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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