The spinal cord injury (SCI) treatment market is on the cusp of a significant transformation, fueled by a rising prevalence of SCI cases and the development of innovative therapies. According to a recent report by DelveInsight, the SCI market across the 7MM (United States, EU4, United Kingdom, and Japan) is projected to grow from USD 345 million in 2023 to a CAGR of 15.4% by 2034. This growth is attributed to increasing awareness, traumatic injuries, aging populations, and advancements in diagnostic tools.
Emerging Therapies Reshaping the SCI Landscape
Several promising therapies are in various stages of development, poised to address the unmet needs in SCI treatment. These therapies aim to improve long-term outcomes and promote functional recovery, moving beyond symptom management to address the underlying condition.
- KP-100IT (Kringle Pharma): This drug is designed to protect nerve cells and promote axonal growth. Phase I/II results demonstrated a strong safety and efficacy profile in patients with severe acute cervical SCI. A Phase III trial assessed its effectiveness in improving recovery, with the primary objective of achieving at least a two-grade improvement in the American Spinal Injury Association (ASIA) score within six months. Kringle Pharma is preparing a marketing application, targeting manufacturing and marketing approval by March 2025.
- Neuro-Cells (Neuroplast): This stem cell therapy aims to treat traumatic spinal cord injury (TSCI) by reducing inflammation and promoting nerve regeneration in the central nervous system. Phase II trials have been completed, confirming a strong safety profile. Neuroplast is progressing through Phase II/III clinical trials for TSCI.
- MT-3921 (Mitsubishi Tanabe Pharma America): Developed in partnership with Osaka University, MT-3921 inhibits repulsive guidance molecule A (RGMa) to enhance neuroregeneration and restore motor function in SCI patients. A Phase II Proof-of-Concept trial is assessing MT-3921's effectiveness in 72 SCI patients across clinical sites in the United States and Japan, focusing on changes in Upper Extremity Motor Score (UEMS) over a six-month treatment period.
Ongoing Clinical Trials and Regulatory Designations
Several companies are actively involved in clinical trials to evaluate the safety and efficacy of their SCI treatments. Mitsubishi Tanabe Pharma America Inc. announced a Phase 2 clinical trial for MT-3921 in March 2024, comparing its efficacy and safety to placebo in subjects with acute traumatic cervical spinal cord injury. NervGen Pharma is also conducting Phase 1 & 2 clinical trials for NVG-291 to evaluate its effect on descending connectivity in subjects with subacute and chronic SCI.
Kringle Pharma's KP-100IT has been granted Orphan Drug Designation for acute-phase SCI by Japan's Ministry of Health, Labour and Welfare (MHLW) in September 2019. MT-3921 was granted Fast Track Designation (FTD) by the U.S. FDA in July 2021.
Addressing Unmet Needs in SCI Treatment
Despite advancements, there remains a significant unmet need for targeted treatments that address the underlying condition of SCI rather than merely managing symptoms. Current therapies often focus on symptom management, leaving a gap in addressing the root causes of SCI and promoting functional recovery.
Market Dynamics and Future Outlook
The anticipated launch of emerging therapies is expected to transform the SCI market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SCI in the 7MM is expected to grow significantly, driven by the rising prevalence of SCI and advancements in diagnostic tools.
However, challenges remain, including the high cost of treatments, skepticism regarding stem cell therapies, and the need for more efficient therapies targeting SCI-related symptoms and complications. Continuous dedication to basic and clinical research is essential to forging a new path toward regenerative medicine in SCI.
