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1705102

유잉육종 시장 - 시장 인사이트, 역학, 시장 예측(2034년)

Ewing Sarcoma - Market Insight, Epidemiology, and Market Forecast - 2034

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

    
    
    




■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

주요 하이라이트

  • 2023년 미국은 주요 7개국 유잉육종 치료제 시장에서 가장 큰 점유율(약 53%)을 차지했습니다.
  • 대부분의 유잉육종 환자들은 20세 미만이기 때문에 후기 독성 위험이 적은 분자표적치료가 도움이 될 수 있습니다.
  • 난치성 또는 재발성 유잉육종에 대한 표준 2차 치료법은 없지만, 몇몇 후향적 연구에서 기존 치료법에 대해 보고한 바 있습니다.
  • 현재 유잉육종의 치료는 화학요법과 국소요법(수술 및/또는 방사선 요법)이 주류를 이루고 있습니다.
  • VDC/IE 요법의 채택으로 생존기간이 유의하게 연장되었습니다. 전이성 유잉육종 환자는 여전히 예후가 좋지 않아 향후 치료제에 대한 수요가 증가할 것으로 예상됩니다.
  • 유잉육종의 예후는 치료의 발전으로 매년 개선되고 있습니다. 국소성 유잉육종의 5년 생존율은 약 70-80%인 반면, 전이성 질환의 생존율은 약 30-40%로 낮습니다. 그러나 생존율은 개별적인 요인이나 치료에 대한 반응에 따라 달라질 수 있다는 점에 유의해야 합니다.
  • NCCN 가이드라인 2.2023 최신판에서는 루비넥틴이 유잉육종의 2차 치료제로 추가되었습니다(R/R 또는 전이성 병변의 경우).
  • 유잉육종은 아직 치료제가 승인되지 않았기 때문에 이 분야에 진출하여 선점 이익을 얻는 기업에게는 큰 시장 기회가 있습니다.
  • 표적 유잉육종 치료, 면역요법, 정밀 종양학 및 기타 새로운 치료법이 일부 암종 치료에 사용되고 있지만, 많은 육종 아형에서는 여전히 화학요법이 치료의 주류를 이루고 있습니다. 많은 육종 아형에 대해 특히 병이 진행된 후 환자에게 효과적으로 투여할 수 있는 치료제는 승인되지 않았거나 매우 적습니다.
  • 적응증 외 치료의 사용은 새로운 치료법의 보급을 방해할 수 있습니다.
  • 전이성 유잉육종에 대한 1차 치료는 국소 병변에 대한 치료와 마찬가지로 원발 부위와 전이 부위 모두에 대해 충분한 국소 조절이 가능한 동일한 화학요법의 근간을 이용합니다.
  • 유잉육종 치료제 개발은 주로 Salarius Pharmaceuticals, Jazz Pharmaceuticals, Pfizer, Eli Lilly and Company, BioAlta, Inhibrx 등 유명 유잉육종 기업들이 주도하고 있습니다. 이들 주요 유잉육종 기업들은 2차 라인(2L) 이상의 환자를 대상으로 한 치료제 개발에 집중하고 있습니다.
  • 예상치 못한 중대한 이상반응(SUSAR)의 가능성으로 인해 Salarius는 지난해 세클리뎀스타의 유잉육종 치료제로서 임상 I/II상 시험의 신규 환자 등록을 자발적으로 중단했으며, FDA는 2023년 5월 세클리뎀스타의 신청에 대해 심사를 종료하고 임상시험을 재개할 가능성이 있다고 선언했습니다.

본 보고서는 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본의 유잉육종의 역사적 및 예측 역학, 그리고 유잉육종의 시장 동향을 상세히 전해드립니다.

현재 치료법, 신약, 각 치료법별 유잉육종 시장 점유율, 2020년에서 2034년까지 주요 7개국 유잉육종 시장 규모 현황 및 예측을 제공합니다. 또한, 현재 유잉육종 치료제의 시장 관행/알고리즘과 유잉육종에 대한 미충족 의료 수요를 파악하여 최적의 기회를 발굴하고 시장 잠재력을 평가합니다.

유잉육종은 보통 뼈에서 증식을 시작하는 암성 종양입니다. 주로 소아 및 젊은 성인에게 발생하며, 대부분 10대에 발병하는 경우가 많습니다. 유잉육종은 모든 뼈에서 발생할 수 있지만 보통 대퇴골, 경골, 상완골과 같은 긴 뼈에서 발생합니다. 골반 뼈도 종종 침범합니다. 때로는 종양이 근육이나 연부조직에서 시작되기도 합니다. 가장 흔한 증상은 뼈와 뼈 주변 조직의 뻣뻣함, 통증, 부종, 압통입니다.

환자의 증상으로는 안정 시에도 지속되는 뼈의 통증, 부종, 환부의 뼈에 큰 종괴가 있는 등의 증상으로 시작됩니다. 이후 정형외과를 방문하여 MRI, CT 스캔, 단순 X-선 촬영 등의 진단 검사를 제안받게 됩니다. 진단 후 환자는 추가 치료를 위해 종양 전문의에게 의뢰됩니다. 확진 진단을 위해 영상 진단으로 판단된 암의 가장 진행된 부위에서 떼어낸 종괴의 조직 생검을 시행합니다. 유잉육종으로 확진되면 환자에게 적절한 치료를 시행합니다.

