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2082999

활막육종 : 시장 인사이트, 역학 및 예측(2036년)

Synovial Sarcoma - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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활막육종에 대한 인사이트 및 동향

  • 활막육종 시장은 주요 시장 전반에 걸쳐 꾸준한 성장세를 보이고 있으며, 조사 기간 동안 시장 규모와 혁신 측면에서 미국이 1위를 차지했고, 그 뒤를 EU4(독일, 프랑스, 이탈리아, 스페인), 영국, 일본 순으로 이어졌습니다.
  • 일본은 2025년 G7 국가를 대상으로 한 활막육종 시장에서 3위의 점유율을 차지했으며, 2036년까지 그 점유율이 확대될 것으로 예측됩니다.
  • 활막육종은 환자 수가 적은 희귀암의 일종입니다. 이러한 부담은 특히 남성을 중심으로 한 청소년 및 젊은 성인에게 불균형적으로 집중되어 있으며, 질병의 진행, 재발 및 사망률을 낮추기 위해서는 조기 진단, 전문 육종 센터로의 적시 의뢰, 첨단 치료에 대한 접근성 확보, 그리고 다학제적 협력을 통한 치료가 필요하다는 점이 강조되고 있습니다.
  • 활막육종의 치료법으로는 수술, 방사선 치료, 화학요법(독소루비신, 이포스파미드 등) 및 아파미트레세겐-오토로이셀(TECELRA)과 같은 첨단 세포 치료가 포함됩니다. 이러한 치료법은 종양 제어, 재발 억제, 전이성 질환 관리 및 생존율 향상을 목적으로 하며, 최적의 치료 성과를 얻기 위해서는 다학제적 협력을 통한 치료와 정기적인 경과 관찰이 필수적입니다.
  • TECELRA는 미국에서 고형암 치료제로 승인된 최초의 유전자 변형 세포 치료제로, 활막육종 환자에게 10년 만에 처음으로 제시되는 새로운 치료 선택지가 될 것입니다.
  • 활막육종에 대한 다양한 진단 및 임상 평가 방법에는 MRI, CT, 조직병리학적 평가, 면역조직화학 검사, 그리고 SS18 : : SSX 유전자 융합에 대한 분자 검사가 포함됩니다. 이러한 기법은 정확한 진단, 병기 분류, 치료 계획 수립 및 장기적인 경과 관찰을 지원하여 환자의 예후를 최적화합니다.
  • 현재 개발이 진행 중인 활막육종의 치료 후보로는 진행기 질환의 치료 성과를 개선하는 것을 목적으로 하는 TCR(T세포 수용체) 기반 세포 치료법 및 표적 치료제에 중점을 두고 있습니다. 주요 후보 약물로는 TBI-1301(타카라바이오), lete-cel 및 afami-cel(미국 WorldMeds), ADP-600(Adaptimmune Therapeutics), 염산 카테켄티닙/AL3818(Advenchen Laboratories) 등이 있으며, 이들 모두 종양 특이적 표적화를 강화하고, 활막육종 치료 분야에서 중요한 미충족 의료 수요를 해결하는 것을 목표로 하고 있습니다.

본 ‘활막육종 시장 보고서’에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, 활막육종 환자의 부담 추이, 매출액 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료 도입률 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서는 활막육종 분야에서 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 환경을 분석하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

활막육종 시장을 주도하는 주요 요인

활막육종의 발병률 증가

특히 남성의 활막육종 발병률 증가는 진행기 및 재발 질환의 부담 증가, 진단 능력 향상, 그리고 새로운 표적 치료법 및 세포 면역 요법의 등장 등에 힘입어 활막육종 시장의 확장을 이끄는 주요 요인이 되고 있습니다.

활막육종에 대한 새로운 치료법의 기회 확대

진행성 및 전이성 활막육종 분야에서 해결되지 않은 중대한 의료적 요구 사항으로 인해, 치료의 지속성 향상, 내성 극복 및 장기적인 치료 성과 향상을 목표로 하는 표적 치료, 유전자 변형 T세포 수용체(TCR) 치료 및 기타 면역종양학 접근법의 개발이 추진되고 있습니다.

