Over the years, around 200 biologics have been approved for the treatment of various disease indications in the US and Europe. In 2020, 18 new biologics received approval by the USFDA. Despite their complex and cost intensive manufacturing protocols, biopharmaceuticals (once approved) are considered to be highly profitable assets. In the recent past, many biological interventions have achieved blockbuster status (in some cases, registering revenues worth over USD 4 billion a year); prominent examples include (arranged in decreasing order of 2020 revenues) Humira®, Keytruda®, Stelara®, Opdivo®, Avastin®, Trulicity®, Enbrel®, Ocrevus™ and Rituxan®.
Key Market Insights
More than 65 top selling biologics (revenues equal to or above USD 500 million in 2020) are currently available in the market
Majority (54%) of the aforementioned candidates are monoclonal antibodies, followed by hormones (19%) and enzymes (9%). Further, subcutaneous route (50%) emerged as the most preferred route of administration for such therapies, followed by the intravenous route (40%).
More than 50% the developers of top selling biologics are based in North America
The top selling biologics market is currently dominated by the presence of large companies (82%). Additionally, majority of such players were established before the year 2000.
Over 2,450 clinical trials registered for the evaluation of top selling biologics, till Q3 2020
Of the total, 1,892 trials were registered for the evaluation of products targeting oncological disorders, followed by those investigating biologics intended for the treatment of metabolic disorders (122) and autoimmune disorders (98).
Around 250 biosimilars of top selling biologics are currently approved / under development
Close to 30% of the aforementioned candidates have already been approved. It is worth mentioning that over 100 biosimilars have received approval in Asia Pacific. Within this region, India and South Korea emerged as key hubs, having granted maximum approvals for biosimilars of top selling biologics (in terms of 2020 revenues).
Monoclonal antibodies are anticipated to capture over 75% of the market share by 2030
Over 40% of the market share is anticipated to be capture by Genentech / Roche and Merck by 2030. It is worth mentioning that as the patents of the currently marketed products have already / are expected to expire towards the end of the forecast period, the market is likely to reach maturity.
Key Questions Answered
The USD 156 billion (by 2030) financial opportunity associated with the top selling biologics market has been analyzed across the following segments: