Tenosynovial Giant Cell Tumors Market

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:

1. 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.)

2. The Tenosynovial Giant Cell Tumors market report provides insights on the current and emerging therapies.

3. Tenosynovial Giant Cell Tumors market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. 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 a type of abnormal tissue growth that arises from the synovial lining and stimulates immune cell responses—particularly macrophages—resulting in tumor formation. These tumors are classified by their growth behavior (localized or diffuse) and their anatomical location (intra-articular or extra-articular).

One of the major challenges in managing TGCT is its tendency to recur, which plays a critical role in guiding treatment strategies.

Diagnosis typically involves identifying hallmark symptoms, reviewing the patient’s medical history, performing a detailed physical examination, and utilizing advanced diagnostic tools. However, early signs can be vague, often delaying diagnosis. Imaging modalities like X-rays and MRI are standard for confirming TGCT, while biopsies may be conducted in select cases.

In the 7MM (US, EU4, UK, and Japan), diagnostic pathways are largely consistent, starting with a referral from a general practitioner to an ortho-oncologist. Once TGCT is confirmed, treatment planning depends on the tumor’s growth characteristics and whether surgery is a viable option.

Localized TGCT recurrence appears to be more common in the EU4 and the UK than in other 7MM countries like the US and Japan.

Tenosynovial Giant Cell Tumors Treatment Market

Real-world evidence shows that surgery remains the primary treatment option for Tenosynovial Giant Cell Tumors (TGCT). Although generally effective, surgical interventions are often associated with high recurrence rates. While surgery tends to be more cost-effective than immunotherapy, the financial burden can still be considerable, especially in cases requiring complex procedures.

TURALIO is currently approved only in the United States, as its application was denied in Europe over concerns about its risk–benefit profile—particularly due to potentially life-threatening liver toxicity in a non-life-threatening condition. Daiichi Sankyo is pursuing approval in Japan through ongoing clinical trials. In the U.S., TURALIO’s distribution is tightly controlled through the REMS (Risk Evaluation and Mitigation Strategy) Program and is limited to designated treatment centers.

The TGCT treatment landscape in the U.S. is expected to evolve significantly with the anticipated arrival of newer therapies such as vimseltinib, emactuzumab, pimicotinib, and AMB-05X. TURALIO has faced limited uptake due to concerns around safety and tolerability, leading many patients to seek off-label alternatives like tyrosine kinase inhibitors (TKIs) such as imatinib or monoclonal antibodies (mAbs) like infliximab. These newer agents, offering improved safety and effectiveness, are expected to be rapidly integrated into clinical practice.

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Tenosynovial Giant Cell Tumors Market Outlook

The treatment landscape for Tenosynovial Giant Cell Tumor (TGCT) in the U.S. is undergoing transformation, with major developments on the horizon. While surgery continues to be the primary treatment option, recurrence remains a significant issue and can greatly affect a patient’s physical function. Complete tumor excision reduces the risk of recurrence but may necessitate removing critical functional tissues. In contrast, partial resection preserves functionality but comes with a higher chance of tumor regrowth.

TURALIO filled a critical therapeutic gap by offering a systemic option for patients who are not suitable candidates for surgery. However, its use has been limited due to serious safety concerns, particularly life-threatening liver toxicity in a condition that is not typically fatal. Consequently, many clinicians turn to off-label therapies such as imatinib, despite their modest effectiveness.

Research is also underway to explore TURALIO’s potential in perioperative settings, including its use before surgery to shrink tumors (neoadjuvant) and after surgery to lower the risk of recurrence (adjuvant).

There is a strong need for safer and more effective treatment alternatives, and several emerging therapies are expected to significantly impact the TGCT treatment market. However, early diagnosis remains a challenge due to the tumor’s slow progression, non-specific symptoms, and low disease awareness, all of which hinder timely treatment and limit the uptake of newer options.

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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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.

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.

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