활막육종의 이해와 치료 알고리즘

활막육종의 개요와 진단

활막육종은 SS18(SYT) 유전자와 관련된 염색체 전좌를 특징으로 하는 드물고 침습성이 높은 연조직 육종이며, 이 전좌로 인해 종양 발병을 촉진하는 발암성 융합 단백질이 생성됩니다. 그 명칭과는 달리, 활막 조직에서 발생하는 것이 아니라 관절, 힘줄, 활액낭 근처에 있는 심부 연부 조직, 특히 사지에서 가장 많이 발생합니다. 일반적으로 사춘기부터 젊은 성인에게서 많이 나타나지만, 모든 연령대에서 발병할 가능성이 있으며, 대부분의 경우 깊은 부위에 위치한 종괴로 나타나고, 전이 위험이 높으며, 특히 폐로 전이되는 경우가 가장 흔합니다. 질병의 경과와 예후는 종양의 크기, 부위, 조직학적 아형, 전이 유무, 그리고 수술, 방사선 치료, 전신 치료를 포함한 다각적인 치료에 대한 반응 등의 요인에 따라 달라집니다.

활막육종의 진단은 임상 평가, 영상 검사, 조직병리학적 검사 및 분자 검사를 종합적으로 실시하여 이루어집니다. MRI는 종양의 크기와 국소적인 확산 정도를 평가하는 데 사용되며, 생검을 통해 확실한 조직학적 진단을 내릴 수 있습니다. 또한, FISH, RT-PCR 또는 차세대 염기서열 분석 등의 기술을 활용하여 특징적인 SS18 : : SSX 유전자 융합을 확인함으로써 진단을 뒷받침할 수 있으며, 이는 치료 계획 수립에도 도움이 됩니다.

활막육종의 치료

활막육종 치료의 주요 목표는 종양을 완전히 제어하고, 재발 및 전이를 예방하며, 기능을 보존하고, 장기 생존율을 높이는 것입니다. 치료는 다학제적 협력을 통해 이루어지며, 일반적으로 수술, 방사선 치료, 전신 화학요법을 병행하여 시행됩니다. 진행성 사례나 고위험 사례에서는 독소루비신이나 이포스파미드 등의 약제가 사용됩니다. 절제 불가능한 사례나 전이 사례의 경우, 새로운 분자 표적 치료법과 세포 치료법이 등장하면서 치료 선택의 폭이 점차 넓어지고 있습니다. MAGE-A4를 표적으로 하는 T세포 수용체(TCR) 치료법인 'TECELRA'는 이 분야에서 중요한 유전자 변형 세포 치료법 중 하나입니다. 치료 효과 평가, 재발 감지 및 향후 치료 방침 결정을 위해서는 영상 진단과 임상 평가를 통한 지속적인 모니터링이 필수적입니다.

활막육종의 역학

활막육종의 역학 분석 및 예측에 관한 주요 연구 결과

  • G7 국가 전체의 활막육종 신규 환자 총수는 진단 기술의 발전, 희귀 연조직 육종에 대한 인식 제고, 분자 검사의 보급, 그리고 다학제적 협력을 통한 치료로 인한 생존율 개선을 배경으로, 2022년부터 2036년에 걸쳐 증가할 것으로 예측됩니다.
  • 주요 7개국 중 2025년 활막육종의 발생률은 미국이 가장 높았으며, 예측 기간 동안 환자 수가 증가할 것으로 예측됩니다.
  • EU-4 및 영국 내에서 독일의 활막육종 발생률이 가장 높은 것으로 보고되고 있습니다. 2025년 시점에서 유럽 국가 중 확진자 수가 가장 적은 나라는 스페인인 것으로 밝혀졌습니다.
  • DelveInsight의 추정 및 예측에 따르면, 2025년 일본에서는 2기 활막육종이 가장 높은 발생률을 차지했으며, 예측 기간 동안 환자 수가 증가할 것으로 전망됩니다.
  • 활막육종은 남성에게서 많이 발생하며 발병 연령도 이른 편이므로, 장기적인 예후를 개선하기 위해서는 조기 진단, 전문 육종 센터로의 신속한 의뢰, 그리고 연령과 위험 요인에 따른 치료 전략이 필수적입니다.

