1. Prepared by : AMIN BHAVIK S
Roll No : 02
B Pharm Semester VI
KBIPER.
28-Feb-2011 1

2. Pharmaceutical Industries
 The Pharmaceutical Industry develops, produces,
and markets drugs licensed for use as medications.
 Pharmaceutical companies can deal in generic and/or
brand medications.
 They are subject to a variety of laws and regulations
regarding the patenting, testing and marketing of drugs.
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3. HISTORY
 Most of today's major pharmaceutical companies were founded
in the late 19th and early 20th centuries.
 Key discoveries of the 1920s and 1930s, such as insulin and
penicillin, became mass-manufactured and distributed.
 Switzerland, Germany and Italy had particularly strong
industries, with the UK, US, Belgium and the Netherlands
following suit.
 The industry remained relatively small scale until the 1970s
when it began to expand at a greater rate.
 Pharmaceutical manufacturing became concentrated, with a few
large companies holding a dominant position throughout the
world and with a few companies producing medicines within
each country.
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4.  The pharmaceutical industry entered the 1980s
pressured by economics and a host of new regulations,
both safety and environmental, but also transformed by
new DNA chemistries and new technologies for analysis
and computation.
 Managed and Health maintenance organizations(HMOs)
spread during the 1980s as part of an effort to contain
rising medical costs, and the development of preventative
and maintenance medications became more important.
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5. RESEARCH AND DEVELOPMENT
 “Drug discovery “ is the process by which
potential drugs are discovered or designed. In the
past most drugs have been discovered either by
isolating the active ingredient from traditional
remedies or by serendipitous discovery.
 “Drug development ― refers to activities
undertaken after a compound is identified as a
potential drug in order to establish its suitability as
a medication.
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6. Cost Of Innovation
 Drug discovery and development is very
expensive.
 Each year, only about 25 truly novel drugs (New
chemical entities) are approved for marketing.
This approval comes only after heavy investment
pre-clinical development and clinical trials, as well
as a commitment to ongoing safety monitoring.
 Drugs which fail part-way through this process
often incur large costs, while generating no
revenue in return.
 If the cost of these failed drugs is taken into
account, the cost of developing a successful new
drug (New Chemical Entity or NCE), has been 6

7.  These estimates also take into account the
oppurtunity cost of investing capital many years
before revenues are realized.
 Because of the very long time needed for
discovery, development, and approval of
pharmaceuticals, these costs can accumulate to
nearly half the total expense.
 Some approved drugs, such as those based on
re-formulation of an existing active ingredient (also
referred to as Line-extensions) are much less
expensive to develop.
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8. Industry revenues
 For the first time ever, in 2006, global spending on
prescription drugs topped $643 billion, even as growth
slowed somewhat in Europe and North America.
 The United States accounts for almost half of the global
pharmaceutical market, with $289 billion in annual sales
followed by the EU and Japan.
 Emerging markets such as China, Russia, South Korea
and Mexico outpaced that market, growing a huge 81
percent.
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9.  US profit growth was maintained even whilst other top
industries saw little or no growth.
 Despite this, "..the pharmaceutical industry is — and has been
for years — the most profitable of all businesses in the U.S.
 In the annual Fortune 500 survey, the pharmaceutical industry
topped the list of the most profitable industries, with a return of
17% on revenue.
 Pfizer's cholesterol pill Lipitor remains a best-selling drug
world wide. Its annual sales were $12.9 billion, more than
twice as much as its closest competitors.
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10. Market leaders in terms
of revenue
 Thefollowing is a list of the 20 largest
pharmaceutical and biotech companies ranked by
healthcare revenue. Some companies (e.g.,
Bayer, Johnson and Johnson and Procter &
Gamble) have additional revenue not included
here.
 The phrase ―Big Pharma” is often used to refer to
companies with revenue in excess of $3 billion,
and/or R & D expenditure in excess of $500
10
million.

