01-08-2005: 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 (www.healthcare.frost.com), 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
"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.
Lack of cellular target specificity is largely responsible for the toxicity issues in gene
therapy, as viral vectors, the most commonly used gene delivery system, may infect even
healthy cells while transporting genes to the body. There is the danger of the new gene
being inserted in the wrong location in the DNA that can possibly cause cancer or other
mutations. Even over-expression of the introduced gene sequences can cause an unfavourable
"Trends in clinical development have shown that there is significant focus on terminal
diseases such as monogenic and oncology disorders," notes Mr Webster. "There is also an
increasing trend in non-terminal cardiovascular disorders, wherein existing products are
available to significantly prolong the life of a patient but do not necessarily offer a
The historically associated risks of gene therapy are now lessening, predominantly through
scientific advances in gene delivery by industry participants. Regulatory restrictions
will diminish if the clinical success rate improves and more products are submitted for
If you are interested in a virtual brochure, which provides manufacturers, end users, and
other industry participants with an overview of the latest analysis of the World Gene Therapy
Markets, please use the button 'Contact / Info'.
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