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市場調査レポート
商品コード
1666172
強皮症の世界市場:2025年~2033年Global Scleroderma Market - 2025-2033 |
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カスタマイズ可能
適宜更新あり
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強皮症の世界市場:2025年~2033年 |
出版日: 2025年02月24日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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強皮症の世界市場は、2024年に23億8,473万米ドルに達し、2033年には41億3,307万米ドルに達すると予測され、予測期間2025-2033年のCAGRは6.4%で成長すると予測されています。
世界の強皮症市場の需要は、複数の要因によって牽引されています。主な要因の一つは、強皮症の有病率の上昇と治療選択肢の進歩です。この増加は、遺伝的素因、環境因子、免疫系の機能障害など、相互に関連したいくつかの要素に起因しています。
全米生物工学情報センター(NCBI)が2023年3月に発表した調査結果によると、全身性硬化症(SSc)の世界的発症率は10万人年当たり8.64例であり、有病率は10万人当たり18.87例です。このことは、年間約67万人が新たに全身性硬化症と診断されることを示唆しています。また、世界の83.9%の国ではSScに関する疫学的データがありません。罹患率や有病率は女性、成人、高所得国で高くなっています。
加えて、政府の取り組みや主要企業の製品上市・承認が市場成長の原動力となるとみられています。例えば、2023年12月、Scleroderma Research Foundation (SRF)は、FDAが治験薬(IND)申請を承認したと発表しました。この承認により、SRFはCONQUEST臨床試験プラットフォームを立ち上げ、患者の登録を開始することができます。SanofiとBoehringer IngelheimはCONQUEST試験にそれぞれ実験的薬剤を提供することに合意しており、新しい強皮症治療法の臨床開発を促進するためにデザインされたこのプロトコルにコミットする最初の製薬パートナーとなっています。
ヘルスケア専門家および強皮症に罹患しやすい個人における認知度の向上は、市場の成長を促進すると予想されます。強皮症の治療のために、製薬業界は常に新規の強化された治療法を生み出しています。幹細胞治療、遺伝子治療戦略、免疫調節薬の調整などを含むこれらの開発は、より良い疾患管理のために有望であり、利用可能な治療選択肢の増加につながります。これらすべての要因が、世界の強皮症市場に需要をもたらしています。さらに、新規製品開発に対する需要の高まりは、世界の強皮症市場の拡大に寄与しています。
厳しい規制要件は世界の強皮症市場に大きな影響を与えています。強皮症の新しい治療法の開発と承認は、米国食品医薬品局(FDA)や欧州医薬品庁(EMA)のような当局によって厳しく規制されています。これらの規制プロセスは、通常、新しい治療法の安全性と有効性を確認するために大規模な臨床試験を必要とするため、しばしば時間と費用がかかります。その結果、製薬会社は、救命につながる可能性のある医薬品の上市に遅れが生じ、患者にとっての新たな治療法の利用可能性に影響を及ぼす可能性があります。
当レポートでは、世界の強皮症市場について調査し、市場の概要とともに、疾患タイプ別、治療タイプ別、流通チャネル別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。
The global scleroderma market reached US$ 2,384.73 million in 2024 and is expected to reach US$ 4,103.07 million by 2033, growing at a CAGR of 6.4% during the forecast period 2025-2033.
Scleroderma is a rare and intricate autoimmune condition characterized by the abnormal thickening and stiffening of the skin and underlying connective tissues. This disorder is marked by an overactive immune system that triggers excessive production of collagen, leading to the formation of scar tissue (fibrosis) in various parts of the body.
The rising prevalence of scleroderma and advancements in treatment options are driving the market. The scleroderma market is witnessing significant advancements in treatment modalities, particularly with the development of novel drugs, including biologics and targeted therapies. Innovations in the treatment of scleroderma, emphasize their role in improving patient outcomes. These factors have driven the global scleroderma market expansion.
Market Dynamics: Drivers & Restraints
Rising Prevalence of Scleroderma and Advancements in Treatment Options
The demand for the global scleroderma market is driven by multiple factors. One of the primary factors is the rising prevalence of scleroderma and advancements in treatment options. This rise can be attributed to several interconnected elements, including genetic predispositions, environmental factors, and immune system dysfunction.
As per the National Center for Biotechnology Information (NCBI) research publication in March 2023, the global incidence of systemic sclerosis (SSc) is 8.64 cases per 100,000 person-years, while the prevalence is 18.87 cases per 100,000 individuals. This suggests that approximately 670,000 people are newly diagnosed with SSC annually. The publication also says that 83.9% of countries around the world do not have epidemiological data on SSc. The incidence and prevalence rates are higher among females, adults, and in high-income countries.