NCCN은 국소 및 전이성 유잉육종 치료 시 수술, 화학요법, 방사선 치료를 포함한 다학제적 접근법을 일반적으로 사용하며, NCCN은 국소 및 전이성 유잉육종 치료를 위해 다양한 화학요법 조합을 권장하고 있습니다. 이포스파미드, 에토포사이드), VAIA(빈크리스틴, 독소루비신, 이포스파미드, 닥티노마이신), VIDE(빈크리스틴, 이포스파미드, 독소루비신, 에토포사이드)는 NCCN에서 전이성 질환의 1차 치료 및 1차 치료제로 권고하고 있습니다. 추천하고 있습니다. 2차 치료로는 사이클로포스파미드와 토포테칸, 일리노테칸+테모졸로미드+-, NCCN은 빈크리스틴, 이포스파미드, 카보플라틴, 에토포사이드, 루비넥틴을 추천하고 있습니다.

  • 주요 7개국에서 유잉육종 환자 수가 가장 많은 국가는 미국으로 전체 환자 수의 약 41%를 차지합니다.
  • EU 4개국 중 유잉육종 발병 건수가 가장 많은 국가는 독일로 전체 발병 건수의 약 15%를 차지했고, 가장 적은 국가는 이탈리아였습니다.
  • 미국에서는 모든 연령대 중 10-14세의 유잉육종 환자 수가 약 30%로 가장 많았고, 15-19세(26%)가 그 뒤를 이었습니다.
  • 분석에 따르면, 남성은 여성보다 유잉육종에 걸릴 확률이 더 높습니다. 미국에서는 2023년 남성의 유잉육종 우발적 사례가 300건 정도 발생할 것으로 추정됩니다.

유잉육종의 최근 동향

  • 2024년 11월 12일, Actuate Therapeutics, Inc는 신규 글리코겐 합성효소 키나아제-3β(GSK-3B) 억제제인 엘라글루시브(Elaglucib)가 미국 식품의약국(FDA)으로부터 유잉육종(EWS) 치료제로서 희귀 소아질환 지정을 받았다고 발표하였습니다.
  • 2024년 11월 12일, FDA는 신규 GSK-3B 억제제 엘라글루시브(9-ING-41)를 유잉육종 환자의 희귀 소아질환 치료제로 지정했습니다.
  • 세크레뎀스타트 Salarius Pharmaceuticals

Seclidemstat(SP-2577)은 LSD1의 효소 활성과 비계 기능을 억제하며, SP-2577은 유잉육종 환자를 대상으로 I/II상 임상시험이 진행 중입니다. 살라리우스는 SP-2577과 토포테칸 및 사이클로포스파미드(TC)와의 병용요법을 연구하고 있으며, TC 단독요법보다 환자 예후를 개선하는 것을 목표로 하고 있습니다.

    • 2022년 10월, 회사는 프로토콜 설계에 따라 유잉육종 및 FET 재배열육종 치료제로서 세크리뎀스타의 임상 I/II상 시험의 신규 환자 등록을 자발적으로 중단했습니다. 신규 환자 등록 중단은 예상치 못한 심각한 이상반응(SUSAR)으로 분류된 전이성 FET 재배열육종 환자의 사망에 따른 것입니다.
    • 이후 2023년 5월, 회사는 FDA로부터 회사가 제출한 신청서에 대한 심사가 완료되어 유잉육종 임상시험을 재개해도 좋다는 결론을 받았다는 통보를 받았습니다.
  • ZEPZELCA(Lurbinectedin) : Jazz Pharmaceuticals 및 PharmaMar

Lurbinectedin(PM1183)은 현재 임상시험 중인 합성 화합물입니다. 많은 종양이 특히 의존하는 발암성 전사 프로그램의 선택적 억제제입니다.

    • 2019년 12월, PharmaMar와 Jazz Pharmaceuticals는 lurbinectedin의 미국 내 독점 라이선스 계약을 체결했다고 발표했습니다.
    • NCCN 가이드라인 2.2023 업데이트 버전에서 루빈넥틴은 유잉육종(R/R 또는 전이성 질환)에 대한 2차 치료 옵션으로 추가되었습니다. 카테고리 2B에서는 특정 상황에서 권장하는 데 유용합니다.

CDK 억제제: CDK9, CDK12, CDK13과 같은 RNA의 전사, 처리 및 번역에 관여하는 단백질은 단독으로 또는 종양 단백질 및 성장 인자를 표적으로 하는 것과 결합하여 전임상시험에서 유망한 결과를 보였으며, 현재도 시험이 진행 중입니다. 또한, 기능이 다른 세포주기 단백질인 CDK4와 CDK6는 여러 스크리닝에서 융합형 암 단백질과 무관한 잠재적 표적으로 확인되었으며, CDK4와 CDK6 억제제를 재발성 유잉육종에 대한 화학요법 요법에 병용하는 시험이 진행 중입니다.

