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How are Strong Regulatory Frameworks Aiding Growth to Gene Therapy in North America – Exclusive Analysis by Fact.MR

Gene Therapy Market

Gene therapies have emerged as a viable therapy option for a variety of diseases, including cancer and certain genetic disorders, that may be treated with a single dose. Sales of Gene Therapy is expected to grow at a sluggish CAGR. Although they are expected to save money in the long run, their high upfront costs and uncertainty about their long-term efficacy constitute a current barrier for market players.

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both approved the use of the drugs Kymriah and Yescarta to treat elapsed/refractory B-cell Acute Lymphoblastic Leukemia (ALL) and diffuse large B-cell lymphoma, respectively (DLBCL). However, both of these gene therapy treatments have had a minimal market uptake.

Gene Therapy Market: Key Takeaways

  • Yescarta dominates the gene therapy market in terms of revenue, while Luxturna leads in terms of yearly growth rate.
  • Because of the significant increase in caseloads of various cancer kinds, almost half of gene therapy research studies are focused on oncology.
  • In the gene therapy industry, the United States presently offers the most profitable opportunities, but Europe is predicted to overtake the region by the end of the projection period.
  • The rapid approval and marketing of gene therapy products by regulatory agencies in the United States and Europe is expected to drive market expansion.

“Cancers such as DLBCL and acute lymphoblastic leukaemia (ALL) are among the leading causes of death worldwide, particularly in developed nations. Governments are investing in gene therapy treatment centres to improve access to a larger patient pool, realising the great promise of gene therapy in treating rare diseases,” says an analyst at Fact.MR.

Empirical Novel Drugs Discovery for Rare Disorders Aiding Market Growth?

Gene therapy is attracting the attention of a growing number of academic institutes and research centres, particularly in the field of oncology, because of its potential for producing medications that can treat rare ailments.

In the midst of a surge in gene therapy, the healthcare industry must rethink its research and reimbursement framework for medicines and treatment approaches that differ from the traditional approach to illness treatment.

Market participants are collaborating with biopharmaceutical firms, research institutes, and clinical research organisations (CROs) to develop and scale up essential healthcare innovations, services, and products. While over 150 empirical innovative medications for gene therapy have been patented in recent years, Fact.MR predicts that this number will rise (10-15 annually) in the near future.

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