TROP2抗体の世界市場：薬剤販売、臨床試験見通し（2028年）

当レポートは、世界のTROP2抗体市場について調査し、市場の概要とともに、薬剤動向、臨床試験動向、地域別動向、および市場に参入する企業の競合情勢などを提供しています。

目次

第1章 TROP2標的療法市場のイントロダクション

• 概要
• TROP2標的療法メカニズム

第2章 TROP2：癌にとっての理想的な臨床バイオマーカー

第3章 最初に承認されたTROP2標的抗体-Trodelvy

• 臨床概要
• 承認、特許、独占権

第4章 Trodelvy-商業的洞察（2020年～2022年）

• 投与量と価格の分析
• 売上分析

第5章 世界のTROP2標的療法市場分析

• 現在の市場シナリオ（2020年～2022年）
• 将来の市場機会（2023年～2028年）

第6章 世界のTROP2標的療法市場の機会、地域別

• 米国
• 欧州
• 日本
• オーストラリア
• 英国
• 中国

第7章 TROP2標的療法の進行中の臨床試験インサイト

• 会社別
• 国別
• 患者セグメント別
• 相別

第8章 世界のTROP2抗体臨床パイプライン：会社別、適応症別、相別

• 調査
• 前臨床
• 第I相
• 第I/II相
• 第III相

第9章 上市済みTROP2抗体の臨床的洞察

第10章 世界のTROP2標的療法市場力学

• 市場促進要因
• 市場の課題

第11章 競合情勢

• Amunix
• BiOneCure Therapeutics
• Biosion
• Bio-Thera Solutions
• CytomX Therapeutics
• Daiichi Sankyo Company
• Eucure Biopharma
• Gilead Sciences
• Hangzhou DAC Biotech
• Janux Therapeutics
• Klus Pharma
• LegoChem Biosciences
• Molecular Templates
• KAEDI Biotech
• Peak Bio
• Radiopharm Theranostics
• Shanghai Henlius Biotech
• Suzhou GeneQuantum Healthcare
• 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

“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

With advancements in science and technology and convergence of trends in drug development, the landscape for commercial market for medicines has developed a deep understanding about the need to delivery novel approaches, having targets that have previously remained untouched. Despite the range of anti-cancer drugs available there still remains a surge in the number of cases which have led researchers in the quest to pursue unique targets with different strategies to fight the tumor. One such novel target discovered in multiple solid tumors is TROP-2.

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.

Table of Contents

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