CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

  • ID: 2669726
  • Report
  • Region: India
  • 235 pages
  • GlobalData
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India’s Pharmaceuticals Market Will Skyrocket from $20 Billion in 2015 to $55 Billion by 2020
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

Summary

We have released our latest report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India". The report is an essential source of information on and 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 Our team of industry experts.

India is the second most populated country in the world with a population of approximately 1.24 billion in 2014. The country’s pharmaceutical market was estimated at $24.2 billion in 2014 and is expected to reach approximately $60.5 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 16.5%. The value of the Indian medical device market was $6.6 billion in 2008, and is expected to register a CAGR of 7.7% to reach an estimated $10.3 billion in 2020.

The main growth factors are -
- Increasing coverage of healthcare insurance
- Improving access to medical facilities in both urban and rural areas
- Government initiatives for easy access to healthcare facilities

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 analyses of the major players in the pharmaceutical market: Dr Reddy’s, Lupin, Cipla, Aurobindo and Cadila; and profiles and SWOT analyses of the major players in the medical device market: Siemens Healthcare, Johnson & Johnson, DePuy, Roche and Philips
- Insightful review of the 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 political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
- An overview of the opportunities for and challenges to growth in the 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 affect India’s healthcare market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investment, and strategic partnerships
- Identify, understand, and capitalize on the opportunities and challenges in India’s healthcare market
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1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Report Guidance

