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市場調査レポート
商品コード
1376841
皮膚筋炎市場 - 市場の洞察、疫学、市場予測:2032年Dermatomyositis - Market Insight, Epidemiology and Market Forecast - 2032 |
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カスタマイズ可能
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皮膚筋炎市場 - 市場の洞察、疫学、市場予測:2032年 |
出版日: 2023年11月01日
発行: DelveInsight
ページ情報: 英文 224 Pages
納期: 1~3営業日
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皮膚筋炎の診断有病率は、人口と認知度の増加により米国で増加しています。2022年、皮膚筋炎の市場規模は主要7ヶ国諸国の中で米国が最も大きく、約1億3,930万米ドルを占めました。2032年までに増加すると予想されています。
副腎皮質ステロイドが主要な治療薬として最も処方されているにもかかわらず、免疫グロブリン製剤はOCTAGAMが承認されたことにより、高コストが高収益につながったため、最大の収益を上げました。2022年の米国における免疫グロブリンの売上は8,880万米ドルで、米国における皮膚筋炎市場全体の64%近くを占めています。
皮膚筋炎の治療オプションは、コルチコステロイドを含む適応外投薬が中心ですが、これらは骨粗鬆症、感染症感受性の増加、クッシングロイドの特徴など、いくつかの副作用や有害事象を伴います。研究の進歩により、C5補体、IFNB1、FcRnを標的とする新規分子が発見され、将来有効な選択肢となる可能性があります。新たな治療薬であるブレポシチニブ(PF6700841)、ULTOMIRIS(ravulizumab)(ALXN1210)、エフガルチギモド、PF-06823859(抗βインターフェロン)、HIZENTRA(IgPro20)は、皮膚筋炎の市場規模にプラスの変化をもたらす可能性があります。
主要7ヶ国における皮膚筋炎の総市場規模は、2022年に約2億3,060万米ドルであり、予測期間中(2023-2032年)に拡大すると予測されています。
主要7ヶ国の中で米国は皮膚筋炎の市場シェアが最も大きく、2022年の収益は約1億3,930万米ドルで、疾患に対する認知度の向上、現在承認されている治療法の成長、新興治療法の上市により、調査期間中にCAGR 17.0%で拡大すると予測されています。
EU4諸国と英国の中で、2022年の皮膚筋炎の市場規模はドイツが最大で、英国がそれに続き、スペインは最下位でした。日本は主要7ヶ国の中で2番目に大きな皮膚筋炎市場を占め、2022年の収益は約3,080万米ドルであったが、予測期間中に変化することが予想されます。
当レポートでは、主要7ヶ国における皮膚筋炎市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
DelveInsight's "Dermatomyositis - Market Insights, Epidemiology, and Market Forecast - 2032" report delivers an in-depth understanding of the dermatomyositis historical and forecasted epidemiology as well as the market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The dermatomyositis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM dermatomyositis market size from 2019 to 2032. The report also covers current dermatomyositis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2019-2032
Idiopathic inflammatory myopathies (IIM) are a heterogeneous group of connective tissue disorders characterized by progressive muscle weakness. IIM is the umbrella term that includes 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 characterized by muscle inflammation (myositis) and skin inflammation (dermatitis). Proximal muscle weakness is a hallmark feature, affecting muscles close to the trunk, such as those in the thighs and upper arms, including heliotrope rash (purplish discoloration around the eyes), Gottron's papules (reddish bumps on knuckles), and photosensitive rash on sun-exposed areas.
The onset of the disease is usually insidious or acute, with a waxing and a waning course. The signs and symptoms of dermatomyositis can appear suddenly or develop gradually over time. Individuals with dermatomyositis also develop characteristic skin changes that, in some cases, may precede muscle weakness. Systemic symptoms such as fever, malaise, and weight loss are also present.
Dermatomyositis is a complex condition with variable presentations and often requires a comprehensive assessment to prevent misdiagnosis. Diagnosing dermatomyositis involves a combination of clinical evaluation, laboratory tests, imaging studies, and, in some cases, muscle biopsies.
Dermatomyositis often has elevated creatine kinase (CK) at presentation, which may also raise suspicion of the disease in a patient presenting with weakness, leading to difficulty in activities of daily living.
Key diagnostic criteria include muscle weakness, characteristic skin rash, elevated muscle enzymes, myositis-associated enzyme levels, electromyography, and muscle biopsy. Muscle biopsy is the most accurate test to confirm the diagnosis and to exclude other causes of muscle weakness or skin rash. However, choosing the right muscle for a biopsy is crucial to prevent a missing diagnosis.
Further, the development of diagnostic guidelines like the European League Against Rheumatism/American College of Rheumatology classification Criteria for Adult and Juvenile IIM, Clinical Practice Guidance for Juvenile Dermatomyositis (JDM) 2018, Japan have improved diagnosis.
There is no cure for dermatomyositis; however, medication can reduce inflammation and vasculitis, invariably minimize symptomatology, and improve the patient's quality of life. The recent approval of OCTAGAM and the presence of several management guidelines have revolutionized the treatment landscape of dermatomyositis. Several other off-label medications, including corticosteroids, immunosuppressants, antimalarial drugs, antibiotics, and topical ointments, are combined to eliminate symptoms.
