api-china-2013 - Indian Drug Manufacturers` Association

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AFFORDABLE EFFICACIOUS MEDICINES
ALL ROADS LEAD TO INDIA
DAARA B PATEL
SECRETARY - GENERAL
INDIAN DRUG MANUFACTURERS’ ASSOCIATION
(IDMA)
4TH SINO-INDIA FORUM: FINISHED DRUGS EXPORT
China, 14th November 2013

IDMA’s HQ

80 % Pharma
Corporate Office
are located
2
INDIAN DRUG MANUFACTURERS’ ASSOCIATION
Founded in 1961 – now in 52nd year of service as premier
Association of the Indian Pharma Industry
Regarded in Government, Media & Industry Circles as the
‘Voice of the National Sector’
6 Region-wise State Boards
19 Sub-Committees, headed by Experts
Membership Strength – over 700 Members
Publications: IDMA Bulletin (Weekly), Indian Drugs (Monthly) &
Annual Publication
Awards presented on Annual Day for Quality Excellence, Best
Patents, Quality Research,
At IDMA- PAC Awards for Eminent Analyst, Outstanding Analyst,
Young Analyst
Seminars/ Workshops on Regulatory, Technical, Medical affairs,
Harmonization projects with US FDA, IP, USP, EDQM, ANVISA
3
IDMA GOING GLOBAL
• IDMA is in talks with leading Associations and
Organisations globally for closer Co-operation and
Networking on International issues concerning the
Pharmaceutical Industry and has signed MOUs with :
 IDMA-CPIA (China Pharmaceutical Industry
Association)
 IDMA-KPMA (Korean Pharmaceutical Manufacturers
Assn)
 IDMA-Dubiotech (Dubai Biotechnology Park)
 IDMA-ABLE (Assn. of Biotechnology Led
Enterprises)
 IDMA- Pro Genericos - Brazil (in discussion)
4
IDMA GOING GLOBAL (contd…)
• Active participation in International Fora:
IGPA Conference, Canada
USP Convention, Washington
API China Spring, Harbin
Propak Asia, Bangkok
2nd Annual Pharma Manufacturing China
Summit, Shanghai
Generics R&D & Partnering Asia, Shanghai
India-Japan Pharma Industry Seminar, Osaka
International Pharmaceutical Ingredients
Expo & Conference, Japan
Sino-India Forums
5
DEMAND DRIVERS
Accessibility
 Over USD 200 Billion to be spent on
medical infrastructure in the next
decade
 New business models expected
to penetrate tier-2 and tier-3 cities
 Over 160,000 hospital beds expected
to be added each year in the next
decade
 Increasing access to lower-income
segments due to Government
initiatives that increase access and
affordability (e.g. RSBY)
Acceptability
 Rising levels of education to increase the
acceptability of pharmaceuticals
 Patients to show greater propensity to selfmedicate, boosting the OTC market
 Acceptable of biologics and preventive
medicines to rise
 Vaccine market could grow 20 per cent per year
in the next decade
 Surge in medical tourism due to increased
patient inflow from other countries
Affordability
Epidemiological Factors
 Rising income could drive 73 millions households
to the middle class over the next 10 years
 Over 650 million people expected to be covered
by Health Insurance by 2020
 Government-sponsored programmes set to
provide health benefits to over 380 million BPL
people by 2017
 By 2017, the Government plans to provide free
generic medicines to half the population at an
estimated cost of USD 5.4 billion
 Patient pool expected to increase over 20% in the
next 10 years, mainly due to rise in population
 New diseases and lifestyle changes to boost
demand
 Increasing prevalence of lifestyle diseases
6
EVOLUTION OF INDIAN PHARMA INDUSTRY
7
GROWTH IN PURCHASING POWER
8
INDIAN PHARMA INC
 Knowledge based Industry and one of the
world's largest and most developed.
