India Medical Device Testing and Certification Market, By Service Type ; By Sourcing Type ; By Device Class ; By Technology ; By Region, Trend Analysis, Competitive Landscape & Forecast, 2019-2029

India medical device testing and certification market is flourishing due to the rising demand for medical device verification and validation, a growing number of small medical device companies lacking in-house expertise, and increasingly stringent government regulations.

BlueWeave Consulting, a leading strategic consulting and business research firm, in its recent study, estimated that the India medical device testing and certification market size at USD 1,674.9 million in 2022. During the forecast period between 2023 and 2029, BlueWeave expects the India medical device testing and certification market size to grow at a CAGR of 5.2% reaching a value of USD 2,388.4 million by 2029. Rising demand for medical device verification and validation, a growing number of small medical device companies lacking in-house expertise, and increasingly stringent government regulations are key drivers propelling the India medical device testing and certification market during the period in analysis.

Opportunity: Government's initiatives promoting domestic manufacturing and supporting medical device companies

Government initiatives, such as the "Make in India" campaign, actively promote the growth of domestic medical device manufacturing. This results in an increased production of medical devices that require rigorous testing and certification to meet quality and safety standards. Government regulations are becoming increasingly stringent to ensure the safety and effectiveness of medical devices. Manufacturers must comply with these regulations, leading to a higher demand for testing and certification services to meet regulatory requirements. Government incentives, subsidies, and grants provide financial support to medical device companies. This financial assistance helps manufacturers invest in testing and certification processes, which are often costly but essential for compliance.

Class 1 segment holds the largest market share by device class

Based on device class, the class 1 segment is expected to grow in the forecast period. India's healthcare sector is expanding, with increasing healthcare infrastructure and facilities. This growth leads to greater demand for a wide range of medical devices, including Class 1 devices. Class 1 devices encompass a broad range of products, from simple bandages to handheld surgical instruments. The diversity of healthcare needs and applications drives the demand for these devices. While Class 1 devices are considered low-risk, they still need to meet regulatory compliance standards set by authorities like the Central Drugs Standard Control Organization (CDSCO). Certification is essential to demonstrate compliance.

Impact of COVID-19 on India Medical Device Testing and Certification Market

The COVID-19 pandemic resulted in a sharp rise in the requirement for medical equipment, including ventilators, diagnostic tools, personal protective gear (PPE), and other healthcare devices. This surge in demand necessitated rapid testing and certification procedures to ensure the quality and safety of these products. To address the urgent healthcare needs arising from the pandemic, regulatory bodies in India, such as the Central Drugs Standard Control Organization (CDSCO), accelerated the approval and certification processes, particularly for critical medical devices like COVID-19 diagnostic kits and ventilators. Disruptions in the global supply chain, brought about by lockdowns and transportation restrictions, created shortages of specific medical devices. This situation underscored the need for domestic manufacturing and expedited certification processes.

Competitive Landscape:

The India medical device testing and certification market is fragmented, with numerous players serving the market. The key players dominating the India medical device testing and certification market are SRL Limited, Bureau Veritas India, SGS India Private Limited, Intertek India Private Limited, UL India Private Limited, Asia Quality Focus, Micom Laboratories India Pvt Ltd, Toxikon India Pvt Ltd, Cliniminds, and RMS Healthcare. These players use various strategies including facility expansion, product diversification, alliances, collaborations, partnerships, and acquisition to expand their customer reach and gain a competitive edge in the overall market.

The report's in-depth analysis provides information about growth potential, upcoming trends, and the India Medical Device Testing and Certification Market statistics. It also highlights the factors driving forecasts of total market size. The report promises to provide recent technology trends in the India Medical Device Testing and Certification Market along with industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyses the growth drivers, challenges, and competitive dynamics of the market.

