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Medical device Industry 2015
The document provides a comprehensive overview of the medical device sector in India, including its growth, market dynamics, regulatory environment, and comparison with the global market. It highlights that India's medical device market is expected to grow at a faster rate than the overall healthcare sector, driven by various factors such as technological advancements and increasing healthcare needs. The summary also outlines device classifications and discusses strengths, weaknesses, opportunities, and threats (SWOT) in the context of the Indian medical device industry.
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Medical device Industry 2015
- 1. MEDICAL DEVICES Presented By: Rushikesh. S. Markad Management Scholar: 15PMM542 Department Of Pharmaceutical Management, NIPER, Mohali.
- 2. FLOW OF PRESENTATION Healthcare Sector In India Medical Device Difference between Drug & Device Device Classification Medical Devices – Global Scenario US medical Device Market Indian Medical Device Market Regulations Current Scenario In India SWOT Analysis Conclusion
- 3. Earlier Scenario ofHealthcare Sector in India
- 4. Healthcare Sector- PresentScenario Source: Industry Report, Healthcare: India, The Economist Intelligence Unit, July 2014 $ 96.3 US billion 1 Bed/1050 Per capita $ 61 US 71% share in healthcare expenditure 0.7 Doctor/1000 33% share of govt. in healthcare 4%
- 5. Growth Pattern inHealthcare sector- India 0 20 40 60 80 100 120 140 160 2012 2013 2014 2015 2016 2017 US$Billion FY 98 113 129 Source: RNCOS •Healthcare Sector in India is growing at a CAGR of 10-11%
- 6. Revenue Split Hospitals Meical Equipmentand Supplies Medical Insurance Diagnostics Pharmaceuticals 71% 9% 4% 3% 13% Source: India Brand Equity Foundation, November 2011
- 7.
- 8. Definition As perSchedule M-III Medical tool which does not achieve its primary intended action in or on the human body by Pharmacological, Immunological or Metabolic means An instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions and does not achieve its purposes through chemical action within or on the body Medicinal products covered under D&C act will not fall under schedule M-III In case there is uncertainty about whether the product falls under drug or medical device category regulators will consider mode of action
- 9. Sector split OrthopedicImplants & Prosthetics Cardiovascular Neurovascular Dental Life Science Tools & Services Patient Monitoring Equipment & Therapies Disposable Equipment & Supplies General Equipment & Supplies In Vitro Diagnostics, Supplies & Equipment Ophthalmic Goods, Optical Instruments & Lenses
- 10. Segmentation By Application-India Source: Global marketing Emergo group Inc.
- 11. Segmentation By Revenue-India Other medical & Therapeutic Devices Spinal Devices Cardiovascular Devices Neuromodulation Devices Diabetes Devices Urology Devices Surgical Technology 22% 18% 10% 5% 3% 3% 6%
- 12. DIFFERENCE Based onChemistry & Pharmacology Safety & Efficacy Clinical Trials Local and Systemic Toxicity Long Product Life Cycle Drug Interaction Large Population Less user interaction Based on Engineering Safety & Performance Clinical Evaluation Biocompatibility Short Product Life Cycle Device Malfunction Limited Population Significant user interaction DRUG DEVICE
- 13. Device classification CLASS RISKLEVEL EXAMPLE A Low Risk Surgical retractors / tongue depressors B Low-moderate Risk Hypodermic Needles / suction equipment C Moderate-high Risk Lung ventilator / bone fixation plate D High Risk Heart valves / implantable defibrillator •As per Risk levels and Intended use •Classified in accordance with Annexure-IX of Schedule M-III provided by Drug Technical Advisory Board (DTAB)
- 14. Global Scenario ofMedical Device Market 0 100 200 300 400 500 2011 2012 2013 2018 UDbillion FY Market Size • Indian Medical Device Market is growing at almost twice rate than Global market
- 15. GLOBAL MEDICAL DEVICEMARKET USA Western Europe Middle/East Africa Eastern Europe Asia/ Pacific Asia/Pacific 24% Western Europe 24% Source: EPSICOM USA 45% Eastern Europe 4% Middle/East Africa 3%
- 16. • US • JAPAN •GERMANY • ITALY • FRANCE 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% USA(US $120) Japan( US $ 31.5) BRIC( US $ 26.28) Germany( US $ 23.38) MarketShare market Share Major Players
- 17. Process Flow ofRise of Emerging Markets MNC’s define the market and enter with high quality, usually imported devices not available locally Local companies identify the opportunity and reverse engineer/adapt to local requirements and get prepared to compete with MNC’s Survival of the Fittest Step I Step II Step III
- 18. TOP 10 MEDICALDEVICE MANUFACTURERS Name of Company Revenue(In $US BN) Market Cap($US BN) Johnson & Johnson 28.7 294.2 General Electric Co. 18.1 243.6 Medtronic Inc. 17.1 61.2 Siemens AG 17 92.2 Baxter International Inc. 16.4 38.7 Fresenius Medical Care AG & Co. KGAA 15.2 21.1 Koninklike Phillips 11.8 26.1 Cardinal Health Inc. 11.0 25.1 Novartis AG 10.7 227.5 Covidien plc 10.4 40.1
- 19. Mergers & acquisitions 20112012 Number of deals 443 330 Total deals (with values disclosed) Number of deals 191 141 Transaction value (£m) 28,293 28,820 Average deal size (£m) 148 204 Deals less than £500m (with values disclosed) Number of deals 181 133 Transaction value (£m) 10,370 7,393 Average deal size (£m) 57 56
- 20. Mergers & acquisitions ACQUIRERTARGET DEAL VALUE (£ mn) Johnson & Johnson Synthes Gmbh 12745 Hologic Inc. Gen- probe Inc. 2388 Agilent Technologies Dako 1390 Boston Scientific Corporation Cameron Health 869 Asclepius Zoll Medical Corporation 1367 EQT Parteners AB BSN Medical Gmbh 1452 Fujifilm Holdings Corp. Sonosite 624 Thermo Fisher Scientific One Lambda 592 Linde Inc Air Products & Chemicals 487
- 21. US MARKET • Valuedat more than US$ 60 Billion • Accounts for 20% of global industry by production • World’s largest Medical device market and accounts for 45% of global market by sales • In 2013 US have spend 18% of its GDP on healthcare which is more than any other country • Domestic consumption- 40% • >6000 medical device manufacturers • Current Issue: 2.3% medical device tax under affordable care act in 2010
- 22. Sector Breakdown ofDeals General Equipments & supplies Patient monitoring equipment & therapies Life Sciences tools & Services Disposable Equipment and Supplies Orthopaedic Implants & prostheticsIn vitro diagnostics, supplies& Equipment 14% 18% 17% 12% 13% 6% 4% 6% 7% 3%
- 23.
