Dermatomyositis Market Outlook 2032 | Insights into Evolving Market Dynamics, Growth Opportunities, Epidemiology Trends, Emerging Therapies, Treatment Algorithms, and Key Companies

Dermatomyositis Market Outlook 2032 | Featuring Priovant Therapeutics, CSL Behring, Alexion Pharmaceuticals, AstraZeneca, Argenx, Pfizer, and Janssen.

DelveInsight's report, "Dermatomyositis Market Insights, Epidemiology, and Market Forecast 2032," offers a comprehensive analysis of the disease, including historical and projected epidemiology. It details the Dermatomyositis market size, share, trends, and growth opportunities across the seven major markets (7MM), which include the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

The report examines emerging therapies, current treatment practices, and the market share of individual treatments, along with current and forecasted market sizes from 2019 to 2032. Additionally, it evaluates treatment algorithms, key drivers and barriers affecting market growth, and unmet medical needs, providing valuable insights into potential opportunities and the overall market landscape.

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Key highlights from the dermatomyositis market report:

The diagnosed prevalence of dermatomyositis in the US has been rising, driven by population growth and increased awareness of the condition. Updated international diagnostic and clinical guidelines facilitate evidence-based therapeutic approaches and screening strategies, improving identification rates.

Current treatment regimens for dermatomyositis adopt a multidisciplinary approach aimed at suppressing inflammation and alleviating symptoms. First-line treatment typically involves corticosteroids, particularly glucocorticosteroids, while immunosuppressants (such as methotrexate, cyclosporine, and mycophenolate), biologics (including rituximab and abatacept), and immunoglobulins are used as adjunct therapies or for relapse/refractory cases. Nonpharmacological interventions, like exercise and physical therapy, play a crucial role in enhancing muscle strength, mobility, and overall function.

Significant advances in understanding the disease and its pathogenesis have led to the identification of novel mechanisms of action targeting C5 complement, IFNß1, FcRn, and others. Recently, the US FDA approved Octapharma's OCTAGAM 10% for treating adult dermatomyositis.

Dermatomyositis is a complex condition with diverse presentations, often requiring comprehensive assessments to avoid misdiagnosis. Obtaining accurate epidemiological data is challenging due to the rarity of the condition and inconsistencies in reporting and diagnosis across different regions. Limited large-cohort studies further complicate this understanding.

In 2022, the dermatomyositis market size was highest in the US among the seven major markets, reaching approximately USD 139.3 million, with expectations for growth by 2032. While corticosteroids remain the most frequently prescribed treatments, immunoglobulins, particularly OCTAGAM, generated the highest revenue-USD 88.8 million in the US in 2022-capturing nearly 64% of the total market.

Therapeutic options for dermatomyositis largely revolve around off-label medications, including corticosteroids, which come with various side effects and adverse events, such as osteoporosis and increased infection risk. Advances in research have led to the discovery of novel agents targeting C5 complement, IFNß1, and FcRn, which may provide effective future treatment options.

Emerging therapies like brepocitinib (PF6700841), ULTOMIRIS (ravulizumab), efgartigimod, PF-06823859 (anti-beta Interferon), and HIZENTRA (IgPro20) have the potential to significantly influence the dermatomyositis market. AstraZeneca's ULTOMIRIS, the first long-acting C5 complement inhibitor, promises immediate and sustained complement inhibition, offering hope for refractory patients and is expected to see moderate uptake following its US market entry.

CSL Behring's HIZENTRA is anticipated to enter the US market by 2025, projected to capitalize on its first-mover advantage in a market that requires more approved products. It is expected to meet the needs of patients requiring add-on treatment to corticosteroids, with anticipated revenue of USD 2.1 million by 2025.

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Dermatomyositis Overview

Idiopathic inflammatory myopathies (IIM) encompass a diverse group of connective tissue disorders characterized by progressive muscle weakness. This term includes conditions such as dermatomyositis, polymyositis (PM), overlap myositis (OM), sporadic inclusion body myositis (IBM), and necrotizing autoimmune myopathy (NAM), also known as immune-mediated necrotizing myopathy (IMNM).

Dermatomyositis is a rare autoimmune disorder marked by both muscle inflammation (myositis) and skin inflammation (dermatitis). A key feature is proximal muscle weakness, affecting muscles close to the trunk, such as those in the thighs and upper arms. Patients may also present with distinctive skin manifestations, including heliotrope rash (purplish discoloration around the eyes), Gottron's papules (reddish bumps on the knuckles), and a photosensitive rash on sun-exposed areas.

The onset of dermatomyositis can be insidious or acute, with symptoms that may wax and wane. Signs can appear suddenly or develop gradually, and in some cases, skin changes may precede muscle weakness. Systemic symptoms like fever, malaise, and weight loss are also common.

