Global Scleroderma Therapeutics Market Grows Steadily at a CAGR of 4.03%

Introduction

Scleroderma therapeutics refer to medical treatments and therapies aimed at managing scleroderma, a chronic autoimmune disease that causes the skin and connective tissues to harden and tighten. The condition can affect internal organs as well, leading to complications in the heart, lungs, kidneys, and digestive system. Therapeutics for scleroderma include medications to control inflammation, suppress the immune system, and manage symptoms such as skin thickening, pain, and blood vessel problems.

Market Dynamics

Rising prevalence of scleroderma drives the global market

The increasing global prevalence of scleroderma is a significant driver of the scleroderma therapeutics market. The rising number of autoimmune disease cases, combined with genetic and environmental factors, is contributing to a higher incidence of scleroderma, which in turn is driving the demand for more effective treatments.

• For example, a study published in March 2023 by the National Library of Medicine estimated the global prevalence of systemic sclerosis (SSc) at 18.87 per 100,000 people, impacting approximately 1.47 million individuals. The study also highlighted that the incidence and prevalence were higher among females, adults, and individuals in high-income countries, underscoring the increasing burden of the disease.

As the prevalence of scleroderma continues to rise, the demand for innovative treatments grows, fueling the expansion of the scleroderma therapeutics market.

Collaborative research initiatives create tremendous opportunities

Collaborative research between academic institutions, pharmaceutical companies, and healthcare providers presents a valuable opportunity to advance both scleroderma research and treatment. By combining resources, expertise, and data, these partnerships can expedite the development of innovative therapies, enhance disease understanding, and help identify new biomarkers.

• An example of such collaboration is the October 2024 Genome Research in African American Scleroderma Patients (GRASP) study, a joint effort between Yale University, Johns Hopkins University, and the National Human Genome Research Institute. This study focuses on the genetic factors influencing scleroderma in African American patients. Through the collection of clinical data and blood samples, the initiative aims to enhance treatment strategies specifically tailored to this population.

Such collaborative efforts are expected to make significant strides in advancing scleroderma research, facilitating the development of targeted therapies, and ultimately improving treatment outcomes for a wide range of patient groups.

Regional Analysis

North America holds a dominant position in the global scleroderma therapeutics market, driven by a high rate of early diagnosis and increasing awareness of the disease. The region benefits from the presence of leading pharmaceutical companies, advanced research institutions, and a robust healthcare system. The widespread adoption of innovative therapies, including immunosuppressants and targeted biologics, is further accelerating market growth. Moreover, North America’s strong focus on clinical trials and cutting-edge treatment innovations solidifies its leadership, driving sustained demand for effective scleroderma therapies.

Key Highlights

• The global scleroderma therapeutics market size was valued at USD 2.66 billion in 2024 and is projected to grow from USD 2.79 billion in 2025 to reach USD 3.83 billion by 2033, exhibiting a CAGR of 4.03% during the forecast period (2025-2033).
• Based on type, the global scleroderma therapeutics market is segmented into localized scleroderma, systemic sclerosis, diffuse sclerosis, and others. The systemic sclerosis segment is the largest revenue contributor.
• Based on drug class, the market is segmented into immunosuppressors, phosphodiesterase 5 inhibitors – PHA, endothelin receptor antagonists, prostacyclin analogs, and others. The immunosuppressors segment is the largest revenue contributor.
• Based on the route of administration, the global scleroderma therapeutics market is segmented into parenteral, oral, and topical. The oral segment is the largest revenue contributor to the market.
• Based on end-users, the global scleroderma therapeutics market is segmented into hospitals, clinics, and others. The hospital segment is the largest revenue contributor to the market.
• North America is the highest shareholder in the global market.

Competitive Players

1. Hoffmann-La Roche AG
2. BLRBio
3. Corbus Pharmaceuticals Holdings Inc.
4. Calliditas Therapeutics AB.
5. Celgene Corporation
6. Certa Therapeutics
7. Bayer AG
8. Sanofi
9. Cytori Therapeutics Inc.
10. Cabaletta Bio Inc
11. Prometic Life Sciences
12. AMYLYX Pharmaceuticals

Recent Developments

• March 2024- Cabaletta Bio, Inc. announced that the U.S. FDA granted Orphan Drug Designation (ODD) to CABA-201, a fully human CD19-CAR T cell investigational therapy for the treatment of systemic sclerosis (SSc). This breakthrough is part of Cabaletta's RESET clinical trial program, which includes Phase 1/2 trials for autoimmune diseases driven by B cells, including the Phase 1/2 RESET-SSc trial, marking significant progress in developing targeted therapies for scleroderma.

Segmentation

1. By Type
   1. Localized Scleroderma
   2. Systemic Sclerosis
   3. Diffuse Sclerosis
   4. Others
2. By Drug Class
   1. Immunosuppressors
   2. Phosphodiesterase 5 Inhibitors – PHA
   3. Endothelin Receptor Antagonists
   4. Prostacyclin Analogues
   5. Others
3. By Route of Administration
   1. Parenteral
   2. Oral
   3. Topical
4. By End-User
   1. Hospitals
   2. Clinics
   3. Others
5. By Regions
   1. North America
   2. Europe
   3. Asia-Pacific
   4. Central & South America
   5. The Middle East and Africa