COVID-19, Oncology, CNS and Infectious Disease Trials Will Dominate in 2021, Survey Predicts
COVID-19, oncology, central nervous system (CNS) and infectious diseases will be the top therapeutic areas studied in trials this year.
In its annual State of the Biopharmaceutical Industry survey, market research firm GlobalData said oncology trials are expected to total about 734 in 2021, followed by CNS (482) and infectious diseases (342), according to the survey. Nearly 200 trials are planned for cardiovascular therapies.
“COVID-19 has demonstrated that new paths can be explored when it comes to drug development and time to market,” an executive based in North America told GlobalData for the survey. “The industry will be impacted in general based on these possibilities [not new but now more evident and proven].” The survey, conducted from Nov. 17 to Dec. 11, had 198 respondents, 89 of whom were from North America.
About 150 trials targeting COVID-19 are planned for launch in 2021, followed by pain with about 140. Other therapy areas noted by the survey were gastrointestinal, metabolic disorders, immunology, respiratory, musculoskeletal disorders and ophthalmology. Breast cancer, solid tumor, nonsmall-cell lung cancer, colorectal cancer, ovarian cancer, prostate cancer, melanoma and pancreatic cancer were the other top indications for planned trials launching in 2021.
GlobalData said it forecasts 2,525 clinical trials will be initiated in 2021, the majority of which (42.9 percent) will be phase 2. Phase 1 trials are expected to make up 26.4 percent of initiated trials, followed by phase 3 (20.9 percent) and phase 4 (9.8 percent).
About 62 percent of the planned trials will be industry-sponsored, with Novartis and its 32 planned trials leading the way and Takeda a distant second at 16 trials. Other top sponsors noted by the survey were Pfizer and Daiichi Sankyo, both of which plan to launch 15 trials in 2021, followed by Sanofi (13), Merck (12), Shionogi, Regeneron and F. Hoffmann-La Roche (Roche) (10 each) and Alexion (9).
The survey found that, among trials with a reported location, about 35 percent of planned trials in 2021 will be conducted in the U.S., far ahead of China, which was second on the list. Australia, France, Japan, Canada, the UK, India, Germany, Italy and Spain were the other top countries noted by the survey.
Expectations of a recovering trial industry are high. “Companies, regulators and clinicians will need to rapidly adjust expectations of clinical trials to overcome the delays and subsequent ripple effects from 2020,” said a European executive who responded to the survey.
Clinical trials for small molecules and biologics are expected to dominate trials in 2021, with about 1,400 small molecule trials planned and about 1,000 targeting biologics. Both drug types are far ahead of trials planned for synthetic peptides, oligonucleotides and polymers. “Small molecules will account for 55.9 percent of trials, representing more than all other molecule types combined,” GlobalData said. “While biologics will account for approximately 40.7 percent of trials, this drug type will have an almost equal percent of phase 1 studies compared to small molecules.”
In terms of trial completions, GlobalData estimates that the majority (45.8 percent) will be phase 2. “Out of these, the greatest proportion are ongoing, recruiting trials (60.9 percent) followed by planned trials (25.5%),” GlobalData said. “Many of these planned trials will likely update or change their projected start and end date before they initiate.”
Phase 1 is expected to account for 19.6 percent of completed trials, followed by phase 4 (18 percent) and phase 3 (16.6 percent). Johnson & Johnson, Novartis and Eli Lilly lead the field in terms of sponsors with trials projected to be completed in 2021, at 101, 92 and 90 trials, respectively. Pfizer follows on that list with 74 trials, followed by AstraZeneca (72), Merck and AbbVie (56 each), Roche (53), Boehringer Ingelheim (52) and Bristol Myers Squibb (46).
Among the top 10 sponsors, Pfizer, Shionogi and Takeda each plan to launch six phase 1 trials in 2021, followed by Daiichi Sankyo (5), Merck (2), and Alexion, Novartis, Regeneron and Roche (1 each).
Novartis widely leads all others in planned phase 2 trials with 13 to launch in 2021, followed by Alexion (6), Daiichi Sankyo, Pfizer and Takeda (5 each), Sanofi (4), Regeneron and Shionogi (3 each), and Merck and Roche (2 each).
Novartis also leads significantly in planned phase 3 trials with 16, followed by Merck (8), Roche (7), Regeneron and Sanofi (6 each), Daiichi Sankyo and Takeda (5 each), Pfizer (3), Alexion (2) and Shionogi (1). Sanofi has no phase 1 trials planned for launch in 2021, but it has three phase 4 trials planned.
Novartis and Pfizer are the only other top sponsors planning to start phase 4 trials, with two and one, respectively.