Global TROP2 Antibody Market, Drug Sales & Clinical Trials Outlook 2028
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Global TROP2 Antibody Market, Drug Sales & Clinical Trials Outlook 2028 Report Highlights:
Trophoblast cell-surface antigen or TROP-2 is known by many names such as; tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor associated antigen (GA733-1) and surface marker 1 (M1S1). This emerging target has been gathering a staggering amount of attention towards its potential therapeutic use. Even though TROP-2 has garnered curiosity among researchers, there remains just one approved and commercially available antibody against it, Trodelvy.
Getting its first approval on April 2020, Trodelvy developed by Gilead has shown immense success both among the patients and the commercial market. The drug is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer who have received two or more prior systemic therapies and for locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either PD-1/PDL-1 inhibitor.
The year 2022 proved to be beneficial for Trodelvy as its sales increased by more than 70% to surpass US$600 Million in 2022 which reflected continued adoption in metastatic triple negative breast cancer in the US and Europe. The sales are further expected to increase in the coming years as in February 2023, the US FDA further approved Trodelvy for pre-treated HR+/HER2- metastatic breast cancer, becoming a recommended Category 1 preferred drug for the indication. HR+/HER2- breast cancer is among the most therapy resistant cancer and for Trodelvy to show statistically significant and clinically meaningful progression free survival and overall survival, displays that the drug will now further dominate the market gaining increased market penetration.
Even though Gilead is leading the current TROP-2 targeted therapy market segment, it is not the only market player. Just behind Gilead are Daiichi Sankyo and AstraZeneca, who entered into a collaborative agreement to develop and commercialize the new TROP-2 antibody drug conjugate, DS-1062 which could refine the treatment standards for lung, breast and multiple other cancers. AstraZeneca had faith in the concept and after two years for it providing US$1 Billion up-front to Daiichi Sankyo for rights of DS-1062, the drug has finally entered the phase III trial which will be evaluating it with Merck’s blockbuster, Keytruda in patients with non-small cell lung cancer with PD-1 expression. Earlier trails have proven to be successful for this combinational use and it is expected to provide the same promising outcomes.
Following the burgeoning competition from AstraZeneca and Daiichi Sankyo, Gilead has also started testing its TROP-2 antibody drug conjugate as a first line therapy for non-small cell lung cancer in combination with Keytruda in a trial which is being sponsored by Merck. Apart from the fierce competition between these leading pharmaceuticals, there are several pharmaceutical underdogs that have been slowly but steadily developing their novel TROP-2 targeted therapies. For instances, recently, BiOneCure Therapeutics received the US FDA clearance for its Investigational new drug BIO-106, an antibody drug conjugate designed to target TROP-2 to treat a broad range of advanced solid tumors.
Moreover, the commercial success of Trodelvy has pushed the preclinical pipeline for several targeted drug candidates and it can be estimated that there are approximately 20 TROP-2 targeted therapies in clinical trials. It can be predicted that in the next 5 years, there will be 2 more TROP-2 antibody drug conjugates available in the market, further increasing the sales for this market segment by US$ 3 Billion. Additionally, looking at the robust scientific channel of several companies, roughly 30-40 more drugs can enter their clinical phase in the coming years.
This report provides insight about the upcoming TROP-2 targeted drug candidates as well as comprehensive analysis about the success of Trodelvy, the only approved TROP-2 antibody drug conjugate and what were the reasons for its colossal triumph. Our report also provides information about the current market players and the strategies adopted by them in terms of technology exchange, licensing agreements, cooperative research arrangements or forming alliances among each other so as to climb the ladder of success in case of TROP-2 targeted antibody market.
