Medical Devices Report

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From the Editor’s Desk
Shailja Dutt
Chairperson
Having worked for the healthcare industry over the last 20 years, I have had a fantastic ringside view to the evolution of the industry in India, beginning with the advent of the large device majors, growth in the diagnostics space, the coming of age of generic pharma and a veritable boom of healthcare services and hospitals in India.
I distinctively recall in the late 90s, when I was hiring leadership for the medical devices sector, not
04 06 08 10 12 13
Overview
Indian Healthcare and Medical Device Market
Medical Devices Industry Structure
Growth Drivers and Potential
Medical Devices Sector Outlook
Regulatory Environment
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many candidates had heard of companies like BD, Baxter or Zimmer. Today, these companies are coveted destinations on a candidate’s career trajectory. Sample collection at home, doctor on call, viewing doctor reviews online were a distant dream in the late 90s and today they are “de-rigueur”.
Having seen the industry evolve over the last two decades, I do believe it’s now mature, at a
tipping point, waiting to catch its second wind and push to its next phase of exponential growth. Most multinationals have endeavoured, without much success, to create sizeable businesses in the devices and disposables space, whilst Indian manufacturers have battled the challenge of quality and R&D led issues. However, the forecast for India continues to be extremely optimistic for the sector.
IdobelievethatAyushmanBharat
will provide the much-needed impetus to healthcare services growth across India, further expanding the market for low cost, technology-ef cient products, in turn fuelling double digit growth for the devices majors.
This is a “carpe-diem” moment for both MNCs and Indian device makers to re-strategize their India businesses to capitalize on what lies ahead.
141617 24 2627
Current Status of Key Focus Areas
Sector Challenges
Become a Billion Dollar Company
Respond to
Market
Challenges 18
Leverage
Intrinsic Strategic Measures 20
Expected
Changes -
Drawing Parallel from National Pharmaceutical Policy 2006 22
About Stellar
Healthcare Practice
Annexure I About Stellar
24
References
3


11
10Drawing parallel from the outcome of the
National Pharmaceutical Policy 2006, it is expected that the medical devices sector would witness increased M&A activity, shift towards rural population as a new growth driver, greater R&D focus and newer business models
12Other strategic initiatives include gain in product
intelligence and spreading medical education; investment in R&D, focus on exports to markets beyond US and Europe, opening offices in medical parks, etc.
Key strategic initiatives
suggested to become a billion dollar company – diversification of product portfolio; establishment of partnerships to expand rural reach and knowledge transfer.
over
9Manufacturers can 8 mitigate many
challenges via
collaboration with the government
Broadly, accessibility, affordability,
low insurance coverage, cultural aspects,
low indigenous manufacturing are some of the key challenges
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1The Indian medical device sector is valued at
USD 6 billion
2
v i e w
The market is highly
fragmented with around
750 manufacturers
and not dominated by large MNCs
3It is highly dependent on imports, but also exports 38%
of locally manufactured medical devices
4Key manufacturing clusters are located in Delhi/Haryana, Gujarat, Karnataka and
Tamil Nadu
5Rising income levels,
an ageing population, increasing insurance coverage, under penetrated healthcare sector are key demand drivers
7100% FDI,
new medical parks, modified inverted
duty structure, healthcare insurance
of up to INR 5 lakhs, preferential market draft policy are some of the favorable measures
6During the last
four years, the Indian government has
taken many positive initiatives including ‘Make in India’ that would have a favorable impact on the medical devices market
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INDIAN HEALTHCARE AND MEDICAL DEVICES MARKET
INDIAN HEALTHCARE SECTOR, 2016
6%
3%
KEY INSIGHTS
In 2016, the Indian healthcare industry was valued at USD 100 billion and is expected to grow at a CAGR of 20% to reach USD 175 billion by 2020
The Indian medical devices market was valued at USD 6 billion in 2016
It is amongst the top 20 markets globally and 4th largest in Asia, after Japan, China and South Korea
The industry is highly fragmented with about 750 medical devices manufacturers. Around 38% of locally manufactured medical devices are exported.
