Internship project by Apurv SIngh

1. Pharmaceutical
Industry

2. Index
1. Introduction
2. Evolution
3. Characteristics
4. Classification
Generics
Bio Phrama
Formulations
CRAMS
5. Regulations
Global
Indian
6. Global Pharmaceutical Industry
• Indian Pharmaceutical Industry

3. 7. Patents
8. Future
…………………………………………………..

4. Introduction
• The industry is one of the basic industries
in any country.
• has facilities to manufacture various types
of medicine.
• The Size of Indian Pharma is $ 25 billion
as of April 2010

5. Global Overview
• Highly research based
• Revenues and profits are being squeezed,
• The costs and risks of developing new
drugs are climbing, and
• The industry is rapidly transforming from a
U.S./E.U.-focused business to a global
market for both developing and selling
drugs.

6. Indian Overview
• Self-reliance displayed by the production of 70% of bulk
drugs
• · Low cost of production;
• · Low R&D costs;
• · development of cost effective technologies;
• · Increasing balance of trade in pharmacy sector;
• · An efficient and cost effective source for procuring
generic drugs
• especially the drugs going off patent in the next few
years;
• · An excellent centre for clinical trials in view of the
diversity in population.

7. Evolution
• Global Industry
• Indian Industry

8. Global
• In the 1940s and 1950s
– Penicillin was a major discovery for the emergent
industry, and during R&D became firmly established
within the sector.
• in the 1960s
– The industry expanded rapidly, benefiting from
significant new discoveries with permanent patent
protection.
– Regulatory controls on clinical development and
marketing were light and healthcare spending
boomed as economies prospered.
– Decision-making was in the hands of medical
practitioners who were insensitive to price but
susceptible too drug men enabling me too drugs,
which had the same therapeutic outcome.

9. • In the 1970’s
– There was tighter regulation control on clinical trials,
greatly increasing development costs
– Enactment of legislation to set a fixed period on
patent protection (typically 20 years from initial filing
as a research discovery) led to the appearance of
“generic” medicines which led to substantial
increases in R&D spending.
• In the 1980’s
– Many countries introduced some form of price or
reimbursement control and price increases began to
be outlawed. The industry lacked the public or political
support to resist these changes.
– Emergence of small biotechnology start-ups

10. • In the 1990s,
– Worldwide economic recession reduced cash for
provision of healthcare through government and
employer funded systems.
– In 1993, Overall pharmaceutical sales fell by 11 per
cent while the four leading generics manufacturers
increased their sales between 10 and 63 per cent.
– Putting Pressure on the industry to deliver genuine
products.
• Year 2000 to date
– Even after substantially increasing the R&D expense
number of new drug approvals has declined steadily.
As a result, many drug firms are focusing on ways to
improve the efficiency and productivity of their R&D
programs.

11. Characteristics Of Industry
• New products drive revenue growth.
• Patent protection encourages new product
development.
• Selling effort is direct to doctors.
• Price increases are restricted by
government and institutional buyers.
• Distribution network for mass market
drugs is crucial in most countries.

12. Classification Of Industry
Formulations
– Types of drugs
• Branded formulations
• Generics
• Orphan
• Active Pharmaceutical Ingredient (API)
• Contract Research And Manufacturing
Services (CRAMS).
• Bio Pharma

13. Regulations For Pharmaceutical
Industry
• Global
• Indian

14. Global
Despite this controversy, a series of regulatory
and legislative changes have been implemented
that are helping launch this segment of the
pharmaceutical industry.
– EMEA’s (the European Medicines Agency)
establishment of a legal framework for biosimilars in
2004, followed in 2007 by guidelines for their final
approval.
– EMEA and FDA gave approval to Novartis for
Omnitrope, a biosimilar version of a growth hormone
designed to compete with Genotropin, a biologic
manufactured by Pfizer.

