Tenosynovial Giant Cell Tumors Market: Analysis of Epidemiology, Pipeline Products, and Key Companies Working, DelveInsight | Deciphera Pharmaceuticals, SynOx Therapeutics (Celleron Therapeutics)

Tenosynovial Giant Cell Tumors emerging therapies such as TURALIO (pexidartinib), Vimseltinib (DCC-3014), and others are expected to boost the Tenosynovial Giant Cell Tumors Market in the upcoming years.

DelveInsight has launched a new report on "Tenosynovial Giant Cell Tumors - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Tenosynovial Giant Cell Tumors, historical and forecasted epidemiology as well as the Tenosynovial Giant Cell Tumors market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Tenosynovial Giant Cell Tumors Market Report:

In 2023, the Tenosynovial Giant Cell Tumor (TGCT) market size in the 7MM was approximately USD 300 million and is expected to grow throughout the forecast period (2024-2034). The majority of TGCT cases exhibit a localized growth pattern, with around 12,610 incident cases reported in the United States.
In 2023, the United States had approximately 250,000 prevalent cases of Tenosynovial Giant Cell Tumor (TGCT), making it the largest contributor to the incident population among the 7MM, accounting for around 43% of cases. Meanwhile, EU4 and the UK collectively represented 43% of the incident cases, while Japan accounted for 14% of the total share.
Among the 7MM, the United States had the largest TGCT market in 2023, valued at approximately USD 240 million, with further growth anticipated by 2034. Currently, Daiichi Sankyo's TURALIO is the only FDA-approved therapy for TGCT. However, due to its safety and tolerability concerns, many patients still opt for off-label treatments like imatinib.
In April 2024, Deciphera Pharmaceuticals announced a definitive merger agreement with ONO Pharmaceutical, under which ONO will acquire all outstanding shares of Deciphera, followed by a merger with ONO's wholly-owned subsidiary.
In June 2020, TURALIO was denied European approval due to its potentially life-threatening hepatotoxicity, which resulted in an unfavorable risk-benefit assessment for treating the non-fatal condition of TGCT.
The anticipated launch of vimseltinib (Ono Pharmaceuticals) in 2025 is expected to significantly reshape the TGCT treatment landscape, providing safer and more effective options for patients.
TURALIO is covered under Medicare plans, typically placed in Tier 5 of formularies, where patients are required to pay 25-33% of the drug's retail cost.
Other promising emerging therapies include Emactuzumab (SynOx Therapeutics), pimicotinib (Abbisko Therapeutics), AMB-05X (AmMax Bio), and Enrupatinib (Elixiron Immunotherapeutics).
Key Tenosynovial Giant Cell Tumors companies such as Deciphera Pharmaceuticals, SynOx Therapeutics (Celleron Therapeutics), and others are evaluating new drugs for Tenosynovial Giant Cell Tumors to improve the treatment landscape.
Promising Tenosynovial Giant Cell Tumors pipeline therapies in various stages of development includeTURALIO (pexidartinib), Vimseltinib (DCC-3014), and others.
Key benefits of the Tenosynovial Giant Cell Tumors market report:
Tenosynovial Giant Cell Tumors market report covers a descriptive overview and comprehensive insight of the Tenosynovial Giant Cell Tumors Epidemiology and Tenosynovial Giant Cell Tumors market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
The Tenosynovial Giant Cell Tumors market report provides insights on the current and emerging therapies.
Tenosynovial Giant Cell Tumors market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Tenosynovial Giant Cell Tumors market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Tenosynovial Giant Cell Tumors market.

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Tenosynovial Giant Cell Tumors Overview

Tenosynovial Giant Cell Tumor (TGCT) is an abnormal tissue growth originating from the synovium, which triggers immune cell activation, particularly macrophages, leading to mass formation. These tumors are categorized based on their growth pattern (localized or diffuse) and location (intra- or extra-articular).

Recurrence is a frequent challenge in TGCT, significantly influencing treatment decisions.

Diagnosing TGCT involves recognizing characteristic symptoms, obtaining a detailed patient history, conducting a thorough clinical evaluation, and utilizing specialized diagnostic tests. Early symptoms are often non-specific, leading to delays in diagnosis. Imaging techniques such as X-ray and MRI are commonly used to confirm TGCT, while biopsy may be performed in specific cases.

Across the 7MM, the diagnostic process is generally uniform, beginning with a primary care provider referring the patient to an ortho-oncologist. Upon confirmation of TGCT, patients are evaluated based on tumor growth patterns to determine their suitability for surgical intervention.

Localized TGCT recurrences are reported more frequently in EU4 countries and the UK compared to other 7MM regions, such as the US and Japan.

