Some say biologics have entered a golden age; others call it a bubble. Few separate the two questions: whether industry fundamentals are improving or worsening, and how much optimism is already priced in. biotech_pulse uses 18,601 biologics trials in progress, 481 FDA Biologics License Applications, and 7,347 China-registered trials to produce two independent readings: an industry score of 34.8, and a market score of 93.3.
scroll — two questions, one at a timeSeven fundamental signals combine into a score of 34.8 (out of 100). Two numbers are heading the wrong way: the share of first-in-class drugs, −13.9pp, and the share of priority reviews, −10.6pp, are both declining; only 36.4% of pipelines show a stable trend. The only thing still rising is the count of new molecular entities, +30.6%, and the number of trials underway, +20.1% — but that's just more volume, not better quality. J&J's ERLEADA data illustrates this: the new regimen cut the risk of recurrence or death by 62%, but the drug itself has long been approved, and this new use hasn't been cleared yet. What to watch next is whether this "volume up, quality flat" gap closes.
The excess-return score (how much more it's gained than the broader market) is still 93.3, driven by continued buying interest in biotech stocks rather than a broader market rally. On Oct 30 the Fed's tone leaned toward a rate hike, the S&P 500 fell 1.82%, while XBI fell only 1.15%, a smaller drop than the broader market. Small- and mid-cap biotech led the way: XBI's 3-month gain rose to +1.68% and its 6-month gain rose to +14.64%, both higher than last time; big pharma's 3-month gain, by contrast, slipped a bit from last time to +20.62%, with momentum shifting toward smaller caps. The Shenwan Pharma & Biotech index is +7.14% over 6 months, and the A-share innovative-drug basket is +4.71% over 3 months. Akeso's new drug beat AstraZeneca's in a head-to-head trial, cutting mortality risk by 25%, which helped support overseas-licensing valuations. Next up: whether Agios's new sickle cell disease drug gets FDA approval on Nov 1, and how much drug prices get cut in year-end medical insurance negotiations.
An industry score of 34.8 against a market score of 93.3 falls into the complacent quadrant: the market is stronger than the underlying fundamentals. The quadrant to really worry about isn't "both weak" — that one has already sold off. This is the one that hasn't sold off yet. There are also 5 warning signals (not included in the score, but each one that appears warrants a bit more caution).
Annual FDA biologics approvals rose from 29 to 43 in 2024, a record high — most coverage stops right there. Split those approvals into "first-in-class" and "me-too" drugs, and it becomes clear where the growth actually came from:
This isn't a subjective call — it's broken down drug-by-drug by active ingredient, with the rules laid out in the methodology.
For each pipeline, look at how growth has changed over three years: this period's growth rate minus the prior period's is called "acceleration" (whether growth is speeding up or slowing down). Still rising but starting to slow down is worth watching. The entire ADC family is in that state right now: the ADC class is at +71% (acceleration −9.5pp), HER2 at +79% (−14.0pp), and TROP2 at +117% (−70.1pp) — three independent measures pointing to the same conclusion. Regulators are confirming this too: Daiichi Sankyo and Merck voluntarily withdrew the U.S. application for their ADC drug I-DXd after the FDA said the data weren't sufficient. Growth is slowing and approval standards are tightening, and this signal hasn't reversed yet.
By contrast, bispecifics at +120% (acceleration +64.5pp), CD3 at +115% (+134.1pp), and cell therapy are all still accelerating, and consistently so — CD3 is a shared component of T-cell engagers, so it should move in step with bispecifics. The cell therapy pipeline carries its own risk signal, though: Artiva in the U.S. discontinued a cell therapy and cut 94% of its staff after two deaths and insufficient durability of response, and is now looking for a buyer. A pickup in acceleration doesn't mean the safety issues are resolved. Vaccines are still trending down: Vaxcyte's new drug hit all its Phase 3 endpoints and the stock jumped 50% in a day, but that hasn't changed the pipeline's overall downward turn. For anyone trying to guess the "next ADC," these three accelerating pipelines are sending the signal earlier than ADC itself did.
How reliable is this: 20/31 pipelines reach the same conclusion under a different statistical window; treat the rest with caution for now.
This page is just a snapshot — the full dashboard updates in real time. It also includes: a breakdown of regulatory approvals, a growth-rate-vs-acceleration quadrant chart, a signal table for 31 pipelines, a ten-year trend by modality, crowding levels across 32 target groups, shifts in the U.S.-China landscape, China's domestic trial registry, and a section devoted to what this data can't show.
That last section is especially worth a look: 12 AI drug-discovery companies have 43 trials in global registries combined, but only 3 of them count as biologics — Isomorphic and Xaira both have zero. A force that could rewrite everything five years from now is almost invisible in this set of signals today.
A record number of approvals doesn't mean innovation itself has increased. The market score of 93.3 sitting this far above the industry score of 34.8 points to valuation risk, not genuine industry improvement.
If the share of first-in-class drugs climbs back above 60%, or the priority-review share returns to 50%, the "approvals are all me-too drugs" narrative would no longer hold, and the industry score's low reading would need to be reconsidered.