SHANKAR R 14114

GEORGE JACOB 14095

DIVYA LIZ GEORGE 14093

DHARA B SHAH

14067

MARY MONISHA 14060

G5INDIAN PHARMACEUTICAL INDUSTRY

Committed to a healthier life

Indian Pharmaceuticals

World’s 3rd largest [volume]

6th largest market globally [size]

2.4% of the Global Pharma Industry

Domestic demand [2014-15] close to $36.8 billion

cCAGR 13%, to continue for the next 5 years

90% of drugs sold estimated to be generics

1

KEY STRENGTHS

Fair protection of intellectual property rights

Strong manufacturing base.

Drug prices 1/10th of international price and 40 % cheaper to set up plants.

60-70% cheaper for bulk drug production.

Highly trained pool of scientists and professionals.

Highest quality approvals from USFDA

Growing biotechnology industry.

Low labour cost

2

INDIAN PHARMA

API / Bulk Drugs

Formulations

Branded Generics Chronic Acute

• Cardiovascular

• Anti-diabetics

• Gastro-

intestinal

• Neurological

• Anti-infectives

• Respiratory

• Pain

• Gynaecology

12.3% 13-15%

2010-15 2015-20E

Exports [CAGR]2010-15 17.7%2015-20 11-13%E

2010-15 2015-20E

15.2% 10-12%

3

Major Players – Top 10

Sun Abbott Cipla Cadila ManKind Alkem Glaxo Lupin Pfizer Emcure

8.90%

6.20%

5.00% 5.00%

3.60% 3.60% 3.50% 3.40%3.00%

2.70%

4

REGULATIONS

PRICE BASIS QUALITY

PATENTS

Co-coordinating Activities

Central Govt. State Govt.

DCGI State DCO

5

NOTABLE TRENDS IN INDIAN PHARMA

R&D ExportRevenue JV’s

Expansion by Indian Players

Abroad

Patent’s Act Product Patents

Less timeFor approval

6

2009 2010 2011 2012 2013 2014 2015E0

100

200

300

400

500

600

700

800

0.00%

2.00%

4.00%

6.00%

8.00%

10.00%

12.00%

14.00%

16.00%

18.00%

20.00%

10.40%

17.80%

15.50% 15.50%

12%

6%

12.9%

Market Size [In bn] Growth Rate

Domestic Pharma Market Size 7

Growth trend in formulation exports [in bn]

2010 2011 2012 2013 2014 2015E

2.7 3.6 4.3 5.2 5.7 6.2

3.6 4.4 4.9 5.4 6.2 6.7

Regulated markets Unregulated markets

8

Growth trend in bulk drug exports [in bn]

2010 2011 2012 2013 2014 2015E

2.7 3.6 4.3 5.2 5.7 6.2

3.6

4.44.9

5.46.2

6.7

Regulated markets Unregulated markets

9

2011 2012 2013 2014 2015E 2016P 2017P

18.40%

16.80%

17.00%

18.80%

18.20%

18.50%

18.50%

Profitability Trend of Large Formulation Companies

2011 2012 2013 2014 2015E 2016P 2017P

18.40%

16.80%17.00%

18.80%

18.20%

18.50%

18.50%

Profitability trend of mid sized and small sized formulation companies

2011 2012 2013 2014 2015E 2016P 2017P

18.40%

16.80%

17.00%

18.80%

18.20%

18.50% 18.50%

Trend in Profitability for bulk drug manufacturers

Growth drivers

Demand Side

Drivers

Policy Support

Supply Side

Drivers

Cost advantage

Manufacturing hub

546 sites registered

Penetration of

chemists

Accessibility to

improve

Health insurance

Stress related disease

Diagnostic facilities

Reduction in approval

time

Pharma education

Accessibility for BPL

Exemptions

10

Key challenges

Drug Quality, not adhering to cGMP

Clinical trial quality

Low margin of profits due to Govt pricing policy – Drug price control

order

Patent issues

Low input for R & D

USFDA checks

11

Opportunities

$44 billion lose due to patent expiry in US

Expansion of Biosimilars and Bio-pharmaceuticals.

Growth of CRAMS

NMITLI & DPRP schemes

Fiscal incentives to R &D units

12

India’s share in anda approvals

2006 2007 2008 2009 2010 2011 2012 2013 2014 YTD 20150

100

200

300

400

500

600

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

370398

433 418 421442

499

380 379

59

21%

28% 29% 30% 31%

35%

40%

43%

34%

41%

Total Approvals India as a % of total approvals

13

BIOSIMILAR : THE next big thing

Active Ingredients sourced from living organisms Sensitive

to storage and

handlingApproval – Multi step process

Complex nature –

Not easily copied

USD 1.4 billion by

2016

Overall market sales – 20%

growth

CadilaBiocon

Dr Reddy’sLupin

WockhardtCadila’s Exemptia, biosilmilar of Humira

14

SOURCE : CRISIL RESEARCH

THANK YOU!!