Tenosynovial Giant Cell Tumors Market to Witness Growth by 2032 | Companies- AmMax Bio, Deciphera Pharmaceuticals, SynOx Therapeutics, Abbisko Therapeutics Co, Hutchison Medipharma Limited, Elixiron Immunotherapeutics, expected to boost the market

DelveInsight's "Tenosynovial Giant Cell Tumors Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of 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.


The Tenosynovial Giant Cell Tumors market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Tenosynovial Giant Cell Tumors market size from 2019 to 2032, segmented by seven major markets. The Report also covers current Tenosynovial Giant Cell Tumors treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Tenosynovial Giant Cell Tumors market.

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Tenosynovial Giant Cell Tumors: An Overview

Tenosynovial Giant Cell Tumor is an abnormal growth of tissue derived from the synovium that causes activation of immune cells, specifically macrophages, leading to mass formation. These tumors are often classified by their growth pattern (localized or diffused) and location (intra-or extra-articular).

Recurrences are quite common in Tenosynovial Giant Cell Tumors, a major concern for decisions regarding treatment choice.

Tenosynovial Giant Cell Tumor Diagnosis

The diagnosis of tenosynovial giant cell tumor is based on identifying characteristic symptoms, a detailed patient history, a thorough clinical evaluation, and a variety of specialized tests. The initial symptoms of these tumors are often vague and may go unrecognized. Consequently, there is usually a significant delay from the onset of symptoms until a diagnosis is made. Imaging techniques like X-ray and MRI are frequently used to confirm the diagnosis of TGCT, but biopsy is also used in certain cases.

The current approach to diagnosing these patients is quite similar across the 7MM, where the journey begins with a referral to an ortho-oncologist by a primary care provider upon its diagnosis. Upon diagnosis, the patients are evaluated based on their tumor-growth pattern, and assessments are done to know if they are amenable to surgery.

Recurrences of localized tenosynovial giant cell tumors are observed more commonly in the EU4 countries and the UK than in countries of the 7MM, like the US and Japan.

Tenosynovial Giant Cell Tumor Treatment

Based on real-world data analysis, surgery is the most preferred treatment for tenosynovial giant cell tumors. Although surgery is quite effective for the management of tenosynovial giant cell tumors, recurrences after surgery are quite common. Despite surgeries being comparatively cheap compared to other immunotherapeutic options, there are significant other costs associated with very high surgeries. This ends up making the total cost of surgery quite expensive.

TURALIO is approved only in the US, while its approval in the EU got rejected. Daiichi Sankyo is also conducting trials to obtain its approval in Japan. TURALIO's Marketing Authorization Application (MAA) was rejected by the European Commission (EC) because of its unfavorable risk-benefit ratio. TURALIO had potentially fatal hepatotoxic effects, although used to treat a non-fatal condition. Even in the US, its use is heavily monitored through the Risk Evaluation and Mitigation Strategy (REMS) Program, and its availability is restricted to certain specific centers.

Over the next few years, the US TGCT Market is expected to change substantially and experience growth, as it will be dominated by two upcoming products, vimseltinib and emactuzumab. The safety and tolerability concerns of TURALIO are hindering its adoption in the treatment setting, with many patients preferring the usage of off-label TKIs like imatinib and mAbs like infliximab. Vimseltinib and emactuzumab, with their significantly better safety profiles and improved efficacy, are expected to be readily adopted in the treatment setting.

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Key Highlights from the Tenosynovial Giant Cell Tumors (TSGCTs) Market Report:

Most Tenosynovial Giant Cell Tumor patients have a localized growth pattern, with approximately 12,610 incident cases in the United States.
In 2022, the market size of Tenosynovial Giant Cell Tumor was the highest in the US among the 7MM, accounting for approximately USD 150 million, which is further expected to increase by 2032.
Daiichi Sankyo's TURALIO is the only FDA-approved Tenosynovial Giant Cell Tumors therapy. However, a significant number of patients still use an off-label treatment like imatinib due to TURALIO's problematic safety and tolerability profile.
In June 2020, the European approval of TURALIO was rejected due to its potentially life-threatening hepatotoxic effects, leading to an unfavorable risk-benefit ratio in the treatment of the non-fatal condition of Tenosnovial Giant Cell Tumor.
The expected launch of vimseltinib (Deciphera Pharmaceuticals) and emactuzumab (SynOx Therapeutics, a subsidiary of Celleron Therapeutics) in 2025 is set to bring major changes in the treatment landscape of Tenosynovial Giant Cell Tumor, bringing in safer and more effective treatment options for Tenosynovial Giant Cell Tumor patients.
TURALIO is covered by Medicare plans, typically listed on Tier 5 of their formulary, where patients must pay 25-33% of the retail cost for drugs.
Other emerging therapies include AmMax Bio's AMB-05X, Novartis Pharmaceuticals' lacnotuzumab, and Abbisko Therapeutics' pimicotinib, which are in the early developmental stage.

