More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.

More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline. At the start of the biotech industry, progress was slow. Between 1983 and 1995, the U.S. FDA approved an average of two biologics each year. Now, biologics have taken the lead by the smallest of margins, accounting for 50.1% of drugs in development at the start of 2026, according to the Pharma Annual Review 2026, published by Pharmaprojects, a firm that tracks global pharma R&D.

More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.

For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.

For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.

Illumina Inc. presented at the J.P. Morgan 2026 Healthcare Conference on Jan. 13 and introduced what it said is the world's largest genome-wide genetic perturbation dataset, being built to accelerate drug discovery through AI across the pharmaceutical ecosystem. This is a move away from its core focus on DNA sequencing technology.

Insilico Medicine founder and CEO Alex Zhavoronkov told BioWorld that he tries to spend as much time as possible in China, because that's where the artificial intelligence (AI) drug development company conducts synthesis and tests for early stage discovery. “And nowadays, not a day goes by without somebody launching an AI drug discovery company,” he said, noting that Chinese AI company Deepseek could be a huge disrupter.

Insilico Medicine founder and CEO Alex Zhavoronkov told BioWorld that he tries to spend as much time as possible in China, because that's where the artificial intelligence (AI) drug development company conducts synthesis and tests for early stage discovery. “And nowadays, not a day goes by without somebody launching an AI drug discovery company,” he said, noting that Chinese AI company Deepseek could be a huge disrupter.