The European Monoclonal Antibodies Therapeutics Market - Biologics Market Research

The European Monoclonal Antibodies Therapeutics Market
Frost & Sullivan
October 25, 2004
Pub ID: MC1064751
US $6,813.00 Electronic Access - Single User
US $8,313.00 Electronic Delivery - Global Site License
US $7,313.00 Hard Copy Mail Delivery
Abstract
Countries covered: Europe

Resolving the Issues Surrounding Clinical Trials Must Receive Top Priority
Expensive, lengthy and complex clinical trials prove to be a significant challenge while developing therapeutic monoclonal antibodies (mAbs). It could take between 8 and 16 years and around $500 million to $1 billion to develop a commercially viable mAb therapy. Companies need to look at projects that can justify the high development costs, considering that 75 per cent of the costs are upfront payments and failure rates are extremely high even in late stage trials. Moreover, documented methods used for design, conduct and analysis in clinical trails require greater validation. For higher accuracy of results, companies must also strive to gain control over clinical trial enrolment, co-ordination and sample size.
This research examines the emerging and innovative technologies for producing monoclonal antibodies. It discusses the impact of various market drivers and restraints and evaluates the challenges that the industry faces in terms of gaining commercial success. Revenue forecasts for the European mAb therapeutics market are also provided for the oncology, autoimmune and inflammatory disorder, organ transplant, cardiovascular disorders and infectious disease segments.
Companies Must Establish a Favourable Cost-Benefit Ratio for mAb Drugs
Due to the high development costs involved, most companies adopt a premium pricing strategy for monoclonal antibody products. Moreover, many of the mAb drugs need to be used in combination with the traditional immuno-suppression regimen, increasing the overall treatment cost. "In Europe, although monoclonal antibodies may possess clear advantages over conventional drugs, lower priced small molecule drugs remain the first line treatment choice," says the analyst of the research.
In order to expand the customer base and increase reimbursements, companies need to highlight the benefits of using mAb therapies as opposed to conventional drugs. For example, mAbs minimise the side effects and are more likely to be cost-effective in the long run in terms of preventing recurrences and long hospital stays. They also possess the capabilities to extend survival rate for terminally ill patients - something conventional small molecule drugs have failed to accomplish. The onus is on the companies developing mAb therapies to ensure quick and widespread acceptance through detailed and clear pharmacoeconomic analysis.
Constant Efforts in Improving the Efficacy of mAb Therapeutics Likely to Prove Beneficial for Sustained Growth
Despite the challenges associated with costs and lengthy clinical trials, companies are keeping a positive frame of mind and are working towards improving the technology for producing mAbs. Companies have moved from highly toxic murine products towards chimeric, humanised and human mAbs that are more effective and less immunogenic. Moreover, their ability to target specific antigens involved in the pathology of diseases has made mAb drugs a phenomenal success in clinical applications.
Biotechnology companies producing mAb therapies are also looking to extend their reach in the market by establishing strategic alliances with larger pharmaceutical companies. "In such a partnership, established pharmaceutical companies use their sales and marketing experience and product expertise to market the mAb drugs produced by the biotech firms," explains the analyst.