Market Research Report: Medical Devices Market in India 2010


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The medical device market is a thriving segment of the healthcare industry in India. Rise in the number of hospitals and increasing requirement of healthcare facilities is creating a need for sophisticated devices and equipments which can provide accurate treatment to individuals. The global market is growing rapidly and India has also joined the bandwagon of being one of the fastest growing countries in this respect. The government is expected to develop a regulatory structure leading to quality products by manufacturers. However, the regulatory structure currently lacks active participation from the government but with the increase in competition in the sector, it is due to follow in a very short period of time. Currently, imports account for a large share of primarily the high-end medical device segment and players are gearing up establishing large manufacturing facilities in India to tap the opportunities.

The report begins with an introduction of medical devices in India and their classification based on relative parameters set by the Indian Government. The market overview section provides the market size and growth. It also provides an overview of the segments that are existent in the market along with their market share. The import and the export structure of the medical devices in India are also given.

This is followed by an analysis of the drivers fueling growth in the market including increasing hospital infrastructure, increasing healthcare spending, changing demographics and growing target consumer group, increasing lifestyle diseases and therapies and increasing medical tourism in India. The key challenges identified include high dependency on exports and lack of standard regulatory structure. The key trends in the market have also been identified including outsourcing/relocating of manufacturing facilities, increasing joint ventures and tie-ups and various exhibitions and trade fairs.

The involvement of government in this industry is also included. It shows the role of various government bodies that are involved in regulating this sector and also involved in the promotion of this sector in India. It also highlights the regulations set in terms of assessment of a medical device manufacturing organization in India along with the procedure involved in registration of an organization and procurement of an import license. The initiatives taken by the government in order to promote the sector by providing tax reliefs and import duty relaxations have also been highlighted.

The competitive landscape provides a look into the nature of the market, and the active players in the market. A product portfolio matrix is also given to highlight the dominant player in each segments of the market. Profiles of the major domestic and foreign players have been included. Furthermore, key developments in the market over the last one year have also been highlighted.

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Market Research Report: Medical Devices Market in India 2010

