Approach:
Data was collected from a comprehensive range of authoritative sources, including treatment guidelines, clinical trials, systematic reviews, meta-analyses, real-world evidence articles, widely respected medical websites (such as Medscape, Medline, and UpToDate), PubMed, and general searches. Approximately 200 autoimmune indications, with potential for immunosuppressant use and including both conditions with and without FDA-approved drugs, were identified. These diseases were categorized based on the effectiveness of immunosuppressants and steroids in their treatment. Additionally, the prevalence estimates were adjusted to reflect the current year’s population. This structured collection and categorization enable a thorough understanding of autoimmune indications relevant to immunosuppressant therapy, supporting strategic insight into treatment landscape and market potential.
Key findings:
Among the identified indications, 48 demonstrated effectiveness with currently approved corticosteroid or immunosuppressant treatments by the FDA, while 35 indications showed these therapies to be ineffective.
In contrast, for indications without FDA-approved corticosteroid or immunosuppressant treatments, 46 were found to respond effectively to existing corticosteroid or immunosuppressant therapies, whereas 18 indications were recorded as ineffective.
This differentiation highlights the variability in treatment response across autoimmune conditions, underscoring the need for continued evaluation and potential development of targeted therapeutic options where current treatments show limited efficacy.
Business Impact:
The client received a comprehensive evaluation of corticosteroids and immunosuppressants across approximately 200 indications, providing critical insights into treatment effectiveness and regulatory approval landscapes. This detailed analysis enabled the client’s team to pinpoint significant gaps where therapies are effective but lack FDA approval, identifying 46 high-opportunity indications with strong potential for regulatory expansion. These findings present the client with actionable intelligence to prioritize development and approval efforts, enhancing the likelihood of successfully demonstrating efficacy and securing formal regulatory endorsements. Ultimately, this empowers the client to strategically expand their portfolio, address unmet medical needs, and strengthen their competitive position within the immunosuppressant market.