Multiple Product Approval by FDA Intensifies the Competition in Biologics Market

04 Aug 2017

The biologics market is gaining traction with the rising competition in the market among the existing market giants as well as the new players. The introduction of biosimilars in this domain has fuelled the competition further in the market. With companies filing for approvals of new products to get approval from the Food and Drug Administration (FDA), the market is propelled towards a pool of opportunities, especially in the emerging economies. Roche was among the top companies with biologic products in 2016 as it has 11 monoclonal antibiotics in the market, which was the highest selling class of biologics, with their U.S. sales reaching approx. $37.6 billion, an 18.3% growth over their 2015 sales.

The FDA accepted two new filings for drugs that mirror Roche's Herceptin in July 2017, an Amagen Inc. drug and a Mylan NV biosimilar, potentially expanding the list of therapies capable of taking away market share from the blockbuster biologic. In a similar development, Amgen and Allergan plc's ABP 980 and Celltrion Inc.'s CT-P6 are now under review by the FDA. They follow Mylan and Biocon's Herceptin biosimilar, MYL-1401O, which the FDA accepted for review almost seven months ago.1 It will be interesting to see the steps taken by Roche to stay ahead of the competitors in the market.

Acknowledging the abundance of product releases and intense competition in the market, BIS Healthcare has compiled a comprehensive market report titled ‘Global Biologics Market -Analysis and Forecast (2017-2025)'. According to the analyst at BIS Research, "The global biologics market generated a revenue of $238.8 million in 2016. The introduction of targeted therapies coupled with rising adoption of patient centric personalized medicine is expected to fuel the demand for biologics drugs in the future." The market is expected to grow at an exponential rate owing to the robust growth in the emerging markets and increasing adoption of monoclonal antibodies (MAbs) and human insulin for the treatment of patients.

This report is comprised of the extensive analysis of various factors affecting the global biologics market. The entire market has been estimated and validated through three different approaches namely, by product, by therapeutic areas, and by geographical destination. In terms of product, the market has been categorized into monoclonal antibody (mAbs), hormones, growth factors, fusion proteins, cytokines, therapeutic enzymes, vaccines, blood factors, and anticoagulants.

1 BioPharma Dive


Request a Sample


Twitter Feeds