Indian Pharma Abroad View US Journey

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    Objective of Study

    i) To observe the opportunity as India puts an

    iconic model for world in this sector

    ii) Obstacles created by USFDA:Analysis &

    Solution

    iii) Understanding US attitudes towards INDIA

    market in this sector with SWOT

    iv) Scope in global market

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    Sector statistics

    4.8 % of worlds Pharma Market

    4th ranking in production(1.04L cr market domstc+intrl)

    400 bulk drugs and around 60,000finished medicines

    Around 3 % of countrys FDI

    Growth Rate about 912%

    USD 10 Billion marketestimated to reach USD 40 Billionby 2020

    CIIpharma summit 2012

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    Domestic Key Players

    20%

    14%

    13%9%

    10%

    7%

    16%

    11%

    Market sharesun ranbaxy cipla lupin gsk cadilla drl others

    Pharmabiz.com

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    Indias Robust growth

    0

    50,000

    100,000

    150,000

    200,000

    250,000

    2005 2008 2015 2020

    market value(Cr)

    http://profit.ndtv.com/news/pharma

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    Global Scenario

    31 new molecular entities introduced 2013.

    Spending on medcn expected to $1,100 billion by2015

    17 high growth emerging markets including China, India, Brazil, Russia andMexico will contribute 28 per cent of total spending by 2015, up from only12 per cent in 2005

    Pfizer is at the top with $ 50 billion sales.

    Expand market by 17% each year.

    India holds 60% export.

    More than 200 mfg unit in India approved by USFDA,WHO-GMP,UK-MCA

    On the other hand, share of patented brands which accounted for nearly 70 percent of global pharmaceutical spending in 2010 are expected to decline to 53 percent in 2015

    Global pharma summit 2013,hyderabad. Gmpsummit.com

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    Contd...Spending by segment

    70%

    20%

    10%

    2005 605$ billion

    brand

    generic

    other

    53%39%

    8%

    2015(estimated) 1025$

    billion

    brand

    generic

    other

    IMS Market Prognosis, April 2013

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    Key drivering of change

    Global spending on diabetes is increase by 47% over the fiveyears

    Global oncology spending will reach $ 75 bn by 2015

    Annual spending growth through 2015 will slow to 25% forasthma and COPD medicines compared to nine per centgrowth over the past five years

    ** Some innovative research products to be launched are

    expected to drive markets (especially in the developedmarkets) in the next few years which will span disease areaslike arrhythmia, autoimmune diseases, diabetes, hepatitisC,Prostate cancer

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    Opportunities for entry route

    Pharmabiz.com

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    Top 5 World Market by 2015

    Name of country Estimatemarket($billion)

    Incremental growth

    point(100)

    USA 444 96

    CHINA 150 23

    GERMANY 82 14

    ITALY 38 13

    BRAZIL 20 17

    http://www.mckinsey.com/insights/globalization/global_flows_in_a_digital_age

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    Foreign chasers

    8% 7%

    9%

    5%

    4%3%3%

    5%

    8%

    48%

    world exportpfizer Astra zeneca Abott Gsk

    Sanofi aventis Daichii sankyo Novartis Roche

    J&J Others

    www.pharmexcil.org

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    Export to Abroad

    0

    5,000

    10,000

    15,000

    20,00025,000

    30,000

    35,000

    40,000

    45,000

    50,000

    export drug & pharma

    DGCIS,KOLKATA

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    Patent War:foreign vs domestic2013-14

    Cipla vs Novartis on Glivec

    Cipla,Natco vs Bayer on Nexavar

    Sun vs J&J on psychological disorder drugRisperdal

    Cipla vs Roche cancer drug Erlocip

    Glenmark vs Merck on diabetes drugSitagliptin

    http://in.reuters.com/article/india-drugs-patent

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    Disease & Dose Gambol rate inUSA11

    3.316.91

    2.8

    4.7

    2.53.8

    6.08

    14.6

    2005 2015(estimated)

    Chart TitleCoronary Heart Disease Diabates CNS / Neuro Cancer

    Disease chronical by SCRIBD.COM

    0

    1000

    2000

    3000

    4000

    5000

    cr

    Major export to US fromIndia

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    USFDA TUSSLE

    USFDA chief Mrs.Margaret A.

    Hamburg; bitter smile !

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    Indian Drug Giants US Stigma

    Some reports which slaps domestic major

    .Sun pharma recalls Cephalexin unit 3,40,553 in june forcontamination

    .Lupin pulls 9,000 bottles of anti infective Suprex in mid june

    .DRL recalls 13,000 bottles of hypertention drug Metoprolol

    wrong product of mg. In july

    .Wockhard reshipment 840 capsule of Buproprion in june

    .Ranbaxy mohali plant is totally banned for export to USA inJune

    http://profit.ndtv.com/news/pharma/march-june/14

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    The bitter pill!

    BT:March14,jp morgan estimate

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    Hamburgers Harrashment

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    Swot Analysis in US market

    Strength:

    1)$444 billion estimated growth

    2)Increase of cns/chd/diabetes alomost double

    3)280 USFDA plant approved indian drug major.4)Manufacturers are one of the lowest cost

    producers of drugs in the world.

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    Contd...Weekness:

    1) The industry witnesses price competition, which

    reduces the growth of the industry in value term

    2)Us global players are strong in NME.

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    Contd...

    Opportunity:

    Since generic drugs are necessary commodities by nature,

    Indian producers have the competitive advantage, as they are

    the lowest cost producers of drugs in the world.

    .Large number of drugs going off-patent in the US during 2005

    - 2009 offers a big opportunity for the Indian companies to

    capture this market

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    Contd...

    Threat:

    1) Threats from other low cost countries like China and Israel

    exist. However, on the qualityfront, India is better placed

    relative to China 2)USFDA norms

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    Conclusion

    1)Robust growth in global market

    2)Avoid infringement or contamination

    problem

    3)Need USFDA like mock test in domestic

    plant

    4)Medicine is necessity ,here brand image is

    secondary issue,India have to capture this

    opportunity