  1. 1. Medical Devices Market – India August 2010
  2. 2. Executive Summary Medical devices market in India is pegged at INR XX bn in 20-- and is expected to grow to INR YY Market bn at the end of 20-- with diagnostic equipments being the leading segment Growing hospital infrastructure and healthcare spending is fostering the need for high-end devices for accurate and fast treatment LE Drivers: Challenges: Increasing hospital infrastructure Various summits and seminars P Drivers & Increasing healthcare spending Initiatives for consumer awareness Changing demographics and Growing Target Public private partnerships Challenges M consumer group A Increasing lifestyle diseases and therapies S Increasing Medical tourism in India Outsourcing/Relocating of manufacturing facilities Trends Increasing joint ventures and tie-ups Various exhibitions and trade fairs Govt. bodies and associations like A1, A2 and A3 are aiming to provide medical devices in India a Govt. Bodies, regulatory structure in order to promote indigenous production Regulations & A2 has laid down registration and license regulations to regularize imports of drugs Initiatives Govt. has provided tax reliefs, import duty relaxations and has implemented major initiatives to boost the sector in India The industry has a huge influx of foreign players who have consolidated their operations in India either through establishing subsidiaries or tying up with Indian distributors Competition Players in India are also increasing their manufacturing capacities and are looking at diversifying their product quality and portfolio MEDICAL DEVICES MARKET IN INDIA 2010.PPT 2
  3. 3. •Introduction •Market Overview •Drivers & Challenges •Trends •Government Involvement Government Bodies Government Regulations Government Initiatives •Competition •Key Developments MEDICAL DEVICES MARKET IN INDIA 2010.PPT 3
  4. 4. Medical Devices are classified as per the risk level and their intended use PLE •Medical devices under the meaning of Section 3 (b) (iv) of the L refers to: M Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article which is: A – intended by the manufacturer to be used alone or in combination for human beings for one or more specific purposes of diagnosis, S prevention, monitoring, treatment or alleviation of disease and, – which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means Medical Devices in India are classified as per their risk levels and intended use . They are divided into classes and the classification is carried out in accordance with Annex IX of Schedule M-III provided by A1 Class A Class B Class C Class D Low Risk Low-moderate Risk Moderate-high Risk High Risk • Contains devices like P1, • Contains devices like • Contains devices like • Contains devices like P2, P3 and P4 PB1, PB2, PB3 and PB4 PC1, PC2, PC3 and PC4 PD1, PD2, PD3 and PD4 • Cannot commence • Can commence clinical • Can commence clinical • Can commence clinical clinical investigations investigations investigations investigations immediately after the immediately after the immediately after the immediately after the date of information and date of information and date of information and date of information and submission to A2 submission to A2 submission to A3 submission to A4 If a manufacturer desires to reclassify a device to a lower class, it must submit justification to A2 for evaluation that the movement to the lesser stringent class will assure sufficient safety & effectiveness of the device MEDICAL DEVICES MARKET IN INDIA 2010.PPT 4
  5. 5. India's medical device market is currently the T largest market in Asia and ranks among the world’s top P Market Overview Market Size and Growth • Good healthcare infrastructure, population rise and INR bn growing economy are fueling growth in the medical equipment market 100 a% YY • There are some 700 medical devices makers in India 80 LE Most of them make low-value products such as needles, XX 60 syringes, catheters, blood collection tubes, medical 40 P electronics and implants High-end specialist products are catered by foreign firms 20 AM • India requires major foreign participation, especially in high-tech devices that account for roughly 45-55% S of the entire market Currently, most of the reputed Indian healthcare institutes use foreign medical equipments for the purpose of 0 2009 Segmentation of Market 2010e surgery, diagnosis of cancer and imaging s5% Segment 1 • Currently, according to the new guidance, all s4% Segment 2 medical devices sold in India must carry the ICAC s1% Segment 3 mark (Indian Conformity Assessment Certificate) to Segment 4 indicate their conformity with the provisions of this Segment 5 schedule to enable them to move freely within the s3% country s2% Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT 5
  6. 6. Drivers & Challenges – Summary Drivers Increasing hospital infrastructure Challenges Increasing healthcare spending High dependency on exports Changing demographics and Growing Target consumer group Lack of standard regulatory structure Increasing lifestyle diseases and therapies Increasing Medical tourism in India MEDICAL DEVICES MARKET IN INDIA 2010.PPT 6
  7. 7. Trends – Summary Outsourcing/Relocating of manufacturing facilities Key Trends Various exhibitions and Increasing joint ventures trade fairs and tie-ups MEDICAL DEVICES MARKET IN INDIA 2010.PPT 7
  8. 8. •Introduction •Market Overview •Drivers & Challenges •Trends •Government Involvement Government Bodies Government Regulations Government Initiatives •Competition •Key Developments MEDICAL DEVICES MARKET IN INDIA 2010.PPT 8
  9. 9. The efforts of A2 have provided areas of improvement in medical devices sector of India A2 A3 Serves as the main regulatory body for • It is the authority regulating medical devices in India medical devices that will classify medical devices, and any manufacturer seeking a LE under A1 less stringent classification must justify it to • It lays down rules, standards and approves import and the A2 P manufacturing of T1, T2, T3 and T4 • Establishes standards and regulations for R1, R2, R3, R4, R5, R6 M and R7 Act and Regulatory status of A2 A • Companies must register all their products with the A2 S before its products can be introduced into the Indian market • It issued a Gazette Notification S.O. 14-- (20--) that declared L categories of sterile devices to be considered A4 Regulates the import, manufacture, sale, as drugs under Section 3 (b) (iv) of the Q Act distribution of X medical devices classified • In late 20--, A3 (DCGI) prepared an expanded list of as drugs and also provides licenses which are compulsory for the importers and medical devices which require registration manufacturers to deal in the said devices • The list now includes over X medical devices • Currently working on a road map to include current A2 has also adopted and recognized BIS YY or its status review as well as guiding principles of medical revisions & ISO KK in respect of the specifications devices and a regulatory process implementation phases to be followed for quality in order for the to make it an all inclusive process manufacturer to demonstrate conformity with the relevant regulatory requirements Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT 9
  10. 10. Segmentation of Players (1/2) Electronic Diagnostic Surgical Imaging Players treatment Others Equipment Equipment Devices Devices Domestic Players Player 1 Player 2 Player 3 Player 4 Player 5 Player 6 Player 7 Player 8 Player 9 Player 10 Player 11 Player 12 Player 13 Player 14 Player 15 Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT 10
  11. 11. Major Domestic Players (1/12) Company Snapshot: Company 1 Corporate Information Financial Performance Revenue Headquarters XX Revenue Profit INR mn Profit / Loss INR mn Founded 19-- 600 R1 R4 40 R2 R3 30 400 Products Product 1, Product 2 and Product 3 20 200 10 Key People NA 0 0 2005-06 2006-07 2007-08 2008-09 Business Highlights • It provides products and services in information technology and healthcare sectors in India PLE • Its healthcare division provides medical equipments to critical care, trauma, and operation theatre areas in the hospitals; develops specialty critical care/trauma care ambulances; manufactures and supplies of mobile medical units for diagnostics; and undertakes turnkey projects for providing customized solutions for construction of modular • Operates as a subsidiary of Company K S M operation theatres, surgical pendants, and intensive care units A • Its customer base includes major corporates, defense establishments, software technology parks, MNC's and Super- specialty hospitals Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT 11
  12. 12. Thank you for the attention The Medical Devices Market report is part of Research on India’s Healthcare Industry Series. For more detailed information or customized research requirements please contact: Gagan Uppal Gaurav Kumar Phone: +91 96191 00122 Phone: +91 98303 09715 E-Mail: E-Mail: Research on India is a product of Netscribes (India) Pvt. Ltd. Research on India is dedicated to disseminating information and providing quick insights on “hot” industries in India and other emerging markets. Track our new releases and major updates in these industries on About Netscribes Netscribes is a knowledge-consulting and solutions firm with clientele across the globe. The company’s expertise spans areas of investment & business research, business & corporate intelligence, content-management services, and knowledge-software services. At its core lies a true value proposition that draws upon a vast knowledge base. Netscribes is a one-stop shop designed to fulfil clients’ profitability and growth objectives. Disclaimer: This report is published for general information only. Although high standards have been used the preparation, Research on India, Netscribes (India) Pvt. Ltd. or “Netscribes” is not responsible for any loss or damage arising from use of this document. This document is the sole property of Netscribes (India) Pvt. Ltd. and prior permission is required for guidelines on reproduction. MEDICAL DEVICES MARKET IN INDIA 2010.PPT 12