The Indian government has allowed 100% FDI via automatic route in hospital and medical devices sector
100% = USD 100 BILLION
77%
14%
Diagnostics Medical Devices
Pharmaceuticals Hospitals
INDIAN MEDICAL DEVICES SECTOR, 2016
9% 8%
100% = USD 6 BILLION
54%
Consumables and disposables
Equipment and instruments
13% 16%
Stents Implants Patient Aids
Source: World Bank, WHO
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The Indian Healthcare sector valued at USD100 billion has grown with a CAGR of 20% over the past few years. The medical devices industry accounts for 6% and is the 4th largest market in Asia.
SEGMENT
Equipment and Instruments
Consumables and Implants
Patient Aids and Others
IMPORT DEPENDENCE
KEY TRENDS/CHARACTERISTICS
Rising health issues and complex surgeries are driving demand for therapeutic, ophthalmic, and sterilizing equipments
Diagnostics equipment's demand majorly driven by hospitals, research institutions and imaging clinics
Focus is on low cost products
Local consumption along with significant exports demand continue to drive this segment
Rising levels of Osteoporosis, Osteoarthritis and Obesity
Major importing countries: Ireland, US, Australia, Singapore, China and South Korea
73%
27%
50%
50%
75%
25%
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DELHI/HARYANA
Manufacturing focus areas: Low-end consumables and dental equipment
Key companies: Polymed, Hindustan Syringes, Narang Medical, Healthium, etc.
MEDICAL DEVICES INDUSTRY STRUCTURE
5%
USD > 24 Million 30% USD 2.4 to 24 Million
65% USD 2.4 Million
Source: Association of Indian Medical Device Industry- AIMED
upcoming medical device parks
8
Highly Fragmented Industry
Manufacturing Clusters


Presently, there are around 750 local and foreign manufacturers with 95% of the firms generating sales less than USD 24 million annually
NO. OF FIRMS TYPE OF FIRMS TARGET MARKET
30-40 firms
Major domestic and MNC players
Major presence in domestic and exports markets
200-220 firms
Mix of domestic/MNC players Large presence in domestic and (Low-med tech product categories) moderate in exports markets
450-490 firms Mostly domestic players
Major presence in domestic (catering to consumables segment) and low in exports markets
GUJARAT
Manufacturing focus area: Stent manufacturing
Key companies: Boston Scientific, Envision Scientific, Invent Biomed, Shajanand Medical, etc.
KARNATAKA
Manufacturing focus areas: Insulin pens, medical IT, cardiac stents and implants, PCR machines
Key companies: Medived, Biocon, Skanray, Bigtec Labs, etc.
TAMIL NADU
Manufacturing focus areas: Diagnostics, critical life support systems and ophthalmology
Key companies: Trivitron, OCI, Perfint, etc.
Low-end consumables are largely manufactured in Northern India due to low-cost labor and policy incentives, whereas high-end medical devices manufacturing is concentrated in southern zone
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Under-penetrated market
Indian healthcare market remains under-penetrated and lags behind both developed and other developing economies on key healthcare parameters
Out of pocket expenses have been increasing in India, i.e., more people are using private healthcare services either due to rising income levels or inadequate public healthcare expenditure.
