What market share can Mainz Biomed capture in the UK colorectal screening market versus existing competitors?

Market outlook & capture potential

The UK’s NHS‑run colorectal cancer (CRC) screening programme processes roughly 3.8 million stool‑sample kits a year, with an expected ≈ 7 % positive detection rate. Today the market is dominated by the quantitative faecal immunochemical test (FIT) – > 90 % of kits – and by the FIT‑DNA product (Cologuard, used on a modest pilot basis). FIT’s unit cost is about £7–£9 per kit; Cologuard commands a premium (£12–£14) but still faces NHS reimbursement uncertainty.

ColoAlert, now registered with the Medicines and Healthcare products Regulatory Agency (MHRA), is positioned as a molecular‑biomarker panel that can triage FIT‑negative individuals, promising higher specificity (≈ 95 %) and a modestly lower false‑positive rate versus FIT alone. If Mainz can demonstrate a net cost saving of £1–2 per test (through reduced follow‑up colonoscopies) and secure NHS endorsement, realistic uptake on the existing FIT base could be 10‑15 % of the total annual kit volume within 12‑18 months – i.e., roughly 380 k‑450 k kits or ≈ 10 % market share. A more aggressive rollout (e.g., adoption in all 4 UK regions plus private providers) could push it toward the 20 % share ceiling, but that would require a pricing advantage or a formal “FIT‑plus” reimbursement pathway.

Trading implications

• Fundamentals: Capturing ~10 % of the 3.8 M‑kit base translates to ~£30 M–£35 M annual revenue at a projected £8–£9 per kit, enough to lift the company’s FY‑2025 topline by > 50 % versus the current guidance. A successful NHS contract will also open the door to European roll‑outs, adding a multi‑year revenue catalyst.
• Catalyst risk: The next 4‑6 weeks will focus on NHS tender announcements and any data releases on ColoAlert’s clinical utility vs. FIT. A missed or delayed endorsement markedly caps upside.
• Technical view: Mainz Biomed’s share has broken above the 50‑day SMA on the news, trading at a modest 12 % premium to its 3‑month average. Volume is still thin; a break‑out above the 20‑day EMA (~£0.28) with sustained upside could trigger a short‑cover rally. Conversely, a pull‑back below the 20‑day EMA would signal that the market is still skeptical about NHS uptake.

Actionable take‑away

If you are bullish on a ~10 % UK market capture and the associated revenue boost, consider a small‑position entry near current levels with a 10 % stop‑loss to guard against a potential NHS‑contract delay. A breakout above the 20‑day EMA with accompanying positive NHS tender news can be used as a buy signal; meanwhile, monitor any competing moves from FIT‑DNA manufacturers for downside pressure.