Prepared by : AMIN BHAVIK SRoll No : 02B Pharm Semester VIKBIPER.           28-Feb-2011        1
Pharmaceutical Industries   The Pharmaceutical Industry develops, produces,    and markets drugs licensed for use as medi...
HISTORY   Most of todays major pharmaceutical companies were founded    in the late 19th and early 20th centuries.   Key...
   The pharmaceutical industry entered the 1980s    pressured by economics and a host of new regulations,    both safety ...
RESEARCH AND DEVELOPMENT “Drug discovery “ is the process by which  potential drugs are discovered or designed. In the  p...
Cost Of Innovation Drug discovery and development is very  expensive. Each year, only about 25 truly novel drugs (New  c...
 These estimates also take into account the  oppurtunity cost of investing capital many years  before revenues are realiz...
Industry revenues   For the first time ever, in 2006, global spending on    prescription drugs topped $643 billion, even ...
   US profit growth was maintained even whilst other top    industries saw little or no growth.   Despite this, "..the p...
Market leaders in terms          of revenue Thefollowing is a list of the 20 largest pharmaceutical and biotech companies...
Total    Healthcare Net income/Revenue                                      Revenues R&D 2006 (loss) 2006       Employees ...
Healthcare    Net income/ Revenue                                 Total Revenues                                 Employees...
Net                                      Total        Healthcare Revenue                                                  ...
Healthcare    Net income/ Revenue                               Total Revenues                                 Employees  ...
Market leaders in terms of sales   The top 15 pharmaceutical companies    by 2008 are                                    ...
Rank    Company          Sales ($M)   Based/Headquartered in 1         Pfizer          43,363               US 2     Glaxo...
Rank       Company             Sales ($M) Based/Headquartered in 8         Merck & Co.           26,191             US 9  ...
Merck & Co.   Merck & Co., Inc. (NYSE: MRK), also known as Merck    Sharp & Dohme or MSD outside the United States and   ...
   Merck & Co. or MSD describes itself as a "a global    research-driven pharmaceutical company.   Merck discovers, deve...
   The Merck Company Foundation has distributed over $480    million to educational and non-profit organizations since it...
Pfizer   Pfizer Incorporated (NYSE: PFE) is a global    pharmaceutical company, ranking number one in sales in    the wor...
Ranbaxy Laboratories   Ranbaxy Research Laboratories Limited Type Public Industry    Pharmaceutical Founded 1961 Headquar...
History   Ranbaxy was started by Ranbir Singh and Gurbax Singh in    1937 as a distributor for a Japanese company Shionog...
Trading   In 1998, Ranbaxy entered the United States, the worlds largest    pharmaceuticals market and now the biggest ma...
   Ranbaxy presently competes with the maker of brand-    name Zocor, Merck & Co.; IVAX Corporation (which was    acquire...
Acquisition   On June 11, 2008, Daiichi-Sankyo acquired a 34.8% stake    in Ranbaxy, for a value $2.4 billion.   In Nove...
TORRENT PHARMACEUTICALS“Torrent Pharmaceuticals Ltd. “is the flagship company of the Torrent Group. Based in Ahmedabad, i...
 TorrentPharmaceuticals operates in more than 50 countries with over 1000 product registrations globally. Moreover, it h...
Operations The  companys key areas are Formulations, API,  Drug Discovery, Marketing and Sales of Drugs. Its  operations ...
Patents and generics Depending on a number of considerations, a company  may apply for and be granted a patent for the dr...
Mergers, acquisitions, and co-         marketing of drugs   A merger, acquisition, or co-marketing deal between    pharma...
Marketing   Pharmaceutical companies commonly spend a large    amount on advertising, marketing and lobbying.   In the U...
To healthcare professionals   Physicians, physician assistants, and nurse practitioners    are perhaps the most important...
   The largest companies have tens of thousands of    representatives. Currently, there are approximately    100,000 phar...
Charitable programmes   Charitable programs and drug discovery & development    efforts are routinely undertaken by pharm...
   In 2006, Novartis committed USD 755 million in corporate    citizenship initiatives around the world, particularly    ...
Industry associations   European Confederation of Pharmaceutical    Entrepreneurs(EUCOPE)   Drug Information Association...
   Japan Pharmaceutical Manufacturers Association (JPMA)   New York Health Products Council (NYHPC)   Pharmaceutical Re...
Regulatory authorities   International Conference on Harmonisation of Technical    Requirements for Registration of Pharm...
 Medicinesand Healthcare products Regulatory Agency (MHRA) Central        Drugs Standards Control Organisation (India) C...
42
Pharma industries  _bhavik s amin
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Pharma industries _bhavik s amin

  1. 1. Prepared by : AMIN BHAVIK SRoll No : 02B Pharm Semester VIKBIPER. 28-Feb-2011 1
  2. 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. 2
  3. 3. HISTORY Most of todays 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. 3
  4. 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. 4
  5. 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. 5
  6. 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. 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. 7
  8. 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. 8
  9. 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. Pfizers 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. 9
  10. 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 $500 10 million.