3 Overview of the Pharmaceutical and Medical Device Markets

3.1 Pharmaceutical Market

3.1.1 Market Overview

3.1.2 Pharmaceutical Exports and Imports

3.1.3 Supply Channels

3.1.4 Market Segments

3.1.5 Major Therapeutic Areas

3.1.6 Major Players

3.2 Medical Device Market

3.2.1 Market Overview

3.2.2 Overview of Top Five Segments

3.2.3 Diagnostic market

3.2.4 Major Players

3.3 Market Drivers and Barriers

3.3.1 Drivers

3.3.2 Barriers

4 Market Access

4.1 Reimbursement and Payer Landscape

4.1.1 Overview of Healthcare System

4.1.2 Reimbursement Process

4.1.3 Overview of Insurance Providers

4.1.4 Patient Share in Healthcare Spending

4.1.5 Drug Price Change

4.1.6 Pricing Policies

4.2 Regulatory Landscape

4.2.1 Overview of Regulatory Agencies

4.2.2 New Drug Approval Procedure for Pharmaceutical Products

4.2.3 Market Authorization Procedure for Medical Devices

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing

4.2.5 Licensing Process for Pharmaceutical Exports and Imports

4.2.6 Intellectual Property Rights

4.2.7 Clinical Trial Regulations

4.2.8 Pharmaceutical Advertising Regulations

4.2.9 Pharmacy Regulations

4.2.10 Labeling and Packaging Regulations

5 Country Analysis

5.1 Political Environment

5.1.1 Political Structure

5.1.2 Analysis of the Current Political Environment

5.1.3 Healthcare Policy Initiatives

5.2 Economic Landscape

5.3 Economic Indicators

5.3.1 Gross Domestic Product

5.3.2 National Income per Capita

5.3.3 Inflation

5.3.4 Currency Exchange Rate

5.3.5 Foreign Direct Investment

5.3.6 Foreign Exchange Reserves

5.3.7 Trade Balance

5.3.8 Government Structural Balance

5.3.9 General Government Gross Debt

5.3.10 Major Industries

5.4 Demographics

5.4.1 Population

5.4.2 Education and Literacy

5.4.3 Employment

5.4.4 Disease Burden

5.5 Healthcare Infrastructure

5.5.1 Healthcare Facilities

5.5.2 Healthcare Parameters

5.5.3 Environmental Health

5.5.4 Healthcare Personnel

5.6 Healthcare Expenditure

5.6.1 Overview

5.6.2 Components of Healthcare Spending

5.6.3 Public and Private Sector Share

5.6.4 Spending in Pharmaceutical R&D

5.7 Trade Associations

5.7.1 Indian Pharmaceutical Association

5.7.2 Indian Drug Manufacturer’s Association

5.7.3 Organization of Pharmaceutical Producers of India

5.7.4 Indian Pharmacy Graduates Association

5.8 Trade Fairs

6 Opportunities and Challenges

6.1 Opportunities

6.2 Challenges

7 Appendix

7.1 Abbreviations

7.2 Bibliography

7.3 Research Methodology

7.3.1 Coverage

7.3.2 Secondary Research

7.3.3 Forecasts

7.3.4 Expert Panel

7.4 Disclaimer

1.1 List of Tables

Table 1: Pharmaceutical Market, India, Revenue ($bn), 2008-2014

Table 2: Pharmaceutical Market, India, Revenue Forecast ($bn), 2014-2020

Table 3: Pharmaceutical Market, India, Exports and Imports ($bn), 2008-2013

Table 4: Biotechnology Market, India, Market Segments of Bio-technology Industry, Share (%), 2015

Table 5: Major Therapeutic Areas, India, Turnover ($m), 2010

Table 6: Dr. Reddy’s, Global, Major Products, 2014

Table 7: Dr Reddy’s, Global, Late-Stage Pipeline, 2015

Table 8: Medical Device Market, India, Revenue ($bn), 2008-2014

Table 9: Medical Device Market, India, Revenue Forecast ($bn), 2015-2020

Table 10: Medical Device Market, India, Revenue by Segment, 2014

Table 11: Medical Device Market, India, Ophthalmic Devices Market ($m), 2008-2014

Table 12: Medical Device Market, India, Ophthalmic Devices Market, Market Share for Major Players (%), 2012

Table 13: Medical Device Market, India, IVD Market ($bn), 2008-2014

Table 14: Medical Device Market, India, IVD Market, Market Share for Major Players (%), 2012

Table 15: Medical Device Market, India, Orthopedic Device Market ($bn), 2008-2014

Table 16: Medical Device Market, India, Orthopedic Device Market, Market Share for Major Players (%), 2012

Table 17: Medical device market, India, Wound Care Management Market ($bn), 2008-2014

Table 18: Medical Device Market, India, Wound Care Management Market, Market Share for Major Players (%), 2012

Table 19: Medical Device Market, India, Cardiovascular Device Market ($bn), 2008-2014

Table 20: Medical Device Market, India, Cardiovascular Device Market, Market Share for Major Players (%), 2012

Table 21: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2008-2014

Table 22: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2014-2020

Table 23: Major Public Insurance Schemes, India, 2013

Table 24: Insured Population, India, Share ($bn), 2014

Table 25: Healthcare Spending, India, Out-of-Pocket Expenditure (% of Private Expenditure on Health), 2008-2013

Table 26: Market Access, India, Drug Price Change (%), 2008-2014

Table 27: Specific Requirements, New Drug Application, India, 2015

Table 28: Market Access, India, Schedule of Patent Fees, 2014

Table 29: Market Access, India, Schedule of Trademark Fees, 2014

Table 30: Specific Requirements, Clinical Trial Approval, India, 2011

Table 31: Economic Indicators, India, GDP per Capita ($), 2008-2014

Table 32: Economic Indicators, India, GDP per Capita Forecast ($), 2015-2020

Table 33: Economic Indicators, India, GDP Annual Growth (%), 2008-2014

Table 34: Economic Indicators, India, GDP Annual Growth Forecast (%), 2015-2020

Table 35: Economic Indicators, India, National Income per Capita ($), 2008-2014

Table 36: Economic Indicators, India, Average Consumer Price Index Forecast, 2008-2014

Table 37: Economic Indicators, India, Average Consumer Price Index Forecast, 2015-2020

Table 38: Economic Indicators, India, Average Consumer Price Annual Change (%), 2008-2014

Table 39: Economic Indicators, India, Currency Exchange Rate (INR/$), 2008-2014

Table 40: Economic Indicators, India, FDI ($bn), 2008-2014

Table 41: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2008-2014

Table 42: Economic Indicators, India, Imports of Goods and Services ($bn), 2008-2014

Table 43: Economic Indicators, India, Exports of Goods and Services ($bn), 2008-2014

Table 44: Economic Indicators, India, Government Structural Balance ($bn), 2008-2014

Table 45: Economic Indicators, India, General Government Gross Debt (% of GDP), 2008-2014

Table 46: Economic Indicators, India, General Government Gross Debt Forecast (% of GDP), 2015-2020

Table 47: Economic Indicators, India, Major Industries, National income by Industry ($bn), 2013

