The document discusses the global pharmaceutical industry. It provides data showing steady growth in global pharmaceutical sales from 2003-2012, with the US market accounting for the largest share. The top 10 pharmaceutical companies are also listed. R&D spending and trends in major markets like the US, Europe, and Japan are examined. Details are also provided about the large and growing pharmaceutical industries in India and their competitive advantages in generics manufacturing.
Present Status and Scope of Pharmaceutical industry in IndiaMadhuraNewrekar
The Indian pharmaceutical industry came into existence in 1901, when Bengal Chemical & Pharmaceutical Company started its maiden operation in Calcutta.
The next few decades saw the pharmaceutical industry moving through several phases, largely in accordance with government policies. The development, present status and scope of pharmaceutical industry in India.
Present Status and Scope of Pharmaceutical industry in IndiaMadhuraNewrekar
The Indian pharmaceutical industry came into existence in 1901, when Bengal Chemical & Pharmaceutical Company started its maiden operation in Calcutta.
The next few decades saw the pharmaceutical industry moving through several phases, largely in accordance with government policies. The development, present status and scope of pharmaceutical industry in India.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
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Pharmaceutical Industry-EXPORT IMPORT INDIA
The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices
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Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
This is a Equity Research Report on Pharmaceutical Industry.
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Presentation studies the Impact of COVID on Different Sectors of Indian Stock Market. Article observes significant changes in Indian Industrial Sectors in the wake of COVID 19 Pandemic.
Pharmaceutical market india a comprehensive industry analysis - Reports CornerReports Corner
"1.0 Summary
“Pharmaceutical Market: India, A Competitive Industry Analysis” by Kelly Scientific Publications is a comprehensive report on the pharmaceutical and biotechnology industry in India and its impact on international markets. This report scrutinises top Indian pharmacos and their battle within domestic and international therapeutic markets. The business environment in which they compete is analysed as are key drivers, constraints, challenges and opportunities.
The Indian pharmaceutical market is set to become the eight largest pharma market globally by 2015. In 2012 it was worth $13 billion. It is forecast to reach $50 billion by 2015 and increase its dominance as a leading player in Asia. It is predicted that the Indian pharma market will be a significant global competitor by 2020 with an expected worth of up to $74 billion.
This report describes the current therapeutics that are propelling the biopharmaceutical market in India. It examines the current economic climate and how India compares to other emerging markets and also evolved markets such as the US and Europe. Current developments relating to patent expirations, government funding, and regulations are discussed. The emerging trends that appear in key sub-markets such as generics, oncology, cardiovascular, diabetes and vaccines are elucidated and analysed.
This study reveals market figures of the overall Indian pharmaceutical market and sub-markets. Forecast projections and future growth rates are provided to give the reader a forthcoming perspective of this growing industry.
https://www.reportscorner.com/reports/15826/Pharmaceutical-Market:-India-A-Comprehensive-Industry-Analysis/
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.
Similar to Pharmaceutical Industry Global & Indian (20)
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2. PHARMACEUTICAL INDUSTRY
The pharmaceutical industry develops, produces, and
markets drugs or pharmaceuticals licensed for use as
medication .
3. GLOBAL PHARMACEUTICAL MARKET
600
580
750
710
670
790
959
940
900
880
IN US
BILLION $
0 200 400 600 800 1000 1200
2012
2011
2010
2009
2008
2007
2006
2005
2004
2003
Pharma Sales
Pharma Sales
Source of
Data
By Deloitte
4. Globally region wise Sales
959 US BILLION$
2012-2013
America
Europe
Australia, Asia and
Africa
Japan
45.36
12.02
18.26
24.36
Source of Data
By Deloitte
5. MAJOR PLAYERS OF THE WORLD
1. Johnson & Johnson
2. Pfizer
3. Roche
4. GlaxoSmithKline
5. Novartis
6. Sanofi
7. AstraZeneca
8. Abbott Laboratories
9. Merck & Co.
10.Bayer HealthCare
6. MAIN TRENDS
The research based pharmaceutical industry is
playing a major role in reviving Europe’s economy.
