Cutaneous Fibrosis Treatment Market Size, Share, and Industry Analysis, By Drug (Immunosuppressants, Corticosteroids, Monoclonal Antibody, and Others), By Route of Administration (Parenteral, Oral, and Topical), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast 2025-2032

Cutaneous fibrosis treatment involves the treatment of excessive collagen accumulation and other extracellular matrix components in the skin, leading to thickening, hardening, and scarring. It is a characteristic medical condition that includes systemic sclerosis, also known as scleroderma. Systemic sclerosis is an autoimmune disorder characterized by excessive collagen deposition leading to skin fibrosis. Management of cutaneous fibrosis involves pharmacotherapy, physical therapy, and supportive care to manage the symptoms and prevent complications associated with the disease. The systemic sclerosis disorder comes under the rare disease category, with a relatively smaller pool of patients. Despite the limited patient population, there is a significant unmet need for effective therapies to manage symptoms and slow disease progression.

• For instance, according to data published by the Rare Disease Advisor, a systemic review was published in 2021 on the global systemic sclerosis incidence and prevalence. The study found that the incidence rate of systemic sclerosis was 1.4 per 100,000 person-years and the prevalence rate of systemic sclerosis was 17.6 cases per 100,000.

The increasing research and development initiatives to fulfill the treatment demand for such niche patient populations are set to drive market growth.

This autoimmune disease is rare and life-threatening, with no FDA-approved treatments available. Therefore, market players are actively taking initiatives in research and development to address the unmet medical need. The rising research and development activities by key players to launch novel drug treatments in the market are anticipated to propel the growth of the cutaneous fibrosis treatment market during the forecast period.

• For instance, in September 2020, Corbus Pharmaceuticals Holdings, Inc. reported top-line results from the 52-week Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc). Lenabasum targets the endocannabinoid system and has shown promise in addressing the symptoms of systemic sclerosis.

Moreover, an increase in funds by government organizations to foster research and development for innovative and high-quality treatment options related to systemic sclerosis will help expand the market in the future.

• For instance, the National Scleroderma Foundation presents the New Investigator Award with a funding of USD 200,000 for three years.

Such initiatives by government bodies boost market expansion.

Key Insights

The report covers the following key insights:

• Prevalence of Key Diseases, By Key Countries/Region, 2023
• Regulatory and Reimbursement Scenarios
• Key Industry Developments (Mergers, Acquisitions, Collaborations, and Others)
• Impact of COVID-19 on the Market

Segmentation

Analysis by Drug

Based on product, the cutaneous fibrosis treatment market is segmented into immunosuppressants, corticosteroids, monoclonal antibodies, and others.

The immunosuppressant segment accounted for a significant share of the global cutaneous fibrosis treatment market in 2023. The segment growth is augmented by its effectiveness in managing symptoms and slowing disease progression. These drugs work by suppressing the immune system, thereby reducing inflammation and the abnormal immune response contributing to fibrosis in systemic sclerosis.

• For instance, in March 2021, according to data published by the National Institute of Health (NIH), the Canadian Scleroderma Research Group conducted a study to investigate the pattern and trends in immunosuppressive agents used in early systemic sclerosis. It was found that immunosuppressants are more often prescribed for the treatment of cutaneous systemic sclerosis.

Thus, the increasing adoption of immunosuppressant is set to propel the segment growth during the forecast period. Furthermore, increasing research activities and funding for the launch of optimized treatment options for patients suffering from the disease boosts industry expansion.

Regional Analysis

North America held a significant position in the global cutaneous fibrosis treatment market in 2023 and is anticipated to uphold its leading position throughout the projected timeframe. The advanced healthcare infrastructure, well-established research institutes, and efficient healthcare systems drive the region's dominance in the market. This facilitates the development, approval, and adoption of cutaneous fibrosis treatment.

Furthermore, the increasing awareness and comprehensive reimbursement policies in the region expand the region's growth in the market.

• For instance, according to the Centers for Medicare & Medicaid Services article advisory on billing and coding for the Removal of Benign Skin Lesions Local Coverage Determination (LCD) L34938. The scar conditions and fibrosis of the skin are covered under code L90.5.

Such reimbursement policies increase the adoption of the drugs and boost the regional growth in the market.

Key Players Covered

The report includes the profiles of cutaneous fibrosis treatment market key players such as Genentech, Inc., Baxter, GLENMARK PHARMACEUTICALS LTD., LEO Pharma Inc., Eisai Co., Ltd., GSK plc., Pfizer Inc., Amgen Inc., and Bayer.

Key Industry Developments

• In March 2024, Mirador Therapeutics, Inc. raised over USD 400.0 million to advance the development of precision medicines for immune-related disorders such as immune-mediated inflammatory and fibrotic diseases, marking a significant and rare early-stage fundraising achievement.
• In February 2024, Eisai Co., Ltd. obtained approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for manufacturing and marketing a Metoject Subcutaneous injection (Methotrexate) pen.

In October 2023, Amgen Inc. acquired Horizon Therapeutics plc to provide groundbreaking medications that positively impact patients with severe illnesses.