The IVD Industry in 2030: Five Shifts That Will Reshape Diagnostics

Over the last two decades, advances in molecular biology, automation and analytical technology transformed what laboratories can measure. The next decade will change something more fundamental: not only what we can test, but where testing happens, how results are interpreted, and how diagnostics are built into patient care.

By 2030, the familiar model — a test performed in a central laboratory, producing a discrete result reviewed by a clinician — will be only one part of a much broader diagnostic ecosystem. The technologies driving that change are already developing rapidly, and their impact reaches well beyond the technology itself, into regulation, quality, clinical evidence, data management and commercialisation.

Here are the five shifts likely to have the greatest impact on IVD companies over the coming decade.

That creates real opportunity, and equally real questions. How should an AI-based algorithm be validated?

1 - AI will become embedded in the diagnostic pathway

Artificial intelligence is moving to the centre of diagnostics — not by replacing the underlying assay, but by sitting alongside it: interpreting complex results, identifying patterns, combining multiple biomarkers and supporting clinical decisions.

This matters most where data is dense and interpretation is hard — multiplex molecular assays, genomic and next-generation sequencing data, digital pathology, imaging, risk prediction and treatment selection. The shift is from a product that generates data to one that interprets and contextualises it.

That creates real opportunity, and equally real questions. How should an AI-based algorithm be validated? What happens when it is updated? How is performance monitored in routine use, and how does a manufacturer show it performs consistently across different patient populations and care settings? Regulatory frameworks will also have to accommodate software that can evolve far faster than traditional IVD technology.

For manufacturers, the lesson is that AI cannot be treated as a late-stage feature. It has to be considered from the outset — in requirements definition, verification and validation, performance evaluation, risk management, cybersecurity, post-market surveillance and change control.

The key shift: diagnostics move from measuring biological information to helping interpret it.

2 - Diagnostics will move closer to the patient

The central laboratory remains critical, but testing is becoming distributed. Near-patient and community diagnostics, pharmacy-based testing, emergency-department testing and home diagnostics are all part of a wider move towards decentralised care.

The drivers are compelling. Health systems need to improve access while managing cost and capacity. Clinicians want diagnostic information at the point where treatment decisions are made. And patients are increasingly comfortable testing outside traditional settings.

This rewards systems that are smaller, faster, more automated, connected to laboratory and healthcare information systems, and able to produce reliable results with minimal operator intervention. But decentralisation also introduces new quality challenges. A test run by a trained professional in a controlled laboratory is a very different proposition from the same test operated in a GP surgery, a pharmacy or a patient’s home.

The market already shows both outcomes. Continuous glucose monitors from Abbott and Dexcom are the model done well — laboratory-grade measurement worn continuously, now sold over the counter and trusted for real treatment decisions. Cue Health is the cautionary version: a genuinely capable at-home molecular platform that reached a multi-billion-dollar valuation before collapsing into bankruptcy in 2024, after regulators flagged unauthorised changes to its test. The technology was rarely the limiting factor; sustaining quality, change control and viable economics outside the laboratory was.

Source: Cue Health Chapter 7 bankruptcy filing (May 2024) and FDA action advising against use of its COVID-19 test over unauthorised changes.

Manufacturers therefore have to design for the whole user environment: operator training, usability, sample collection, ambient conditions, connectivity, quality control and result interpretation all affect real-world performance. The challenge is to deliver laboratory-quality information without a laboratory around it — turning the diagnostic laboratory from a place into a network.

3 - Multiplexing and genomics will redefine what a “test” is

The traditional model is simple: identify a specific analyte or pathogen and report the result. Technology has already moved past it. Multiplex assays analyse many targets at once, and next-generation sequencing (NGS) can generate vast quantities of genomic information from a single sample — a single infectious-disease test identifying multiple pathogens and resistance markers, or genomic profiling characterising a tumour and its actionable mutations.

The technical capability, though, is only half the story. The more information a test produces, the more it matters to know which of that information is clinically useful. A diagnostic that generates hundreds of data points is not inherently more valuable than one that returns a single result which directly changes patient management.

That places the emphasis squarely on clinical utility and evidence — and on the infrastructure behind it: bioinformatics, data quality and standardisation, reference databases, data security and integration into clinical workflows. Regulators and health systems will also have to work out how fast-evolving genomic technologies can be evaluated and monitored appropriately.

Multi-cancer early detection shows how high that bar now sits. GRAIL’s Galleri test can screen for a signal shared by many cancers from a single blood draw — technically remarkable — yet its largest randomised study, the 140,000-participant NHS-Galleri trial, missed its primary endpoint of reducing late-stage disease, even as it increased overall detection and cut diagnoses made through emergency presentation. The assay works; the clinical case for screening at population scale is still being made, and regulators are still weighing it.

Source: NHS-Galleri randomised controlled trial (~140,000 participants, NCT05611632); topline results reported February 2026, full results presented at ASCO 2026. Galleri is available in the US as a laboratory-developed test, with an FDA premarket approval application under review.

The key shift: a diagnostic’s value depends on how well it converts large volumes of biological data into clinically actionable information.

4 - Companion diagnostics will draw IVD and pharma even closer

Precision medicine is binding diagnostics and therapeutics together. A companion diagnostic can identify patients suitable for a therapy, predict response, or flag those at higher risk of an adverse reaction — which makes the diagnostic an integral part of the drug development strategy rather than a supporting product.

