Dublin, Dec. 11, 2024 (GLOBE NEWSWIRE) -- The "FcRn Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.
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 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.
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.
Key Highlights from the Report
- 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.
FcRn Inhibitors Epidemiology
- 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.
Key Updates on FcRn Inhibitors
- 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.
For more information about this report visit https://www.researchandmarkets.com/r/7q8xuo
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