11. Total Healthcare Net income/
Revenue
Revenues R&D 2006 (loss) 2006 Employees
Rank Company Country
(USD milli (USD millio (USD millio 2006
2008
ons) ns) ns)
1 Novartis Switzerland 53,324 7,125 11,053 138,000
2 Pfizer USA 48,371 7,599 19,337 122,200
3 Bayer Germany 44,200 1,791 6,450 106,200
United
4 GlaxoSmithKline 42,813 6,373 10,135 106,000
Kingdom
Johnson and
5 USA 37,020 5,349 7,202 102,695
Johnson
6 Sanofi-Aventis France 35,645 5,565 5,033 100,735
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12. Healthcare Net income/
Revenue Total Revenues Employees
Company Country R&D 2006 (loss) 2006
Rank 2008 (USD millions) 2006
(USD millions) (USD millions)
Hoffmann–La
7 Switzerland 33,547 5,258 7,318 100,289
Roche
United
8 AstraZeneca 26,475 3,902 6,063 50,000+
Kingdom
9 Merck & Co. USA 22,636 4,783 4,434 74,372
Abbott
10 USA 22,476 2,255 1,717 66,800
Laboratories
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13. Net
Total Healthcare
Revenue income/ Employees
Company Country Revenues R&D 2006
Rank 2008 (loss) 2006 2006
(USD millions) (USD millions)
(USD millions)
Bristol-Myers
12 USA 17,914 3,067 1,585 60,000
Squibb
Eli Lilly and
13 USA 15,691 3,129 2,663 50,060
Company
14 Amgen USA 14,268 3,366 2,950 48,000
Boehringer
15 Germany 13,284 1,977 2,163 43,000
Ingelheim
Schering-
16 USA 10,594 2,188 1,057 41,500
Plough
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14. Healthcare Net income/
Revenue Total Revenues Employees
Company Country R&D 2006 (loss) 2006
Rank 2008 (USD millions) 2006
(USD millions) (USD millions)
Baxter
17 USA 10,378 614 1,397 38,428
International
Takeda
18 Pharmaceutical Japan 10,284 1,620 2,870 15,000
Co.
19 Genentech USA 9,284 1,773 2,113 33,500
Procter &
20 USA 8,964 n/a 10,340 29,258
Gamble
SUM 497,519 70,843 110,077 1,342,700
AVERAGE 24876 3542 5504 67135
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15. Market leaders in terms of sales
 The top 15 pharmaceutical companies
by 2008 are
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16. Rank Company Sales ($M) Based/Headquartered in
1 Pfizer 43,363 US
2 GlaxoSmithKline 36,506 United Kingdom
3 Novartis 36,506 Switzerland
4 Sanofi-Aventis 35,642 France
5 AstraZeneca 32,516 United Kingdom
Hoffmann–La
6 30,336 Switzerland
Roche
Johnson &
7 29,425 US 16
Johnson

17. Rank Company Sales ($M) Based/Headquartered in
8 Merck & Co. 26,191 US
9 Abbott 19,466 US
10 Eli Lilly and Company 19,140 US
11 Amgen 15,794 US
12 Wyeth 15,682 US
13 Teva 15,274 Israel
14 Bayer 15,660 Germany
15 Takeda 13,819 Japan 17

18. Merck & Co.
 Merck & Co., Inc. (NYSE: MRK), also known as Merck
Sharp & Dohme or MSD outside the United States and
Canada, is one of the largest pharmaceutical companies in
the world.
 The headquarters of the company is located in Whitehouse
Station, New Jersey, an unincorporated area in Readington
Township.
 The company was established in 1891 as the United
States subsidiary of the German company now known as
Merck KGaA.
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19.  Merck & Co. or MSD describes itself as a "a global
research-driven pharmaceutical company.
 Merck discovers, develops, manufactures and markets a
broad range of innovative products to improve human and
animal health, directly and through its joint ventures."
 In common with many other German assets in the United
States, Merck & Co. was confiscated in 1917 during World
War I and then set up as an independent company.
 Currently, it is one of the seven largest pharmaceutical
companies in the world both by market capitalization and
revenue.
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20.  The Merck Company Foundation has distributed over $480
million to educational and non-profit organizations since it
was founded in 1957.
 Merck publishes ―The Merck Manuals” , a series of
medical reference books. These include the Merck Manual
of Diagnosis and Therapy, the world's best-selling medical
textbook, and the Merck Index , a collection of information
about chemical compounds.
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22. Pfizer
 Pfizer Incorporated (NYSE: PFE) is a global
pharmaceutical company, ranking number one in sales in
the world.
 The company is based in New York City, with its research
headquarters in Groton, Connecticut.
 Pfizer's shares were made a component of the Dow Jones
Industrial Average on April 8, 2004.
 Pfizer pleaded guilty in 2009 to the largest health care
fraud in U.S. history and received the largest criminal
penalty ever levied for illegal marketing of four of its drugs.
Called a repeat offender, this was Pfizer's fourth such
settlement with the U.S. Department of Justice in the
previous ten years. 22

