Executive summary

Blood tests that screen asymptomatic people for many cancers simultaneously, typically by detecting circulating tumour DNA methylation patterns or fragmentomics, and predicting tissue of origin. The distinct value chain is population screening infrastructure — sample logistics, high-throughput sequencing, classifier development, and a diagnostic-resolution pathway — sitting outside both oncology and traditional pathology. Commercially it is currently a cash-pay concierge product awaiting a reimbursement decision, and the entire industry's future turns on two things: the NHS Galleri trial outcome and US Medicare coverage legislation.

A. At a glance

Metric	Value	Basis
Global revenue (2025)	$0.5–1.0B T	Dominated by GRAIL's Galleri (test volumes and ~$949 list price disclosed in GRAIL filings S), plus Exact Sciences, Guardant Shield (colorectal-focused, approved 2024 S), Freenome, Delfi, Burning Rock and Chinese players. Note Guardant Shield is single-cancer and sits at the category boundary.
5-yr revenue CAGR	60–90% T	From a near-zero 2020 base; GRAIL's disclosed revenue growth is the anchor.
CAGR to 2031	30–50% E-LC	Enormously wide because it is a binary reimbursement outcome, not a smooth curve.
EBITDA band	−300% to −80% SGRAIL public filings show losses far exceeding revenue
Firm count	30–60 with a clinical-stage or commercial product E-LC
Employment	6,000–10,000 E-LC
Wage share	~35% of operating spend E-LC	Bioinformatics, lab operations, and a large clinical evidence function.
Capital intensity	High — CLIA/CAP laboratory infrastructure, sequencing capacity, and vast prospective trials.

Proxy note: the correct commercial proxy is Cologuard (Exact Sciences' stool DNA colorectal screening test): a non-invasive screening test that took roughly a decade from approval to multi-billion revenue, and whose adoption curve was determined by USPSTF recommendation and CMS coverage rather than by clinical performance SExact Sciences historical disclosures. Every structural feature of MCED's commercial path is visible in Cologuard's history.

B. Life cycle

Stage: emerging.

Test	Reading
Entry–exit ratio	~2:1 but capital-constrained; several firms have narrowed from multi-cancer to single-cancer claims, which is a form of retreat. GRAIL's spin-off from Illumina after an EU/US antitrust unwind (completed 2024 S) was a structural rather than commercial exit.
Product definition stability	Contested. The category cannot agree whether the product is a multi-cancer test, a set of single-cancer tests, or a risk-stratification tool. Regulators and payers treat these very differently.
Buying basis	Capability, expressed as sensitivity at a fixed high specificity (typically >99%) and tissue-of-origin accuracy. Price is currently irrelevant because it is cash-pay to affluent consumers.

Trigger for next stage: a positive mortality or stage-shift readout enabling a USPSTF recommendation and CMS national coverage. Under US law, a USPSTF Grade A/B recommendation triggers mandatory private insurance coverage without cost sharing SACA provisions — a legislative switch that would multiply this industry's revenue by an order of magnitude in a single step. That is why the industry is worth more as an option than as a business today.

C. Structure

CR4: ~70–80% E-LC, trend falling slowly. GRAIL holds the dominant revenue position by a wide margin, followed by Exact Sciences, Guardant and Freenome. This industry currently fails the "no player >40% share" screen on revenue — it qualifies on the other criteria. Falling as competitors reach market and as single-cancer tests take share of the same screening budget.

Revenue by product line E-LC:

Line	Share
Multi-cancer methylation-based tests (cash-pay)	55%
Single-cancer blood screening (CRC, lung)	25%
Biopharma research services & trial support	12%
Minimal residual disease testing (adjacent, same platform)	8%

Revenue by end market E-LC:

End market	Share
Concierge / executive health & employer wellness	40%
Direct-to-consumer cash-pay	22%
Health system pilot programmes	18%
National health service pilots (NHS)	10%
Biopharma partnerships	10%

Where value accrues: currently to a single scaled player plus the sequencing supplier. If reimbursement arrives, value would accrue to whoever holds the USPSTF-recommended test and the CMS code — a winner-take-most structure. If it does not, value accrues to adjacent incumbents: the sequencing platform vendor and the large reference labs (Quest, Labcorp) who would run whatever test wins.