15. Indian
• The Drugs and Cosmetics Act, 1940: This Act regulates the
import, manufacture, distribution and sale of drugs in India.
· Schedule M of the Drugs and Cosmetics Act specifies the general and
specific requirements for factory premises and materials, plant and
equipment and minimum recommended areas for basic installation
for certain categories of drugs.
· Schedule T of the Drugs and Cosmetics Act prescribes Good
Manufacturing Practices (GMP) specifications for manufacture of
Ayurvedic, Siddha and Unani medicines.
· Schedule Y of the Drugs and Cosmetics Act governs the clinical trials
legislative requirements of the Drugs and Cosmetics Act.
• The Pharmacy Act, 1948: This legislation regulates the profession
of Pharmacyin India. Under the provisions of this act the Central
Government constitutes a Central Pharmacy Council of India and
the State Governments constitute State Pharmacy Councils.

16. • The Drugs and Magic Remedies (Objectionable Advertisement)
Act, 1954: This Act provides to control the advertisements regarding
drugs and prohibits the advertising of remedies alleged to possess
magic qualities.
• The Narcotic Drugs and Psychotropic Substances Act, 1985: This
is an act concerned with control and regulation of operations relating
to Narcotic Drugs and Psychotropic Substances.
• The Medicinal and Toilet Preparations (Excise Duties) Act, 1956:
An Act to provide for the levy and collection of duties of excise on
medicinal and toilet preparations
• The Drugs Price Control Order (DPCO), 1995: This is an order issued
by the
• Government of India under the Essential Commodities Act,1955
To regulate the prices of drugs. The Order provides the list of price
controlled drugs, procedure for fixation of prices of drugs, method of
implementation of prices fixed by Government and penalties for
contravention of provisions among other things. For the purpose of
implementing provisions of DPCO, powers of the Government have
been vested in the National Pharmaceutical Pricing Authority (NPPA).

17. • Good Clinical Practice (GCP) Guidelines: The Ministry
of Health, along with Drugs Controller General of India
(DCGI) and Indian Council for Medical Research (ICMR)
has come out with draft guidelines for research in human
subjects. These GCP guidelines are essentially based on
Declaration of Helsinki, World Health Organization
(WHO) guidelines and International Conference on
Harmonization (ICH) requirements for good clinical
practice.
• The following are laws which have a bearing on
pharmaceutical manufacture, distribution and sale in
India:
· The Industries (Development and Regulation) Act, 1951
· The Trade and Merchandise Marks Act, 1958
· The Indian Patent and Design Act, 1970
· Factories Act

18. Regulatory Bodies:
• Ministry of Chemicals and Fertilisers (MoC&F):
• The following departments are entrusted with the
responsibility of policy making, planning, development
and regulations relating to Chemicals, Petrochemicals
and Pharmaceuticals.
• Department of Chemicals & Petro-Chemicals:achieving
growth and development of pharmaceuticals in the
country and to attract investment.
• The first comprehensive pharmaceutical policy in India
was formulated in 1978. new policy guidelines issued in
1986, 1994 and recently in 2002.

19. • Pharmaceutical Policy 2002
• To ensure availability of good quality essential pharmaceuticals at
reasonable prices for mass consumption.
• To strengthen the indigenous capability for cost effective quality
production and export of pharmaceuticals by reducing trade barriers
in the
• pharmaceutical sector.
• · Quality control system for pharmaceutical production and
distribution to
• make quality an essential attribute of the domestic industry.
• · Encouraging pharmaceutical R&D that is compatible with the
country's
• needs.
• · To encourage new investment in the pharmaceutical industry and
the
• introduction of new technologies and new drugs.

20. • · To ensure availability of good quality essential pharmaceuticals at
reasonable prices for mass consumption.
• · To strengthen the indigenous capability for cost effective quality
• production and export of pharmaceuticals by reducing trade barriers
in the
• pharmaceutical sector.
• · Quality control system for pharmaceutical production and
distribution to
• make quality an essential attribute of the domestic industry.
• · Encouraging pharmaceutical R&D that is compatible with the
country's
• needs.
• · To encourage new investment in the pharmaceutical industry and
the
• introduction of new technologies and new drugs.