Management of dermatomyositis typically involves a multidisciplinary approach. Line-wise treatment aims to suppress inflammation and relieve associated symptoms. The first-line treatment is systemic glucocorticoids with or without immunosuppressant (methotrexate, cyclosporine, mycophenolate, azathioprine, and others), biologic (rituximab, abatacept, and others). Initially, prednisolone is given at high doses for the first few months until the muscle enzyme levels decline and muscle strength improves. Once alternate diagnoses are ruled out, steroid-sparing immunosuppressant can be added. If biologics fails, IVIG or a combination of immunosuppressants are used as a second-line therapy.
Moreover, exercise and physical therapy maintain muscle functioning and mobility. Treatment may also include managing internal organ involvement, such as interstitial lung disease (ILD) or cardiac issues.
Furthermore, patients who do not respond to these conventional interventions or who relapse after an initial response have refractory disease and require the initiation of more aggressive therapies. Treatment options for resistant cases include using rituximab, mycophenolate mofetil, calcineurin inhibitors, IVIG, and cyclophosphamide.
As the market is derived using a patient-based model, the dermatomyositis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of dermatomyositis, age-specific diagnosed prevalent cases of dermatomyositis, gender-specific diagnosed prevalent cases of dermatomyositis, severity-specific diagnosed prevalent cases of dermatomyositis, chronicity-specific diagnosed prevalent cases of dermatomyositis, and comorbidity-specific diagnosed prevalent cases of dermatomyositis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.
In the US, females had a higher preponderance of dermatomyositis than males. There were approximately 26,051 females diagnosed with dermatomyositis while nearly 12,215 males in 2022
The drug chapter segment of the dermatomyositis report encloses a detailed analysis of dermatomyositis, currently used drugs, and mid-stage (Phase II and Phase I) pipeline drugs. It also helps understand the dermatomyositis 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.
OCTAGAM 10% (immune globulin intravenous) is the first and only intravenous immunoglobulin (IVIg) product indicated for the treatment of adult dermatomyositis.
IVIG replacement therapy is the apparent treatment of choice for humoral primary immunodeficiency, such as dermatomyositis, as these patients cannot mount an effective immune response toward pathogens. IVIg acts as a corticosteroid-sparing agent and represents a unique treatment option for dermatomyositis patients. They are safe and effective treatment options, especially in patients showing no response or incomplete response to corticosteroids or who experience severe side effects. It is made from healthy human blood with a high level of certain defensive substances (antibodies), which help fight infections and are also used to increase the blood count.
In July 2021, the US FDA approved Octapharma's OCTAGAM 10% for adult dermatomyositis, while in 2021, Octapharma received approval from the European authorities for OCTAGAM 10% for the treatment of adults with dermatomyositis. Following the EU approval, OCTAGAM 10% received national approval in Germany in May 2021. In May 2017, the US FDA granted Octapharma's OCTAGAM 10% orphan drug designation for treating dermatomyositis.
Brepocitinib is a small molecule, a potential first-in-class dual inhibitor of tyrosine kinase (TYK2) and Janus kinases1 (JAK1). Its novel mechanism of action potentially provides greater efficacy in multiple highly inflammatory autoimmune diseases than agents that inhibit either TYK2 or JAK1 alone.
The drug is under investigation for dermatomyositis in a Phase III clinical trial, with top-line results expected by the second half of 2025.
ULTOMIRIS (ravulizumab/ALXN1210) is the first and only long-acting C5 complement inhibitor that offers immediate, complete, and sustained complement inhibition. Ravulizumab works by inhibiting the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated uncontrolled, the complement cascade over-responds, leading the body to attack its healthy cells. ULTOMIRIS will be administered intravenously every 8 weeks in adult patients, following a loading dose. The drug is undergoing a Phase II/III clinical trial in adult participants with dermatomyositis, and according to the company, data from the trial is anticipated by Q1 2024. Further, multiple other trials are ongoing to treat NMOSD, thrombotic microangiopathy, paroxysmal nocturnal hemoglobinuria, lupus nephritis, chronic kidney disease, and others.
Note: Detailed emerging therapies assessment will be provided in the final report.
According to most guidelines, the treatment should start with corticosteroids, and depending on the response, combination therapy should be added and/or nonpharmacologic interventions considered.
Corticosteroids, such as prednisone or prednisolone, are commonly prescribed medications in treating dermatomyositis. These medications are a mainstay in managing the inflammatory and autoimmune aspects of the disease. In dermatomyositis, inflammation plays a significant role in the muscle and skin symptoms. Corticosteroids work by suppressing the immune response and reducing inflammation in affected tissues. High doses of corticosteroids are prescribed initially, as this high-dose "induction therapy" aims to control the disease and its symptoms quickly. After the initial high-dose treatment phase, the dosage of corticosteroids is usually gradually reduced (tapered) to find the lowest effective dose to maintain symptom control. This is done to minimize the risk of side effects associated with long-term corticosteroid use.
