Posted by Medical devices have an undeniable role in healthcare. They help diagnose, treat, monitor, and prevent various complicated conditions. The medical devices market in India is on the cusp of a major transformation, fuelled by breakthrough advancements and government initiatives.
If a handful of challenges are met, the market is poised to become a global manufacturing hub, bringing plenty of opportunities for new businesses and manufacturers. In this comprehensive article, we explore the current size, growth trajectory, and future outlook of the burgeoning medical devices industry in India.
Key Segments in the Indian Medical Devices Market
The following segments make up the medical devices industry in India.
The medical device industry can be broadly divided into key segments based on application, technology, and usage. Here are the main segments:
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Key Segments |
Application, Technology & Usage |
| 1. Diagnostic Devices |
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| 2. Therapeutic Devices |
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| 3. Monitoring Devices |
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| 4. Life Support Devices |
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| 5. Home Healthcare Devices |
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| 6. Surgical and Infection Control |
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| 7. Medical Software and Digital Health |
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| 8. Dental Devices |
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| 9. Ophthalmic Devices |
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| 10. Cardiovascular Devices |
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Market Size of Medical Devices in India
The medical devices market in India, consisting of multinational companies and medium-sized firms was valued at Rs. US$ 15.35 billion in 2023. As per IBEF’s (India Brand Equity Foundation) latest analysis, it will increase to US$ 20.51 billion by 2029 and take up a 1.65% share in the international market.
The medical devices industry in India is expanding steadily, driven by the growth of the healthcare segment and government initiatives. Its growth rate is projected to be 8.31% between 2024 and 2029. Furthermore, the market is set to touch $250 billion by 2047.
A noteworthy thing is the slight shift from import to export. From the beginning, the medical devices industry in India has been largely dependent on imports. Most local manufacturers produced devices at the lower end of the technology value chain.
However, between 2022-2023, medical device exports experienced a 16% increase and imports declined by 33%.
Still, a majority of India’s advanced medical devices are imported, which may soon change because of the government’s increasing focus on them.
Currently, India’s medical device manufacturing segment is among the top twenty in the world market size. It is fourth in Asia after Japan, China, and South Korea.
Reasons for the Expansion in the Market Size of Medical Devices in India
The main reasons for the evolution of the medical devices market in India are a greater focus on innovations in the medical devices domain, increased health awareness, and the progress of the MedTech sector. New government initiatives and policy support are also boosting the size of the medical devices market in India.
In a nutshell, India’s medical devices market is poised to grow exponentially because of the following factors:
- A growing demand for diagnostic imaging equipment, surgical devices, and monitoring devices that enhance the healthcare experience.
- Schemes like Production Linked Incentive (PLI) and Atma Nirbhar Bharat emphasize innovation and global collaboration and aim to make India independent and a leader in medical device manufacturing.
- A unique quality standardization framework similar to international standards that certifies the quality and safety of Indian medical devices
- Increase in foreign direct investment to support research and innovation in medical device technologies.
- A greater demand for medical devices that can help diagnose and treat communicable and non-communicable diseases.
- An increase in the number of MNCs setting up production lines for medical devices in India.
- Increasing urbanization and the amount of disposable income among people.
- A greater part of the budget allocation (Rs. 89,287 crore/US$ 10.73 billion) is for the healthcare sector.
Government Initiatives to Expand the Medical Devices Market in India
The Indian government has set up various strategies and policies to expand the market size of medical devices in India and improve exports. It has also enabled 100% foreign direct investment (FDI) to support the growth of advanced technologies.