Table 48: Demographics, India, Population (billion), 2008-2014

Table 49: Demographics, India, Population Forecast (billion), 2015-2020

Table 50: Demographics, India, Urban-Rural Population (%), 2008-2014

Table 51: Demographics, India, Population Distribution by Age Group (%), 2008-2014

Table 52: Demographics, India, Population Distribution by Age Group Forecast (%), 2015-2020

Table 53: Demographics, India, Births (per 1,000 Population), 2008-2014

Table 54: Demographics, India, Mortality (per 1,000 Population), 2008-2014

Table 55: Demographics, India, Major Causes of Mortality (%), 2012

Table 56: Demographics, India, Children <5 Years Age, Infant Mortality Rate (per 1,000 Live Births), 2008-2014

Table 57: Demographics, India, Immunization Rate (%), 2013

Table 58: Demographics, India, Major Causes of Male Mortality (‘000), 2008

Table 59: Demographics, India, Major Causes of Male Mortality (‘000), 2008

Table 60: Demographics, India, Gender Ratio (M/F), 2008-2014

Table 61: Demographics, India, Life Expectancy at Birth (Years), 2008-2014

Table 62: Demographics, India, Number of students enrolled by level of education (millions), 2013

Table 63: Demographics, India, Unemployment Rate (%), 2008-2014

Table 64: Demographics, India, Employment by Sector (Number of Employees, Millions), 2013

Table 65: Demographics, India, Disease burden, DALYs, 2013

Table 66: Healthcare Infrastructure, India, Public Hospitals, 2008-2014

Table 67: Major Private Hospitals, India, 2012

Table 68: Healthcare Infrastructure, India, Urban-rural share (%), 2008-2014

Table 69: Healthcare Infrastructure, India, Healthcare Centers, 2008-2014

Table 70: Healthcare Infrastructure, Diagnostic Units (Per 100,000 Population), 2008

Table 71: Healthcare Infrastructure, India, Hospital Beds (per 1,000 Population), 2008-2014

Table 72: Healthcare Infrastructure, India, Doctors (‘000), 2008-2014

Table 73: Healthcare Infrastructure, India, PM10 (µg/m3), 2008-2014

Table 74: Healthcare Infrastructure, India, CO2 emissions (mt per Capita), 2008-2014

Table 75: Healthcare Infrastructure, India, Nurses (per 1,000 Population), 2008-2014

Table 76: Healthcare Infrastructure, India, Pharmacists (per 1,000 Population), 2008-2014

Table 77: Healthcare Infrastructure, India, Dentists (per 1,000 Population), 2008-2014

Table 78: Healthcare Expenditure, India , Healthcare Expenditure (% of GDP), 2008-2014

Table 79: Healthcare Expenditure of Ministry of Health and Family Welfare, India, Share by Department (%), 2014

Table 80: Healthcare Expenditure, India, Major Components of Healthcare Spending, Share (%), 2013

Table 81: Healthcare Expenditure, India, Public-Private Share (%), 2008-2014

Table 82: Healthcare Expenditure, India, Pharmaceutical R&D Expenditure ($m), 2008-2014

Table 83: Healthcare Expenditure, India Major Healthcare Trade Fairs, 2015-2016

1.2 List of Figures

Figure 1: Pharmaceutical Market, India, Revenue ($bn), 2008-2014

Figure 2: Pharmaceutical Market, India, Revenue Forecast ($bn), 2015-2020

Figure 3: Pharmaceutical Market, India, Exports and Imports ($bn), 2008-2014

Figure 4: Pharmaceutical Market, India, Supply Channels, 2013

Figure 5: Biotechnology Market, India, Market Segments of Bio-technology Industry, Share (%), 2015

Figure 6: Major Therapeutic Areas, India, Turnover ($m), 2010

Figure 7: Medical Device Market, India, Revenue ($bn), 2008-2014

Figure 8: Medical Device Market, India, Revenue Forecast ($bn), 2015-2020

Figure 9: Medical Device Market, India, Revenue by Segment ($bn), 2014

Figure 10: Medical Device Market, India, Ophthalmic Devices Market ($m), 2008-2014

Figure 11: Medical Device Market, India, Ophthalmic Devices Market, Market Share for Major Players (%), 2012

