ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
ㅁ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송기일은 문의해 주시기 바랍니다.
한글목차
주요 하이라이트
신생아 Fc 수용체(FcRn)는 Brambell 수용체로도 알려져 있으며 FCGRT 유전자에 의해 코딩되는 주요 조직 적합성 복합체(MHC) I 관련 수용체입니다. 1960년대 Brambell은 어머니에서 유아로의 IgG 수송을 중재하는 수용체가 존재할 가능성을 먼저 제창했습니다.
FcRn 억제제는 중증근무력증, 갑상선안증, 기타 수포성류포포, 만성염증성 탈수성 다발신경염, 온성자가면역성 용혈성 빈혈, 바세도병 등 많은 적응증에 효과적인 치료제입니다.
Johnson & Johnson Innovative Medicine, UCB Biopharma, Pfizer, Viridian Therapeutics 등 여러 회사가 FcRn 억제제를 개발하기 위해 노력하고 있으며 많은 승인 및 신약이 있습니다.
중증근무력증 시장에서는 Efgartigimod alfa가 우위를 확립하고 이끌고 있으며, ADHERE 시험은 중증근무력증 등의 적응 확대가 기대되고 있습니다. ADHERE 시험은 CIDP 치료제로서 최대 규모의 랜덤화 비교 시험이며, CIDP 병태에서 병원성 자가항체의 역할을 지지하고 있습니다.
2024년 9월 Johnson & Johnson의 자회사인 Janssen-Cilag International NV는 nipocalimab을 GMG 환자의 치료제로 처음 승인하기 위해 유럽 의약청(EMA)에 판매 승인 신청(MAA)을 제출했다고 발표했습니다.
FLEX 시험으로 명명된 본 시험에서는 batoclimab이 재연소시 증상 경감, 근무력증의 악화·위기 예방, 관해 유지 등 질병의 다양한 단계를 통해 환자의 중요한 요구에 대응할 수 있는지 여부를 검토합니다. 4부로 구성된 3단계 시험에서는 3군의 환자를 무작위로 배정하고 batoclimab 또는 위약의 2회 투여량 중 하나를 투여합니다(AJMC, 2024).
2023년 VYVGART와 VYVGART SC가 창출한 세계적인 순제품 수익은 각각 9억 800만 달러와 2억 4,600만 달러였습니다.
2024년 3월, Johnson&Johnson(J&J)은 nipocalimab에 대해 미국 식품의약국(FDA)으로부터 면역 결핍의 임신 성인에 있어서의 태아와 신생아 면역 결핍성 혈소판감소증(FNAIT) 위험의 경감을 목적으로 한 패스트랙 지정을 취득했습니다.
2024년 9월, Immunovant는 바세도우 병을 대상으로 하는 batoclimab의 2단계 시험에서 좋은 결과를 얻었다고 발표했습니다. Immunovant는 또한 미국 FDA와의 제휴를 발표하고 FcRn 억제제인 IMVT-1402의 바세도우병에서 중요한 임상시험을 2024년 12월까지 시작했으며, 시험허가(IND)를 취득했습니다(Immunovant, 2024).
FcRn 억제제는 병원성 IgG 감소에 대한 보다 표적화된 치료 접근법에 대한 긴급한 요구에 부응하여 PLEX 요법, IA 요법, 면역조절 고용량 IVIg 요법을 대체하는 보다 침습적이고 시간이 걸리지 않는 대체 요법을 제공할 수 있습니다.
FcRn 억제제 시장 전망
FcRn 억제제 시장은 향후 몇 년 동안 크게 성장할 것으로 예측됩니다. 이는 wAIHA, 전신성 홍반성 루푸스, 바세도우병, 갑상선안증, 기타 많은 적응증으로 진단되는 환자 증가, FcRn 억제제에 대한 인지도의 향상, 각 회사가 임상시험 중 및 승인 신청 중 신약 증가 등에 기인합니다.
FcRn의 높은 친화력은 류마티스 관절염, 심한 근무력증, 심상성 천포창과 같은 IgG를 통한 자가면역 질환에 악영향을 미칩니다. FcRn을 표적으로 하고 FcRn의 순환을 억제함으로써 IgG의 이화를 개선할 수 있어, IgG와 병원성 자가항체의 수준이 저하되고, IgG에 의해 유도되는 모든 자가면역 이상을 감소시킬 것으로 예측됩니다. 파이프라인에는 nipocalimab 및 batoclimab와 같은 중증 근무력증, 갑상선안증, CIPD와 같은 다양한 적응증을 치료하기 위해 FcRn을 대상으로 개발된 많은 약물이 있습니다. VYVGART 및 RYSTIGGO와 같은 약물은 중증 근무력증으로 FDA의 승인을 받았으며 다른 적응증에서도 개발 중입니다.