21. Global Pharmaceutical Industry
• Size
• Region Wise Break up
• Top 12 players
• Top therapies
• Top drugs by sale

22. Size
• The global pharmaceutical market is roughly $750 billion
as of April 2010.
• The global pharmaceutical market is forecasted to grow
to $1 trillion in 2013, an equivalent compound annual
growth rate (CAGR) of 5.5-8% over the next three years.
• Even as growth slowed somewhat in Europe and North
America, the United States accounts for almost half of
the global pharmaceutical market, with followed by the
EU and Japan.
• Emerging markets such as China, Russia, South Korea
and Mexico outpaced that market, growing a huge 81
percent.

23. Region Wise Break Up
• Thirty-four major pharmaceutical markets
from North America, Latin America,
Europe, Asia-Pacific and Africa have been
selected as the most important regions to
be presented in this report.

24. • Latin America
– The Latin American pharmaceutical market generated
$28.8bn sales in 2008, an increase of 15.3%from
previous year. Therapeutic indications that fuelled
growth include included antihypertensives,
dermatologicals and sex hormone preparations.
• Brazil was the largest market with $11.4bn sales amounting
to 39.6% share of the Latin American market.
• Peru was the smallest accounting for only 1.9% share.
• Venezuela at 32.2% increase was the fastest growing
regional market in 2008.
• Recession hit Mexico reported flat y-o-y growth of 0.1%.
• Argentinean pharmacy market is US$3.0 billion

25. • drug sales in Germany reached US$53.73bn in 2009.
• Eastern Europe.
– The Eastern European pharma market is forecast to grow at a
CAGR of 10.2% to reach a value of $41.4bn in 2014. The
cardiovascular market is expected to register the highest sales
($7.8bn) in 2014, followed by alimentary canal & metabolic
disorders ($6bn).
– Romania recorded the highest growth in pharma sales over the
2006–07 period (44.6%), followed by Slovakia (37.1%). Growth
in these markets has been driven by increasing access to
modern medicines, as regional branded generic manufacturers
enter the market and take share from domestic suppliers.
– Novartis led the Eastern European pharma market with $1.5bn
sales in 2007, a 27.3% increase over 2006. The company has
the unique advantage of marketing both generic and branded
pharma products across a wide range of therapy areas.
– Lovenox (enoxaparin) from Sanofi-Aventis was the leading
treatment in the Eastern European pharma market in 2007, with
sales of $152m. Other leading brands were dominated by low
molecular weight fractionated heparin and ACE inhibitor drugs.

26. • Russian
– In 2005 the Russian pharmaceuticals market
was worth approx. $9bn in consumer prices
and $7.2bn in wholesaler prices
• UK
– In the UK the retail pharmacy market was
worth £12.8bn in 2006
– little is written about this sector as a whole.

27. Company Country Total Revenue Total Income/loss R&D costs Fortune 500 rank
Johnson & Johnson United States 61897 12266 6986 103
Pfizer United States 50009 8635 7845 152
Roche Switzerland 45304 7,678.00 8909 171
GlaxoSmithKline United Kingdom 44421 8,405 6088 168
Novartis Switzerland 44267 8454 7469 183
Sanofi-Aventis France 40870 8471 4583 181
AstraZeneca United Kingdom 32804 7544 4409 268
Abbott Laboratories United States 30765 5746 2744 294
Merck & Co. United States 27428 13024 5800 378
BayerHealthCare Germany 22297 1696 1845 154
Eli Lilly United States 21836 4328 N/A 455
Bristol-Myers Squibb United States 18808 4420 3647 435
Top Players

28. In 25 years, the market capitalization of the top 6 companies has
grown from less than $25 billion in 1982 to nearly $525 billion by
2006.
Industry Consolidation has Turned 51 Companies Into 10.
Pfizer
Warner Lambert
Pharmacia AB
Agouron
The Upjohn
Company
Monsanto (Searle)
Esperion
Therapeutics Inc.
Vicuron
Pharmaceuticals Inc.
Abbott
Knoll AG
Thera Sense Inc.
Kos Pharmaceuticals
Inc.
SmithKline Beckman
Beecham Group
Glaxo
Wellcome
Diversified
Pharmaceutical Services
Inc.
Sterling Health
Block Drug Co.
ID Biomedical Corp.
Merck
Sirna
Serono
Medco
Pfizer
Merck
GlaxoSmithKline
Abbot