In addition, government initiatives and key player's product launches & approvals would drive this market growth. For instance, in December 2023, the Scleroderma Research Foundation (SRF), announced that the FDA had cleared its Investigational New Drug (IND) application. This clearance allows SRF to launch the CONQUEST clinical trial platform and begin enrolling patients. Sanofi and Boehringer Ingelheim have agreed to contribute an experimental agent each to the CONQUEST trial, making them the first pharmaceutical partners to commit to this protocol designed to expedite the clinical development of new scleroderma treatments.
The increased awareness among healthcare professionals and also individuals who are prone to the condition is expected to drive market growth. For the treatment of scleroderma, the pharmaceutical industry is constantly creating novel and enhanced treatments. These developments, which include stem cell therapies, gene therapy strategies, and tailored immunomodulatory medications, provide promise for better disease management and can lead to an increase in the number of available therapeutic options. All these factors demand the global scleroderma market. Moreover, the rising demand for novel product development contributes to the global scleroderma market expansion.
Stringent Regulatory Requirements
Stringent regulatory requirements significantly impact the global scleroderma market. The development and approval of new treatments for scleroderma are closely regulated by authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulatory processes are often time-consuming and expensive, as they typically require extensive clinical trials to confirm the safety and efficacy of new therapies. As a result, pharmaceutical companies can face delays in bringing potentially life-saving medications to market, affecting the availability of new treatments for patients.
Moreover, varying regulatory standards across countries further complicate the situation. Differences in clinical trial protocols, approval timelines, and reimbursement policies can slow the global introduction of scleroderma treatments. These complexities can pose additional challenges for smaller biotech firms that lack the resources to meet strict regulatory requirements, limiting their ability to innovate and compete. Ultimately, these stringent regulations can hinder the overall growth of the scleroderma market and restrict patient access to effective treatments. Thus, the above factors could be limiting the global scleroderma market's potential growth.
The global scleroderma market is segmented based on disease type, treatment type, distribution channel, and region.
The immunosuppressants segment is expected to dominate the global scleroderma market share
The immunosuppressants segment holds a major portion of the global scleroderma market share and is expected to continue to hold a significant portion of the global scleroderma market share during the forecast period. The immunosuppressants segment encompasses a range of drugs that are critical for managing scleroderma. This is particularly important given the autoimmune nature of the disease and its widespread effects on multiple organ systems throughout the body. Immunosuppressants are frequently utilized in the management of systemic sclerosis (SSc), also referred to as scleroderma. While these medications can enhance lung function and skin conditions, they may also lead to significant side effects and necessitate regular laboratory monitoring.
The immunosuppressants segment encompasses a variety of drug classes, including biologics and small-molecule therapies. Biologics these medications are derived from living organisms and specifically target components of the immune system. An instance is Boehringer Ingelheim's Ofev (nintedanib), which has received approval for treating systemic sclerosis with interstitial lung disease.
Traditional immunosuppressants mostly, used drugs in this category include methotrexate and mycophenolate mofetil, which are employed to alleviate symptoms of scleroderma and reduce inflammation. There is a strong pipeline of new immunosuppressant therapies currently in development, aimed at enhancing patient outcomes. Ongoing research is focused on discovering novel drug candidates that can improve the efficacy and safety profiles of existing treatments. This includes investigating new biologics and small molecules that may offer better management options for scleroderma patients.
Immunosuppressants are a critical class of medications used in the treatment of scleroderma, particularly systemic sclerosis. These drugs function by inhibiting or preventing the immune system's activity, which is essential in managing the autoimmune aspects of the disease. Methotrexate (MTX) is a widely used immunosuppressant in the treatment of scleroderma, particularly for managing skin manifestations. Its mechanism of action involves inhibiting DNA synthesis, which has several important implications for reducing the autoimmune activity characteristic of this disease.
Moreover, key players more focus on the treatment for systemic sclerosis and the research studies, rising number of clinical trials that would propel this market growth. As per the University of Alberta in October 2022, researchers have identified genetic mutations in the cells of scleroderma patients that resemble those found in cancer, which may lead to new treatment options for this challenging condition. These findings explain why scleroderma, an incurable skin disease, often does not respond well to traditional immunosuppressive therapies. The study aims to clarify the mechanisms linking abnormal DNA damage responses to the disease's fibrosis and inflammation, potentially paving the way for innovative treatment strategies.
Also, in March 2024, Cabaletta Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted an Orphan Drug Designation (ODD) to CABA-201. This investigational therapy is a fully human CD19-CAR T cell treatment that contains 4-1BB and is being explored for its potential to treat systemic sclerosis (SSc). These factors have solidified the segment's position in the global scleroderma market.