향후 유잉육종 치료 시장 상황은 4가 데스 레셉터 5(DR5) 작용제, CDK 억제제, LSD1 억제제, AXL 억제제 등 새로운 계열의 약물이 등장하면서 더욱 확대될 것으로 예상됩니다. DR5는 삼량체 종양괴사인자 관련 세포사멸 유도 리간드(TRAIL)에 대한 두 가지 세포사멸 촉진 수용체 중 하나이며, DR5의 활성화에 의해 유도되는 종양 특이적 세포사멸을 이용하도록 설계되었습니다.

유잉육종 치료에서 화학요법, 수술, 방사선 치료 등의 발전으로 일부 환자의 생존율이 개선된 반면, 일부 환자의 생존율은 정체된 상태입니다. 고위험군 유잉육종 및 기타 관련 육종의 관리는 고위험군의 생물학적 특성에 대한 이해가 불완전하고 발생 빈도가 상대적으로 낮기 때문에 여전히 논란의 여지가 있습니다. 이러한 요인으로 인해 고위험군 유잉육종 환자나 희귀한 아형 육종 환자들을 대상으로 한 종합적인 임상시험을 수행하기 어려운 실정입니다.

난치성 또는 재발성 유잉육종에 대한 표준 2차 치료법은 없으나, 몇몇 후향적 연구에서 기존 치료법에 대한 후향적 연구가 보고된 바 있습니다. 일반적인 치료법으로는 토포테칸, 사이클로포스파미드, 일리노테칸, 테모졸로미드 또는 대량 화학요법(HDC) 후 조혈모세포 재주입이 있으며, HDC와 자가 줄기세포 이식(auto-SCT)의 병용요법은 수년 동안 활발한 관심과 연구 및 논의의 대상이 되어 왔습니다. 논의의 대상이 되어 왔습니다. 여러 후향적 연구와 단일군 연구 결과, 초기 조건부 요법에 따라 차이가 있음에도 불구하고 고위험 난치성 유잉육종 환자에서 유망한 결과를 보여주었습니다. 유잉육종에서 암 단백질을 표적으로 하는 다른 잠재적인 전략으로는 RNA 간섭, 단백질 분해제, 새로운 에피토프를 표적으로 하는 면역요법 등이 있습니다. 화학요법, 방사선요법, 수술요법 등이 현재 유잉육종의 치료법입니다.

향후 기대되는 치료의 시작, 조기 환자 검진의 통합, 2 차 의료 및 기타 임상 현장에서의 유잉육종 약물 치료, 최적의 실행 방법의 조사, 인식 개선은 궁극적으로 효과적인 치료법 개발을 촉진할 것입니다. 유잉육종에 대한 효과적인 치료 옵션이 현저히 부족하다는 것은 이 질환에 대한 대응의 진전이 시급하다는 것을 강조하고 있습니다. 그러나 유잉육종은 희귀질환이기 때문에 임상시험을 진행하는데 어려움이 있어, 희귀질환에 대한 임상시험 수를 늘리기 위한 노력이 시급히 요구되고 있습니다.

  • 주요 7개국의 유잉육종 치료제 시장 규모는 2023년 약 3,000만 달러로 예측 기간(2024-2034년) 동안 성장할 것으로 예상됩니다.
  • EU 4개국 중 유잉육종 시장 규모가 가장 큰 국가는 독일로, EU 4개국 전체와 영국 시장 점유율의 25%를 차지하고 있습니다.
  • Seclidemstat TC는 2034년까지 2L의 신흥 치료제 중 가장 높은 유잉육종 시장 점유율을 차지할 것으로 예상됩니다.
  • 표적치료, 면역치료, 병용요법 등 새로운 치료법의 도입으로 유잉육종의 치료 영역이 확대되고, 생존율 향상과 화학요법, 방사선 치료 등 기존 치료의 부작용을 줄일 수 있을 것으로 기대됩니다.

본 보고서는 주요 7개국 유잉육종 시장에 대해 조사했으며, 시장 개요, 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 미충족 의료 수요 등을 조사하여 전해드립니다.

목차

제1장 중요한 인사이트

제2장 보고서 소개

제3장 주요 요약

제4장 주요 사건

제5장 역학과 시장 예측 조사 방법

제6장 유잉육종 시장 개요

  • 2023년 치료법별 시장 점유율(%) 분포
  • 2034년 치료법별 시장 점유율(%) 분포

제7장 질환 배경과 개요

  • 소개
  • 원인
  • 징조와 증상
  • 스테이징
    • TNM 시스템
  • 위험요인
  • 병리학적 진단
  • 진단 테스트
    • 영상 검사
    • 외과적 검사
    • 기타 임상 검사