29. American Cyanamid
(Lederle)
American Home
Products
A.H. Robins Co.
Genetics Institute Inc.
Rhone-Poulenc
Rorer
Marion Laboratories
Merrel Dow Pharmaceuticals
Hoechst
Roussel Uclaf
Synthelabo
Sanofi
Fisons
Bristol-Myers
Squibb
DuPont
Pharmaceuticals
Astra AB
Zeneca Group PLC
MedImmune
Cambridge Antibody
Technology
Ciba-Geigy
Sandoz
Eon Labs
Hexal AG
Chiron
Eli Lilly
ICOS Corp.
AstraZenca
Sanofi-Aventis
Novartis
Bristol-Myers
Squibb
Eli Lilly
Wyeth

30. Top Therapautic
Areas

31. Cardiovascular
In cholesterol management, Lipitor will almost certainly remain the top statin
in 2010, but the availability of generic simvastatin has resulted in increased
therapeutic substitution and declining franchise share
• Potential new product is GlaxoSmithKline's darapladib
• In hypertension, Merck's Cozaar, goes off patent in April.
• Novartis's Tekturna,
• In the antiplatelets arena Bayer and Johnson & Johnson's rivaroxaban will
go before the FDA once again in early 2010, seeking approval for the
treatment of venous thromboembolism post-surgery. If approved, the
drug will be the first new oral anticoagulant to reach the market in 40 years.
• Effient may be more effective than Plavix in preventing death, myocardial
infarction and stroke, but it may also cause more serious bleeding.
• The Plavix patent expiry in 2011 will present a further opportunity for Effient,
should additional bleeding data become available in 2010.
• AstraZeneca's Brilinta, is the first reversible oral ADP receptor antagonist,
and is also expected to go before the FDA in August 2010.

32. Oncology
• Despite varied therapeutic development, it is still cancer which grabs the
lion's share of the industry's attention.
• Two major anticancer categories are expected to post further significant
increases in 2011.
• In particular, monoclonal antibodies are gaining market share, with six
antibodies now appearing in the top 15 drugs of 2011 by sales.
• Targeted therapies are changing the cancer market and are expected to be
used in most cancer patients within five years. Indeed, cancer monoclonal
antibody sales could reach over $20 billion in 2011.
• Rituxan, is likely to remain the world's best selling cancer drug with forecast
sales reaching $7 billion.
• Roche's Avastin, has validated anti-angiogenesis as a therapeutic strategy,
and follows closely behind with expected sales of $6.9 billion.
• Sales of supportive care drugs for anemia (Amgen's Aranesp and J&J's
Procrit) are being decimated by safety issues, but the market for white blood
cell support (Amgen's Neupogen/Neulasta) is expected to remain strong,
approaching $5 billion in 2011.

33. Central nervous system
• Selective serotonin reuptake inhibitors should continue to be the mainstay
treatment for depression and anxiety, despite concerns over suicide, but
sales of the class are declining due to generics, as well as issues
of efficacy.
• Patent expiry for Effexor XR in 2010 will bring further generic erosion to the
sector.
• Dual-acting agents impacting both serotonin and norepinephrine (stress
hormone) systems should continue to gain prescription market share from
the SSRIs in 2010, driven primarily by Lilly's Cymbalta.
• Melatonin (biological clock) receptor agonists are also in development for
depression, with one of the lead compounds, agomelatine (from Novartis),
now entering the market in Europe and expected to gain ground in 2010.
Compared with existing antidepressants, agomelatine is the first
melatonergic agent to demonstrate favorable data in its effect on sleep,
weight and sexual function.
• The migraine market is unlikely to grow significantly in 2010, given the little
differentiation between Imitrex generics.
• The antipsychotics (disordered thought) market may begin to change in
2010 as a third generation of antipsychotics reach the market, which may
provide broader efficacy, reduced side effects and improved tolerability.
Among them is sertindole (from Lundbeck), associated with less sedation
when used to treat schizophrenia, and asenapine (from Schering-Plough).

