MAbs to fill vacuum left by ineffective conventional therapies, study predicts

Unlike several conventional (small molecule) therapies that offer only short-term symptomatic relief and can potentially cause serious side effects, biopharmaceuticals, such as monoclonal antibodies (MAbs), can provide effective treatments with greater efficacy and tolerability.

According to Frost & Sullivan in its study of the European Monoclonal Antibodies Therapeutics Market, while demand for MAbs may be rising, market success will depend on clearly establishing their clinical and cost benefits.

Amongt the most important attributes of MAbs is their high specificity. The ability to target specific antigens involved in the pathology of disease, while minimising side effects has underlined the popularity of MAbs in clinical applications. Earlier, the attribute of high specificity had restricted the target population that could be treated with MAbs. Now, numerous MAbs therapeutic products in clinical development are being investigated for the treatment of more than one disease or for different forms of the same disease.

Thus, while most products are expected to be approved initially for specific forms of a disease, label expansion is likely to follow, thereby expanding the patient population that can be treated and boosting revenue potential.

The improved side effect profile of MAbs offers the patient a well-tolerated therapy, while also lowering overall disease-management costs. MAbs have also provided significant benefits in terms of extending the survival rate of terminally ill patients, says Frost & Sullivan. In contrast, small molecule drugs have been liable to producing undesired side effects that extract heavy costs in terms of both patient health and financial outlays. However, lower priced small molecule drugs remain the first line treatment choice in comparison to highly priced MAbs alternatives.

'While costs are expected to go down as competition increases and development procedures are refined, the benefits of the drugs need to be clearly demonstrated in terms of overall cost savings and effectiveness,' said Frost & Sullivan industry manager Dr Raju Adhikari. 'Biopharmaceutical and pharmaceutical companies should assess themselves and provide detailed and clear pharmacoeconomic analysis of these products so that MAbs may become less restricted, reimbursement may be granted to additional patient groups, the rate of uptake enhanced and the potential revenue generated increased.'

Frost & Sullivan expects the total European monoclonal antibody therapeutics market to grow at a compound annual growth rate of 34.1% from an estimated US$1.47bn in 2004 to $11.4bn in 2011. There are currently 10 products commercially available in Europe, including Remicade, Zevalin, Campath, Herceptin, Rituxan, Simulect, Zenapax Synagis, ReoPro and the fully human MAb Humira. While chimeric MAbs currently control the market, humanised and human MAbs are expected to dominate in future.

Oncology is likely to remain the leading revenue generator with sales of approximately $6.5bn forecast in 2011. AIID indications are set to follow with esti-mated sales of $4.5bn in 2011. Other indication areas such as cardiovascular disorder, organ transplantation and infectious diseases are likely to show less encouraging growth.