Nipocalimab Sales Forecast, and Market Size Analysis - 2034
상품코드:1909213
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
니포칼리맙(Nipocalimab)의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 수 증가
니포칼리맙은 후기 개발 단계에서 빠르게 상업화 단계로 진입하여 전신성 중증 근무력증(gMG)을 시작으로 자가항체 질환에 대한 FcRn 차단제 계열에서 중요한 점유율을 차지할 것으로 예측됩니다.
임상 3상 시험의 양호한 데이터와 미국에서의 최초 승인으로 전문 신경과 클리닉과 치료 대상인 소아 및 청소년 환자군에서 신규 환자 수가 크게 증가할 것으로 예측됩니다.
존슨앤드존슨의 상업화 계획(신경과 KOL과의 협력, 전문 유통망 구축, 보험사 전략)은 항체 양성으로 적응증 기준을 충족하는 환자에서 신속한 도입을 촉진하기 위해 고안되었습니다.
2. 중요한 적응증으로 확대
전신 중증 근무력증(gMG) : 주요 상업적 적응증 - 니포칼리맙은 지속적인 증상 조절을 입증한 임상 3상 결과를 바탕으로 gMG(항AChR 항체 또는 항MuSK 항체 양성 성인 및 12세 이상 청소년 환자)에 대한 미국 승인을 획득했습니다.
쇼그렌 증후군(SjD) : 유망한 임상 2상 데이터를 바탕으로 중등도에서 중증의 쇼그렌 증후군에 대한 FDA의 획기적 치료제 지정을 획득하여 유병률이 높은 류마티스 적응증에 대한 신속한 개발이 기대되고 있습니다.
희귀 자가항체 및 타가항체 매개 질환: 개발 프로그램과 규제 지정(HDFN, wAIHA, CIDP, FNAIT 등 적응증에 대한 패스트트랙/오판 지정)을 통해 희귀 혈액질환 및 신경질환의 항체 매개 질환에 대한 향후 적응증 확대를 지원하고 있습니다.
3. 지역적 확장
니포칼리맙의 미국 승인으로 초기 상업적 시장이 형성되었습니다. 다른 지역(예: EU의 롤링 리뷰/CHMP 활동, 일본에서의 신청 등)에서는 규제 당국의 심사 및 긍정적인 규제 마일스톤이 진행 중으로, 광범위한 세계 출시가 가능할 것으로 예측됩니다.
유럽, 일본, 기타 시장으로의 확대는 전문의에 대한 접근성이 높은 환자층(3차 신경과 및 소아과 센터)을 우선적으로 고려하고 있습니다. 이들 지역에서의 실제 임상 적용은 라벨링, 상환, 지역 처방에 따라 달라질 수 있습니다.
4. 신규 적응증 승인
니포칼리맙은 전신 중증 근무력증(gMG)에 대한 미국 승인을 받았으며, 기타 항체 매개 질환 및 모체 및 태아 관련 적응증에서 다수의 신속심사 지정(Breakthrough, Fast Track, Orphan)을 획득한 바 있습니다. 이러한 지정은 개발을 가속화하고, 주요 임상 데이터가 양호한 경우 추가 적응증 승인으로 이어질 수 있습니다.
셰그렌 증후군, wAIHA(용혈성 요산뇨증), HDFN(인간 공여자 혈청병) 및 기타 자가항체/동종항체 질환을 대상으로 진행 중인 임상 II/III상 시험은 향후 수년간 적응증 확대의 명확한 경로를 보여주고 있으며, 좋은 결과를 기다리고 있습니다.
5. 강력한 수량 증가 모멘텀
임상 3상 시험의 좋은 결과(gMG에서 IgG 및 임상 지표의 지속적인 감소)와 그에 따른 승인으로 신경과 센터의 처방 의욕이 높아졌습니다. 초기 리얼월드 데이터에 따르면 일부 데이터세트에서 84주 동안 지속되는 효과를 보여주었습니다.
추가 적응증 확대 및 지역적 승인, 광범위한 적응증(IgG 매개 질환), 다수의 신속심사 지정 및 승인된 적응증으로 처방 모멘텀이 지속될 것으로 예측됩니다.