Product Code: BWC23803

1. Research Framework

1.1. Research Objective
1.2. Product Overview
1.3. Market Segmentation

2. Executive Summary

3. India Medical Device Testing and Certification Market Insights

3.1. Industry Value Chain Analysis
3.2. DROC Analysis
- 3.2.1. Growth Drivers
  - 3.2.1.1. Rising healthcare needs due to a growing population and increasing lifestyle-related diseases
  - 3.2.1.2. Stringent regulations and compliance standards set by government bodies
  - 3.2.1.3. Rapid technological advancements and innovations in medical device manufacturing
- 3.2.2. Restraints
  - 3.2.2.1. High testing and certification costs
  - 3.2.2.2. Complex and evolving regulatory frameworks
- 3.2.3. Opportunities
  - 3.2.3.1. Government initiatives promoting domestic manufacturing and supporting medical device companies
  - 3.2.3.2. Collaboration between testing laboratories, manufacturers, and research institutions
- 3.2.4. Challenges
  - 3.2.4.1. Risks associated with intellectual property theft or infringement during the testing and certification process
3.3. Technological Advancements/Recent Developments
3.4. Regulatory Framework
3.5. Porter's Five Forces Analysis
- 3.5.1. Bargaining Power of Suppliers
- 3.5.2. Bargaining Power of Buyers
- 3.5.3. Threat of New Entrants
- 3.5.4. Threat of Substitutes
- 3.5.5. Intensity of Rivalry

4. India Medical Device Testing and Certification Market Overview

4.1. Market Size & Forecast, 2019-2029
- 4.1.1. By Value (USD Million)
4.2. Market Share & Forecast
- 4.2.1. By Service Type
  - 4.2.1.1. Testing Services
  - 4.2.1.2. Inspection Service
  - 4.2.1.3. Certification Services
- 4.2.2. By Sourcing Type
  - 4.2.2.1. In-House
  - 4.2.2.2. Outsourced
- 4.2.3. By Device Class
  - 4.2.3.1. Class I
  - 4.2.3.2. Class II
  - 4.2.3.3. Class III
- 4.2.4. By Technology
  - 4.2.4.1. Active Implant Medical Device
  - 4.2.4.2. Active Medical Device
  - 4.2.4.3. Non-active Medical Device
  - 4.2.4.4. In Vitro Diagnostic Medical Device
  - 4.2.4.5. Ophthalmic Medical Device
  - 4.2.4.6. Orthopedic and Dental Medical Device
  - 4.2.4.7. Others
- 4.2.5. By Region
  - 4.2.5.1. North India
  - 4.2.5.2. South India
  - 4.2.5.3. East India
  - 4.2.5.4. West India

5. North India Medical Device Testing and Certification Market

5.1. Market Size & Forecast, 2019-2029
- 5.1.1. By Value (USD Million)
5.2. Market Share & Forecast
- 5.2.1. By Service Type
- 5.2.2. By Sourcing Type
- 5.2.3. By Device Class
- 5.2.4. By Technology

6. South India Medical Device Testing and Certification Market

6.1. Market Size & Forecast, 2019-2029
- 6.1.1. By Value (USD Million)
6.2. Market Share & Forecast
- 6.2.1. By Service Type
- 6.2.2. By Sourcing Type
- 6.2.3. By Device Class
- 6.2.4. By Technology

7. East India Medical Device Testing and Certification Market

7.1. Market Size & Forecast, 2019-2029
- 7.1.1. By Value (USD Million)
7.2. Market Share & Forecast
- 7.2.1. By Service Type
- 7.2.2. By Sourcing Type
- 7.2.3. By Device Class
- 7.2.4. By Technology

8. West India Medical Device Testing and Certification Market

8.1. Market Size & Forecast, 2019-2029
- 8.1.1. By Value (USD Million)
8.2. Market Share & Forecast
- 8.2.1. By Service Type
- 8.2.2. By Sourcing Type
- 8.2.3. By Device Class
- 8.2.4. By Technology

9. Competitive Landscape

9.1. List of Key Players and Their Offerings
9.2. India Medical Device Testing and Certification Company Market Share Analysis, 2022
9.3. Competitive Benchmarking, By Operating Parameters
9.4. Key Strategic Developments (Mergers, Acquisitions, Partnerships, etc.)

10. Impact of Covid-19 on India Medical Device Testing and Certification Market

11. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)

11.1. SRL Limited
11.2. Bureau Veritas India
11.3. SGS India Private Limited
11.4. Intertek India Private Limited
11.5. UL India Private Limited
11.6. Asia Quality Focus
11.7. Micom Laboratories India Pvt Ltd
11.8. Toxikon India Pvt Ltd
11.9. Cliniminds
11.10. RMS Healthcare
11.11. Other Prominent Players

12. Key Strategic Recommendations

13. Research Methodology

13.1. Qualitative Research
- 13.1.1. Primary & Secondary Research
13.2. Quantitative Research
13.3. Market Breakdown & Data Triangulation
- 13.3.1. Secondary Research
- 13.3.2. Primary Research
13.4. Breakdown of Primary Research Respondents, By Region
13.5. Assumptions & Limitations

*Financial information of non-listed companies can be provided as per availability.