The disease can have systemic involvement, affecting multiple organs and leading to various complications. It is a complex condition that manifests differently in adults (ADM) and children (JDM). Dermatomyositis exhibits a bimodal age distribution, with most juvenile cases presenting between ages 5 and 14, while adult cases typically arise in the fifth and sixth decades of life. Although the pathogenesis may be similar for both groups, there are significant differences in clinical features, associated disorders, and outcomes.

While dermatomyositis can affect individuals of any gender, it is more prevalent in females, consistent with many autoimmune diseases. The exact cause remains unclear, but it likely involves a combination of genetic susceptibility and environmental triggers. The disease can have a varied course, with many individuals experiencing chronic symptoms or requiring ongoing treatment beyond 24 months post-diagnosis.

Primarily affecting the muscles and skin, dermatomyositis is associated with several comorbidities typical of chronic conditions. Interstitial lung disease (ILD) is a serious complication that can significantly impact lung function, although not all patients develop it. Adults with dermatomyositis face an increased risk of cancer and may also experience gastrointestinal issues, such as dysphagia or esophagitis. Additionally, there is a heightened risk of cardiovascular problems, including vasculitis and myocarditis, along with complications like calcinosis, Raynaud's phenomenon, joint pain, and inflammation.

Dermatomyositis Causes:

The exact cause of dermatomyositis is unknown, but it is believed to involve a combination of genetic predisposition, environmental triggers, and autoimmune factors. In some cases, it may be associated with certain cancers, such as ovarian, lung, or gastrointestinal cancers, although this link is not fully understood.

Dermatomyositis Symptoms:
Muscle Weakness: Symmetrical muscle weakness, typically affecting the muscles closest to the trunk, such as those in the hips, thighs, shoulders, and upper arms. Weakness may progress gradually over weeks to months.
Skin Rash: Characteristic skin rash, often seen as a reddish-purple discoloration, typically on the face, eyelids, knuckles, elbows, knees, or chest. This rash may be accompanied by swelling and tenderness.
Fatigue: Generalized fatigue and malaise, which may be severe and debilitating.
Difficulty Swallowing: Weakness in the muscles involved in swallowing, leading to difficulty swallowing (dysphagia).
Joint Pain: Joint pain and inflammation, particularly in the wrists, fingers, and knees.
Other Symptoms: Additional symptoms may include fever, weight loss, lung inflammation (interstitial lung disease), and inflammation of the blood vessels (vasculitis).

Dermatomyositis Diagnosis:

Diagnosing dermatomyositis involves a combination of clinical evaluation, blood tests, imaging studies, and sometimes muscle biopsy. Key diagnostic tests include:

Blood Tests: To check for elevated levels of muscle enzymes (creatine kinase, aldolase) and autoantibodies associated with dermatomyositis, such as anti-Jo-1 and anti-Mi-2 antibodies.
Muscle Biopsy: Removal and microscopic examination of a small sample of muscle tissue to look for characteristic changes, such as inflammation and muscle fiber damage.
Imaging Studies: MRI or CT scans may be performed to assess muscle inflammation and detect abnormalities.

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Dermatomyositis Treatment Market:

There is currently no cure for dermatomyositis; however, medications can effectively reduce inflammation and vasculitis, alleviate symptoms, and enhance the patient's quality of life. The recent approval of OCTAGAM, along with various management guidelines, has significantly transformed the treatment landscape for dermatomyositis. Additional off-label medications, such as corticosteroids, immunosuppressants, antimalarials, antibiotics, and topical ointments, are often used in combination to manage symptoms.

The management of dermatomyositis typically involves a multidisciplinary approach focused on suppressing inflammation and relieving symptoms. The first-line treatment usually consists of systemic glucocorticoids, with or without immunosuppressants (such as methotrexate, cyclosporine, mycophenolate, or azathioprine) and biologics (like rituximab or abatacept). Initially, high doses of prednisolone are administered for a few months until muscle enzyme levels decrease and muscle strength improves. Once other diagnoses are ruled out, steroid-sparing immunosuppressants can be introduced. If biologics are ineffective, intravenous immunoglobulin (IVIG) or a combination of immunosuppressants may be used as a second-line treatment.

Exercise and physical therapy are essential for maintaining muscle function and mobility. Treatment may also address complications involving internal organs, such as interstitial lung disease (ILD) or cardiac issues.

For patients who do not respond to conventional treatments or who experience a relapse after initial improvement, aggressive therapies may be necessary. Options for treating resistant cases include rituximab, mycophenolate mofetil, calcineurin inhibitors, IVIG, and cyclophosphamide.

