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Pharmaceutical Industry Analysis
VARUN KESAVAN, M.PHIL RESEARCH SCHOLAR, BHARATHIAR SCHOOL OF
MANAGEMENT ENTREPRENEUR DEVELOPMENT, BHARATHIAR UNIVERSITY,
COIMBATORE. Email Id – varunkesavan@yahoo.com
Indian Pharma Sector
India is among the top six global pharmaceutical producers in the world. Indian vaccines are
exported to 150 countries. India produces 40-70 per cent of the WHO demand for DPT & BCG
and 90 per cent of measles vaccine. Approximately 70 per cent of the patients in developing
countries receive Indian medicines through NGOs like The Clinton Foundation, Bill & Melinda
Gates Foundation, Doctors without Borders, the UNCTAD etc.
Presently there are 10,500 manufacturing units and over 3,000 pharma companies in India,
growing at an exceptional rate. India has about 1,400 WHO GMP approved manufacturing units.
India has been accredited with approximately 1,105 CEPs, more than 950 TGA approvals and
584 sites approved by the USFDA. Globally more than 90 per cent of formulations approvals for
Anti-retroviral (ARVs), Anti-tubercular & Anti-malarial (WHO pre-qualified) has been granted to
India. Manufacturing costs in India are approximately 35-40 per cent of those in the US due to
low installation and manufacturing costs. India ranks amongst the top global generic formulation
exporters in volume terms.
India's exports of pharma and drugs stood at US$ 16.8 bn. India exports all forms of
pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian
medicines. The country's pharmaceutical industry accounts for about 1.4 per cent of the global
pharmaceutical industry in value terms and 10 per cent in volume terms.
2
The Government of India has announced a host of measures to create a facilitating environment
for the Indian pharmaceutical industry. The policies of the Government of India are aimed at
building more hospitals, boosting local access to healthcare, improving the quality of
pharmaceuticals, and improving the quality of medical training. The Government of India is
committed to setting up robust healthcare and delivery mechanisms. India is well placed to
become one of the major drivers in providing healthcare to all while controlling the ever-
increasing healthcare spend of both developed and developing nations
Market Size
The Indian pharma industry, which is expected to grow over 15 per cent per annum between
2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual
rate of 5 per cent between the same periods. The market is expected to grow to US$ 55 billion
by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size,
India has also maintained its lead over China in pharmaceutical exports with a year-on-year
growth of 11.44 per cent to US$ 12.91 billion in FY 2015-16, according to data from the Ministry
of Commerce and Industry. Imports of pharmaceutical products rose marginally by 0.80 per cent
year-on-year to US$ 1,641.15 million.
Overall drug approvals given by the US Food and Drug Administration (USFDA) to Indian
companies have nearly doubled to 201 in FY 2015-16 from 109 in FY 2014-15. The country
accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80
billion US generics market.
3
India's biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio-
industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a
year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and
diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs
12,600 crore (US$ 1.88 billion).
AN OVERVIEW OF INDIAN PHARMA SECTOR
 As per 'Pharma Vision 2020', the Government of India aims to make India a global leader in
end-to-end drug manufacturing.
 Manufacturing costs in India are approximately 35-40 per cent of those in the US due to low
installation and manufacturing costs.
 Pharmaceutical exports from India have grown at a CAGR of 21 per cent over the last
decade.
 Indian vaccines are exported to 150 countries.
 The projected human resource requirement in the Indian pharma sector is estimated to be
about 21, 50,000 by 2020.
4
Pharma Manufacturing & Patents
 India is home to 10,500 manufacturing units and over 3,000 pharma companies.
 India accounts for 36.9 per cent (3,411) of the 9,296 Drug Master Files (DMFs) filed with the
USA, which is the highest outside of the USA (as on December 31, 2013).
 Higher spending on R&D, owing to products patents has made India a major destination for
generic drug manufacturing.
 India has been accredited with approximately 1,105 CEPs, more than 950 TGA approvals
and 584 sites registered by the USFDA.
 Following the introduction of product patents, several multinational companies are expected
to launch patented drugs in India.
Exports
 India's pharma exports stood at US$ 15 billion in 2013-14.
 Pharmaceutical exports from India have grown at a CAGR of 21 per cent over the last
decade.
 India ranks fourth in terms of the total pharma market share in the Asia Pacific.
 Approximately 70 per cent of the patients in developing countries receive Indian medicines
through NGOs like The Clinton Foundation, Bill & Melinda Gates Foundation, Doctors
without Borders, the UNCTAD etc.
5
Household Spend & Growth in Rural India
 The Government of India is committed to setting up robust healthcare and delivery
mechanisms.
 Due to increasing population and income levels, demand for high-end drugs in India is
expected to reach US$ 8 billion by 2015.
 Expenditure on pharmaceuticals is likely to increase to over 40 per cent of the total spending
on healthcare by households by 2015.
 With 70 per cent of India's population residing in rural markets, various pharma companies
are investing in the distribution network in rural areas.
Road Ahead
The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, driven
by increasing consumer spending, rapid urbanization, and raising healthcare insurance among
others.
Going forward, better growth in domestic sales would also depend on the ability of companies to
align their product portfolio towards chronic therapies for diseases such as such as
cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.
