Systemic Sclerosis Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Systemic Sclerosis Market is segmented By Disease Type (Limited Cutaneous Systemic Sclerosis (IcSSc), Diffuse Cutaneous Systemic Sclerosis (dcSSc)), By Drug Type (Immunosuppressants, Phosphodiesterase 5 (PDE-5) Inhibitors, Endothelin Receptor Antagonists (ERAs), Prostacyclin Analogues, Calcium Channel Blockers, Others), By Distribution Channels (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Report Overview

The Global Systemic Sclerosis Market reached US$ 1.62 billion in 2023 and is expected to reach US$ 2.19 billion by 2031 growing with a CAGR of 3.8% during the forecast period 2024-2031.

Systemic sclerosis (SSc) is a rare and potentially life-threatening chronic autoimmune disease characterized by progressive fibrosis of the skin and internal organs, which can lead to severe complications such as interstitial lung disease, pulmonary hypertension, and scleroderma renal crisis. The exact cause of SSc remains poorly understood, but the involvement of autoantibodies and B cells in its pathology supports the investigation of CAR T cell therapy for treatment. 

This condition leads to significant morbidity and severely impacts the quality of life for affected individuals. Patients often experience a loss of mobility and functionality, chronic pain, and fatigue, which can also take a toll on their mental health. Among rheumatic diseases, scleroderma has the highest mortality rate, underscoring the seriousness of this condition.

Current treatment options are limited and typically involve general immunosuppressive agents or medications aimed at specific symptoms, which provide only modest benefits. Although autologous hematopoietic stem cell transplantation may offer some advantages for organ involvement, it carries significant risks, including mortality, infertility, and the potential for secondary autoimmune diseases.

Market Scope

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Market Dynamics: Drivers

Rising prevalence of systemic sclerosis and advancements in treatment options

The demand for the global systemic sclerosis market is driven by multiple factors. The increasing global incidence of systemic sclerosis (SSc) is a significant factor driving the growth of the market for its treatments. This rise can be attributed to several interconnected elements, including genetic predispositions, environmental factors, and immune system dysfunction.

As per 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. 

Similarly, most of the research studies suggest that genetics are a key factor in the development of systemic sclerosis. Specific genetic markers and family backgrounds can make people more susceptible to autoimmune disorders like SSc. Identifying the precise genetic mutations linked to SSc can enhance our comprehension of the disease and open up possibilities for innovative treatment approaches.

Furthermore, the emergence of new therapies, including biologics and targeted treatments, is revolutionizing the treatment landscape for systemic sclerosis. Recent approvals, like Boehringer Ingelheim's Ofev for systemic sclerosis associated with interstitial lung disease, highlight the advancements being made in this field. The ongoing development of a strong pipeline of innovative therapies is anticipated to improve treatment effectiveness and enhance patient outcomes.

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.

Also, in February 2023, GSK plc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Benlysta (belimumab), a monoclonal antibody that inhibits B-cells, for the potential treatment of systemic sclerosis. GSK intends to begin a phase II/III clinical trial of belimumab for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in the first half of 2023.

Restraints

Factors such as stringent regulatory requirements, shortage of specialized healthcare providers, undiagnosed and unreported cases, and reimbursement challenges, are expected to hamper the market.

Market Segment Analysis

The global systemic sclerosis market is segmented based on disease type, drug type, distribution channels, and region.

The immunosuppressants segment accounted for approximately 56.3% of the global systemic sclerosis market share

The immunosuppressants segment is expected to hold the largest market share over the forecast period. The immunosuppressants segment encompasses a range of drugs that are critical for managing systemic sclerosis (SSc). 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 systemic sclerosis 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 systemic sclerosis patients.

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).

Market Geographical Share

North America accounted for approximately 42.3% of the global systemic sclerosis market share

North America region is expected to hold the largest market share over the forecast period owing to 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.

Moreover, advancements in treatment options, favorable reimbursement policies, key players more 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) 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.

Market Segmentation

By Disease Type

• Limited Cutaneous Systemic Sclerosis (IcSSc)
• Diffuse Cutaneous Systemic Sclerosis (dcSSc)

By Drug Class

• Immunosuppressants
  • Biologics
  • Small Molecule Immunosuppressors
• Phosphodiesterase 5 (PDE-5) Inhibitors
• Endothelin Receptor Antagonists (ERAs)
• Prostacyclin Analogues
• Calcium Channel Blockers
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • The rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Market Competitive Landscape

The major global players in the systemic sclerosis market include Genentech, Inc., GSK plc, Certa Therapeutics, F. Hoffmann-La Roche Ltd, Boehringer Ingelheim International GmbH., Novartis AG, AstraZeneca, Pfizer Inc, Teva Pharmaceuticals USA, Inc. and Eli Lilly and Company among others.

Key Developments

• In February 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to belimumab (brand name Benlysta), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis (SSc). Belimumab is a fully human monoclonal antibody that binds to soluble B-lymphocyte stimulator (BLyS), which is found to be elevated in patients with systemic autoimmune diseases like systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Why Purchase the Report?

• To visualize the global systemic sclerosis market segmentation based on disease type, drug type, distribution channels, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of the systemic sclerosis market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in Excel consisting of key products of all the major players.

The global systemic sclerosis market report would provide approximately 62 tables, 55 figures, and 183 pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies