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市場調査レポート
商品コード
1374830
びまん皮膚硬化型全身性強皮症(DcSSc)治療薬の世界市場-2023年~2030年Global Diffuse cutaneous systemic sclerosis(DcSSc) Drugs Market - 2023-2030 |
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適宜更新あり
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びまん皮膚硬化型全身性強皮症(DcSSc)治療薬の世界市場-2023年~2030年 |
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 187 Pages
納期: 即日から翌営業日
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びまん皮膚硬化型全身性強皮症(DcSSc)は全身性強皮症(全身性硬化症)の亜型であり、皮膚の硬化(線維化)と全身の多くの臓器の障害を特徴とします。この病気は年齢に関係なく発症しますが、主に40~50歳の人が罹患します。口の渇きや歯の病変が起こることもあります。関節痛(arthralgias)、筋肉痛、脱力感、けいれん、手指や足指の先端の破壊(骨端溶解)などが頻繁に生じます。肺(線維症または肺高血圧症)や腎臓に深刻な問題が起こることもあります。
さらに、この疾患の正確な原因は不明です。びまん皮膚硬化型全身性強皮症の治療法は今のところありません。治療は症状によって異なりますが、薬物療法や手術が行われます。レイノー現象はカルシウム拮抗薬で治療できます。胃の逆流に対してはプロトンポンプ阻害薬が投与されます。重度の石灰沈着症に対しては外科的切除が必要となります。最近の重度の皮膚病変を有する症例または進行性の肺線維症では、免疫抑制剤を併用した低用量のコルチコステロイドが必要です。肺動脈性肺高血圧症の場合は、肺血管拡張薬が投与されます。
びまん皮膚硬化型全身性強皮症の治療に対する革新的な薬剤に対する需要の増加は、予測期間にわたって市場を牽引すると予想されます。びまん皮膚硬化型全身性強皮症の既存の治療法は十分な効果が得られなかったり、副作用が大きかったりするため、こうしたアンメット・メディカル・ニーズに対応できる革新的な薬剤に対する需要が高まっています。革新的医薬品は、より良い疾患管理のための代替または補完的な治療オプションを提供することで、びまん皮膚硬化型全身性強皮症の管理に関連するアンメットニーズを解決することを目的としています。
さらに、びまん皮膚硬化型全身性強皮症の治療においてより良い結果を示す革新的な薬剤の開発のために、多くの臨床試験が行われています。新薬の有効性と安全性を評価する臨床試験で良好な結果が得られれば、需要が高まる可能性があります。新薬が臨床試験でDcSScの治療において有意な改善を示せば、採用が増える可能性が高いです。
例えば、2023年2月21日、アンメットニーズの高い線維性炎症性疾患に対する革新的な治療薬の発見と開発に注力する臨床段階のバイオテクノロジー企業であるChemomAb Ltd.は、びまん皮膚硬化型全身性強皮症の成人を対象としたフェーズ2試験でCM-101を評価するための同社の治験薬(IND)申請が米国食品医薬品局(FDA)から承認されたことを発表しました。
さらに、びまん皮膚硬化型全身性強皮症の有病率の増加、FDA承認の増加、臨床試験の増加、薬剤の入手可能性に関する認知度の増加、新薬開発の進歩が、予測期間にわたって市場を牽引すると予想されます。
薬剤の大量投与に伴う合併症、一部の治療薬の高コスト、適切な治療の欠如、代替治療オプションの利用可能性などの要因が、市場の抑制要因になると予想されます。
Diffuse cutaneous systemic sclerosis (DcSSc) is a subtype of systemic scleroderma (systemic sclerosis) characterized by skin hardening (fibrosis) and problems in many organs of the body. The disease can occur at any age but mainly affects people between 40 and 50 years of age. Dry mouth and dental involvement can occur. Joint pain (arthralgias), muscular pain, weakness, cramps, and destruction of the tips of the fingers or toes (acroosteolysis) are frequent. Severe problems involving the lung (fibrosis or pulmonary hypertension) and kidney problems may also occur.
Moreover, the exact cause of the condition is unknown. There is currently no cure for diffuse cutaneous systemic sclerosis. Treatment depends on the symptoms but may include medication and surgery. Raynaud's phenomenon can be treated with calcium channel blockers. Proton pump inhibitors are given for gastric reflux. Surgical resection of severe calcinosis may be required. Low doses of corticosteroids with immunosuppressive agents are needed in cases with recent severe cutaneous involvement or in progressive lung fibrosis. Pulmonary vasodilators are given in case of pulmonary arterial hypertension.
