World Gene Therapy Market

Abstract

Combination Trials in Gene Therapy Market to Improve Clinical Efficiency

Recent failures of clinical trials in gene therapy have caused the termination of several research projects and the retraction of many participants from the market. Only one gene therapy product, Gendicine, has reached the market in China, and its launch has been weighed down with debates about regulatory concerns over its clinical safety and efficacy. However, gene therapy still holds promise as a potential "one-stop" treatment for life threatening diseases. An increasingly popular method of improving clinical efficiency is to combine gene therapy trials with conventional therapeutics. These combination trials sometimes involve collaboration outside the gene therapy market with companies having established products or expertise in healthcare.

This Frost & Sullivan insight examines the current status of the world gene therapy market with a focus on its benefits and drawbacks and upcoming trends. It also provides market drivers and restraints as well as strategic analyses and recommendations to overcome industry challenges. This research enables companies to align their positioning strategies to benefit from the changing markets and obtain maximum return on investment.

High Prevalence of Untreatable Diseases Drives Demand for New Treatments

The gene therapy market has seen both devastating clinical failures and incredible breakthroughs for the treatment of severe diseases. The launch of Gendicine finally signifies a huge boost for gene therapy. The risks historically associated with gene therapy are now lessening, predominantly through scientific advances in gene delivery by industry participants.

"Numerous products are in the clinical pipeline with regulatory approval anticipated within the next three years," says the analyst of this research. "The market faces major challenges in patient recruitment and in the improvement of clinical success, but if these are overcome, the results will herald a new era of medicine."

First Gene Therapy Products Approach the Market

The Chinese State Food and Drug Administration (FDA) approved Gendicine for the treatment of head and neck cancer, for sale in China in January 2004. Following this first authorization, there have been a substantial number of products in the clinical development pipeline poised to reach the European and the United States markets. Many of these products have achieved regulatory fast track and orphan drug status, as they represent areas of unmet medical need.

"Revenue generated from sales of these products can potentially reach $5.73 billion by 2011," notes the analyst. "The gene therapy market is therefore poised to have a significant impact on the healthcare industry, provided that current market and technical challenges are overcome."