GROWTH DRIVERS AND POTENTIAL
Demand Factors
Rising income levels, an ageing population, increasing insurance coverage, under-penertrated hospital sector
According to the World Bank, India’s per capita income would rise from USD1,862 in 2016 to USD3,500 by 2020
India’s population above the age of 60 is expected to increase to 200 million by 2025, from 104 million in 2011
Government Initiatives
Medical devices was amongst the priority sectors in the Make in India Campaign
100% FDI allowed in 2015
Indian Medical Device Regulations, effective January 2018
Newer Markets
India has been developing low cost products (at par with global quality), which can result in creating a niche market in many regions globally
As per an Indian government survey, around 85.2% respondents cited to comply with CE certification
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Health Medical devices Government Beds1 Physicians1 Expenditure2 Expenditure2 Expenditure3
Global 27 14 948 948 59% India 7 7 75 75 30%
Out of pocket Expenditure2
50%
62%
32%
26% 14%
11% 13%
China Brazil Japan US
38 23
29
15
420
1318
4519
9892
5267
420
1318
4519
9892
5267
2) USD per capita
56% 46% 84% 48% 77%
19 137 23
82 Source: World Bank, WHO
25 38
1) Per 10,000 population
3) Percent of total healthcare expenditure
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MEDICAL DEVICES SECTOR OUTLOOK
The sector is expected to grow at a CAGR of around 11% to reach USD 8.2 billion in 2020, assuming continued focus of Indian government to improve healthcare infrastructure
Patient aids is expected to be the fastest growing segment. The growth would be largely
Medical Devices Sector, 2017-2020
driven by hearing aids, pacemakers and similar products
Implants and stents would continue to grow albeit price control on them can restrain growth levels
Medical Devices Sector by Segment, 2017-2020
In USD billion
In USD billion
0.53 0.7 0.49 0.68
0.79 1.2 0.96 1.29
2017 2020
CAGR:11%
6
8.2
2017
2020
Stents
Implants
Patient Aids
Consumables and disposables
Equipment and instruments
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REGULATORY ENVIRONMENT
During the last four years, the Indian government has taken initiatives to encourage growth of the medical devices market by streamlining imports, manufacture, grant of license to operate in India
Dec 2014
100% FDI allowed
Introduced “Make in India”
Promote domestic medical devices industry
Reduce healthcare services cost in next 5-10 years
Jan 2015
Drugs & Cosmetics Act(Draft) Bill, 2015 Released
To regulate the import, manufacture and distribution of devices
Apr 2015
Medical Device Regulations, 2015
Draft to formulate regulatory structure for medical devices
Oct 2016
Medical Device Regulations
Amended draft post industry consultation
Jan 2017
Notified Medical Device Regulations
Implemented Medical Device Regulations
Sep 2014
Increase availability of skilled manpower
Implementation of medical device rules
Regulatory and Policy Frameworks
Build medical devices parks and testing facilities
Government’s Focus Areas to Boost Growth
Besides the ‘Make in India’ initiative, which has already allowed 100% FDI under automatic route for greenfield and brownfield projects, the Indian government recommended initiatives can be broadly classified into the following five categories:
Source: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India
Skill Development
Infrastructure
Medical Devices Industry
Research and Development
Promote domestic manufacturing and indigenization
Duty Structure
Changes in inverted duty structure
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Jan 2018


CURRENT STATUS OF KEY FOCUS AREAS
Focus Area
Regulatory and Policy Frameworks
Key Initiatives
Creation of an independent regulatory body for Medical Devices Industry
Formulate “Medical Device Regulatory Act”
Single window regulatory clearances
Separate price control order for medical devices
Set up medical devices parks
Financial Support
Concessional power tariff for up to 5-10 years
Set up medical device testing centers
Current Status
Central Drugs Standards Control Organization is the regulatory body, with a dedicated medical devices division
Implemented Medical Device Regulations 2017, in January 2018
Based on international precedence w.r.t regulation of medical devices
Launched E-governance through SUGAM portal. However, lying defunct
Lack of transparency, inclusiveness and arbitrary price control mechanisms have disappointed industry players
Three industrial parks planned
Andhra Pradesh MedTech Zone (APMZ) company formed to set up park in Tamil Nadu
Other parks planned in Gujarat and Maharashtra
APMZ received funding approval from the state government in 2016
Gujarat medical park awaiting funds from the Central government (as of Oct 2017)
Planned concessional power tariff for the medical park in Gujarat
APMZ lacks clarity on the concession
Testing centers being set up in APMZ and planned for Gujarat medical park
Implementation level
Infrastructure
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Source: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India; Press articles


Key initiatives planned by Indian Government, when fully implemented, are expected to boost medical devices manufacturing capabilities and reduce reliance on imports of finished goods
Focus Area
Key Initiatives
Current Status
Implementation level
Rationalize the adverse / inverted duty structure
Raised import duty on 67 ITC categories of Medical Devices from 5% to 7.5% in 2016
However, allowed exemption of 2.5% to device importers in Budget 2018
Zero import duty on few devices such as stents still exists. This discourages domestic production
Minimum / zero customs duty for import of raw materials used for medical devices and maximum on finished products.
