FcRn Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast - 2034

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.

This 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, Sjögren'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.

The 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.

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.