Search tips
Search criteria 


Logo of biotechhealthLink to Publisher's site
Biotechnol Healthc. 2010 Summer; 7(2): 31.
PMCID: PMC2899801

With Injectable Biologic Therapies on the Rise, Payers Face Tough Reimbursement Issues

Katherine T. Adams, Managing Editor

Injectable biologic therapies for the treatment of secondary care indications will be the chief drivers of sales growth in the United States out to 2014, fueled by a high unmet need that is satisfied by these drugs combined with their high price points and recent entry into the market, according to Datamonitor’s recent “Pharmaceutical Key Trends 2010” report. Of new drug approvals by the U.S. Food and Drug Administration in 2009, 27 percent (7 out of 26) were biologic license applications, the highest proportion of biologic approvals since 2003. The number of orphan drug designations has more than doubled in the last decade, from 207 to 444, while the number of orphan drug approvals grew from 32 to 47, an increase of 47 percent. Monoclonal antibody therapies will lead the growth of biologic therapies. Bevacizumab (Avastin), trastu-zumab (Herceptin), rituximab (MabThera), adalimumab (Humira), and infliximab (Remicade), which held the lion’s share of mAB sales in 2008, will be given a run as more mABs are projected to enter the market.

All is not rosy, however. The growth of biologics will present reimbursement issues as payers are forced to make tough decisions regarding which drugs they will pay for among all the offerings available.

“The small molecule market has dried up, and specialty drugs are where the market is right now, probably for the next decade,” says Jeffrey Dunn, PharmD, formulary and contract manager at Select Health, in Utah. “And it will be a while before we see the impact of biosimilars.” What we need, says Dunn, are better systems to capture data. “There are technology issues, knowledge gaps, and benefit design issues that prohibit plans from proper management right now.”


  • Emerging market expansion — growth potential of 12% year-on-year
  • Biologics market expansion — biologics set to grow by $41 billion between 2009 and 2014
  • Cost saving initiatives — cost-cutting required to grow profits, offsetting slowing sales growth
An external file that holds a picture, illustration, etc.
Object name is f1-BTH07_2p031.jpg

Biologic drugs for the treatment of secondary care indications will experience the largest sales growth globally between 2009 and 2014

Bubble size illustrates forecast 2009–2014 sales growth as a percentage of 2009 annual sales. Dotted line denotes negative sales growth.

Articles from Biotechnology Healthcare are provided here courtesy of MediMedia, USA