spn report on india today

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India Today………. Compiled by: CK Shah Client Confidential

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Page 1: Spn report on india today

India

Today……….

Compiled by:CK Shah

Client Confidential

Page 2: Spn report on india today

Shresth Pharma Nexus(SPN) is a businessconsulting company active within the fieldof Pharmaceuticals and Health Care. Itspecialises in providing a Global network toits customers, allowing them to choose fromthe best in the market. The idea is to bringthe market to the customer, providing themsolutions and making business an easy task.We work with organizations in the arena ofstrategic management, which requires adistinctive approach from operationalmanagement.

Client Confidential

Page 3: Spn report on india today

Our key role is to build the road to your prosperity:

We Lay Foundation for Future GrowthClient Confidential

Page 4: Spn report on india today

Range of Services

Business Consultancy

For Merger, Acquisition

& Disposal

Strategic tie-ups

Project Evaluation

CRAMs & Analytical

Services

Registration of API/FF

With DCGI, India

Enterprise Risk

Management

Market Assessment

& Intelligence

Business plan review

Organizational review

Shresth Pharma Nexus

Client Confidential

Page 5: Spn report on india today

What We Offer

API Manufacturer

Sourcing Intermediates from India/China

Sales & Marketing

Custom Synthesis

Technology

Turn Key Projects

Finished Formulation

Manufacturer

Sourcing of API

In & Out Licensing

CRAMs

Generic NDDS, Formulation dossier

Whole chain of analytical services.

Client Confidential

Page 6: Spn report on india today

Our PhilosophyWe comprehend our customers’ needsaccurately and provide them with bestbusiness alternatives, as we believe thatbusiness should always be customer driven.However, we offer more than mere business.We help you make relations and partnershipthat lead towards triumph. We giveimportance to confidentiality andtransparency in our business. And that is ourmotive to deliver, with honesty and trust.Our key role is to build the road to yourprosperity.

“We Lay Foundation for

Future Growth”Client Confidential

Page 7: Spn report on india today

India

Today……….

Client Confidential

Page 8: Spn report on india today

Projected Growth ofIndian Pharmaceutical Market

Currently

• Total Worth $19billion– Domestic Market: $11bn

– Exports: $8bn

• Ranked 14th in World

Forecasted Growth for 2020

• Increase to $50billion– Domestic Market: $30bn

– Exports: $20bn

• Will be one of top 10 markets

Source: PwC, Global pharma looks to India: Prospects for growth

Client Confidential

Page 9: Spn report on india today

India is expected to be the 7th largest market by 2020

Top Pharma Markets 2015* & 2020 (US$ bn)

However, among all Top 10 global markets of 2015 India shows the highest growth rate among all countries analysed by McKinsey

Source: BCG, Goldman Sachs, McKinsey Reports

Client Confidential

Page 10: Spn report on india today

Global API Manufacturer

Source: TR Newport Premium™ Client Confidential

Page 11: Spn report on india today

Local

PotentialFuture

LessEstablished

Established

Companies serving their local markets. Lack quality, regulatory, experience to supply major markets

Companies usually make older molecules, may supply intermediates to Established companies, often working to upgrade & forge links with dose firms in major markets

Meet regulatory, quality, & other criteria for limited number of molecules. May be moving from older to new molecules, may supply intermediates to Established companies.

Leading companies with business experience, regulatory, quality, non-infringing processes, and track record of supplying regulated markets

