Scleroderma Market Summary
- According to DelveInsight, Scleroderma market is expected to grow at a decent CAGR by 2034.
- Major drivers such as increasing prevalence, technological advancements, and forthcoming therapies are expected to significantly boost the market in the forecast period (2024-2034).
Scleroderma Market and Epidemiology Analysis
- According to the National Scleroderma Foundation (2023), about 300,000 Americans have scleroderma.
About one-third of those people have the systemic form of scleroderma. Localized scleroderma is more common in children, whereas systemic scleroderma is more common in adults. Overall, females with scleroderma outnumber males about 4:1. - According to a study by Royle et al. (2018), The prevalence of systemic sclerosis was 307 (290–323) per million with the highest prevalence in the 70–84 years age group. It was estimated that there are currently 1180 new cases of systemic sclerosis each year in the UK, and 19,390 people living with systemic sclerosis
- Scleroderma Drugs approved for the treatment of scleroderma include OFEV (nintedanib, Boehringer Ingelheim), ACTEMRA (tocilizumab, Roche), and RITUXAN (rituximab, Zenyaku Kogyo/Chugai Pharmaceutical).
- The introduction of novel treatments for scleroderma, along with a promising pipeline of upcoming products, is likely to spur industry growth. The pipeline of scleroderma holds a few latestage and some mid-stage drugs such as LUMICEF (Kyowa Kirin), BENLYSTA (GSK), SAPHNELO (AstraZeneca), UPLIZNA (Amgen [Horizon Therapeutics]/Mitsubishi Tanabe Pharma), Vixarelimab (Roche [Genentech]/Kiniksa Pharmaceuticals), Efzofitimod (aTyr Pharma/Kyorin Pharmaceutical), and others.
Factors Affecting Scleroderma Market Growth
Increasing Disease Awareness and Diagnosis Rates
Greater awareness among healthcare professionals and patients, along with improved diagnostic techniques (e.g., autoantibody testing, capillaroscopy), is leading to earlier and more accurate diagnosis of scleroderma. This expands the patient pool and increases demand for therapeutic interventions.
Rising Prevalence and Incidence
Although scleroderma is a rare autoimmune disease, epidemiological studies indicate a growing diagnosed population globally, particularly in regions with aging demographics. Enhanced screening and reporting are also contributing to apparent rises in prevalence.
Advancements in Therapeutic Development
Ongoing clinical research and drug development have yielded new targeted therapies addressing fibrosis, immune modulation, and vascular complications. Novel agents in Phase II/III trials and biologics with improved efficacy and safety profiles are projected to be key growth drivers.
Unmet Medical Needs and Limited Treatment Options
Current standard of care focuses on symptom management and organ-specific complications rather than disease modification. The high unmet need for effective, disease-modifying therapies continues to stimulate R&D and investment.
Government Initiatives and Funding Support
Public health support, increased funding for rare disease research, and accelerated approval pathways (e.g., orphan drug designations in the U.S. and Europe) help expedite development and commercialization of new scleroderma treatments.
Reimbursement and Healthcare Infrastructure
Favorable reimbursement policies and the presence of robust healthcare systems in developed markets encourage the adoption of advanced therapies. Conversely, limited reimbursement in emerging regions can impede access and market growth.
Growing Adoption of Personalized Medicine
Precision medicine approaches such as biomarker-driven patient stratification to enhance therapeutic outcomes and are increasingly integrated into clinical trial designs and treatment strategies, driving market differentiation.
Investments and Strategic Collaborations
Biopharmaceutical collaborations, licensing agreements, and mergers & acquisitions focused on scleroderma and related fibrotic diseases are accelerating pipeline expansion and commercialization capabilities.
Technological Advancements in Drug Delivery and Monitoring
Innovations like targeted delivery systems, digital health monitoring tools, and telemedicine improve patient adherence, outcomes tracking, and long-term disease management.