Tax benefits for R&D activities - 200% weighted tax deduction on approved expenditure on R&D
Customs duty reduced from 7.5% to 2.5% in 2016, on raw materials, parts and accessories for manufacturing of select medical devices, but not for all
MST* has established various centers such as Healthcare Technology Innovation Centre at IIT-M; Centre for Bioscience and Bioengineering at IISc., Bangalore; and Centre for Biodesign at Translational Health Science & Technological Institute (THSTI), Faridabad to focus on the development of affordable implants and devices
Set up/ promote Incubation centers
Provide seed capital, viability gap funding and co-fund start-up projects
DIPP^ has supported bio-incubators under the Biotech Equity Fund. It offers INR 10 million to bio-incubators. Around 20 bio-incubators have been supported
Any expenditure in the nature of “cost of any land or building” is not being considered for exemption after April 31, 2017
Deduction reduced to 150% from 2017-18 to 2019-20, and from 2020-21 and onwards 100% weighted deduction is applicable
Duty Structure
Research and Development
Skill Development
Set up a Skill development committee
Working with stakeholders such as Healthcare Sector Skill Council (HSSC) under National Skill Development Council (NSDC) to promote training of engineering workforce for medical devices industry
*Ministry of Science and Technology; ^Department of Industrial Policy and Promotion
Source: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India; Press articles
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HIGH PRIORITY INITIATIVES AREAS
High Capital requirement
Low Indigenous Manufacturing
Nascent Regulatory Environment
Complex Rules and Guidelines
Affordability
Absence of quality certification authority
s
Lo Pe
SECTOR CHALLENGES
Accessibility, Low penetration, low insurance coverage and cure-based healthcare market are key challenges which are beyond the control of manufacturers
LOW PRIORITY INITIATIVES AREAS
Cultural Aspects
Accesibility
Low Insurance w Coveragenetration
Low
High Degree of Control for Manufacturers
Degree of Challenge
Medium Degree of Control for Manufacturers
High
Low Degree of Control for Manufacturers
Note: Please refer to Annexure I for brief description of challenges
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Low Industry’s ability to cope High


BECOME A BILLION DOLLAR
COMPANY
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Challenge
External Support / Government Role
Strategic measures by manufacturer
Many companies such as ITC, Paras Healthcare, Manipal Hospitals, etc. and several state governments have recently opened or are planning to open new hospitals
PPP increasing the reach of health care services to rural
Government recognizes the vital role of private healthcare companies to expand services to rural areas
Free healthcare coverage of up to INR 5 lakh for 100 million families (40% of total population) announced during 2018 Budget
Government to arrange funding through taxation
Likely to be successful due to stronger economy and more importantly, elections in 2019
Healthcare insurance plan announced in 2018 Budget
Pradhan Mantri Suraksha Bima and Jeevan Jyoti Yojana (Government accident and life insurance scheme)
RESPOND TO MARKET CHALLENGES
Low Penetration
Accessibility
Affordability
Target key geographic locations in India that are attracting healthcare service providers
Leverage the knowledge of your distributors to identify hot spots
Target hospitals focused on semi-urban and rural areas. For example, Vaatsalya Hospital
Collaborate with home-healthcare service providers such as Portea Medical which targets Tier II cities
Collaborate with digital healthcare service providers and evaluate E-commerce
Target private hospitals in Tier 1 & 2 cities as public hospitals are plagued by long queues, poor quality of health services and corruption
Invest in R&D and manufacture innovative and cost effective medical devices
Collaborate with medical device innovation centers
Large out of pocket expenses for patients is a challenge and could be addressed by manufacturers in collaboration with Hospitals that are selling medical devices at a high margin
Low Insurance Coverage
* National Accreditation Board for Testing and Calibration Laboratories
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The Indian government has taken initiatives in the right direction and its success would depend upon their effective and timely implementation
It is expected that the government would gradually embrace key suggestions from the industry participants, resulting into more conducive business environment
The existing challenges can be mitigated, provided there is a necessary support through government policies and counter strategic measures undertaken by medical device manufacturers to drive growth
Challenge
External Support / Government Role
Government’s preventive healthcare initiatives - ‘Health for All’ and ‘The National Health Assurance Mission’
Tax waiver on preventive health check-up (up to INR 5000)
Strategic measures by manufacturer
Recently implemented Medical Device Regulation
Medical Devices Preferential Market Access Draft released