D. Demand

Rank	Variable	Direction & elasticity	Trajectory	Trackable series
1	CMS/USPSTF coverage decision (adoption — a binary switch)	+, effectively infinite at the moment of decision	Pending. The Medicare Multi-Cancer Early Detection Screening Coverage Act has been reintroduced across multiple Congresses S and would create a coverage pathway	Congressional bill trackers; USPSTF topic list S
2	Mortality/stage-shift trial evidence (adoption)	+, absolute	NHS-Galleri trial (140,000 participants) results reporting from 2026 S; PATHFINDER 2 and NHS results are the key readouts	NHS England announcements; NEJM/Lancet publications
3	False-positive rate & downstream diagnostic burden (adoption, negative)	−, high	The central clinical objection; each false positive triggers expensive imaging	Published PPV data from PATHFINDER and NHS-Galleri S
4	Sequencing cost per sample (spend, cost side)	−cost, moderate-high	Falling with new sequencer generations and Illumina/Element/Ultima competition	Illumina disclosures; sequencer list pricing S
5	Employer & concierge health spending (spend-per-adopter, current market)	+, moderate	Stable	Employer benefit surveys (Mercer, KFF) S
6	Consumer health anxiety & wellness-testing culture (adoption)	+, moderate	Rising	DTC diagnostics market growth

Adoption vs spend separation: reimbursement determines whether the population screens at all; test price and repeat frequency (annual vs biennial) determine spend per adopter. Note that annual repeat testing is what makes the TAM large — a one-time test is a much smaller business.

E. Cost structure

Parent-sector benchmark passed as context (Clinical laboratory & diagnostic testing services): purchases ~32%, labour ~28%, depreciation ~7%, marketing ~7%, rent/utilities ~4%, other ~12%, profit ~10%. Benchmark T from composited Labcorp/Quest/Exact Sciences segment disclosures.

Line	This industry E-LC	Δ	Explanation
Purchases (sequencing reagents, flow cells, consumables)	30%	−2 pts	Broadly normal in ratio, but note the dependency: reagent cost is set by one dominant supplier.
Labour	26%	−2 pts	Lab operations plus bioinformatics.
Depreciation	9%	+2 pts	Sequencer fleets and lab automation.
Marketing & selling	18%	+11 pts ⚑⚑	The defining anomaly of the current business model. Selling a $949 cash-pay test to individuals and to concierge physicians is expensive per unit. This line collapses toward the benchmark the moment reimbursement arrives — which is precisely why the industry's economics are a step function, not a curve.
Rent & utilities	4%	0
Other — clinical evidence generation	35%	+23 pts ⚑⚑	The largest anomaly. Running 140,000-participant prospective trials is a cost no diagnostic company historically carried. It is effectively a pharmaceutical-scale evidence programme attached to a lab test.
Profit	−22%	−32 pts ⚑⚑

Direction at scale: the clinical evidence line is largely one-time and falls away once the evidence exists. Marketing collapses with reimbursement. Purchases fall with sequencing cost curves. This is one of the few cost structures in this series with a credible path to high profitability — conditional entirely on the reimbursement switch.

F. Five forces

Force	Score	Mechanism	What changes it
Rivalry	3	Few firms have commercial products; competition is for the evidence lead, not for customers	Multiple approved tests competing for the same screening slot
New entrants	2	The cost of a 100,000-person prospective trial is a near-absolute barrier	A validated surrogate endpoint accepted by regulators would cut this dramatically
Supplier power	5	Sequencing is dominated by one vendor whose reagent pricing sets the cost floor	Element, Ultima, MGI, Roche SBX competition — genuinely emerging
Buyer power	5	Two decision-makers effectively — USPSTF and CMS — hold complete power over whether the market exists	Nothing; this is structural
Substitutes	4	Existing organ-specific screening (mammography, colonoscopy, LDCT, PSA), which is recommended, reimbursed and entrenched	MCED demonstrating it finds cancers those miss, in a mortality endpoint

Basis of competition: sensitivity for stage I–II cancers at ≥99% specificity, plus tissue-of-origin accuracy, plus — decisively — the quality and size of the prospective evidence base.

Rivalry suspended? Yes, strongly. The industry's shared existential contest is with the payer and guideline system, not with each other. Firms have jointly lobbied for the Medicare MCED coverage legislation, which is an explicit collective action against the real obstacle.

G. Barriers to entry

Overall: very high.

Component	Level	Note
Capital	Very high	Multi-hundred-million-dollar trials
Technology	Medium	Methylation sequencing and classifier training are well-published; the science is not the moat
Talent	Medium
Regulatory	High and rising fastest	FDA's LDT final rule (2024) began phasing laboratory-developed tests into device regulation S, though its legal status has been challenged — a major and unsettled shift for this industry specifically
Data / network	High	Large annotated cohorts with outcome follow-up are the real asset and take years to accrue
Supply access	Medium-high	Sequencing capacity and reagent pricing
Brand	Medium	Physician trust; matters in the cash-pay channel

Fastest-rising: regulatory. The LDT rule, if it survives litigation, converts these from lab-developed tests into regulated devices requiring premarket review — a fundamental change. Eroding: the underlying assay technology, which is now replicable by well-funded competitors including Chinese firms operating at lower cost.

H. Value chain

Upstream:

⚑ Flag: sequencing instruments and reagents. Illumina has historically held well above 50% of global sequencing output and consumable revenue E-LCproxy: Illumina's own disclosed share commentary and competitor revenue comparison. Every MCED firm's gross margin is set by one supplier's reagent pricing. This is the most consequential single-vendor dependency in diagnostics. Note that GRAIL was owned by Illumina until 2024, and the antitrust case that unwound it was fundamentally about this dependency S.
Blood collection tubes (Streck, BD): moderately concentrated, and a genuine bottleneck during supply disruptions.
Cloud compute for classifier inference: not constraining.

Downstream: extraordinarily concentrated. Not in the usual sense of a few large customers, but in the sense that two institutions — USPSTF and CMS — determine whether a market exists. There is no analogue elsewhere in this series except pharmaceutical reimbursement.

Margin pools: today at the sequencing supplier, which earns a reliable consumable margin regardless of whether any MCED firm succeeds. Would migrate to the test owner upon reimbursement.

I. Operating conditions

Volatility: high, ±40% E-LC, driven by pilot-programme starts and stops and by cash-pay channel seasonality. Post-reimbursement it would become a low-volatility annuity.

Rate of technological change: moderate, and favouring incumbents — because the asset is the cohort and the evidence, not the assay. A better classifier does not help a firm with no trial.

Regulation:

Item	Jurisdiction	Status/date	Effect
FDA LDT final rule	US, published 2024, phased implementation; subject to litigation S	Contested	Major barrier if upheld
Medicare MCED Screening Coverage Act	US Congress, reintroduced, not enacted S	Pending	Demand-creator — the single most important pending item in this report
USPSTF review of MCED	US	Not yet initiated for a Grade A/B recommendation E-LCverify current topic list	Gate
FDA breakthrough device designations	US, granted to several MCED tests S	In force	Enabling
NHS England Galleri programme decision	UK, decision expected following trial readout from 2026 S	Pending	Demand-creator; the first national-scale decision globally
EU IVDR	EU, phasing S	Applying	Barrier — significant compliance cost for EU market entry

Subsidies & mandates: the ACA preventive services mandate is the relevant lever — a USPSTF A/B grade makes coverage compulsory for most US private plans without cost-sharing. That is not a subsidy but functions as a demand mandate of extraordinary power.

Trade exposure: moderate. Tests are run in centralised labs; sample logistics cross borders awkwardly. Chinese firms operate largely in a separate domestic market.

