Biosimilars are considered one of the fastest growing sectors of the pharmaceutical industry. Since the launch of the first generation of biopharmaceutical products, manufactured using recombinant technologies in the 1980s, many new therapies for life-threatening and rare illnesses have been introduced.
But the expiry of patents on many world-leading brands will allow for the introduction of generic versions. Within the three main geographic clusters—the US, Europe and Asia—factors such as increased access to payers, speed of uptake and regulatory clarity will impact the market evolution. Most of the immediate value will be sourced from the pharmerging markets. In the long-run, though, the US will be the cornerstone of the global biosimilars market, powering a sector worth between 11 billion USD and 25 billion USD in 2020 (Fig 2) representing a share of the total biologics market between 4% and 10%,
respectively. The overall penetration of biosimilars within the off-patent biologics market is forecast to reach up to 50% by 2020, assuming a price discount in the range of 20% to 30% (or 40% to 50% with tender discounts included).
Flexibility, choice of tools, and operational excellence are three key success factors that will need attention for success in the development of biosimilars. Our aim is to help you and your bioprocessing teams map out the optimal plan to transform a biosimilars project idea into result, with greater flexibility and confidence and with reduced time and cost.