and Price Per ml 5mg/ml Yervoy Intravenous Injection (US$), February’2022
Figure 9-6: UK - Price for 10ml and Price Per ml of Yervoy 50mg Intravenous Injection (GBP/US$), February’2022
Figure 9-7: UK - Price for 40ml and Price Per ml of Yervoy 200mg Intravenous Injection (GBP/US$), February’2022
Figure 9-8: Yervoy – Duration of Single Treatment Cycle and Full Treatment of Metastatic Melanoma and Hepatocellular Carcinoma (Weeks), February’2022
Figure 9-9: Yervoy – Average Cost of Single Treatment Cycle and Full Treatment of Metastatic Melanoma and Hepatocellular Carcinoma (US$), February’2022
Figure 9-10: Yervoy – Average Cost of Single Treatment Cycle, Initial Year and Remaining Years for Management of Metastatic Melanoma (US$), February’2022
Figure 10-1: Global - Keytruda Annual Sales Value (US$ Billion), 2018 - 2021
Figure 10-2: Global - Keytruda Quarterly Sales Value (US$ Billion), 2021
Figure 10-3: Global - Keytruda Quarterly Sales Value (US$ Billion), 2020
Figure 10-4: Global - Yervoy Annual Sales Value (US$ Million), 2018 - 2021
Figure 10-5: US - Yervoy Annual Sales Value (US$ Million), 2018 - 2021
Figure 10-6: Yervoy - Annual Sales Value by Region (US$ Million), 2021
Figure 10-7: Yervoy - Annual Sales Value by Region (US$ Million), 2021
Figure 10-8: Global - Yervoy Quarterly Sales Value (US$ Million), 2021
Figure 10-9: US - Yervoy Quarterly Sales Value (US$ Million), 2021
Figure 10-10: Global - Yervoy Quarterly Sales Value (US$ Million), 2020
Figure 10-11: US - Yervoy Quarterly Sales Value (US$ Million), 2020
Figure 10-12: Global - Opdivo Annual Sales Value (US$ Million), 2021
Figure 10-13: US - Opdivo Annual Sales Value (US$ Million), 2021
Figure 10-14: Global - Opdivo Quarterly Sales Value (US$ Million), 2021
Figure 10-15: US - Opdivo Quarterly Sales Value (US$ Million), 2021
Figure 10-16: Global - Opdivo Quarterly Sales Value (US$ Million), 2020
Figure 10-17: US - Opdivo Quarterly Sales Value (US$ Million), 2020
Figure 10-18: Global - Imfinzi Annual Sales Value (US$ Million), 2019 - 2021
Figure 10-19: US - Imfinzi Annual Sales Value (US$ Million), 2019 - 2021
Figure 10-20: Europe - Imfinzi Annual Sales Value (US$ Million), 2019 - 2021
Figure 10-21: Imfinzi - Annual Sales Value by Region (US$ Million), 2021
Figure 10-22: Imfinzi - Annual Sales Value by Region (%), 2021
Figure 10-23: Global - Imfinzi Quarterly Sales Value US$ Million), 2021
Figure 10-24: US - Imfinzi Quarterly Sales Value US$ Million), 2021
Figure 10-25: Global - Imfinzi Quarterly Sales Value US$ Million), 2020
Figure 10-26: US - Imfinzi Quarterly Sales Value US$ Million), 2020
Figure 10-27: Global - Tecentriq Annual Sales Value (US$/CHF Million), 2019 - 2021
Figure 10-28: US - Tecentriq Annual Sales Value (US$/CHF Million), 2019 - 2021
Figure 10-29: Europe - Tecentriq Annual Sales Value (US$/CHF Million), 2019 - 2021
Figure 10-30: Japan - Tecentriq Annual Sales Value (US$/CHF Million), 2019 - 2021
Figure 10-31: ROW - Tecentriq Annual Sales Value (US$/CHF Million), 2019 - 2021
Figure 10-32: Tecentriq - Annual Sales Value by Region (US$/CHF Million), 2021
Figure 10-33: Tecentriq - Annual Sales Value by Region (%), 2021
Figure 10-34: Global - Tecentriq Quarterly Sales Value (US$ Billion), 2021
Figure 10-35: US - Tecentriq Quarterly Sales Value (US$ Billion), 2021
Figure 10-36: US - Tecentriq Quarterly Sales Value (US$ Million), 2020
Figure 10-37: Global - Libtayo Annual Sales Value (US$ Million), 2018 - 2021
Figure 10-38: US - Libtayo Annual Sales Value (US$ Million), 2018 - 2021
Figure 10-39: Libtayo - Annual Sales Value by Region (US$ Million), 2021
Figure 10-40: Libtayo - Annual Sales Value by Region (%), 2021
Figure 10-41: Global - Libtayo Quarterly Sales Value (US$ Million), 2021
Figure 10-42: US - Libtayo Quarterly Sales Value (US$ Million), 2021
Figure 10-43: Global - Libtayo Quarterly Sales Value (US$ Million), 2020
Figure 10-44: US - Libtayo Quarterly Sales Value (US$ Million), 2020
Figure 10-45: Global - Jemperli Annual Sales Value by Region (US$/GBP Million), 2021
Figure 10-46: Global - Jemperli Annual Sales Value by Region (%), 2021
Figure 10-47: US - Jemperli Quarter Sales Value (US$/GBP Million), Q3 and Q4’2021
Figure 10-48: Global - Bavencio Annual Sales Value (US$ Million), 2020 and 2021
Figure 10-49: US - Bavencio Annual Sales Value (US$ Million), 2020 and 2021
Figure 10-50: Europe - Bavencio Annual Sales Value (US$ Million), 2020 and 2021
Figure 10-51: Bavencio - Annual Sales Value by Region (US$ Million), 2021
Figure 10-52: Bavencio - Annual Sales Value by Region (%), 2021
Figure 10-53: Global - Tyvyt Annual Sales Value (US$ Million), 2019 - 2021
Figure 10-54: Global - Tyvyt Quarterly Sales Value (US$ Million), 2021
Figure 10-55: Global - Tyvyt Quarterly Sales Value (US$ Million), 2020


List of Tables


There Are More Than 500 Tables Representing Comprehensive Information On Biomarkers By Immune Checkpoint Inhibitors Clinical Trials And Indication

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Amgen
  • AstraZeneca
  • Bristol Myers Squibb
  • F-Star Therapeutics
  • GlaxoSmithKline
  • Immutep
  • Innovent
  • Macrogenics
  • Merck
  • Nanobiotix
  • Novartis
  • Ono Pharmaceutical
  • Pfizer
  • Roche
  • Shanghai Junshi Biosciences

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