개요
세계의 활막육종 치료 시장은 2023년에 8억 3,247만 달러에 달하며, 2031년에는 16억 4,661만 달러에 달할 것으로 예측되며, 예측 기간인 2024년에는 CAGR 8.9%로 성장할 전망입니다.
활막육종은 희귀한 유형의 연부육종으로 팔, 다리, 발의 깊은 조직에서 가장 흔하게 발생합니다. 활막세포육종이라고도 불리는 이 악성(암성) 종양은 활막 관절(팔꿈치나 엉덩이와 같은 일반적인 관절)의 세포와 유사하기 때문에 그 이름이 붙여졌습니다.
활막육종은 연부조직 암의 5-10%를 차지합니다. 활막육종의 치료는 일반적으로 수술, 방사선 치료, 화학요법을 병행합니다. 구체적인 치료 방침은 종양의 크기, 부위, 병기, 환자의 전신 건강 상태 및 개인적 선호도에 따라 달라집니다.
촉진요인
활막육종 연구개발 및 FDA 승인 증가
세계 활막육종 치료제 시장 수요는 여러 요인에 의해 주도되고 있습니다. 주요 요인 중 하나는 최근 다양한 연구개발로 인해 시장이 크게 성장하고 있다는 점입니다. 활막육종은 30세 미만의 젊은 환자에서 가장 흔하게 발생합니다. 전체 연부육종의 약 8%를 차지하지만, 청소년과 청년층에서는 15-20%를 차지합니다.
예를 들어 2022년 12월 Adaptimmune Therapeutics는 활막육종 치료를 위해 MAGE-A4를 표적으로 하는 1세대 인공 TCR T세포 치료제인 Afami-cell의 생물학적 제제 승인 신청(BLA)을 시작한다고 발표했습니다. 아파미셀의 생물학적 제제 승인 신청은 진행성 활막육종 환자를 대상으로 한 어댑티뮤의 SPEARHEAD-1 임상시험에서 얻은 양호한 임상 데이터에 의해 지원되고 있습니다. 따라서 위의 요인으로 인해 시장은 예측 기간 중 확대될 것으로 예상됩니다.
또한 활막육종 치료에 대한 FDA의 승인 증가는 이 시장의 성장을 가속할 것으로 보입니다. 예를 들어 2022년 12월 미국 식품의약국(FDA)은 아테졸리주맙(테센트릭, Genentech)을 절제 불가능한 또는 전이성 폐포연조직육종(ASPS)을 가진 성인 및 2세 이상의 소아 환자를 위한 치료제로 승인했습니다. 소아 환자에서 아테졸리주맙 15mg/kg을 21일 간격으로 1회 투여했을 때 효과를 확인했습니다.
또 C4 Therapeutics, Inc.는 2022년 3월 미국 식품의약국(FDA)이 연부육종 치료제로 CFT8634를 희귀질환치료제(ODD)로 지정했다고 발표했습니다.
억제요인
고가의 치료비, 면역치료에 따른 부작용, 인지도 및 진단 부족, 제한된 치료 옵션, 엄격한 규제 요건 및 상환 문제 등이 시장 성장 억제요인으로 작용할 것으로 예상됩니다.
Overview
The global synovial sarcoma treatment market reached US$ 832.47 million in 2023 and is expected to reach US$ 1646.61 million by 2031 growing with a CAGR of 8.9% during the forecast period 2024-2031.
Synovial sarcoma is a rare type of soft tissue sarcoma that develops most frequently in tissues deep within the arms, legs, and feet. Also called synovial cell sarcoma, these malignant (cancerous) tumors got their name from similarities to cells in synovial joints-common joints such as the elbows and hips.
Synovial sarcoma accounts for 5% to 10% of soft-tissue cancers. The treatment for synovial sarcoma typically involves a combination of surgery, radiation therapy, and chemotherapy. The specific treatment plan will depend on the size, location, and stage of the tumor, as well as the patient's overall health and personal preferences.
Market Dynamics: Drivers
Rising Research and Developments & Increasing FDA Approvals for Synovial Sarcoma
The demand for the global synovial sarcoma treatment market is driven by multiple factors. One of the key factors is the market has grown significantly due to various recent research and developments. Synovial sarcoma occurs most commonly in the younger patients under 30 years of age. While overall comprising about 8% of all soft tissue sarcomas, it accounts for 15-20% of the cases in adolescents and young adults.