Global TROP2 Antibody Market, Drug Sales & Clinical Trials Outlook 2028 Report Highlights:
- Global & Regional TROP2 Antibody Market Sales Insight
- Global TROP2 Antibody Sales Opportunity: > USD 3 Billion
- Global TROP2 Antibody Sales Forecast ( 2023 -2028)
- Approved TROP2 Antibody In Market: 1 Drug (Trodelvy in 2020)
- Trodelvy Dosage, Price & Sales Insight
- Trodelvy Global & Regional Sales Insight ( 2020 – 2022)
- TROP2 Antibody Clinical Pipeline By Company, Indication & Phase
- Insight On More Than 20 TROP2 Antibodies in Clinical Trials
Trophoblast cell-surface antigen or TROP-2 is known by many names such as; tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor associated antigen (GA733-1) and surface marker 1 (M1S1). This emerging target has been gathering a staggering amount of attention towards its potential therapeutic use. Even though TROP-2 has garnered curiosity among researchers, there remains just one approved and commercially available antibody against it, Trodelvy.
Getting its first approval on April 2020, Trodelvy developed by Gilead has shown immense success both among the patients and the commercial market. The drug is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer who have received two or more prior systemic therapies and for locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either PD-1/PDL-1 inhibitor.
The year 2022 proved to be beneficial for Trodelvy as its sales increased by more than 70% to surpass US$600 Million in 2022 which reflected continued adoption in metastatic triple negative breast cancer in the US and Europe. The sales are further expected to increase in the coming years as in February 2023, the US FDA further approved Trodelvy for pre-treated HR+/HER2- metastatic breast cancer, becoming a recommended Category 1 preferred drug for the indication. HR+/HER2- breast cancer is among the most therapy resistant cancer and for Trodelvy to show statistically significant and clinically meaningful progression free survival and overall survival, displays that the drug will now further dominate the market gaining increased market penetration.
Even though Gilead is leading the current TROP-2 targeted therapy market segment, it is not the only market player. Just behind Gilead are Daiichi Sankyo and AstraZeneca, who entered into a collaborative agreement to develop and commercialize the new TROP-2 antibody drug conjugate, DS-1062 which could refine the treatment standards for lung, breast and multiple other cancers. AstraZeneca had faith in the concept and after two years for it providing US$1 Billion up-front to Daiichi Sankyo for rights of DS-1062, the drug has finally entered the phase III trial which will be evaluating it with Merck’s blockbuster, Keytruda in patients with non-small cell lung cancer with PD-1 expression. Earlier trails have proven to be successful for this combinational use and it is expected to provide the same promising outcomes.
Following the burgeoning competition from AstraZeneca and Daiichi Sankyo, Gilead has also started testing its TROP-2 antibody drug conjugate as a first line therapy for non-small cell lung cancer in combination with Keytruda in a trial which is being sponsored by Merck. Apart from the fierce competition between these leading pharmaceuticals, there are several pharmaceutical underdogs that have been slowly but steadily developing their novel TROP-2 targeted therapies. For instances, recently, BiOneCure Therapeutics received the US FDA clearance for its Investigational new drug BIO-106, an antibody drug conjugate designed to target TROP-2 to treat a broad range of advanced solid tumors.
Moreover, the commercial success of Trodelvy has pushed the preclinical pipeline for several targeted drug candidates and it can be estimated that there are approximately 20 TROP-2 targeted therapies in clinical trials. It can be predicted that in the next 5 years, there will be 2 more TROP-2 antibody drug conjugates available in the market, further increasing the sales for this market segment by US$ 3 Billion. Additionally, looking at the robust scientific channel of several companies, roughly 30-40 more drugs can enter their clinical phase in the coming years.
This report provides insight about the upcoming TROP-2 targeted drug candidates as well as comprehensive analysis about the success of Trodelvy, the only approved TROP-2 antibody drug conjugate and what were the reasons for its colossal triumph. Our report also provides information about the current market players and the strategies adopted by them in terms of technology exchange, licensing agreements, cooperative research arrangements or forming alliances among each other so as to climb the ladder of success in case of TROP-2 targeted antibody market.