제8장 유잉육종 치료 관리

  • 치료 알고리즘

제9장 유잉육종 치료 가이드라인

제10장 역학과 환자 인구

  • 주요 조사 결과
  • 가정과 근거
  • 주요 7개국의 유잉육종 발생 증례수
  • 미국
  • EU 4개국과 영국
  • 일본

제11장 환자 동향

제12장 유잉육종의 주요 평가 항목

제13장 신흥 약제

  • 주요 경쟁
  • Seclidemstat (SP-2577) : Salarius Pharmaceuticals
  • Zepzelca (Lurbinectedin) : Jazz Pharmaceuticals와 PharmaMar
  • VERZENIO (abemaciclib) : Eli Lilly
  • IBRANCE (palbociclib) : Pfizer
  • Mecbotamab Vedotin (BA3011) : BioAtla
  • Iopofosine I 131 (CLR 131) : Cellectar Biosciences
  • TP-1287 : Sumitomo Pharma Oncology
  • INBRX-109 : Inhibrx

제14장 유잉육종 : 주요 7개국 분석

  • 주요 조사 결과
  • 시장 전망
  • 주요 시장 예측 가정
  • 컨조인트 분석
  • 주요 7개국의 유잉육종 전체 시장 규모
  • 주요 7개국의 유잉육종 시장 규모(치료법별)
  • 미국 시장 규모
  • EU 4개국과 영국의 시장 규모
  • 일본 시장 규모

제15장 미충족 수요

제16장 SWOT 분석

제17장 KOL의 견해

제18장 시장 접근과 상환

  • 미국
  • EU 4개국과 영국
  • 일본
  • 악성 골종양 및 육종의 경제적 부담

제19장 부록

제20장 Delveinsight 서비스 내용

제21장 면책사항

ksm 25.04.22

Key Highlights:

  • In 2023, the US accounted for the maximum share of the Ewing sarcoma Treatment Market in the 7MM, i.e., nearly 53%.
  • A molecular-targeted therapy with minimal risk of late toxicities would be beneficial because most Ewing sarcoma Patients are under 20 years old.
  • Although there is no standardized second-line treatment for refractory or relapsed Ewing sarcoma, several retrospective studies have reported on conventional salvage treatments.
  • Chemotherapy and local therapy (surgery and/or radiation) are dominant in the Ewing sarcoma treatment at the moment.
  • The adoption of the VDC/IE regimen has significantly increased survival. Patients with metastatic ES continue to experience negative outcomes, which will increase the demand for future therapeutics.
  • The Ewing sarcoma Prognosis has improved over the years due to advances in treatment. The 5-year survival rate for localized Ewing sarcoma is around 70-80%, while the survival rate for metastatic disease is lower, around 30-40%. However, it is important to note that survival rates can vary depending on individual factors and the response to treatment.
  • In the updated version 2.2023 of the NCCN guidelines lurbinectedin has been added as a second-line therapy option for Ewing sarcoma (for R/R or metastatic disease).
  • Since no therapies are approved for Ewing sarcoma, there is a significant market opportunity for the companies to enter this space and get the first-mover advantage.
  • Targeted Ewing Sarcoma Treatments, immunotherapies, precision oncology, and other novel treatments are used to treat some cancer types, but chemotherapy is still the mainstay of treatment for many sarcoma subtypes. There are either none or very few approved drugs for treating many subtypes of sarcoma that can be effectively given to patients, especially after disease progression.
  • The usage of off-label therapies may hamper the uptake of new therapies.
  • First-line therapy for Metastatic Ewing Sarcoma is similar to that for localized disease and utilizes the same chemotherapy backbone with adequate local control of both primary and metastatic sites.
  • The development of Ewing sarcoma Therapies is primarily undertaken by prominent Ewing Sarcoma Companies, including Salarius Pharmaceuticals, Jazz Pharmaceuticals, Pfizer, Eli Lilly and Company, BioAlta, Inhibrx, and others. These key Ewing Sarcoma Companies focus on developing treatments specifically for patients in the second line (2L) and above of treatment
  • Due to a potential unexpected significant adverse reaction (SUSAR), Salarius voluntarily stopped enrolling new patients in its Phase I/II trial of seclidemstat as a therapy for Ewing sarcoma last year. The FDA ended its examination of the company's application for seclidemstat in May 2023 and declared that the clinical trial might be restarted.

DelveInsight's "Ewing Sarcoma Treatment Drugs Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of Ewing Sarcoma, historical and forecasted epidemiology as well as Ewing Sarcoma market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Ewing Sarcoma Treatment Market Report provides current treatment practices, emerging drugs, Ewing Sarcoma market share of individual therapies, and current and forecasted 7MM Ewing Sarcoma market size from 2020 to 2034. The report also covers current Ewing Sarcoma treatment drugs market practices/algorithms and Ewing Sarcoma unmet medical needs to curate the best opportunities and assess the market's potential.

Ewing Sarcoma Treatment Market

Ewing sarcoma (also known as Ewing's sarcoma) is a cancerous tumor that usually begins growing in a bone. It occurs primarily in children and young adults, often appearing during the teen years. Although Ewing's sarcoma can develop in any bone, it usually affects the long bones, such as the thighbone (femur), shinbone (tibia), and upper arm bone (humerus). The bones of the pelvis are also often affected. Occasionally, the tumor begins in the muscles and soft tissues. The most common symptoms are stiffness, pain, swelling, or tenderness in the bone or the tissue surrounding the bone.

Ewing Sarcoma Diagnosis

The patient's journey begins with symptoms such as persistent bone pain even at rest, swelling, and a large palpable mass on the affected bone. Followed by a visit to the orthopedist, where the patient is suggested diagnostic tests such as MRI, CT scan, and plain radiography. After the diagnosis patient is referred to an oncologist for further treatment. A tissue biopsy is performed of the mass removed from the most aggressive portion of cancer as determined by imaging for confirmatory diagnosis. Once Ewing Sarcoma is confirmed, relevant treatment is given to the patient.

Ewing Sarcoma Treatment

The Ewing sarcoma treatment typically involves a multidisciplinary approach, including surgery, chemotherapy, and radiation therapy. NCCN recommended different chemotherapy combinations to treat localized and metastatic Ewing sarcoma. VDC/IE (vincristine, doxorubicin, and cyclophosphamide alternating with ifosfamide and etoposide), VAIA (vincristine, doxorubicin, ifosfamide, and dactinomycin), and VIDE (vincristine, ifosfamide, doxorubicin, and etoposide) are recommended by NCCN in the first line and as primary therapy for metastatic disease at initial presentation. For second-line treatment Cyclophosphamide and topotecan, Irinotecan + temozolomide +- NCCN recommends Vincristine, Ifosfamide, carboplatin, etoposide, and Lurbinectedin.

Ewing Sarcoma Epidemiology

As the market is derived using a patient-based model, the Ewing Sarcoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total Ewing Sarcoma Incidence Cases, gender-specific cases of Ewing Sarcoma, age-specific cases of Ewing Sarcoma, and stage-specific cases of Ewing Sarcoma in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. The total incident cases of Ewing sarcoma in the 7MM comprised approximately 1,200 cases in 2023 and are projected to increase during the forecasted period.

  • In the 7MM, the highest Ewing Sarcoma Incidence Cases were seen in the United States, accounting of ~41% of the total cases.
  • In the EU4, Germany accounted for the highest Ewing sarcoma cases accounting of ~15% of the total cases, , whereas Italy accounted for the lowest.
  • In the US, among all the age groups, 10-14 years accounted for the highest number of Ewing sarcoma cases i.e., around 30%, followed by the age-group 15-19 years (26%), in 2023.
  • As per the analysis, males are more likely to get Ewing Sarcoma than females. In the US, in 2023, ~300 incident cases of male Ewing Sarcoma were estimated.

Ewing Sarcoma Recent Developments

  • On November 12, 2024, Actuate Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to elraglusib, a novel glycogen synthase kinase-3 beta (GSK-3B) inhibitor, for the treatment of Ewing sarcoma (EWS).
  • On November 12, 2024, the FDA granted rare pediatric disease designation to elraglusib (9-ING-41), a novel GSK-3B inhibitor, as a potential treatment for patients with Ewing sarcoma.

Ewing Sarcoma Treatment Drugs Market Chapters

The drug chapter segment of the Ewing Sarcoma treatment drugs market report encloses a detailed analysis of the late-stage (Phase II) and Early stage (Phase I/II) Ewing Sarcoma pipeline drug analysis such Seclidemstat (SP-2577), lurbinectedin, Mecbotamab Vedotin (BA3011), and others. There are currently no approved Ewing Sarcoma therapies. It also helps understand the Ewing Sarcoma clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest Ewing Sarcoma news and press releases.

Ewing Sarcoma Emerging Drugs Profile

  • Seclidemstat: Salarius Pharmaceuticals

Seclidemstat (SP-2577) inhibits LSD1's enzymatic activity and its scaffolding function. SP-2577 is being studied in an ongoing Phase I/II trial in Ewing sarcoma. Salarius is studying the combination of SP-2577 with topotecan and cyclophosphamide (TC), two agents are commonly given as second or third-line therapy, to improve patient outcomes over TC alone.

    • In October 2022, the company voluntarily paused new patient enrollment in its Phase I/II trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas per protocol design. The pause in new patient enrollment was due to a metastatic FET-rearranged sarcoma patient death classified as a suspected unexpected serious adverse reaction (SUSAR).
    • Later, in May 2023, the company was notified by FDA that they had completed the review of the company's submission and had concluded that the Ewing Sarcoma clinical trial may be resumed.
  • ZEPZELCA (Lurbinectedin): Jazz Pharmaceuticals and PharmaMar

Lurbinectedin (PM1183) is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent.

    • In December 2019, PharmaMar and Jazz Pharmaceuticals announced that PharmaMar and Jazz Pharmaceuticals had entered into an exclusive license agreement for lurbinectedin in the United States.
    • In the updated version 2.2023 of the NCCN guidelines lurbinectedin has been added as a second-line therapy option for Ewing sarcoma (for R/R or metastatic disease). Under category 2B, this is useful in certain circumstances recommendation.

Ewing Sarcoma Treatment Drugs Market Insights

CDK inhibitors: Proteins involved in RNA transcription, processing, and translation, such as CDK9, CDK12, and CDK13, have shown preclinical promise either alone or in combination with oncoprotein or growth factor targeting, with ongoing trials. Furthermore, CDK4 and CDK6, cell cycle proteins with different functions, have been identified as potential targets unrelated to the fusion oncoprotein in several screens. Trials testing CDK4 and CDK6 inhibitors combined with relapsed Ewing sarcoma Chemotherapy regimens are underway.