Patient Advocacy and Support Networks
Active patient advocacy groups are playing a pivotal role in raising awareness, supporting clinical trial participation, and influencing healthcare policy, thereby indirectly boosting market growth.
DelveInsight's "Scleroderma Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of the Scleroderma, historical and forecasted epidemiology as well as the Scleroderma market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Scleroderma market report provides current treatment practices, emerging drugs, Scleroderma market share of the individual therapies, current and forecasted Scleroderma market Size from 2020 to 2034 segmented by seven major markets. The Report also covers current Scleroderma treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the Scleroderma market.
Scope of the Scleroderma Market | |
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Study Period |
2020-2034 |
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Forecast Period |
2025-2034 |
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Geographies Covered |
US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan |
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Scleroderma Epidemiology |
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Scleroderma Market |
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Market Analysis |
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Scleroderma Market players |
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Future opportunity |
The scleroderma market presents strong future opportunities driven by advancing biologics, anti-fibrotic therapies, and personalized medicine approaches. Growing orphan drug incentives, increasing clinical trial activity, and improved diagnostic capabilities are expected to accelerate innovation, expand treatment options, and enhance long-term disease management outcomes globally. |
Scleroderma Market Disease Understanding and Treatment Algorithm
The DelveInsight’s Scleroderma market report gives a thorough understanding of the Scleroderma by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment.
Scleroderma Overview
Systemic sclerosis, usually referred to as scleroderma, is a collection of uncommon disorders that cause the skin to tighten and stiffen. Additionally, it could affect the digestive system, internal organs, and blood vessels. Scleroderma is frequently labelled as "limited" or "diffuse," which merely describes how much skin is affected. Both forms may involve any other organ or vascular issues. Skin alone is impacted by localised scleroderma, commonly known as morphea.
Scleroderma Diagnosis
Scleroderma diagnosis involves a combination of clinical evaluation, laboratory testing, and imaging studies. Physicians assess characteristic symptoms such as skin thickening, Raynaud’s phenomenon, and internal organ involvement. Blood tests play a key role, particularly the detection of autoantibodies like anti-centromere, anti-topoisomerase I (Scl-70), and anti-RNA polymerase III. Nailfold capillaroscopy is used to identify microvascular abnormalities, aiding early diagnosis. Imaging techniques, including high-resolution CT scans and echocardiography, help evaluate lung and cardiac involvement. Early and accurate diagnosis is essential to initiate timely management and prevent disease progression and organ damage.
Scleroderma Treatment
It covers the details of conventional and current medical therapies available in the Scleroderma market for the treatment of the condition. It also provides Scleroderma treatment algorithms and guidelines in the United States, Europe, and Japan.
Scleroderma Epidemiology
The Scleroderma epidemiology section provides insights about the historical and current Scleroderma patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Scleroderma market report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings from Scleroderma Epidemiological Analyses and Forecast
The disease epidemiology covered in the report provides historical as well as forecasted Scleroderma epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2020 to 2034.
- According to Beukelman et al. (2018), juvenile localised scleroderma occurs 10 times more often than systemic sclerosis in childhood and is believed to have a prevalence of 1 per 100,000 children.
- As per the analysis, the United States accounted for the highest diagnosed prevalent cases of systemic sclerosis with nearly 102,000 cases in 2023.
- Among EU4 and the UK, Italy accounted for the highest number of diagnosed prevalent cases of systemic sclerosis, followed by Germany. Whereas Spain occupied the bottom of the ladder.
Scleroderma Epidemiology Segmentation
- Total Diagnosed Prevalent Cases of Scleroderma
- Type-specific Cases of Scleroderma
- Age-specific Cases of Scleroderma
- Severity-specific Cases of Scleroderma
Learn more- Systemic Scleroderma Epidemiology Forecast 2034
Scleroderma Drugs Analysis
The drug chapter segment of the Scleroderma market report encloses the detailed analysis of Scleroderma marketed drugs and late-stage (Phase-III and Phase-II) Scleroderma pipeline drugs. It also helps to understand the Scleroderma 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.
