Indian Medical Device Market - May'13

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Indian Medical Device Market - May'13

  1. 1. WHITE PAPER MEDICAL DEVICE MARKET: INDIA
  2. 2. Figure 1: Indian Healthcare Market (Billion US$), 2012-2017 Source: RNCOS 75 86 98 113 129 2012 2013 2014 2015 2016 CAGR - 14.9% Infrastructure Indicators • 12,760 hospitals; 5,76,793 beds • Shortage of around 2 Million hospital beds • 50,000 diagnostic labs • Under AYUSH there are 24,465 dispensaries and 3,408 hospitals • 148,124 sub-centers, 23,887 PHCs and 4,809 CHCs • 2,445 licensed blood banks India Healthcare Sector: A Snapshot Table 1: Burden of Major Diseases Disease Incidence (‘000) Diarrheal Diseases 88, Mental Disorders 80, Cardiovascular Diseases 64, COPD and Asthma 59, Diabetes 46, HIV/AIDS 19, Blindness 13, Cancer 1,0 Source: Report of the National Commission on Macroeconomics and Health, National Health Profile 2010 - Central Bureau of Health Intelligence : Indian Healthcare Market (Billion US$), Figure 2: Share of Players by Source of Investment (%), 2012 Source: RNCOS s 129 150 2016 2017 20% Private Government Drivers • Increase in average life expectancy • Rise in average income levels • Rising awareness for health insurance • Growing lifestyle related health issues • Cheaper costs for treatment • Thrust in medical tourism • Government initiatives and focus on Public Private Partnership (PPP) models Infrastructure Indicators Shortage of around 2 Million hospital beds Under AYUSH there are 24,465 dispensaries centers, 23,887 PHCs and India Healthcare Sector: A Snapshot : Burden of Major Diseases (2015) Incidence (‘000) ,000 ,000 ,000 ,600 ,000 ,000 ,000 000 the National Commission on Macroeconomics and Health, National Health Profile Central Bureau of Health Intelligence Table 2: Leading Players in the Indian Healthcare Market Company Apollo Hospitals Manipal Group of Hospitals Fortis Healthcare Ltd Aarvind Eye Hospitals CARE Hospitals Max Hospitals Source: RNCOS : Share of Players by Source of Investment 80% Government Increase in average life expectancy Rise in average income levels Rising awareness for health insurance Growing lifestyle related health issues Cheaper costs for treatment Thrust in medical tourism Government initiatives and focus on Public Private Partnership (PPP) models : Leading Players in the Indian Healthcare Market No. of beds 8,500 7,000 5,050 3,650 1,400 800
  3. 3. Meanwhile, the low to medium-end Medical Disposables and Supplies (Medical Gloves, Bandages, Syringes, Condoms, Contact Lenses, Disinfectants etc.) is largely catered by several domestic players. India is the 4th largest medical device market Asia, accounting for around 7% of its healthcare market, trailing only Japan, China and South Korea. With over 700 medical device makers, it ranks among the world’s top 20. Figure 3: Indian Medical Device Market (Billion US$), 2012-2017 Source: RNCOS 5.1 5.9 6.8 7.9 9.2 2012 2013 2014 2015 2016 Medical Device Market in India CAGR - 15.8% When it comes to areas requiring higher technological sophistication in both the Medical and Diagnostic Equipments (Ultrasound, MRI, PET, CT scanners Dialysis Machines, ECG, EEG; blood, urine and gene analyzers etc.) and Medical Implants (Stents, Artificial joints, Heart defibrillators Prosthetics etc.) markets, there are a limited number of domestic players, and the sector is dominated by multinationals. end Medical Medical Gloves, , Contact Lenses, is largely catered by several Figure 5: Medical Device Market by Segments 2017 Source: RNCOS 25% 19% Medical and Diagnostic Equipments Medical Implants Medical Disposables and Supplies medical device market in accounting for around 7% of its trailing only Japan, China 700 medical device among the world’s top 20. : Indian Medical Device Market (Billion 9.2 10.7 2016 2017 in India When it comes to areas requiring higher technological sophistication in both the Medical and Diagnostic Equipments CT scanners, X-ray, ; blood, urine and and Medical Implants eart defibrillators, markets, there are a limited and the sector is Our study reveals that by 2017, Medical and Diagnostic Equipments market is expected to bolster at a significant growth rate of over 17% and become a US$ 6 Billion market by 2017. : Medical Device Market by Segments (%), 56% Medical and Diagnostic Equipments Medical Disposables and Supplies Our study reveals that by 2017, Medical and market is expected to bolster at a significant growth rate of over 17% and become a US$ 6 Billion market by