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Dermatomyositis Market

There is currently no cure for dermatomyositis, but medications can help reduce inflammation and vasculitis, alleviating symptoms and improving the patient's quality of life. The recent approval of OCTAGAM and several management guidelines, including those from the British Society for Rheumatology and the Japanese Society of Rheumatology, have transformed the treatment landscape for dermatomyositis. Additional off-label medications, such as corticosteroids, immunosuppressants, antimalarial drugs, antibiotics, and topical ointments, are often combined to manage symptoms.

Nonpharmacological management options, including dietary changes and physiotherapy, are also important. For therapy-resistant cases, adjunctive treatments such as plasmapheresis, extracorporeal photochemotherapy, and total body irradiation may be considered. While surgery is not common for dermatomyositis, gastrotomy may be beneficial for severe esophageal dysfunction, and surgical removal of calcific nodules may be performed if necessary. For ophthalmologic care of dry eye, preventive measures can include environmental adjustments, patient education, dietary modifications (including fatty acid supplementation), ocular lubricants, and proper eyelid hygiene.

First-line treatment for muscle disease in dermatomyositis typically involves systemic glucocorticoids, with or without immunosuppressants. Both oral and parenteral therapies are utilized, with the choice of agent based on disease severity. Prednisolone, commonly used at doses of 0.5-1 mg/kg body weight daily, helps reduce inflammation and immune response by affecting antigen processing and T-cell activation. In cases of acute onset or severe symptoms, high-dose pulsed therapy (250-1,000 mg daily for 3-5 days) may be employed. Although no standardized steroid regimen exists, patients are regularly assessed, as muscle enzyme levels can take about six weeks to normalize, with muscle strength improvements potentially taking up to three months. After achieving an adequate response, the dosage of systemic steroids is gradually tapered, with treatment typically lasting between 9 and 12 months. However, prolonged use of high-dose glucocorticoids beyond six weeks can lead to myopathy.

If patients show insufficient improvement after three months of prednisolone therapy, adjuvant treatments are usually necessary. Immunosuppressants and immunomodulators may be added to enhance efficacy and reduce corticosteroid doses. Options include azathioprine, methotrexate, mycophenolate mofetil, cyclophosphamide, tacrolimus, or cyclosporine for individuals who do not respond adequately to steroids alone.

For moderate to severe cases, a combination of steroids and a steroid-sparing immunosuppressant, such as methotrexate, azathioprine, or mycophenolate mofetil, is recommended. Monotherapy with steroids is generally reserved for mild cases due to the delayed onset of steroid-sparing treatments.

Patients who do not respond to therapy with steroids, azathioprine, or methotrexate are classified as having resistant disease. Treatment options for these cases may include rituximab, mycophenolate mofetil, calcineurin inhibitors, IVIG, and cyclophosphamide.

Intravenous immunoglobulin (IVIG) is an effective treatment for dermatomyositis, one of the few therapies shown to be beneficial in clinical trials. Derived from purified human plasma, IVIG has been used off-label as a second or third-line therapy, often in combination with immunosuppressants. It has also been recommended in European guidelines as a glucocorticoid-sparing agent for dermatomyositis patients. A typical dose of IVIG (2 g/kg) can be effective for patients with resistant disease, especially those with esophageal, throat, or lung involvement.

In May 2021, the US FDA and EU approved OCTAGAM 10% (immune globulin intravenous [human]), marking it as the first and only IVIG product specifically indicated for adult dermatomyositis, addressing a significant need for licensed therapies in the US and EU markets. However, OCTAGAM 10% carries a boxed warning for risks of thrombosis, renal dysfunction, and acute renal failure. Several biologic drugs are currently used off-label for dermatomyositis treatment, with B-cell-depleting therapies like rituximab showing promise for refractory cases.

The current market includes various symptomatic therapies such as corticosteroids (including glucocorticoids), immunosuppressants (like azathioprine and methotrexate), intravenous immunoglobulins (including OCTAGAM 10%), biologics (such as rituximab and abatacept), and other therapies (like NSAIDs and antimalarials). These treatments are utilized across the 7MM, reflecting some variations in prescription patterns.

Key players such as Priovant Therapeutics/Pfizer with brepocitinib (PF6700841), AstraZeneca (Alexion) with ULTOMIRIS (ravulizumab) (ALXN1210), Argenx with efgartigimod, Pfizer with PF-06823859 (anti-beta Interferon), and CSL Behring with HIZENTRA (IgPro20) are currently evaluating their lead candidates in various stages of clinical development for the treatment of dermatomyositis.

