Aficamten Sales Forecast, and Market Size Analysis - 2034
상품코드:1909219
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
아피캄텐(Aficamten)의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 수 증가
Cytokinetics가 개발한 차세대 선택적 심근 미오신 억제제인 아피캄텐은 비대성 심근증(HCM) 영역, 특히 폐쇄성 심근증(oHCM)에서 강력한 추진력을 얻고 있습니다.
예측 가능한 약동학 및 신속하고 가역적인 심장 작용으로 1세대 약물에 비해 용량 조절이 단순화될 가능성이 있으며, 의사들의 관심이 높아지고 있습니다.
규제 당국의 승인 가능성과 심장 전문의들 사이에서 인지도가 높아짐에 따라 특히 베타 차단제나 칼슘채널차단제로 잘 조절되지 않는 증상이 있는 심근경색증 환자에서 신규 환자 증가가 가속화될 것으로 예측됩니다.
2. 중요한 적응증으로 확대
폐쇄성 비대성 심근증(oHCM) : 아피캄텐은 운동능력, 좌심실 유출로(LVOT) 압력 차이, 증상에서 유의미한 개선을 보인 강력한 임상 3상 유효성 데이터를 통해 증상이 있는 oHCM에 대한 잠재적 동급 최강의 치료제로 자리매김하고 있습니다.
초기 치료 단계에서의 사용 가능성: 우수한 안전성과 가역성 프로파일로 인해 치료 패러다임에서 더 이른 시기, 특히 중격 축소 치료 전 단계에서의 사용을 지지할 수 있습니다.
비폐색성 비대성 심근증(nHCM) : 이 분야는 임상적 성과를 달성하는 데 어려움이 있지만, 지속적인 지식의 축적이 향후 개발 전략에 도움이 될 수 있습니다.
파이프라인 옵션: 비폐색성 비대성 심근증(oHCM)에서의 성공은 향후 더 광범위한 심근증 및 심부전 환자군으로 수명주기를 확장할 수 있는 가능성을 가지고 있습니다.
3. 지역적 확장
유럽과 미국에 초기 집중: 상업적 전략은 HCM 진단 인프라와 전문 의료 센터가 잘 구축된 주요 심장병 시장을 중심으로 전개될 것입니다.
세계 진출 가능성: 초기 승인 후 일본, 중국 등에서의 HCM에 대한 인지도 향상과 진단이 진행됨에 따라 아시아태평양 시장으로의 확대가 예상됩니다.
전문의 주도의 도입: HCM의 우수 진료센터, 순환기 전문의, 통합 심부전 클리닉을 통해 채용이 추진됩니다.
4. 신규 적응증 승인
oHCM 규제 신청: 임상 3상 시험의 양호한 데이터를 바탕으로 증상성 폐색성 HCM에 대한 규제 신청이 지원됩니다. 이는 Cytokinetics의 중요한 이정표가 될 것입니다.
적응증 확대 가능성: 추가 연구 및 시판 후 데이터를 통해 질환의 중증도 및 치료 라인과 관련된 적응증 확대가 가능할 것으로 예측됩니다.
포트폴리오 다각화 : 이번 승인으로 사이토키네틱스의 심혈관계 영역의 프랜차이즈 권한이 크게 강화되고, 개발 단계의 자산을 넘어선 매출 다각화가 가능해졌습니다.
5. oHCM 환자 수의 강력한 모멘텀
높은 미충족 수요: 폐쇄성 비후성 심근증은 여전히 치료가 제대로 이루어지지 않고 있으며, 표준 치료에도 불구하고 증상이 남아있는 환자들이 많이 존재합니다.
설득력 있는 임상적 이점: 피크 산소 소비량(pVO2), NYHA 분류, 삶의 질(QOL) 지표의 개선이 지속적인 처방 모멘텀을 이끌 것으로 예측됩니다.
장기적 채택 가능성: 아피캄텐은 인지도가 높아지고 실제 임상 경험이 축적됨에 따라 oHCM 관리의 핵심 경구용 치료제가 될 수 있습니다.
6. 경쟁 우위 및 시장 동향
차세대 심근 미오신 억제제: 아피캄텐은 반감기가 짧고, 온/오프 조절이 정밀하여 동급 기존 약물과 차별화됩니다.
투여 및 모니터링 간소화: 수축기 기능 장애의 장기화 위험 감소로 모니터링 부하를 줄여 의사와 환자의 신뢰도를 높일 수 있습니다.
