Impact of India on the Pharmaceutical Industry – Thematic Research

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The Indian pharmaceutical market was valued at $20.0 billion in 2019 which has increased at a CAGR of more than 6% during the forecast period 2020-2025. In 2020, India was ranked third globally for drug production by volume and 14th by value. The growth of the Indian pharmaceutical market is attributed to innovation in R&D, increased pharmaceutical export, infrastructure development, drug manufacturing, and strong domestic demand.

India has the third largest pharma market in the world by volume, after the US and China, driven by its strong manufacturing capabilities. India is the world’s top vaccine manufacturer and among the largest producers and exporters of active pharmaceutical ingredient (API) and generics globally. India is a leader in generics manufacturing. Better-defined regulations are needed for India to become more competitive in the biosimilars market and more investment is needed in R&D of innovative drugs. The top therapy areas among marketed and pipeline products in India are central nervous system (CNS) and infectious disease, respectively.

Overview of the pharmaceutical industry in India

Overview of the pharmaceutical industry in India

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What are the market dynamics in India’s pharmaceutical sector?

Being the world’s top vaccine manufacturer, India supplies over 60% of global vaccine demand, 40% of US generic demand, and 25% of all drugs in the UK. India has the third largest API industry globally, supplying more than 50% of APIs used by the World Health Organization (WHO). The COVID-19 pandemic further highlighted India’s own dependence on API importation and supply chain risks, and the government is actively implementing schemes to promote domestic API production.

More than 90% of marketed products in India are generic and the country occupies 20% share by volume in the supply of generic medicines globally. The Indian biosimilars market is currently limited but will likely see moderate growth over the next few years, with 15 biosimilars currently in development. There is currently less focus on the domestic development of innovative drugs in India, as the industry is focused on manufacturing. For example, there are just over 100 pipeline innovative therapeutics in development in India.

In comparison, leading therapy areas in China are infectious disease for marketed products and oncology for the pipeline. There are currently six marketed COVID-19 vaccines, half of which have been developed by Indian companies.

What are key trends impacting the pharmaceutical sector in India?

India’s Strong Contract Manufacturing Capabilities: India is a leader in contract manufacturing for the pharmaceutical industry and the largest vaccine producer globally, and it heavily influences other APAC manufacturing markets. Contract service agreements (CSAs) saw an upward trend between 2011 and 2019 and remained high in 2020. A major reason for this trend was the growing demand for COVID-19 vaccine production and distribution.

In Asia, India is the leader by number of COVID-19 CSAs and is second worldwide. Serum Institute and Biological E are Indian contract manufacturing organizations with particularly high volumes of COVID-19 contract manufacturing agreements. As part of the Quad vaccine pact signed in March 2021, India signed multiple international vaccine manufacturing contracts but stopped fulfilling contracts and exporting vaccines in April so it could vaccinate the domestic population. However, sources at WHO suggest that Indian vaccine exports may restart sooner than initially planned, possibly in early Q4 2021. India has the most FDA-approved manufacturing facilities in the world, as well over 2,000 WHO-Good Manufacturing Practice-approved pharmaceutical manufacturing facilities and over 250 European Directorate of Quality Medicines (EDQM)-approved plants. 

Government Investment in Domestic API Production: Despite being a major player in API, India still relies heavily on China for imports of APIs and key starting materials. Disruptions in API importation during the pandemic exposed existing vulnerabilities in India’s supply chain. In addition, the US is aiming to push for “onshore” manufacturing and move it away from Asia, mainly due to ongoing tensions with China. If successful, this could have a significant impact on the India API market, with the FDA estimating that 80% of APIs used in the US originate from India or China.

The government has been actively implementing initiatives to strengthen domestic API production. For example, in July 2020, production-linked incentive (PLI) scheme (1.0) was approved by the Indian government for the promotion of domestic manufacturing and aimed to provide approximately $95 M to reduce India’s dependence on imported APIs, drug intermediaries and key starting materials. This PLI scheme led to approval of funding for Aurobindo Pharma, Solara Active Pharma Sciences, Rajasthan Antibiotics, and Vital Laboratories Pvt, among other manufacturers.