Figure 12: Medical Device Market, India, IVD Market ($m), 2008-2014

Figure 13: Medical Device Market, India, IVD Market, Market Share for Major Players (%), 2012

Figure 14: Medical Device Market, India, Orthopedic Device Market ($bn), 2008-2014

Figure 15: Medical Device Market, India, Orthopedic Device Market, Market Share for Major Players (%), 2012

Figure 16: Medical Device Market, India, Wound Care Management Market ($bn), 2008-2014

Figure 17: Medical device market, India, Wound Care Management Market ($m), Market share for Major Players (%), 2012

Figure 18: Medical Device Market, India, Cardiovascular Device Market ($bn), 2008-2014

Figure 19: Medical Device Market, India, Cardiovascular Device Market, Market Share for Major Players (%), 2012

Figure 20: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2008-2014

Figure 21: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2015-2020

Figure 22: Healthcare Market, India, Drivers and Barriers, 2015

Figure 23: Milestones of the Insurance Regulatory System, India, 1938-2009

Figure 24: Healthcare System, India, Medical Tourism Process, 2008

Figure 25: Local Purchase System, Private Hospitals, India, 2013

Figure 26: Centralized Purchase System, Private Hospitals, India, 2013

Figure 27: Tender Purchase System, Private Hospitals, India, 2013

Figure 28: Local and Centralized Purchase System, Private Hospitals, India, 2013

Figure 29: Healthcare Spending, India, Out-of-Pocket Expenditure (% of Private Expenditure on Health), 2008-2014

Figure 30: Market Access, India, Drug Price Change (%), 2008-2014

Figure 31: Market Access, India, Structure of the Central Drugs Standard Control Organization, 2015

Figure 32: Market Access, India, New Drug Evaluation Process, 2014

Figure 33: Organizational Structure of the Controller General of Patents, Designs and Trade Marks, India, 2015

Figure 34: Patent Approval Process, India, 2015

Figure 35: Trademark Registration Process, India, 2015

Figure 36: Clinical Trial Approval Process, India, 2013

Figure 37: Economic Indicators, India, GDP per Capita ($), 2008-2014

Figure 38: Economic Indicators, India, GDP per Capita Forecast ($), 2015-2020

Figure 39: Economic Indicators, India, GDP Annual Growth (%), 2008-2014

Figure 40: Economic Indicators, India, GDP Annual Growth Forecast (%), 2015-2020

Figure 41: Economic Indicators, India, National Income per Capita ($),2008-2014

Figure 42: Economic Indicators, India, Average Consumer Price Index, 2008-2014

Figure 43: Economic Indicators, India, Average Consumer Price Index, 2015-2020

Figure 44: Economic Indicators, India, Average Consumer Price Annual Change (%), 2008-2014

Figure 45: Economic Indicators, India, Currency Exchange Rate (INR/$), 2008-2014

Figure 46: Economic Indicators, India, FDI ($bn), 2008-2014

Figure 47: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2008-2014

Figure 48: Economic Indicators, India, Imports of Goods and Services ($bn), 2008-2014

Figure 49: Economic Indicators, India, Exports of Goods and Services ($bn), 2008-2014

Figure 50: Economic Indicators, India, Government Structural Balance ($bn), 2008-2014

Figure 51: Economic Indicators, India, General Government Gross Debt (% of GDP), 2008-2014

Figure 52: Economic Indicators, India, General Government Gross Debt Forecast (% of GDP), 2015-2020

Figure 53: Economic Indicators, India, Major Industries, National Income by Industry ($bn), 2013

Figure 54: Demographics, India, Population (billion), 2008-2014

Figure 55: Demographics, India, Population Forecast (billion), 2015-2020

Figure 56: Demographics, India, Urban-Rural Population (%), 2008-2014

Figure 57: Demographics, India, Population Distribution by Age Group (%), 2008-2014

Figure 58: Demographics, India, Population Distribution by Age Group Forecast (%), 2015-2020

Figure 59: Demographics, India, Births (per 1,000 Population), 2008-2014

Figure 60: Demographics, India, Mortality (per 1,000 Population), 2008-2014

Figure 61: Demographics, India, Major Causes of Mortality (%), 2012

Figure 62: Demographics, India, Infant Mortality Rate (per 1,000 Live Births), 2008-2014

