NurOwn Sales Forecast, and Market Size Analysis - 2034
상품코드:1909222
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
NurOwn의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 수 증가
NurOwn은 혁신적인 자가유래 세포치료 접근법과 광범위한 임상시험 노출을 통해 ALS 커뮤니티 내에서 강력한 인지도와 참여도를 창출하고 있습니다.
상업적 출시는 아직 시작되지 않았지만, 환자 수요와 임상시험 참여는 꾸준히 증가하고 있으며, 이는 높은 미충족 수요와 혁신적 치료법에 대한 열망을 반영하고 있습니다.
특히 신경근육질환 전문가와 임상연구 및 확대 접근 프로그램 논의에 관여하는 학술 ALS 센터에서 의사들의 인지도가 높아지고 있습니다.
2. 중요한 적응증으로 확대
근위축성측색경화증(ALS) : 가장 많이 진행된 첫 번째 적응증으로, 특정 환자군에서 잠재적 효능을 시사하는 임상 데이터가 확보된 상태다.
진행성 신경퇴행성 질환: 작용기전(신경영양인자 분비 및 신경염증 조절)은 다른 신경퇴행성 질환에서의 연구 가능성을 지지하고 있습니다.
바이오마커 유도 하위집단 전략: 사후 분석 결과, 염증성 바이오마커 수치가 증가한 환자군에서의 유효성 징후가 확인되어 향후 개발의 초점이 되고 있습니다.
파이프라인의 진화는 광범위한 적응증 확대보다는 환자 선택의 정교화에 초점을 맞출 것으로 예측됩니다.
3. 지역적 확장
임상 개발은 강력한 ALS 임상 네트워크와 규제 당국과의 협력을 통해 미국을 중심으로 진행되어 왔습니다.
유럽과 일부 세계 ALS 연구 거점에서는 지원 단체와 연구자 주도의 공동연구를 계기로 국제적인 관심이 집중되고 있습니다.
향후 지역적 확장은 전통적 상업적 확장보다는 규제 당국의 승인 상황, 자금 조달, 전략적 파트너십에 따라 달라질 것으로 보입니다.
4. 신규 적응증 및 규제 경로 진행
NurOwn은 자문위원회 심사 및 대체 승인 경로에 대한 논의를 포함하여 미국 FDA와 광범위한 규제 당국과의 대화를 진행했습니다.
광범위한 승인은 얻지 못했으나, 규제 당국은 ALS에서 바이오마커에 기반한 증거와 하위 그룹에 기반한 증거에 대해 긍정적인 태도를 보이고 있습니다.
향후 규제 전략은 명확하게 정의된 반응자 집단에 초점을 맞출 것으로 예상되며, 가속 승인이나 조건부 승인과 같은 프레임워크를 활용할 가능성이 있습니다.
5. 강력한 ALS 개발 모멘텀
ALS는 여전히 우선순위가 높고 미충족 수요가 큰 치료 분야이며, 질병을 조절할 수 있는 치료 옵션은 제한적입니다.
NurOwn은 지속적인 평가를 적극적으로 지원하는 환자단체 등 강력한 옹호활동이 불러일으키는 모멘텀의 혜택을 계속 누리고 있습니다.
NurOwn의 임상 결과를 맥락적으로 이해하기 위해 실제 질병 레지스트리와 장기 추적 데이터세트의 중요성이 커지고 있습니다.
6. 경쟁 우위 및 시장 동향
자가유래 간엽줄기세포 치료는 항센스 올리고뉴클레오티드, 유전자치료, 저분자 화합물과는 다른 접근법입니다.
신경염증과 신경보호를 동시에 표적화하여 여러 ALS 질환 경로에 대응합니다.
맞춤형 의료, 바이오마커에 기반한 치료법 선택, 비전통적 규제 엔드포인트로 향하는 광범위한 시장 동향은 NurOwn의 개발 전략과 일치합니다.
환자 보고 결과와 리얼월드 증거에 대한 관심이 높아짐에 따라 규제상의 어려움은 있지만 지속적인 관심이 유지되고 있습니다.
NurOwn의 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대해 조사 분석했으며, 각국 시장 규모와 예측, 연구개발(R&D) 활동, 경쟁 구도 등의 정보를 전해드립니다.
