
Home » Number of Phase 3 Biotech Trials Increases 400 Percent Over Decade, Study Finds
Number of Phase 3 Biotech Trials Increases 400 Percent Over Decade, Study Finds

November 13, 2023
From phase 3 trials to mergers/acquisitions and novel therapy approvals by the FDA, the biotech industry has seen a massive boom in the past decade. A new Tufts Center for the Study of Drug Development (CSDD) study reveals that the amount of biotech products in late-stage research has skyrocketed in the past 10 years, among other findings.
The number of active biotech products in phase 3 trials has increased four-fold in the past decade, according to CSDD’s latest Impact Report, with more than 430 companies funding these trials and an annual growth rate of 13.7 percent observed since 2012. The lion’s share of these companies are developing a single biotech program, with just 8 percent (35) of companies funding more than five investigational biotech products individually.
Number of Biotech Products in Phase 3 Trials, 2012-2023
Source: Tufts CSDD
In total, there are nearly 600 novel biotech products in late-stage trials this year, a 20 percent annual growth rate since 2019, the report reads. Already-approved products in phase 3 trials for new indications have seen an 11 percent annual increase, while biosimilars in phase 3 trials have seen a hefty 49 percent growth rate.
Biotech Products in Phase 3 Trials by Product Type, 2019-2023
Source: Tufts CSDD
Biotech product sales made up 30 percent of the $1.5 trillion global pharmaceutical market last year, the study found, with sales growing at five times the rate of traditional pharmaceuticals and hitting $466.3 billion in 2022.
Smaller-size companies have seen tremendous growth in particular, but the biotech market as a whole has seen a vigorous climb in sales since 2018. Small molecule product sales have seen a steady 3 percent annual growth rate in the past five years, raking in $1.1 trillion in sales in 2022, the new study found.
Global Sales of Biotech Products, 2018-2022
Source: Tufts CSDD
More than half the novel therapies approved by the FDA since 2021 have been biotech products, CSDD found, accounting for 56 to 60 percent of approvals. In the past five years, FDA biotech product approvals reached their highest peak (30) during the COVID-19 pandemic, dropping moderately to 24 in 2022 and 25 this year.
Spending on biotech mergers and acquisitions peaked in 2019, when industry spent $177.1 billion in total across 33 transactions, the study found. And despite this number dropping to $50.6 billion across 26 transactions in 2021, industry has bounced back slightly, spending $69.8 billion across 30 transactions in 2022 and $85 billion across 25 transactions this year. AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, and Sanofi are among the key sponsors making these deals.
Access the full report here.
Upcoming Events
-
14Apr