The upcoming Ewing Sarcoma Treatment Market Landscape is poised to expand further after new classes, such as tetravalent death receptor 5 (DR5) agonist antibodies, CDK inhibitors, LSD1 inhibitors, AXL inhibitors, and others. Designed to overcome the limitations of earlier-generation agonists and exploit the tumor-specific cell death induced by DR5 activation. DR5 is one of two pro-apoptotic receptors for the trimeric tumor necrosis factor-related apoptosis-inducing ligand (TRAIL).

Ewing Sarcoma Market Outlook

While advancements in the Ewing Sarcoma treatment, such as chemotherapy and surgical procedures along with radiation therapy, have resulted in better survival rates for some patients, progress has been stagnant for others. The management of high-risk Ewing Sarcoma and other related sarcomas remains controversial, primarily due to an incomplete understanding of their high-risk biological characteristics and relatively low occurrence. These factors have made it challenging to conduct comprehensive clinical trials for the smaller populations of high-risk Ewing Sarcoma patients and the rarer subtypes of sarcomas.

Although there is no standardized second-line treatment for refractory or relapsed Ewing sarcoma, several retrospective studies have reported on conventional salvage treatments. Common salvage regimens involve topotecan, cyclophosphamide, irinotecan, temozolomide, or high-dose chemotherapy (HDC) followed by reinfusion of hematopoietic stem cells. The use of HDC combined with autologous stem cell transplantation (auto-SCT) has been an area of active interest, investigation, and debate for many years. Multiple retrospective and single-arm studies, despite variations in initial conditioning therapy, have shown promising outcomes in patients with high-risk and refractory Ewing Sarcoma. Other potential strategies to target the oncoprotein in Ewing sarcoma include RNA interference, protein degraders, and immunotherapy directed at the novel epitope. Chemotherapy, radiation, surgery, and others are the current Ewing Sarcoma treatment options.

The expected launch of upcoming therapy and greater integration of early patient screening, Ewing Sarcoma medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. The significant lack of effective treatment options for Ewing sarcoma underscores the urgent need for advancements in addressing this disease. However, since Ewing Sarcoma is an orphan disease, it is difficult to conduct clinical trials, hence, efforts to increase the number of studies on this orphan disease are urgently needed.

  • The Ewing Sarcoma Treatment Market Size in the 7MM is approximately USD 30 million in 2023 and is projected to increase during the forecast period (2024-2034).
  • Among EU4 countries, Germany accounts for the maximum Ewing Sarcoma market size i.e. ~25% of the total EU4 and the UK market share.
  • Seclidemstat + TC is expected to capture the highest Ewing Sarcoma market share among emerging therapies in the 2L+ setting by 2034.
  • The introduction of novel treatment options, including targeted therapies, immunotherapies, and combination regimens, will expand the treatment landscape for Ewing sarcoma to improve survival rates and reduce the side effects associated with traditional treatments like chemotherapy and radiation therapy.

Ewing Sarcoma Drugs Uptake

This section focuses on the uptake rate of potential Ewing Sarcoma drugs expected to be launched in the market during 2020-2034. Salarius Pharmaceuticals is currently working on the development of Seclidemstat as a potential Ewing Sarcoma treatment. This drug is anticipated to be well-received with fast uptake, with a projected probability-adjusted peak share of ~42% in the United States for patients in the second line of treatment and beyond.

Ewing Sarcoma Pipeline Development Activities

The Ewing Sarcoma pipeline segement provides insights into therapeutic candidates in Phase II and Phase I stage. It also analyzes key Ewing Sarcoma Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Ewing Sarcoma pipeline segment covers information on collaborations, acquisitions and mergers, licensing, and patent details for Ewing Sarcoma's emerging therapy.

KOL Views

To keep up with current Ewing Sarcoma Pipeline Drugs Market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on evolving Ewing Sarcoma treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists; Orthopedists, and Professors; MD, FACS, Chair of the Department of Orthopedic Surgery, and professor at UC Davis Comprehensive Cancer Center in Sacramento, California; MD, Director, Sarcoma Oncology Center, California; and others.

Delveinsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Sarcoma Oncology Center, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Ewing Sarcoma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and Ewing Sarcoma Therapeutics Market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, 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. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving Ewing Sarcoma treatment landscape.

The analyst views analyze multiple 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; for instance, in Ewing Sarcoma trials, progression-free survival is one of the most important primary outcome measures. Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Ewing Sarcoma Therapeutics Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently. Overall, treatment for bone and joint cancers can easily exceed USD 100,000 for a single patient. This is particularly true if a patient receives surgery, chemotherapy, and radiation therapy. The cost will be much higher if one includes bone-replacing endoprostheses or artificial limbs used in cases requiring amputation.