Able to satisfy local markets Global markets

Unregulated cGMP, FDA Inspected

Older molecules New molecules

Assessing the Capabilities ofAPI Manufacturers

Client Confidential

Page 12: Spn report on india today

Global API Manufacturer rated

Source: TR Newport Premium™ Client Confidential

Page 13: Spn report on india today

API manufacturer-Emerging markets

Source: TR Newport Premium™

Client Confidential

Page 14: Spn report on india today

2nd wave emerging API manufacturers rated

Source: TR Newport Premium™Client Confidential

Page 15: Spn report on india today

India’s API Plants

Client Confidential

Page 16: Spn report on india today

Indian API Manufacturer Ratings 2004 to 2010

1817

56

24

40

92

0

10

20

30

40

50

60

70

80

90

100

Established Less Established Potential Future

Nu

mb

er

of

Co

rpo

rate

Gro

up

s

Corporate API Rating Assessed by Thomson Reuters

2004

2010

Source: Newport Premium™ Client Confidential

Page 17: Spn report on india today

Local

PotentialFuture

LessEstablished

Established

Able to satisfy local markets Global markets

Unregulated cGMP, FDA Inspected

Older molecules New molecules

Capabilities ofIndian API Manufacturers

24 corporate groups, 34 API sitese.g., Cipla, Dr. Reddy’s

40 corporate groups, 47 API sitese.g., MSN, Hetero

92 corporate groups, 91 API sitese.g., Emcure, Sai Advantium

480 corporate groups, 492 API sitese.g., SMILAX Laboratories

Client Confidential

Page 18: Spn report on india today

Comparing the Ability of Indian and Chinese Manufacturers to Supply

Regulated Markets

Source: Newport Premium™

24

40

92

12

34

150

0

20

40

60

80

100

120

140

160

Established Less Established Potential Future

Nu

mb

er

of

Co

rpo

rate

Gro

up

s

Corporate Rating Assessed by Thomson Reuters

India

China

Client Confidential

Page 19: Spn report on india today

DMFs & COS by India & China

Client Confidential

Page 20: Spn report on india today

Year wise US DMFs Submitted by India & China

23

31

44

63

114

184

257

283

331

382

350

5

15

5

25

35

33

52

64

122

119

94

0 100 200 300 400

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

Number of US DMFs

China

India

Source: Newport Premium™

Client Confidential

Page 21: Spn report on india today

COSs Granted 2000 to 2009 to India, Italy, China & ROW (includes US)

2000 2009

Source: Newport Premium™

India24%

China 10%

Italy12%

ROW54%

459 COS 2722 COS

Client Confidential

Page 22: Spn report on india today

US ANDAs Held by Indian Companies

Source: Newport Premium™

210 14 12 18

42

63

117

147139

38

0

10

19

21

17 29

11

0

20

40

60

80

100

120

140

160

180

Nu

mb

er

of

US

AN

DA

s

Year

Tentative

Approved

Client Confidential

Page 23: Spn report on india today

Increase in Indian Holders of US ANDAs

210

14 1218

52

82

138

164168

49

0

5

10

15

20

25

30

0

20

40

60

80

100

120

140

160

180

Nu

mb

er

of

Ind

ia B

ase

d A

ND

A H

old

ers

Nu

mb

er

US

AN

DA

s

by I

nd

ian

Co

mp

an

ies

Source: Newport Premium™

Client Confidential

Page 24: Spn report on india today

Top Ten Paragraph IV Challengers by Volume

149

75 72

57 55

42 3932 30 27

0

20

40

60

80

100

120

140

160

Nu

mb

er

of

PIV

C

ha

lle

ng

es

Source: Newport Premium™

Client Confidential

Page 25: Spn report on india today

Innovation

1

11

6

5

1

4

4

0

7

4

3

12

6

0

4

2

3

0

1

1

0

0

2

0

1

4

0

2

1

4

0

2

1

2

2

2

1

1

1

0

1

1

0

0

1

0

0

1

1

0

0

1

0

1

0

0

0

0

0

2

1

1

0

0

0

0 5 10 15 20

Ipca Laboratories

Dr Reddy's

Ranbaxy [now Daiichi Sankyo]

Glenmark

Nicholas Piramal

Wockhardt

Torrent

Jubilant Organosys

Biocon

Lupin

Sun Pharma

Orchid

Zydus Cadila

Number of Compounds

Pre-Clinical

Phase I

Phase II

Phase III

Review

Source: Newport Premium Deals Module™Client Confidential

Page 26: Spn report on india today

Acquisitions by Foreign Companies of Indian Targets

38

4547

43 42

65

72

56

68

76

0

10

20

30

40

50

60

70

80

Nu

mb

er

of

Ac

qu

isit

ion

s

Year

Source: Newport Premium Deals Module™Client Confidential

Page 27: Spn report on india today

Significant Foreign Acquisitions ofIndian Companies

Mylan’s acquisition of Matrix (2006)

Daiichi’s acquisition of Ranbaxy (2008)

Hospira’s acquisition of Orchid’s injectable business (2009)

Abbott’s acquisition of Piramal’s Healthcare Solutions Business (2010)

Source: Company websites

Client Confidential

Page 28: Spn report on india today

Indian Acquisitions of Foreign Companies

Sun acquired Caraco (2004) & ICN Hungary (2005)

Dr Reddys acquired Betapharm Arzneimittel GmbH (2006)

Strides acquired Diaspa SpA (2007)

Lupin acquired Kyowa Pharmaceutical Industry co Ltd (2007)

Dishman acquired Solvay Pharmaceuticals BV - Fine Chemical & Vitamin Business (2007)

Sun acquired Chattem’s controlled substance facility (2008)

Piramal acquired Minrad International (2008)

Source: Company websites

Client Confidential

Page 29: Spn report on india today

Biotech Capabilities Among Top Indians

Company RecombinantProteins

Monoclonal Antibodies

Vaccines Launches

Biocon FP FP EPO, MAb

Shantha FP UD INF, GCSF

Intas FP UD GCSF, INF, EPO

Panacea FP Vaccines

Lupin FP

Zydus FP FP

Torrent FP Insulin

Wockhardt FP UD Insulin, INF, CGSF, EPO

Glenmark UD FP Novel only

Bharat UD FP

Shasun FP

Source: TR Research Key: FP = Full Production, UD = Under DevelopmentClient Confidential

Page 30: Spn report on india today

Thank You

www.shresthpn.com

Client Confidential