Cutaneous Radiation Injury Treatment Market Trends

Growth Drivers

• Value-based care and financial benefits: The validations gained through numerous clinical studies have readily fostered growth in the cutaneous radiation injury treatment market. In this context, the study by AHRQ in 2022 found that early intervention with CRI significantly reduced hospitalizations thereby saves U.S. healthcare expenditure in a span of two years. Besides the Germany’s Institute for Quality and Efficiency in Healthcare also recommends topical growth factor therapies as cost-effective solutions for moderate CRI cases, thus suitable for standard market development.
• Patient pool and disease prevalence: Increased cancer incidence is one of the drivers that require the treatment of cutaneous radiation injury. According to the NLM research in August 2023, 7 million patients receive radiotherapy globally and the majority of them have skin injury. Higher cancer survivorship and increased application of radiation therapy are the drivers of the larger patient pool. Prophylactic and therapeutic demand in North America is propelled by exposure-related accidents and scheduled medical procedures. Growing awareness among clinicians and patients regarding early treatment to prevent severe skin necrosis further fuels market uptake, ensuring that hospitals and burn centers remain primary end users.
• Strategic public-private alliances: Firms are increasingly making use of alliances with government institutions for sharing the cost and risk of development. One good example is the alliance between the BARDA and Partner Therapeutics to ensure the availability of Leukine (sargramostim) for the Strategic National Stockpile. These collaborations are one major strategy utilized by manufacturers for coping with the high-risk, high-cost development setting and accessing markets in case of successful product approval.

Summary of Clinical Trials on Cutaneous Radiation Injury Treatment

Source: Clinical Trials September 2023, NLM January 2022

Challenges

• Price caps and reimbursement barriers: This aspect demonstrates a major issue in the market, delaying the manufacturer's profitability. In this regard, strict price ceilings imposed by Germany’s AMNOG system hinder players' interest in investing in this sector. However, in 2023, Smith & Nephew addressed this by collaborating with France’s HAS, thereby securing a broader market access for its PICO 7 dressing. Furthermore, cutaneous radiation injury treatments are completely reimbursed under the U.S. Medicare system owing to its exacerbated costs.
• Robust regulatory pathways: The manufacturers have to deal with the Animal Rule problem in which human efficacy studies are unacceptable. The U.S. FDA demands strong data from animal models for approval, a cumbersome and expensive process. Neupogen approval for Acute Radiation Syndrome, for instance, involved large-scale studies coordinated by the National Institute of Allergy and Infectious Diseases (NIAID). This route requires a huge initial investment without a certain return on the commercial side, setting a high entry barrier for any but the most highly capitalized firms.