North America is expected to hold a significant position in the global scleroderma market share
North America holds a substantial position in the global scleroderma market and is expected to hold most of the market share. The rising prevalence of systemic sclerosis in North America is a primary driver of market growth. Systemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune disease that affects around 75,000 individuals in the United States. Interstitial lung disease (ILD) is a common complication of SSc, with up to 80% of patients developing this progressive condition. ILD can significantly impair lung function and, in severe cases, may be life-threatening.
In North America, localized scleroderma is becoming more common, much like many other autoimmune illnesses. This is caused by a complicated interaction between environmental and genetic factors. The increasing incidence of scleroderma, particularly localized scleroderma and systemic sclerosis, is driving the demand for effective treatment options globally. Localized scleroderma primarily affects the skin and underlying tissues. It occurs more commonly in children but can also appear in adults. The estimated incidence of localized scleroderma is 2.7 per 100,000 individuals in the U.S.
Systemic sclerosis, also known as systemic scleroderma, affects the skin, tissues, blood vessels, and major organs. The estimated incidence of systemic sclerosis is 1.4 per 100,000 person-years. This means that for every 100,000 people in the population, 1.4 new cases of systemic sclerosis are diagnosed each year. A larger patient base seeking treatment due to more diagnosed cases raises the demand for medications, therapies, and related services. This promotes market expansion in several industries, including healthcare, biotechnology, and pharmaceuticals. The need for early diagnosis means that there will undoubtedly be a growing need for precise and effective diagnostic instruments, such as skin biopsies, blood tests, and imaging methods like MRI and ultrasound.
Moreover, advancements in treatment options, favorable reimbursement policies, key player's focus on research and development (R&D) activity, and growing healthcare expenditure are driving this market growth in this region. In addition, in this region, a major number of key player's presence, well-advanced healthcare infrastructure, and product launches & approvals would propel this market growth. For instance, in February 2024, Certa Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational therapy FT011 for treating systemic sclerosis (scleroderma). This designation comes after the FDA previously granted Orphan Drug Designation to FT011 for the same indication.
Also, in September 2022, The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to efzofitimod, a potential first-in-class immunomodulator, for the treatment of interstitial lung disease associated with systemic sclerosis. Thus, the above factors are consolidating the region's position as a dominant force in the global scleroderma market.
Asia Pacific is growing at the fastest pace in the global scleroderma market share
Asia Pacific holds the fastest pace in the global scleroderma market and is expected to hold most of the market share. The scleroderma market in the Asia-Pacific region is experiencing significant growth due to several factors, including rising prevalence, increasing awareness, improved healthcare infrastructure, and the introduction of innovative therapies. Countries like China, India, Japan, and South Korea are playing leading roles in the development of this market.
With the increasing prevalence of autoimmune diseases, including systemic sclerosis, there is a growing demand for effective treatments in Asia-Pacific including China, Japan, and South Korea. Due to the vast population, the potential patient pool for scleroderma is significant. For instance, according to the study conducted by NIH, the pooled prevalence of SSc-ILD in East Asia was 56%. The SSc-ILD prevalence was higher in China (72%) than in Japan (46%) and Korea (51%).
Despite the advancements, awareness of scleroderma remains relatively low in some parts of the region, leading to delayed diagnosis and treatment. Increasing education and awareness programs could further drive market growth. For instance, on August 24. 2024, National Scleroderma Symposium and Patient Awareness Program, this Symposium intends to provide a unique platform for Rheumatologists and allied professionals from across India to share their experiences update their knowledge, and interact with each other. They anticipate more than 250 participants to join. The program will cover various topics related to Scleroderma and CTD-ILD and will be conducted by renowned experts in the field. This program will be beneficial for the medical community in our Institution and will contribute to the overall improvement of patient care.
International companies are beginning to introduce advanced therapies in this region, although access to biologics remains limited in some areas. New treatments like Ofev (nintedanib) have become available for systemic sclerosis patients in major urban centers. Moreover, generics and biosimilars are helping to improve accessibility at lower costs.
There is an increasing number of clinical trials, including those for autoimmune diseases like scleroderma. Collaborations between pharmaceutical companies and global players with support from regulatory bodies are also bringing innovative treatments to the local market. This further boosts the market growth in the Asia-Pacific region. Thus, the above factors are consolidating the region's position as the fastest-growing force in the global scleroderma market.
The major global players in the scleroderma market include GSK plc, Certa Therapeutics, F. Hoffmann-La Roche Ltd, Boehringer Ingelheim International GmbH., Sun Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc, Teva Pharmaceuticals USA, Inc., Eli Lilly and Company, and AUROBINDO PHARMA LIMITED among others.
The global scleroderma market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
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