23. Ranbaxy Laboratories
 Ranbaxy Research Laboratories Limited Type Public Industry
Pharmaceutical Founded 1961 Headquarters Gurgaon,
Haryana, India Products Pharmaceuticals and diagnostics
Employees 1100 in R&D Website http://www.ranbaxy.com/
―Ranbaxy Laboratories Limited ―(BSE: 500359) is India's
largest pharmaceutical company.
 Incorporated in 1961, Ranbaxy exports its products to 125
countries with ground operations in 46 and manufacturing
facilities in seven countries.
 The company went public in 1973 and Japanese pharmaceutical
company Daiichi Sankyo gained majority control in 2008.
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24. History
 Ranbaxy was started by Ranbir Singh and Gurbax Singh in
1937 as a distributor for a Japanese company Shionogi.
 The name Ranbaxy is a combination of the names of its
first owners Ranbir and Gurbax.
 Bhai Mohan Singh bought the company in 1952 from his
cousins Ranbir and Gurbax.
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25. Trading
 In 1998, Ranbaxy entered the United States, the world's largest
pharmaceuticals market and now the biggest market for
Ranbaxy, accounting for 28% of Ranbaxy's sales in 2005.
 Most of Ranbaxy's products are manufactured by license from
foreign pharmaceutical developers, though a significant
percentage of their products are off-patent drugs that are
manufactured and distributed without licensing from the original
manufacturer because the patents on such drugs have expired.
 On 23 June 2006, Ranbaxy received from the United States
Food & Drug Administration a 180-day exclusivity period to sell
simvastatin (Zocor) in the U.S. as a generic drug at 80 mg
strength.
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26.  Ranbaxy presently competes with the maker of brand-
name Zocor, Merck & Co.; IVAX Corporation (which was
acquired by and merged into Teva Pharmaceutical
Industries Ltd.), which has 180-day exclusivity at strengths
other than 80 mg; and Dr. Reddy's Laboratories, also from
India, whose authorized generic version (licensed by
Merck) is exempt from exclusivity.
 On 10 June 2008, Japan's Daiichi Sankyo Co. agreed to
take a majority (50.1%) stake in Ranbaxy, with a deal
valued at about $4.6 billion.
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27. Acquisition
 On June 11, 2008, Daiichi-Sankyo acquired a 34.8% stake
in Ranbaxy, for a value $2.4 billion.
 In November 2008, Daiichi-Sankyo completed the takeover
of the company from the founding Singh family in a deal
worth $4.6 billion by acquiring a 63.92% stake in Ranbaxy.
 The addition of Ranbaxy Laboratories extends Daiichi-
Sankyo's operations - already comprising businesses in 22
countries.
 The combined company is worth about $30 billion.
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28. TORRENT PHARMACEUTICALS
“Torrent Pharmaceuticals Ltd. “is the
flagship company of the Torrent Group.
Based in Ahmedabad, it was promoted by
U. N. Mehta initially as Trinity Laboratories
Ltd. and was later renamed to its current
name Torrent Pharmaceuticals Ltd.
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29.  TorrentPharmaceuticals operates in more than 50
countries with over 1000 product registrations
globally.
 Moreover, it has 6 fully owned subsidiaries:
 Heumann Pharma GmbH & Co Generica KG,
Germany
 Torrent Pharma GmbH, Germany
 Torrent do Brazil Ltda., Brazil
 ZAO Torrent Pharma, Russia
 Torrent Pharma Inc., United States
 Torrent Pharma Philippines Inc., Philippines
 Torrent Pharmaceuticals acquired Heumann GmbH,
a Pfizer group company in 2005. 29

