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."
Table of Contents
- 1. Executive Summary
- 2. Glossary
- 3. Introduction
- 1. Gene Therapy-An Overview
- 1. Market Definition
- 2. Technologies Used in Gene Therapy
- 4. Market Overview
- 1. Market Challenges
- 1. Challenges for the Gene Therapy Market
- a. Lack of Clinical Success
- b. High Levels of Surveillance and Compliance Expectations from Regulatory Agencies
- c. Negative Perception and Acceptance of Gene Therapy
- d. Technical and Safety Issues over Gene Delivery Specificity
- e. Lack of Standardisation of Clinical Procedures and Manufacturing Methodologies
- f. High Anticipated Cost of Gene Therapy Products
- 2. Clinical Research Trends in Gene Therapy
- 1. Research Trends
- 2. Clinical Pipeline Analysis
- 3. Regulatory Affairs
- 1. Regulatory Affairs in the United States
- 2. Regulatory Affairs in Europe
- 5. Market Analysis
- 1. Research Methodology
- 1. Methodology and Assumptions
- 2. Market Drivers and Restraints
- 1. Market Drivers
- a. Demand for Treatments for Areas of Unmet Medical Need
- b. Licensing of Key Gene Delivery Patents Generates Market Revenue
- c. New Technologies Improve Transgene Expression
- d. Human Genome Project Provides New Leads
- 2. Market Restraints
- a. Clinical Failures and Patient Fatalities
- b. Retraction of Key Industry Participants and Pharmaceutical Giants
- c. Patient Recruitment Issues in Clinical Trials
- d. High Cost of Finished Products
- 3. Market Analysis
- 1. Market Engineering Measurements
- 2. Revenue Forecasts
- 6. Competitive Analysis
- 1. Competitive Structure
- 1. Competitive Highlights
- 2. Competitive Analysis
- 1. Competitors in the Gene Therapy Market-Oncology
- 2. Competitors in the Gene Therapy Market-Cardiovascular
- 3. Competitors in the Gene Therapy Market-Monogenic
- 4. Competitors in the Gene Therapy Market-Enabling Technologies and Generalist Providers
- 7. Strategic Analysis and Recommendations
- 1. Market Engineering Strategy
- 1. Strategic Analysis
- 2. Strategic Priorities
- 8. Frost & Sullivan Awards
- 1. Frost & Sullivan Award Candidates
- 1. Introduction to Frost & Sullivan Awards
- 2. Technology Leadership Award
- 3. Entrepreneurial Company Award
- 4. Growth Strategy Leadership Award
- 9. Decision Support Databases
- 1. Pharmaceutical and Biotechnology Market Metrics
- 1. Number of Biotechnology Companies
- 2. Biotechnology Private Investment
- 3. Government Investment in Biotechnology
- 4. Total Healthcare Expenditure
- 2. Disease Prevalence
- 1. Prevalence of Bladder Cancer
- 2. Prevalence of Breast Cancer
- 3. Prevalence of Colon Rectum Cancer
- 4. Prevalence of Liver Cancer
- 5. Prevalence of Lung Cancer
- 6. Prevalence of Prostrate Cancer
- 7. Prevalence of Stomach Cancer