34. Diabetes
• Insulin will remain the cornerstone of treatment in 2011, for which sales will
be driven by increased penetration of insulin analogs.
• Lantus appears poised to retain its position as the leading insulin.
• Lilly's Humalog and Novo Nordisk's Novolog share the market and new
competitors are expected to have little impact.
• Oral DPP-IV inhibitors are shaping up to be the next oral diabetes
blockbusters.
• The launch of Merck's Januvia has been positive, but the drug faces new
competition from BMS/AstraZeneca's Onglyza.
• Novartis's Galvus has been delayed indefinitely in the US on safety
concerns.
• In the GLP (glucagon-like peptide) analog sector, Lilly/Amylin's Byetta
forecasts have slowed since the launch of Januvia, although Byetta LAR, a
long-acting formulation, is expected to hit the US market in 2010.
• Other GLP-1 analogs which look promising include Novo Nordisk's
liraglutide, which has demonstrated a lower risk of hypoglycemia than
existing drugs.
• Liraglutide is expected to be launched in the US in 2010
• MannKind could gain approval for a delivery system that administers an
inhaled dry-powder insulin formulation.

35. Infectious disease
• GlaxoSmithKline will almost certainly maintain its pole position in the
antibiotic/antiviral drug category in 2011, although Merck's share should
increase, driven by its vaccine franchise (Gardasil, Zostavax).
• Quinolones and macrolides have been impacted by generics, and sales
forecasts are declining, but a number of new anti-MRSA antibiotics are in
late-stage development and could make significant advances in 2011.
These include telavancin, dalbavancin and iclaprim.
• HIV, hepatitis and influenza also offer large market opportunities for new
drugs in the sector. Merck's Isentress had a strong launch in 2008,
and its sales are expected to top $1 billion in 2011.
• H1N1 will be a particularly significant boost in 2010/2011 for vaccine
manufacturers GlaxoSmithKline, sanofi-aventis, Novartis, AstraZeneca and
CSL.
• Roche/Gilead and GSK will also benefit from significant Tamiflu and
Relenza demand respectively, both of which are expected to double sales
from 2008 levels.

36. Top Drugs As Of 2008
Rank Drug Name Of Company Total Retail Dollars ($000) % change from 2007
1 Lipitor Phyzer 5,880,128 -4.60%
2 Nexium AstraZenca 4,794,450 10.10%
3 Plavix Bristol 3,796,221 23.10%
4 Advair Diskus GSK 3,572,473 5.40%
5 Prevacid Takeda Pharmaceuticals 3,295,465 -0.60%
6 Seroquel AstraZenca 2,908,971 15.50%
7 Singulair Merck 2,898,060 1.20%
8 Effexor XR Eli lilly 2,657,729 7.80%
9 OxyContin Purdue Pharma 2,502,982 139.80%
10 Actos Takeda Pharmaceuticals 2,447,602 9.80%
11 Lexapro Takeda Pharmaceuticals 2,412,048 4.70%
12 Abilify Ostuka 2,371,795 33.10%

37. 13 Topamax AstraZenca 2,177,348 18.50%
14 Cymbalta Elililly 2,170,162 25.20%
15 Zyprexa Eli lilly 1,748,259 10.70%
16 Valtrex Pfizer 1,684,192 20.70%
17 Crestor AstraZenca 1,676,553 22.60%
18 Vytorin Merck 1,545,643 -20.30%
19 Lamictal GSK 1,539,101 -10.40%
20 Celebrex pfizer 1,526,818 7.80%
21 Lantus Aventis 1,475,110 13.20%
22 Levaquin GSk 1,461,080 2.00%
23 Adderall XR Shire pharmaceuticals 1,446,629 12.20%
24 Lyrica GSK 1,389,205 38.90%
25 Diovan Novartis 1,283,141 14.80%
26 Tricor Abbott 1,249,299 12.90%
27 Flomax Pfizer 1,236,963 23.40%
28 Risperdal J&J 1,221,505 -31.80%

