ROCKVILLE, Md., Dec. 4, 2017 /PRNewswire/ -- Well known biodrug brands like Humira and Botox could soon face myriad competitors, according to Kalorama Information's new report on biosimilars. These are close replicas (there is no exact copy of a biopharmaceutical) or generic-like versions of biological drugs. The healthcare market researcher says that for years, U.S. pharmaceutical companies relied on the complexity of their formulations to protect them. After that, a lack of a regulatory pathway has hampered biosimilars in the world's largest pharmaceutical market. That's changing. Developments worldwide and improvements in drug manufacturing have increased competition. Kalorama estimates that the global market for biosimilar products has grown to be worth almost $4.4 billion according to its new report, Biosimilars: Global Market, Trends and Competitor Analysis.
Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biosimilars are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics. The worldwide prescription generic drug market has stood the test of time and has endured numerous growing pains. However, it has evolved into a formidable and important participant in the complex world of health care. Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process are facilitating bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years.
"Biosimilars are not generics," said Bruce Carlson, Publisher of Kalorama Information. "Despite the benefits, both economical and to patient health, the market has been slower to develop than generic drugs and is only a fraction of its potential.'
The path to making biosimilars as common as traditional generic drugs has historically been a slow and agonizing process for all involved; but there are some major industry changes in the past couple years that have extended the market, improved regulatory processes and brought more biological options to health professionals and patients around the world. There's more development of the biosimilar arena; however, the United States is still lagging due to regulatory stumbling blocks. Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection. This opens up the market with a potential of $40 billion and the market is growing at over 30% per year if the regulatory hurdles can be overcome.
Kalorama has identified the biopharmaceuticals that have lost patent protection and should be the first products to reach the market, as well as some soon to expire biodrugs, in its report.
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.
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SOURCE Kalorama Information