• by bcarlson@marketresearch.com
  • October 17 2013

With Fingers Crossed, Biosimilars Market Expected to Grow

With Fingers Crossed, Biosimilars Market Expected to Grow

 It’s not the first prediction that has been made about the market for generic forms of biopharmaceutical drugs, but according to Kalorama Information a multi-billion dollar market for biosimilars will arrive in the next five years.   Kalorama Information’s new report, The World Market for Biosimilars (EPO, G-CSF, HGH, Insulin, Interferon alpha, Monoclonal Antibodies, Others),   predicts a market of nearly $5 billion dollars.  There’s a reason.  Biosimilar development is in almost everyone’s interest - payors, governments, providers and patients seeking low-cost alternatives to the most expensive and effective therapies. 

 Biopharmaceuticals account for about 750 of the more than 10,000 drugs on the market but represent a disproportionate share of the nation’s healthcare spending.

"Some of the most expensive drugs in the world are biologics," said Mary Ann Crandall, Kalorama analyst and author of the report.  “So there’s a large demand for a generic solution, but also great challenges.   Yet a number of generic companies have opted to accept the challenge.”

Kalorama’s recent report says that the generic biologic drug market presents many more challenges than the traditional generic market and regulatory restrictions remain.   Generic biological drugs are more difficult to produce and a few firms have the expertise.  Unlike generics, they are not the exact same as the brand, they have a similar structure and function. Insulin, blood products and monoclonal antibodies (mAbs) are expected to show the most potential for generic equivalent products with blood products leading in revenues.    The EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, can lead to a competitive advantage to the EU biosimilars industry, according to the report.


“Traditional generic drugs sell for a fraction of the cost of the equivalent brand name drugs because the process for approval is abbreviated and there are no lengthy clinical trials to demonstrate safety and efficacy,” Crandall said.     “However, this is not the case with biosimilar products. At present biotechnology companies have a monopoly on pricing due to virtually no patent challenges.”

Kalorama’s report The World Market for Biosimilars (EPO, G-CSF, HGH, Insulin, Interferon alpha, Monoclonal Antibodies, Others).contains predictions of biosimilar markets in certain biologic drug segments, as well as market by regions.  The report contains specific forecasts for each type of biopharmaceutical and breaks out forecasts by region.  The report can be found at http://www.kaloramainformation.com/Biosimlars-EPO-CSF-7804133/