The Ewing Sarcoma Clinical Trials Market Report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Ewing Sarcoma Therapeutics Market Report Scope

  • The Ewing Sarcoma Therapeutics Market Report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight into the Ewing Sarcoma epidemiology segments and forecasts, disease progression, and Ewing Sarcoma treatment guidelines has been provided.
  • Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current Ewing Sarcoma Treatment Market Landscape.
  • A detailed review of the Ewing Sarcoma Pipeline Drugs Market, historical and forecasted Ewing Sarcoma market size, Ewing Sarcoma market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The patient-based Ewing Sarcoma Market Forecasting 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 shape and drive the 7MM Ewing Sarcoma Therapeutics Market.

Ewing Sarcoma Therapeutics Market Report Insights

  • Patient-based Ewing Sarcoma Market Forecasting
  • Therapeutic Approaches
  • Ewing Sarcoma Pipeline Drugs Analysis
  • Ewing Sarcoma Market Size
  • Ewring Sarcoma Market Trends
  • Existing and Future Ewing Sarcoma Pipeline Drugs Market Opportunity

Ewing Sarcoma Therapeutics Market Report Key Strengths

  • 11 Years Ewing Sarcoma Market Forecast
  • The 7MM Coverage
  • Ewing Sarcoma Epidemiology Segmentation
  • Key Cross Competition
  • Ewring Sarcoma Pipeline Drugs Uptake
  • Key Ewing Sarcoma Market Forecast Assumptions

Ewing Sarcoma Treatment Market Report Assessment

  • Current Ewing Sarcoma Treatment Market Practices
  • Ewing Sarcoma Unmet Needs
  • Ewing Sarcoma Pipeline Drugs Analysis Profiles
  • Ewing Sarcoma Drugs Market Attractiveness
  • Qualitative Analysis (SWOT and Analyst Views)

Key Questions:

Ewing Sarcoma Treatment Market Insights

  • What was the Ewing Sarcoma market size, the market size by therapies, Ewing Sarcoma market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
  • What will be the impact of Seclidemstat's expected approval by 2025?
  • How would CDK inhibitors perform as a class in the second line?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Ewing Sarcoma Epidemiology Insights

  • What are the disease risk, burdens, and Ewing Sarcoma unmet needs? What will be the growth opportunities across the 7MM concerning the patient population with Ewing Sarcoma?
  • What is the historical and forecasted Ewing Sarcoma patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
  • Which gender has a higher Ewing Sarcoma Incidence?
  • How many Ewing Sarcoma patients are diagnosed with localized or metastatic disease?
  • Which age group of Ewing Sarcoma has a high patient share?

Current Ewing Sarcoma Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

  • What are the current options for the Ewing Sarcoma treatment? What are the current guidelines for treating Ewing Sarcoma in the US and Europe?
  • How many companies are developing therapies for the Ewing Sarcoma treatment?
  • How many emerging therapies are in the mid-stage and late stage of development for treating Ewing Sarcoma?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
  • What key designations have been granted for the emerging therapies for Ewing Sarcoma?
  • What is the cost burden of current therapies on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, current therapies? Focusing on the reimbursement policies.
  • What is the 7MM historical and forecasted Ewing Sarcoma Drugs Market?

Reasons to Buy:

  • The Ewing Sarcoma market outlook report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Ewing Sarcoma Pipeline Drugs Market.
  • Insights on patient burden/disease Ewing Sarcoma Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing Ewing Sarcoma Pipeline Drugs Market opportunity in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the Ewing Sarcoma Pipeline Drugs 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 Analyst view section to provide visibility around leading classes.
  • Highlights of Access and Reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet need of the existing Ewing Sarcoma Clinical Trials Market so that the upcoming Ewing Sarcoma companies can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2 Report Introduction

3 Executive Summary of Ewing Sarcoma

4 Key Events

5 Epidemiology and Market Forecast Methodology

6 Ewing Sarcoma Market Overview at a Glance

  • 6.1 Market Share (%) Distribution by Therapies in 2023
  • 6.2 Market Share (%) Distribution by Therapies in 2034

7 Disease Background and overview

  • 7.1 Introduction
  • 7.2 Causes
  • 7.3 Signs and Symptoms
  • 7.4 Staging
    • 7.4.1 The TNM System
  • 7.5 Risk Factors
  • 7.6 Pathological Diagnosis
  • 7.7 Diagnostic Tests
    • 7.7.1 Imaging Tests
    • 7.7.2 Surgical Tests
    • 7.7.3 Other Laboratory Tests

8 Treatment Management of Ewing Sarcoma

  • 8.1 Treatment Algorithm

9 Treatment Guidelines for Ewing Sarcoma

  • 9.1 NCCN Guidelines: 2023
  • 9.2 Ewing Sarcoma: ESMO-PAEDCAN-EURACAN Clinical Practice Guidelines for Diagnosis, Treatment, and follow-up
  • 9.3 Japan Guideline

