India – Healthcare, Regulatory and Reimbursement Landscape

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GlobalData, the industry analysis specialist, has released its latest report: “India – Healthcare, Regulatory and Reimbursement Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in India. It identifies the key trends in the country’s healthcare market and provides insights into its demographic, regulatory and reimbursement landscape, and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of its pharmaceutical and medical device markets. It uses data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

The Indian pharmaceutical market was worth $13.56B in 2013, which increased to $20.03B in 2019 at a CAGR of 6.57%. The market value is expected to increase further to $29.34B by 2025. In 2020, India was ranked third globally for drug production by volume and 14th by value. It is the largest provider of generic medicines, with a 20% share of global supply by volume. In terms of vaccine production, India meets 62% of the global demand. The growth of the pharmaceutical market is attributed to the innovation and R&D, medical tourism, increased pharmaceutical export, infrastructure development, strong drug manufacturing, and strong domestic demand.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in India, and includes:

An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers

Profiles and SWOT analysis of the major players in the pharmaceutical market: Sun Pharma, Aurobindo Pharma, Dr. Reddy's Laboratories, GSK, and Novartis

Profiles and SWOT analysis of the major players in the medical device market: GE Healthcare, Siemens Healthineers, DePuy Synthes, Olympus, and Poly Medicure

An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, HealthTech landscape, reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices

Detailed analysis of the country’s healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure

An overview of the opportunities for and challenges to growth in the India healthcare market

Reasons to Buy

This report will enhance your decision-making capability by allowing you to:

Develop business strategies by understanding the trends shaping and driving India’s healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact India’s healthcare market in the future

Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance

Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership

Table of Contents

1. Table of Contents

1.1 List of Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about the Indian Healthcare Market

2.3 Key Highlights: Healthcare Startups in India

2.4 Key Events: Indian Healthcare Timeline, 2015–2021

2.5 Key Events: Indian Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2019–2020

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, India, 2020

3. Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.4 Pharmaceutical Market – Supply Channels, India

3.5 Pharmaceutical Market – Market Segments

3.6 Major Therapeutic Areas, India

3.7 COVID-19 Epidemiology, India

3.8 COVID-19 Impact and Developments in the Healthcare Market, India

3.9 COVID-19 Clinical Trials Landscape, India

3.10 Pharmaceutical Market – Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5. Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, India, 2019–2021

6.2 Deal Analysis: Medical Device Market, India, 2019–2021

7. HealthTech Landscape

7.1 HealthTech Landscape, India

7.2 HealthTech Deals Landscape, India

7.3 Key HealthTech Deals, India

7.4 Adoption of Technology in Healthcare, India

7.5 Key Developments: Digital Applications for Dealing with the COVID-19 Crisis, India

7.6 Regulatory Scenario Covering Use of Technology in Healthcare, India

7.7 HealthTech Landscape: Benefits and Risks, India

8. Market Access

8.1 Overview of Healthcare System, India

8.2 Reimbursement Process, India

8.3 Overview of Insurance Providers, India

8.4 Healthcare Spending and Medicine Price Index, India

8.5 Pricing Policies, India

8.6 Regulatory Landscape, India

8.6.1 Overview of Regulatory Agencies

8.6.2 Marketing Authorization for Pharmaceutical Products, India

8.6.3 Market Authorization for Medical Devices, India

8.6.4 Market Authorization for Biosimilars, India

8.6.5 Intellectual Property Rights, Patent, India

8.6.6 Intellectual Property Rights, Trademark, India

8.6.7 Clinical Trial Regulation Process, India

8.6.8 Pharmaceutical Clinical Trials Landscape, India

8.6.9 Medical Devices Clinical Trials Landscape, India

8.6.10 Pharmaceutical Export and Import, India

8.6.11 Pharmaceutical Advertisement Regulations, India

8.6.12 Pharmacy Regulations, India

8.6.13 Labeling and Packaging Regulations, India

9. Country Healthcare Landscape

9.1 Indian Healthcare Policy Highlights

9.2 Healthcare Facilities, India

9.3 Healthcare Parameters, India

9.4 Life Expectancy and Immunization Rate, India

9.5 Environmental Health, India

9.6 Healthcare Personnel, India

9.7 Disease Burden, India

9.8 Healthcare Expenditure, India

10 Trade Associations, India

11 Trade Fairs, India

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.2 Bibliography

13.3 About GlobalData

13.4 Contact Us

13.5 Disclaimer

Table

Table 1: Approved Biosimilars, India, 2014–2020

Table 2: Top Five Therapeutic Areas by Annual Turnover ($B), India, 2018

Table 3: COVID-19 Indicators (Number of Cases), Global and India, 2021

Table 4: COVID-19 Vaccines Development Landscape, India, 2020–2021

Table 5: Supply of COVID-19 Vaccine to Neighbouring Countries, India, 2021

Table 6: Growth in the Medical Device Manufacturing After COVID-19 Outbreak, India, 2020