 Current turnover estimated at US$ 25 bln. growing
@ 12%
 About 300 Large & over 10,000 SMEs
 About 77% units make Formulations and about 23%
units make APIs
 Over 64,000 formulations in market covering almost
every therapeutic segment with about 10 to 200
brands per molecule
 For example, Ciprofloxacin has over 180 brands and
Atorvastatin has about 96 brands competing in the
market.
9
INDIAN PHARMA INC
(contd…)
 Medicines constitute only about 15% of total
healthcare spend in India
 About 90% of India’s pharmaceutical market is
made up of branded generics and has the potential
to grow at an accelerated 15 to 20% CAGR in the
next five years.
 Patented drugs account for 1% of $12 bln. market,
set to grow to 5% of est. $ 50-60 bln. market by 2020
 Globally ranks 4th largest in volume and 12th in
value
 10% of World’s Production but 1.5% of Value
(Extremely Competitive Prices)
10
SHARE OF GENERIC AND PATENTED
DRUGS IN INDIAN MARKET
By 2016, share of generics may be about 90% of Indian
pharma market, as patented drugs increase to about 10%
11
FORMULATION EXPORTS
($ bio)
12
INDIAN PHARMA INC
(contd…)
 Exports at $12 bln. with formulations at
$ 7.5 bln. and APIs at $ 4.5 bln.
 Exports estimated to cross $16 bln. by
2013-14
 Exports to almost all countries, with major
share in regulated markets
 Rated world’s single largest producer and
top exporter of generic drugs
 Every Third Tablet consumed in the World
is ‘Made in India’
13
INDIAN PHARMA INC
(contd…)
 India’s five of the largest export markets are
USA, UK, Germany, Russia and South Africa
 Three out of Global Top 10 fastest growing
generic companies are Indian - Glenmark, Dr
Reddy’s and Sun Pharma
 The Indian pharma market is expected to grow
at 12–15 % over next two years
 The Indian drugs and pharma sector attracted
FDI worth US$ 9.6 bln. between April 2000 to
May 2012
14
INDIAN PHARMA INC
(contd…)
• India is now among the top five pharma
emerging markets globally
• Front runner in a wide range of specialties
involving complex drugs' manufacture,
development and technology
• Expected to touch $36 bln. by 2016
• India has about 40% of all ANDA approvals
from US FDA during January-July 2013.
• USFDA approvals speak about the stringent
norms followed by the Indian companies
15
INDIA’S API INDUSTRY
 The Indian API Industry services the Domestic and
International Market
 The Indian API manufacturing industry is the third largest
in the world, to grow at CAGR 17% over 2011-17
Producing over 400 APIs
 Growth in Generic Industry spurred API demand worldwide
 Increased emphasis of contract manufacturing increases
scope of captive API demand
 High percentage of API exports are high value, servicing
Highly regulated markets with complex APIs
 Globally Indian companies hold more than 90% of APIs
approvals for ARVs, Anti-TBs and Anti-malarials
16
RECENT COLLABORATIONS WITH INDIAN COs
MNC
INDIAN
THE DEAL
FROM
RATIONALE
Mylan Labs,
USA
Matrix labs
71.5%
August
2006
Expand mfgr
platform, Access
to key markets
Daiichi Sankyo,
Japan
Ranbaxy
Acquired
June 2008
Access to low cost
manufacturing
Pfizer, USA
Aurobindo
Contract
March
Manufacturing 2009
60 products for
regulated markets
Fresenius Kabi,
Germany
Dabur
Acquired
Access to
oncology
manufacturing
Pfizer, USA
Claris
Lifesciences
Contract
May 2009
Manufacturing
Access to sterile
injectable drugs
GSK, UK
Dr Reddy’s
Partnership
Develop & market
select products for
emerging markets
April 2009
June 2009
17
RECENT COLLABORATIONS WITH INDIAN COs
MNC
INDIAN
THE DEAL
FROM
RATIONALE
Mylan Labs, US
Biocon
Contract mfgr & dev.
