In-Depth Market Analysis of Rare Autoimmune Disorders: Myasthenia Gravis, Systemic Sclerosis, Axial Spondyloarthritis, and Idiopathic Inflammatory Myositis | DelveInsight

Rare autoimmune disorders may not be as widely known, but they impact the lives of millions globally. While these conditions may not always be in the spotlight, understanding them is crucial for advancing treatments and improving the quality of life for those affected.

LAS VEGAS, Dec. 17, 2024 /PRNewswire/ -- The rare autoimmune disorders market is evolving rapidly, driven by advancements in biotechnology and an increasing understanding of immune system dysfunctions. With a growing prevalence of autoimmune diseases and an expanding patient population, the demand for targeted therapies is rising. Biopharmaceutical companies are investing heavily in the development of novel treatments, including biologics, monoclonal antibodies, and gene therapies.

The market is also witnessing the emergence of precision medicine, allowing for personalized treatment plans based on genetic and molecular profiling. Additionally, regulatory bodies are fast-tracking approvals for orphan drugs, fostering innovation, and enhancing access to life-saving treatments for patients with rare autoimmune conditions.

DelveInsight has expertise in the rare disease market with an experienced team handling the rare disease domain proficiently. DelveInsight has recently released a series of epidemiology-based market reports on rare autoimmune disorders including Myasthenia Gravis, Systemic Sclerosis, Axial Spondyloarthritis, and Idiopathic Inflammatory Myositis. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034  segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Additionally, the reports feature an examination of prominent companies working with their lead candidates in different stages of clinical development. Let's deep dive into the assessment of these rare autoimmune disorders markets individually.

Myasthenia Gravis Market

Myasthenia gravis is an autoimmune disorder in which the immune system mistakenly attacks the body's tissues. In this condition, the immune attack disrupts the communication between nerves and muscles at the neuromuscular junction. The primary target of the harmful autoantibodies in myasthenia gravis is the nicotinic acetylcholine receptor (AChR), followed by muscle-specific kinase (MuSK) and lipoprotein receptor-related protein 4 (LRP4). As per DelveInsight's estimations, the total diagnosed prevalent cases of myasthenia gravis in the 7MM were 287K cases in 2023 and are projected to increase during the forecast period.

Myasthenia gravis has a wide range of treatment options within its disease landscape. The management typically involves cholinesterase enzyme inhibitors, immunosuppressive drugs, biological therapies, and thymectomy when necessary. For treatment-resistant cases, options such as VYVGART (efgartigimod alfa-fcab), SOLIRIS, ULTOMIRIS (Ravulizumab), plasma exchange/IVIG, and other therapies are significant revenue drivers in the current treatment market. 

In 2023, the total market size for myasthenia gravis across the 7MM reached USD 4.9 billion, with substantial growth expected during the forecast period. The United States led the market in 2023, capturing nearly 76% of the total share. The total market size of the myasthenia gravis treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments.

Myasthenia Gravis Pipeline Therapies and Companies 

• UPLIZNA (Inebilizumab): Horizon Therapeutics/Amgen
• Nipocalimab: Janssen Research & Development, LLC
• ENSPRYNG (satralizumab): Hoffmann-La Roche
• Batoclimab: Immunovant Sciences GmbH
• Gefurulimab (ALXN-1720): Alexion, AstraZeneca Rare Disease
• Pozelimab + Cemdisiran: Regeneron Pharmaceuticals
• KYV-101: Kyverna Therapeutics

For a comprehensive view of the myasthenia gravis market, check out the Myasthenia Gravis Market Assessment

Systemic Sclerosis Market

Systemic sclerosis is a group of rare diseases characterized by the hardening and tightening of the skin. It is an autoimmune disorder that leads to the abnormal growth of connective tissue. In systemic sclerosis, this tissue becomes thick or stiff, which can result in swelling or pain in the muscles and joints.

In the 7MM, the US accounted for the highest number of systemic sclerosis diagnosed prevalent cases, with nearly 102K in 2023. Among the subset-specific cases, the cases of limited systemic sclerosis are much higher than those of diffuse systemic sclerosis and systemic sclerosis sine scleroderma.

