The true role of the central lab in 2026: As decentralized diagnostics grows, what's actually changing?
Vatsal Tiwari; Director, Healthcare Strategy
Key Takeaways
Point of care (POC) testing is expanding quickly, with the global market on track to grow roughly 38%, from $21.7 billion in 2025 to $29.9 billion by 2033, but that expansion isn't stealing volume from the central lab.
Reference and central lab services are growing too: the market is headed toward $510 billion by 2033, and deals like Quest Diagnostics' 2025 acquisition of Spectra Laboratories and its Corewell Health joint venture show labs consolidating and scaling, not exiting.
Physicians still send confirmatory samples to the central lab after a POC result comes back, because POC platforms trade some accuracy for speed, a trade off regulators are tightening scrutiny around, not loosening.
The lab's job has moved from being the only place testing happens to being the place that validates and handles what decentralized tools can't, a shift in specialization, not a sign of decline.
MedTech manufacturers win by designing for connectivity, positioning for referral over replacement, and building for physician skepticism, not by trying to out compete the lab head on.
Every time a new point of care (POC) device hits the market, the same narrative resurfaces: the central lab is dead. The assumption is that decentralization is winning and the future belongs to whoever can fit a diagnostic test into a physician’s pocket.
But the data reveals a more nuanced reality. The growth numbers for POC are massive, but the substitution story is a myth. Decentralized testing and central labs aren't competing for the same job. For product leaders and manufacturers developing diagnostic platforms, understanding this distinction is the key to building tools clinicians actually adopt.
The growth is real, but so is lab consolidation
POC diagnostics is undeniably booming. Driven by chronic disease management and the demand for immediate, bedside answers, industry estimates put the global market on track to climb from $21.7 billion in 2025 to nearly $29.9 billion by 2033. (i)
However, central labs aren't shrinking to make room. Industry estimates put the global clinical laboratory services market on track toward $510 billion by 2033 (ii), and capital is actively flowing into lab consolidation, not away from it: Quest Diagnostics acquired Spectra Laboratories' assets in 2025 (iii), and its Corewell Health joint venture closed in January 2026 (iv).
If central labs were becoming obsolete, capital wouldn't be flowing into acquiring more of them.
Why physicians still lean on the lab
Market size is one thing, but physician behavior tells the real story. When a rapid strep test comes back negative but clinical suspicion remains high, physicians still send a PCR to the lab. This isn't habit, it's a rational safeguard: POC platforms trade some analytical performance for speed, and regulators agree. CLIA's 2024 Final Rule tightened personnel standards for POC (v), and 2025 proficiency changes for analytes like hemoglobin A1C set stricter accuracy thresholds (vi). The central lab remains the accuracy benchmark.
The result: central labs are losing exclusivity, not relevance. They're now one node, often still the most trusted node, in a network that also includes point of care devices, home testing kits, and continuous monitoring. Physicians have adapted accordingly, using decentralized tools for triage and screening, and reserving the lab for confirmation and complex cases where a wrong answer carries real consequences.
This is specialization, not obsolescence.
What this means for go to market strategy
For MedTech manufacturers, this shift in the lab's role demands a new playbook:
1. Connectivity earns physician trust
Data integration is no longer optional: it's how decentralized results earn physician trust. A POC device that doesn’t integrate smoothly into an EHR workflow or automatically trigger lab confirmation when a result needs it, is essentially asking physicians to operate on blind faith.
2. The real opportunity is referral, not replacement
POC testing and the central lab don't compete for volume. They feed each other: POC generates central lab referrals, and central labs generate POC follow up, running in both directions. The stronger position enables the handoff: decentralized for the first read, centralized for the confirmatory or complex case, with data flowing seamlessly between them.
3. Design assuming physicians start skeptical
Demonstrated analytical performance under real world conditions earns physician trust. Marketing claims of "lab quality accuracy" don't. Physicians are trained to verify, so prove performance in clinical conditions before you claim it in marketing.
Looking ahead
The next generation platforms that win won't pick a side of this divide. They'll make it invisible to the physician, blending the decentralized first read with the lab's confirmation into one seamless result.
Phronesis’ Medical Diagnostics and broader Healthcare Research teams study exactly this: how physicians build trust in a result, and where that trust breaks down.
Sources:
[v] Centers for Medicare & Medicaid Services, Final Rule CMS-3326-F (personnel qualifications)
[vi] Final Rule CMS-3355-F, detailed in memo QSO-24-15-CLIA (proficiency testing standards)Related Solutions
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