활막육종 시장 전망

활막육종 시장은 정밀 종양학 및 세포 면역 요법의 발전과 육종의 생물학적 특성에 대한 이해가 깊어짐에 힘입어 큰 변화를 겪고 있습니다. 현재 수술, 방사선 치료, 전신 화학요법 등 기존의 치료법이 주류를 이루고 있는 반면, 진행성 활막육종에 대한 최초의 유전자 변형 TCR-T 세포 치료제인 ‘TECELRA’가 승인되어 치료의 전망에 있어 중요한 이정표가 되었습니다.

치료 패러다임은 유효성과 치료 효과의 지속성을 향상시키는 것을 목표로 하는 바이오마커 주도형 및 항원 표적형 치료로 점차 전환되고 있습니다. Mipetresgene autoleucel, lete-cel, afami-cel, 염산 카테켄티닙 등의 새로운 후보 약물은 유전자 변형 T세포 수용체 기술, 종양 관련 항원 표적화, 다중 키나아제 억제를 활용하는 혁신적인 접근 방식을 추진하고 있으며, 이 희귀암 분야에서 해결되지 않은 중대한 의료적 요구를 충족시키는 것을 목표로 하고 있습니다.

양자 세포 치료, 표적 치료제 및 면역종양학 분야의 지속적인 발전이 활막육종 시장의 성장을 견인할 것으로 예측됩니다. 파이프라인 확대, 종양 특성에 대한 보다 상세한 규명, 그리고 진행성 질환의 치료 성과 개선에 대한 강력한 집중이 이 분야의 개발 기업들에게 큰 기회를 창출하고 있습니다.

  • 추산에 따르면, 조사 기간 동안 주요 시장 중 미국이 활막육종 시장에서 가장 큰 점유율을 차지했습니다.
  • 미국은 연구 활동과 상업적 잠재력 면에서 주도적인 입지를 차지하고 있는 반면, 유럽과 일본은 활발한 임상 개발, 희귀질환 지원 체계, 그리고 혁신적인 세포 치료 및 정밀 의학의 도입 확대에 힘입어 적극적인 참여를 보이고 있습니다.
  • 티로신 키나제 억제제(TKI) : 염산 카테켄티닙 등 임상시험 중인 치료법은 VEGFR 및 FGFR을 포함한 수용체 티로신 키나제를 표적으로 하여 종양의 증식과 혈관 신생을 억제합니다.
  • NY-ESO-1을 표적으로 하는 TCR 치료법 : TBI-1301이나 lete-cel(GSK3377794)과 같은 새로운 세포 치료법은 유전자 변형된 T세포를 이용하여 NY-ESO-1 항원을 발현하는 종양 세포를 인식·제거함으로써, 종양 특이적인 면역 활성을 높입니다.
  • MAGE-A4 및 PRAME를 표적으로 하는 TCR 치료법 : TECELRA, afami-cel, ADP-600 등의 치료법은 활막육종 세포에서 발현되는 MAGE-A4 또는 PRAME 항원을 표적으로 하도록 설계되어 있어, 면역 매개를 통한 종양 세포의 정밀한 파괴를 가능하게 하며, 임상적 예후의 개선이 기대되고 있습니다.

전반적으로, 화학요법은 여전히 활막육종 치료의 중요한 요소이지만, TCR 기반 세포요법과 표적 키나제 억제제가 혁신을 주도하며, 진행성 질환 환자를 위한 미래의 치료 방식을 재구축해 나가고 있습니다.

