How to Start Manufacturing Business of IVD Strips (Glucose, Urine & Pregnancy)

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The Manufacturing Business of IVD Strips (In Vitro Diagnostic Strips) has witnessed significant growth in recent years, driven by rising demand for point-of-care testing, increasing cases of lifestyle-related diseases like diabetes, and the urgent need for rapid diagnostic solutions post-COVID-19. These strips are essential tools used in diagnostic kits to detect glucose levels, pregnancy hormones, infectious diseases, and more—making them a critical part of the medical device industry.

With India’s diagnostic industry projected to grow at a CAGR of over 14% in the next five years, the manufacturing business of IVD strips presents immense potential for startups and SMEs. Entrepreneurs investing in this sector can benefit from high margins, export opportunities, and government support under the “Make in India” and PLI schemes for medical devices.

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Why Invest in the Manufacturing Business of IVD Strips?

The manufacturing business of IVD strips is emerging as a game-changer due to its low entry barriers, consistent demand, and scalable applications. These strips are vital in hospitals, diagnostic labs, clinics, and even at home. The increasing adoption of self-monitoring devices has further boosted their consumption.

India’s rising burden of chronic diseases—like diabetes, which affects over 77 million people—creates a robust market for glucose monitoring strips alone. With rapid urbanization and awareness, the demand for other IVD strips (for cholesterol, ketones, dengue, malaria, HIV, etc.) is also expanding swiftly.

Types of IVD Strips in the Market

Glucose Monitoring Strips
Pregnancy Test Strips
Urinalysis Strips
Cholesterol Testing Strips
COVID-19 Antigen Test Strips
Malaria/Dengue Rapid Test Strips
HIV/STD Detection Strips

Manufacturing Process Overview

The manufacturing business of IVD strips involves precision, cleanroom standards, and adherence to biomedical regulations. Here’s a step-by-step outline of the process:

1. Substrate Preparation

PET film or membrane base is cleaned and coated
Surface treated to enhance reagent absorption

2. Reagent Formulation

Chemical reagents are formulated specific to the diagnostic function (e.g., glucose oxidase, anti-HIV antibodies)

3. Strip Coating

Reagents are uniformly coated on the strip using a slot-die coater or spray machine in a humidity-controlled room

4. Drying and Curing

Controlled heat drying systems are used to ensure reagent stability

5. Cutting and Assembly

Coated sheets are slit into narrow strips and assembled into plastic housings or cassettes

6. Packaging

Strips are sealed in foil pouches with desiccants and labeled according to IVD norms

7. Quality Control

Sensitivity, accuracy, and stability testing is done before dispatch

Raw Materials Required

PET membrane rolls
Nitrocellulose membrane
Reagent chemicals (e.g., enzymes, antibodies, surfactants)
Plastic strip casings
Foil pouches
Desiccants
Barcode labels and kits

Read Similar Articles: Production of IVD Strips (Glucose, Urine & Pregnancy)

Machinery & Equipment Needed

Coating machine
Cutting/slitting machine
Drying oven
Strip assembly line
Packaging line
Quality control instruments (spectrophotometer, humidity chamber, etc.)

Licenses & Compliance

To set up a manufacturing business of IVD strips in India, the following approvals are essential:

CDSCO registration for Class B/C IVD devices
BIS certification (as per IS/ISO standards)
Pollution control board NOC
Factory license and GMP compliance
ISO 13485:2016 certification (Medical Device QMS)

Market Potential and Growth

According to industry research, the Indian IVD market was valued at USD 1.3 billion in 2023 and is expected to cross USD 2.5 billion by 2028. The rapid growth is due to:

Increased health awareness
Need for affordable testing in rural areas
Government’s Ayushman Bharat health initiatives
Expanding private diagnostic labs

Domestic manufacturing is also gaining traction to reduce dependency on imports from China, Germany, and the U.S.

Investment & Profitability

Initial Investment: ?50 lakh – ?1.5 crore depending on scale
Gross Profit Margin: 35%–50%
Breakeven Period: Within 12–18 months (with bulk B2B orders)

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Target Customers & Sales Channels

Government hospitals and procurement agencies
Private diagnostic labs (e.g., Dr Lal PathLabs, SRL)
E-commerce platforms (for glucose and pregnancy kits)
B2B export markets (Middle East, Africa, Southeast Asia)
Medical distributors and wholesalers

Challenges & Considerations

Strict regulatory compliance
Need for precision in reagent coating and packaging
High sensitivity to humidity and contamination
Competition from established global brands

Conclusion

The manufacturing business of IVD strips offers an exciting opportunity for entrepreneurs and MSMEs to enter India’s fast-growing diagnostic sector. With health awareness rising, government support, and a vast untapped rural market, this business promises high returns and scalability. If you’re considering venturing into medical manufacturing, IVD strips are a solid, future-forward choice.

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