June 2009
Develop monoclonal
antibody
Mylan
Labs,USA
Famy
Care
15% stake
August
2009
Access to oral
contraceptive mfg.
Sanofi Pasteur,
France
Shantha
Biotech.
Controlling stake
August
2009
Access to vaccine
manufacturing
Hospira
Orchid
Chem.
Buyout of injectable
antibiotics
Dec 2009
Access to low cost
manufacturing
Pfizer, USA
Strides
Collaboration
Jan 2010 & Access to 78
May 2010
oncology products &
sterile injectables
Reckitt
Benckister, UK
Paras
Pharma
Takeover
March
2010
Access to OTC
market
Abbott Labs,
USA
Nicholas
Piramal
Takeover of
healthcare business
May 2010
Access to generic
products
18
RECENT COLLABORATIONS WITH INDIAN COs
MNC
INDIAN
THE DEAL
FROM
RATIONALE
Pfizer , USA
Vetnex Animal
Health
Controlling
stake
June 2009
Access to animal
health business
Vetoquinol,
France
Wockhardt (vet
division)
Buyout
June 2009
Access to Indian
market
Abbott Lab.,
USA
Wockhardt
(nutrition Div)
buyout
July 2009
Access to Indian
nutrition market
Reckitt
Benckister, UK
Paras Pharma
Takeover
March
2010
Access to OTC
market
Litha ealthcare,South
Africa
Natco Pharma
Marketing
of products
Sept 2011
Access to multitude of
dossiers
B. Braun
Singapore
Ahlcon
Parenterals(I)
Controlling
stake
March
2012
Iv Fluid and medical
disposals
Buyout
Sept 2013
Injectables catering to
oncology
Mylan Inc, USA Strides Arcolab
(Agila
Specilaities)
19
TOP INDIAN M&A SECTORS
Automotive
13%
FMCG, Food &
Beverages
14%
Oil & Gas
21%
Others
18%
Manufacturing
4%
IT & ITES
4%
Banking &
Financial
Services
4%
Power & Energy
5%
Cement
6%
Pharma, Healthcare &
Biotech
11%
20
INTERNATIONAL REGULATORY APPROVALS
No. of manufacturing sites (APIs + formulations) registered /
approved by US FDA (as on 31-3-2013)
550 / 323
Total no. of DMFs filed from India as on 31-3-2013
> 3000
No. of ANDAs final / tentative approvals received from USFDA in 178 / 42
Year 2012
No. of ANDAs final / tentative approved by US FDA between
Jan-June 2013
87 / 25
No. of CEPs (certificates of suitability) from EDQM received by
130 companies
902
No. of sites approved by PDMA (Japan) – 20% of all PDMA
aprrovals
>190
WHO GMP certified plants
> 800
Australian TGA approvals
845
21
R&D Investment in India
• R&D investments overall is approx 18% of
revenue
• Spending on R&D by 30 leading Indian pharma
companies up significantly by 19.7% during the
year ended March 2013 over the previous year.
• Focus of R&D by these companies is on new cost
effective generic products in key therapeutic
areas
• With higher spending on R&D, Indian Pharma Inc.
is set to tap upcoming opportunities from loss of
patent exclusivity in the coming years.
(Improve / Add Value to generics / patented products)
22
R&D Investment in India
• Net outcome of this trend is higher
approvals for ANDAs and DMFs from
highly regulated authorities like US, Europe
and Japan.