자주 묻는 질문

  • 활막육종 시장의 주요 성장 요인은 무엇인가요?
  • 활막육종의 치료 방법에는 어떤 것들이 있나요?
  • 활막육종 시장의 미래 전망은 어떻게 되나요?
  • 2025년 활막육종의 발생률은 어떻게 예측되나요?
  • 활막육종의 진단 방법에는 어떤 것들이 있나요?
  • 활막육종 치료에 있어 TECELRA의 중요성은 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 활막육종 : 역학 및 예측 조사 방법

제6장 활막육종 : 시장 개요

제7장 활막육종 : 질환 배경 및 개요

제8장 활막육종 : 역학 및 환자 인구

제9장 활막육종 : 환자 경과

제10장 시판 치료제

제11장 신흥 치료제

제12장 활막육종 : 주요 7개국 분석

제13장 활막육종 : 미충족 수요

제14장 활막육종 : SWOT 분석

제15장 활막육종 : KOL(Key Opinion Leader)의 견해

제16장 활막육종 : 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

KTH 26.07.24

Synovial Sarcoma Insights and Trends

  • The Synovial Sarcoma market is witnessing steady growth across the major markets, with the United States leading in market size and innovation, followed by the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan during the study period.
  • Japan holds the third-largest share of the 7MM synovial sarcoma market in 2025, which is expected to increase by 2036.
  • Synovial sarcoma is a rare cancer with a small patient population. Its burden is disproportionately concentrated among adolescents and young adults, particularly males, underscoring the need for early diagnosis, timely referral to specialized sarcoma centers, access to advanced therapies, and multidisciplinary care to reduce disease progression, recurrence, and mortality.
  • Treatment of synovial sarcoma includes surgery, radiation therapy, chemotherapy (e.g., doxorubicin and ifosfamide), and advanced cellular therapies such as afamitresgene autoleucel (TECELRA). These approaches aim to achieve tumor control, reduce recurrence, manage metastatic disease, and improve survival, with multidisciplinary care and regular follow-up remaining essential for optimal outcomes.
  • TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the US, and the first new therapy option in more than a decade for synovial sarcoma.
  • Various diagnostic and clinical assessment approaches for synovial sarcoma include MRI, CT, histopathological evaluation, immunohistochemistry, and molecular testing for the SS18::SSX gene fusion. These tools support accurate diagnosis, disease staging, treatment planning, and long-term monitoring to optimize patient outcomes.
  • The emerging synovial sarcoma pipeline is focused on TCR-based cell therapies and targeted agents designed to improve outcomes in advanced disease. Key candidates include TBI-1301 (Takara Bio), lete-cel and afami-cel (US WorldMeds), ADP-600 (Adaptimmune Therapeutics), and catequentinib hydrochloride/AL3818 (Advenchen Laboratories), all of which aim to enhance tumor-specific targeting and address significant unmet needs in synovial sarcoma management.

DelveInsight's 'Synovial Sarcoma - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Synovial Sarcoma, historical and forecasted epidemiology, as well as the Synovial Sarcoma market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

The Synovial Sarcoma market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates Synovial Sarcoma patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in Synovial Sarcoma and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Synovial Sarcoma Market

Rising Synovial Sarcoma Incidence

The increasing incidence of synovial sarcoma, particularly among males, is a primary driver of synovial sarcoma market expansion, supported by the growing burden of advanced and recurrent disease, improving diagnostic capabilities, and the emergence of novel targeted and cellular immunotherapies.

Rising Opportunities in Novel Synovial Sarcoma Therapies

Significant unmet needs in advanced and metastatic synovial sarcoma are driving the development of targeted therapies, engineered T-cell receptor (TCR) therapies, and other immuno-oncology approaches to improve treatment durability, overcome resistance, and enhance long-term outcomes.

Emerging Synovial Sarcoma Competitive Landscape

The synovial sarcoma pipeline is advancing with TCR-based cell therapies and targeted therapies. Key candidates, including TBI-1301, lete-cel, afami-cel, ADP-600, and catequentinib hydrochloride, are being developed to address unmet needs and improve outcomes in advanced and metastatic disease.

