India’s Pharmaceutical exports An Overview

21st June 2014

2

(source: IMS)

International Pharma Trade Scenario

Top 25 Global Generic Companies –June 2012

Top 25 Companies account for 28% of global generics market. 8 Indian Companies are among the Top 25 accounting for 4.8% Note: After merger of Sun & Ranbaxy, Sun becomes 5th largest pharma.

Source :BMI

India’s exports share in Global Generic

Market is 3.3%.

Over 55% exports of India are to highly

regulated markets.

U.S.A the largest exports destination

followed by UK

Largest exporter of formulations in

terms of volume during 2010 with 14%

market share and 2nd after Germany in

2011. Source: UN COMTRADE

4

The Indian Pharma Industry : The Flag Bearer

2008-09 2009-10 2010-11 2011-12 2012-13 CAGR%

8.8 8.95 10.7 13.3 14.6 13

India’s Exports of Pharmaceuticals during the last Five

years (USD billion)

2008-09 2009-10 2010-11 2011-12 2012-13

8.8 9.0

10.7

13.2 14.50

India's Exports of Drugs, pharmaceuticals & fine chemicals

(figs. in US$ Bn)

India’s Pharmaceutical Contribution to Global HealthCare During 2012-13

Region

Values in

USD million

% Contbn

North America 4000 27

EU 2635 18

Africa 2594 18

Middle East 1018 7

Asean 938 6

LAC 916 6

CIS 887 6

Asia (Excluding Middle East)

548 4

South Asia 523 4

Oceania 239 2

Other European Countries

153 1

Other America 86 1

Others 51 0

World 14,590 100

North America +Other

America 28%

EU+Other Europe

19% Africa 18%

Middle East 7%

Asean 6%

LAC 6%

CIS 6%

Asia(Excluding

Middle east) 4%

South asia 4%

Oceania 2%

0%

0%

0%

0%

Source: DGCIS

Top 10 prescribed Generic Products in US Market (in million) and India’s Market authorizations (ANDAS) of the product

Ra

nk Products 2012 ANDAs No of companies

1 Hydrocodone/par

acetamol 135.3 NIL India Has No Presence

2 levothyroxine

sodium 107.5 NIL India Has No Presence

3 lisinopril 90.8 18 3

4 Simvastatin 86.1 25 5

5 Metoprolol 78.1 19 8

6 Amlodipine 66 26 10

7 Omeprazole 65.7 9 2

8 Metformin 61.6 37 12

9 Salbutamol 61.5 NIL 0

10 Atorvastatin 54.9 4 1

11 Azithromycin 54.5 6 4

12 Amoxicillin 52 20 3

13 Alprazolam 49.2 16 4

14 Hydrochlorothiazi

de 47.7 14 4

15 Zolpidem 43.8 8 4

Total Rxs 1054.7 8 4

Percentage of Top

15 25.8%

Grand Total

Prescriptions 4,078

Indian Pharma in US Market

Authority Name of Regulatory Agency Nos.

EUROPE

Number of CEPs received (as of 31st

Jan 2014) 1105

Number of companies with CEPs 155

Number of Molecules for which CEPs have been filed with EDQM 344

No of Sites approved by EDQM In India(As on 30th April 2013) 353

UK MHRA (Medicines Healthcare Regulatory Agency), Market authorizations as

March 2013 1110

Number of CEPs with Irish Medicines Board 300

Number of companies registered in Irish Medicines Board 19

number of Authorisations with Sweden MPA (Läkemedelsverket) 209

Number of companies having MA`s with Sweden MPA (Läkemedelsverket) 14

Indian Pharma with European Market

Source: UN Comtrade

Top ten countries exporting formulation to USA in Volumes (Metric

Tonnes)

Values(USD

mn)