Table 7: COVID-19 IVD Products (May ‘20- January ‘21), India, 2020–2021

Table 8: Medical Device Market, India, Major Segments ($B), 2020

Table 9: Diagnostic Imaging Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 10: General Surgery Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 11: Orthopedic Devices Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 12: Cardiovascular Devices Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 13: Wound Care Management Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 14: Number of Persons Covered under Health Insurance, India, 2017-2018

Table 15: CGHS Contribution, India, 2021

Table 16: ECHS Contribution, India, 2021

Table 17: COVID-19 Health Insurance, India, 2021

Table 18: Legal Provisions for Permission to Import/Manufacture New Drugs, India, 2021

Table 19: Fees for the New Drugs Licensing, India, 2021

Table 20: Consequences of Medical Device (Amendment) Rules 2020, India, 2021

Table 21: Fees for the Medical Device Licensing, India, 2021

Table 22: Patent Fees, India, 2021

Table 23: Trademark Fees, India, 2021

Table 24: Fees for the Clinical Trial of New Drugs, India, 2021

Table 25: Fees for the Import of Drugs, India, 2021

Figures

Figure 1: Pharmaceutical Market, India, Revenue ($B), 2013–2020

Figure 2: Medical Device Market, India, Revenue ($B), 2015–2020

Figure 3: Healthcare Startups in India, 2020

Figure 4: Number of Deals (2019–2020)

Figure 5: Deal Overview by Region, 2019–2020

Figure 6: Country Profile, India, 2020

Figure 7: Pharmaceutical Market, India, Revenue ($B), 2013–2020

Figure 8: Pharmaceutical Market, India, Revenue Forecast ($B), 2021–2025

Figure 9: Pharmaceutical Clusters, India, 2021

Figure 10: Pharmaceutical Exports ($B), India, 2012–2019

Figure 11: Top Export Partners, India, 2019

Figure 12: Pharmaceutical Imports ($B), India, 2012–2019

Figure 13: Top Import Partners, India, 2019

Figure 14: Pharmaceutical Supply Channel, India, 2021

Figure 15: Number of Biologics and Biosimilars Approved, India, 2014–2019

Figure 16: OTC Market, India, Revenue ($B), 2013–2020

Figure 17: OTC Market by Drug Category, India, Revenue ($M), 2020

Figure 18: Top Five Therapeutic Areas by Annual Turnover ($B), India, 2018

Figure 19: COVID-19 Cases, India, 2020–2021

Figure 20: COVID-19 Deaths, India, 2020–2021

Figure 21: Vaccine Cold Chain Distribution Network, India, 2021

Figure 22: COVID-19 Vaccination Comparison, Number of Days, India, 2020–2021

Figure 23: COVID-19 Vaccination Progress, Million Population, India, 2021

Figure 24: Supply of COVID-19 Vaccine to Neighbouring Countries, India, 2021

Figure 25: COVID-19 Clinical Trials Count By Trial Status, India, 2020–2021

Figure 26: COVID-19 Clinical Trials Count By Phase, India, 2020–2021

Figure 27: Top Five COVID-19 Clinical Trials Sponsors By Count, India, 2020–2021

Figure 28: Medical Device Market, India, Revenue ($B), 2015–2020

Figure 29: Medical Device Market, India, Revenue Forecast ($B), 2021–2025

Figure 30: Medical Devices Manufacturing Clusters, India, 2020

Figure 31: Medical Device Market, India, Major Segments (%), 2020

Figure 32: Diagnostic Imaging Market, India, Revenue ($B), 2017–2025

Figure 33: Diagnostic Imaging Market, India, Market Share of Major Players (%), 2019

Figure 34: General Surgery Market, India, Revenue ($B), 2017–2025

Figure 35: General Surgery Market, India, Market Share of Major Players (%), 2019

Figure 36: Orthopedic Devices Market, India, Revenue ($B), 2017–2025

Figure 37: Orthopedic Devices Market, India, Market Share of Major Players (%), 2019

Figure 38: Cardiovascular Devices Market, India, Revenue ($B), 2017–2025

Figure 39: Cardiovascular Devices Market, India, Market Share of Major Players (%), 2019

Figure 40: Wound Care Management Market, India, Revenue ($B), 2017–2025

Figure 41: Wound Care Management Market, India, Market Share of Major Players (%), 2019

Figure 42: Diagnostic Market, India, Revenue ($B), 2015–2020

Figure 43: Diagnostic Market, India, Revenue Forecast ($B), 2021–2025

Figure 44: Medical Devices Market, Revenue ($B) of Major Companies, India, 2019

Figure 45: Deal Value and Deal Count, Pharmaceutical Market, India, 2019–2021

Figure 46: Deal Value and Deal Count Sub-types, Pharmaceutical Market, India, 2019–2021

