In vitro diagnostics is a technique used to identify many diseases and health conditions in a controlled artificial environment. The wide ranging of application in various diagnostics (biological and medical) industries provides a competitive edge to the IVD device and reagents manufacturers. In-Vitro Diagnostic(IVD) kits/reagents which are notified in India are regulated under Central Drugs Standard Control Organization (CDSCO). and the regulatory process deals with obtaining three key licenses – Form 11, Performance Evaluation Report(PER) and Form 41.
The Indian IVD industry is of important amount at present. Comparing IVD globally, matured markets are reaching a stage of saturation and most of these countries look at India as a future market because of industrial development. At present it is estimated to be around 700 million. Its growth in the next 5 years is supposed to be substantial and we will cross a billion dollar mark very soon.
India is going to be the future market. The main growth drivers are the changes in the market situations. There is a lot of consolidation of laboratories, pathology lab chains merging together, hospital setups coming into India and lot of foreign direct investment also putting in money into the Indian IVD industry. Emerging markets like India are the focus for many of the multinational companies, the biggest advantage that countries like India have is volumes and as the markets mature these volumes are going to be important bottom lines for the multinationals.
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