As of 2008, Kalorama Information estimates a $60 million biosimilar market in the European Union. A variety of factors have contributed to this diminished market size, including end-user resistance. Also, rather than the scores of entrants in this marketplace that were expected, competition is limited and typically against branded drugs rather than other generic drugs. The production and distribution competency required for the biosimilar process severely limits the number of players.
The robust competition among a few experienced and strongly funded competitors will create a U.S. market for biosimilar drugs that Kalorama Information estimates could reach $30 million by 2013. As products develop, the U.S. market will build over the next decade. We expect the same pattern that occurred in the generic industry in the ’80s. Slower than anticipated growth with some resistance at first, then a flourishing market. Our U.S. market figure may surprise some due to the generous predictions made when biogeneric approval was first discussed.
Don’t tell a product manager at an established branded biologic that U.S. biosimilars won’t be a significant headache. The total market may be smaller than previously projected, but those products that face biosimilar competition will need to change their business plans dramatically.
This does not mean there won’t be competitive activity, just that the field of play will be narrower than previously thought. Competition will open up between producers of biosimilars and producers of branded biopharmaceuticals if, as looks likely, Congress approves these drugs in the U.S.
It’s a small but experienced group that will lead the competition in the U.S. Some of the leaders emerging in the market are Cangene, Biocon, Sandoz, TEVA, and Dr. Reddy’s. Having successfully marketed biogeneric products in Europe and Asia, these companies will come prepared to the new market. Among biological products being challenged is Amgen’s chemotherapy drug Neupogen, which stimulates production of white blood cells, and Genentech’s Rituxan, a protein used in the treatment of rheumatoid arthritis and non-Hodgkin’s lymphoma.
Currently, the world market for biosimilars is fueled primarily by the demand for bioequivalent versions of erythropoietin and G-CSF. Sales for these products were estimated at $62 million in 2008. This includes sales for products in Europe and throughout the world where lenient biosimilar laws exist.
Insulin is a long-time favorite for biosimilar production with a relatively simple manufacturing method to follow. However, sales continue to be minimal in contrast to the total insulin market.
Another focus for biosimilar production in the United States and key markets in Europe is HGH. Sales, however, have failed to show the significant gains that manufacturers expected. Sales for bioequivalent HGH have been estimated at $15 million globally for 2008.