From India to the world: Cupid’s diagnostic kits gain CE certification

Cupid Limited (BSE: 530843, NSE: CUPID), a leading Indian healthcare and diagnostics manufacturer, announced it has been granted CE (EU IVDR) certification for two of its flagship in-vitro diagnostic (IVD) devices the CupiSURE Pregnancy (hCG) Test Kit and the CupiKIT Syphilis Antibody Test Kit. This approval confirms compliance with the European Union Regulation (EU) 2017/746 (IVDR), enabling Cupid to distribute these kits across the European Economic Area and other CE-recognized international markets.

The development marks a significant step in Cupid’s transition from a domestic healthcare exporter to a globally certified IVD solutions provider. The company’s certified kits target high-growth diagnostic segments. The global pregnancy test kit market was valued at USD 1.7 billion in 2024 and is projected to reach USD 2.9 billion by 2034, growing at a CAGR of 5.4%. Meanwhile, the syphilis immunoassay diagnostics market is estimated at USD 611 million in 2025 and expected to expand to USD 993 million by 2034, at a CAGR of 5.6%.

Cupid is also in the final stages of securing CE certification for its HIV 1 & 2 Antibody and Hepatitis B Antigen IVD kits, expected by December 2025. These products address some of the largest and fastest-growing diagnostic markets globally. The HIV antibody diagnostics market is projected to grow from USD 3.6 billion in 2025 to USD 6.1 billion by 2030 (CAGR ~10.7%), while the Hepatitis B antigen diagnostics market is expected to surpass USD 2 billion by 2033 (CAGR ~4.2%). Collectively, these four segments represent a vast global market opportunity for Cupid in both public health and private clinical sectors.

With CE approvals, Cupid is positioned to participate in European, African, and Latin American tenders for maternal health, STD, and infectious-disease screening. Leveraging its cost-effective Indian manufacturing base, the company aims to provide competitively priced global IVD solutions while diversifying beyond sexual-health products into broader preventive and diagnostic healthcare.

Commenting on the milestone, Mr. Aditya Kumar Halwasiya, Chairman and Managing Director, said, “The CE (EU IVDR) certification for our Pregnancy and Syphilis Antibody IVD kits validates Cupid’s global quality standards and technical excellence. With HIV and Hepatitis B kits on track for approval by December 2025, we are poised to become one of India’s few integrated diagnostic companies with a globally certified product suite. Our goal is to build a strong international footprint and make accurate, affordable diagnostics accessible to all.”