The Indian government has taken many steps to reduce costs and bring down healthcare
expenses. Speedy introduction of generic drugs into the market has remained in focus and is
expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health
programmes, lifesaving drugs, and preventive vaccines also augurs well for the pharmaceutical
companies.

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Pharmaceutical Industry Analysis

  • 1. 1 Pharmaceutical Industry Analysis VARUN KESAVAN, M.PHIL RESEARCH SCHOLAR, BHARATHIAR SCHOOL OF MANAGEMENT ENTREPRENEUR DEVELOPMENT, BHARATHIAR UNIVERSITY, COIMBATORE. Email Id – varunkesavan@yahoo.com Indian Pharma Sector India is among the top six global pharmaceutical producers in the world. Indian vaccines are exported to 150 countries. India produces 40-70 per cent of the WHO demand for DPT & BCG and 90 per cent of measles vaccine. Approximately 70 per cent of the patients in developing countries receive Indian medicines through NGOs like The Clinton Foundation, Bill & Melinda Gates Foundation, Doctors without Borders, the UNCTAD etc. Presently there are 10,500 manufacturing units and over 3,000 pharma companies in India, growing at an exceptional rate. India has about 1,400 WHO GMP approved manufacturing units. India has been accredited with approximately 1,105 CEPs, more than 950 TGA approvals and 584 sites approved by the USFDA. Globally more than 90 per cent of formulations approvals for Anti-retroviral (ARVs), Anti-tubercular & Anti-malarial (WHO pre-qualified) has been granted to India. Manufacturing costs in India are approximately 35-40 per cent of those in the US due to low installation and manufacturing costs. India ranks amongst the top global generic formulation exporters in volume terms. India's exports of pharma and drugs stood at US$ 16.8 bn. India exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines. The country's pharmaceutical industry accounts for about 1.4 per cent of the global pharmaceutical industry in value terms and 10 per cent in volume terms.
  • 2. 2 The Government of India has announced a host of measures to create a facilitating environment for the Indian pharmaceutical industry. The policies of the Government of India are aimed at building more hospitals, boosting local access to healthcare, improving the quality of pharmaceuticals, and improving the quality of medical training. The Government of India is committed to setting up robust healthcare and delivery mechanisms. India is well placed to become one of the major drivers in providing healthcare to all while controlling the ever- increasing healthcare spend of both developed and developing nations Market Size The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same periods. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, India has also maintained its lead over China in pharmaceutical exports with a year-on-year growth of 11.44 per cent to US$ 12.91 billion in FY 2015-16, according to data from the Ministry of Commerce and Industry. Imports of pharmaceutical products rose marginally by 0.80 per cent year-on-year to US$ 1,641.15 million. Overall drug approvals given by the US Food and Drug Administration (USFDA) to Indian companies have nearly doubled to 201 in FY 2015-16 from 109 in FY 2014-15. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market.
  • 3. 3 India's biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio- industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs 12,600 crore (US$ 1.88 billion). AN OVERVIEW OF INDIAN PHARMA SECTOR  As per 'Pharma Vision 2020', the Government of India aims to make India a global leader in end-to-end drug manufacturing.  Manufacturing costs in India are approximately 35-40 per cent of those in the US due to low installation and manufacturing costs.  Pharmaceutical exports from India have grown at a CAGR of 21 per cent over the last decade.  Indian vaccines are exported to 150 countries.  The projected human resource requirement in the Indian pharma sector is estimated to be about 21, 50,000 by 2020.
  • 4. 4 Pharma Manufacturing & Patents  India is home to 10,500 manufacturing units and over 3,000 pharma companies.  India accounts for 36.9 per cent (3,411) of the 9,296 Drug Master Files (DMFs) filed with the USA, which is the highest outside of the USA (as on December 31, 2013).  Higher spending on R&D, owing to products patents has made India a major destination for generic drug manufacturing.  India has been accredited with approximately 1,105 CEPs, more than 950 TGA approvals and 584 sites registered by the USFDA.  Following the introduction of product patents, several multinational companies are expected to launch patented drugs in India. Exports  India's pharma exports stood at US$ 15 billion in 2013-14.  Pharmaceutical exports from India have grown at a CAGR of 21 per cent over the last decade.  India ranks fourth in terms of the total pharma market share in the Asia Pacific.  Approximately 70 per cent of the patients in developing countries receive Indian medicines through NGOs like The Clinton Foundation, Bill & Melinda Gates Foundation, Doctors without Borders, the UNCTAD etc.
  • 5. 5 Household Spend & Growth in Rural India  The Government of India is committed to setting up robust healthcare and delivery mechanisms.  Due to increasing population and income levels, demand for high-end drugs in India is expected to reach US$ 8 billion by 2015.  Expenditure on pharmaceuticals is likely to increase to over 40 per cent of the total spending on healthcare by households by 2015.  With 70 per cent of India's population residing in rural markets, various pharma companies are investing in the distribution network in rural areas. Road Ahead The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, driven by increasing consumer spending, rapid urbanization, and raising healthcare insurance among others. Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise. The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programmes, lifesaving drugs, and preventive vaccines also augurs well for the pharmaceutical companies.