Synovial Sarcoma Understanding and Treatment Algorithm

Synovial Sarcoma Overview and Diagnosis

Synovial sarcoma is a rare, aggressive soft tissue sarcoma characterized by a chromosomal translocation involving the SS18 (SYT) gene, which leads to oncogenic fusion proteins driving tumor development. Despite its name, it does not arise from synovial tissue but most commonly occurs in the deep soft tissues near joints, tendons, and bursae, especially in the extremities. It typically affects adolescents and young adults, though it can occur at any age, and often presents as a deep-seated mass with a high risk of metastasis, most commonly to the lungs. Disease behavior and prognosis depend on factors such as tumor size, location, histologic subtype, metastatic status, and response to multimodal treatment, including surgery, radiotherapy, and systemic therapy.

Synovial sarcoma is diagnosed using a combination of clinical assessment, imaging, histopathology, and molecular testing. MRI is used to evaluate tumor size and local extent, while a biopsy provides definitive histological confirmation. The diagnosis is further supported by identifying the characteristic SS18::SSX gene fusion using techniques such as FISH, RT-PCR, or next-generation sequencing, which also aid in treatment planning.

Synovial Sarcoma Treatment

The primary goals of synovial sarcoma treatment are to achieve complete tumor control, prevent recurrence and metastasis, preserve function, and improve long-term survival. Management is multidisciplinary, typically combining surgery, radiation therapy, and systemic chemotherapy, with agents such as doxorubicin and ifosfamide used in advanced or high-risk disease. For unresectable or metastatic cases, emerging targeted and cellular therapies are expanding treatment options. TECELRA, a MAGE-A4-directed T-cell receptor (TCR) therapy, represents a key engineered cell therapy in this setting. Ongoing monitoring with imaging and clinical evaluation is essential to assess response, detect recurrence, and guide further management decisions.

Synovial Sarcoma Unmet Needs

The section "unmet needs of Synovial Sarcoma" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Limited treatment options for advanced and metastatic disease.

2. High rates of recurrence after treatment and lack of approved targeted therapies.

3. Need for reliable predictive biomarkers, and others.....

Synovial Sarcoma Epidemiology

Key Findings from Synovial Sarcoma Epidemiological Analysis and Forecast

  • The total number of incident Synovial Sarcoma cases across the 7MM is expected to increase over 2022-2036, driven by improved diagnostics, greater awareness of rare soft tissue sarcomas, wider use of molecular testing, and improved survival from multidisciplinary care.
  • Among the 7MM, the United States has the highest incidence of Synovial Sarcoma in 2025, and these cases are expected to increase during the forecast period.
  • Among the EU-4 & UK, Germany reported the highest incidence of Synovial Sarcoma. Spain was found to have the fewest cases in 2025 among all European countries.
  • According to DelveInsight estimates, Stage II Synovial Sarcoma accounts for the highest incidence in Japan in 2025, with cases expected to rise over the forecast period.
  • The male predominance and earlier onset of Synovial Sarcoma underscore the need for early diagnosis, prompt referral to specialized sarcoma centers, and age- and risk-adapted treatment strategies to improve long-term outcomes.

Synovial Sarcoma Drug Chapters & Competitive Analysis

The Synovial Sarcoma drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Synovial Sarcoma treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Synovial Sarcoma therapeutics market.

Approved Therapies for Synovial Sarcoma

Afamitresgene autoleucel (TECELRA): Adaptimmune Therapeutics

TECELRA is a MAGE-A4-directed autologous TCR-engineered cell therapy administered as a single intravenous infusion after lymphodepleting chemotherapy. It received FDA accelerated approval in August 2024 based on results from the SPEARHEAD-1 (Cohort 1) trial for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02 positive, and have MAGE-A4-positive tumors. The therapy is used in the second-line or later setting and works by engineering patient T cells to recognize and destroy MAGE-A4-expressing tumor cells. Approval was based on overall response rate and duration of response, with continued approval dependent on confirmation of clinical benefit in ongoing studies.