• Major companies like Shasun Pharma,
Unichem Lab., Biocon, Natco Pharma etc
have pushed their R&D expenses over 50%
during 2012-13
• For example, R&D expenditure of Shasun
Pharma went up by 179%
23
FOCUSSED APPROACH
• Designing products specifically for low
income group
• Identifying and servicing completely new
needs
• Focusing on New Drug Delivery Systems
• Greater focus on prevention rather than
treatment, including increasing use of
information and communication
technologies
24
INDIAN BIOTECHNOLOGY MARKET
Global Biotech Revenue
$262 billion
Indian Biotech Market at $ 4.3 bln.
expected to touch $ 11.6 bln. by 2017
25
INDIAN BIOTECH SET-UP
• World's largest producer of vaccines: 60% of the world’s
vaccines are manufactured in India – exported to over 150
countries - accounts for 60–80% of annual UN vaccine purchases
• Over 300 companies in operation
• Among the five rising biotech industries in Asia-Pacific
• Annual revenue generated is over $4 bln at a growth rate of
21.5%
• Revenue from biotech exports at $ 2.2 bln in 2013 accounting
for 51% of total industry revenues
• Genome Valley project at Hyderabad is the largest single cluster
for biotech research, training and manufacturing, earns foreign
exchange of over $ 1 bln per year
26
THE INDIAN SCENARIO
India's growing respect and
legal / regulatory framework
for IPR, favourable economic
policies and availability of
huge talent pool for sustaining
and growing operations is
making India an attractive
choice for global pharma
companies for investment, tieups, mergers, acquisitions.
27
THE INDIAN SCENARIO
Because of patent expirations
of blockbuster drugs, Indian
firms are expected to actively
participate in the production of
generic version of these
products. Indian companies are
also ready with generic version
of biotech drugs. Therefore,
India will be able to maintain a
large
basket
of
qualitty
affordable
generics
with
assured safety and efficacy.
28
GLOBAL HEALTHCARE COSTS
 Rapid hike in prices
 Overall economic slowdown
 Rising Govt. deficit
 Reduction in Healthcare budgets
 High priced prescription drugs
 Aging population
 Administrative costs
 Spending on chronic diseases etc
 Companies forced to reduce prices
29
INDUSTRY’S CHALLENGES
Declining Productivity
Competitive Pressure
Reducing drug approvals
Stringent regulations
Implementation of cost control
measures by Governments
 Increasing development costs
 Increase in Clinical trial period due to
tightened drug safety regulations
- thereby Leading to higher





development costs and increased
time-to-market
30
GLOBAL PHARMA MARKET
31
GLOBAL PHARMA TRENDS
• Spending on medicines will reach $1.2 trn. by 2016
• Rising influence of healthcare access and funding World
over is driving demand towards low cost generic options
from India
• Anti-Diabetic Drugs and those for cardiovascular
diseases are expected to see the fastest growth.
• Cardiovascular patients estimated globally at over 250
million, mainly due to changes in demographics and
lifestyle
• Pharmaceutical industry's R&D programs will need to
adjust to broad availability of low-cost generics from
India
• Demand for generics will also increase in oncology,
diabetes, multiple sclerosis and HIV therapy areas
32
WHAT IS THE SOLUTION?
 Globally, Governments and pharma companies are
looking at opportunities to procure medicines at
affordable prices, reduce costs, improve pipeline
and reduce the time-to-market
 To reduce healthcare costs, they are adopting
strategies like:
 SOURCING FROM INDIA
 Outsourcing (manufacturing, research, Clinical
Trials etc) to India
 Restructuring their R&D models to consider
generics
 Adopting efficient sales & marketing functions to
promote ‘value-added’ generics as alternatives
 In-Licencing Arrangements
33
ADVANTAGE INDIA
34
ADVANTAGE INDIA
• While clinical trials cost approximately $300 to 350 million in
US, they cost only about $25 million in India
• India has the 2nd highest number of qualified doctors in the
world. Of every six medical doctors in the US, one is Indian
• Investigational New Drug stage costs about $100 to 150
million in US, but costs only around $10 to 15 million in India
• 700,000 science and engineering graduates & 1500 PhDs
qualify annually. Over 15,000 scientists
• India’s huge population and the prevalence of a wide
spectrum of disease conditions offer a wide patient-resource
for clinical trials
35
ADVANTAGE INDIA
On demand
• India manufactures and
exports medicines from all
therapeutics groups.