Figure 63: Demographics, India, Immunization Rate (%), 2013

Figure 64: Demographics, India, Major Causes of Male Mortality (‘000), 2008

Figure 65: Demographics, India, Major Causes of Female Mortality (‘000), 2008

Figure 66: Demographics, India, Gender Ratio (M/F), 2008-2014

Figure 67: Demographics, India, Life Expectancy at Birth (Years), 2008-2014

Figure 68: Demographics, India, Number of Students Enrolled by Level of Education (millions), 2013

Figure 69: Demographics, India, Unemployment Rate (%), 2008-2014

Figure 70: Demographics, India, Employment by Sector (Number of Employees, Millions), 2013

Figure 71: Demographics, India, Disease burden, DALYs (per 100,000 Population), 2013

Figure 72: Healthcare Infrastructure, India, Public Hospitals, 2008-2014

Figure 73: Healthcare Infrastructure, India, Urban rural share (%), 2008-2014

Figure 74: Healthcare Infrastructure, India, Healthcare centers, 2008-2014

Figure 75: Healthcare Infrastructure, India, Diagnostic Equipment (per 100,000 population), 2008

Figure 76: Healthcare Infrastructure, India, Hospital Beds (per 1,000 Population), 2008-2014

Figure 77: Healthcare Infrastructure, India, Doctors (‘000), 2008-2014

Figure 78: Healthcare Infrastructure, India, PM10 (µg/m3), 2008-2014

Figure 79: Healthcare Infrastructure, India, CO2 emissions (mt per capita), 2008-2014

Figure 80: Healthcare Infrastructure, India, Nurses (per 1,000 Population), 2008-2014

Figure 81: Healthcare Infrastructure, India, Pharmacists (per 1,000 Population), 2008-2014

Figure 82: Healthcare Infrastructure, Dentists (per 1,000 Population), 2008-2014

Figure 83: Healthcare Expenditure, India, Healthcare Expenditure (% of GDP), 2008-2014

Figure 84: Healthcare Expenditure of Ministry of Health and Family Welfare, India, Share by Department (%), 2014

Figure 85: Healthcare Expenditure, India, Major Components of Healthcare Spending, Share (%), 2013

Figure 86: Healthcare Expenditure, India, Public-Private Share (%), 2008-2014

Figure 87: Healthcare Expenditure, India, Pharmaceutical R&D Expenditure ($m), 2008-2014

Figure 88: Healthcare Market, India, Opportunities and Challenges, 2015
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Indian Pharmaceutical Market to Reach $56 billion in 2020, says The authors

Driven by the country’s growing economy and population income, the Indian pharmaceutical market will increase significantly from approximately $21 billion in 2013 to $56 billion in 2020, at a Compound Annual Growth Rate (CAGR) of 15%, forecasts research and consulting firm The authors.

According to the company’s latest report*, the medical device sector will also experience steady growth from $7.5 billion in 2013 to $15.3 billion in 2020, at a CAGR of 11%. In 2012, the main segments were ophthalmic devices (38.3%), In-Vitro Diagnostics devices (9%), hospital supplies (8.9%) and cardiovascular devices (8.1%).

Joshua Owide, Director of Healthcare Industry Dynamics, says: “India is an emerging healthcare market that has remained unsaturated due to the limited penetration of healthcare insurance and poor access to healthcare facilities, especially in rural areas. However, an increasing demand for high-quality services, affordability, and a growing medical tourism industry will provide the necessary momentum for the growth of the pharmaceutical market.”

Still, the lack of transparency in the Indian drug regulatory system and weak patent laws are a major challenge for foreign multinational companies attempting to enter or expand in the Indian healthcare market.

“In order to increase transparency in the regulatory system, the Ministry of Health and Family Welfare is planning to introduce a bill into parliament in 2013, to create the Central Drug Authority (CDA), which will replace the current Central Drug Standard Control Organization. Once the CDA is formed, it will greatly improve the regulatory environment for pharmaceuticals, medical devices and clinical trials,” says Owide.

However, there is also a need for India to improve its healthcare infrastructure in rural areas and expand its universal health coverage, since 80.6% of the population was not covered by any form of health insurance in 2012 - a factor which could hinder further growth of the market.

*CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

This report provides information and analysis on India’s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by The authors’s team of industry experts.
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