**The segmentation and the companies are subject to modifications based on in-depth secondary research for the final deliverable.

Product Code: BWC23803

List of Figures

Figure 1 India Medical Device Testing and Certification Segmentation
Figure 2 India Medical Device Testing and Certification Market Value Chain Analysis
Figure 3 Company Market Share Analysis, 2022
Figure 4 India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Figure 5 India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Figure 6 India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Figure 7 India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Figure 8 India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Figure 9 India Medical Device Testing and Certification Market Share, By Region, By Value, 2019-2029
Figure 10 North India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Figure 11 North India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Figure 12 North India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Figure 13 North India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Figure 14 North India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Figure 15 South India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Figure 16 South India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Figure 17 South India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Figure 18 South India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Figure 19 South India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Figure 20 East India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Figure 21 East India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Figure 22 East India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Figure 23 East India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Figure 24 East India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Figure 25 West India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Figure 26 West India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Figure 27 West India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Figure 28 West India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Figure 29 West India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029

List of Tables

Table 1 India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Table 2 India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Table 3 India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Table 4 India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Table 5 India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Table 6 India Medical Device Testing and Certification Market Share, By Region, By Value, 2019-2029
Table 7 North India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Table 8 North India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Table 9 North India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Table 10 North India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Table 11 North India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Table 12 South India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Table 13 South India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Table 14 South India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Table 15 South India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Table 16 South India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Table 17 East India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Table 18 East India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Table 19 East India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Table 20 East India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Table 21 East India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Table 22 West India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019-2029
Table 23 West India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019-2029
Table 24 West India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019-2029
Table 25 West India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019-2029
Table 26 West India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019-2029
Table 27 SRL Limited Company Overview
Table 28 SRL Limited Financial Overview
Table 29 Bureau Veritas India Company Overview
Table 30 Bureau Veritas India Financial Overview
Table 31 SGS India Private Limited Company Overview
Table 32 SGS India Private Limited Financial Overview
Table 33 Intertek India Private Limited Company Overview
Table 34 Intertek India Private Limited Financial Overview
Table 35 UL India Private Limited Company Overview
Table 36 UL India Private Limited Financial Overview
Table 37 Asia Quality Focus Company Overview
Table 38 Asia Quality Focus Financial Overview
Table 39 Micom Laboratories India Pvt Ltd Company Overview
Table 40 Micom Laboratories India Pvt Ltd Financial Overview
Table 41 Toxikon India Pvt Ltd Company Overview
Table 42 Toxikon India Pvt Ltd Financial Overview
Table 43 Cliniminds Company Overview
Table 44 Cliniminds Financial Overview
Table 45 RMS Healthcare Company Overview
Table 46 RMS Healthcare Financial Overview

India Medical Device Testing and Certification Market, By Service Type ; By Sourcing Type ; By Device Class ; By Technology ; By Region, Trend Analysis, Competitive Landscape & Forecast, 2019-2029

Description

Table of Contents

List of Tables

India Medical Device Testing and Certification Market Size Booming to Touch USD 2.4 Billion by 2029.

Opportunity: Government's initiatives promoting domestic manufacturing and supporting medical device companies

Class 1 segment holds the largest market share by device class

Impact of COVID-19 on India Medical Device Testing and Certification Market

Competitive Landscape:

Table of Contents

1. Research Framework

2. Executive Summary

3. India Medical Device Testing and Certification Market Insights

4. India Medical Device Testing and Certification Market Overview

5. North India Medical Device Testing and Certification Market

6. South India Medical Device Testing and Certification Market

7. East India Medical Device Testing and Certification Market

8. West India Medical Device Testing and Certification Market

9. Competitive Landscape

10. Impact of Covid-19 on India Medical Device Testing and Certification Market

11. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)

12. Key Strategic Recommendations

13. Research Methodology

List of Figures

List of Tables