본 보고서는 FcRn 억제제의 주요 7개 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대한 조사 분석을 통해 각 지역 시장 규모, 현재 치료법, 암메트니즈, 신약 등의 정보를 제공합니다.
목차
제1장 중요한 지견
제2장 보고서 서론
제3장 FcRn 억제제 주요 요약
제4장 주요 사건
제5장 역학 시장 예측 수법
제6장 주요 7개 FcRn 억제제 시장 개요
시장 점유율 분포 : 치료법별(2023년)
시장 점유율 분포 : 치료법별(2034년)
시장 점유율 분포 : 적응증별(2023년)
시장 점유율 분포 : 적응증별(2034년)
제7장 FcRn 억제제 : 배경 및 개요
서론
다양한 적응증에서 FcRn 억제제의 가능성
FcRn 억제제의 임상 응용
제8장 다양한 적응증에서의 역학과 환자 인구
전제조건과 근거
FcRn 억제제의 적응증의 총 환자 수
제9장 표적 환자 집단
주요 조사 결과
전제조건 및 근거 : 주요 7개 시장
주요 7시장의 역학 시나리오
주요 7개 시장의 총 적격 환자 수 : FcRn 억제제의 적응증별
주요 7개 시장의 총 치료 가능 환자 수 : FcRn 억제제의 적응증별
제10장 출시된 치료법
주요 경쟁
VYVGART(Efgartigimod) : Argenx
RYSTIGGO(rozanolixizumab-noli) : UCB Biopharma
제11장 새로운 치료법
주요 경쟁
Batoclimab : Immunovant
Nipocalimab : Johnson & Johnson Innovative Medicine
제12장 FcRn 억제제 : 주요 7개 시장 분석
주요 조사 결과
시장 전망
컨조인트 분석
주요 시장 예측의 전제조건
코스트의 상정과 리베이트
가격 동향
아날로그 평가
상시년과 치료의 보급
주요 7개 시장의 FcRn 억제제 시장 규모 : 적응증별
미국
미국의 FcRn 억제제 전체 시장 규모
미국의 FcRn 억제제 시장 규모 : 적응증별
미국의 FcRn 억제제 시장 규모 : 치료법별
유럽 4개국 및 영국
유럽 4개국 및 영국의 FcRn 억제제 전체 시장 규모
유럽 4개국 및 영국의 FcRn 억제제 시장 규모 : 적응증별
유럽 4개국 및 영국의 FcRn 억제제 시장 규모 : 치료법별
일본
일본의 FcRn 억제제 전체 시장 규모
일본의 FcRn 억제제 시장 규모 : 적응증별
일본의 FcRn 억제제 시장 규모 : 치료법별
제13장 SWOT 분석
제14장 KOL의 견해
제15장 미충족 수요(Unmet Needs)
제16장 시장 진입과 상환
제17장 부록
제18장 DelveInsight의 서비스 내용
제19장 면책사항
제20장 DelveInsight 정보
KTH
영문 목차
영문목차
Key Highlights:
Neonatal fragment crystallizable (Fc) receptor (FcRn), also known as the Brambell receptor, is the major histocompatibility complex (MHC) I-related receptor encoded by the FCGRT gene. In the 1960s, Brambell was the first to propose that there might be a receptor capable of mediating the transport of IgG from mother to infant.
FcRn inhibitors are effective treatments for myasthenia gravis, thyroid eye disease, and other indications like bullous pemphigoid, chronic inflammatory demyelinating polyneuropathy, warm autoimmune hemolytic anemia, Graves' disease, and many more indications.
Several companies, including Johnson & Johnson Innovative Medicine, UCB Biopharma, Pfizer, and Viridian Therapeutics, are engaged in the development of FcRn inhibitors, with many approved and emerging drugs.
In the myasthenia gravis market, Efgartigimod alfa is leading with established dominance and potential expansion into indications like myasthenia gravis with the trial ADHERE. It is the largest randomized controlled trial of any CIDP treatment to date. It supports the role of pathogenic autoantibodies in CIDP pathology.
In September 2024, Janssen-Cilag International NV, a Johnson & Johnson company, announced the submission of the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking the first approval of nipocalimab for the treatment of people living with gMG.
