Gene Therapy Market Trends

Growth Drivers

• Surge in the approval for gene therapy products – Gene therapy products are subject to stringent regulatory review before approval. They produce longer–lasting and more powerful therapeutic effects than conventional methods by acting at the genetic level. Because of this significant benefit, it has been seen that the number of approvals for gene therapy products has increased.
  
  According to the National Institute of Health, gene therapy products have been approved for use in the European Union and seven other nations. It is projected that by 2030, there will be more than 60 new certified products in the market. Furthermore, a sizable number of clinical pipeline drugs are anticipated to obtain final approval during the projected period.
   
• Growing R&D activities in genetic therapies – The study of cell and gene therapies has seen an increase in research and development efforts. This is because gene and cell treatments can treat a variety of conditions, particularly neurological indications for which there is now no proven cure.
  
  Pharmaceutical and biotechnology businesses have the chance to invest in the research and marketing of innovative cell and gene therapies in this field. Additionally, specific therapeutic effects are produced by gene and cell therapies. As a result, their adoption has been primarily motivated by the desire to lower ongoing medical expenses.
   
• Surge in technological advancements in recombinant DNA technology – The continued advancements in recombinant DNA technology will increase the number of active gene therapy clinical trials. These developments are mostly being made in relation to different expression systems and gene–editing instruments to support product R&D. The development of ZFN, TALEN, and CRISPR/Cas9 nuclease has made genome editing simple and accurate. Because of this, there have been a lot of research projects in the gene–editing field recently, which is anticipated to have an impact on the gene therapy market.

Challenges

• Higher costs of gene therapy products – Extensive research and development efforts are being made to create cutting–edge remedies like gene therapy. As such, they require a substantial time and financial commitment. Clinical trials, regulatory approval, preclinical testing, and laboratory research are all included in the expenditures. Products use vectors, which must be created and separately engineered under specifications. This adds to the entire manufacturing process' complexity. Production expenses are increased by the need for extremely controlled manufacturing processes and strict adherence to quality standards.
   
• Shorter shelf life – Products used in cell and gene therapy have drastically differing shelf lives. The brief shelf life of viral vectors raises their price and restricts their availability. Because short–lived viral vectors must be produced in small batches, the entire procedure is costly and time–consuming.
  
  Furthermore, cell and gene therapy products, as well as some biological samples, require extremely cold temperatures, ranging from –4°C and –20°C to –80°C, –120°C, –150°C, and beyond. This contrasts standard biological therapies, which also require temperature management.