At Sunstone, we invest in early-stage therapeutics with the aim of developing future and clinically relevant drug candidates for partnering with, or acquisition by, the pharmaceutical industry. The challenge is to triangulate potential patient benefit and development risk with something much harder to predict: where will Big Pharma’s interest be five years from now?
This spring, we collaborated with Sergio Castañeda Zegarra as part of his MBA at Copenhagen Business School (CBS), to explore whether a subset of the almost 50,000 Phase III trials registered on ClinicalTrials.gov could provide an intelligence signal for changes in Big Pharma’s therapeutic and modality interests.
Sergio compared Phase III trials sponsored by Big Pharma (market cap >$10bn) with those sponsored by the rest of the industry. He then selected two mutually exclusive groups of Phase III trials; one group of trials currently Recruiting, andanother group that has completed enrollment but not yet reported data, looking for differences across therapeutic areas and modalities.
From this, Sergio constructed a Big Pharma Concentration Index, where ~1.00 represents neutral industry representation in a therapeutic area or in a modality.
The hypothesis is simple: if Big Pharma is overrepresented in an area the index will be above 1.00 – it could indicate greater future appetite for partnering or M&A; if the index is higher than 1.00 among newly recruiting trials than among trials that have already completed enrollment, it could signal increasing interest. A declining index could indicate the opposite. Sergio goes on to suggest that changes of more than 0.20 seem to be significant.
Oncology could provide a useful reference. It has consistently been a dominant therapeutic area across the industry, and, as expected, its concentration index is close to 1.00 with little difference between the two groups of Phase III trials. In simple terms: Big Pharma’s relative interest appears stable, and partnering opportunity supply broadly meets demand.
Two other areas look quite different:
Psychiatry: 0.28 → 1.26 (+0.98)
Big Pharma appears to have leaned substantially into psychiatry from a very low level of relative engagement. Its concentration index rises from just 0.28 among trials that have completed enrollment to 1.26 among trials currently recruiting.
This suggests a significant shift toward psychiatry – and it seems consistent with recent increased M&A and partnering activity involving Karuna, Cerevel, Intra-Cellular and Gilgamesh, alongside growing interest in novel mechanisms, digital biomarkers and psychedelics.
Perhaps a therapeutic area worth keeping an eye on?
Autoimmune disease: 1.53 → 1.85 (+0.32)
Here, Big Pharma is already substantially overrepresented – and the higher concentration among recruiting trials suggests that interest may be increasing further.
Again, the signal appears consistent with recent increase in acquisitions and transactions involving companies such as Orna, Candid and Merida.
Sergio’s Phase III analysis identifies a number of other potentially interesting signals across both therapeutic areas and drug modalities – including areas that appear to be gaining as well as losing Big Pharma attention.
The interesting question is whether these signals are genuinely leading indicators.
Ongoing Phase III trials provide a much larger dataset for studying changes in Big Pharma’s strategic focus than the relatively occasional M&A transaction. But does a change in Phase III concentration today correlate with partnering and M&A activity tomorrow?
If judged by the sequence of events that followed the Phase III trials of anti PD1’s the answer would be: Yes. The craze came after the trials.
What do you think? Could Phase III activity provide an early signal of where Big Pharma is heading next?
And if you find the approach interesting, feel free to reach out to Sergio Castañeda Zegarra