December 2025 | Endo Lab & Medical Systems
Clinical Lab Newsletter
Innovation, Regulation, and Strategic Trends in Molecular
Testing & Remnant Sample Research
1. Clinical Laboratory Market Strengthens Heading into 2026
The diagnostic ecosystem continues its expansion, with the clinical laboratory services market projected to grow from $251.9M in 2025 to $358.6M by 2034. Demand is driven by chronic disease prevalence, aging populations, and a push toward personalized medicine.
The broader clinical laboratory tests market is also expected to climb toward $210.6B by 2030, underscoring ongoing need for high-quality lab infrastructure and service partners.
2. Automation, IoMT, and Data Intelligence Are Reshaping Lab Operations
Industry analyses show labs accelerating adoption of automation, interconnected IoMT devices, and data-driven workflow intelligence. These enable more accurate, error-free pre-analytical operations - barcoding, aliquoting, sorting - while freeing technologists to focus on higher-value tasks.
AI-powered analytics are also gaining adoption for workflow optimization, compliance oversight, and real-time decision support.
3. Regulatory Pressure & Reimbursement Compression Expected in 2026
Industry organizations and policy groups continue sounding the alarm about potential tightening in reimbursement through the Clinical Laboratory Fee Schedule (CLFS). Without stabilization measures, reductions may create strain for labs across the U.S.
Additional considerations now gaining attention:
Increased audit activity: Both federal and commercial payors are escalating audits related to molecular testing, medical necessity, and billing accuracy.
Staffing cost inflation: While reimbursements tighten, labor costs for certified technologists continue to rise, widening the margin squeeze on many independent labs.
Potential impact on regional labs: Smaller labs may face consolidation or closures if reimbursement decreases are not balanced by efficiency gains or diversified revenue streams.
Greater scrutiny on LDTs (Laboratory Developed Tests): Regulatory discussions continue around FDA oversight, potentially affecting validation requirements for molecular and specialty assays.
If you have concerns concerning regulatory pressure, please give us a call and we are happy to discuss ways ENDO may be able to assist. Contact: john.castelino@endogroupllc.com
4. Remnant Collections Gaining Momentum in Clinical Research
Academic centers, diagnostics developers, and biotechs are increasing their use of clinical remnant samples - leftover blood, plasma, serum, swabs, and tissue no longer required for patient care.
These specimens support:
Biomarker discovery
Diagnostic assay validation
Retrospective clinical studies
Multi-omics and phenotypic analysis
Institutions such as Boston University Medical Center publicly highlight the value of remnant-sample access for accelerating translational research.
If you haven't yet tapped into producing a revenue stream via de-identified remnant samples, please contact us. This an expertise of ours. Contact: david.curley@endogroupllc.com
5. Clinical-Research Sites Under Strain - Increasing Value of Reliable Sample Partners
A global survey of 600 clinical-research sites reports mounting challenges: staffing shortages, protocol complexity, inconsistent funding, and slower technology adoption.
Yet decentralized trials, AI-assisted workflows, and real-world evidence strategies are expected to streamline timelines and expand patient access.
These challenges provide opportunity for your lab. If you want to know how, contact: david.curley@endogroupllc.com
6. Digital Pathology & AI Adoption Accelerating Entering 2026
Digital pathology is moving from “innovation phase” to “routine deployment” as adoption grows across mid-size and large laboratories.
Key developments reported across 2025–2026 industry updates include:
Increasing availability of FDA-cleared whole-slide imaging systems
AI algorithms demonstrating strong performance in cancer grading, cell counting, and image triage
Growing use of cloud-based slide storage for multi-site workflows
Expanded enterprise integration between digital pathology platforms and LIS systems
Hospitals and independent labs are beginning to integrate AI-assisted pattern recognition not only for cancer diagnostics, but also for metabolic and inflammatory disease insights.
Upcoming Industry Events (December–Early 2026)
AACC Middle East – Dubai, UAE
December 2025
Focus: Clinical chemistry, global lab management, point-of-care advances.
JP Morgan Healthcare Conference – San Francisco
January 13–16, 2026
Key event for diagnostics investment, biotech partnerships, and research collaborations.
Molecular & Precision Medicine Expo – Chicago
February 2026
Focus: Genomics, proteomics, multi-omics pipelines and diagnostic innovation.
SPATIAL Biology World Congress – Boston
March 2026
Focus: Spatial transcriptomics, tissue-mapping, next-gen biomarker discovery.
Fun Fact of the Month|
In 2021, researchers found that the human body contains roughly 37 trillion cells - but your gut microbiome contains more than 100 trillion microbial cells.
Your body is technically more microbe than human.
This is just a lovely reminder that biology doesn’t care about our need for simplicity - it thrives in complexity.