Dubbed the FLEX trial, the study will explore whether batoclimab will address important patient needs throughout different phases of the disease, including reducing symptoms during flares, preventing myasthenic exacerbation/crisis, and maintaining remission. The 4-part phase 3 study will randomize 3 groups of patients to receive 1 of 2 doses of batoclimab or placebo (AJMC, 2024).
In the full year 2023, the global net product revenues generated by VYVGART and VYVGART SC were USD 908 million and USD 246 million respectively.
In March 2024, Johnson & Johnson (J&J) obtained fast-track designation from the US Food and Drug Administration (FDA) for its nipocalimab to reduce foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in alloimmunised pregnant adults.
In September 2024, Immunovant Announced positive results from its Phase IIa trial of batoclimab in Graves' Disease. Immunovant also announced alignment with the U.S. FDA and received Investigational New Drug Application (IND) clearance, with a pivotal trial of IMVT-1402 in Graves' Disease which is also a FcRn inhibitor expected to initiate by December 2024 (Immunovant, 2024).
FcRn inhibitors have the potential to meet an urgent need for a more targeted therapeutic approach to pathogenic IgG reduction and provide a less invasive and time-consuming alternative to PLEX, IA, and immunomodulatory high-dose IVIg therapies.
DelveInsight's "FcRn inhibitors - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the FcRn inhibitor, historical and Competitive Landscape as well as the FcRn inhibitors' market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The FcRn inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM FcRn inhibitor market size from 2020 to 2034. The report also covers current FcRn inhibitor treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Geography Covered:
The United States
EU4 (Germany, France, Italy, and Spain) and the United Kingdom
Japan
Study Period: 2020-2034
FcRn Inhibitors Disease Understanding and Treatment Algorithm
FcRn Inhibitors Overview
The neonatal fragment crystallizable (Fc) receptor (FcRn) functions as a recycling mechanism to prevent degradation and extend the half-life of IgG and albumin in circulation. FcRn plays a crucial role in the maintenance of IgG levels by salvaging IgG from lysosomal degradation, thereby prolonging its half-life. In non-human primates, anti-FcRn antibodies reduced IgG levels by over 60%, without significant, concomitant changes in the serum content of albumin, IgA, or IgM. FcRn inhibitors are anti-FcRn monoclonal antibodies with high affinity for FcRn at both neutral and acidic pH. Inside the cell, FcRn inhibitors compete with IgG for binding to FcRn. Because of their higher affinity, FcRn inhibitors prevent IgG from binding to FcRn, and IgG is transported to the lysosome and degraded, which leads to a decrease in circulating IgG levels. FcRn: Neonatal Fc receptor; IgG: immunoglobulin G.
FcRn Inhibitors Market Overview
Neonatal Fc receptor-targeted therapies are engineered to selectively target FcRn through various methods, such as Fc fragments or monoclonal anti-FcRn antibodies. These approaches enhance the breakdown of autoantibodies by blocking the immunoglobulin G recycling pathway. This mechanism reduces overall plasma immunoglobulin levels, including the levels of pathogenic autoantibodies, without affecting the other immunoglobulin classes immunoglobulin a, immunoglobulin E, immunoglobulin M, and immunoglobulin D levels. Drugs that inhibit FcRn include efgartigimod, rozanolixizumab, batoclimab, and nipocalimab. These medications can be administered either intravenously or subcutaneously. Numerous clinical trials are currently underway to investigate their effectiveness, safety, and tolerability in various neurological conditions, including myasthenia gravis and other neurological disorders such as chronic inflammatory demyelinating polyneuropathy, myositis, neuromyelitis optica, and myelin oligodendrocyte glycoprotein antibody disease. Positive results from clinical trials of efgartigimod and rozanolixizumab led to their approval for the treatment of generalized myasthenia gravis. Additional clinical trials are still ongoing.
FcRn Inhibitors Epidemiology
The FcRn inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for FcRn inhibitors, total eligible patient pool of selected indication for FcRn inhibitors, total treated cases in selected indications for FcRn inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
In 2023, chronic inflammatory demyelinating polyneuropathy (CIDP) affected approximately 21,000 patients in the United States.
Graves' disease had an estimated prevalence of around 1,241,720 cases across the EU4 and the UK in 2023.
Thyroid eye disease impacted approximately 84,000 patients across the seven major markets (7MM) in 2023.