Draft Medical Devices Preferential Market Access
Tax waiver for R&D activity
May consider import duty hike on some medical devices
Single window clearance system has been established
Established new quality certification schemes - ICMED 13485 and ICMED 9000
Accredited TÜV SÜD to grant certifications for ICMED 9000 and ICMED 13485
NABL* carried an awareness program on accreditation of Medical Device Calibration in January 2018
Cultural Aspects
Nascent Regulatory Environment
Low Indigenous Manufacturing
Complex Rules and Guidelines
High Capital Requirement
Absence of Quality Certification Authority
Take proactive marketing measures to raise awareness
Or, wait and watch as other healthcare companies are raising awareness about preventive healthcare and then capitalize on it
Push or suggest the government with improvement measures suitable for industry growth, especially benefitting domestic companies
Diversify product portfolio
Identify low cost substitutes of raw materials used in medical devices
Evaluate new vendors from low-cost manufacturing countries such as China
Push government to centralize all processes into a single department
Push government for financial incentives Establish presence in upcoming medical parks such as APMZ
Continue to focus on quality and adhere to new quality standards in India
processes into a single department
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Diversify Product Portfolio
Diversify product portfolio within the low-end medical products segment and gradually move to high-end or advanced medical products
Introduce new products based on the growing segment of diseases. For example, cardiovascular and respiratory diseases
LEVERAGE INTRINSIC STRATEGIC MEASURES
Develop Partnerships
Enter into technology exchange or product intelligence based partnerships worldwide
Partner with doctors in the Indian hospitals to understand changing needs and/or upcoming technologies
Collaborate with medical device innovation centers such as Department of Biotechnology (Ministry of Science and Technology) to understand new innovations
Evaluate options to provide loans to start-ups for innovating and bridging technology gap. Commercialize successful innovations.
20
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Embrace New Technologies
Invest in new technologies such as 3D printing, Cloud and IoT (Internet of Things) based medical devices that would soon disrupt the market
Focus on material sciences - nanotechnology, chemistry, and biomaterials, to develop new types of materials for manufacturing
Automate manufacturing facilities to raise productivity
Establish Presence in Medical Parks
Integrated medical parks with facilities such as centralized testing facilities, regulatory and certification support, export facilitation and financial institutions along with tax benefits will enable in maximizing profits by reducing operational costs
Or, push government to offer same benefits to existing medical device manufacturing clusters
Research and Development
Invest in in-house R&D facility for designing and developing innovative products
Establish product development/design team. Train people to become specialists in this domain
International Markets
The Middle East and South American markets can offer new avenues for growth, besides traditional growth markets of US and Europe
According to a 2018 survey by EMERGO, 57% and 56% of respon- dents indicated average to high growth potential in the Middle East and South America region, respectively
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EXPECTED CHANGES - DRAWING PARALLEL FROM NATIONAL PHARMACEUTICAL POLICY 2006
Merger & Acquisitions, R&D activities, Business model changes and shift in target market will drive the expected change in the medical devices industry like it did in Pharmaceuticals around a decade back
Mergers & Acquisitions:
M&A doubled in 2008 compared to previous year, despite the global recession
Business Models:
Key areas of change post National Pharmaceutical
Policy 2006
R&D activities:
Companies intensified focus and developed in-house R&D programs with minimal government support
Target market:
Rural market, where 70% of the population resides, became much more important as a growth driver
The Indian Pharmaceutical sector witnessed significant business opportunities when National Pharmaceutical Policy 2006 was introduced
The Indian medical devices market can expect similar changes
100% FDI and new medical parks offering incentives would attract
international medical device players
Healthcare institutions have started to focus on semi-urban and rural areas
Greater focus on in-house R&D programs
More partnerships/collaborations are on the radar considering the recent initiatives by the Indian government
Transformed as joint ventures, partially or wholly owned subsidiaries, franchising, licensing models became new norm
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HEALTHCARE PRACTICE
We help our clients build leadership teams that focus on innovation & creation of business value. Our strong understanding and in-depth insights into the trends shaping the industry globally, allow us to hire the right leadership for our clients with ease.