목차
제1장 리포트 개요
제2장 알츠하이머병, 근위축성측색경화증, 다발성 경화증 등의 잠재적 적응증에서 NurOwn의 개요
제품 상세
NurOwn 임상 개발
NurOwn 임상 연구
NurOwn 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 개요
제3장 NurOwn의 경쟁 상황(출시 치료법)
제4장 경쟁 구도(후기 단계 새로운 NurOwn 요법)
제5장 NurOwn 시장 평가
잠재적 적응증에서 NurOwn 시장의 전망
주요 7 시장 분석
주요 7 시장의 잠재적 적응증용 NurOwn 시장 규모
각국의 시장 분석
미국의 잠재적 적응증용 NurOwn 시장 규모
독일의 잠재적 적응증용 NurOwn 시장 규모
영국의 잠재적 적응증용 NurOwn 시장 규모
제6장 NurOwn SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 리포트 구입 옵션
KSA
영문 목차
영문목차
Key Factors Driving NurOwn Growth
1. Market Share Gains and New Patient Starts
NurOwn has generated strong awareness and engagement within the ALS community, driven by its novel autologous cell therapy approach and extensive clinical trial exposure.
While not commercially launched, patient demand and trial participation have remained robust, reflecting high unmet need and willingness to pursue innovative therapies.
Physician familiarity has increased, particularly among neuromuscular specialists and academic ALS centers involved in clinical studies and expanded-access discussions.
2. Expansion Across Key Indications
Amyotrophic Lateral Sclerosis (ALS): Primary and most advanced indication, with clinical data suggesting potential benefit in specific patient subgroups.
Progressive Neurodegenerative Disorders: The mechanism of action-neurotrophic factor secretion and neuroinflammation modulation-supports exploratory potential in other neurodegenerative diseases.
Biomarker-Guided Subpopulation Strategy: Post-hoc analyses have highlighted signals in patients with elevated inflammatory biomarkers, informing future development focus.
Pipeline evolution is expected to emphasize refined patient selection rather than broad label expansion.
3. Geographic Expansion
Clinical development has been centered in the United States, supported by a strong ALS trial network and regulatory engagement.
International interest has emerged from Europe and select global ALS research hubs, driven by advocacy groups and investigator-led collaborations.
Future geographic expansion would depend on regulatory outcomes, funding, and strategic partnerships, rather than traditional commercial rollout.
4. New Indication and Regulatory Pathway Progress
NurOwn has undergone extensive regulatory interaction with the U.S. FDA, including advisory committee review and discussions around alternative approval pathways.
While broad approval has not been granted, regulators have shown openness to biomarker-supported and subgroup-based evidence in ALS.
Any future regulatory strategy is expected to focus on well-defined responder populations, potentially leveraging accelerated or conditional frameworks.
5. Strong ALS Development Momentum
ALS remains a high-priority, high-unmet-need therapeutic area, with limited disease-modifying options available.
NurOwn continues to benefit from strong advocacy-driven momentum, including patient organizations actively supporting continued evaluation.
Real-world disease registries and long-term follow-up datasets are increasingly important to contextualize NurOwn's clinical findings.
6. Competitive Differentiation and Market Trends
Autologous mesenchymal stem cell-derived therapy differentiates NurOwn from antisense oligonucleotides, gene therapies, and small molecules.
Targets neuroinflammation and neuroprotection simultaneously, addressing multiple ALS disease pathways.
Broader market trends toward personalized medicine, biomarker-driven treatment selection, and non-traditional regulatory endpoints align with NurOwn's development strategy.
Growing emphasis on patient-reported outcomes and real-world evidence supports continued interest despite regulatory challenges.
NurOwn Recent Developments
With USFDA clearance secured, the Company is advancing key pre-initiation activities for the Phase IIIb clinical trial of NurOwn. The upcoming Phase IIIb ENDURANCE study, is expected to enroll approximately 200 participants at leading ALS centers. The trial will include a 24-week, randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B) to further assess long-term safety and durability of effect. The primary efficacy measure will be change from baseline to Week 24 on the ALSFRS-R. Data from Part A is expected to support a Biologics License Application (BLA).
A Citizen Petition was filed with the FDA by representatives of the ALS community. The petition requests a renewed regulatory review of the data supporting NurOwn. BrainStorm acknowledges the petition as a constructive development that underscores the continued interest in NurOwn's potential therapeutic value. The Company did not participate in the drafting or submission of this petition.