FcRn Inhibitor Drug Chapters
The drug chapter segment of the FcRn inhibitor reports encloses a detailed analysis of approved FcRn inhibitors late-stage (Phase III and Phase II) FcRn inhibitors. It also helps understand the FcRn inhibitor's clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
VYVGART (Efgartigimod): Argenx
Efgartigimod is designed as a first-in-class investigational antibody fragment to target the neonatal Fc receptor (FcRn). It is being evaluated for the treatment of patients with severe autoimmune diseases with confirmed presence of pathogenic immunoglobulin G, and IgG autoantibodies, where a severe unmet medical need exists. Efgartigimod's subcutaneous form is coformulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology, which allows for subcutaneous delivery of biologics that are typically administered via infusion. In December 2021, it was approved by the FDA for Generalised Myasthenia Gravis. It is in the pipeline for various other indications including thyroid eye disease, Myositis, and many more diseases.
RYSTIGGO (rozanolixizumab-noli): UCB Biopharma
It is a high-affinity humanized immunoglobulin G4 monoclonal antibody directed against human neonatal Fc receptor (FcRn). It is administered subcutaneously. It received its first approval on 27 June 2023 in the USA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. Rozanolixizumab is the first agent to be approved in the USA for both anti-AChR and anti-MuSK antibody-positive gMG. A regulatory assessment of rozanolixizumab for the treatment of gMG is currently underway in the EU and Japan. Clinical development is ongoing for the treatment of leucine-rich glioma-inactivated 1 autoimmune encephalitis, myelin oligodendrocyte glycoprotein (MOG) antibody disease, and severe fibromyalgia syndrome.
Emerging Drugs
Batoclimab: Immunovant
Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. Phase II study in myasthenia gravis showed that batoclimab can quickly and significantly alleviate patients' symptoms and improve quality of life. Earlier studies demonstrated that batoclimab is well tolerated and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases. It is being developed as a low-volume subcutaneous (SC) injection for the treatment of a variety of IgG-mediated autoimmune disorders, including myasthenia gravis, thyroid eye disease, chronic inflammatory demyelinating polyneuropathy (CIPD), and Graves' disease. It is currently being evaluated for the Phase II trial for myasthenia gravis. Immunovant is conducting its trials in Phase II and III.
Nipocalimab: Johnson & Johnson Innovative Medicine
Nipocalimab is an investigational, high affinity, fully human, aglycosylated, effectorless, monoclonal antibody that is believed to selectively block the Fc receptor (FcRn) to reduce levels of circulating immunoglobulin G (IgG) antibodies, including autoantibodies and alloantibodies that underlie multiple conditions. Nipocalimab is being studied in all three segments of autoantibody-driven disease: rare autoantibody diseases (e.g., generalized myasthenia gravis in adults and children, chronic inflammatory demyelinating polyneuropathy, warm autoimmune hemolytic anemia, and idiopathic inflammatory myopathies); maternal-fetal diseases mediated by maternal autoantibodies - also known as alloantibodies (e.g., HDFN); and prevalent rheumatologic diseases (e.g., rheumatoid arthritis, Sjogren's syndrome, and systemic lupus erythematosus).1,2-10 Blockade of FcRn by nipocalimab has the potential to reduce overall autoantibody levels while maintaining immune function. FcRn blockade is also believed to prevent the placental transfer of maternal alloantibodies to the fetus.
FcRn Inhibitor Market Outlook
The market for FcRn inhibitors is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with wAIHA, systemic lupus erythematosus, Graves disease, thyroid eye disease, and many more indications; the growing awareness of FcRn inhibitors, and the increasing number of emerging drugs that are under clinical trials and filed for approval by various companies.
The greater affinity of FcRn has adverse effects on IgG-mediated autoimmune diseases like rheumatoid arthritis, myasthenia gravis, or pemphigus vulgaris. Targeting FcRn and inhibiting FcRn circulation can improve IgG catabolism, resulting in reduced IgG and pathogenic autoantibody levels, which is anticipated to decrease all autoimmune abnormalities induced by IgG. There are many drugs in the pipeline like Nipocalimab and Batoclimab, that are being developed to target FcRn to cure various indications like Myasthenia gravis, thyroid eye disease, CIPD, and many more. Drugs like VYVGART and RYSTIGGO have received FDA approval for Myasthenia gravis and are in the pipeline for other indications.
Several key players, including ArgenX, UBC Biopharma, Pfizer, and others, are involved in developing drugs for FcRn inhibitors for various indications such as myositis, myasthenia gravis, fibromyalgia, systemic lupus erythematosus, and others. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of FcRn inhibitors and define their role in the therapy of autoimmune and neurological disorders.
FcRn inhibitor Drugs Uptake
This section focuses on the uptake rate of potential approved and emerging FcRn inhibitors expected to be launched in the market during 2020-2034.
