The Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US, and 25% of medicine in the UK. It is dominated by small and medium enterprises, though the largest 250 companies control 70% of the Indian market. India has gained prominence as the pharmacy of the world and biggest generic supplier due to its innovatively engineered generic drugs and active pharmaceutical ingredients. It accounts for around 30% of the $70-80 billion US generics market by volume and 10% by value.

1. BIOCON INDIA
GROUP

2. INDIAN PHARMACEUTICAL SECTOR
In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and
bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were
exported, mostly to the United States and Russia. Most of the players in the market are small-to-
medium enterprises; 250 of the largest companies control 70% of the Indian market . Thanks to the
1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago.
Most pharma companies operating in India, even the multinationals, employ Indians almost
exclusively from the lowest ranks to high level management. Homegrown pharmaceuticals, like
many other businesses in India, are often a mix of public and private enterprise.
In terms of the global market, India currently holds an accountable share and is known as pharmacy
of the world and biggest generic supplier. India gained its foothold on the global scene with its
innovatively engineered generic drugs and active pharmaceutical ingredients (API),
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. Growth in other fields notwithstanding, generics are still a
large part of the picture. India is the largest provider of generic drugs globally. Indian pharmaceutical
sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of
generic demand in the US and 25 per cent of all medicine in UK. India is the largest contributor in
UNESC with over 50-60% share .

3. ANALYSIS INDIAN PHARMACEUTICAL SECTOR

4. Biocon Limited is an Indian biopharmaceutical company based
in Bangalore, India by Kiran Mazumdar-Shaw, the founder. The Company
manufactures generic active pharmaceutical ingredients (APIs) that are sold in over
120 countries across the globe, including the developed markets of the United
States and Europe . It also manufactures novel biologics, as well as, biosimilar
insulins and antibodies, which are sold in India as branded formulations. Biocon's
biosimilar products are also sold in both bulk and formulation forms in several
emerging markets . In research services,
Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon.
Biocon Indian Limited

5. KEY THERAPEUTIC
AREAS

6. Timeline
Biocon was founded in 1978 with ₹10,000 (US$140) as the initial capital.
Biocon's first product to go to market was papain, an enzyme found in papaya which is
used to prevent beer from turning hazy . Until 1983, the company blended enzymes and
supplied them to brewing, textiles, biofuels, animal feed and other such industries across
the world.
In 1989, the Irish Biocon was acquired by Unilever.
Biocon's milestone events in each year are as follows:
•29 November 1978 - Biocon India is incorporated as a joint venture between Biocon
Biochemicals Ltd. of Ireland and Kiran Mazumdar-Shaw.
•1979 - Becomes the first Indian company to manufacture and export enzymes to USA
and Europe.
•1989 - Unilever acquires Biocon Biochemicals Ltd. in Ireland and merges it with its
subsidiary, Quest International; Biocon receives US funding for proprietary

7. •2001 - Becomes the first Indian company to be approved by USFDA for the manufacture
of lovastatin; Pla Fractor is granted a US 2001 and worldwide patent.
•2003 - Biocon becomes the first company worldwide to develop human insulin on
a Pichia expression system.
•2006 - BIOMAb EGFR, first indigenously developed humanised monoclonal antibody for
head-and-neck cancer is launched and Dr. APJ Abdul Kalam inaugurates India's Largest
Biotech-Hub "Biocon Park".
•* 2008 - Biocon acquires a 70% stake in German pharmaceutical company, AxiCorp
GmbH.
•2009 – Syngene -Bristol Myers Squibb research facility is established in Bengaluru.
•2009 - Mylan announces strategic collaboration with Biocon to Enter the Global Generic
Biologics Market.
•2010 - Biocon expands to Malaysia, biopharmaceutical manufacturing and R&D facility
established in Iskandar Malaysia, Johor.
Contd...

8. •2011 - Biocon launches INSUPen®, a convenient and affordable reusable insulin
delivery device.
•2012 - Abbott announces collaboration with Syngene to Open First Nutrition R&D
Centre in India.
•2013 - Biocon launches biologic drug ALZUMAb to treat psoriasis.
•2014 - Biocon launches world's first biosimilar drug CANMAb to treat breast cancer.
•2015 - Biocon launches hepatitis-C drug in India under brand name CIMIVIR-L.
•2016 - Becomes the first Indian company to launch a biosimilar Insulin Glargine pen in
Japan.
•2016 - Syngene sets up Amgen R&D centre in Bangalore.
•2017- Biocon's Insugen is the first locally manufactured biosimilar product to be
approved for sale by the Malaysian drug regulator.
•2017 - USFDA approves Mylan-Biocon's biosimilar for cancer drug Herceptin.
•2018 - Biocon, Mylan get European Commission approval to market biosimilar insulin
glargine.
Contd...

11. CASE STUDY :
Q1. What are the advantages and disadvantages of starting and operating a pharmaceutical
firm in India?
ADVANTAGES
• High quality work force
• Indian patent laws
• Diverse population for clinical trials
• Policy support for manufacturing firms
• Well established pharmaceutical industry
• Huge domestic market
• Low cost operations
• Foreign investments