Scleroderma Marketed Drugs
The report provides the details of the marketed products/off-label treatments available for Scleroderma treatment.
Scleroderma Emerging Drugs
SAPHNELO (anifrolumab): AstraZeneca
SAPHNELO is a first-in-class, fully human monoclonal antibody. It disrupts the Type I interferon autoamplification loop that can trigger the loss of immune tolerance and autoimmunity. In addition, it partially inhibits the upregulation of costimulatory molecules and the production of pro-inflammatory cytokines by plasmacytoid dendritic cells (pDCs).
- This drug is currently in Phase III developmental stage. The first patient commenced dosing in the fourth quarter of 2023, the first estimated filing acceptance and the data is anticipated >2025 in the Phase III DAISY clinical trial.
Dersimelagon (MT-7117): Mitsubishi Tanabe Pharma
Dersimelagon is a synthetic, orally administered, non-peptide small molecule being developed for multiple indications that acts as a selective agonist of MC1R. It reduces inflammation, vascular dysfunction, and fibrosis through its pleiotropic effects on inflammatory cells, endothelial cells, and fibroblasts and is a potential therapeutic agent for the treatment of systemic sclerosis.
- The drug is currently in Phase II clinical development. In April 2020, Mitsubishi Tanabe Pharma was granted Fast Track Designation for MT-7117 for the treatment of diffuse cutaneous systemic sclerosis.
Avenciguat (BI 685509): Boehringer Ingelheim
Avenciguat is an orally administered, nitric oxide-independent activator of soluble guanylate cyclase (sGC) being developed by Boehringer Ingelheim. It restores cGMP and improves the functionality of nitric oxide pathways.
- It is being investigated in Phase II clinical development. The US FDA has granted Fast Track Designation to avenciguat for the treatment of systemic sclerosis.
Scleroderma Market Outlook
The Scleroderma market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Scleroderma market trends by analyzing the impact of current Scleroderma therapies on the market, unmet needs, drivers and barriers, and demand for better technology.
This segment gives a thorough detail of Scleroderma market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Scleroderma market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the Scleroderma market in 7MM is expected to witness a major change in the study period 2020-2034.
Scleroderma is a complex autoimmune disease requiring a multifaceted treatment approach to manage symptoms, prevent complications, and enhance the quality of life. Early diagnosis and continuous monitoring are crucial, with regular assessments of skin involvement, organ function, and overall health. Treatment typically involves a multidisciplinary team, including rheumatologists, dermatologists, pulmonologists, and other specialists tailored to the patient's specific needs.
Medications play a central role, with immunosuppressants like methotrexate and mycophenolate mofetil used to manage autoimmune activity and reduce skin thickening. For organ-specific complications, treatments vary: pulmonary hypertension may be managed with endothelin receptor antagonists, while interstitial lung disease might require cyclophosphamide or nintedanib. Raynaud's phenomenon, a common symptom, is often treated with vasodilators such as calcium channel blockers. Physical therapy and occupational therapy are integral to maintaining mobility and managing pain, while skin care regimens help alleviate dryness and tightness. In cases of localized scleroderma (morphea), topical treatments such as corticosteroids and calcipotriene, along with phototherapy, are commonly employed.
Boehringer Ingelheim’s OFEV (nintedanib) has been approved by the US FDA, EMA, and the Japanese MHLW to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. The US FDA has also approved Roche’s (Genentech) ACTEMRA (tocilizumab) for a similar indication. Zenyaku and Chugai obtained approval from the Japanese MHLW for an antiCD20 monoclonal antibody, RITUXAN (rituximab), for systemic sclerosis. Although OFEV and ACTEMRA are approved therapies, both of these medications have demonstrated no significant difference in change in modified Rodnan skin score (mRSS) compared to placebo. Rituximab is the only drug that showed statistically significant improvements in mRSS in the actual drug group compared with the placebo group.