Rank Countries 2012 %contbn Actual

1 India 74336 22.90 3021

2 China 66274 20.42 963

3 Mexico 62925 19.39 400

4 Germany 18892 5.82 9,278

5 United Kingdom 16619 5.12 6625

6 Belgium 8299 2.56 8234

7 Austria 7407 2.28 566

8 Japan 7400 2.28 752

9 Italy 7147 2.20 1211

10 France 6419 1.98 2485

USA's total imports 324542 100.00 61,934

Top 10 formulations suppliers (excepting Israel) to US by volumes

Top 10 formulations suppliers (excepting Israel) to US by volumes

S.No. Company

1. DR REDDYS LABORATORIES LIMITED

2. LUPIN LIMITED

3. MYLAN LABORATORIS LIMITED

4. AUROBINDO PHARMA LIMITED

5. CIPLA LIMITED

6. HETERO DRUGS LIMITED

7. SUN PHARMACEUTICAL INDUSTRIES

8. GLENMARK GENERICS LIMITED

9. RANBAXY LABORATORIES

10. SERUM INSTITUTE OF INDIA

During 2012-13

Exporters %contbn

Top 5 25

Top9 33

Top 23 50

Top 91 75

Total of 6945 100

Value in USD million

India’s exports During Last Five Years

Category 2009-10 2010-11 Gr% 2011-12

Gr% 2012-13 Gr% 2013-14 Gr%

Bulk drugs 3650 3972 8.8% 4704 18.4 4536 -3.6 3900 -14.02

Formulations 5183 6612 27.6 8388 26.8 9912 18.1% 10800 8.95

Herbals 120 142 6.1 176 16 232 -10.3% 200 -13.85

Total 8954 10725 19.8 13268 23.7 14681 10.6 14,900 1.49

India’s exports of Pharmaceuticals

2013-14 data is provisional.

Value in Inr Cr

India’s exports During Last Five Years

Category 2009-10 2010-11 Gr% 2011-12

Gr% 2012-13 Gr% 2013-14 Gr%

Bulk drugs 17307 18099 4.5 22557 24.7 24699 37.34 23171 -6.2

Formulations 24571 30130 23 49218 33.4 53973 34 65100 20.7

Herbals 571 646 13.1 845 16 1264 50 570 --55

Total 42449 48875 15.1 63620 30.2 79934 25 89,506 12

India’s exports of Pharmaceuticals

2013-14 data is provisional.

India’s exports of Pharmaceuticals - top ten countries

Value in USD million

India's Pharma exports Top ten Destination Countries-Progress

Country 2011-12 Gr% 2012-13 Gr% 2013-14 Gr% Deviation

USA 3268 30.88 3729 14.10 3907 4.80 493

Russia 410 -10.04 572 39.52 559 -2.28 128

UK 491 25.56 513 4.48 519 1.12 124

Germany 463 27.95 467 0.95 467 -0.02 75

South Africa 383 12.25 441 15.04 497 12.76 62

Nigeria 310 38.41 341 9.83 378 10.86 59

Brazil 279 21.19 328 17.68 305 -7.12 59

Canada 258 68.60 286 10.60 254 -11.06 48

Kenya 230 25.72 252 9.65 246 -2.26 44

Netherlands 230 16.22 249 8.16 250 0.50 25

Total of top Ten 6323 25.80 7178 13.60 7384 2.86 1590

Grand Total 13268 23.71 14681 10.65 14,900 1.5 Deviation

2013-14 data is provisional.

India’s exports of Pharmaceuticals

Values in USD million

Estimated Actual value Deviation in Fy-14 Due to reduced Growth rates of some destinations

Country Rank in 2012-13

Rank in 2013-14 2012-13

Value in 2013-14

Gr% in 2013-14

Cagr last Four Years

Calculated Value for 2013-14

applying CAGR Gr% Deviation USA 1 1 3729 3907 4.8 18 4400 493

Russia 2 2 572 559 -2.28 20 687 128

Singapore 14 27 187 123 -34.14 32 247 124

Canada 8 8 286 254 -11.06 15 329 75 Brazil 7 7 328 305 -7.12 12 367 62 Kenya 9 10 252 246 -2.26 21 305 59

Ghana 16 21 184 153 -17.12 15 212 59

Turkey 12 17 200 170 -14.65 9 218 48 Japan 18 19 179 176 -2.01 23 220 44 Spain 19 19 174 163 -6.47 10 188 25 Grand Total 14680 14900 1.5 13 16490 1590

2013-14 data is provisional. Estimated growth loss in 2013-14 is 9%

India’s exports of Pharmaceuticals - top ten countries

India’s contribution data is provisional.