• Many original innovator
companies source their
discovered drugs from Indian
companies.
• India is a world leader in antiAIDS and anti-TB segments
and for some of the latest
medicines like Glitazones,
Celecoxib, Statins,
Montelukast and many anticancer drugs
36
US PATENT EXPIRIES
Year
No. of
Patents
Year
No. of
Patents
2010
70
2020
171
2011
130
2021
133
2012
165
2022
88
2013
207
2023
95
2014
253
2024
64
2015
235
2025
45
2016
162
2026
37
2017
203
2027
42
2018
209
2028
21
2019
2013
2029
22
(Source: USFDA Orange Book, Oct 2011)
37
GLOBAL RECOGNITION
• Bill Clinton's foundation, Clinton
Health Access Initiative (CHAI) got
further discounts from Indian generic
manufacturers that reduced the cost
of combination drug treatments for
AIDS, which can reach thousands of
dollars per year in the West, to as
low as $120 a year per patient.
• Many Indian companies are part of
this agreement where Lamivudine,
Stavudine, Zidovudine, Nevirapine
will be supplied to a few African
countries.
• India has highest number of
approvals from the US President's
Emergency Plan for AIDS Relief
(PEPFAR).
38
39
INDIA AS PHARMACY OF
DEVELOPING WORLD – Examples
• Main procurement agencies for
developing countries depend
overwhelmingly on India
• 70-90% of essential medicines of
developing countries comes from India
• 50% of medicines procured by UNICEF
for developing countries are from India
• 75-80% of medicines distributed by
Dutch-based International Dispensary
Association (IDA) Foundation, the chief
medical supplier to developing
countries is sourced from India
40
INDIA AS PHARMACY OF
DEVELOPING WORLD – Examples
(contd….)
• 80% of medicines for AIDS issued by MSF
(Doctors Without Borders) come from
India and are distributed in treatment
projects in over 30 countries
• Globally, 70% of treatment for 87
countries provided by UNICEF, The Global
Fund to Fight AIDS, Tuberculosis and
Malaria, the Clinton Foundation, etc. come
from India
• 91% of the generic ARVs approved by the
US FDA for PEPFAR, the US President’s
AIDS initiative for distribution in
developing countries are from India,
resulting in cost-savings up to 90%.
41
INDIA AS PHARMACY OF
DEVELOPING WORLD – Examples
(contd….)
• In Zimbabwe, 75% of all tenders for
medical expenditure come from India
• In Lesotho, it is 95%
• 90% of the ARVs used in Zimbabwe’s
national treatment programme come from
India
• In addition, raw materials are exported
from India to other countries for local
production of affordable medicines
• This has been crucial to enable national
AIDS programmes, such as those in Brazil
or Thailand, to provide universal free
access to ARVs.
• Thailand gets 90% of its raw materials for
ARV production from India
42
INDIA’S SUPPORT TO USA
• Over 40% of generics prescribed are from India
• To ensure continued supply of the low cost quality generics
from India, the US FDA has opened India office
• 1 out of 5 US FDA inspections for approvals are in India
• Indian firms have over 40% of total ANDA approvals in USA
• 80% of all retail prescriptions filled in USA are for generic
drugs
• Based on their marketing and distribution networks and
manufacturing capacities, Indian firms could see as much as
15-28% annual growth from the US, predict experts.
• To overcome the recent shortage of cancer drugs J & J’s
Doxil in USA, the US FDA sought Sun Pharma’s help in
providing their chemotherapeutic drug Lipodox drugs from
India
43
LARGEST SUPPLIER TO UNICEF
•
•
•
•
•
India has consistently been the largest
supplier to UNICEF since 2007.
