Cupid Limited Achieves CE (EU IVDR) Certification for Pregnancy And Syphilis Test Kits, Paving the Way for Global Expansion in The Multibillion US Dollar IVD Market

PNN
Mumbai (Maharashtra) [India], October 18: Cupid Limited, (BSE - 530843, NSE - CUPID), Cupid Limited, a leading Indian healthcare and diagnostics manufacturer, announced today that it has been granted CE (EU IVDR) Certification for two of its key in-vitro diagnostic (IVD) devices -- the CupiSURE Pregnancy (hCG) Test Kit and the CupiKIT Syphilis Antibody Test Kit.
These certifications confirm compliance with the European Union Regulation (EU) 2017/746 (IVDR), authorizing Cupid to distribute these kits across the European Economic Area and other CE-recognized global markets. The development marks a major step in Cupid's transition from an Indian healthcare exporter to a globally certified IVD solutions provider.
Strong Global Market Outlook
Cupid's certified IVD kits target two of the fastest-growing diagnostic categories:
Pregnancy (hCG) Test Kits -- Global market valued at USD 1.7 billion in 2024, projected to reach USD 2.9 billion by 2034 (CAGR ~5.4%).
Syphilis Immunoassay Diagnostics -- Estimated at USD 611 million in 2025, expected to grow to USD 993 million by 2034 (CAGR ~5.6%).
In addition, Cupid is in the final stages of securing CE (EU IVDR) Certification for its HIV 1 & 2 Antibody and Hepatitis B Antigen IVD kits, expected by December 2025 -- products that address some of the world's largest and most urgent diagnostic markets:
HIV 1 & 2 Antibody Diagnostics -- Global market estimated at USD 3.6 billion in 2025, projected to expand to USD 6.1 billion by 2030 (CAGR ~10.7%).
Hepatitis B Antigen IVD Diagnostics -- Valued at USD 1.3 billion in 2024, expected to surpass USD 2.0 billion by 2033 (CAGR ~4.2%).
Collectively, these four segments represent a vast global market opportunity, offering substantial room for Cupid's expansion in both public health and private clinical sectors.
Strategic Significance for Cupid Ltd.
With these CE (EU IVDR) approvals, Cupid can now:
Participate in European, African, and Latin American tenders for maternal health, STD, and infectious-disease screening.
Leverage its low-cost, high-quality manufacturing base in India to deliver competitively priced global IVD solutions.
The certifications also reinforce Cupid's commitment to diversifying beyond sexual-health products into the broader preventive and diagnostic healthcare space, aligning with the global shift toward early detection and rapid testing.
Commenting on the Development, Mr. Aditya Kumar Halwasiya, Chairman and Managing Director said, "The CE (EU IVDR) Certification for our Pregnancy and Syphilis Antibody IVD kits is a milestone achievement that validates Cupid's global quality standards and technical excellence. These certifications open up huge opportunities for us across Europe, Africa, and Asia. With HIV 1&2 Antibody and Hepatitis B Antigen kits on track for approval by December 2025, Cupid is poised to become one of India's few integrated diagnostic companies with a globally certified product suite. We aim to build a strong international footprint and make accurate, affordable diagnostics accessible to all."
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