10 Epidemiology and Patient Population

  • 10.1 Key findings
  • 10.2 Assumptions and Rationale
  • 10.3 Total Incident Cases of Ewing Sarcoma in the 7MM
  • 10.4 The United States
    • 10.4.1 Total Incident Cases of Ewing Sarcoma in the United States
    • 10.4.2 Age-specific Cases of Ewing Sarcoma in the United States
    • 10.4.3 Gender-specific Cases of Ewing Sarcoma in the United States
    • 10.4.4 Stage-specific Cases of Ewing Sarcoma in the United States
  • 10.5 EU4 and the UK
    • 10.5.1 Total Incident Cases of Ewing Sarcoma in EU4 and the UK
    • 10.5.2 Age-specific Cases of Ewing Sarcoma in EU4 and the UK
    • 10.5.3 Gender-specific Cases of Ewing Sarcoma in EU4 and the UK
    • 10.5.4 Stage-specific Cases of Ewing Sarcoma in EU4 and the UK
  • 10.6 Japan
    • 10.6.1 Total Incident Cases of Ewing Sarcoma in Japan
    • 10.6.2 Age-specific Cases of Ewing Sarcoma in Japan
    • 10.6.3 Gender-specific Cases of Ewing Sarcoma in Japan
    • 10.6.4 Stage-specific Cases of Ewing Sarcoma in Japan

11 Patient Journey

12 Key Endpoints in Ewing Sarcoma

13 Emerging Drugs

  • 13.1 Key Competitors
  • 13.2 Seclidemstat (SP-2577): Salarius Pharmaceuticals
    • 13.2.1 Product Description
    • 13.2.2 Other Development Activities
    • 13.2.3 Clinical Development
      • 13.2.3.1 Clinical Trials Information
    • 13.2.4 Safety and Efficacy
  • 13.3 Zepzelca (Lurbinectedin): Jazz Pharmaceuticals and PharmaMar
    • 13.3.1 Product Description
    • 13.3.2 Other Development Activities
    • 13.3.3 Clinical Development
      • 13.3.3.1 Clinical Trials Information
    • 13.3.4 Safety and Efficacy
  • 13.4 VERZENIO (abemaciclib): Eli Lilly
    • 13.4.1 Product Description
    • 13.4.2 Clinical Development
      • 13.4.2.1 Clinical Trials Information
  • 13.5 IBRANCE (palbociclib): Pfizer
    • 13.5.1 Product Description
    • 13.5.2 Clinical Development
      • 13.5.2.1 Clinical Trials Information
  • 13.6 Mecbotamab Vedotin (BA3011): BioAtla
    • 13.6.1 Product Description
    • 13.6.2 Other Development Activities
    • 13.6.3 Clinical Development
      • 13.6.3.1 Clinical Trials Information
  • 13.7 Iopofosine I 131 (CLR 131): Cellectar Biosciences
    • 13.7.1 Product Description
    • 13.7.2 Other Development Activities
    • 13.7.3 Clinical Development
      • 13.7.3.1 Clinical Trials Information
  • 13.8 TP-1287: Sumitomo Pharma Oncology
    • 13.8.1 Product Description
    • 13.8.2 Other Development Activities
    • 13.8.3 Clinical Development
      • 13.8.3.1. Clinical Trials Information
  • 13.9 INBRX-109: Inhibrx
    • 13.9.1 Product Description
    • 13.9.2 Clinical Development
      • 13.9.2.1 Clinical Trials Information

14 Ewing Sarcoma: The 7MM Analysis

  • 14.1 Key Findings
  • 14.2 Market Outlook
  • 14.3 Key Market Forecast Assumptions
  • 14.4 Conjoint Analysis
  • 14.5 Total Market Size of Ewing Sarcoma in the 7MM
  • 14.6 Market Size of Ewing Sarcoma by Therapies in the 7MM
  • 14.7 United States Market Size
    • 14.7.1 Total Market Size of Ewing Sarcoma in the United States
    • 14.7.2 Market Size of Ewing Sarcoma by First-line Therapies in the United States
    • 14.7.3 Market Size of Ewing Sarcoma by Second-line and Above Therapies in the United States
  • 14.8 EU4 and the UK Market Size
    • 14.8.1 Total Market Size of Ewing Sarcoma in EU4 and the UK
    • 14.8.2 Market Size of Ewing Sarcoma by First-line Therapies in EU4 and the UK
    • 14.8.3 Market Size of Ewing Sarcoma by Second-line and Above Therapies in EU4 and the UK
  • 14.9 Japan Market Size
    • 14.9.1 Total Market Size of Ewing Sarcoma in Japan
    • 14.9.2 Market Size of Ewing Sarcoma by First-line Therapies in Japan
    • 14.9.3 Market Size of Ewing Sarcoma by Second-line and Above Therapies in Japan

15 Unmet Needs

16 SWOT Analysis

17 KOL Views

18 Market Access and Reimbursement

  • 18.1 The United States
    • 18.1.1 Centre for Medicare & Medicaid Services (CMS)
  • 18.2 EU4 and the UK
    • 18.2.1 Germany
    • 18.2.2 France
    • 18.2.3 Italy
    • 18.2.4 Spain
    • 18.2.5 United Kingdom
  • 18.3 Japan
    • 18.3.1 MHLW
  • 18.4 Economic Burden of Malignant Bone Tumors and Sarcomas

19 Appendix

  • 19.1 Bibliography
  • 19.2 Report Methodology

20 Delveinsight Capabilities

21 Disclaimer

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