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Trodelvy Patent, Sales & Clinical Trials Insight 2028

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    Report

  • 84 Pages
  • October 2021
  • Region: Global
  • Kuick Research
  • ID: 5459397

Trodelvy Patent, Sales & Clinical Trials Insight 2028 Report Analysis & Data Highlights:

  • Trodelvy  Patent  Insight: 29 Patents
  • Trodelvy  Dosage & Price 
  • Trodelvy  Sales Forecast 2028: > USD 3 Billion
  • Trodelvy  Role in Cancer Therapy
  • Trodelvy  Structure & Pharmacokinetics Properties 
  • Trodelvy  Ongoing Clinical Trials: > 30 Clinical Studies
  • Trodelvy  Reimbursement Scenario 

The worldwide prevalence of breast cancer is increasing rapidly due to several risk factors including rise in geriatric population, late pregnancy, and other dramatic changes in lifestyle, sociocultural, and built environments. Triple negative breast cancer (TNBC) constitutes about 15-20% of all breast cancer cases and is characterized by the absence of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (Her-2). Owing to lack of targetable receptors, there are limited treatment options for triple negative breast cancer. Until now, chemotherapy remains the mainstay option for the management of triple negative breast cancer. 

Recently, Trodelvy, a novel targeted therapy developed by Gilead Sciences and has been approved for the management of triple negative breast cancer. The drug is antibody drug conjugate directed to Trop-2 receptor, a protein highly expressed on the surface of cancer cell and has crucial role in the development and progression of cancer. The FDA approval of the drug is supported by clinical studies which have demonstrated statistically significant reduction in the risk of disease worsening or death. In addition, the drug have also shown to extend overall survival rates in patients and enhanced clinical outcomes.    

As of now, the drug has been approved in US, Canada, Australia, Great Britain, and Switzerland. Apart from this, the drug is present in regulatory view in other regions including Europe, China and Singapore. Recently, European Medicines Agency has recommended the marketing of Trodelvy, indicating that the drug will enter the market in coming months. The rapid approval of drug in different regions will fuel the growth of market in coming years. As per report analysis, the global Trodely market is expected to witness high growth rates owing to its high adoption rates among TNBC patients which is due to lack of other effective therapies, and enhanced efficiency of novel drug in targeting the disease. 

In addition to triple negative breast cancer, researchers are also evaluating the role of drug in targeting other cancers including hormone receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer, endometrial carcinoma, urothelial cancer, glioblastoma and hepatocellular carcinoma. In addition, several clinical trials are evaluating Trodelvy in combination with talazoparib, nivolumab, carboplatin, and other cancer therapeutics. The next few years will witness rapid approval of drug as monotherapy or combinational therapy in wide range of cancer which will further boos the growth of market. 

Currently, Trodelvy is the only approved Trop-2 targeting drug in market. However, the pipeline of novel drug class is highly crowded and consists of several potential candidates including DS-1062a, RN927C, BAT8003, SKB264, JS108, and others. These are majorly present in phase-I/II clinical trials and are expected to enter market during forecast period.  The major players in Trop-2 targeting drugs market are Daiichi Sankyo, Immunomedics, Gilead Sciences, AstraZeneca, Pfizer, and BioThera Solution. The emergence of these drugs will increase the competition to Trodelvy, thus restraining its growth of market. However, increased awareness and favorable reimbursement policies are expected to drive the market. 

As per report findings, it has been suggested that the global Trodelvy market is expected to surpass US$ 3 Billion by 2028.  Several factors including increase in geriatric population and subsequent rise in prevalence of cancer, favorable reimbursement policies offered by manufacturers and insurance providers, and rising awareness among population will drive the growth of market. Geographically, US is expected to maintain dominant position during the forecast period which is mainly attributed to the robust sales of drug, increase in target population, and large number of ongoing clinical trials in the region. 


Table of Contents

1. Trodelvy (Sacituzumab Govitecan) - First Approved TROP2 Targeting Antibody Drug Conjugate
1.1 Overview
1.2 Approval & Exclusivity

2. Trodelvy Patent Insight
2.1 US Patents
2.2 Other Regions
2.2.1 Japan
2.2.2 Australia
2.2.3 Russia

3. Trodelvy Commercial Information
3.1 Dosage & Price Analysis
3.2 Sales Analysis

4. Trodelvy Description, Chemistry & Pharmacokinetics

5. Trodelvy Mechanism of Action

6. Trodelvy Role in TNBC

7. Role of Trodelvy in Urothelial Carcinoma

8. Role of Trodelvy in Other Cancers

9. Trodelvy Supplementary Information
9.1 Adverse Events
9.2 Immunogenecity & Drug Interaction
9.3 Application in Specific Population