India was the largest supplier country in
2012, with $558 million worth of supplies
such as vaccines, pharmaceuticals,
nutrition, medical supplies
Of the 2.14 bln. purchases by UNICEF in
2012, more than 25% were from India
Serum Institute of India Ltd., an IDMA
Member supplied vaccines / biologicals
worth $254 mio dollars, making it the
largest supplier in India
Other significant suppliers include Hetero
Labs, Ranbaxy Labs, Aurobindo Pharma,
Haffkine Bio-Pharma Corp., Micro Labs etc,
all Members of IDMA.
44
LARGEST SUPPLIER TO UNICEF
• UNICEF has recognised India's contribution to glocal
aid, and international groups have lauded India's role
in increasing access to medicines in the developing
world.
• Anti RetroViral (ARV) treatment in Europe was
$10,000 per patient a year, until Indian manufactured
drugs brought it down to $95 patient a year.
• India is not only the largest supplier to UN groups,
but also to the MSF and International Dispensary
Association.
45
Affordable Efficacious Medicines –
All Roads Lead
• India happens to be the largest supplier of generic
ARVs to low and middle income countries.
• Paul Cawthome (MSF Access Campaign
Coordinator-Asia) highlighted the worldwide
dependency on India as a drug supplier best, when
he said : 'It comes as a great relief to millions around
the world who depend on a continuous supply of
Indian generic medicines that the Indian Supreme
Court has ruled against Novartis.‘
• To meet increasing global requirements, the
Government of India has set a target of $25 bln. for
pharmaceutical exports by 2016.
46
Affordable Efficacious Medicines –
All Roads Lead to India
• Over 100 countries, mostly in the
developing world, depend on India for
affordable and quality essential medicines,
vaccines and medical supplies
• Every fifth generic drug and every third
HIV drug consumed anywhere in the
world, mostly in the developing world,
home to over 80 % of the world's
population, is manufactured in India
47
CHINDIA BILATERAL TRADE
• China’s Premier Li Keqiang chose India for his first
foreign trip
• Premier Li was confident that “we are not a threat to
each other, nor do we seek to contain each other”
• Prime Minister Manmohan Singh had earlier assured
China that “the world is big enough for both countries
and each is too big to be contained by the other“
• China has emerged as India’s largest trading partner as it
replaced the US (in March 2008)
• Premier Li has assured that China’s markets will be
opened to Indian products to address the trade
imbalance and boost commerce to $100 billion a year
48
CHINDIA BILATERAL TRADE
• Despite a clear value proposition,
Indian companies find it difficult to win
government procurement contracts due
to regulations that favour Chinese
companies.
• Again, China accounts for nearly 73%
of Indian imports of APIs and other
organic compounds.
49
CHINDIA - PARTNERSHIP IN
GLOBAL TENDERING
• As a reciprocal measure, China should
import drug formulations from India to offset
the trade deficit against API imports and set
a timeline for review and approval of drug
dossiers
• India’s closer engagement with China in the
global production network could be a
possible way to improve its technologyintensive exports.
• Our trade must focus on ‘trade creation’ and
‘trade diversion’
50
IN CONCLUSION
A Win-Win situation!!
 IDMA has always promoted access to quality affordable medicines, as our
Annual themes confirm:




Affordable Medicines for All (2003)
Indian Pharmaceutical Industry – Going Global (2004)
People First… Patents Next (2005)
Global Pharma, India has Arrived (2006)
 Contract Research and Manufacturing Services -Destination India (2007)




Indian Pharmaceutical Industry – Exciting Times Ahead (2008)
India’s Quality Affordable Generics: For Global Healthcare (2009)
India- The Generics Pharma Capital of the World (2010)
Healthcare Of People – Always In All Ways (2011)
 INDIAN PHARMA INC. CREATING A GLOBAL IMPACT (2012)
 AFFORDABLE EFFICACIOUS MEDICINES – ALL ROADS
LEAD TO INDIA (2013)
51
Thank You
Xiexie
52
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