There is rapid growth in market and research
environment in the emerging economies such as
brazil, china and India.
In 2012 Nor th America accounted for 41.0% of world
pharmaceutical sales compared with 26.7% for
Europe.
8. PHARMACEUTICAL RESEARCH IN EUROPE
The cost of developing a new chemical was
estimated at 1172 million pounds.
On average, only one to two of every 10,000
substances produced in laboratories will successfully
pass all stages of development process required to
become a marketable medicine.
11. IMPORTANCE OF RESEARCH AND
DEVELOPMENT.
In 2011 the pharmaceutical industry in Europe invested
about € 29,200Million in R&D.
Facing increased competition from emerging economies
like India Brazil and China.
The change of focus towards emerging economies.
According to EUROSTAT data pharmaceutical sector is the
sector contributing huge amount of money to R&D.
12. PRICE STRUCTURE
Distribution margins, are general ly fixed by governments, and
VAT rates vary from country to country in Europe
On average, approximately 35% of the retai l price of a
medicine goes not to the manufacturer, but rather to the
distributors (pharmacists and wholesalers) and state
Breakdown of the retai l
price of a medicine in
2011 (%) .
13. GENERICS
It is usually produced by manufacturer not by inventor.
Marketed according to Intellectual Proper ty Rights.
The market share is higher in European union.
15. ADDED VALUES OF MEDICINES IN HEALTH
CARE
On average, 16.6% of total health expenditure in Europe being
spent on pharmaceuticals and other medical nondurables.
In costly diseases such as cancer and rheumatoid, ar thritis,
medicines account for even less than 10% of the total disease
costs.
18. 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
have made India a major destination for generic drug
manufacturing.
19. MARKET SIZE
From a market size of US$ 12.6 bi l l ion in 2009, the Indian
pharmaceutical market wi l l grow to US$ 55 bi l l ion by 2020,
with the potential to reach US$ 70 bi l lion in an aggressive
growth scenario. In a pessimistic scenario characterized by
regulatory controls and economic slowdown, the market wi l l
be depressed but is sti l l expected to reach US$ 35 bi l l ion.
India currently expor ts drug intermediates, Active
Pharmaceutical Ingredients (APIs) , Finished Dosage
Formulations (FDFs) , Bio-Pharmaceuticals, and Cl inical
Services across the globe.
20. 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.
Indian vaccines are expor ted to 150 countries.
The projected human resource requirement in the Indian
pharma sector is estimated to be about 21,50,000 by 2020
21. ROAD AHEAD
The growth in Indian domestic market wi l l be boosted by
increasing consumer spending, rapid urbanization, increasing
healthcare insurance and so on.
The l ifestyle segments such as cardiovascular, anti -diabetes,
anti -depressants and anti -cancers wi l l continue to be lucrative
and fast growing owing to increased urbanization and change
in l i festyle patterns.
For the US market, Indian companies are developing niche
por tfol ios in various segments. High margin injectables,
dermatology, respiratory, biogenerics, complex generics, etc. ,
have become areas of interest.
22. ADVANTAGES
Due to a genetically diverse population and availability of
ski l led doctors, India has the potential to attract huge
investments to its cl inical trial market.
Demand for generic medicines in rural markets has seen a
sharp growth. Various companies are investing in the
distribution network in rural areas.
Growing demand could open up the market for production of
high-end drugs in India.
The domestic pharma sector is witnessing strong growth due
to higher penetration in tier - I I and tier - I I I cities and greater
focus on the largely - untapped rural market.
23. India is one of the fastest -growing pharmaceutical markets in
the world and has established itself as a global manufacturing
and research hub. A large raw material base and the
avai lability of a ski l led workforce gives the industry a definite
competitive advantage.
The rise of pharmaceutical outsourcing and investments by
multinational companies (MNCs), al l ied with the country's
growing economy, committed health insurance segment and
improved healthcare faci l ities, is expected to drive the
market's growth.
I n d i a ’ s c o s t o f p ro d u c t io n i s s i g n i fican t ly l owe r t h a n t h a t o f
the USA and almost hal f of that of Europe.