The substantial comorbidity burden associated with scleroderma and the lack of disease-modifying therapies result in high direct and indirect healthcare costs, as demonstrated by studies across multiple healthcare systems. Despite these challenges, research has led to improved care for individuals living with
scleroderma.
Key Findings from Scleroderma Market Forecast
This section includes a glimpse of the Scleroderma market in 7MM.
- OFEV (nintedanib) developed by Boehringer Ingelheim is in a class of medications called kinase inhibitors. It is used to slow the rate of decline in lung function in people with systemic sclerosis associated-interstitial lung disease. The company holds an Orphan drug exclusivity for OFEV until 2026. Recommended dosage: 150 mg twice daily, approximately 12 h apart. Approvals: US: 2020; EU: 2020; JP: 2020
- ACTEMRA (tocilizumab) by Roche is an anti-IL-6 receptor biologic and is available in both intravenous (IV) and subcutaneous (SC) formulations. ACTEMRA SC is approved in the US to slow the rate of pulmonary function decline in adult patients with systemic sclerosis associated-interstitial lung disease. The recommended dose of ACTEMRA for adult patients with SScILD is 162 mg, given once every week. Approval: US: 2021.
Scleroderma Regional Analysis
The United States Scleroderma Market Outlook
This section provides the total Scleroderma market size and market size by therapies in the United States.
EU-5 Countries: Scleroderma Market Outlook
The total Scleroderma market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.
Japan Scleroderma Market Outlook
The total Scleroderma market size and market size by therapies in Japan is also mentioned.
Scleroderma Competitive Landscape
The scleroderma competitive landscape is shaped by major pharmaceutical players and emerging biotech firms focused on disease-modifying therapies and symptom management. Established companies like Boehringer Ingelheim, Roche, and AstraZeneca lead with approved and late-stage treatments targeting fibrosis, inflammation, and immune pathways. Other competitors, including Mitsubishi Tanabe Pharma, aTyr Pharma, and Kyorin Pharmaceutical, are advancing emerging candidates in clinical development. Competition centers on efficacy, safety, and novel mechanisms of action, with emphasis on anti-fibrotic agents, biologics, and targeted immune modulators. Strategic collaborations, orphan drug designations, and robust clinical pipelines are driving differentiation and expanding therapeutic options in this rare disease market.
Scleroderma Companies
- Roche Pharma AG
- Allergan
- Bristol-Myers Squibb
- Pfizer
- Gilead Sciences
- Boston University
- Novartis Pharmaceuticals
- Prism Pharma Co Ltd. and several others
Scleroderma Drugs Uptake
This section focuses on the rate of uptake of the potential Scleroderma drugs recently launched in the Scleroderma market or expected to get launched in the market during the study period 2020-2034. The analysis covers Scleroderma market uptake by drugs; patient uptake by therapies; and sales of each drug.
Scleroderma Drugs Uptake helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs on the basis of Scleroderma market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Scleroderma Clinical Trial Activities
The Scleroderma market report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Scleroderma key players involved in developing targeted therapeutics.
Scleroderma Pipeline Development Activities
The Scleroderma market report covers the detailed information of collaborations, acquisition, and merger, licensing, patent details, and other information for Scleroderma emerging therapies.
Reimbursement Scenario in Scleroderma
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Latest KOL- Views on Scleroderma
To keep up with current Scleroderma market trends, we take KOLs and SMEs ' opinion working in the Scleroderma domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Scleroderma market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
What KOLs are saying on Scleroderma Patient Trends?
