The gene therapy market has had limited success with products during the clinical development process. Due to toxicological complications and poor therapy efficacy, healthcare authorities have suspended several gene therapy trials worldwide.
However, research involving novel designs for vectors, methods of introducing ‘naked’ deoxyribonucleic acid (DNA), and the use of electroporation to improve DNA uptake into cells have been successful in pre-clinical studies. These new-age technologies are now entering the clinical development stage and approaching the market.
New analysis from Frost & Sullivan, World Gene Therapy Markets, reveals that revenue in this industry is expected to total USD 150.0 million in 2005 and could reach USD 5,743.6 million in 2011.
An increasingly popular method of improving clinical efficiency is to combine gene therapy trials with conventional therapeutics. These combination trials sometimes involve collaborations outside the gene therapy market with companies having established products or expertise in healthcare.
“A second strategy – particularly for companies with fewer products in development – is to work out a suitable exit strategy, should a gene therapy product fail during clinical development,” explains Frost & Sullivan Industry Analyst Phil Webster. “This involves the objective assessment of a project, which can either be terminated or have its components recycled into a new project.”
The gene therapy market has been on a rollercoaster ride with devastating clinical failures balanced by incredible breakthroughs for the treatment of severe diseases. The launch of Gendicine in China, the only gene therapy product available in the market, signifies a huge boost for gene therapy.
Due to safety concerns, poorly regulated trials, and high levels of clinical attrition, regulatory agencies have stringent authorization laws about gene therapy. Specific ethics commissions, regulatory divisions, and governmental panels all over the world inspect and monitor trials by gene therapy companies.