The key initiatives taken to maximize medical device manufacturing and export include the following:
|
Initiative |
Governing body |
Functions |
| Scheme for Strengthening the Medical Device Industry, 2024 | Minister for Chemicals and Fertilizers | 1. Manufacturing medical devices
2. Skill and infrastructure development 3. Support for clinical studies |
| National Single Window System (NSWS), 2024 | Central Drugs Standard Control Organisation (CDSCO) | A platform to ease doing business in India |
| National Medical Devices Policy, 2023 | Union Cabinet | Methodical growth of medical devices to US$ 50 billion by 2030 |
| Production Linked Incentive Scheme (PLI), 2023 | Ministry of Commerce & Industry | Promotion of domestic manufacturing of medical equipment by offering incremental incentives of 4 to 6% on the sales of devices. |
| Export Promotion Council for Medical Devices, 2022 | Department of pharmaceuticals | Increase the exports of medical devices |
| Promotion of Medical Device Parks Programme, 2022 | Standing Committee on Chemicals and Fertilisers | Establishment of four medical device parks in Uttar Pradesh, Tamil Nadu, Madhya Pradesh, and Himachal Pradesh with common testing facilities and labs. |
| Draft for the new Drugs, Medical Devices and Cosmetics Bill, 2022 | Ministry of Health and Family Welfare | Modernize the outdated Drugs and Cosmetics Act, 1940 and simplify the rules to support new technology |
| Public Procurement Order (PPO), 2021 | The Department of Pharmaceuticals | Incorporation of 19 medical devices in the updated guidelines of the PPO to promote domestic medical device manufacturing |
| Make in India, 2014 | Ministry of Commerce and Industry | 1. 100% FDI
2. PLI scheme 3. Encouragement of medical device parks 4. Support for start-ups in Telemedicine and AI-powered healthcare |
Which Segment Holds the Largest Share in India Medical Device Market?
In the fiscal year 2023-2024, the largest share of India medical device market is held by the hospitals, clinics, and diagnostic centers segment. In the years ahead, the share of this segment is bound to grow.
Within this segment, the market volume of cardiology devices is the highest (US$ 990.70m). This growth is primarily because of the high patient footfall and the wide range of healthcare services provided by a growing number of hospitals and clinics.
Also, chronic diseases, like diabetes, coronary heart disease, and Chronic Obstructive Pulmonary Disease constitute a significant disease burden in India. More advanced clinics are offering specialized treatment for such diseases which requires sophisticated medical devices and equipment for diagnosis, disease management, therapeutic, and monitoring purposes.
Besides, life-saving devices for critical and emergency care are also witnessing expansion. This includes devices like defibrillators, ventilators, and monitoring equipment.
Regional Market Share of Medical Devices in India
North India, particularly Delhi and surrounding places have the largest market share of medical devices and equipment. 48% of medical device clusters are in the North and Central Indian region with the most being in Uttar Pradesh. North India houses many large healthcare centers which use advanced medical technologies and equipment.
After North India, West and Central India hold the largest share in medical devices (28%). It has six medical equipment clusters, in Maharashtra and Haryana. These regions are followed by South India, with five medical device clusters, and lastly, East and Northeast India. There is a single cluster each in Andhra Pradesh, Gujarat, Rajasthan, Tamil Nadu, and Telangana.
Among all these, the major medical device clusters in India are present in Haryana (Gurugram and Bhiwani), Uttar Pradesh (Kanpur), and Telangana (Telangana). The 21 clusters in India have 736 medical device industries, which are a mix of micro, small, medium, and large-scale industries. Among the 736 industries,126 are export-oriented, and the exports are done to the USA, China, Germany, France, Singapore, and UAE.
Differences in the Import and Export of Medical Devices in India
There is a 70-80% import dependency on medical devices in the Indian economy. But it also gives a unique opportunity to domestic manufacturers to increase exports.
The data from the Association of Indian Medical Device Industry reveals that the import of disposable medical devices grew at 17.63% in the fiscal year 2023-24 compared to 2022-2023. It amounted to ₹ 68,885 crore as compared to ₹ 61,179. Before this, imports increased by 41%, from ₹ 44,708 crore to ₹ 63,200 crore between the fiscal year 2021-22 to 2020-21.
Here are the major categories of medical devices whose imports witnessed an increase from 2022-2023 to 2023-2024.
- Disposables – 17.63%
- Electronic equipment – 14.5%
- Implants – 11%
- Consumables – 8.37%
- IVD reagent – 7%
The consumable and disposable category in the medical devices market in India also witnessed a significant increase in exports with a value of more than US$ 1 billion. It increased by 60% to US$1.6 billion. Disposables and electronics closely followed this category.
The lowest growth in export was seen in the following categories of medical devices:
- IV Diagnostic Reagent
- Surgical instruments
- Consumables
- Electronics/Equipment
- Consumable/Equipment
Major Countries and Companies Importing Medical Devices from India
The following countries import medical devices from India:
- S.A
- Singapore
- Netherlands
- China
- U.K
- Thailand
- Japan
- Maldives
- South Korea
- Belgium
Regulatory Environment to Boost Medical Devices Manufacturing in India
The Central Drugs Standard Control Organization (CDSCO), which set up the Drugs and Cosmetics Act of 1940, regulates the import, manufacture, and sale of all types of medical devices licenses in India. After undergoing various changes, it has created a favorable regulatory environment which is fairly straightforward.