  4. 4. Currently almost 72% of the medical devices sold in India are imported. This high percentage can be attributed to the taxation system in the country that is highly skewed to favor imports. Import duty on medical devices averages about 10% which is usually passed on to the customers. Figure 6: Medical Device Market: Import v/s Domestic Production (%), 2012 Source: RNCOS As the product is imported on a SICOI (sale in course of import) basis, value added tax (VAT) is not applicable. However, if parts and equipment were imported for the manufacture of medical devices domestically, a similar import duty would apply, plus excise and This means taxation on domestically products is much higher than the 10% duty paid on finished, imported medical goods Table 3: Leading Players in the Indian Medical Device Market S. No. Company 1 3 M 2 Abbott Vascular 3 Baxter 4 Becton Dickinson 5 Boston Scientific 6 GE Healthcare 7 India Medtronic 8 Johnson & Johnson 9 Philips Medical 10 St. Jude Medical 72% 28% Import Domestic Currently almost 72% of the medical devices sold in India are imported. This high percentage system in the country that is highly skewed to favor imports. Import duty on medical devices averages about 10% which is usually passed on to the : Medical Device Market: Import v/s , 2012 product is imported on a SICOI (sale in course of import) basis, value added tax (VAT) is not applicable. However, if parts and equipment were imported for the manufacture of medical devices domestically, a similar import duty would apply, plus excise and VAT. This means taxation on domestically-produced products is much higher than the 10% duty paid on finished, imported medical goods. : Leading Players in the Indian Medical Company 72% -Economic Growth Leading to Higher Disposable Incomes -Increased Private Investment in Primary Healthcare -Rise in Medical Tourism -Increased Penetration of Health Insurance -Growth in Telemedicine -Low Penetration -High Dependence on Imports -Lack of Funding in R&D -Nascent Regulatory Environment R E S T R A I N S D R I V E R S Economic Growth Leading to Higher Increased Private Investment in Primary Rise in Medical Tourism Increased Penetration of Health Insurance Growth in Telemedicine Low Penetration High Dependence on Imports Lack of Funding in R&D Nascent Regulatory Environment
  5. 5. Regulatory Environment: What You Must Know to Enter India? *Verification of compliance with a Global Harmonization Task Force member regulator’s requirements is expected by CDSCO. Foreign manufacturers should enclose applicant and product information, product regulatory status, device master file information, and post market surveillance data. Additional information is required for drug-eluting combination products. Acceptable documents include device master files, certificates of quality system compliance, ISO 14971 risk assessments and clinical research data. R E S T R A I N Is your device an IVD, or does it fall on the list of “Notified Medical Devices” that requires registration in India? Blood Component Bags, Blood Grouping Sera, Bone Cements, Cardiac Stents, Catheters, Condoms, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, I.V. Cannulae, Internal Prosthetic Replacements, Intra Ocular Lenses, Intra Uterine Devices, IVD Devices for HIV, HBsAG and HCV, Orthopedic Implants, Scalp Vein Sets, Skin Ligatures, Surgical Dressings, Sutures and Staplers, Tubal Rings, Umbilical Tapes No Yes, it’s an IVD, but NOT listed above Yes, it’s a medical device or IVD listed above Appoint an India Authorized Agent to interact with the CDSCO on your behalf. Agent must have valid wholesale license (Forms 20B and 21B) File application* for Device Registration Certificate to CDSCO using Form 40, including Schedules D-1 and D-2 as part of the application Obtain Registration Certificate Form 41 from CDSCO. Certificate is valid for 3 years Identify your distributor (holding Forms 20B and 21B) Apply for Import License using Forms 8 and 9 available from CDSCO Obtain Import License (Form 10) from CDSCO. License is valid for 3 years Import and market your product in India
  6. 6. Looking for an in-depth study Our Proposition RNCOS is a leading Business Consultancy firm helping its clients to enter new geographies and in attaining growth by developing market strategies for them. Critical questions that businesses need to address: • Where should you set up your business? • Who should be your distributors? • What is the current market structure & size? • Who should be your customers? We understand your immediate needs and your long-term goals and objective and work with you on how to accomplish them. RNCOS blends the best of strategy consulting with the best of market research to provide organizations with accurate, succinct answers to their most important business questions. Our offerings Market Insights • What is the market size • Structure of the market • Who are buyers • Buyers’ buying behavior • Expectations from the product Identification • Most suitable distributors and channels for your business. • Analyzing their strength, credibility, scale of operations. • Assisting in distributor selection Product Segments • Similar products in the market • Features, attributes & market share of these products • Customer preferences • Price range of these products Competitive Assessment • Financial & strategic analysis of existing competition • Acceptance level among customers • Emerging competitors • New market entrants GROWTH PARTNER We help you make informed decisions through the practical application of research, hand holding you to your success…
  7. 7. For more information on how we can work with you Contact VARTIKA SEHGAL Sr. Research Specialist RNCOS E mail: vartika.sehgal@rncos.com Website: www.rncos.com Phone: +91 120 4224700 /01 / 02/ 03 Address: B 129, Sector 6, Noida, Uttar Pradesh India - 201301

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