The increasing demand for innovative drugs for the treatment of diffuse cutaneous systemic sclerosis is expected to drive the market over the forecast period. The existing treatments for DcSSc are not fully effective or have significant side effects, there is a high demand for innovative drugs that can address these unmet medical needs. The innovative drugs aim to address the unmet needs associated with the management of diffuse cutaneous systemic sclerosis by providing alternative or complementary treatment options for better disease management.
Moreover, many clinical trials are going on for the development of innovative drugs that show better results in diffuse cutaneous systemic sclerosis treatment. Positive results from clinical trials evaluating the efficacy and safety of new drugs can boost demand. If a novel drug demonstrates significant improvements in treating DcSSc in clinical studies, it is likely to increase the adoption.
For instance, on February 21, 2023, ChemomAb Ltd., a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, released the U.S. Food and Drug Administration (FDA) clearance of the company's Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with diffuse cutaneous systemic sclerosis.
Further, the increasing prevalence of the diffuse cutaneous systemic sclerosis, rising FDA approvals, increasing clinical trials, increasing awareness about the drug's availability and advancements in developing novel drugs are expected to drive the market over the forecast period.
Factors such as complications associated with the high doses of drugs, the high cost of some treatment drugs, lack of appropriate treatment and the availability of alternative treatment options are expected to hamper the market.
The global diffuse cutaneous systemic sclerosis(DcSSc) drugs market is segmented based on drug class, route of administration, distribution channel and region.
The immunosuppressive agents are expected to hold the largest market share over the forecast period. Usually, there is no cure for this disease, but immunosuppressives such as mycophenolate mofetil, methotrexate, cyclophosphamide, rituximab, tocilizumab and other immunosuppressives are most commonly used for the treatment of the diffuse cutaneous systemic sclerosis.
Due to the rising prevalence of the diffuse cutaneous systemic sclerosis, the demand for the use of immunosuppressives is continuously increasing. For instance, according to the National Organization for Rare Disorders, approximately one in 10,000 individuals is affected with systemic sclerosis including diffuse cutaneous systemic sclerosis. It is more common in women and most often develops around age 30 to 50.
Further, methotrexate is commonly used in the treatment of autoimmune diseases, including DcSSc. Methotrexate can help reduce inflammation and modify the immune response. Mycophenolate Mofetil immunosuppressant is another option that is used to treat DcSSc. It works by inhibiting the proliferation of immune cells. Rituximab targets specific B cells in the immune system. It may be used in cases of DcSSc where B cells play a significant role. In addition, their wide adoption also increases the demand for immunosuppressives.
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare facilities. North America especially the United States is known for its strong presence of major players such as pharmaceutical companies and biotechnology companies. This strong presence of major players actively performs in clinical trials for the development of novel drugs.
For instance, on November 9, 2021, Horizon Therapeutics plc released that the first patient has enrolled in a Phase 2b pivotal trial to evaluate its development-stage medicine HZN-825, a lysophosphatidic acid receptor 1 (LPAR1) antagonist to treat people with diffuse cutaneous systemic sclerosis, a subset of systemic sclerosis (also known as scleroderma).
Furthermore, the region is also very well known for its advanced healthcare infrastructure such as hospitals, specialty clinics and academic and research institutes which provide advanced treatment facilities for diffuse cutaneous systemic sclerosis by using novel and better drugs which results in better patient outcomes. The research and academic institutes always focus on the research activities for the development of the innovative drugs
The major global players in the diffuse cutaneous systemic sclerosis (DcSSc) drugs market include: Lupin Pharmaceuticals, Inc., Bayer AG, Genentech, Inc., Pfizer Inc., Jubilant Cadista Pharmaceuticals Inc., Corbus Pharmaceuticals Holdings, Inc., Horizon Therapeutics plc, GlaxoSmithKline plc, F. Hoffmann-La Roche Ltd, Kadmon Pharmaceuticals, LLC. And among others.
The COVID-19 pandemic significantly impacted the global diffuse cutaneous systemic sclerosis (DcSSc) drugs market. The pandemic led to disruptions in clinical trials across various therapeutic areas, including for new DcSSc drugs or those investigating expanded indications may have faced delays temporarily due to the redirected focus towards the COVID-19 pandemic, this results in impacting timelines for drug development and regulatory approvals. The pandemic also disrupted the supply chain of these treatment drugs globally.
The global diffuse cutaneous systemic sclerosis drugs market report would provide approximately 61 tables, 61 figures, and 187 Pages.
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