Synovial Sarcoma Pipeline Analysis

Catequentinib Hydrochloride (anlotinib, AL3818): Advenchen Laboratories

Catequentinib hydrochloride (AL3818), developed by Advenchen Laboratories, is an investigational oral multi-target tyrosine kinase inhibitor being evaluated for synovial sarcoma. It targets key angiogenesis and tumor growth pathways, including VEGFR, FGFR, PDGFR, and c-Kit, with the aim of inhibiting tumor vascularization and disease progression. Separately, anlotinib is another multi-target tyrosine kinase inhibitor under investigation for advanced or metastatic synovial sarcoma, addressing the need for more effective targeted treatment options in this rare disease.

Mipetresgene autoleucel (TBI-1301): Takara Bio

TBI-1301 is an investigational autologous TCR gene therapy for the treatment of synovial sarcoma. The therapy utilizes genetically engineered patient-derived T cells that target the NY-ESO-1 tumor antigen, which is highly expressed in synovial sarcoma cells. By enhancing tumor-specific immune responses, TBI-1301 aims to provide a targeted treatment option for patients with advanced or recurrent disease and improve clinical outcomes beyond those achieved with conventional therapies.

Synovial Sarcoma Key Players, Market Leaders, and Emerging Companies

  • Adaptimmune Therapeutics
  • Advenchen Laboratories
  • Takara Bio
  • US WorldMeds, and others

Synovial Sarcoma Drug Updates

  • In September 2025, Takara Bio announced completion of PMDA review for the confirmatory clinical study of TBI-1301, an NY-ESO-1-targeted TCR gene therapy for synovial sarcoma. Following IRB approvals, patient enrollment and treatment initiation are expected to begin. After revising its regulatory strategy in May 2025, the company is now pursuing full approval based on confirmatory study outcomes rather than conditional approval.
  • In June 2025, Catequentinib Hydrochloride (AL3818) EMA Market Authorization Application (MAA) was successfully submitted.

Synovial Sarcoma Market Outlook

The Synovial Sarcoma market is undergoing a significant transformation driven by advances in precision oncology, cellular immunotherapies, and improved understanding of sarcoma biology. It is currently anchored in conventional treatments such as surgery, radiation therapy, and systemic chemotherapy, alongside the approval of TECELRA, the first engineered TCR-T cell therapy for advanced synovial sarcoma, marking a major milestone in the treatment landscape.

The therapeutic paradigm is increasingly shifting toward biomarker-driven and antigen-targeted therapies designed to improve efficacy and durability of response. Emerging candidates such as Mipetresgene autoleucel, lete-cel, afami-cel, and catequentinib hydrochloride are advancing novel approaches that leverage engineered T-cell receptor technologies, tumor-associated antigen targeting, and multi-kinase inhibition to address the significant unmet needs in this rare cancer.

Continued advances in adoptive cell therapies, targeted agents, and immuno-oncology are expected to drive the Synovial Sarcoma market growth. An expanding pipeline, better tumor characterization, and a strong focus on improving outcomes in advanced disease are creating significant opportunities for developers in this space.

  • According to the estimates, the United States accounted for the largest share of the synovial sarcoma market among the major markets during the study period.
  • The United States leads in research activity and commercial potential, while Europe and Japan demonstrate strong engagement driven by active clinical development, supportive rare disease frameworks, and growing adoption of innovative cell and precision therapies.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Synovial Sarcoma (2022-2036 Forecast)

The synovial sarcoma treatment landscape comprises conventional chemotherapy, multi-target tyrosine kinase inhibitors (TKIs), and emerging engineered TCR therapies targeting tumor-associated antigens such as NY-ESO-1, MAGE-A4, and PRAME. These approaches aim to improve tumor control, enhance anti-tumor immune responses, and address the significant unmet needs in advanced and metastatic disease.