Tenosynovial Giant Cell Tumors Market

The Tenosynovial Giant Cell Tumors market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Tenosynovial Giant Cell Tumors market trends by analyzing the impact of current Tenosynovial Giant Cell Tumors therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

Tenosynovial Giant Cell Tumor treatment in the US has entered a new era, with the dynamics expected to change. Surgery is the primary therapeutic option for Tenosynovial Giant Cell Tumors, but it is frequently accompanied by recurrences and hampering the patient's functional status. When the tumor is removed as a whole, the likelihood of the recurrence of the tumor is reduced; however, complete removal of the tumor sometimes requires the mandatory undesirable removal of the functional structures of the patient. But if the tumor is removed partially to maintain a patient's functional status, recurrences are much more likely to appear.

TURALIO provided a new treatment option for patients with a significant need for systemic treatment. Its approval was set to solve a huge unmet need for treatment in patients with severe morbidity who were not amenable to surgery. Although it faced significant challenges regarding its adoption in the market due to its concerning safety and tolerability profile, causing fatal hepatotoxic effects in a non-fatal conditions. Due to the safety concerns of turalio, off-label treatments like imatinib are used frequently to treat tenosynovial giant cell tumors, although their efficacy is very limiting.

Currently, TURALIO is also being explored in the perioperative setting, where it is used in the neoadjuvant setting for tumor shrinkage, to help in appropriate resection, and in the adjuvant setting to prevent recurrences post-resection.

Patients and physicians have long cited a desire for effective therapy for tenosynovial giant cell tumors without sacrificing its safety and tolerability. The expected launch of upcoming therapies and a high unmet need for a therapy with a better safety profile than TURALIO will eventually facilitate the development of effective treatment options. However, the diagnosis of tenosynovial giant cell tumor is often associated with diagnostic delays and misdiagnosis due to its slow-growing nature, not well-differentiated symptoms, and lack of awareness of the disease among patients and providers. These factors often become a hindrance for both physicians and patients when adopting newer therapies.

Key players such as Deciphera Pharmaceuticals (vimseltinib), SynOx Therapeutics (emactuzumab), and others are evaluating their lead candidates in different stages of clinical development respectively. They aim to investigate their products for the treatment of Tenosynovial Giant Cell Tumor.

The total market size of Tenosynovial Giant Cell Tumor in the 7MM is approximately USD 200 million in 2022 and is projected to increase during the forecast period (2023-2032).
The market size in the 7MM will increase at a CAGR of 8% due to increasing awareness of the disease and the launch of emerging therapies.
Among EU4 countries, Germany accounts for the maximum market size in 2022, while Spain occupies the bottom of the ladder 2022.
In Japan, there are no approved therapies for Tenosynovial Giant Cell Tumors, with current treatment being done primarily by surgery, but off-label systemic therapies are also used in certain cases.

According to DelveInsight, the Tenosynovial Giant Cell Tumors market in 7MM is expected to witness a major change in the study period 2019-2032.

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Tenosynovial Giant Cell Tumors Epidemiology

The Tenosynovial Giant Cell Tumors epidemiology section provides insights into the historical and current Tenosynovial Giant Cell Tumors patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Tenosynovial Giant Cell Tumors market report also provides the diagnosed patient pool, trends, and assumptions.

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Tenosynovial Giant Cell Tumors Therapy Assessment
TURALIO (pexidartinib): Daiichi Sankyo

TURALIO (pexidartinib) is an orally administered small molecule tyrosine kinase inhibitor that targets colony-stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) harboring an internal tandem duplication (ITD) mutation. The US FDA approves it for treating adult patients with symptomatic tenosynovial giant cell tumors associated with severe morbidity or functional limitations which are not amenable to improvement with surgery.

