Patent losses open up $30 billion biologics market to generic competition

With powerhouse biologics, such as human growth hormone and insulin, losing their U.S. patent protection in 2005 and many more set to expire within the next 4 years, generic competition in the lucrative biopharmaceutical market is imminent, according to a new study from Kalorama Information.

With the current market worth over $30 billion, the potential for generics seizing a sizable portion of the market is great ... but the hurdles for these generics may prove greater.

The new study, The Market for Generic Biologics, 2nd Edition, predicts that the world market for biogenerics will likely reach $6.6 billion by 2010, with 61.5% of this potential market coming from popular drugs that are still currently under patent protection. However, anticipated resistance from innovator companies-particularly from those whose proprietary drugs demonstrate sales of more than $1 billion per year-is expected to be fierce as these companies fight to protect their vested interests and present a strong case for ensuring the safety and efficacy of their high-tech biopharmaceuticals.

"While the market potential is huge, the area of generic biologic participation is an extremely complex one involving many variables, with safety being the paramount issue," notes Mary Anne Crandall, RN, the author of the final report. "There are many stumbling blocks that could preclude generic participation in production of biologic products including access to innovators' key intermediates, process controls, specially designed and adapted analytical procedures, and validation studies."

The Market for Generic Biologics takes an in-depth look at the major issues facing the biogenerics pharmaceutical market, including: legal and regulatory, scientific, pricing, barriers to entry, bioequivalence, innovator strategies and challenges, and international regulations.