Lord's Mark Industries Ltd. has announced receiving approval from the Central Licensing Authority (Licence No. MFG/IVD/2023/000058) for its LordsMed HIV 1&2 Self Test. This makes the company the second in India among only three approved players nationally, and one of nine companies globally to achieve this milestone.
Approval Details and Market Context
The approval enables the manufacture and export of a Class D in-vitro diagnostic self-test, designed for private use and compliant with India's Medical Devices Rules, 2017. This approval is specifically for export markets, with the product currently not intended for domestic commercial distribution in India. Exports are set to commence from June 2026, targeting key international markets across Africa, Europe, and Latin America—regions witnessing a structural shift toward decentralised, self-administered diagnostics.
Global HIV Self-Testing Market Growth
The global HIV self-testing market is projected to reach approximately USD 600–650 million by 2033, expanding at a CAGR of over 13%. This growth is driven by increasing awareness, policy support, and the need for accessible testing solutions. Africa remains the epicentre of demand, accounting for the highest HIV burden globally, with large-scale donor-funded programs and public health initiatives accelerating adoption. Europe is seeing a steady rise in consumer-led testing, with privacy-driven healthcare behaviour and expanding pharmacy and online distribution channels contributing to double-digit growth. Latin America is emerging as a strong growth market, supported by government-backed testing programmes and increased availability through retail and digital platforms, with Brazil leading regional adoption.
Company Statement
Commenting on the development, Sachidanand Upadhyay, Managing Director of Lord's Mark Industries Ltd., said: "This approval marks a defining moment not just for Lord's Mark, but for India's role in global healthcare. Being among the only nine companies worldwide to receive this clearance reflects our commitment to quality, innovation, and accessibility. With the LordsMed HIV Self Test, we aim to expand access to reliable and private diagnostics across regions where early detection can significantly improve health outcomes."
Product Features and Manufacturing
The LordsMed HIV 1&2 Self Test is a single-use, rapid diagnostic solution that enables individuals to detect HIV-1 and HIV-2 antibodies using a simple finger-prick blood sample, without requiring laboratory infrastructure. Built on globally accepted lateral flow immunoassay technology, the product aligns with current market demand, where blood-based rapid tests account for a significant majority of HIV self-testing usage worldwide.
LordsMed's Role in Diagnostics
This milestone is underpinned by LordsMed, the healthcare division of Lord's Mark Industries, which has been steadily expanding its footprint in diagnostics and medical technology. With WHO-GMP compliant manufacturing facilities and globally recognised certifications, LordsMed offers a broad portfolio of diagnostic solutions across rapid testing, reagents, and medical devices. The division's focus on innovation and scale has enabled it to cater to both domestic and international healthcare ecosystems, positioning it as a credible player in the global diagnostics landscape.
Outlook
As Lord's Mark prepares to operationalise exports, the approval not only strengthens its international market entry but also reinforces India's growing credibility as a hub for high-quality, regulation-compliant medical diagnostics.
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