FcRn阻害薬の市場規模、対象となる集団、競合情勢、市場予測（2034年）

主なハイライト

• 新生児Fc受容体（FcRn）は、Brambell受容体としても知られ、FCGRT遺伝子によってコードされる主要組織適合性複合体（MHC）I関連受容体です。1960年代、Brambellは、母親から乳児へのIgGの輸送を仲介する受容体が存在する可能性を初めて提唱しました。
• FcRn阻害薬は重症筋無力症、甲状腺眼症、その他の水疱性類天疱瘡、慢性炎症性脱髄性多発神経炎、温性自己免疫性溶血性貧血、バセドウ病などの多くの適応症に有効な治療薬です。
• Johnson & Johnson Innovative Medicine、UCB Biopharma、Pfizer、Viridian Therapeuticsなど数社がFcRn阻害薬の開発に取り組んでおり、多くの承認薬や新薬があります。
• 重症筋無力症市場では、Efgartigimod Alfaが優位性を確立しリードしており、ADHERE試験により重症筋無力症などの適応拡大が期待されています。ADHERE試験は、CIDP治療薬としては最大規模のランダム化比較試験で、CIDP病態における病原性自己抗体の役割を支持しています。
• 2024年9月、Johnson & Johnsonの子会社であるJanssen-Cilag International NVは、nipocalimabをGMG患者の治療薬として初めて承認するため、欧州医薬品庁（EMA）に販売承認申請（MAA）を提出したと発表しました。
• FLEX試験と名付けられたこの試験では、batoclimabが、再燃時の症状軽減、筋無力症の増悪・危機の予防、寛解の維持など、疾患のさまざまな段階を通じて患者の重要なニーズに対応できるかどうかを検討します。4部からなるフェーズ3試験では、3群の患者を無作為に割り付け、batoclimabまたはプラセボの2つから1つを投与します（AJMC、2024年）。
• 2023年通年で、VYVGARTとVYVGART SCが創出した世界の純製品収益は、それぞれ9億800万米ドルと2億4,600万米ドルでした。
• 2024年3月、Johnson & Johnson（J&J）は、nipocalimabについて米国食品医薬品局（FDA）より、免疫不全の妊娠成人における胎児と新生児免疫不全性血小板減少症（FNAIT）リスクの軽減を目的としたファストトラック指定を取得しました。
• 2024年9月、Immunovantはバセドウ病を対象としたbatoclimabのフェーズIIa試験で良好な結果が得られたと発表しました。Immunovantはまた、米国FDAとの提携を発表し、FcRn阻害薬でもあるIMVT-1402のバセドウ病における重要な臨床試験を2024年12月までに開始する予定であり、治験許可（IND）を取得しました（Immunovant、2024年）。
• FcRn阻害薬は、病原性IgGの減少に対するより標的を絞った治療アプローチに対する緊急のニーズに応え、PLEX療法、IA療法、免疫調節高用量IVIg療法に代わる、より低侵襲性で時間のかからない代替療法を提供する可能性があります。

FcRn阻害薬の市場見通し

FcRn阻害薬の市場は今後数年間で大きく成長すると予測されます。これは、wAIHA、全身性エリテマトーデス、バセドウ病、甲状腺眼症、その他の多くの適応症と診断される患者の増加、FcRn阻害薬に対する認知度の向上、各社の臨床試験中や承認申請中の新薬の増加などに起因します。

FcRnの高い親和性は、関節リウマチ、重症筋無力症、尋常性天疱瘡のようなIgGを介する自己免疫疾患に悪影響を及ぼします。FcRnを標的とし、FcRnの循環を阻害することで、IgGの異化を改善することができ、その結果、IgGと病原性自己抗体のレベルが低下し、IgGによって誘導されるすべての自己免疫異常を減少させることが期待されます。nipocalimabやbatoclimabのように、重症筋無力症、甲状腺眼症、CIPDなどのさまざまな適応症を治療するためにFcRnをターゲットとして開発中のパイプラインにある薬剤は多いです。VYVGARTやRYSTIGGOのような薬剤は重症筋無力症でFDAの承認を得ており、その他の適応症でも開発中です。