Treatment options for systemic sclerosis are primarily focused on managing organ disease manifestations, with immunosuppressants commonly used. A significant advancement occurred in September 2019 when the US FDA approved Boehringer Ingelheim's OFEV as the first and only treatment to slow the progression of pulmonary function decline in patients with systemic sclerosis-associated interstitial lung disease. 

Boehringer Ingelheim's 2023 annual report highlighted the strong and growing adoption of OFEV in systemic sclerosis with interstitial lung disease. In March 2021, Roche's ACTEMRA (Genentech) was also approved by the FDA to slow pulmonary function decline in adults with systemic sclerosis-associated interstitial lung disease, becoming the first biologic therapy for the condition.

In September 2021, Japan's MHLW approved Zenyaku's anti-CD20 monoclonal antibody, RITUXAN. Biosimilars of RITUXAN are already available in Japan for various indications. The introduction of nintedanib, tocilizumab, and rituximab has greatly expanded treatment options for both skin sclerosis and systemic sclerosis-associated interstitial lung disease, marking a new era in the management of systemic sclerosis.

In 2023, the total systemic sclerosis market size was nearly USD 1.8 billion in the 7MM. The largest market size was captured by the US. The introduction of novel treatments for systemic sclerosis, along with a promising pipeline of upcoming products, is likely to spur industry growth.

Systemic Sclerosis Pipeline Therapies and Companies 

• LUMICEF (BRODALUMAB): KYOWA KIRIN
• BENLYSTA (BELIMUMAB): GSK
• SAPHNELO (ANIFROLUMAB): ASTRAZENECA
• UPLIZNA (INEBILIZUMAB): AMGEN (HORIZON THERAPEUTICS)/MITSUBISHI TANABE PHARMA
• VIXARELIMAB (RG6536): ROCHE (GENENTECH)/KINIKSA PHARMACEUTICALS
• AVENCIGUAT (BI 685509): BOEHRINGER INGELHEIM
• DERSIMELAGON (MT-7117): MITSUBISHI TANABE PHARMA
• EFZOFITIMOD: ATYR PHARMA/KYORIN PHARMACEUTICAL
• FIPAXALPARANT: AMGEN (HORIZON THERAPEUTICS)
• VASCULAN (IFETROBAN): CUMBERLAND PHARMACEUTICALS

To gain a deeper understanding of the systemic sclerosis market, be sure to explore the Systemic Sclerosis Market Outlook

Axial Spondyloarthritis Market

Axial Spondyloarthritis (axSpA) is a type of arthritis that primarily causes pain and inflammation in the spine and sacroiliac joints, which connect the spine to the pelvis. It can also affect other joints and is considered a systemic condition, potentially impacting various organs and body parts. 

DelveInsight estimates that in 2023, the total prevalent population of axial spondyloarthritis across the 7MM was 4.5 million, with cases expected to rise significantly during the study period (2020–2034). Specifically, in the US, the diagnosed population of non-radiographic axial spondyloarthritis was around 569K cases in 2023. 

While there is no cure for axial spondyloarthritis, the goal of treatment is to alleviate pain and stiffness in the back and other affected areas, maintain spinal alignment, prevent joint and organ damage, preserve joint function and mobility, and improve the overall quality of life. Early and aggressive treatment is essential to prevent long-term complications and joint damage. A comprehensive treatment approach typically includes medication, non-pharmacological therapies, healthy lifestyle changes, and sometimes surgery.

The US FDA has approved UCB's CIMZIA, Eli Lilly's TALTZ, Novartis's COSENTYX, and AbbVie's RINVOQ to treat both r-axSpA and nr-axSpA. In comparison, Immunex/Amgen's ENBREL, Pfizer's XELJANZ, and Johnson & Johnson's SIMPONI are only approved for ankylosing spondylitis. Furthermore, LUMICEF has been approved in Japan for the treatment of both r-axSpA and nr-axSpA.

