Biomerica announced an expansion of its Contract Development and Manufacturing Organization (CDMO) services, adding lateral flow, point‑of‑care diagnostics, ELISA tests and multiplex ELISA assays to its portfolio. The move is designed to meet a rising demand for outsourced diagnostic development and production, positioning the company to serve both large diagnostic firms and innovative start‑ups.
The company’s CDMO offering is underpinned by more than 40 years of assay‑development experience and a suite of regulatory credentials, including ISO 13485 certification, CE‑mark expertise and an FDA‑registered cGMP manufacturing facility. These qualifications give Biomerica a distinct advantage in a market where regulatory compliance is a critical barrier to entry.
Financially, Biomerica reported a 5 % year‑over‑year revenue increase in Q2 FY2025, with gross margins rising from 21 % to 27 %. The growth was driven in part by the expanding CDMO segment, which has become a growing contributor to the company’s top line. The company’s earnings per share beat analyst expectations by $0.04, reflecting disciplined cost management amid the revenue uptick.
CEO Zack Irani explained that the expansion responds to “a meaningful increase in interest from both large diagnostic organizations and smaller innovative companies” seeking a partner with deep regulatory expertise. He noted that formalizing and scaling CDMO services will diversify Biomerica’s revenue base beyond its proprietary diagnostic products and create a new source of top‑line growth.
The broader market context shows a surge in demand for outsourced diagnostic solutions, driven by the need for rapid, compliant product development and the growing prevalence of point‑of‑care testing. Biomerica’s regulatory credentials and manufacturing capabilities position it to capture this tailwind, while supply‑chain vulnerabilities and competitive pressure remain potential headwinds.
By expanding its CDMO services, Biomerica strengthens its competitive moat and opens a new revenue stream that can offset headwinds in its core product lines. The company’s improved gross margin and earnings beat suggest that the expansion is already delivering financial benefits, and the strategic focus on regulatory compliance and end‑to‑end support signals confidence in sustained growth in the diagnostic CDMO market.
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