6. 경쟁 우위 및 시장 동향
FcRn 억제 작용기전: 니포칼리맙은 신생아 Fc 수용체(FcRn)를 억제함으로써 순환하는 병원성 IgG 자가항체를 감소시킵니다. 이는 항체 매개 질환에 대한 직접적인 질병 변형 접근법이며, 대증요법이나 광범위한 면역억제요법과는 차별화됩니다.
다양한 적응증 가능성: 니포칼리맙은 유병률이 높은 질환(쇼그렌병, 중증근무력증)부터 희귀질환(HDFN, wAIHA, CIDP, FNAIT)까지 다양한 항체매개질환을 대상으로 개발되어 광범위한 상업적 성장기반을 가지고 있으며, IgG 관련 질환의 플랫폼 치료제로서의 잠재력을 가지고 있습니다. 될 수 있는 가능성을 가지고 있습니다.
시장 동향 : 표적치료제에 대한 관심 증가, 적격 환자를 정의하기 위한 바이오마커(항체) 검사의 보급, 입원율과 재발률을 낮추는 치료법에 대한 보험사의 관심 등 실제 임상에서 효과가 입증된 FcRn 억제제에 유리한 환경이 조성되고 있습니다.
위험과 역풍: FcRn 억제제 계열 및 다른 면역조절제와의 경쟁, 장기적인 안전성 및 감염 위험 모니터링의 필요성, 전문 의료 시장에서의 가격 책정 및 상환 협상, 여러 적응증에 대한 지속적인 효과 입증의 필요성이 최종 시장 침투를 결정지을 것으로 보입니다.
니포칼리맙의 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본) 시장을 조사 분석했으며, 각국 시장 규모와 예측, 연구개발(R&D) 활동, 경쟁 구도 등의 정보를 전해드립니다.
목차
제1장 리포트 개요
제2장 니포칼리맙 개요(중증근무력증 등의 승인된 적응증과 태아적모구증, 신생아 동종면역성 혈소판 감소증, 쇼그렌 증후군, 전신 홍반성 루푸스 등의 잠재적 적응증)
제품 상세
니포칼리맙 임상 개발
니포칼리맙 임상시험
니포칼리맙 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 개요
제3장 니포칼리맙의 경쟁 상황(출시 약품)
제4장 경쟁 구도(후기 단계 새로운 니포칼리맙 요법)
제5장 니포칼리맙 시장 평가
승인된/잠재적 적응증에서 니포칼리맙 시장의 전망
주요 7 시장 분석
주요 7 시장의 승인된/잠재적 적응증용 니포칼리맙 시장 규모
각국의 시장 분석
미국의 승인된/잠재적 적응증용 니포칼리맙 시장 규모
독일의 승인된/잠재적 적응증용 니포칼리맙 시장 규모
영국의 승인된/잠재적 적응증용 니포칼리맙 시장 규모
제6장 니포칼리맙 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 Nipocalimab Growth
1. Market Share Gains and New Patient Starts
Nipocalimab has rapidly moved from late-stage development to commercial availability and is positioned to capture meaningful share in the FcRn-blocker class for autoantibody-driven diseases, beginning with generalized myasthenia gravis (gMG).
Strong new-patient starts are expected in specialty neurology clinics and pediatric/adolescent populations now eligible for treatment, supported by positive Phase III data and an initial US approval.
Johnson & Johnson's commercial plan (neurology KOL engagement, specialty distribution and payer strategy) is designed to drive rapid uptake where patients are antibody-positive and meet label criteria.
2. Expansion across Key Indications
Generalized Myasthenia Gravis (gMG): Primary commercial indication - nipocalimab received US approval for gMG (adults and adolescents >=12 years who are anti-AChR or anti-MuSK antibody-positive) after positive Phase III results showing durable symptom control.
Sjogren's Disease (SjD): Granted FDA Breakthrough Therapy designation for moderate-to-severe Sjogren's disease based on promising Phase II data, positioning it for accelerated development in prevalent rheumatology indications.
Rare Autoantibody and Alloantibody-Mediated Diseases: Development programs and regulatory designations (Fast Track/Orphan in indications such as HDFN, wAIHA, CIDP, FNAIT) support future label expansions into rare hematologic and neurologic antibody-mediated disorders.