DelveInsight predicts that the market for axial spondyloarthritis will expand from USD 9 million in 2023, with significant growth expected through 2034. This increase is driven by the emergence of new therapies and the growing prevalence of the disease. Additionally, the market for axSpA has been steadily advancing, bolstered by improvements in diagnostics, the availability of biologics, and a rising patient population.

The pharmaceutical sector for axSpA has seen significant progress, particularly with the introduction of biological treatments like TNF inhibitors and IL-17 inhibitors, which are now key components of treatment plans. These therapies have not only enhanced patient outcomes but also sparked competition among leading pharmaceutical companies. The market includes both established biologics and newer options, with ongoing research focused on expanding treatment alternatives, including oral small molecule drugs like JAK inhibitors. This shift in treatment approaches is expected to continue fueling market growth in the years ahead.

Discover which therapies are expected to grab major axial spondyloarthritis market share @ Axial Spondyloarthritis Market Report

Idiopathic Inflammatory Myositis Market

Idiopathic inflammatory myositis (IIM) is a rare autoimmune condition that causes inflammation in the muscles, resulting in muscle weakness and, in some instances, skin rashes. It includes various disorders, such as polymyositis, dermatomyositis, inclusion body myositis, and necrotizing autoimmune myopathy. The total diagnosed prevalent cases of idiopathic inflammatory myositis in the 7MM were approximately 191K cases in 2023, which are expected to increase during the forecast period (2020–2034).

The treatment approach for idiopathic inflammatory myositis has evolved into a multifaceted strategy that combines medications, physical therapy, and supportive care. High-dose corticosteroids, such as prednisone or ACTHAR GEL, are typically used as first-line treatments to control inflammation and immune activity. Immunosuppressants like methotrexate, azathioprine, and tacrolimus help reduce reliance on steroids over the long term. When initial therapies are insufficient, biologics such as rituximab are employed for targeted immune suppression. 

Physical therapy plays a key role in maintaining muscle strength and function, and supportive treatments like NSAIDs and sun protection are used to alleviate symptoms. Intravenous Immunoglobulin (IVIG) therapy, including OCTAGAM 10% (approved in the US and Europe) and VENOGLOBULIN-IH 5% (available in Japan), is also an option. For severe, treatment-resistant cases, IV cyclophosphamide may be considered, although its use is limited due to the risk of severe side effects. 

Treatment plans are tailored to each patient based on disease severity and response, aiming to balance effectiveness and minimize side effects. There is a significant need for new treatments, as current options often do not fully address the condition.

According to DelveInsight's analysis, the market is set for significant growth from USD 447 million in the 7MM in 2023 at a CAGR of ~21% by 2034. As per the estimates, among the therapies currently in use, immunoglobulins held the largest market share, generating USD 270.3 million in revenue in 2023 across the 7MM.

This growth is mainly driven by the introduction of new therapies along with the increasing number of cases, influenced by risk factors like genetic predisposition, viral infections, and UV exposure, which is anticipated to further heighten the demand for effective treatments.

Idiopathic Inflammatory Myositis Pipeline Therapies and Companies 

• Dazukibart PF-06823859 (anti-beta interferon): Pfizer
• Efgartigimod: Argenx
• SAPHNELO (Anifrolumab): AstraZeneca
• Brepocitinib: Priovant Therapeutics/Pfizer
• HIZENTRA: CSL Behring
• Empasiprubart: Argenx
• Ulviprubart (ABC008): Abcuro, Inc.
• Daxdilimab: Amgen
• Nipocalimab: Janssen
• Froniglutide (PF1801): Immunoforge
• GLPG3667: Galapagos NV
• Enpatoran (M5049): Merck KGaA (EMD Serono Research & Development Institute)
• CABA-201: Cabaletta Bio
• Umbilical Cord Lining Stem Cells (ULSC): Restem

Explore in-depth for a comprehensive understanding of the Idiopathic Inflammatory Myositis Clinical Trials

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SOURCE DelveInsight Business Research, LLP