Figure 47: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, India, 2019–2021

Figure 48: Top Five Therapy Areas by Deal Value and Deal Count, Pharmaceutical Market, India, 2019–2021

Figure 49: M&A Deals by Therapy Area, Pharmaceutical Market, India, 2019–2021 (by Value ($M) and by Number)

Figure 50: PE Deals by Therapy Area, Pharmaceutical Market, India, 2019–2021 (by Value ($M) and by Number)

Figure 51: VC Deals by Therapy Area, Pharmaceutical Market, India, 2019–2021 (by Value ($M) and by Number)

Figure 52: Medical Devices Market Deals by Deal Value ($M), India, 2019–2021

Figure 53: Medical Devices Market Deals by Deal Count, India, 2019–2021

Figure 54: Medical Devices Market Deals Share by Deal Value, India, 2019–2021

Figure 55: Medical Devices Market Deals Share by Deal Count, India, 2019–2021

Figure 56: Top Therapy Area by Deal Value and Deal Count, Medical Devices Market, India, 2019–2021

Figure 57: M&A Deals by Therapy Area, Medical Devices Market, India, 2019–2021 (by Value ($M) and by Number)

Figure 58: VC Deals by Therapy Area, Medical Devices Market, India, 2019–2021 (by Value ($M) and by Number)

Figure 59: Deal Value ($M), HealthTech, India, 2019–2020

Figure 60: Deal Count (No. of Deals), HealthTech, India, 2019–2020

Figure 61: Organization of Healthcare System, India, 2020

Figure 62: National Formulary of India Review Process, India, 2011

Figure 63: Process for Revision of NLEM, India, 2015

Figure 64: PM-JAY Milestones, India, 2021

Figure 65: OOP Expenditure (% of Total Expenditure on Health), India, 2012–2020

Figure 66: Annual Rate of Change (%), Health Price Index, India, 2014–2020

Figure 67: CDSCO, Organization Chart, India, 2020

Figure 68: BIRAC Initiatives, India, 2020

Figure 69: DCGI Approval Process for Drug Substance/Drug Product, India, 2021

Figure 70: Medical Devices Approval Process for Application Received in Hard Copy, India, 2021

Figure 71: Medical Devices Approval Process for Application Received in Online Sugam Portal, India, 2021

Figure 72: Patent Approval Process, India, 2021

Figure 73: Office Actions in Processing Applications for Registration of Trademarks, India, 2021

Figure 74: Pharmaceutical Clinical Trials Count by Trial Status, India, 2019–2021

Figure 75: Pharmaceutical Clinical Trials Count by Indication, India, 2019–2021

Figure 76: Pharmaceutical Clinical Trials Count by Phase, India, 2019–2021

Figure 77: Top Five Pharmaceutical Clinical Trials Sponsors by Count, India, 2019–2021

Figure 78: Medical Devices Clinical Trials Count by Trial Status, India, 2019–2021

Figure 79: Medical Devices Clinical Trials Count by Indication, India, 2019–2021

Figure 80: Medical Devices Clinical Trials Count by Category, India, 2019–2021

Figure 81: Top Five Medical Devices Clinical Trial Sponsors by Count, India , 2019–2021

Figure 82: Number of Government Hospitals, India, 2014–2020

Figure 83: Number of Diagnostic Equipment, India, 2015–2020

Figure 84: Number of Total Government Hospital Beds, India, 2014–2020

Figure 85: Number of Government Rural Hospital Beds, India, 2014–2020

Figure 86: Number of Government Urban Hospital Beds (per 1,000 Population), India, 2014–2020

Figure 87: Life Expectancy at Birth (Years), India, 2014–2020

Figure 88: Immunization Rate (%), India, 2014–2020

Figure 89: PM2.5 (µg per m3), India, 2012–2019

Figure 90: CO2 Emissions (Billion Tons), India, 2012–2019

Figure 91: Physicians (per 1,000 Population), India, 2014–2020

Figure 92: Dental Surgeons (per 1,000 Population), India, 2014–2020

Figure 93: Pharmacists (per 1,000 Population), India, 2014–2020

Figure 94: Nurses (per 1,000 Population), India, 2014–2020

Figure 95: Major Causes of Mortality (per 100,000 population), India, 2019

Figure 96: Major Causes of Male Mortality (per 100,000 population), India, 2019

Figure 97: Major Causes of Female Mortality (per 100,000 population), India, 2019

Figure 98: Disability-Adjusted Life Years by Major Disease (per 100,000 population), India, 2019

Figure 99: Healthcare Expenditure as Percentage of GDP (%), India, 2014–2018

Figure 100: Public Health Expenditure (Center-State Share %), India, 2014–2018

Figure 101: Composition of Total Public Expenditure on Health, India, 2015-2016

Figure 102: Composition of Public Expenditure of States on Medical and Public Health (%), India, 2015–2016

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