38. 29 Diovan HCT Novartis 1,212,308 15.30%
30 Zetia Merck 1,183,627 -15.80%
31 Aricept pfizer 1,149,221 16.90%
32 Spiriva Pfizer 1,142,746 31.60%
33 Concerta Novartis 1,103,973 7.10%
34 Aciphex Eisai Co. 1,052,133 -4.30%
35 Imitrex Oral GSK 972,778 2.30%
36 Lidoderm Endo pharma 970,208 20.10%
37 Keppra UCB 940,941 32.80%
Drugs.com

39. Drugs Going Off Patent

47. Future Of The Global Pharmacy
Industry
• Prepare for accelerating importance of open
innovation
– External partners to improve the performance of R&D
departments.
– reasons why pharmaceutical companies increasingly engage in
R&D activities with external partners.
• Intensive competition
• access to markets
• scarce own resources
• lack of know-how
• cost cutting or re-structuring
• growth aspirations
• synergies and efficiencies
• and last but not least risk reduction represent the foremost

48. • Commercialize internal research results more
strategically
– Pharmaceutical companies should not only actively
look for potential in-licensing candidates but also for
out-licensing candidates coming from their own
inventory of intellectual property.
• Balance quality and volatility of the
development
– Better quality and less volatility
• Re-define the traditional pharmaceutical
business model.
– fewer companies with more blockbusters.
– diseases will also become increasingly more complex
to treat.
– tailor-made drugs
– New business models are required.
• Eg. Even a single compound can create its own market.

49. • Reduce serendipity in discovery
– eliminating the reliance on serendipity alone for future
successes by involving:
• Advanced database technologies
• faster algorithms
• improving statistical analyses
• Establish strategy how to benefit from
scientific breakthroughs.
– number of targets will increase to over 10,000 targets
in the near future.
– With
– access to technologies is estimated to require a
minimum US$100 million annual commitment.
• Complement R&D with marketing
capabilities.
– Which will result in in a shift from a product- to a
patient-driven strategy.

50. • Merge functional and therapeutic knowledge
– The formation of multidisciplinary teams is necessary
– Marketing experts should be included as early in the
R&D process as possible.
– Confronting the tension between an organization by
function and an organization by product group.
• Challenge R&D employees
– Thus eliminate the linear structured process and
move towards more group- and team-oriented R&D.
• Enhance people development.
– Better run companies by
• people development
• Training
• Thus enabling a more flexible career

51. • Balance scale and creativity
– R&D is most likely to occur in smaller teams.
– Hence, with any acquisition of outside
knowledge, which is expected to be a major
driver for improvement in R&D, there is a
possible loss of creativity.
– Embedded small functional units within the
larger unit is a successful approach.

52. Future Of Indian Pharmaceutical
Industry
• The capability of Indian laboratories is growing by leaps
and bounds each year, largely because they are stocked
with people who have trained at universities and worked
for companies in the U.S. and E.U. However creative
work – such as the design of a molecule for a certain
target – is still produced in the U.S.
• The R&D costs in laboratories in India are a fraction of
that in the U.S. or E.U.
– There is a more favorable regulatory environment for developing
new drugs in India as It is a national priority for India to develop
its own pharmaceutical industry.
– Consequently, India often pursues a more cooperative rather
than adversarial relationship with pharmaceutical companies.

53. • Finally, because India wants to build its own
pharmaceutical industry and export their drugs to
other markets, we have begun the first stages of
abiding by and respecting the intellectual property
rights of foreign drug manufacturers.
– For example, to comply with the Trade Related
Aspects of Intellectual Property Rights (TRIPs)
Agreement of the World Trade Organization (WTO),
India introduced product patent protection for
pharmaceuticals in January 2005. China also has
begun to make progress by implementing new drug
administration laws designed to streamline product
registration and protect intellectual property rights.