A combination of these factors, along with high demand and lack of generic competition, expects to create exciting new possibilities and ensure continued market growth.
New analysis from Frost & Sullivan (pharma.frost.com), U.S. Biotechnology - Therapeutic Monoclonal Antibodies Market, finds the market earned revenues of over $12.61 billion in 2007 and estimates this to reach $34.47 billion in 2014.
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“Several more marketed monoclonal antibodies are being approved for multiple indications, which increases the potential patient pool that can use these products,” says Frost & Sullivan Research Analyst Katheryn Symank. “This trend is also noted within the pipeline, where antibodies in development are being researched for several indications to maximize the possibility of receiving FDA approval.”
Accelerated approvals energize the marketplace. For instance, one of the new products has received FDA approval for seven different applications, while another is evaluated in Phase III clinical trials for the treatment of nine different diseases. Expansion of product lines, bolstered by additional indications, enables the use of this therapy by a wide cross-section of the patient populace.
In 2007, there were more than 20 active competitors in the market with new participants often making entry; meanwhile, competition continues to increase in this emerging market. Furthermore, over 50 companies are involved in developing new therapeutic monoclonal antibodies.
Research focused on vital improvements in monoclonal antibodies, such as refining its functions, along with expediting safety and efficacy. The launch of six new products – Erbitux, Avastin, Tysabri, Lucentis, Vectibix and Soliris, together with additional indications, expanded market potential to reach an extensive customer base. The fully human monoclonal antibody is the current weapon in the armory, although its development is limited by its complexity and high cost.
“As the inadequacies of conventional medicine were particularly apparent with regard to oncology, autoimmune and inflammatory disorders, monoclonal antibodies have offered a new approach, presenting a less toxic and more targeted solution,” notes Symank.
An emerging trend is the development of monoclonal antibodies used in conjunction with some vaccines. The outcome sees monoclonal antibodies boosting the immune system and triggering an effective response of the vaccine, a technique that is still undergoing clinical trials.
Despite proven effectiveness of therapeutic monoclonal antibodies, however, its high cost proves to be a deterrent to use. Therefore, it is imperative to demonstrate the capabilities of this therapy. In addition, companies must be more commercially astute to balance the cost constraints. Shining light on the benefits of therapeutic monoclonal antibodies against conventional therapies is one way to deal with the problem.
Furthermore, technological innovations make the production of monoclonal antibodies more efficient, which allows for greater yields and helps decrease cost. Extensive research can expedite the development of more targeted treatment options for various other diseases, and these advances encourage market expansion.
“Intensive research in genetic engineering, the immune system, and molecular biology has imbued the sector with a fresh impetus,” notes Symank. “Innovations, such as the use of monoclonal antibody fragments, rather than the full-length antibody, and the introduction of high-potency monoclonal antibodies are helping the momentum.”
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U.S. Biotechnology - Therapeutic Monoclonal Antibodies Market