FcRn Inhibitor Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
The presence of numerous drugs under different stages is expected to generate immense opportunity for FcRn inhibitors market growth over the forecasted period.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for FcRn inhibitor therapies.
KOL Views
To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on FcRn inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center and others.
Their opinion helps understand and validate current and emerging therapy treatment patterns or FcRn inhibitor 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 market Intelligence analysis using various approaches, such as SWOT analysis. 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 treatment landscape.
Market Access and Reimbursement
Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.
In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Continuing Medical Education (CME) program, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.
The 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.
Key Updates on FcRn Inhibitor
In February 2024, Viridian Therapeutics gave their fourth-year quarter and full-year financial reports for 2023 in which it was highlighted that Fc receptor (FcRn) inhibitors were on track with VRDN-006 Investigational New Drug Application (IND) submission anticipated by year-end 2024 and VRDN-008 non-human primate data expected in the second half of 2024.
In October 2024, Johnson & Johnson announced positive Phase II/III results for nipocalimab in adolescents (12-17 years) with generalized myasthenia gravis (gMG). Participants receiving nipocalimab plus standard of care showed significant IgG reduction over 24 weeks and improvements in MG-ADL and QMG scores. These findings will be presented at the Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, alongside 25 other abstracts from Johnson & Johnson.
In November 2023, Janssen announced positive results from a mid-stage study of its investigational FcRninhibitor in rheumatoid arthritis (RA).
UCB Pharma developed RYSTIGGO (rozanolixizumab) for addressing autoimmune illnesses. It gained its initial approval in June 2023 in the US for managing generalized myasthenia gravis in adults with either anti-AChR or anti-MuSK antibodies.
The abstract list is not exhaustive, will be provided in the final report
Scope of the Report:
The report covers a segment of key events, an executive summary, and a descriptive overview of the FcRn inhibitor, explaining its mechanism, and therapies (current and emerging).
Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have 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 landscape.
A detailed review of the FcRn inhibitor market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM FcRn inhibitor market.
FcRn Inhibitor Report Insights
FcRn inhibitors Targeted Patient Pool
Therapeutic Approaches
FcRn Inhibitor Pipeline Analysis
FcRn Inhibitor Market Size and Trends
Existing and future Market Opportunity
FcRn Inhibitor Report Key Strengths
Eleven years Forecast
The 7MM Coverage
Key Cross Competition
Drugs Uptake and Key Market Forecast Assumptions
FcRn Inhibitor Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Qualitative Analysis (SWOT)
Key Questions:
What was the FcRn inhibitor total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
Which drug is going to be the largest contributor in 2034?
Which is the most lucrative market for FcRn inhibitors?
What are the pricing variations among different geographies for approved therapies?
How the reimbursement landscape has for FcRn inhibitors evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
What are the risks, burdens, and unmet needs of treatment with FcRn inhibitors? What will be the growth opportunities across the 7MM for the patient population of FcRn inhibitors?
What are the key factors hampering the growth of the FcRn inhibitor market?
What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
What key designations have been granted to the therapies for FcRn inhibitors?
What is the cost burden of approved therapies on the patient?
Patient acceptability in terms of preferred therapy options as per real-world scenarios?
What are the country-specific accessibility issues of expensive, recently approved therapies?
Reasons to buy:
The report will help develop business strategies by understanding the latest trends and changing dynamics driving the FcRn inhibitor market.
Understand the existing market opportunities 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 market will help devise strategies to help get ahead of competitors.
Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
Highlights of Access and Reimbursement policies of approved 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 needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary of FcRn Inhibitor
4. Key Events
5. Epidemiology Market Forecast Methodology
6. FcRn Inhibitor Market Overview at a Glance in the 7MM
6.1. Market Share (%) Distribution by Therapies in 2023
6.2. Market Share (%) Distribution by Therapies in 2034
6.3. Market Share (%) Distribution by Indications in 2023
6.4. Market Share (%) Distribution by Indications in 2034
7. FcRn Inhibitor: Background and Overview
7.1. Introduction
7.2. Potential of FcRn Inhibitors in Different Indications
7.3. Clinical Applications of FcRn Inhibitors
8. Epidemiology and Patient Population in Different Indications
8.1. Assumptions and Rationale
8.2. Total Incident Cases of Selected Indications for FcRn Inhibitors
9. Target Patient Pool
9.1 Key Findings
9.2 Assumptions and Rationale: 7MM
9.3 Epidemiology Scenario in the 7MM
9.3.1 Total Eligible Patient Pool by Indication for FcRn Inhibitor in the 7MM
9.3.2 Total Treatable Cases by Indication for FcRn Inhibitor in the 7MM