질환 특이적 치료로의 전환: 비특이적 증상 관리보다 표적화된 작용기전에 기반한 순환기계 약물을 선호하는 시장 동향이 확산되고 있습니다.
리얼월드 데이터(RWE)의 역할 확대: 승인 후 리얼월드 데이터는 보험 적용 범위, 치료 알고리즘, 장기적인 채택을 형성하는 데 있으며, 매우 중요합니다.
세계 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)의 아피캄텐 시장을 조사 분석했으며, 각국 시장 규모와 예측, 연구개발(R&D) 활동, 경쟁 구도 등의 정보를 전해드립니다.
목차
제1장 리포트 개요
제2장 비대형 심근증 등의 승인된 적응증에서 아피캄텐의 개요
제품 상세
아피캄텐 임상 개발
아피캄텐 임상 연구
아피캄텐 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 개요
제3장 아피캄텐의 경쟁 상황(출시 치료법)
제4장 경쟁 구도(후기 단계 새로운 아피캄텐 요법)
제5장 아피캄텐 시장 평가
승인된 적응증에서 아피캄텐 시장의 전망
주요 7 시장 분석
주요 7 시장의 승인된 적응증용 아피캄텐 시장 규모
각국의 시장 분석
미국의 승인된 적응증용 아피캄텐 시장 규모
독일의 승인된 적응증용 아피캄텐 시장 규모
영국의 승인된 적응증용 아피캄텐 시장 규모
제6장 아피캄텐 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 Aficamten Growth
1. Market Share Gains and New Patient Starts
Aficamten, a next-generation selective cardiac myosin inhibitor developed by Cytokinetics, is gaining strong traction in the hypertrophic cardiomyopathy (HCM) space, particularly in obstructive HCM (oHCM).
Increasing physician interest is being driven by its predictable pharmacokinetics and rapid, reversible cardiac effects, which may simplify dose titration compared with first-generation agents.
Anticipated regulatory approval and growing awareness among cardiologists are expected to translate into accelerated new patient starts, especially among symptomatic oHCM patients inadequately controlled on beta-blockers or calcium channel blockers.
2. Expansion Across Key Indications
Obstructive Hypertrophic Cardiomyopathy (oHCM): Aficamten is positioned as a potentially best-in-class therapy for symptomatic oHCM, supported by strong Phase III efficacy data demonstrating meaningful improvements in exercise capacity, LVOT gradients, and symptoms.
Earlier-Line Use Potential: Favorable safety and reversibility profile may support use earlier in the treatment paradigm, potentially before septal reduction therapy.
Non-Obstructive HCM (nHCM): Although clinical outcomes have been more challenging in this segment, continued learnings may inform future development strategies.
Pipeline Optionality: Success in oHCM may enable lifecycle expansion into broader cardiomyopathy or heart failure populations over time.
3. Geographic Expansion
Initial Focus on the U.S. and Europe: Commercial strategy is centered on major cardiology markets with established HCM diagnosis infrastructure and specialist centers.
Global Expansion Potential: Following initial approvals, expansion into Asia-Pacific markets is expected, supported by increasing recognition and diagnosis of HCM in countries such as Japan and China.
Specialty-Driven Uptake: Adoption will be driven through HCM centers of excellence, cardiology specialists, and integrated heart failure clinics.
4. New Indication Approvals
Regulatory Filings for oHCM: Positive Phase III data support regulatory submissions for symptomatic obstructive HCM, which would mark a significant milestone for Cytokinetics.
Label Expansion Opportunities: Additional studies and post-marketing data could support expanded labeling related to disease severity or treatment lines.
Portfolio Diversification: Approval would significantly strengthen Cytokinetics' cardiovascular franchise and diversify revenue beyond development-stage assets.
5. Strong oHCM Volume Momentum
High Unmet Need: Obstructive HCM remains underserved, with many patients remaining symptomatic despite standard therapies.
Compelling Clinical Benefits: Improvements in peak oxygen consumption (pVO2), NYHA class, and quality-of-life measures are expected to drive sustained prescription momentum.
Long-Term Adoption Potential: As familiarity increases and real-world experience accumulates, aficamten could become a cornerstone oral therapy in oHCM management.
6. Competitive Differentiation and Market Trends
Next-Generation Cardiac Myosin Inhibitor: Aficamten offers shorter half-life and precise on/off control, differentiating it from earlier agents in the class.