- 24. Medical Device MarketBy Segmentation Column1 Medical and Diagnostic Equipments Medical Implants Medical Disposables and Supplies 56% 25% 19% Source: RNCOS
- 25. Factors Affecting MedicalDevice Industry Medical Device Industry Local Market Sentiment s Economic based factors Unmet clinical needs due to technology mismatch Regulatory Environme nt Healthcare Providers Reimburse ment Policies
- 26. FACTS Market size-$ 7.9 US billion Contributes only 6% of India’s US $ 40 billion healthcare sector It is growing at a faster annual rate of 15% than 10-12 % growth seen in the Healthcare sector in its entirety >14,000 different products types, as per the Global Medical Device Nomenclature (GMDN) Ranks 4th in Asia and 20th in the world 70% of the medical devices are met by imports
- 28. Growth of MedicalDevice Industry 0 2 4 6 8 10 12 2012 2013 2014 2015 2016 2017 US$Billion FY 5.1 5.9 6.8 7.9 9.2 10.7 Source: RNCOS • Growth of Medical Sector alone is higher than the entire Healthcare sector in India
- 29. Top Players • 3M • India Medtronic • Johnson & Johnson • Becton Dickinson • Abbott Vascular • Bausch & Lomb • Baxter • Zimmer India • Edwards Life Sciences • St. Jude Medical
- 30. Regulation In MedicalDevices
- 31. Regulation In MedicalDevices • India had no regulations for medical devices in place prior to 2005. • The import, manufacturing, distribution and sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945). • Controls and inspections are carried out by the CDSCO, state drug controllers and central/state laboratories. • CLAA- Branch of CDSCO ( Major regulatory body) • All medical devices will undergo conformity assessment procedures to ensure compliance with quality and safety standards before they are allowed to Indian markets
- 32. Regulation In MedicalDevices • CLAA will adopt to regulatory Standards of Bureau Of Indian Standards (BIS) and International Organization of Standards (ISO) specification for quality management • For Class A devices- Manufacturers may perform their own conformity assessment procedures • For B, C, D – CLAA in consultation with BIS publish list of notified bodies authorized to perform conformity assessment • Imported Medical devices that are already approved in US/or and EU Union or that have been deemed equivalent to CE mark and FDA approved device will be allowed on Indian market without undergoing separate conformity assessment procedure
- 33. Regulation In MedicalDevices- US Classification according to 21 CFR 860 which is a part of Medical Device Amendments of 1976 and safe medical device act of 1990 Class I: General Control Eg: Elastic Bandages, Examination gloves Class II: General control with Special control Eg: Infusion pumps, surgical drapes Class III: General controls and premarket approvals Eg: Implantable pacemakers, pulse generator, HIV diagnostic tests, Heart valves
- 34. List of NotifiedMedical Devices Disposable Hypodermic Syringes Disposable Hypodermic Needles Disposable Perfusion Sets In vitro Diagnostic Devices for HIV, HbsAg and HCV Cardiac Stents Drug Eluting Stents Catheters Intra Ocular Lenses I.V. Cannulae Bone Cements Heart Valves Scalp Vein Set Orthopedic Implants Internal Prosthetic Replacements
- 35. Growth Drivers &Restraints Drivers: • Expanding Healthcare Sector • Changing Demographic profile • Booming economy • Ageing population • Increase in outsourcing • Increased prevalence of Lifestyle Diseases • Telemedicine Restraints: • Reliance on Import • Lack of access to technology • Regulatory system • High capital requirement • Lack of Government interest • Less expenditure by Government in healthcare sector as compared with other nations
- 36. Current Scenario • MedicalDevice and NPPA • Amendment of D & C Act • Regulated Medical Devices sector • Role of Government Regulatory Control Make In India Foreign Direct Investment Education of Medical Devices Medical Device Parks National Centre of Medical Devices
- 37. SWOT Analysis • FDI •Increased JV • Regulations • Monopoly of MNC’s • Low per capita expenditure • Unaware rural market • Huge Market • Growing Private hospital Sector Strength Weakness OpportunityThreats
- 38. Conclusion • Medical Technologycompanies are accelerating their Investments in emerging markets and India is a prime target because of its growing population, growing middle class and improving healthcare infrastructure • Till date most Medtech multinationals have pursued a conservative business strategy and operating model in India focused on delivering their existing offering to the premium segment of the market • But now the playing field is becoming more competitive and companies in search of growth need to move beyond the traditional model
Editor's Notes
- #21 Medical Equipment and Supplies Report 2013, A Clearwater Healthcare Team Report