India’s Healthtech Revolution: The health tech industry in India has undergone enormous growth in recent years. This has been driven by improved access to the internet, increased use of smartphones and health apps by consumers, new government policies, and the need to transform a neglected healthcare system burdened with many issues. These include low government investment in healthcare, a major shortage of healthcare professionals to treat its massive population, unaffordable modern treatments compared to traditional medicine, and health inequalities for rural and low-income populations. Like other countries, COVID-19 has had a significant impact on the health tech market in India, with the telemedicine, online diagnostics, and e-pharmacy sectors reporting massive growth.

Which are the key players in the pharmaceutical sector of India?

The leading players in the Indian pharmaceutical sector include Sun Pharma, Aurobindo, Dr. Reddy’s, GlaxoSmithKline, Novartis, Lupin, Cipla, Cadila Healthcare, Micro Labs, and IntraLabs India Pvt Ltd (ILI).

Indian pharmaceutical market, by key players

Indian pharmaceutical market, by key players

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Market report scope

Market Size (Year-2019) $20.0 billion
Growth rate (CAGR) >6%
Forecast period 2020-2025
Key Companies Sun Pharma, Aurobindo, Dr. Reddy’s, GlaxoSmithKline, Novartis, Lupin, Cipla, Cadila Healthcare, Micro Labs, and IntraLabs India Pvt Ltd (ILI).


  • Overview of marketed products including top therapy areas and indications, regulatory and market access details as well as company profiles.
  • Key topics covered for India’s pharma market include trends, value chain, market analysis, opportunities, challenges and unmet needs and example deals.
  • Pipeline and Clinical Trials analysis: Comprehensive data on emerging therapies under development by therapy areas, indications and companies as well as segmented by molecule type.
  • Contract Manufacturing providing insightful review of the key manufacturing hubs in the country as well as of different types of services offered by contract development and manufacturing organizations (CDMO) in India.

Key Highlights

India has the third largest pharma market in the world by volume, after the US and China, driven by its strong manufacturing capabilities.

India is a leader in generics manufacturing. Better-defined regulations are needed for India to become more competitive in the biosimilars market and more investment is needed in the R&D of innovative drugs.

The top therapy areas among marketed and pipeline products in India are central nervous system (CNS) and infectious disease, respectively.

Reasons to Buy

The report will enable you to:

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential.
  • Develop business strategies by understanding the trends shaping and driving the Indian pharma market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact India’s pharma market in the future.
  • Design your development strategy through a review of potential novel targets or combinations across indications.
  • Understand the challenges and strategies impacting the development of therapy agents in Indian preclinical studies and clinical trials.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the classes of therapies and indications that present maximum opportunities for consolidations, investments and strategic partnerships in India.

Sun Pharma
Dr. Reddy’s Laboratories
Cadila Healthcare
Micro Labs
IntraLabs India Pvt

