The gene therapy analysis report discusses all gene therapies under the broad criteria of genetic material introduced to the cell for a therapeutic purpose. Detailed discussion on gene therapy pipeline, its production strategies and main challenges to gene therapy development is also included in the report. The report will useful for finding out future prospects and opportunities in Gene Therapy.
Gene therapy is a medical procedure involving insertion of nucleic acid polymers in a patient’s cell with the purpose of preventing or treating genetic diseases. The various approaches involved are: replacement of the mutated, disease causing gene with a healthy copy of the gene; inactivation of an improperly functioning mutated gene; and introduction of a new gene into the body for treatment of the disease.
Gene therapies have been in development in humans for 25 years, and a number of products have begun to enter the pharmaceutical market. However, due to various challenges and clinical trial setbacks, progress in developing this technology and achieving suitability for commercial usage has been slow. Gene therapies only account for a marginal market share and many efficacy and safety concerns remain unaddressed. However, the pipeline is robust; 906 pipeline gene therapies are currently in development. Most are at an early stage of development, with 76% at the Discovery or Preclinical stage. However, there are currently 23 gene therapy programs in Phase III development and two at the Pre-registration stage. This indicates that although gene therapies are beginning to reach the market after two decades of research in humans, the majority remain in relatively early development.
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The report provides a comprehensive view of the clinical, R&D, commercial and competitive landscape of Gene Therapy, and assesses key developments in delivery vector technology, and challenges and advances associated with the production of such vectors.
Scope of the Gene therapy analysis report:
Despite 25 years of clinical research, only a few gene therapies of all types have reached the market globally, and none have achieved strong clinical or commercial success –
Why do gene therapies still occupy only a minimal market share in
their respective indications?
– What can be learned from the gene therapies that have already reached the market?
A number of different viral and non-viral vector types are currently in development for the delivery of gene therapies –
– What are the relative advantages and disadvantages of each vector type and which hold the most promise?
– What proportion of the overall gene therapy R&D pipeline is occupied by each vector type?
current pipeline for gene therapies is diverse in terms of the
approaches and vectors covered; 50% are gene silencing therapies,
while 31% involve the insertion of a functional gene
– In which therapy areas is there the highest level of R&D activity for gene therapies?
– At which stage of development does the majority of pipeline gene therapies reside?
– What is the proportion of the pipeline occupied by each intervention and vector type overall?
A number of companies are currently actively developing pipeline gene therapies, including private, public and institutional enterprises –
– How do gene therapies fit into the overall portfolios of these companies?
– What is the level of involvement in gene therapy research from the top 20 Big Pharma companies?
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The report will allow to –
– Understand the current status of the field of therapeutic gene therapies, and the relative clinical and commercial success of currently marketed products, comprising Glybera, Kynamro, Macugen, Vitravene, Gendicine, Oncorine, and Neovasculgen.
– Assess the pipeline for gene therapies split by therapy area, vector type and intervention type, and stage of development. Additionally, a granular assessment of the pipeline is provided across the four major therapy areas for gene therapy: oncology, infectious diseases, central nervous system disorders, and genetic disorders.
– Gain a picture of the current competitive landscape, with a detailed breakdown of companies actively involved in the gene therapy pipeline. Understand the level of involvement on the part of big pharma companies, and the extent to which gene therapies fit into the overall portfolios of companies in this field. Additionally, a highly granular breakdown of companies developing multiple gene therapies is provided.
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