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 the convergence of trends in drug development, the landscape for the commercial market for medicines has developed a deep understanding of the need to deliver 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 has 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), a gastrointestinal tumor-associated antigen (GA733-1) and surface marker 1 (M1S1). This emerging target has been gathering a staggering amount of attention toward 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 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 trials 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 instance, recently, BiOneCure Therapeutics received 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 into the upcoming TROP-2 targeted drug candidates as well as a comprehensive analysis of 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 the case of TROP-2 targeted antibody market.