Immunosuppressants and immunomodulators are used as adjuvants with glucocorticoids for boosting efficacy and decreasing the dose of corticosteroids. Therapy with immunosuppressants such as azathioprine, methotrexate, mycophenolate mofetil, cyclophosphamide, tacrolimus, or cyclosporine may be beneficial for some affected individuals who have an insufficient response to steroid therapy alone, dose-limiting adverse effects, or frequent relapses. Immunosuppressive drugs are prescribed to dampen autoimmune responses and reduce inflammation. They help control inflammation and reduce the need for high doses of corticosteroids, inhibit the activity of certain immune cells, and even help in symptom management.
There is no cure for dermatomyositis; however, medication can reduce inflammation and vasculitis, invariably minimize symptomatology, and improve the patient's quality of life. The recent approval of OCTAGAM and the presence of several management guidelines, including the British Society for Rheumatology guideline, the Japanese Society of Rheumatology guideline, and others, have revolutionized the treatment landscape of dermatomyositis. Several other off-label medications, including corticosteroids, immunosuppressants, antimalarial drugs, antibiotics, and topical ointments, are combined to eliminate symptoms.
The current market has been covered by various symptomatic therapies like corticosteroids, including glucocorticoids, immunosuppressants like azathioprine and methotrexate, cyclosporine, mycophenolate mofetil, etc., intravenous immunoglobulins including OCTAGAM 10%, biologics like rituximab, abatacept, etc., and other therapies like NSAIDs, antimalarials, etc., especially in refractory cases or cases of relapse that are used across the 7MM, which presents minor variations in the overall prescription pattern. Corticosteroids, immunosuppressants, intravenous immunoglobulins, biologics, and other therapies like NSAIDs, antimalarials, etc., are the major drug classes considered for the current treatment in the forecast model.
Key players Priovant Therapeutics/Pfizer's brepocitinib (PF6700841), AstraZeneca's (Alexion) ULTOMIRIS (ravulizumab) (ALXN1210), Argenx's efgartigimod, Pfizer's PF-06823859 (anti-beta Interferon), and CSL Behring's HIZENTRA (IgPro20) are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of dermatomyositis.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, Priovant Therapeutics/Pfizer's brepocitinib (PF6700841), a TYK2 and JAK1 inhibitor, with an anticipated entry by 2026 in the US, is predicted to have a slow-medium uptake during the forecast period.
The report provides insights into therapeutic candidates in Phase II and Phase I. It also analyzes key players involved in developing targeted therapeutics.
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for dermatomyositis.
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape of dermatomyositis, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like Southern Illinois University School of Medicine, the University of Washington, the University Hospital of Tours, Navarra Institute for Health Research, the University of Tokyo School of Medicine, and the National Center of Neurology and Psychiatry were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or dermatomyositis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
According to our primary research analysis, an early diagnosis and the proper course of therapy are crucial to manage the illness and enhance long-term outcomes effectively. Corticosteroids, though the primary treatment, are associated with side effects, and the approved IVIG, OCTAGAM 10%, has not been able to capture the market as anticipated. The standard of care has suboptimal effectiveness and significant safety risks. Moreover, therapies centered on corticosteroids and immunosuppressants are often ineffective at controlling symptoms and/or maintaining response in many patients. Prolonged use of these therapies is associated with numerous complications that may contribute to morbidity. Common side effects of corticosteroids are osteoporosis, cardiovascular infections, and metabolic disorders like diabetes. The clinical course suggests poor prognosis and poor treatment outcomes. Despite being treated with currently available therapies, patients often experience flares contributing to disability and loss of productivity. Hence, there is a need for safer and more effective treatment options that will improve the outcomes of the patients.
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint 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.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. To analyze the effectiveness of these therapies, we have calculated their attributed analysis by giving them scores based on their effectiveness in other related conditions to analyze the effectiveness of these therapies due to the limited availability of efficacy data in dermatomyositis for most products.
The therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.
In 2017, the company started a new financial support program for immunology disease patients. The Octapharma copay assistance is available to patients receiving OCTAGAM IVIg (Human) 10% liquid preparation or having a prescription to begin the therapy in those aged 18 or older with chronic immune thrombocytopenic purpura. The new program offers eligible patients a maximum of USD 5,000 in copay assistance each calendar year for copay, co-insurance, and deductible expenses associated with their treatment without regard for their ability to pay. To participate in the program, patients must have third-party commercial insurance.
However, the company plans to offer financial assistance to help cover the cost of treating dermatomyositis. Eligible patients with commercial health insurance will access the company's Copay Assistance Program, which will cover out-of-pocket costs, such as co-insurance, copay expenses, and deductibles, up to USD 2,500 per year. This assistance is provided without regard for the ability to pay. By law in the US, the company cannot offer this coverage to those with government plans such as Medicare, Medicaid, or Tricare. Patients without insurance or who have lost their insurance may also get assistance through a compassionate use program.
Several private insurers like Cigna Policy in the US cover dermatomyositis under critical illness insurance. Cigna covers immunoglobulin products when considered medically necessary on meeting the specific medical necessity criteria by condition and non-covered product criteria.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.