Tenosynovial Giant Cell Tumors Treatment Market

Real-world data analysis indicates that surgery is the preferred treatment for tenosynovial giant cell tumors (TGCT). While surgery is generally effective in managing TGCT, recurrence rates remain high. Although surgical procedures are less expensive than immunotherapy, the associated costs-especially for complex surgeries-can make the overall expense significant.

TURALIO is currently approved only in the US, as its European approval was rejected due to concerns over its risk-benefit ratio, particularly its potentially fatal hepatotoxic effects for a non-fatal condition. Daiichi Sankyo is conducting trials to seek approval in Japan. Even in the US, TURALIO's use is strictly regulated under the Risk Evaluation and Mitigation Strategy (REMS) Program and is only available at select treatment centers.

The US TGCT market is expected to undergo significant changes in the coming years, driven by the introduction of vimseltinib, emactuzumab, pimicotinib, and AMB-05X. Due to safety and tolerability concerns, TURALIO has struggled with adoption, leading many patients to opt for off-label tyrosine kinase inhibitors (TKIs) like imatinib or monoclonal antibodies (mAbs) like infliximab. The emerging therapies, with better safety profiles and improved efficacy, are anticipated to gain rapid acceptance in the treatment landscape.
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Tenosynovial Giant Cell Tumors Market Outlook

The treatment landscape for Tenosynovial Giant Cell Tumor (TGCT) in the US is evolving, with significant changes expected. Surgery remains the primary treatment approach, but recurrence is common and can severely impact a patient's functional status. While complete tumor removal lowers the risk of recurrence, it may require the removal of essential functional structures. Conversely, partial tumor removal helps preserve function but increases the likelihood of recurrence.

TURALIO introduced a much-needed systemic treatment for patients ineligible for surgery, addressing a critical gap. However, its adoption has been limited due to safety concerns, particularly fatal hepatotoxic effects in a non-fatal disease. As a result, off-label treatments like imatinib are frequently used despite their limited efficacy.

TURALIO is also being investigated for perioperative use, including neoadjuvant therapy to shrink tumors before surgery and adjuvant therapy to reduce post-surgical recurrence.

There is a high demand for safer and more effective therapies, and upcoming treatments are expected to reshape the TGCT market. However, delays in diagnosis and frequent misdiagnosis-due to slow tumor growth, vague symptoms, and lack of awareness-pose challenges in early intervention and adoption of new therapies.

Tenosynovial Giant Cell Tumor Marketed Drugs

TURALIO (pexidartinib): Daiichi Sankyo

Tenosynovial Giant Cell Tumor Emerging Drugs

Vimseltinib (DCC-3014): Ono Pharmaceuticals

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Scope of the Tenosynovial Giant Cell Tumors Market Report

Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Tenosynovial Giant Cell Tumors Companies: Deciphera Pharmaceuticals, SynOx Therapeutics (Celleron Therapeutics), and others
Key Tenosynovial Giant Cell Tumors Therapies: TURALIO (pexidartinib), Vimseltinib (DCC-3014), and others
Tenosynovial Giant Cell Tumors Therapeutic Assessment: Tenosynovial Giant Cell Tumors current marketed and Tenosynovial Giant Cell Tumors emerging therapies
Tenosynovial Giant Cell Tumors Market Dynamics: Tenosynovial Giant Cell Tumors market drivers and Tenosynovial Giant Cell Tumors market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Tenosynovial Giant Cell Tumors Unmet Needs, KOL's views, Analyst's views, Tenosynovial Giant Cell Tumors Market Access and Reimbursement

Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Tenosynovial Giant Cell Tumors Patient Share (%) Overview at a Glance
5. Tenosynovial Giant Cell Tumors Market Overview at a Glance
6. Tenosynovial Giant Cell Tumors Disease Background and Overview
7. Tenosynovial Giant Cell Tumors Epidemiology and Patient Population
8. Country-Specific Patient Population of Tenosynovial Giant Cell Tumors
9. Tenosynovial Giant Cell Tumors Current Treatment and Medical Practices
10. Unmet Needs
11. Tenosynovial Giant Cell Tumors Emerging Therapies
12. Tenosynovial Giant Cell Tumors Market Outlook
13. Country-Wise Tenosynovial Giant Cell Tumors Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Tenosynovial Giant Cell Tumors Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Tenosynovial Giant Cell Tumors Pipeline Insights, DelveInsight

"Tenosynovial Giant Cell Tumors Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Tenosynovial Giant Cell Tumors market. A detailed picture of the Tenosynovial Giant Cell Tumors pipeline landscape is provided, which includes the disease overview and Tenosynovial Giant Cell Tumors treatment guidelines.

Contact Info:

Kritika Rehani, Team Leader Marketing & Branding
krehani@delveinsight.com
info@delveinsight.com
www.delveinsight.com
+14699457679

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

This release was published on openPR.