For IVD developers, the implications are substantial. Diagnostic development increasingly has to run in step with drug development, with biomarker selection, assay design, clinical studies and regulatory strategy decided far earlier than before. It also raises the stakes on collaboration between organisations that historically sat in different parts of the ecosystem — pharmaceutical sponsors, IVD manufacturers, assay developers, clinical laboratories, CROs, trial sites and regulators. Managing those interfaces well becomes a core competence, and quality systems have to accommodate externally developed assays, third-party laboratories and complex development partnerships.

The contrast is already visible in oncology. Where the diagnostic and the therapy are developed together, it works: PARP inhibitors paired with BRCA and homologous-recombination-deficiency testing, or the original model of HER2-targeted therapy paired with HER2 testing, are now routine practice. Where the therapy moves faster than the test, it stalls — as HER2-directed treatment extended into “HER2-low” and “HER2-ultralow” disease, the established immunohistochemistry assay, designed to separate HER2-positive from HER2-negative, proved unreliable at distinguishing those lower categories, and agreement between pathologists fell away. Training programmes and AI-assisted scoring are now being introduced to close a gap that earlier co-development might have anticipated.

Sources: DESTINY-Breast06 (Bardia et al., N Engl J Med 2024); FDA approval of the HER2-ultralow indication with the Ventana PATHWAY HER2 (4B5) companion diagnostic, January 2025; pathologist interobserver concordance studies, 2024–25.

The challenge, then, is not simply to build a technically robust assay. It is to establish an integrated development and quality framework spanning the entire diagnostic ecosystem — developing the diagnostic and the therapy as interconnected parts of a single clinical strategy.

5 - Regulation will become a lifecycle activity, not a pre-market event

Regulatory compliance has traditionally been viewed through the lens of getting a product to market. That model is giving way. The growing complexity of IVDs — software, AI, connected devices, evolving technologies — is turning development and regulatory oversight into continuous processes.

The European IVDR already places far greater weight on performance evaluation, clinical evidence, post-market surveillance and ongoing assessment of product performance. The defining question is moving from “How do we get this product approved?” to “How do we demonstrate and maintain its safety, performance and clinical value across its whole lifecycle?”

That has direct consequences for quality systems. Development, regulatory, clinical, quality and post-market teams have to work far more closely, with product changes, software updates, new evidence, complaints, real-world performance and emerging risks all feeding a continuous assessment of the product. In practice, regulatory strategy can no longer sit at the end of development — it has to be embedded from the start.

The two largest markets are testing this in real time — and pulling in opposite directions. Europe’s IVDR is the lifecycle model in full, and it is straining: limited notified-body capacity has forced the transition deadlines to be pushed out repeatedly, amid warnings that essential tests could disappear from the market, and in December 2025 the Commission proposed simplifying the very framework it had built. The United States moved the other way — the FDA’s 2024 rule to regulate laboratory-developed tests as devices was struck down in court and formally rescinded in 2025. Lifecycle oversight is the clear direction of travel; how it is implemented is still being fought over.

Source (EU): IVDR (Regulation (EU) 2017/746) transitional periods extended by Regulation (EU) 2024/1860 to 2027–2028; European Commission proposal to simplify the MDR/IVDR framework, December 2025.

Source (US): FDA laboratory-developed tests final rule (May 2024) vacated in American Clinical Laboratory Association v. FDA (E.D. Tex., 31 March 2025); FDA rescinded the rule, September 2025.

The key shift: regulatory compliance becomes a lifecycle discipline rather than a milestone before launch.

What this means for IVD companies

The IVD industry of 2030 is unlikely to be defined by any single breakthrough. The bigger change comes from convergence — a single product combining biomarkers, molecular technology, automation, software, AI, connectivity and genomic data, developed across a network of IVD manufacturers, pharmaceutical sponsors, CROs, clinical laboratories, technology providers and health systems.

That makes for a more complex development environment. Companies will need to consider regulatory requirements earlier, build stronger quality systems around external partners, generate meaningful clinical evidence, and think in terms of the whole product lifecycle rather than market entry alone. Above all, the successful diagnostics will be the ones that solve a clinical problem — not simply the ones that demonstrate impressive technical performance.

The question is no longer “What can our technology do?” It is “What clinical problem does our technology solve, and what evidence will we need to prove its value?”

The next decade offers the IVD industry significant opportunity. AI can make interpretation more powerful; decentralised testing can bring diagnostics closer to patients; genomics and multiplexing can give a far richer picture of disease; companion diagnostics can tie diagnostics ever more closely to therapy. But that potential will only be realised where it is supported by robust development processes, credible clinical evidence, effective quality systems and regulatory strategies that reflect the changing nature of diagnostics.

The organisations that start addressing these challenges now will be the best placed to navigate the diagnostic landscape of 2030. Because the future of IVD is not simply about developing better tests. It is about developing better diagnostic solutions.

How Dolmen Diagnostics can help

Each of these shifts turns on the same underlying capability: getting regulatory strategy, quality and evidence right early, and sustaining them across the lifecycle and across partners. That is where I work.

Dolmen Diagnostics supports IVD manufacturers, pharmaceutical sponsors and clinical organisations with:

• Regulatory strategy from day one — embedding IVDR and clinical trial regulatory requirements into development rather than bolting them on before launch.

• Companion diagnostic co-development — aligning assay and drug programmes, and managing the interfaces between sponsors, assay developers, laboratories and CROs.

• Quality oversight of external partners — building quality systems that hold up when assays, testing and data sit outside your own organisation.

• Performance evaluation and post-market planning — treating evidence and surveillance as a continuous lifecycle activity under IVDR.

If any of these themes are live for your organisation, I’d be glad to talk them through.