"NurOwn Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of NurOwn for potential indication like Alzheimer's disease; Amyotrophic lateral sclerosis; Multiple sclerosis in the 7MM. A detailed picture of NurOwn's existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the NurOwn for potential indications. The NurOwn market report provides insights about NurOwn's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current NurOwn performance, future market assessments inclusive of the NurOwn market forecast analysis for potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of NurOwn sales forecasts, along with factors driving its market.
NurOwn Drug Summary
NurOwn is an autologous cell therapy developed by BrainStorm Cell Therapeutics for amyotrophic lateral sclerosis (ALS), involving mesenchymal stem cells (MSCs) harvested from a patient's bone marrow, expanded ex vivo, and induced to secrete neurotrophic factors (MSC-NTF cells). These cells are administered via combined intrathecal and intramuscular injections to provide neuroprotection through factors like GDNF, BDNF, VEGF, HGF, and LIF, while modulating neuroinflammation via reduced MCP-1 and SDF-1, aiming to slow motor neuron degeneration and functional decline. Despite mixed Phase III results in 2022 (missing primary endpoint but positive in early-stage subgroups), it received FDA RMAT designation and is under evaluation in an ongoing Phase IIIb trial (NCT06973629) for early symptomatic ALS with moderate progression, dosed every 8 weeks. The report provides NurOwn's sales, growth barriers and drivers, post usage and approvals in multiple indications.
Scope of the NurOwn Market Report
The report provides insights into:
A comprehensive product overview including the NurOwn MoA, description, dosage and administration, research and development activities in potential indication like Alzheimer's disease; Amyotrophic lateral sclerosis; Multiple sclerosis.
Elaborated details on NurOwn regulatory milestones and other development activities have been provided in NurOwn market report.
The report also highlights NurOwn's cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
The NurOwn market report also covers the patents information, generic entry and impact on cost cut.
The NurOwn market report contains current and forecasted NurOwn sales for potential indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The NurOwn market report also features the SWOT analysis with analyst views for NurOwn in potential indications.
Methodology:
The NurOwn market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.
NurOwn Analytical Perspective by DelveInsight
In-depth NurOwn Market Assessment
This NurOwn sales market forecast report provides a detailed market assessment of NurOwn for potential indication like Alzheimer's disease; Amyotrophic lateral sclerosis; Multiple sclerosis in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted NurOwn sales data uptil 2034.
NurOwn Clinical Assessment
The NurOwn market report provides the clinical trials information of NurOwn for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.
NurOwn Competitive Landscape
The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.
NurOwn Market Potential & Revenue Forecast
Projected market size for the NurOwn and its key indications
Commercial partnerships, licensing deals, and M&A activity
NurOwn Clinical Differentiation
NurOwn Efficacy & safety advantages over existing drugs
NurOwn Unique selling points
NurOwn Market Report Highlights
In the coming years, the NurOwn market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
The NurOwn companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence NurOwn's dominance.
Other emerging products for Alzheimer's disease; Amyotrophic lateral sclerosis; Multiple sclerosis are expected to give tough market competition to NurOwn and launch of late-stage emerging therapies in the near future will significantly impact the market.
A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of NurOwn in potential indications.
Analyse NurOwn cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted NurOwn sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of NurOwn in potential indications.
Key Questions:
What is the class of therapy, route of administration and mechanism of action of NurOwn? How strong is NurOwn's clinical and commercial performance?
What is NurOwn's clinical trial status in each individual indications such as Alzheimer's disease; Amyotrophic lateral sclerosis; Multiple sclerosis and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the NurOwn Manufacturers?
What are the key designations that have been granted to NurOwn for potential indications? How are they going to impact NurOwn's penetration in various geographies?
What is the current and forecasted NurOwn market scenario for potential indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of NurOwn in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
What are the other emerging products available and how are these giving competition to NurOwn for potential indications?
Which are the late-stage emerging therapies under development for the treatment of potential indications?
How cost-effective is NurOwn? What is the duration of therapy and what are the geographical variations in cost per patient?
Table of Contents
1. Report Introduction
2. NurOwn Overview in potential indication like Alzheimer's disease; Amyotrophic lateral sclerosis; Multiple sclerosis