1. INTRODUCTION TO TROP2 TARGETING THERAPY MARKET
1.1 Overview
1.2 TROP2 Targeting Therapeutics Mechanism
2. TROP2 IDEAL CLINICAL BIOMARKER FOR CANCER
3. FIRST APPROVED TROP2 TARGETING ANTIBODY - TRODELVY
3.1 Clinical Overview
3.2 Approval, Patent & Exclusivity
4. TRODELVY - COMMERCIAL INSIGHT 2020 -2022
4.1 Dosage & Price Analysis
4.2 Sales Analysis
5. GLOBAL TROP2 TARGETING THERAPY MARKET ANALYSIS
5.1 Current Market Scenario (2020 -2022)
5.2 Future Market Opportunity (2023 -2028)
6. GLOBAL TROP2 TARGETING THERAPY MARKET OPPORTUNITY BY REGION
6.1 US
6.2 Europe
6.3 Japan
6.4 Australia
6.5 UK
6.6 China
7. TROP2 TARGETED THERAPY ONGOING CLINICAL TRIALS INSIGHT
7.1 By Company
7.2 By Country
7.3 By Patient Segment
7.4 By Phase
8. GLOBAL TROP2 ANTIBODY CLINICAL PIPELINE BY COMPANY, INDICATION & PHASE
8.1 Research
8.2 Preclinical
8.3 Phase-I
8.4 Phase-I/II
8.5 Phase-III
9. MARKETED TROP2 ANTIBODY CLINICAL INSIGHT
10. GLOBAL TROP2 TARGETED THERAPY MARKET DYNAMICS
10.1 Market Drivers
10.2 Market Challenges
11. COMPETITIVE LANDSCAPE
11.1 Amunix
11.2 BiOneCure Therapeutics
11.3 Biosion
11.4 Bio-Thera Solutions
11.5 CytomX Therapeutics
11.6 Daiichi Sankyo Company
11.7 Eucure Biopharma
11.8 Gilead Sciences
11.9 Hangzhou DAC Biotech
11.10 Janux Therapeutics
11.11 Klus Pharma
11.12 LegoChem Biosciences
11.13 Molecular Templates
11.14 KAEDI Biotech
11.15 Peak Bio
11.16 Radiopharm Theranostics
11.17 Shanghai Henlius Biotech
11.18 Suzhou GeneQuantum Healthcare
11.19 SystImmune
1.1 Overview
1.2 TROP2 Targeting Therapeutics Mechanism
2. TROP2 IDEAL CLINICAL BIOMARKER FOR CANCER
3. FIRST APPROVED TROP2 TARGETING ANTIBODY - TRODELVY
3.1 Clinical Overview
3.2 Approval, Patent & Exclusivity
4. TRODELVY - COMMERCIAL INSIGHT 2020 -2022
4.1 Dosage & Price Analysis
4.2 Sales Analysis
5. GLOBAL TROP2 TARGETING THERAPY MARKET ANALYSIS
5.1 Current Market Scenario (2020 -2022)
5.2 Future Market Opportunity (2023 -2028)
6. GLOBAL TROP2 TARGETING THERAPY MARKET OPPORTUNITY BY REGION
6.1 US
6.2 Europe
6.3 Japan
6.4 Australia
6.5 UK
6.6 China
7. TROP2 TARGETED THERAPY ONGOING CLINICAL TRIALS INSIGHT
7.1 By Company
7.2 By Country
7.3 By Patient Segment
7.4 By Phase
8. GLOBAL TROP2 ANTIBODY CLINICAL PIPELINE BY COMPANY, INDICATION & PHASE
8.1 Research
8.2 Preclinical
8.3 Phase-I
8.4 Phase-I/II
8.5 Phase-III
9. MARKETED TROP2 ANTIBODY CLINICAL INSIGHT
10. GLOBAL TROP2 TARGETED THERAPY MARKET DYNAMICS
10.1 Market Drivers
10.2 Market Challenges
11. COMPETITIVE LANDSCAPE
11.1 Amunix
11.2 BiOneCure Therapeutics
11.3 Biosion
11.4 Bio-Thera Solutions
11.5 CytomX Therapeutics
11.6 Daiichi Sankyo Company
11.7 Eucure Biopharma
11.8 Gilead Sciences
11.9 Hangzhou DAC Biotech
11.10 Janux Therapeutics
11.11 Klus Pharma
11.12 LegoChem Biosciences
11.13 Molecular Templates
11.14 KAEDI Biotech
11.15 Peak Bio
11.16 Radiopharm Theranostics
11.17 Shanghai Henlius Biotech
11.18 Suzhou GeneQuantum Healthcare
11.19 SystImmune
LIST OF FIGURES
Figure 1-1: Evolution of TROP2 Targeting Therapeutics
Figure 1-2: TROP2 Stimulated Effectors, Biomarker & Pathways
Figure 1-3: TROP2 Regulated Oncogenic Cell Signaling Pathways