30. Operations
 The company's key areas are Formulations, API,
Drug Discovery, Marketing and Sales of Drugs. Its
operations locations are:
 Manufacturing plant at Chhatral, Near Kadi, in
North of Gujarat
 Manufacturing plant at Baddi, Himachal Pradesh
 Manufacturing plant at Sikkim
 Manufacturing plant at Dahej, Gujarat (under
progress)
 Research Centre, Ahmedabad-Gandhinagar
region, Gujarat
 Corporate Office, off Ashram Road, Ahmedabad
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31. Patents and generics
 Depending on a number of considerations, a company
may apply for and be granted a patent for the drug, or the
process of producing the drug, granting exclusivity rights
typically for about 20 years.
 Patent protection enables the owner of the patent to
recover the costs of research and development through
high profit margins for the branded drug..
 When the patent protection for the drug expires, a generic
drug is usually developed and sold by a competing
company.
 Often the owner of the branded drug will introduce a
generic version before the patent expires in order to get a
head start in the generic market.
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32. Mergers, acquisitions, and co-
marketing of drugs
 A merger, acquisition, or co-marketing deal between
pharmaceutical companies may occur as a result of
complementary capabilities between them.
 It may be in both companies' interest to enter into a deal to
capitalize on the synergy between the companies.
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33. Marketing
 Pharmaceutical companies commonly spend a large
amount on advertising, marketing and lobbying.
 In the US, drug companies spend $19 billion a year on
promotions.
 Advertising is common in healthcare journals as well as
through more mainstream media routes.
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34. To healthcare professionals
 Physicians, physician assistants, and nurse practitioners
are perhaps the most important players in pharmaceutical
sales because they write the prescriptions that determine
which drugs will be used by the patient.
 Influencing the physician is often seen as the key to
prescription pharmaceutical sales.
 A medium-sized pharmaceutical company might have a
sales force of 1000 representatives.
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35.  The largest companies have tens of thousands of
representatives. Currently, there are approximately
100,000 pharmaceutical sales reps in the United States
pursuing some 120,000 pharmaceutical prescribers.
 The number doubled in the four years from 1999 to 2003.
Drug companies spend $5 billion annually sending
representatives to physician offices.
 Pharmaceutical companies use the service of specialized
healthcare marketing research companies to perform
Marketing research among Physicians and other
Healthcare professionals.
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36. Charitable programmes
 Charitable programs and drug discovery & development
efforts are routinely undertaken by pharmaceutical
companies. Some examples include:
 "Merck's Gift," wherein billions of River Blindness drugs
were donated in Africa
 Pfizer's gift of free/discounted fluconazole and other
drugs for AIDS in South Africa
 “GSK's commitment” to give free albendazole tablets to
the WHO for, and until, the elimination of lymphatic
filariasis worldwide.
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37.  In 2006, Novartis committed USD 755 million in corporate
citizenship initiatives around the world, particularly
focusing on improved access to medicines in the
developing world through its Access to Medicine projects,
including donations of medicines to patients affected by
leprosy, tuberculosis, and malaria; Glivec patient
assistance programmes; and relief to support major
humanitarian organizations with emergency medical needs
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38. Industry associations
 European Confederation of Pharmaceutical
Entrepreneurs(EUCOPE)
 Drug Information Association (DIA)
 European Federation of Pharmaceutical Industries and
Associations (EFPIA)
 European Pharmaceutical Market Research Association
(EphMRA)
 International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA)
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39.  Japan Pharmaceutical Manufacturers Association (JPMA)
 New York Health Products Council (NYHPC)
 Pharmaceutical Research and Manufacturers of America
(PhRMA)
 Irish Pharmaceutical Healthcare Association(IPHA)
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40. Regulatory authorities
 International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use (ICH)
 European Medicines Agency (EMEA)
 U.S. Food and Drug Administration (FDA)
 Ministry of Health, Labour and Welfare (Japan)
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41.  Medicinesand Healthcare products
Regulatory Agency (MHRA)
 Central
Drugs Standards Control
Organisation (India) CDSCO
 Ukrainian Drug Registration Agency
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