  11. 11. Total Healthcare Net income/Revenue Revenues R&D 2006 (loss) 2006 Employees Rank Company Country (USD milli (USD millio (USD millio 2006 2008 ons) ns) ns) 1 Novartis Switzerland 53,324 7,125 11,053 138,000 2 Pfizer USA 48,371 7,599 19,337 122,200 3 Bayer Germany 44,200 1,791 6,450 106,200 United 4 GlaxoSmithKline 42,813 6,373 10,135 106,000 Kingdom Johnson and 5 USA 37,020 5,349 7,202 102,695 Johnson 6 Sanofi-Aventis France 35,645 5,565 5,033 100,735 11
  12. 12. Healthcare Net income/ Revenue Total Revenues Employees Company Country R&D 2006 (loss) 2006Rank 2008 (USD millions) 2006 (USD millions) (USD millions) Hoffmann–La 7 Switzerland 33,547 5,258 7,318 100,289 Roche United 8 AstraZeneca 26,475 3,902 6,063 50,000+ Kingdom 9 Merck & Co. USA 22,636 4,783 4,434 74,372 Abbott 10 USA 22,476 2,255 1,717 66,800 Laboratories 12
  13. 13. Net Total Healthcare Revenue income/ Employees Company Country Revenues R&D 2006Rank 2008 (loss) 2006 2006 (USD millions) (USD millions) (USD millions) Bristol-Myers 12 USA 17,914 3,067 1,585 60,000 Squibb Eli Lilly and 13 USA 15,691 3,129 2,663 50,060 Company 14 Amgen USA 14,268 3,366 2,950 48,000 Boehringer 15 Germany 13,284 1,977 2,163 43,000 Ingelheim Schering- 16 USA 10,594 2,188 1,057 41,500 Plough 13
  14. 14. Healthcare Net income/ Revenue Total Revenues Employees Company Country R&D 2006 (loss) 2006Rank 2008 (USD millions) 2006 (USD millions) (USD millions) Baxter 17 USA 10,378 614 1,397 38,428 International Takeda 18 Pharmaceutical Japan 10,284 1,620 2,870 15,000 Co. 19 Genentech USA 9,284 1,773 2,113 33,500 Procter & 20 USA 8,964 n/a 10,340 29,258 Gamble SUM 497,519 70,843 110,077 1,342,700 AVERAGE 24876 3542 5504 67135 14
  15. 15. Market leaders in terms of sales The top 15 pharmaceutical companies by 2008 are 15
  16. 16. Rank Company Sales ($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. 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. 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. 18
  19. 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. 19
  20. 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 worlds best-selling medical textbook, and the Merck Index , a collection of information about chemical compounds. 9/21/2012 20
  21. 21. 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. Pfizers 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 Pfizers fourth such settlement with the U.S. Department of Justice in the previous ten years. 22
  22. 22. 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 Indias 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. 23
  23. 23. 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. 24
  24. 24. Trading In 1998, Ranbaxy entered the United States, the worlds largest pharmaceuticals market and now the biggest market for Ranbaxy, accounting for 28% of Ranbaxys sales in 2005. Most of Ranbaxys 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. 25
  25. 25.  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. Reddys Laboratories, also from India, whose authorized generic version (licensed by Merck) is exempt from exclusivity. On 10 June 2008, Japans Daiichi Sankyo Co. agreed to take a majority (50.1%) stake in Ranbaxy, with a deal valued at about $4.6 billion. 9/21/2012 26
  26. 26. 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- Sankyos operations - already comprising businesses in 22 countries. The combined company is worth about $30 billion. 9/21/2012 27
  27. 27. 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. 9/21/2012 28
  28. 28.  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
  29. 29. Operations The companys 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 9/21/2012 30
  30. 30. 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. 31
  31. 31. 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. 32
  32. 32. 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. 33
  33. 33. 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. 34
  34. 34.  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. 35
  35. 35. Charitable programmes Charitable programs and drug discovery & development efforts are routinely undertaken by pharmaceutical companies. Some examples include: "Mercks Gift," wherein billions of River Blindness drugs were donated in Africa Pfizers gift of free/discounted fluconazole and other drugs for AIDS in South Africa “GSKs commitment” to give free albendazole tablets to the WHO for, and until, the elimination of lymphatic filariasis worldwide. 36
  36. 36.  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 37
  37. 37. 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) 38
  38. 38.  Japan Pharmaceutical Manufacturers Association (JPMA) New York Health Products Council (NYHPC) Pharmaceutical Research and Manufacturers of America (PhRMA) Irish Pharmaceutical Healthcare Association(IPHA) 39
  39. 39. 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) 40
  40. 40.  Medicinesand Healthcare products Regulatory Agency (MHRA) Central Drugs Standards Control Organisation (India) CDSCO Ukrainian Drug Registration Agency 9/21/2012 41
  41. 41. 42

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