Spatial Biology Poised for Explosion by 2027
By Allison Proffitt
March 14, 2023 | Spatial biology is poised for an explosion in the next few years, said Colin Enderlein, a principle at DeciBio Consulting. Speaking in San Diego at the Molecular and Precision Med Tri-Con, Enderlein shared the results of DeciBio’s recent market report on the space.
Spatial biology is a broad field, Enderlein said, with many technologies laying claim to the name. “Fundamentally, it’s the measurement of biomarkers or cells in their native context. Really, we’ve already seen this implemented in a lot of different ways,” he said. Spatial biology can reveal where specific cells are within a tumor or tissue and where cells of interest are relative to each other. Spatial biology can shed light on the spatial distribution of proteins and RNA biomarkers. And the technology can give insight into biomarkers and which cells are expressing which—and how much—biomarkers.
“This has massive implications across multiple disease areas,” he said.
The global market for spatial biology technologies is about $320M in 2022, DeciBio has estimated, which will grow to a $1.2B by 2027. Currently, Enderlein said, the total addressable market is less than 5% penetrated, and rapid growth is happening.
“Really these are research tools today. More than half of the market is driven by the translational and clinical research side of things,” he said. “When thinking about routine clinical adoption, this is really not expected until these further out years: maybe 2026, 2027, when we start seeing more of these clinical trials reading out that actually include these tools.”
Today, Enderlein said, academia and biopharma are driving the research—owning about 80% of total spend and investments in these technologies. “Pharma, in particular, really plays a vital role in driving this space forward, looking at translational studies, starting to actually conduct pivotal registrational trials and actually putting the money forward in order to investigate multiple of these tools in parallel.” The outcomes of this research and investment—once publicly available in high impact journals—will serve as the tipping point for the technology, Enderlein predicts.
But while big pharma and academia may hold the lion’s share of the market now, Enderlein highlighted the role of specialty CROs in technology uptake. These companies—he highlighted NeoGenomics and Akoya as examples—are investing the upfront capital to offer the technologies as a service, working closely with their clients to understand the research questions and run pilot studies to help pharma choose where to invest. “In terms of the total spend, [the CROs] are not necessarily the largest share of the market, but they are very critical in terms of actually enabling access to these tools,” he said.
Spatial biology is useful anywhere the spatial distribution of cells and the signaling between them is biologically relevant, Enderlein said, and he shared a non-exhaustive list of dozens of players with RNA/DNA, RNA and proteins, proteins, and multi-omics offerings.
Much of the investment today is around translational and clinical research, Enderlein observed, but even within the research setting he sees a lot of diversity in how the tools are being used. Assessments of the tumor microenvironment and how it changes in response to therapies is a major use case, though not the only one.
“Even outside of immuno-oncology, there’s a lot of utility associated with these [technologies], and that’s really where we’re seeing a lot of the academia research today, looking at things like infectious disease, looking at autoimmune disease, cardiology, neurology,” he said. “All of these have tightened interactions between cell-cell interactions and the overall autoimmune process and the recruitment of immune cells.”
Technically, tools are now about evenly split between proteomics and transcriptomics, with proteomics taking a slight upper hand. Panel design seems to be diverging, Enderlein said. Large panels are increasing in popularity, but so are very small, narrow panels. “As we see these tools moving toward the clinic, we expect to see more and more use of relatively small, focused panels that are really focused on specific disease states,” he predicted. Single cell gene expression is also gaining ground as higher fidelity tools are developed.
“The technology ultimately comes back to identifying spatial signatures that can predict response to treatment,” Enderlein said. Today this is useful for feeding into companion diagnostics and predictive algorithms for risk-stratification, but the current state of the technology is queued up for much bigger growth. Routine clinical diagnostics will be coming online in 2026-2027 and later, Enderlein predicts, but he doesn’t expect those tools to be simply more mature versions of what we have now. He predicts focused panels of just a few genes or proteins, likely to be more amenable to scaling and regulatory approval. He also predicts that the earliest adoption will be as laboratory-developed tests for “very specific use cases.”
Enderlein did flag some future pain points he expects in the space. Cost and reimbursement, of course, will be a barrier to these tools growing in use in the clinic. There will be no replacement for establishing clinical utility as a predictive biomarker via prospective clinical trials published in high impact journals, he said, and noted that these types of trials are underway.
Clinical scalability and standardization are other areas that could be a pain point: not only do the tests work, but how easy will they be to use in the clinic? Are workflows scalable and standardized? What is the throughput for the tests? Do samples need to be sent to a central lab, and if so, what capacity will that lab have? “Establishing workflows across an entire clinical population is an entire set of capabilities that has not necessarily been brought to bear yet,” he said.