Figure 1-4: General Mechanism of TROP2 Targeting Therapy
Figure 1-5: Trodelvy - Mechanism of Action
Figure 2-1: Frequency of TROP2 Expression by Cancer Type (%)
Figure 2-2: Role of TROP2 in Cancer
Figure 3-1: Trodelvy – Response Rate in Clinical Study (%)
Figure 3-2: Trodelvy – FDA Approval Year Indication
Figure 3-3: Trodelvy – Patent Expiration Year by Region
Figure 3-4: Trodelvy – Approval Year By Country
Figure 3-5: Trodelvy – FDA Orphan Designation Year by Indication
Figure 4-1: Trodelvy – Average Cost of Single Dose Cycle & Single Treatment Cycle (US$), February’2023
Figure 4-2: Global - Annual Trodelvy Sales (US$ Million), 2020-2022
Figure 4-3: Global - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-4: Trodelvy Sales By Region (%), 2022
Figure 4-5: Trodelvy Sales By Region (%), 2021
Figure 4-6: US - Annual Trodelvy Sales (US$ Million), 2019-2022
Figure 4-7: US - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-8: EU - Annual Trodelvy Sales (US$ Million), 2021-2022
Figure 4-9: EU - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-10: ROW - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-11: Global - Quarterly Trodelvy Sales (US$ Million), 2021
Figure 4-12: US - Quarterly Trodelvy Sales (US$ Million), 2021
Figure 4-13: EU - Quarterly Trodelvy Sales (US$ Million), 2021
Figure 5-1: Global – Number of Newly Diagnosed Cancer Cases (Million), 2020, 2025 & 2030
Figure 5-2: Global – Number of Cancer Deaths (Million), 2020, 2025 & 2030
Figure 5-3: Global - TROP2 Antibody Sales (US$ Million), 2020-2022
Figure 5-4: Global - Quarterly TROP2 Antibody Sales (US$ Million), 2022
Figure 5-5: Global - TROP2 Antibody Sales By Region (%), 2022
Figure 5-6: Global - TROP2 Antibody Sales By Region (%), 2021
Figure 5-7: Global – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2023-2028
Figure 5-8: Global – TROP2 Targeting Therapy Market Opportunity By Indication (%), 2028
Figure 6-1: US – Number of Newly Diagnosed Cancer Cases (Million), 2020-2026
Figure 6-2: US – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2021-2028
Figure 6-3: Europe – Number of Newly Diagnosed Cancer Cases (Million), 2020-2026
Figure 6-4: Europe – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2022-2028
Figure 6-5: Japan – Number of Newly Diagnosed Cancer Cases (Million), 2020-2026
Figure 6-6: Japan – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2023-2028
Figure 6-7: Australia - TROP2 Targeting Therapy Market Opportunity (US$ Million), 2023 - 2028
Figure 7-1: Global –TROP2 Antibody Clinical Pipeline By Company, 2023 till 2028
Figure 7-2: Global –TROP2 Antibody Clinical Pipeline By Country, 2023 till 2028
Figure 7-3: Global –TROP2 Antibody Clinical Pipeline By Patient Segment, 2023 till 2028
Figure 7-4: Global –TROP2 Antibody Clinical Pipeline By Phase, 2023 till 2028
Figure 7-5: Global – TROP2 Related Clinical Trials by Phase (%), November’2022
Figure 10-1: Global TROP2 Targeting Therapy Market Drivers
Figure 10-2: Challenges for Global TROP2 Targeting Therapy Market
Figure 1-1: Evolution of TROP2 Targeting Therapeutics
Figure 1-2: TROP2 Stimulated Effectors, Biomarker & Pathways