We urgently need innovative therapeutic options for this very severe condition. Some preclinical and clinical studies are currently underway and could pave the way for potent tailored therapies for SSc-PAH patients. - Aston University, UK
For systemic sclerosis, most patients are treated with mycophenolate mofetil, which really has become our go-to for softening the skin. As we come to better understand what's happening, not just in the skin. - University of Wisconsin School of Medicine, United States
As scleroderma is a heterogeneous disease, exercise and physical therapy regimens will likely need to be specifically tailored to each patient’s unique presentation. Our findings suggest that closely monitoring patients’ functional status is important. - Aichi Medical University, Japan
Scleroderma Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the Scleroderma Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Scleroderma Market Report
- The report covers the descriptive overview of Scleroderma, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
- Comprehensive insight has been provided into the Scleroderma epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for Scleroderma is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
- A detailed review of the Scleroderma market; historical and forecasted is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Scleroderma market
Scleroderma Market Report Highlights
- In the coming years, the Scleroderma market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
- The companies and academics are working to assess challenges and seek opportunities that could influence Scleroderma R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Scleroderma Major players are involved in developing therapies for Scleroderma. The launch of emerging therapies will significantly impact the Scleroderma market
- A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Scleroderma
- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Scleroderma Market Report Insights
- Scleroderma Patient Population
- Therapeutic Approaches
- Scleroderma Pipeline Analysis
- Scleroderma Market Size
- Scleroderma Market Trends
- Scleroderma Market Opportunities
- Impact of upcoming Scleroderma Therapies
Scleroderma Market Report Key Strengths
- 11 Years Forecast
- 7MM Coverage
- Scleroderma Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Scleroderma Market
- Scleroderma Drugs Uptake
Scleroderma Market Report Assessment
- Current Treatment Practices
- Unmet Needs
- Scleroderma Pipeline Product Profiles
- Scleroderma Market Attractiveness
- Scleroderma Market Drivers
- Scleroderma Market Barriers
Key Questions Answered in the Scleroderma Market
Scleroderma Market Insights
- What was the Scleroderma drug class share (%) distribution in 2020 and how it would look like in 2034?
- What would be the Scleroderma total market size as well as market size by therapies across the 7MM during the forecast period (2020-2034)?
- What are the key findings pertaining to the market across 7MM and which country will have the largest Scleroderma market size during the forecast period (2020-2034)?
- At what CAGR, the Scleroderma market is expected to grow by 7MM during the forecast period (2020-2034)?
- What would be the Scleroderma market outlook across the 7MM during the forecast period (2020-2034)?
- What would be the Scleroderma market growth till 2034, and what will be the resultant market Size in the year 2034?
- How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?
Scleroderma Epidemiology Insights
- What are the disease risk, burden, and regional/ethnic differences of the Scleroderma?
- What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What is the historical Scleroderma patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of Scleroderma in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to Scleroderma?
- Out of all 7MM countries, which country would have the highest prevalent population of Scleroderma during the forecast period (2020-2034)?
- At what CAGR the patient population is expected to grow in 7MM during the forecast period (2020-2034)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
- What are the current options for the Scleroderma treatment in addition to the approved therapies?
- What are the current treatment guidelines for the treatment of Scleroderma in the USA, Europe, and Japan?
- What are the Scleroderma marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
- How many companies are developing therapies for the treatment of Scleroderma?
- How many therapies are in-development by each company for Scleroderma treatment?
- How many are emerging therapies in mid-stage, and late stage of development for Scleroderma treatment?
- What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the Scleroderma therapies?
- What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Scleroderma and their status?
- What are the current challenges faced in drug development?
- What are the key designations that have been granted for the emerging therapies for Scleroderma?
- What are the global historical and forecasted market of Scleroderma?
Reasons to buy the Scleroderma Market Report
- The Scleroderma market report will help in developing business strategies by understanding trends shaping and driving the Scleroderma market
- To understand the future market competition in the Scleroderma market and Insightful review of the key market drivers and barriers
- Organize sales and marketing efforts by identifying the best opportunities for Scleroderma in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
- Identification of strong upcoming Scleroderma companies in the Scleroderma market will help in devising strategies that will help in getting ahead of competitors
- Organize sales and marketing efforts by identifying the best opportunities for Scleroderma market
- To understand the future market competition in the Scleroderma market