ArgenX、UBC Biopharma、Pfizerなどの複数の主要企業が、筋炎、重症筋無力症、線維筋痛症、全身性エリテマトーデスなどのさまざまな適応症のFcRn阻害薬の開発に携わっています。全体として、これは開発の大きな可能性を秘めた将来有望な新しいクラスの薬剤です。今後数年間にわたる現在の研究の成熟により、FcRn阻害薬の理解が深まり、自己免疫疾患や神経疾患の治療におけるその役割が明確になると見られます。

当レポートでは、FcRn阻害薬の主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 FcRn阻害薬のエグゼクティブサマリー

第4章 重要な出来事

第5章 疫学市場の予測手法

第6章 主要7市場のFcRn阻害薬市場の概要

• 市場シェアの分布：治療法別（2023年）
• 市場シェアの分布：治療法別（2034年）
• 市場シェアの分布：適応症別（2023年）
• 市場シェアの分布：適応症別（2034年）

第7章 FcRn阻害薬：背景と概要

• イントロダクション
• 各適応症におけるFcRn阻害薬の可能性
• FcRn阻害薬の臨床応用

第8章 各適応症における疫学と患者人口

• 前提条件と根拠
• FcRn阻害薬の特定の適応症の総発症数

第9章 対象となる患者集団

• 主な調査結果
• 前提条件と根拠：主要7市場
• 主要7市場の疫学シナリオ

第10章 上市済みの治療法

• 主な競合
• VYVGART（Efgartigimod）：Argenx
• RYSTIGGO（rozanolixizumab-noli）：UCB Biopharma

第11章 新治療法

• 主な競合
• Batoclimab：Immunovant
• Nipocalimab：Johnson & Johnson Innovative Medicine

第12章 FcRn阻害薬：主要7市場の分析

• 主な調査結果
• 市場見通し
• コンジョイント分析
• 主な市場予測の前提条件
• 主要7市場のFcRn阻害薬の市場規模：適応症別
• 米国
• 欧州4ヶ国・英国
• 日本

第13章 SWOT分析

第14章 KOLの見解

第15章 アンメットニーズ

第16章 市場参入と償還

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of FcRn Epidemiology (2020-2034)
• Table 2: Total Eligible Patient Pool by Indications in the 7MM (2020-2034)
• Table 3: Total Treated Patients by Indications in the in the 7MM (2020-2034)
• Table 4: Key Cross Competition of Marketed Therapies
• Table 5: VYVGART, Clinical Trial Description, 2024
• Table 6: VYVGART HYTRULO, Clinical Trial Description, 2024
• Table 7: RYSTIGGO, Clinical Trial Description, 2024
• Table 8: Key Cross Competition of Emerging Therapies
• Table 9: Nipocalimab, Clinical Trial Description, 2024
• Table 10: Batoclimab, Clinical Trial Description, 2024
• Table 11: Total Market Size of FcRn in the 7MM, USD million (2020-2034)
• Table 12: Market Size by Indications in the 7MM, USD million (2020-2034)
• Table 13: Market Size by Therapies in the7MM, USD million (2020-2034)
• Table 14: Market Size by Indications in the United States, USD million (2020-2034)
• Table 15: Market Size by Therapies in the United States, USD million (2020-2034)
• Table 16: Market Size by Indications in EU4 and the UK, USD million (2020-2034)
• Table 17: Market Size by Therapies in EU4 and the UK, USD million (2020-2034)
• Table 18: Market Size by Indications in Japan, USD million (2020-2034)
• Table 19: Market Size by Therapies in Japan, USD million (2020-2034)