  • Tyrosine Kinase Inhibitors (TKIs): Investigational therapies such as Catequentinib hydrochloride target receptor tyrosine kinases, including VEGFR and FGFR, to inhibit tumor growth and angiogenesis.
  • NY-ESO-1-Targeted TCR Therapies: Emerging cell therapies such as TBI-1301 and lete-cel (GSK3377794) utilize genetically engineered T cells to recognize and eliminate tumor cells expressing the NY-ESO-1 antigen, enhancing tumor-specific immune activity.
  • MAGE-A4- and PRAME-Targeted TCR Therapies: Therapies including TECELRA, afami-cel, and ADP-600 are designed to target MAGE-A4 or PRAME antigens expressed on synovial sarcoma cells, enabling precise immune-mediated tumor cell destruction and potentially improving clinical outcomes.

Overall, chemotherapy remains a key component of synovial sarcoma management, while TCR-based cellular therapies and targeted kinase inhibitors are driving innovation and reshaping the future treatment landscape for patients with advanced disease.

Synovial Sarcoma Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the synovial sarcoma market's uptake by drugs, patient uptake by therapy, and sales of each drug.

Market Access and Reimbursement of Ascites

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

Synovial Sarcoma Therapies Price Scenario & Trends

Pricing and analogue assessment of synovial sarcoma therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Synovial Sarcoma

To keep up with Synovial Sarcoma market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the Synovial Sarcoma emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in Synovial Sarcoma, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of Mississippi Medical Center, University of Bologna, and Teikyo University School of Medicine, etc. were contacted. Their opinion helps understand and validate current and emerging Synovial Sarcoma therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Synovial Sarcoma.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Synovial Sarcoma, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of Synovial Sarcoma, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the synovial sarcoma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Synovial Sarcoma market.

Report Insights

  • Synovial Sarcoma Patient Population Forecast
  • Synovial Sarcoma Therapeutics Market Size
  • Synovial Sarcoma Pipeline Analysis
  • Synovial Sarcoma Market Size and Trends
  • Synovial Sarcoma Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year Forecast
  • Synovial Sarcoma Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Synovial Sarcoma Treatment Addressable Market (TAM)
  • Synovial Sarcoma Competitive Landscape
  • Synovial Sarcoma Major Companies Insights
  • Synovial Sarcoma Price Trends and Analogue Assessment
  • Synovial Sarcoma Therapies Drug Adoption/Uptake
  • Synovial Sarcoma Therapies Peak Patient Share Analysis

Report Assessment

  • Synovial Sarcoma Current Treatment Practices
  • Synovial Sarcoma Unmet Needs
  • Synovial Sarcoma Clinical Development Analysis
  • Synovial Sarcoma Emerging Drugs Product Profiles
  • Synovial Sarcoma Market Attractiveness
  • Synovial Sarcoma Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Synovial Sarcoma market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of Synovial Sarcoma?
  • What are the disease risks, burdens, and unmet needs of Synovial Sarcoma? What will be the growth opportunities across the 7MM concerning the patient population with Synovial Sarcoma?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of Synovial Sarcoma? What are the current guidelines for treating Synovial Sarcoma in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Synovial Sarcoma market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarizes and simplifies complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology of Synovial Sarcoma

6. Synovial Sarcoma Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (by Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of Synovial Sarcoma by Therapies in the 7MM, in 2026
  • 6.3. Market Share (%) Distribution of Synovial Sarcoma by Therapies in the 7MM, in 2036

7. Disease Background and Overview of Synovial Sarcoma

  • 7.1. Introduction
  • 7.2. Signs and Symptoms
  • 7.3. Genetics of Synovial Sarcoma
  • 7.4. Clinical and Pathologic Features
  • 7.5. Histopathologic and Immuno-histochemical findings
  • 7.6. Differential Diagnosis
  • 7.7. Diagnosis
  • 7.8. Treatment
    • 7.8.1. Treatment Guidelines
    • 7.8.2. UK Guidelines for Management of Soft-tissue Sarcomas

