The Orphan Drugs Market is projected to grow from USD 225.9 Billion in 2023 to USD 493.21 Billion by 2031, driven by rising prevalence of rare diseases, unmet medical needs, favorable regulatory policies, technological advancements, and growing public and patient advocacy. Key challenges include high R&D costs, limited patient populations, pricing and reimbursement issues, and lack of long-term data. Trends include focus on gene therapies, personalized medicine, stakeholder collaboration, and expansion into emerging markets. North America leads the market, followed by Europe and Asia Pacific.