3. Geographic Expansion
Nipocalimab's US approval establishes the initial commercial market; regulatory reviews and positive regulatory milestones are progressing in other regions (e.g., rolling EU review / CHMP activity and Japan filings), enabling broader global launches.
Expansion into Europe, Japan and other markets is being prioritized for populations with high specialist access (tertiary neurology and pediatric centers); real-world uptake in these regions will depend on labeling, reimbursement and local formularies.
4. New Indication Approvals
Nipocalimab has secured US approval for gMG and multiple expedited regulatory designations (Breakthrough, Fast Track, Orphan) across other antibody-mediated and maternal-fetal indications - these designations accelerate development and could result in additional indications if pivotal data are positive.
Ongoing Phase II/III programs in Sjogren's disease, wAIHA, HDFN and other autoantibody/alloantibody disorders create a clear pathway for label expansion over the next several years pending successful readouts.
5. Strong Volume Momentum
Positive Phase III results (sustained reductions in IgG and clinical measures in gMG) and subsequent approval generated strong prescribing interest in neurology centers; early real-world presentations show durable benefit up to 84 weeks in some datasets.
The combination of broad target applicability (IgG-mediated disease), multiple expedited regulatory designations, and an approved indication supports continued prescription momentum as additional label expansions and geographic approvals occur.
6. Competitive Differentiation and Market Trends
FcRn-blocker mechanism: By blocking the neonatal Fc receptor (FcRn), nipocalimab reduces circulating pathogenic IgG autoantibodies - a direct disease-modifying approach for antibody-mediated disorders that differentiates it from symptomatic or broad immunosuppressive therapies.
Multi-indication potential: Development across both prevalent (SjD, gMG) and rare (HDFN, wAIHA, CIDP, FNAIT) antibody-mediated conditions gives nipocalimab a broad commercial runway and the potential to become a platform therapy for IgG-driven diseases.
Market trends supporting uptake: Growing focus on targeted therapies, increasing use of biomarker (antibody) testing to define eligible patients, and payer interest in therapies that reduce hospitalizations/flare rates all favor FcRn blockers with demonstrated clinical and real-world benefit.
Risks & headwinds: Competition within the FcRn class and other immunomodulators, long-term safety and infection-risk monitoring needs, pricing/reimbursement negotiation in specialty markets, and the necessity of demonstrating durable benefit across multiple indications will determine ultimate market penetration.
Nipocalimab Recent Developments
In December 2025, Johnson & Johnson announced that the European Commission approved a Marketing Authorisation for IMAAVY (Nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). gMG is a chronic, incurable autoantibody disease that causes debilitating symptoms such as muscle weakness, difficulty chewing, swallowing and speaking. This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive.
In October 2025, an open-label extension trial testing the efficacy of Nipocalimab in patients transitioning from placebo revealed continued improvement in MG-Activities of Daily Living scores over a long-term period.
In April 2025, the US FDA approved Johnson & Johnson's IMAAVY (Nipocalimab) for the treatment of treatment of generalized myasthenia gravis (gMG). Following FDA Priority Review designation, this approval offers a new, effective treatment option for adults and pediatric patients 12 years of age and older with gMG who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
"Nipocalimab Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Nipocalimab for approved indication like Myasthenia gravis; as well as potential indications like Fetal erythroblastosis; Neonatal alloimmune thrombocytopenia; Sjogren's syndrome; and Systemic lupus erythematosus in the 7MM. A detailed picture of Nipocalimab's existing usage in approved and 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 Nipocalimab for approved and potential indications. The Nipocalimab market report provides insights about Nipocalimab'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 Nipocalimab performance, future market assessments inclusive of the Nipocalimab market forecast analysis for approved and 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 Nipocalimab sales forecasts, along with factors driving its market.