8. Epidemiology and Patient Population of Synovial Sarcoma

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale
  • 8.3. Total Incident Cases of Synovial Sarcoma in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Incident Cases of Synovial Sarcoma in the United States
    • 8.4.2. Gender-specific Cases of Synovial Sarcoma in the United States
    • 8.4.3. Ager-specific Cases of Synovial Sarcoma in the United States
    • 8.4.4. Location-specific Cases of Synovial Sarcoma in the United States
    • 8.4.5. Stage-specific Cases of Synovial Sarcoma in the United States
    • 8.4.6. Antigen-specific (MAGE-A4, NY-ESO-1, PRAME, and others) Cases of Synovial Sarcoma in the United States
    • 8.4.7. Line-wise treated Patient Pool of Synovial Sarcoma in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Incident Cases of Synovial Sarcoma in EU4 and the UK
    • 8.5.2. Gender-specific Cases of Synovial Sarcoma in EU4 and the UK
    • 8.5.3. Age-specific Cases of Synovial Sarcoma in EU4 and the UK
    • 8.5.4. Location-specific Cases of Synovial Sarcoma in EU4 and the UK
    • 8.5.5. Stage-specific Cases of Synovial Sarcoma in EU4 and the UK
    • 8.5.6. Antigen-specific (MAGE-A4, NY-ESO-1, PRAME, and others) Cases of Synovial Sarcoma in EU4 and the UK
    • 8.5.7. Line-wise treated Patient Pool of Synovial Sarcoma in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Incident Cases of Synovial Sarcoma in Japan
    • 8.6.2. Gender-specific Cases of Synovial Sarcoma in Japan
    • 8.6.3. Age-specific Cases of Synovial Sarcoma in Japan
    • 8.6.4. Location-specific Cases of Synovial Sarcoma in Japan
    • 8.6.5. Stage-specific Cases of Synovial Sarcoma in Japan
    • 8.6.6. Antigen-specific (MAGE-A4, NY-ESO-1, PRAME, and others) Cases of Synovial Sarcoma in EU4 and the UK
    • 8.6.7. Line-wise treated Patient Pool of Synovial Sarcoma in EU4 and the UK

9. Patient Journey of Synovial Sarcoma

10. Marketed Therapies

  • 10.1. Competitive landscape of marketed therapies
  • 10.2. Afamitresgene autoleucel (TECELRA): Adaptimmune Therapeutics
    • 10.2.1. Drug Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Clinical Development
      • 10.2.5.1. Clinical Trial Information
    • 10.2.6. Analyst's Views

11. Emerging Drugs

  • 11.1. Competitive landscape of emerging therapies
  • 11.2. Catequentinib Hydrochloride (VEGFr, FGFr)/anlotinib (AL3818): Advenchen Laboratories
    • 11.2.1. Drug Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trials Information
    • 11.2.4. Analyst's Views
  • 11.3. Mipetresgene autoleucel (TBI-1301): Takara Bio
    • 11.3.1. Drug Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trials Information
    • 11.3.4. Analyst's Views

12. Synovial Sarcoma: 7MM Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook
  • 12.3. Conjoint Analysis
  • 12.4. Key Market Forecast Assumptions
  • 124.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of Synovial Sarcoma in the 7MM
  • 12.6. Total Market Size of Synovial Sarcoma by Therapies in the 7MM
  • 12.7. The United States
    • 12.7.1. Total Market Size of Synovial Sarcoma in the United States
    • 12.7.2. Total Market Size of Synovial Sarcoma by Therapies in the United States
  • 12.8. EU4 and the UK
    • 12.8.1. Total Market Size of Synovial Sarcoma in EU4 and the UK
  • 12.2. Total Market Size of Synovial Sarcoma by Therapies in EU4 and the UK
  • 12.9. Japan
    • 12.9.1. Total Market Size of Synovial Sarcoma in Japan
    • 12.9.2. Total Market Size of Synovial Sarcoma by Therapies in Japan

13. Unmet Needs of Synovial Sarcoma

14. SWOT Analysis of Synovial Sarcoma

15. KOL Views of Synovial Sarcoma

16. Market Access and Reimbursement of Synovial Sarcoma

  • 16.1. The United States
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Synovial Sarcoma Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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