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Dermatomyositis Epidemiology Assessment

In 2022, the total number of diagnosed prevalent cases of dermatomyositis across the seven major markets (7MM) was estimated at approximately 71,351. Among these cases, nearly 9% were juvenile, while 91% were adult cases, with expectations for growth during the forecast period.

The United States had the highest proportion of diagnosed cases, accounting for nearly 54% of the total, while Spain reported the lowest at around 4%. In the US alone, there were approximately 38,266 diagnosed cases of dermatomyositis in 2022, with numbers projected to rise by 2032.

Within the EU4 and the UK, Germany led with about 5,280 diagnosed cases, followed by the UK with approximately 4,568 cases and Italy with around 3,978 cases. The total number of cases in these regions is also expected to increase by 2032.

In terms of age-specific prevalence in the EU4 and the UK, the 60-79 age group accounted for the highest number of cases at nearly 9,181, while the 0-17 age group had the fewest in 2022, with expectations for growth in all age categories by 2032.

In the US, dermatomyositis was more common in females than in males, with about 26,051 diagnosed female cases compared to nearly 12,215 male cases in 2022.

In the EU4 and the UK, mild cases of dermatomyositis outnumbered moderate to severe cases, with Germany reporting nearly 2,950 mild cases and approximately 2,329 moderate to severe cases in 2022.

DelveInsight estimates indicate that, in 2022, among the total diagnosed prevalent cases in the US, there were approximately 11,480 acute cases and 26,786 chronic cases, both expected to rise during the study period.

In Japan, the diagnosed prevalent cases associated with comorbidities included interstitial lung disease (ILD) at nearly 2,462 cases, cardiovascular disease (CVD) at 2,206 cases, cancer malignancies at 511 cases, and other conditions such as osteoporosis, dysphagia, Raynaud's syndrome, and calcinosis at 7,269 cases, all projected to change throughout the study period.

The Report Covers the Dermatomyositis Epidemiology, Segmented by -
Total Prevalent Cases of Dermatomyositis
Total Diagnosed Prevalent Cases of Dermatomyositis
Gender-specific Diagnosed Prevalent Cases of Dermatomyositis
Age-specific Diagnosed Prevalent Cases of Dermatomyositis
Severity-specific Diagnosed Prevalent Cases of Dermatomyositis
Classification-Specific Diagnosed Prevalent Cases of Dermatomyositis
Chronicity-Specific Diagnosed Prevalent Cases of Dermatomyositis
Co-morbidity-Specific Diagnosed Prevalent Cases of Dermatomyositis
Treated cases of Dermatomyositis

Dermatomyositis Drugs Uptake and Pipeline Development Activities

The drug uptake section focuses on the rate of uptake of the potential drugs recently launched in the Dermatomyositis market or expected to be launched during the study period. The analysis covers the Dermatomyositis market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Dermatomyositis pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyses recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

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Dermatomyositis Therapeutics Analysis

The goal of treatment is to reduce inflammation and vasculitis, consistently alleviate symptoms, and improve the patient's quality of life. Achieving this requires the early initiation of a treatment plan, which calls for a collaborative approach among healthcare professionals. Managing dermatomyositis typically involves administering steroids, particularly high-dose prednisolone, to address muscle weakness effectively. Additionally, many leading companies worldwide are actively working to advance therapeutic options for dermatomyositis treatment.

Leading Companies in the Dermatomyositis Therapeutics Market Include:
Priovant Therapeutics
CSL Behring
Alexion Pharmaceuticals
AstraZeneca
Argenx
Pfizer
Janssen
And Many Others

The Report Covers the In-depth Assessment of the Emerging Drugs & Key Companies. Download the Sample Report to Learn More @ https://www.delveinsight.com/report-store/dermatomyositis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Table of Contents

1. Key Insights
2. Executive Summary
3. Dermatomyositis Competitive Intelligence Analysis
4. Dermatomyositis Market Overview at a Glance
5. Dermatomyositis Disease Background and Overview
6. Dermatomyositis Patient Journey
7. Dermatomyositis Epidemiology and Patient Population (In the US, EU5, and Japan)
8. Dermatomyositis Treatment Algorithm, Current Treatment, and Medical Practices
9. Dermatomyositis Unmet Needs
10. Key Endpoints of Dermatomyositis Treatment
11. Dermatomyositis Marketed Products
12. Dermatomyositis Emerging Drugs and Latest Therapeutic Advances
13. Dermatomyositis Seven Major Market Analysis
14. Attribute Analysis
15. Dermatomyositis Market Outlook (In US, EU5, and Japan)
16. Dermatomyositis Access and Reimbursement Overview
17. KOL Views on the Dermatomyositis Market
18. Dermatomyositis Market Drivers
19. Dermatomyositis Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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