Systemic Sclerosis Market Report and Forecast 2025-2034

Systemic Sclerosis Market Outlook

The systemic sclerosis market size is expected to grow at a CAGR of 6.3% during the forecast period of 2025-2034. The growth of the market in the seven major markets is driven by increased research and development efforts to provide effective treatment alternatives to patients, along with growing focus on offering patient centric care.

Systemic Sclerosis Market Overview

Systemic sclerosis (SSc) is an autoimmune disorder that involves skin tightening and hardening due to excessive collagen production in the body. It first affects the fingers, hands, feet, and face. Raynaud’s phenomenon is also common and observed in more than 95% of the people with the condition. It occurs due to exaggerated contraction of small blood vessels in toes and fingers in response to cold or emotional distress.

The global incidence of systemic sclerosis is estimated to be 8.64 per 100,000 people  annually. The prevalence is relatively higher in high income level countries. Adult females are more prone to develop the condition than males with an average of 5:1 .Children and teens below 15 years of age are less susceptible to the disease. The systemic sclerosis market demand is driven by increasing drug development activities and a subsequent growth in approvals from the regulatory authorities.

Surge in FDA Approvals to be a Key Driver

The market growth is driven by the increasing number of drug approvals developed by employing the latest technologies. In October 2023, Kyverna Therapeutics’  new investigational drug called KYV-101 received the application approval by the FDA for treating scleroderma. It is an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy aiding deep B cell depletion.

In February 2023, ChemomAb Ltd.’s  new investigation drug for systemic sclerosis called CM-101 gained FDA clearance as per the results of phase 2 trials conducted in adults. CM-101 is a monoclonal antibody designed to interfere with vital biological pathways that are related to SSc. It has been well tolerated and helped with inflammatory reduction in patients.

Emphasis on Developing Effective Drugs that Address Disease Complications

Managing complications and side-effects is one of the major systemic sclerosis market trends. Interstitial lung disease (ILD) is a leading cause of death in systemic scleroderma disease affecting approximately half of the patients. To combat the number of mortalities associated with SSc-ILD, Benlysta (belimumab) , a B-cell inhibiting monoclonal antibody developed by GSK plc has been granted orphan drug designation (ODD) by the FDA in February 2023. It is the first and only approved biologic for the condition and can be administered to the pediatric population as well. The newly assigned status is aimed at offering further research to address a wider section of patients suffering from the condition.

Development in Non-Pharmacological Interventions

The growing application of alternative therapeutics is also expected to boost the systemic sclerosis market growth globally. Along with pharmacological interventions, haematopoietic stem cell transplantation (HSCT)  is another treatment option for severe systemic sclerosis. Physiotherapy, occupational therapy, diet, psychology, and podiatry are some of the common management techniques suggested by the European Alliance of Associations for Rheumatology (EULAR).

Systemic Sclerosis Market Segmentation

Market Breakup by Diagnosis

• Skin Biopsy

• Imaging Techniques

• Blood test

• Electrocardiogram

• Pulmonary Function Test

Market Breakup by Type

• Limited Systemic Sclerosis

• Diffuse Systemic Sclerosis

• Sine Systemic Sclerosis

Market Breakup by Drug Class

• Immunosuppressors

• PDE-5 Inhibitors

• Endothelin Receptor Antagonist

• Prostacyclin Analogues

• Others

Market Breakup by End User

• Hospitals

• Clinics

• Research Institutes

• Others

Market Breakup by Region

• United States

• EU-4 and the United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom

• Japan

Systemic Sclerosis Market Regional Analysis

The United States is a major market with a robust medical ecosystem that works continuously to improve the therapeutic options available in the market. The presence of key healthcare providers also drives the market growth in the region. In October 2023, Certa Therapeutics’  systemic sclerosis candidate FT011 gained FDA’s orphan drug designation. It demonstrated clinically meaningful improvements for over 60% of the patients after 12-week treatment.

Europe is among the largest markets for systemic scleroderma with a substantial portion of geriatric population which is more prone to developing the condition. Having several academic and well-equipped research institutions at home also boosts the systemic sclerosis market growth. Mergers and acquisitions between vital pharmaceutical companies to adopt better technologies and develop effective solutions is a major market trend in the region.

In the Asia Pacific region, Japan is a leading region with the largest systemic sclerosis market share. However, other regions such as Australia, China, and India are also emerging as a prominent market with the help of growing investments in the region. For instance, ‘Shine Like a Sunflower’ funding drive in Australia aims to raise a significant amount to facilitate a cure and improve treatment in patients.

Systemic Sclerosis Market: Competitor Landscape

In April 2023, Merck & Co. acquired Prometheus Biosciences for a USD 10.8 billion to expand their immunology drug pipeline. Prometheus’ lead candidate, PRA023, a humanized monoclonal antibody is aimed at treating several autoimmune conditions including Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). Such mergers and acquisitions are a frequent occurrence in the market, especially with larger companies showing keen interest in small biotech firms to adapt their latest technologies and develop effective solutions.

The key features of the systemic sclerosis market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

• F. Hoffmann La Roche Ltd.

• Johnson & Johnson Services

• United Therapeutics

• Boehringer Ingelheim International GmbH

• GlaxoSmithKline plc

• Pfizer

• Eli Lilly and Company

• Bayer AG

• Mylan N.V.

• Teva Pharmaceutical Industries Ltd.

• Gilead Sciences Inc

• Novartis AG

• Cumberland Pharmaceuticals

• Organon LLC

• Lupin Ltd

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

Key Highlights of the Report