Scleroderma Therapeutics Market Analysis North America, Europe, Asia, Rest of World (ROW) - Canada, US, Denmark, China, India - Size and Forecast 2024-2028

Scleroderma Therapeutics Market Size 2024-2028 

The scleroderma therapeutics market size is estimated to grow by USD 467 million at a CAGR of 4.5% between 2023 and 2028. In the healthcare sector, there is a growing recognition of the significant unmet medical needs, particularly in areas such as rare diseases and chronic conditions. This has led to a surge in awareness-raising initiatives from various stakeholders, including governments, non-profit organizations, and pharmaceutical companies. In response, there has been an increase in funding for research and development (R&D) activities to address these needs. Pharmaceutical companies are investing heavily in R&D to discover and develop new treatments and therapies, while governments and non-profits are providing grants and other forms of financial support to accelerate the research process. This trend is expected to continue, as the need for innovative solutions to address unmet medical needs becomes increasingly pressing.

What will be the Size of the Market During the Forecast Period?

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Market Dynamic and Customer Landscape

Boehringer Ingelheim's Nintedanib and Nilotinib are promising new treatments for systemic sclerosis. Scleroderma affects women more than men, and pregnancy and menopause can worsen symptoms. The disease can also lead to depression and physical activity limitations. Non-profit organizations provide support and resources for those living with scleroderma. The market is expected to grow due to the increasing prevalence of the disease and the need for effective treatments. The market is driven by the development of new drugs and the growing awareness of scleroderma. The market is also influenced by the high morbidity and disability associated with the disease. Collagen, a protein involved in the formation of connective tissues, plays a crucial role in scleroderma. Macrophages, a type of white blood cell, are also implicated in the disease's development. Understanding these mechanisms can lead to new therapeutic targets and treatments for scleroderma.

Key Market Driver

High unmet medical needs is notably driving market growth. The complex nature of autoimmune diseases, including scleroderma, hinders the development of innovative drugs due to the unknown etiology. Current treatments primarily consist of corticosteroids, immunosuppressors like calcineurin inhibitors and mTOR inhibitors, NSAIDs, and disease-modifying antirheumatic drugs (DMARDs), often used off-label. Immunosuppressors, such as Imatinib Mesylate, calcium channel blockers, proton pump inhibitors, phosphodiesterase 5 inhibitors, endothelin receptor antagonists, and prostacyclin analogs, are commonly used to manage symptoms and prevent complications.

Furthermore, the heterogeneous nature of scleroderma necessitates personalized treatment plans, creating a significant unmet need in the therapeutics market. This need presents an opportunity for pharmaceutical companies to invest in research and development of targeted therapies with minimal side effects. The diverse patient population, including the growing middle class, utilizes various channels, such as hospital pharmacies, retail pharmacies, and online pharmacies, for drug procurement. Additionally, medical devices like catheters and cannulas, drug delivery systems, and medical tubing are integral components of scleroderma treatment. Thus, such factors are driving the growth of the market during the forecast period.

Significant Market Trends

The introduction of stem cell therapy in scleroderma treatment is the key trend in the market. The market is witnessing significant advancements due to ongoing research and development initiatives by governments and pharmaceutical companies. New treatment modalities, such as stem cell therapy, are under exploration, offering potential solutions for scleroderma patients. Immunosuppressors, calcium channel blockers, proton pump inhibitors, phosphodiesterase 5 inhibitors, endothelin receptor antagonists, and prostacyclin analogs remain the primary treatment options.

Furthermore, hospital pharmacies, retail pharmacies, and online pharmacies distribute these medications. Medical devices like catheters and cannulas, drug delivery systems, and medical tubing are essential components of scleroderma care. The middle class population's increasing access to healthcare and medical devices fuels market growth. Imatinib Mesylate is a potential treatment for systemic sclerosis, adding to the market's potential. Stem cell therapy, an emerging treatment, holds promise for scleroderma patients with limited therapeutic options. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenge

High cost of treatment is the major challenge that affects the growth of the market. Scleroderma, a chronic and complex autoimmune disease, necessitates various treatment modalities, including medications and medical devices. The choice of therapy depends on the severity and organ involvement. For mild cases, non-steroidal anti-inflammatory drugs (NSAIDs) and prednisone can be used, which are relatively affordable. However, the treatment becomes more expensive when immunosuppressants, such as mycophenolate mofetil or azathioprine, are required.

Furthermore, the cost can escalate further if the patient experiences serious organ involvement, like lung involvement, which may necessitate advanced treatments like endothelin receptor antagonists, prostanoids, or even a lung transplant. The average cost for such treatments can reach up to USD6,500. This financial burden can significantly impact patients, particularly those in developing countries, leading them to abandon treatment. In addition to hospital pharmacies, retail pharmacies, and online pharmacies, medical devices like catheters and cannulas, drug delivery systems, and medical tubing are essential components of scleroderma treatment. Immunosuppressors, calcium channel blockers, proton pump inhibitors, phosphodiesterase 5 inhibitors, and Imatinib Mesylate are some of the medications used in the treatment of scleroderma. The middle class population, in particular, faces challenges in managing the high costs associated with these treatments. Hence, the above factors will impede the growth of the market during the forecast period

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

F. Hoffmann La Roche Ltd. - The company offers scleroderma therapeutics that provide products such as actemra, alecensa, avastin, cellcept, cotellic, enspryng, erivedge, esbriet, evrysdi, fuzeon, gazyva, gazyvaro, hemlibra, herceptin.