24. GOVERNMENT SUPPORT
The Government of India plans to set up a US$ 640 mi l l ion
venture capital fund to boost drug discovery and strengthen
pharma infrastructure. Government expenditure on health has
increased from US$ 14 bi l lion in 2008 to US$ 23 bi l l ion in
2011.
FDI in India al lowed upto 100% on pharma industry.
Al location of INR 5000 Mi l l ion to set up four more institutions
of the stature of AI IMS in Andhra Pradesh, West Bengal,
Maharashtra and U.P.
Ful l exemption from excise duty is being provided for
HIV/AIDS drugs and diagnostic kits.
25. OPPORTUNITY FOR FUTURE
Sites that al low onl ine ordering and del ivery of prescriptions.
Manufacturer sponsored sites to access rel iable health care
information.
Apps that remind patients to take medicine, schedule fol low
up doctors visits.
Apps for patients to use as tools to monitor their health.
Customized interactive platforms with a focus on doctor
engagement for sales reps to uti l ize during of fice visits.
26.
27. Since Pfizer was founded by cousins Charles Pfizer and Charles Erhart in 1849, the
pharmaceutical company has remained dedicated to discovering and developing new, and
better, ways to prevent and treat disease and improve health and well being for people
around the world.
CEO: Ian Read
Pfizer Locations: Corporate Headquarters:
New York, NY (USA)
Stock Exchange Listings: New York Stock Exchange (PFE)
London (PFZ)
Euronext
Swiss
29. Revenue, Net Income
Millions of Dollars 2013 2012 2011
REVENUE $ 51,584 54,657 $ 61,035
NET INCOME $ 22,003 $ 14,570 $ 10,009
Research and
development
expenses
$ 6,678 $ 7,482 $ 8,681
30. REVENUE
Total revenues were $51.6 billion in 2013, a
decrease of 6% compared to 2012, Which
reflects an operational decline of $1.9 billion,
or 4%. Total revenues were $54.7 billion in
2012, a decrease of 10% compared to 2011,
which reflects an operational decline of $5.0
billion, or 8%.
31. THE OPERATIONAL DECREASE WAS
PRIMARILY THE RESULT OF:
The continued erosion of branded Lipitor (Cholesterol fighter)
in the U.S. , developed Europe and cer tain other developed
markets (approximately $1.7 bi l l ion);
The loss of exclusivity for Geodon in March 2012 in the U.S.
(approximately $130 mi l l ion) ;
Other product losses of exclusivity (approximately $1.3
bi l lion);
Decreased government purchases of the Prevnar family of
products and Enbrel in cer tain emerging markets
(approximately $160 mi llion) ; and lower revenues from
generic atorvastatin (approximately $145 mi l l ion)
32. R&D EXPENSES
2013 v. 2012 : R&D expenses decreased 11% in 2013, compared
to 2012, primarily due to:
-- lower charges related to implementing cost -reduction and
productivity initiatives.
2012 v. 2011: R&D expenses decreased 14% in 2012, compared
to 2011, primarily due to:
-- savings generated by the discontinuation of cer tain therapeutic
areas and R&D programs in connection with their previously
announced cost -reduction and productivity initiatives.
33.
34. SUN PHARMA
I t was establ ished in 1983.
Headquar ters are in Mumbai , Maharasht ra.
I t was l isted on the stock exchange in 1994.
Chai rman is Israel Makov.
25 manufacturing faci l i ties in 4 count r ies.
I t ’ s ma j o r a c q u i s i t i o n s l i k e Ta r o , U R L Pharma and Mi lmet , Able and
many more.
2014- Acqui red Ranbaxy for 4bi l l ion$.
35. Sun Pharma to sustain its ranking as the 5th largest
global specialty generic pharma company
No. 1 pharma company in India
No. 1 by prescriptions in 13 specialty segments, Strong
OTC business with trusted brands
No. 1 Indian pharma company in US market.
More than 75% of its sales from international markets.
36. REVENUE COMPOSITION
Gross Annual Sales (Rs 161,995 million )
US Formulations ( 60%
)
International Generics (
38% )
API's ( 11% )
India Branded Generics
( 23% )