10. Global Trodelvy Market Analysis
10.1 Current Market Scenario
10.2 Future Market Opportunity

11. Trodelvy Sales Forecast 2028

12. Trodelvy Reimbursement Policy

13. Trodelvy Clinical Trial Insight
13.1 By Phase
13.2 By Development Status
13.3 By Region

14. Trodelvy Ongoing Research & Development

15. Competitive Landscape
15.1 Amunix
15.2 ARIUS Research
15.3 AstraZeneca
15.4 Biothera
15.5 Daiichi Sankyo Company
15.6 Gilead
15.7 Immunomedics
15.8 Janux Therapy
15.9 Klus Pharma
15.10 Myeloid therapeutics
15.11 Pfizer
15.12 Shanghai Junshi Bioscience

List of Figures

Figure 1-1: Trodelvy - Response Rate in Clinical Study (%)
Figure 1-2: Trodelvy - FDA Approval Year Indication
Figure 1-3: Trodelvy - Patent Expiration Year by Region
Figure 1-4: Trodelvy - FDA Orphan Designation Year by Indication

Figure 2-1: Trodelvy - US Patent US10137196B2 Issue & Expected Expiration Year
Figure 2-2: Trodelvy - US Patent US9797907B2 Issue & Expected Expiration Year
Figure 2-3: Trodelvy - US Patent US9707302B2 Issue & Expected Expiration Year
Figure 2-4: Trodelvy - US Patent US10130626B2 Issue & Expected Expiration Year
Figure 2-5: Trodelvy - US Patent US10130718B2 Issue & Expected Expiration Year
Figure 2-6: Trodelvy - US Patent US10195175B2 Issue & Expected Expiration Year
Figure 2-7: Trodelvy - US Patent US10058621B2 Issue & Expected Expiration Year
Figure 2-8: Trodelvy - US Patent US10206918B2 Issue & Expected Expiration Year
Figure 2-9: Trodelvy - US Patent US10413539B2 Issue & Expected Expiration Year
Figure 2-10: Trodelvy - US Patent US10744129B2 Issue & Expected Expiration Year
Figure 2-11: Trodelvy - US Patent US10918734B2 Issue & Expected Expiration Year
Figure 2-12: Trodelvy - US Patent US10799597B2 Issue & Expected Expiration Year
Figure 2-13: Trodelvy - US Patent US10954305B2 Issue & Expected Expiration Year
Figure 2-14: Trodelvy - US Patent US10436788B2 Issue & Expected Expiration Year
Figure 2-15: Trodelvy - US Patent US10682347B2 Issue & Expected Expiration Year
Figure 2-16: Trodelvy - US Patent US11116846B2 Issue & Expected Expiration Year
Figure 2-17: Trodelvy - US Patent US10266605B2 Issue & Expected Expiration Year
Figure 2-18: Trodelvy - US Patent US11052081B2 Issue & Expected Expiration Year
Figure 2-19: Trodelvy - US Patent US11052156B2 Issue & Expected Expiration Year
Figure 2-20: Trodelvy - US Patent US10653793B2 Issue & Expected Expiration Year
Figure 2-21: Trodelvy - US Patent US10849986B2 Issue & Expected Expiration Year
Figure 2-22: Trodelvy - US Patent US10918721B2 Issue & Expected Expiration Year
Figure 2-23: Trodelvy - US Patent US10709701B2 Issue & Expected Expiration Year
Figure 2-24: Trodelvy - US Patent US10988539B2 Issue & Expected Expiration Year
Figure 2-25: Trodelvy - Japan Patent JP6746845B2 Issue & Expected Expiration Year
Figure 2-26: Trodelvy - Australia Patent AU2016281622B2 Issue & Expected Expiration Year

Figure 3-1: Trodelvy - Average Cost of Single Dose Cycle & Single Treatment Cycle (US$), October’2021
Figure 3-2: Global - Trodelvy Quarterly Sales Value (US$ Million), Q2 - Q4, 2020
Figure 3-3: Global - Trodelvy Quarterly Sales Value (US$ Million), Q1 & Q2, 2021
Figure 3-4: Global - Trodelvy Half Yearly Sales (US$ Million), H1, 2020 & 2021

Figure 4-1: Structure of Trodelvy

Figure 5-1: TROP2 Stimulated Effectors, Biomarker & Pathways
Figure 5-2: TROP2 Regulated Oncogenic Cell Signaling Pathways
Figure 5-3: General Mechanism of TROP2 Targeting Therapy
Figure 5-4: Trodelvy - Mechanism of Action

Figure 6-1: Global - Newly Diagnosed Cases & Deaths Related to Breast Cancer (Million), 2020
Figure 6-2: Global - Breast Cancer Incidence by Type (%), 2020

Figure 7-1: Global - Newly Diagnosed Cases & Deaths Related to Breast Cancer, 2020
Figure 7-2: Global - Bladder Cancer Incidence by Type (%), 2020

