Major challenges hindering the growth of the global orphan drugs market.

The global orphan drugs market is expected to grow at a CAGR of 11.77% during the forecast period. Major challenges hindering the growth of the global orphan drugs market include delay in diagnosis, risk associated with the clinical development of novel orphan drugs, challenges associated with pricing and reimbursements for orphan drugs.

Despite the emergence of innovative and promising technologies to develop orphan drugs, the challenge lies in the development of these technologies in an efficient and accelerated way to create near-term value for all stakeholders. The market is facing a wide spectrum of challenges associated with the clinical development of innovative orphan drugs with regard to drug delivery, the preclinical and clinical models, pharmacological issues, toxicity, immune response, ethical and legal consideration, and production issues.

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Both ex-vivo and in-vivo delivery approaches have similar issues with manufacturing. However, the autologous ex-vivo approach is more complex than the allogenic ex-vivo approach, since in autologous, cells are extracted from the same patients, and the process is time-consuming. Moreover, the manufacturing and processing costs are high and are around $60,000 per patient. Therefore, the risks associated with the clinical development of novel orphan drugs is expected to hamper the market growth. However, despite the challenges, the global orphan drugs market is expected to grow in an accelerating momentum during the forecast period.