The current regulations are based on the Medical Devices Rules 2017. It mandates that all devices for import, manufacture, and sale are safe and perform as intended.
The Medical Devices Rules 2017, set up by CDSCO governs the approval process, covering device-related regulations, classification, registration, production, import, sales, and post-market surveillance.
Here are the main rules that define the Indian medical device regulatory landscape:
- The Central Licensing Authority (CLA) of India categorizes medical devices and In-Vitro Diagnostic (IVD) into low-risk-Class A, low moderate risk-Class B, moderate-high risk-Class C, and high risk-Class D.
- To manufacture Class A/B devices, a license or loan license against the device’s application is given by the State Licensing Authority. For class C/D devices, it is given by CLA. The licenses are valid for perpetuity unless the governing body suspends or cancels them.
- For a new IVD, there is a requirement for a clinical performance evaluation. It will be done on human participants’ specimens for optimal performance assessment.
- For a new Medical devices that fall under IMDR needs only an exploratory study and a pivotal study clinical investigation.
- Clinical investigation is crucial for class B, C, and D medical devices if they are investigational without a predicate device and are manufactured in the country. This holds for a new IVD/MD.
- Clinical investigation is not needed to grant the import license, if the device has been marketed for at least 2 years in countries like Australia, Canada, Japan, Europe, or the U.S. and their respective Regulatory Authority are satisfied with the clinical evidence.
- The manufacturer must make a vigilance report or PMS data from their medical devices placed in the Indian market. It should have the report procedure, complaints, and corrective and preventive action made for that equipment.
What Hinders The Optimal Growth of the Medical Devices Market in India?
The growth of the native medical devices market in India faces key challenges. These include supply chain issues, few component suppliers, rapid changes in regulatory policies, and a lack of access to value-driven market access of devices. Some measures that will help surpass these roadblocks include the following:
Key Pointers to Address & Overcome Roadblocks:
- A strategic roadmap to mend the supply chain gaps with a focus on finding alternative suppliers, optimizing inventory management, and using new technologies.
- Create a market access strategy by developing medical device trials, understanding the market, and building value packages and economical models. Market access strategies should also leverage India’s IT prowess.
- Innovation should happen across the medical device range, by changing from high-volume and low-quality items to high-quality and sophisticated equipment.
- To get rid of medical device counterfeits, thwart faking products like holograms, barcoding, and UDI (Unique Device Identifier) should come into use.
- The regulatory framework for India’s medtech should be made time-efficient and affordable. Regulations should make it easier to get approvals and show compliance.
- Efforts to increase the number of trained workforce to operate, repair, and service medical equipment should be increased.
Frequently Asked Questions (FAQ’s)
1. Which is The No. 1 Medical Device Consultant in India?
Dueran Consultants Private Limited is a prominent name in the Indian medical device consultancy industry, recognized for its expertise and leadership in helping medical device companies navigate complex regulatory landscapes and achieve success in the market. As the No. 1 medical device consultant in India, Dueran Consultants has built a strong reputation for offering high-quality, end-to-end solutions for medical device manufacturers, distributors, and entrepreneurs.
2. Is India The 4th Largest Market For Medical Devices in Asia?
Yes. India comes after Japan, China, and South Korea for its size of medical devices in Asia. India’s medical device market is set to reach $50 billion by 2025.
3. What Are The 4 Medical Device Parks in India?
Telangana, Kerala, Andhra Pradesh, and Tamil Nadu are the four places where manufacturing clusters or Medical device parks have been constructed in India under the PLI Scheme 2.0.
Conclusion:
The market size of medical devices in India is growing, driven by a stimulating environment for innovation and population and income growth. Initiatives to enhance the country’s self-reliance, increase the workforce, and develop critical infrastructure are other factors causing a steady expansion of the industry. However, stakeholders have yet to overcome regulatory hurdles and establish a defined supply chain ecosystem. Still, the outlook is bright for the coming years.
If you find it difficult to get past the current landscape of medical device regulatory compliances and legal requirements, we are here to help you. As an experienced regulatory solutions provider, we support and guide businesses comprehensively with medical device registration and license approval.
Contact us for a free consultation and find out how we can help you uncover opportunities in the Indian medical device market while easing your regulatory journey.