Values in million USD

TOP 10 GLOBAL GENERIC DRUG MARKETS BY VALUE in the calendar year 2013

Country Generic market

India's Contribution By

Value

India’s contribution by

Percentage UNITED STATES 67000 3301 4.9

CHINA 55000 12 0.02 JAPAN 12500 63 0.5

GERMANY 12500 207 1.6 BRAZIL 10500 158 1.5 RUSSIA 9250 573 6.19

UNITED KINGDOM 9000 384 4.26 FRANCE 7500 125 1.66

SOUTH KOREA 7000 12 1.78 Canada 5400 147 2.72

Generic market source : BMI/IMS, India’s contribution source : Pharmexcil

USA: Mainly because USFDA’s reports of Indian manufacturing facilities citing non compliance of GMP/Data documentation.

Some of the other Important Destination countries Like Russia, Brazil are pursuing their agenda of becoming self reliant swiftly.

Other important Destinations like Canada, Singapore and some others are seem to be influenced by USA’s import alerts.

International price of some of the bulk Drugs/intermediates has dropped.

APIs are being employed for formulations exports.

India’s exports of Pharmaceuticals

Issues

Sri Lanka : Quality Issues

Vietnam : Quality Issues

Ghana: Renewal of market authorizations

and delayed registration process

India’s Pharmaceutical Regulatory Performance

YEAR

NAI (No Action Indicated)

VAI (Voluntary Action indicated)

OAI (Official Action Indicated)

2009 (14/49) 29% (34/49) 69% (1/49) 2%

2010 (6/18) 33% (9/18) 50% (3/18) 17%

2011 (18/43) 42% (24/43) 56% (1/43) 2%

2012 (15/57) 26% (40/57) 70% (2/57) 4%

2013 (8/25) 32% (13/25) 52% (4/25) 16%

Sources: USFDA’s Inspection Classification Database Search.

http://www.fda.gov/ICECI

USFDA Inpections and its Subsequent Actions of Indian Pharmaceutical Firms – Last 5 Years (ANDA approved only)

COUNTRY TOTAL INSPECTIONS

ANDA APPROVED

INSPECTIONS

NAI

VAI

OAI

INDIA 60 25 (8/25) 32%

(13/25) 52%

(4/25) 16%

US 606 111 (53/111)

48%

(53/111) 48%

(5/111) 4%

USFDA Inspections and its subsequent actions indicated for US and Indian Firms – 2013 (ANDA approved only)

State wise Membership with Pharmexcil During 2012-13

State Number Of Regns

Maharashtra 1621

Gujarat 568

A.P. 520

Delhi 348

Tamil nau 238

Karnataka 154

Haryana 86

U.P 80

M.P 71

West bengal 53

Punjab 48

Kerala 41

Chandigarh 37

Rajahstan 34

Uttarnachal 23

H.P 21

Goa 12

Bihar 8

Jammu& Kashmir 6

Orissa 4

Chattisgarh 2

Assam 1

Total 3976

State wise membership with Pharmexcil during 2012-13

Pharmacy of the World International Exhibition for Pharma and Healthcare

21-23rd May 2014

Bombay Exhibition Center, Mumbai

SHOW NAME INTERNATIONAL EXHIBITION

FOR PHARMA AND HEALTH CARE (iPHEX)

SHOW

DESCRIPTION

The second edition of one of

the largest showcase of Indian

pharmaceutical products and

technologies supported by the

Ministry of Commerce &

Industry, Government of India,

and organised by PHARMEXCIL.

DATES 21-23rd May

FREQUENCY Annual

VENUE Hall 1, 2 Bombay Exhibition Centre, Mumbai

SHOW SIZE Over 120,00 m 2 gross

EXHIBITORS Over 300 companies show

casing formulations, APIs, AYUSH and all related sector

FOREIGN

DELEGATES Over 400 hosted buyers

including regulators from

Africa, South America, Central

America, ASEAN +2, CIS, Middle East, Europe & USA

VISITORS Over 5000 professional visitors from India and overseas

FACT SHEET 2014