More than fifteen therapeutic mAbs have been approved, several of which have reached blockbuster status. Numerous diagnostic mAbs have also been approved, making this one of the fastest growing fields in biotechnology. Today, the industry is working hard to perfect the design and production of MAbs for therapeutic, diagnostic, and other purposes.
The report identifies oncology and autoimmune and inflammatory disorders (AIID) as the primary areas of commercial prosperity. Oncology is likely to remain the leading revenue generator with sales of approximately $6.5 billion forecast in 2011.
The AIID market is expected to follow a similar pattern with estimated sales of $4.5 billion in 2011. However, areas set to show less encouraging growth include the organ transplantation and infectious diseases sectors.
Currently the limited efficacy of conventional therapies combined with serious side effects, has increased demand for monoclonal (mAbs), market success will depend on clearly establishing their clinical and cost benefits.
The improved side effect profile of mAbs is a significant advantage and offers the patient a well-tolerated therapy while also lowering overall disease management costs. They have also provided significant benefits in terms of extending the survival rate of terminally ill patients.
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 spending. Nowhere is this truer than in the treatment of cancer, which historically has been characterised by the use of nonspecific cytotoxic agents and radiation.
Another advantage to mAbs is their high specificity. The ability to target specific antigens (within cells, tissues and organs) involved in the pathology of disease, while minimising side effects has underlined the popularity of mAbs in clinical applications.
The report pointed out that while high specificity can restrict the number of people that could be treated with mAbs. However, advances in mAbs production technology means those therapeutic products for the treatment of more than one disease or for different forms of the same disease being produced.
Label expansion is a theme that is likely to follow products that have initially been approved for specific forms of a disease. This expands the patient population that can be treated and boosting revenue potential.
Remicade is a product, which initially gained marketing authorisation for the treatment of severe and active Crohn's disease, was later approved for reducing the signs and symptoms associated with rheumatoid arthritis.
The report, entitled: 'European Monoclonal Antibodies Therapeutics Market', identified price as the main stumbling block. Despite the advantages of these new 'biotech drugs' over the more traditional 'small molecule blockbuster' model, lower priced small molecule drugs remain the first line treatment choice in comparison to highly priced mAbs alternatives
Due to the sizeable development costs involved, most companies have adopted premium pricing for mAb products. High costs assume increased relevance when mAbs are used in combination with conventional drugs, or in cases where continuous treatment is required resulting in only very specific patient populations receiving mAbs, and uptake being slow.
"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," commented 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," he added.
The prediction for the next few years will see strategic alliances formed between mAb developers and big pharmaceutical companies, which will contribute to market growth. To capitalise on this both industries will need to continue to evolve towards offering competitive pricing, developing holistic solutions, from diagnosis to treatment to after care and providing technical and efficient customer care.
Adhikari concluded: "Success will depend on a medley of key factors including innovative molecular engineering, shorter development times, higher success rates, robust and efficient intellectual property (IP) protection and development of cost-effective manufacturing."