List of Figures

• Figure 1: Mechanism of Action of FcRn Inhibitors.
• Figure 2: Timeline of First FDA Approvals for FcRn Inhibitors
• Figure 3: Total Eligible Patient Pool by Indications in the 7MM (2020-2034)
• Figure 4: Total Treated Patients by Indications in the in the 7MM (2020-2034)
• Figure 5: Market Size of FcRn in the 7MM, in USD million (2020-2034)
• Figure 6: Market Size by Indications in the 7MM, USD million (2020-2034)
• Figure 7: Market Size by Therapies in the 7MM, USD million (2020-2034)
• Figure 8: Market Size by Indications in the United States, USD million (2020-2034)
• Figure 9: Market Size by Therapies in the United States, USD million (2020-2034)
• Figure 10: Market Size by Indications in EU4 and the UK, USD million (2020-2034)
• Figure 11: Market Size by Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 12: Market Size by Indications in Japan, USD million (2020-2034)
• Figure 13: Market Size by Therapies in Japan, USD million (2020-2034)
• Figure 14: Unmet Needs
• Figure 15: Health Technology Assessment
• Figure 16: Reimbursement Process in Germany
• Figure 17: Reimbursement Process in France
• Figure 18: Reimbursement Process in Italy
• Figure 19: Reimbursement Process in Spain
• Figure 20: Reimbursement Process in the United Kingdom
• Figure 21: Reimbursement Process in Japan

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

10. Marketed Therapies

• 10.1. Key Competitors
• 10.2. VYVGART (Efgartigimod): Argenx
  • 10.2.1. Product Description
  • 10.2.2. Regulatory milestones
  • 10.2.3. Other developmental activities
  • 10.2.4. Clinical development
  • 10.2.5. Safety and efficacy
• 10.3. RYSTIGGO (rozanolixizumab-noli): UCB Biopharma
  • 10.3.1. Product Description
  • 10.3.2. Regulatory milestones
  • 10.3.3. Other developmental activities
  • 10.3.4. Clinical development
  • 10.3.5. Safety and efficacy

11. Emerging Therapies

• 11.1. Key Competitors
• 11.2. Batoclimab: Immunovant
  • 11.2.1. Product Description
  • 11.2.2. Other developmental activities
  • 11.2.3. Clinical development
  • 11.2.4. Safety and efficacy
• 11.3. Nipocalimab: Johnson & Johnson Innovative Medicine
  • 11.3.1. Product Description
  • 11.3.2. Other developmental activities
  • 11.3.3. Clinical development
  • 11.3.4. Safety and efficacy

12. FcRn Inhibitor: Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Conjoint Analysis
• 12.4. Key Market Forecast Assumptions
  • 12.4.1. Cost Assumptions and Rebates
  • 12.4.2. Pricing Trends
  • 12.4.3. Analogue Assessment
  • 12.4.4. Launch Year and Therapy Uptakes
• 12.5. Total Market Sizes of FcRn Inhibitors by Indications in the 7MM
• 12.6. The United States
  • 12.6.1. Total Market Size of FcRn Inhibitors in the United States
  • 12.6.2. Market Size of FcRn Inhibitors by Indication in the United States
  • 12.6.3. Market Size of FcRn Inhibitors by Therapies in the United States
• 12.7. EU4 and the UK
  • 12.7.1. Total Market Size of FcRn Inhibitors in EU4 and the UK
  • 12.7.2. Market Size of FcRn Inhibitors by Indications in EU4 and the UK
  • 12.7.3. Market Size of FcRn Inhibitors by Therapies in EU4 and the UK
• 12.8. Japan
  • 12.8.1. Total Market Size of FcRn Inhibitors in Japan
  • 12.8.2. Market Size of FcRn Inhibitor by Indications in Japan
  • 12.8.3. Market Size of FcRn Inhibitors by Therapies in Japan

13. SWOT Analysis

14. KOL Views

15. Unmet Needs

16. Market Access and Reimbursement

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight