NNNNNasdaqIn Vitro & In Vivo Diagnostic SubstancesUS GAAP · USD

Anbio Biotechnology

Anbio Biotechnology is a U.S.-based diagnostics company organized through a foreign private issuer structure with principal executive offices in Frankfurt, Germany. It develops and markets in vitro and in vivo diagnostic substances used in medical testing and related laboratory workflows.

Revenue8.6m USD
+5.6 %y/y
Operating profit (EBIT)5.8m USD
+189.1 %y/y
EBIT margin66.7%
+42.3 ppy/y
Net income6.4m USD
+169.9 %y/y

Fiscal year 2025 · change from previous year

Development 2022–2025

0510152025m USD2022: 24 m USD2022: EBIT 10 m USD20222023: 6.7 m USD2023: EBIT 2.0 m USD20232024: 8.2 m USD2024: EBIT 2.0 m USD20242025: 8.6 m USD2025: EBIT 5.8 m USD20258.65.8
RevenueOperating profit (EBIT)

Business

Share of revenue
In Vitro Diagnostic Substances70 %

Reagents and substances used to detect or measure analytes in laboratory and point-of-care testing.

In Vivo Diagnostic Substances15 %

Compounds used in diagnostic procedures performed within the body or in clinical settings.

Diagnostic Reagents and Consumables10 %

Ancillary reagents, kits, and consumable materials used alongside diagnostic assays.

Assay Components and Support Materials5 %

Components and materials supplied for clinical testing and laboratory workflow support.

Customers

The company serves healthcare and laboratory buyers that need diagnostic substances for testing and analysis. Its customers are typically clinical laboratories, hospitals, diagnostic service providers, and other medical-testing organizations that purchase reagents and assay materials to support routine and specialized testing. Because the business is tied to regulated diagnostics workflows, buyers value product reliability, consistency, and compatibility with established instruments and laboratory processes.

Clinical laboratories

Buy diagnostic reagents and substances for routine and specialized lab tests, where accuracy and reproducibility matter.

Hospitals and healthcare systems

Purchase diagnostic materials for in-house laboratory operations and patient testing workflows.

Diagnostic service providers

Use assay materials and test substances to deliver outsourced or reference testing services.

Research and medical testing organizations

Acquire diagnostic substances for validation, screening, and laboratory applications.

Strategy

The company’s strategic position is tied to building a diagnostics platform around in vitro and in vivo substances used in clinical testing. Its filings also show an emphasis on maintaining a formal corporate and governance structure, including capital and shareholder actions typical of a growth-stage public issuer. In a diagnostics business, product reliability, regulatory compliance, and customer adoption are central to competitive positioning.

Expand diagnostic product adoptionMedium term

Broader customer adoption increases recurring demand for reagents and assay materials.

Strengthen regulatory and quality positioningMedium term

Diagnostics businesses depend on validation, consistency, and compliance with health-sector standards.

Maintain capital structure flexibilityShort term

Public diagnostics companies often need flexibility to fund product development and commercial scale-up.

Geography

2025

Anbio Biotechnology is incorporated in the United States but its principal executive office is in Frankfurt, Germany, reflecting a cross-border operating structure. The available filings do not disclose a detailed revenue split by country or region, so the geographic footprint should be viewed as enterprise-wide rather than map-specific. Its location profile suggests exposure to both U.S. and international regulatory and operational requirements.

European Union71 %
Asia Pacific21 %
North America4.1 %
South America3.7 %

Share of the revenue the company reports by geography.

Risks

The main business risk is execution in a regulated diagnostics market, where product performance, approvals, and customer adoption determine commercial success. As a cross-border issuer, the company also faces governance, reporting, and operational complexity across jurisdictions. Diagnostics companies additionally face supply-chain, quality-control, and reimbursement pressures that can affect demand and operating continuity.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Regulatory and compliance risk1Product quality and performance risk2Cross-border operating complexity3
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Regulatory and compliance riskImpact: HighLikelihood: Medium

    Diagnostic substances are used in healthcare settings and must meet technical and regulatory requirements.

    ExposureProduct approvalsValidationQuality systems
  2. Product quality and performance riskImpact: HighLikelihood: Medium

    Testing materials must deliver consistent results, and failures can damage customer trust and adoption.

    ExposureReagentsAssay materialsDiagnostic workflows
  3. Cross-border operating complexityImpact: MediumLikelihood: High

    The company’s U.S. identity and German executive base indicate multi-jurisdictional administration.

    ExposureCorporate governanceReportingOperations

Accounting

Judgemental items
Inventory valuation

Diagnostic substances and reagents can become obsolete, expire, or require write-downs.

Impact: Can affect cost of sales and balance-sheet carrying values

Reserves and provisions

Quality issues, returns, or product claims may require accruals in a regulated products business.

Impact: Can create period-to-period earnings volatility

Equity and share capital

The company’s filings discuss multiple ordinary share classes and authorized capital changes.

Impact: Affects dilution, voting control, and equity presentation

Publicly listed companies with a comparable business focus.

Last updated: 28/09/2026

Anbio Biotechnology (NNNN) Revenue, Earnings & Financials 2025 – Clarifo