J. Key success factors (ranked)

Prospective cohort scale with outcome follow-up — the operational capability to enrol, retain and follow tens of thousands of asymptomatic participants for years. This is a clinical operations business masquerading as a technology business, and it is the only durable asset.
Positive predictive value at population prevalence — engineering specificity high enough that the false-positive burden does not overwhelm the health system. A test with 99% specificity still generates enormous absolute false positives when screening millions; managing that is the difference between adoption and rejection.
Diagnostic resolution pathway design — building the referral, imaging and follow-up protocol that a health system can actually execute after a positive result. Health systems reject tests they cannot act on, regardless of accuracy.
Cost per test at scale, decoupled from a single sequencing vendor — qualifying a second sequencing platform is a concrete operational project with direct gross-margin consequence.
Guideline and payer engagement capability — the specific skill of assembling a dossier that USPSTF and CMS will act on, including the health-economic modelling they require. Firms staff this thinly and it is the highest-leverage function in the company.
Cash-pay channel operations — until reimbursement, survival depends on running an efficient concierge and employer sales motion at 18% of revenue. Firms that cannot fund themselves this way will not reach the reimbursement decision.

K. Outlook

Scenario	Prob. E-LC	Revenue path	Load-bearing assumption
Base	45%	$0.75B (2025) → $3.5–5B (2031)	NHS and US evidence shows meaningful stage shift; partial coverage (some private payers, some national systems); no full USPSTF Grade A/B by 2031.
Bull	20%	→ $12–18B (2031)	Mortality benefit demonstrated, USPSTF recommendation and CMS coverage achieved, annual screening adopted.
Bear	35%	→ $1–1.5B (2031)	See below.

Bear case, at full strength. Cancer screening has a long history of tests that detect more cancer without saving more lives, and the burden of proof reflects that history. Stage shift — finding cancers earlier — is not the same as mortality benefit, because a test can preferentially detect slow-growing cancers that would never have killed the patient (overdiagnosis) while missing the aggressive ones that do. The NHS-Galleri trial's primary endpoint is stage shift, not mortality, which means even a positive result will leave USPSTF with the question it cares most about unanswered — and USPSTF has been notably unwilling to recommend screening on surrogate endpoints since the PSA experience. Interim NHS results reported in 2024 were not sufficiently compelling to trigger immediate national rollout S. Meanwhile, at population prevalence, even 99.5% specificity generates false positives in the thousands per hundred thousand screened, each requiring imaging and sometimes biopsy: the downstream cost and harm may exceed the benefit, and health economists have said so. The FDA's LDT rule threatens to impose device-grade premarket review on a category whose entire commercial existence has depended on the LDT exemption. The industry's dominant firm loses money at a rate that requires continuous capital access, and its former parent was forced to divest it. Sequencing costs are controlled by a supplier that competes in adjacent markets. The plausible bear outcome is that MCED remains a premium cash-pay wellness product for the affluent worried-well — a real business of $1–1.5B, never reimbursed, never recommended, and remembered as a technology that worked exactly as designed while failing to demonstrate that it helped.

Five signals checkable within 12 months:

What does the NHS-Galleri final trial readout show on stage shift, and does NHS England commit to a rollout?
Does the Medicare MCED Screening Coverage Act advance out of committee?
Does USPSTF add multi-cancer screening to its active topic list?
What happens to the FDA LDT rule in litigation?
Does any firm publish positive predictive value at real population prevalence from an unselected screening cohort — the number that decides the clinical argument?

L. Notable companies

Representative operators, not a ranking and not investment advice. Chosen for being named in the analysis above or for being among the most significant independent firms in the value chain. Acquisitions are noted where the buyer now sets strategy. Every link was resolved and checked against the destination page on 25 July 2026.

Company	What it does	Site
GRAIL	Galleri; the category-defining test	grail.com
Freenome	Multiomics blood screening	freenome.com
Delfi Diagnostics	Fragmentomics-based detection	delfidiagnostics.com
Harbinger Health	Early-origin methylation signals	harbingerhealth.com
Exact Sciences	Cancerguard; Cologuard incumbent	exactsciences.com
Guardant Health	Shield colorectal screening	guardanthealth.com