Here is a Detailed Project Report on the IVD Strips (Glucose, Urine & Pregnancy), its process, market position, demands, investment opportunity and project financials. It comprises a comprehensive analysis of the industry. The report also includes plant capacity, requirement of land and building, raw material detail with supplier list, plant & machinery, flow sheet diagram, total Capital investment along with detailed calculation on rate of return, break-even analysis and profitability analysis.
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IVD is short for In Vitro Diagnosis. Vitro means glass, which means in IVD context, these tests are done in test tubes, which as we know are made of glass. IVD or In Vitro Diagnosis can diagnose diseases, infections and medical conditions in patients. But in this article we’ll talk about IVD strips, what they are, what are their uses and their market in India and business opportunities.
Related Business Plan: Start your own Manufacturing Business of IVD Strips for Glucose, Urine and Pregnancy Test
What are IVD strips?
IVD strips are in-home diagnosis instruments, which are used to diagnose glucose levels in individuals, urine or pregnancy. The strips are mostly used by individuals at home to self check their urine and pregnancy or even glucose level in their body. It is mostly used by women to check the effects of pregnancy on them.
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What are the uses of IVD strips?
Well, IVD strips are used to diagnose glucose level, urine and pregnancy at home. But it is also used by medical experts in clinics to check gestational diabetes and preeclampsia in pregnant women. Diabetic patients with Type 2 Diabetes use IVD strips to check their daily glucose levels and to monitor the medication’s operation. Many Diabetic patients use the strips to check their sugar level, when they’re not taking Insulin shots. This helps them take appropriate action before things get out of hand. Aside from that the strip can also be used to check Haemoglobin & Cholesterol counts. This helps the doctors decide the perfect treatment for the patient. During Covid, IVD strips were used by hospitals, companies, hotels and individuals to check covid-19. During that time though, instead of urine or blood, they had used a swab that was inserted in an individual’s nostrils.
How does IVD strip work?
The strips have very precise reagents in them. The strips are made of small cells that hold these reagents. Now when these reagents come in direct contact with human blood or urine, they change their colour based on the component inside the blood or urine. This colour indicates the glucose level or urinary tract infection, etc.
IVD strip Market in India.
In Vitro Diagnosis has seen a rise in its popularity during Covid 19. It has been highly in demand, not only in India but all across the globe since then. Companies and hotels and hospitals were buying the IVD strips in bulk. To be more accurate, IVD strips manufacturers made the most profit in Covid just after Sanitizer and mask manufacturers. IVD strip is a very flexible product, it is highly in demand in both B2B and B2C formats. And both are equally profitable. Even if covid is coming to an abrupt end, hopefully. Diabetes is on the rise. Diabetes is one of the most common illnesses in the world right now. And Every Diabetic patient needs IVD strips to check their glucose level and cholesterol counts. And that is not the only thing that can be checked by IVD strip. It can also check haemoglobin levels, urinary tract infection and Covid-19. And that is exactly why it is so much in demand right now. It is being sold to both hospitals and to the patients. It is a perfect B2B, which means, Business to Business and a perfect B2C, which is Business to Consumer, venture.
Related Feasibility Study Reports: Production Of Ivd Strips (glucose, Urine & Pregnancy) | Profitable Business Opportunities In Medical Sector
Business Opportunities in IVD strip Market, in India.
Well, let’s start with the fact that Medical industry is the fastest growing industry in the world in terms of products, technological advancement and ideas. It is the only industry that was gaining profit during covid. Unlike other industries, Medical industry is a necessity not a luxury. And every entrepreneur that enters the industry pushes it forward, technologically and accessibility wise. And one of the major reasons you should enter the industry is that we do not have big pharma giants like Pfizer and Rochell in India. While we do have Serum like manufacturers. You can’t name anyone else. If this remains so, soon India will suffer from over demand and undersupply. India has a rising amount of special needs patients, and a decrease in Drug companies. And with the government adding heavy taxes to the foreign medicine making them unaffordable to lower middle class and lower class patients. It opens a way for a domestic entrepreneur to get to this part of the population, which by the way, is the largest part. In conclusion it is one of the best investment opportunity in the 21st century. It is low cost and highly profitable.
We at Entrepreneur India provide exhaustive information on the sector/business you plan to pursue, we ensure your start up meets all the rules and regulations. Our market research reports as well as our project counselling provides you with new insights which not only gives you a humongous head start, but also helps accelerate growth.
The Project report presented by Entrepreneur India for new businesses includes a broad commercial centre investigation. The report covers region wise patterns trending in the sector, overseas trade, and the regulatory framework with complete SWOT analysis of the business.