Table of Contents

1. Table of Contents (PowerPoint Deck)

1.1. Preface

1.1.1. Table of Contents

1.1.2. Abbreviations

1.1.3. Related Reports

1.2. Executive Summary

1.2.1. Key Findings

1.3. Introduction

1.3.1. India’s Pharma Market: Growing Capabilities But More Investment Needed in Innovation

1.3.2. Key Influencer Twitter Chat Related to India

1.4. Trends

1.4.1. Industry Trends – India’s Strong Contract Manufacturing Capabilities

1.4.2. Industry Trends – Government Investment in Domestic API Production

1.4.3. Industry Trends – The India Pharma Market Is Dominated By Generics

1.4.4. Industry Trends – Low Levels of R&D Innovation

1.4.5. Industry Trends – Overcoming Drug Scandals

1.4.6. Industry Trends – CNS and Pain Lead the Indian Pharma Market

1.4.7. Industry Trends – India Has a Thriving Medical Tourism Industry

1.4.8. Regulatory Trends – Regulatory Trends in India

1.4.9. Technology Trends – India’s Healthtech Revolution

1.5. Value Chain

1.6. Market Analysis

1.6.1. India’s Pharma Market Will See Moderate Growth to 2025

1.6.2. Contract Service Agreements and Licensing Agreements Are Leading Deal Types in India

1.6.3. Clinical Research Leads Contract Service Agreement Activity in India

1.6.4. Examples of COVID-19 CSAs in India 2020-2021: All Companies

1.6.5. Licensing Agreements Lead Strategic Alliance Activity in India

1.6.6. Examples of Licensing Agreements in India 2018-2021

1.6.7. Acquisitions Lead With Over Half of M&A Deals in India

1.6.8. Examples of M&As in India 2018-2021

1.6.9. Private Equity Leads Capital Raising Deal Activity in India

1.6.10. Examples of Capital Raisings in India 2018-2021

1.6.11. Examples of Recent Health Technology Deals in India

1.7. Clinical Trials

1.7.1. The Number of Clinical Trials in India

1.7.2. The Majority of Trials in India Are Mid/Late Phase

1.7.3. CNS Indications Dominate Clinical Trials in India

1.7.4. Major Sponsors of Clinical Trials in India

1.7.5. Top 10 Clinical Trials Sites in India by Historical Volume

1.7.6. Top 10 Clinical Trial Investigators in India by Historical Volume

1.7.7. Top 10 Trials in India by Completed Enrollment Since 2019

1.8. Marketed Products

1.8.1. US Is the Largest Importer of Pharmaceuticals from India

1.8.2. Generics Have the Largest Share of Marketed Drugs in India

1.8.3. Majority of Marketed Drugs in India Target Pain

1.8.4. Leading Generics Manufacturers in India

1.8.5. Leading Biosimilar Manufacturers in India

1.8.6. The Majority of Marketed Biologics in India Target Infectious Disease

1.8.7. Examples of India-Approved Biologics (Innovator, Vaccines, etc.)

1.8.8. Examples of India-Approved Biosimilars

1.8.9. Currently Approved COVID-19 Vaccines in India

1.8.10. India Has Second Highest Number of COVID-19 Vaccinations

1.9. Pipeline Products

1.9.1. Majority of Pipeline Drugs Are in Phase II and III and Most Are Innovator Biologics

1.9.2. Cadila Healthcare Leads in Pipeline Products in India

1.9.3. Infectious Disease Leads Pipeline Drug Development in India

1.9.4. Most Innovator Biologics Are in the Infectious Disease Space

1.9.5. Pipeline COVID-19 Vaccines and Treatments in India

1.9.6. Examples of Pipeline COVID-19 Vaccines and Other Treatments in India

1.10. Contract Manufacturing in India

1.10.1. Contract Manufacturing Companies and Facilities in India

1.10.2. Sun Pharma Has the Most Contract Manufacturing Facilities in India

1.10.3. India Is a Global Leader in API Chemical Manufacturing

1.10.4. FDA/EMA – Approved CDMO Facilities Distribution in India

1.11. Regulatory and Market Access

1.11.1. Overview of Healthcare System in India

1.11.2. Organization of Healthcare System in India

1.11.3. Drug Approval Process in India

1.11.4. Regulation of Drugs in India – Generics

1.11.5. Regulation of Drugs in India – Biosimilars

1.11.6. Market Access for Drugs in India – Drug Pricing

1.11.7. Market Access for Drugs in India – Reimbursement

1.11.8. Market Access for Drugs in India – Regulatory Landscape

1.12. Market Drivers and Barriers

1.12.1. Market Drivers in India

1.12.2. Market Barriers in India

1.13. Companies

1.13.1. Sun Pharma

1.13.2. Aurobindo

1.13.3. Dr. Reddy’s

1.13.4. GlaxoSmithKline

1.13.5. Novartis

1.13.6. Lupin

1.13.7. Cipla

1.13.8. Cadila Healthcare

1.13.9. Micro Labs

1.13.10. IntraLabs

1.14. Appendix

1.14.1. Bibliography

1.14.2. Key Themes Impacting the Pharmaceutical Industry

1.14.3. Our Thematic Research Methodology

1.14.4. About the Authors

1.14.5. Contact Us

1.14.6. Disclaimer

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