For instance, in December 2022, Adaptimmune Therapeutics announced the initiation of biologics license application (BLA) submission for Afami-cel which is their first-generation engineered TCR T-cell therapy targeting MAGE-A4 for the treatment of synovial sarcoma. The biologics license submission for afami-cel is supported by positive clinical data from Adapt Immune's SPEARHEAD-1 clinical trial in patients with advanced synovial sarcoma. Thus, owing to the above factors the market is expected to boost over the forecast period.
Moreover, increasing FDA approvals for the synovial sarcoma treatment would propel this market growth. For instance, in December 2022, the Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft tissue sarcoma (ASPS). The efficacy of atezolizumab 15 mg/kg given once every 21 days was tested in pediatric patients.
Also, in March 2022, C4 Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT8634 for the treatment of soft tissue sarcoma.
Restraints
Factors such as the high cost of the treatment, side effects associated with the immunotherapy, lack of awareness & diagnosis, limited treatment options, and stringent regulatory requirements & reimbursement issues, are expected to hamper the market.
The global synovial sarcoma treatment market is segmented based on treatment, end users, and region.
The immunotherapy segment accounted for approximately 45.3% of the global synovial sarcoma treatment market share
The immunotherapy segment is expected to hold the largest market share over the forecast period. Immunotherapy includes drugs that activate the immune system that modify the immune system cells to target tumor cells and monoclonal antibodies, checkpoint inhibitors, and vaccines are the common types of immunotherapies.
The rising number of clinical trials for immunotherapy and the increasing approvals of immunotherapy drugs have contributed to the growing demand for synovial sarcoma treatment. For instance, in February 2024, Immunotherapy before surgery leads to promising long-term survival in sarcoma patients. MD Anderson-led Phase II trial suggests neoadjuvant immunotherapy is safe and may be an effective option for patients with soft-tissue sarcomas.
Similarly, in March 2024, an immunotherapy clinical trial showed promise for treating rare sarcomas. Now, a phase 2 clinical trial testing an experimental cell therapy called afamitresgene autoleucel (afami-cel) found that it significantly shrank sarcoma tumors in more than one-third of patients.
Also, in October 2023, the Clinical Cancer Research publication stated that the immunotherapy with TBI-1301 to target NY-ESO-1-positive tumor cells demonstrated promising results for the treatment of advanced or recurrent synovial sarcoma.
North America accounted for approximately 42.3% of the global synovial sarcoma market share
North America region is expected to hold the largest market share over the forecast period owing to factors such as the rising prevalence of soft tissue sarcoma, increasing research and developments, and technological advancements in synovial sarcoma treatment.
According to the American Cancer Society, the estimation for soft tissue sarcomas in the United States for 2023 is around 13,400 new soft tissue sarcomas that will be diagnosed (7,400 in males and 6,000 in females) and about 5,140 people are expected to die of soft tissue sarcomas. The increasing number of synovial sarcoma diagnoses creates a pressing demand for effective treatments in this region.
In addition, a well-advanced healthcare system, rising clinical trials, and research studies in the treatment of synovial sarcoma would propel this market growth. For instance, in May 2023, Immatics provided an interim update on cohort A of its Phase Ib dose-expansion trial evaluating its leading T-cell receptor-based therapy (TCR-T) candidate IMA203. The best responders to IMA203 in the small cohort were patients with cutaneous and uveal melanoma, synovial sarcoma, and platinum-resistant ovarian cancer.
Also, in June 2023, Replay Holdings LLC and The University of Texas MD Anderson Cancer Center announced that the FDA has cleared the IND application for NY-ESO-1 TCR/IL-15 NK, an engineered T-cell receptor natural killer (TCR-NK) cell therapy for advanced synovial sarcoma and myxoid/round cell liposarcoma.
The major global players in the synovial sarcoma market include Pfizer Inc., Dr. Reddy's Laboratories, Hetero Healthcare, Teva Pharmaceuticals, Sterling Biotech Ltd., Baxter International, Janssen Pharmaceuticals, Concord Biotech Ltd., Novartis AG, Taiho Pharmaceuticals among others.
The global synovial sarcoma treatment market report would provide approximately 54 tables, 47 figures, and 182 Pages.
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