Nipocalimab Drug Summary
Nipocalimab is a fully human IgG1 lambda monoclonal antibody that acts as a high-affinity blocker of the neonatal Fc receptor (FcRn). It binds to FcRn at both neutral and acidic pH, preventing the recycling of IgG antibodies and thereby reducing circulating IgG levels, including pathogenic autoantibodies like those against acetylcholine receptor (AChR) and muscle-specific tyrosine kinase (MuSK). Sold under the brand name IMAAVY (Nipocalimab), it is approved for treating generalized myasthenia gravis (gMG) in adults and pediatric patients aged 12 years and older who are AChR or MuSK antibody positive, with FDA approval granted in April 2025. The drug features an aglycosylated Fc region, lacking effector functions such as complement-dependent cytotoxicity or antibody-dependent cellular cytotoxicity, and is administered intravenously. The report provides Nipocalimab's sales, growth barriers and drivers, post usage and approvals in multiple indications.
Nipocalimab is in the Phase III stage of clinical development for the treatment of patients with Sjogren's Syndrome (NCT06741969) and Thrombocytopenia, Neonatal Alloimmune (NCT06449651).
Scope of the Nipocalimab Market Report
The report provides insights into:
A comprehensive product overview including the Nipocalimab MoA, description, dosage and administration, research and development activities in approved indications like Myasthenia gravis; as well as potential indications like Fetal erythroblastosis; Neonatal alloimmune thrombocytopenia; Sjogren's syndrome; and Systemic lupus erythematosus.
Elaborated details on Nipocalimab regulatory milestones and other development activities have been provided in Nipocalimab market report.
The report also highlights Nipocalimab's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
The Nipocalimab market report also covers the patents information, generic entry and impact on cost cut.
The Nipocalimab market report contains current and forecasted Nipocalimab sales for approved and potential indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The Nipocalimab market report also features the SWOT analysis with analyst views for Nipocalimab in approved and potential indications.
Methodology:
The Nipocalimab 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.
Nipocalimab Analytical Perspective by DelveInsight
In-depth Nipocalimab Market Assessment
This Nipocalimab sales market forecast report provides a detailed market assessment of Nipocalimab for approved indication like Myasthenia gravis; as well as potential indications like Fetal erythroblastosis; Neonatal alloimmune thrombocytopenia; Sjogren's syndrome; and Systemic lupus erythematosus 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 Nipocalimab sales data uptil 2034.
Nipocalimab Clinical Assessment
The Nipocalimab market report provides the clinical trials information of Nipocalimab for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.
Nipocalimab 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.
Nipocalimab Market Potential & Revenue Forecast
Projected market size for the Nipocalimab and its key indications
Commercial partnerships, licensing deals, and M&A activity
Nipocalimab Clinical Differentiation
Nipocalimab Efficacy & safety advantages over existing drugs
Nipocalimab Unique selling points
Nipocalimab Market Report Highlights
In the coming years, the Nipocalimab 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 Nipocalimab companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Nipocalimab's dominance.
Other emerging products for Myasthenia gravis; as well as potential indications like Fetal erythroblastosis; Neonatal alloimmune thrombocytopenia; Sjogren's syndrome; and Systemic lupus erythematosus are expected to give tough market competition to Nipocalimab 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 Nipocalimab in approved and potential indications.
Analyse Nipocalimab cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted Nipocalimab sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Nipocalimab in approved and potential indications.
Key Questions:
What is the class of therapy, route of administration and mechanism of action of Nipocalimab? How strong is Nipocalimab's clinical and commercial performance?
What is Nipocalimab's clinical trial status in each individual indications such as Myasthenia gravis; as well as potential indications like Fetal erythroblastosis; Neonatal alloimmune thrombocytopenia; Sjogren's syndrome; and Systemic lupus erythematosus and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Nipocalimab Manufacturers?
What are the key designations that have been granted to Nipocalimab for approved and potential indications? How are they going to impact Nipocalimab's penetration in various geographies?
What is the current and forecasted Nipocalimab market scenario for approved and potential indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of Nipocalimab 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 Nipocalimab for approved and potential indications?
Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
How cost-effective is Nipocalimab? What is the duration of therapy and what are the geographical variations in cost per patient?
Table of Contents
1. Report Introduction
2. Nipocalimab Overview in approved indications like Myasthenia gravis; as well as potential indications like Fetal erythroblastosis; Neonatal alloimmune thrombocytopenia; Sjogren's syndrome; and Systemic lupus erythematosus