The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• AbbVie Inc.
• Akashi Therapeutics
• Amneal Pharmaceuticals Inc.
• ANTARES PHARMA INC.
• Argentis Pharmaceuticals LLC
• AstraZeneca Plc
• Bayer AG
• Boehringer Ingelheim International GmbH
• Bristol Myers Squibb Co.
• Castle Creek Biosciences Inc.
• Chemomab Therapeutics Ltd.
• Corbus Pharmaceuticals Holdings Inc
• Cumberland Pharmaceuticals Inc.
• Emerald Health Pharmaceuticals
• F. Hoffmann La Roche Ltd.
• Medexus Pharmaceuticals Inc.
• Novartis AG
• Pfizer Inc.
• Sanofi SA
• The Procter and Gamble Co.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Segmentation

By Disease Type 

The market share growth by the Localized scleroderma segment will be significant during the forecast period. Scleroderma is an autoimmune disease characterized by the hardening and thickening of the skin and connective tissues. This condition can affect various internal organs, including the kidneys, lungs, gastrointestinal systems, and heart. Raynaud's disease, a common symptom of scleroderma, causes vasospasms, leading to finger ulcers, Raynaud's phenomenon, and dilated blood vessels. 

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The Localized scleroderma segment showed a gradual increase in the market share of USD 1.01 billion in 2018. The disease's progression results in morbidity, disability, pain, depression, and physical activity limitations. Healthcare organizations are actively researching potential treatments for scleroderma, including immunosuppressive drugs like methotrexate and Tofacitinib. Macrophage activity plays a significant role in the disease's development, making therapies targeting these cells a promising area of research. Women, particularly those experiencing pregnancy or menopause, are disproportionately affected by scleroderma. Systemic sclerosis, a severe form of scleroderma, can lead to scarring and inflammation in the skin and internal organs. Boehringer Ingelheim's Nintedanib and Nilotinib are potential treatments for systemic sclerosis, targeting the disease's fibrosis and inflammation. Non-profit organizations are also contributing to advancing scleroderma research and raising awareness about this debilitating condition. Scleroderma's impact on internal organs, including the kidneys, gastrointestinal tract, and lungs, can lead to complications like interstitial lung disease. These complications can result in significant health issues, including inflammation, pain, and decreased physical function. Collagen, a protein essential for skin and connective tissue health, plays a role in scleroderma's development. Understanding this protein's role and finding effective treatments for scleroderma remain crucial areas of ongoing research.

By Region

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North America is estimated to contribute 37% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

Scleroderma is an autoimmune disease characterized by the hardening and thickening of connective tissues in the skin and internal organs. This condition affects various systems including the skin, kidneys, lungs, gastrointestinal systems, and heart. Raynaud's disease, a common symptom of scleroderma, causes vasospasms leading to Raynaud's phenomenon, finger ulcers, and dilated blood vessels. Scleroderma can lead to morbidity, disability, pain, depression, and reduced physical activity. Systemic sclerosis, a severe form of scleroderma, can cause scarring and inflammation in internal organs, impacting collagen production in the kidneys, gastrointestinal tract, and other organs. Healthcare organizations are actively researching potential treatments for scleroderma, including immunosuppressive drugs such as methotrexate and tofacitinib. Women, especially those experiencing pregnancy or menopause, are disproportionately affected by scleroderma. Boehringer Ingelheim's nintedanib and Nilotinib are among the promising therapeutic options for treating systemic sclerosis and interstitial lung disease. Non-profit organizations play a crucial role in raising awareness and funding for scleroderma research. Macrophages, a type of white blood cell, are also being explored as potential targets for scleroderma therapy.

Segment Overview

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million " for the period 2024-2028, as well as historical data from - for the following segments.

• Disease Type Outlook
  • Localized scleroderma
  • Systemic scleroderma

• Region Outlook 
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • APAC
    • China
    • India
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • Rest of the Middle East & Africa
  • South America
    • Argentina
    • Brazil
    • Chile

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Market Analyst Overview

Scleroderma is an autoimmune disease characterized by the hardening and thickening of the skin and connective tissues. This condition can affect various internal organs, including the kidneys, lungs, gastrointestinal systems, and heart. Scleroderma can manifest as Systemic sclerosis, which affects multiple organs, or Localized scleroderma, which primarily affects the skin. Raynaud's disease, a common symptom of scleroderma, causes vasospasms, leading to finger ulcers, dilated blood vessels, and pain. The disease can also lead to morbidity, disability, and complications such as interstitial lung disease, inflammation, and scarring. Healthcare organizations are actively researching and developing therapeutics for scleroderma. Immunosuppressive drugs like Methotrexate and Tofacitinib are commonly used to manage the disease.

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What are the Key Data Covered in this Market Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting of the market between 2024 and 2028
• Precise estimation of the size of the market size and its contribution to the parent market
• Accurate predictions about upcoming market trends and analysis and changes in consumer behavior
• Growth of the market industry across Europe, North America, APAC, South America, and Middle East and Africa
• Thorough market growth analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive market analysis and report on the factors that will challenge the market research and growth of market companies