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Market Demand
Test strips are required for urinalysis and blood glucose analysis. These test strips are used to check or control diabetes patients’ blood glucose levels. It makes it possible for those who have diabetes or pre-diabetes to regularly check their blood sugar levels without needing to go to a doctor’s office or diagnostic facility. The increased prevalence of diabetes around the world is expected to have a substantial impact on the test strip market over the course of the forecast period. COVID-19 hasn’t seen much of an impact from the worldwide in-vitro diagnostics (IVD) business, which is expected to expand quickly in 2020 and 2021.
Why You Should Start This Business
In terms of innovative concepts and products, the medical sector has one of, if not the fastest growth rates. It is anticipated that by 2020, the market for in vitro diagnostic (IVD) tools and procedures will be worth $67.2 billion. It’s time to take advantage of one of the best investment possibilities available right now, one with excellent profit margins and a low barrier to entry. An oversupply in developing nations will occur in the next five years as a result of tighter regulation and shifting market dynamics, including an increase in patients with special requirements in India and fewer blockbuster medications from corporations like Roche and Pfizer.
Current Regulatory Challenges and Approaches in Registering In-Vitro Diagnostics in India.
As opportunities grow, medical device companies are forced to comply with an increasing number of rules and regulations. By creating high-quality and affordable medical gadgets, the sector is becoming more technologically advanced. On the other hand, with imports accounting for about 75% of the market, the current Indian medical device business is predominantly import-driven. The usage of more than 50,000 medical devices every day in the healthcare industry makes it crucial for regulatory bodies to uphold patient safety. So, it is necessary to control medical gadgets. Figure 1 illustrates the USD 80 million Indian healthcare market, which includes 6% of the market for medical equipment and 3% of the market for in-vitro diagnostic instruments In India, the market for medical devices is worth USD 4.9 billion, of which 53% are IVDs (equipment and instruments), 27% are consumables and disposables, 13% are patient aids, and 7% are implants shown in Figure 2. The global medical device market is estimated to be about $220 billion, and India ranks 20th globally, lower than the rest of the countries, according to the National Medical Device Policy of 2015. The National Medical Device Authority, or NMDA, is in charge of overseeing medical device organisations and setting standards for the global market. To help the industry become self-sufficient, the NMDA will offer a single point of contact. [5, 6] The government will allocate financial resources in accordance with the NMDA’s recommendations. The authority will establish a committee for skill development and identify “Centres for Excellence” to help product development and validation. In order to be included in a distinct list of commodities under the Essential Commodities Act, they will separate the pricing for medical devices. About 3 million USD are spent on medical devices in India, which accounts for 6% of the country’s $40 billion healthcare market. India is the fourth-largest market in Asia and one of the top twenty global markets for medical equipment, however despite this, it still faces numerous difficulties, such as
- Fulfil all legal requirements.
- In order to market its goods, the corporation must combine with a government.
- A talent gap
- The absence of tax incentives.
- A high import dependency
- A lack of funding for research and development
As indicated in Figure 3, in-vitro medical devices (IVDs), whether employed alone or in combination, are utilised for the in-vitro assessment of specimens produced from the human body alone or principally for diagnostic, monitoring, or compatibility reasons. Reagents, calibrators, control materials, kits, and other items may be among them.
Labelling requirements for medical device imports and exports
According to Rule 109A of the D and C Act, the labelling requirements (12) for import and export of medical devices must be printed indelible ink on the label or sticker on the shelf pack of the device or on the outside of such device and on every outer covering in which the device is packaged.
Figure 7: Labelling regulations for medical device import and export
The label, the import licence number, the name and address of the importer, the address of the real manufacturing facilities, the date of manufacture, and, in the case of imported devices, and the permission of the licencing body indicated in Rule 21. If the meaning of the sign is not immediately clear to the device user, the label may include symbols recognised by the Bureau of Indian Standards or International Organization for Standardization (ISO) in place of language, and the device’s safety is not jeopardised.
Conclusion
India had seen great growth in this market and it is anticipated to rise in the next years. The global medical device market has been expanding rapidly throughout the last decade. To enhance the Indian medical device sector and accelerate its global expansion, Indian regulators should take the appropriate actions. More regulation of private businesses is required, and harsher penalties should be established to ensure that rules are followed. In India, centralised processes should be created to ensure that all rules are the same. The government needs to improve the availability and cost of IVDs. We at Entrepreneur India provide exhaustive information on the sector/business you Plan to pursue, we ensure your startup meets all the rules and regulations. Our market research reports as well as our project counselling provides you with new insights which not only gives you a humongous head start, but also helps accelerate growth.
The Project report presented by Entrepreneur India for new businesses includes a broad commercial centre investigation. The report covers region wise patterns trending in the sector, overseas trade, and the regulatory framework with complete SWOT analysis of the business.
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