Figure 1-3: TROP2 Regulated Oncogenic Cell Signaling Pathways
Figure 1-4: General Mechanism of TROP2 Targeting Therapy
Figure 1-5: Trodelvy - Mechanism of Action
Figure 2-1: Frequency of TROP2 Expression by Cancer Type (%)
Figure 2-2: Role of TROP2 in Cancer
Figure 3-1: Trodelvy – Response Rate in Clinical Study (%)
Figure 3-2: Trodelvy – FDA Approval Year Indication
Figure 3-3: Trodelvy – Patent Expiration Year by Region
Figure 3-4: Trodelvy – Approval Year By Country
Figure 3-5: Trodelvy – FDA Orphan Designation Year by Indication
Figure 4-1: Trodelvy – Average Cost of Single Dose Cycle & Single Treatment Cycle (US$), February’2023
Figure 4-2: Global - Annual Trodelvy Sales (US$ Million), 2020-2022
Figure 4-3: Global - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-4: Trodelvy Sales By Region (%), 2022
Figure 4-5: Trodelvy Sales By Region (%), 2021
Figure 4-6: US - Annual Trodelvy Sales (US$ Million), 2019-2022
Figure 4-7: US - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-8: EU - Annual Trodelvy Sales (US$ Million), 2021-2022
Figure 4-9: EU - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-10: ROW - Quarterly Trodelvy Sales (US$ Million), 2022
Figure 4-11: Global - Quarterly Trodelvy Sales (US$ Million), 2021
Figure 4-12: US - Quarterly Trodelvy Sales (US$ Million), 2021
Figure 4-13: EU - Quarterly Trodelvy Sales (US$ Million), 2021
Figure 5-1: Global – Number of Newly Diagnosed Cancer Cases (Million), 2020, 2025 & 2030
Figure 5-2: Global – Number of Cancer Deaths (Million), 2020, 2025 & 2030
Figure 5-3: Global - TROP2 Antibody Sales (US$ Million), 2020-2022
Figure 5-4: Global - Quarterly TROP2 Antibody Sales (US$ Million), 2022
Figure 5-5: Global - TROP2 Antibody Sales By Region (%), 2022
Figure 5-6: Global - TROP2 Antibody Sales By Region (%), 2021
Figure 5-7: Global – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2023-2028
Figure 5-8: Global – TROP2 Targeting Therapy Market Opportunity By Indication (%), 2028
Figure 6-1: US – Number of Newly Diagnosed Cancer Cases (Million), 2020-2026
Figure 6-2: US – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2021-2028
Figure 6-3: Europe – Number of Newly Diagnosed Cancer Cases (Million), 2020-2026
Figure 6-4: Europe – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2022-2028
Figure 6-5: Japan – Number of Newly Diagnosed Cancer Cases (Million), 2020-2026
Figure 6-6: Japan – TROP2 Targeting Therapy Market Opportunity (US$ Million), 2023-2028
Figure 6-7: Australia - TROP2 Targeting Therapy Market Opportunity (US$ Million), 2023 - 2028
Figure 7-1: Global –TROP2 Antibody Clinical Pipeline By Company, 2023 till 2028
Figure 7-2: Global –TROP2 Antibody Clinical Pipeline By Country, 2023 till 2028
Figure 7-3: Global –TROP2 Antibody Clinical Pipeline By Patient Segment, 2023 till 2028
Figure 7-4: Global –TROP2 Antibody Clinical Pipeline By Phase, 2023 till 2028
Figure 7-5: Global – TROP2 Related Clinical Trials by Phase (%), November’2022
Figure 10-1: Global TROP2 Targeting Therapy Market Drivers
Figure 10-2: Challenges for Global TROP2 Targeting Therapy Market
