Scleroderma Therapeutics Market Trends

Growth Drivers

• Rising prevalence of autoimmune disorders: The growing prevalence of autoimmune disease is leading to increasing research to develop immunomodulatory therapy, benefiting the growth of the global scleroderma therapeutics market. For instance, in March 2024, the National Health Council highlighted autoimmune disease affects approximately 50 million U.S. residents and compiled studies indicating an alarming 3% to 12% increase annually. Rising awareness and healthcare spending on combating the surge of autoimmune disease creates a robust pipeline of clinical trials in targeted treatment options. The trends are beneficial for scleroderma therapeutics and improving their efficacy.
• Growing government and organization funding for rare disease research: Governments across the world are creating rare disease frameworks to identify patients diagnosed and provide them with the necessary care, as well as invest in finding orphan drugs. Rising investments benefit the growth of the market. An increasing percentage of countries are creating guidelines for the treatment of scleroderma. For instance, the Brazilian Society of Rheumatology released guidelines for the treatment of scleroderma highlighting the treatment of Raynaud’s phenomenon, prevention of digital ulcers, and more.
  
  Financial incentives, grants for rare diseases, and favorable regulatory ecosystem incentives companies to invest in scleroderma research. Apart from government funding, robust support from non-profit organizations is poised to boost the sector’s growth. For instance, in October 2023, the Scleroderma Research Foundation (SRF) announced that Boehringer Ingelheim will contribute an experimental agent to CONQUEST, i.e., an innovative clinical trial platform created by SRF.
• Increasing investments in stem cell research: The global scleroderma therapeutics market is poised to register a growth curve due to increasing investments in stem cell research. Stem cell research can help in new drug discovery and development, and heighten tissue repair. As per the European Society for Blood and Marrow Transplantation (EBMT) registry, scleroderma is the second most autoimmune disease to be treated with HSCT after multiple sclerosis. Stem cell research targets the underlying cause of tissue damage and has the potential to develop therapeutics that answer the unmet need in scleroderma treatment. Due to the potential of this approach, the market is positioned to register a surge in growth by the end of the forecast period.

Challenges

• High cost of treatment and limited accessibility: Scleroderma treatments can be costly and the long-term nature of the treatment can put a severe economic burden on the patients. This creates a market challenge in emerging economies with low rates of disposable income or lack of health insurance. The long-term treatment costs can be a deterrent in established markets as well. Severe cases may require more intensive treatments, adding to costs. Additionally, due to the rarity of the disease, health infrastructures in many emerging economies may not have the adequate expertise or diagnostic tools to offer adequate care limiting the growth of the scleroderma market.
• Lengthy drug approval process: The rarity of scleroderma cases can be a challenge in attaining quick regulatory approval for treatments as clinical trials may suffer from underrepresentation in research. Small sample sizes and diverse disease manifestations can be a deterrent in formulating effective scleroderma therapeutics. Additionally, it also leads to the approval process becoming more time-consuming as companies may find it challenging to meet all criteria set by the regulatory bodies. This can delay market entry of new treatments stifling the growth of the scleroderma therapeutics market.