TURALIO received approval for the treatment of tenosynovial giant cell tumor patients in August 2019 in the United States. A new dosing regimen of TURALIO was introduced in February 2023, where the 200 mg capsule was discontinued and replaced by a 125 mg capsule. The new recommended dose, which the FDA approved in October 2022, is 125 mg capsules taken twice daily with a low-fat meal, instead of the former 200 mg capsules taken twice daily on an empty stomach. This was done to reduce the toxic effects of the drug.

TURALIO is expected to face heavy competition from therapies such as Deciphera Pharmaceuticals' vimseltinib and SynOx Therapeutics' emactuzumab, which have demonstrated significantly better safety and efficacy profiles than TURALIO in clinical trials.

Vimseltinib (DCC-3014): Deciphera Pharmaceuticals

Vimseltinib (DCC-3014), which is being developed by Deciphera Pharmaceuticals, is an orally administered, potent, and highly-selective switch-control kinase inhibitor of the colony-stimulating factor 1 receptor (CSF1R) with potential antineoplastic, macrophage checkpoint-inhibitory and immunomodulating activities. The drug could be the best-in-class treatment for tenosynovial giant cell tumor patients. The Phase I/II study demonstrated promising preliminary results, encouraging antitumor activity with clinical benefits and manageable adverse events. These results supported its continued evaluation in a Phase III MOTION study, which, if successful, will lead to the FDA approval of the drug before 2026. Key opinion Leaders (KOLs) are convinced with the tolerability and antitumor activity of vimseltinib in clinical trials and have shown a preference toward vimseltinib over imatinib and pexidartinib, for the treatment of tenosynovial giant cell tumors.

Tenosynovial Giant Cell Tumors Pipeline Development Activities

The Tenosynovial Giant Cell Tumors report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Tenosynovial Giant Cell Tumors key players involved in developing targeted therapeutics.

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Tenosynovial Giant Cell Tumors Therapeutics Assessment

Major key companies such as AmMax Bio, Deciphera Pharmaceuticals, SynOx Therapeutics, Abbisko Therapeutics Co, Hutchison Medipharma Limited, Elixiron Immunotherapeutics, and others are working proactively in the Tenosynovial Giant Cell Tumors Therapeutics market to develop novel therapies which will drive the Tenosynovial Giant Cell Tumors treatment markets in the upcoming years.

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Tenosynovial Giant Cell Tumors Report Key Insights

1. Tenosynovial Giant Cell Tumors Patient Population
2. Tenosynovial Giant Cell Tumors Market Size and Trends
3. Key Cross Competition in the Tenosynovial Giant Cell Tumors Market
4. Tenosynovial Giant Cell Tumors Market Dynamics (Key Drivers and Barriers)
5. Tenosynovial Giant Cell Tumors Market Opportunities
6. Tenosynovial Giant Cell Tumors Therapeutic Approaches
7. Tenosynovial Giant Cell Tumors Pipeline Analysis
8. Tenosynovial Giant Cell Tumors Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Tenosynovial Giant Cell Tumors Market

Table of Contents

1. Key Insights
2. Executive Summary
3. Tenosynovial Giant Cell Tumors Competitive Intelligence Analysis
4. Tenosynovial Giant Cell Tumors Market Overview at a Glance
5. Tenosynovial Giant Cell Tumors Disease Background and Overview
6. Tenosynovial Giant Cell Tumors Patient Journey
7. Tenosynovial Giant Cell Tumors Epidemiology and Patient Population
8. Tenosynovial Giant Cell Tumors Treatment Algorithm, Current Treatment, and Medical Practices
9. Tenosynovial Giant Cell Tumors Unmet Needs
10. Key Endpoints of Tenosynovial Giant Cell Tumors Treatment
11. Tenosynovial Giant Cell Tumors Marketed Products
12. Tenosynovial Giant Cell Tumors Emerging Therapies
13. Tenosynovial Giant Cell Tumors Seven Major Market Analysis
14. Attribute Analysis
15. Tenosynovial Giant Cell Tumors Market Outlook (7 major markets)
16. Tenosynovial Giant Cell Tumors Access and Reimbursement Overview
17. KOL Views on the Tenosynovial Giant Cell Tumors Market
18. Tenosynovial Giant Cell Tumors Market Drivers
19. Tenosynovial Giant Cell Tumors Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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