Therapeutic Monoclonal Antibodies Manufacturers Focus on Eliminating Clinical Trial Complexities to Sustain Growth

Business Wire, June 27, 2005

PALO ALTO, Calif. -- Manufacturers in the U.S. therapeutic monoclonal antibodies (mAb) market face their biggest challenge in the form of huge costs and complexities in clinical trials. A typical trial takes 10 to 15 years with a cost range of $800 million to 1 billion for developing a product. Obtaining upfront payments for these trails from investors becomes more difficult than recruiting investigators and subjects.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), U.S. Therapeutic Monoclonal Antibodies Markets, reveals that this market generated revenue of $8.71 billion in 2005. Total market revenue is expected to reach $16.29 billion by 2012.

If you are interested in a virtual brochure, which provides manufacturers, end users, and other industry participants an overview of the latest analysis of the U.S. Therapeutic Monoclonal Antibodies Markets, then send an e-mail to Melina Gonzalez, Corporate Communications, at melina.gonzalez@frost.com with the following information: your full name, company name, title, telephone number, fax number, and e-mail address. Upon receipt of the above information, an overview will be sent to you via e-mail.

"Due to the high risk of failure, companies need to conduct thorough pre-clinical studies before proceeding with more intricate clinical trials for an antibody," notes Frost & Sullivan Industry Manager Dhiraj Ajmani. "Even in later stage trials, the risk persists as drugs may not meet the desired targets in terms of efficacy, safety, and convenience."

This is mainly because most companies in the mAb market are still learning to develop strategies to reduce Phase I to Phase III trial costs. Companies are ill equipped to forecast long-term trial outcomes that are cost effective and free of expensive protocol errors.

As overall healthcare costs escalate in the United States, mAbs are facing the same price-related concerns as other drugs and biologics in the therapeutic monoclonal antibodies market. To counter this, government officials, private medicare reimbursement agencies, and consumers are insisting on changing the relevant pricing systems and implementing better price controls.

In particular, government investigations, public and private litigation, and legislative proposals are advocating the modification of the average wholesale price (AWP) - the main prescription drug reimbursement standard. The recent activities by the Centers for Medicare & Medicaid Services (CMS) and government reports indicate a substantial change in the federal and state governments' prescription drug reimbursement system.

Another challenge is that since mAb molecules are protein-based biologics, they are heavy and large, unlike conventional drugs. In addition, these uniquely characterized antibodies that depend on concurrent controls require an optimal biological dose and are species-specific, resulting in a limited number of applicable animal models.

"The mAb action mechanism is also dependent on biological milieus and is degraded by body systems and not metabolized in a manner akin to smaller chemical drugs," says Ajmani. "This subsequently makes their long-term safety and efficacy evaluation difficult and risky."

To overcome this challenge, the pre-clinical design and implementation should focus on clinical indications, population, and product characteristics with emphasis on unique mAb safety concerns. Manufacturers should work on side-effect reduction and tolerance improvement of new mAbs and highlight the benefits of greater life span and survival rates.

The U.S. Therapeutic Monoclonal Antibodies Markets, a part of the pharmaceutical subscription, provides an overview of and outlook of therapeutic mAbs market in the United States, detailing revenue forecasts by end user. It also looks into the major market sectors for therapeutic mAbs such as oncology, autoimmune and inflammatory disorders, cardiovascular disorders, organ transplants, and infectious diseases. Analyst interviews are available to the press.

Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership services, and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics. For more information, visit http://www.frost.com.

U.S. Therapeutic Monoclonal Antibodies Markets F337

Keywords in this Press Release: monoclonal antibodies, mAb, U.S., therapeutic, oncology, auto-immune, inflammatory, cardiovascular, organ transplant, Centers for Medicare & Medicaid Services, CMS, average wholesale price, AWP, research, information, market, trends, technology, service, forecast.