Simplified Dosing and Monitoring: Reduced risk of prolonged systolic dysfunction may lower monitoring burden, enhancing physician and patient confidence.
Growing Role of Real-World Evidence (RWE): Post-approval RWE will be critical in shaping payer coverage, treatment algorithms, and long-term adoption.
Aficamten Recent Developments
Cytokinetics announced positive topline results from the Phase III SEQUOIA-HCM trial, demonstrating that Aficamten met its primary and key secondary endpoints in patients with symptomatic obstructive HCM, including significant improvements in exercise capacity and LVOT gradients. These results support planned regulatory submissions in the US and other major markets. In contrast, the ODYSSEY-HCM trial in non-obstructive HCM did not meet its primary endpoint, leading the company to prioritize oHCM as the core commercial indication.
"Aficamten Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Aficamten for approved indication like Hypertrophic cardiomyopathy in the 7MM. A detailed picture of Aficamten's existing usage in anticipated entry and performance in approved 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 Aficamten for approved indications. The Aficamten market report provides insights about Aficamten'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 Aficamten performance, future market assessments inclusive of the Aficamten market forecast analysis for approved 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 Aficamten sales forecasts, along with factors driving its market.
Aficamten Drug Summary
Aficamten is an oral small-molecule cardiac myosin inhibitor developed by Cytokinetics and marketed as MYQORZO. Approved by the FDA in December 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), it reduces excessive myocardial contractility by binding to the myosin motor domain, stabilizing a weak actin-binding state, and decreasing the number of force-generating myosin heads. This mechanism improves symptoms like shortness of breath and fatigue, enhances exercise capacity, and alleviates left ventricular outflow tract obstruction without significantly affecting calcium transients or requiring extensive titration due to its favorable pharmacokinetics, including once-daily dosing and rapid steady-state attainment. The report provides Aficamten's sales, growth barriers and drivers, post usage and approvals in multiple indications.
Scope of the Aficamten Market Report
The report provides insights into:
A comprehensive product overview including the Aficamten MoA, description, dosage and administration, research and development activities in approved indication like Hypertrophic cardiomyopathy.
Elaborated details on Aficamten regulatory milestones and other development activities have been provided in Aficamten market report.
The report also highlights Aficamten's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved indications across the United States, Europe, and Japan.
The Aficamten market report also covers the patents information, generic entry and impact on cost cut.
The Aficamten market report contains current and forecasted Aficamten sales for approved indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The Aficamten market report also features the SWOT analysis with analyst views for Aficamten in approved indications.
Methodology:
The Aficamten 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.
Aficamten Analytical Perspective by DelveInsight
In-depth Aficamten Market Assessment
This Aficamten sales market forecast report provides a detailed market assessment of Aficamten for approved indication like Hypertrophic cardiomyopathy 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 Aficamten sales data uptil 2034.
Aficamten Clinical Assessment
The Aficamten market report provides the clinical trials information of Aficamten for approved indications covering trial interventions, trial conditions, trial status, start and completion dates.
Aficamten 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.
Aficamten Market Potential & Revenue Forecast
Projected market size for the Aficamten and its key indications
Commercial partnerships, licensing deals, and M&A activity
Aficamten Clinical Differentiation
Aficamten Efficacy & safety advantages over existing drugs
Aficamten Unique selling points
Aficamten Market Report Highlights
In the coming years, the Aficamten 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 Aficamten companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Aficamten's dominance.
Other emerging products for Hypertrophic cardiomyopathy are expected to give tough market competition to Aficamten 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 Aficamten in approved indications.
Analyse Aficamten cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted Aficamten sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Aficamten in approved indications.
Key Questions:
What is the class of therapy, route of administration and mechanism of action of Aficamten? How strong is Aficamten's clinical and commercial performance?
What is Aficamten's clinical trial status in each individual indications such as Hypertrophic cardiomyopathy and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Aficamten Manufacturers?
What are the key designations that have been granted to Aficamten for approved indications? How are they going to impact Aficamten's penetration in various geographies?
What is the current and forecasted Aficamten market scenario for approved indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of Aficamten 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 Aficamten for approved indications?
Which are the late-stage emerging therapies under development for the treatment of approved indications?
How cost-effective is Aficamten? What is the duration of therapy and what are the geographical variations in cost per patient?
Table of Contents
1. Report Introduction
2. Aficamten Overview in approved indications like Hypertrophic cardiomyopathy