Figure 8-1: Frequency of TROP2 Expression by Cancer Type (%)
Figure 8-2: Role of TROP2 in Various Cancers Cancer

Figure 10-1: Global - Number of Newly Diagnosed Cancer Cases (Million), 2020, 2025 & 2030
Figure 10-2: Global - Number of Cancer Deaths (Million), 2020, 2025 & 2030
Figure 10-3: Global - Number of Newly Diagnosed Breast Cancer Cases (Million), 2021-2028
Figure 10-4: Global - Number of Newly Diagnosed Triple Negative Breast Cancer Cases, 2021-2028
Figure 10-5: Global - Trodelvy Market Opportunity by 2% Adaptation Rate in TNBC (US$ Million), 2021 - 2028
Figure 10-6: Global - Trodelvy Market Opportunity by 4% Adaptation Rate in TNBC (US$ Million), 2021 - 2028
Figure 10-7: Global - Trodelvy Market Opportunity by 6% Adaptation Rate in TNBC (US$ Million), 2021 - 2028
Figure 10-8: Global - Trodelvy Market Opportunity by 8% Adaptation Rate in in TNBC (US$ Million), 2021 - 2028
Figure 10-9: Global - Trodelvy Market Opportunity by 10% Adaptation Rate in TNBC (US$ Million), 2021 - 2028
Figure 10-10: Global - Number of Urotheluial Cancer Cases, 2021-2026
Figure 10-11: Global - Trodelvy Market Opportunity by 1% Adaptation Rate in Urothelial Carcinoma (US$ Million), 2021 - 2028
Figure 10-12: Global - Trodelvy Market Opportunity by 2% Adaptation Rate in Urothelial Cancer (US$ Million), 2021 - 2028
Figure 10-13: Global - Trodelvy Market Opportunity by 3% Adaptation Rate in Urothelial Cancer (US$ Million), 2021 - 2028
Figure 10-14: Global - Trodelvy Market Opportunity by 4% Adaptation Rate in in Urothelial Cancer (US$ Million), 2021 - 2028
Figure 10-15: Global - Trodelvy Market Opportunity by 5% Adaptation Rate in Urothelial CAncer (US$ Million), 2021 - 2028
Figure 10-16: Global - Newly Diagnosed Cases of NSCLC (Million), 2020 & 2028
Figure 10-17: Global - Newly Diagnosed Cases of Glioblastoma, 2020 & 2028

Figure 11-1: Global - Trodelvy Sales Forecast (US$ Million), 2021 - 2028
Figure 11-2: US - Trodelvy Sales Forecast (US$ Million), 2021 - 2028
Figure 11-3: Europe - Trodelvy Sales Forecast (US$ Million), 2022 - 2028
Figure 11-4: Japan - Trodelvy Sales Forecast (US$ Million), 2022 - 2028
Figure 11-5: ROW - Trodelvy Sales Forecast (US$ Million), 2022 - 2028

Figure 12-1: Trodelvy Access Service - Trodelvy Annual Reimbursement (US$), October’2021
Figure 12-2: Medicad - Trodelvy Reimbursement (US$), October’2021
Figure 12-3: Medicaid - Trodelvy Reimbursement Per Vial (US$), October’2021
Figure 12-4: Medicaid - Trodelvy Reimbursement Per Vial (%), October’2021

Figure 13-1: Global - Number of Trodelvy Related Clinical Trials by Phase, October’2021
Figure 13-2: Global - Trodelvy Related Clinical Trials by Phase (%),October’2021

Figure 13-3: Global - Number of Trodelvy Related Clinical Trials by Development Status, October’2021
Figure 13-4: Global - Trodelvy Related Clinical Trials by Development Status (%), October’2021
Figure 13-5: Global - Number of Trodelvy Related Clinical Trials by Region, October’2021

Figure 14-1: IMMU132 Phase II Trial - Prostate Cancer Study Initiation & Completion Year
Figure 14-2: IMMU132 Phase II Trial - Endometrial Carcinoma Study Initiation & Completion Year
Figure 14-3: IMMU132 Phase II Trial - Metastatic Solid Tumors Study Initiation & Completion Year
Figure 14-4: IMMU132 Phase I-II Trial - Epithelial Cancer Study Initiation & Completion Year
Figure 14-5: IMMU132 Phase II Trial - Glioblastoma Study Initiation & Completion Year


Companies Mentioned (Partial List)

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

  • Amunix
  • ARIUS Research
  • AstraZeneca
  • Biothera
  • Daiichi Sankyo Company
  • Gilead
  • Immunomedics
  • Janux Therapy
  • Klus Pharma
  • Myeloid therapeutics
  • Pfizer
  • Shanghai Junshi Bioscience