Unparalleled reach and access to the top 500,000 Executives shaping the future of the healthcare industry, globally
Excellent track record of consistently delivering success across fast growing geographies in Asia, Africa & Latin America. Having placed more than 500 Executives in leadership roles across the industry, with a 95% retention rate, we continue to impact the business
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Our clients range from small/emerging and midsized companies to leading
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Pharmaceuticals
Generics
Biologics
API & Specialty Chemicals
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Contract Research & Manufacturing Medical Devices & Disposables Implants and Diagnostics
Healthcare Services, Hospitals & Clinics Healthcare Analytics
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Fortune 500 global giants. Having honed our expertise in all facets of Life Sciences & Healthcare Executive Search, our consultants are well equipped to anticipate client needs and customize solutions in advance
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CHALLENGE
BRIEF DESCRIPTION
ANNEXURE I
Low Penetration Accessibility
Affordability
Low Insurance Coverage
Cultural Aspects
Nascent Regulatory Environment
Low Indigenous Manufacturing Complex Rules and Guideline
High Capital requirement
Absence of Quality Certification Authority
Inadequate per capita healthcare facilities
Limited access to Rural and Tier2/3 cities have limited healthcare services
Cost of care continues to remain high
Expenses paid by patients and their families, rather than through Insurance
India largely (50%) is a cure-based market
Effectiveness of recently implemented Medical Device Regulation remains unclear
High dependence on imports
Involvement of too many government bodies creates unnecessary hassles for manufacturers
High investment required to meet demand for high-end medical devices. Most of it will be self-funded
No Indian Quality Certification Authority
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1. 2.
3. 4.
5.
6. 7.
8. 9.
10. 11.
12. 13. 14.
15. 16.
17. 18 .
http://www.pharmabiz.com/NewsDetails.aspx?aid=107495&sid=1 http://pharmaceuticals.gov.in/sites/default/files/medicalde- vicemanufacturinginindia-asunrise-170221053503%20%281%29.pdf http://pharmabiz.com/ArticleDetails.aspx?aid=104564&sid=1 http://pharmaceuticals.gov.in/sites/default/files/medicalde- vicemanufacturinginindia-asunrise-170221053503%20%281%29.pdf https://medicalbuyer.co.in/index.php/perspec- tive/15542-time-to-change-the-regulatory-environment-for-medtech-industry https://www.pwc.com/gx/en/tax/pdf/pwc-global-r-and-d-brochure-april-2017.pdf http://indianexpress.com/article/business/business-oth- ers/tax-breaks-on-rd-dipp-finance-ministry-not-on-the-same-page-5085243/ https://www.nytimes.com/2018/02/01/business/india-modi-health-care.html https://health.economictimes.indiatimes.com/news/indus- try/preventive-healthcare-the-need-of-the-hour-for-corporates/60002254 https://www.devex.com/news/india-turns-to-the-private-sec- tor-to-bring-health-care-to-underserved-areas-90541 https://economictimes.indiatimes.com/news/economy/for- eign-trade/government-may-consider-import-duty-hike-on-some-medical-devices/articleshow/6268 1116.cms
http://www.mydigitalfc.com/editorial/aim-healthy-growth https://www.pwc.com/gx/en/pharma-life-sciences/pdf/global-pharma-looks-to-india-final.pdf http://belmont.bme.umich.edu/wp-content/up- loads/sites/377/2018/03/Emergo_OutlookSurvey_2018.pdf https://www.advamed.org/sites/default/files/resource/medi- cal_industry_in_india_-_the_evolving_landscape_oppurtunities_and_challenges_white_paper.pdf https://www.biospectrumindia.com/interviews/74/8651/the-medi- cal-device-industry-is-driven-by-innovation-and-new-technologies.html http://www.makeinindiamit- telstand.de/wp-content/uploads/2015/09/Opportunities-in-the-Medical-Equipment-Market-India.pdf http://pharmaceuticals.gov.in/sites/default/files/medicalde- vicemanufacturinginindia-asunrise-170221053503%20%281%29.pdf https://health.economictimes.indiatimes.com/news/medical-de- vices/2017-in-review-milestones-in-the-medical-device-revolution-in-india/62250639
REFERENCES
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