international pharmaceutical market opportunities for india...title: microsoft powerpoint -...

J. B. Chemicals & Pharmaceuticals Ltd.

www.jbcpl.com © Copyright 2005 J. B. Chemicals Pvt. Ltd.

Dr. Milind JoshiPresident Global Regulatory Management

Internat ional Pharmaceut ical Market

Opportunit ies for India

http://www.jbcpl.com

www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. 2J. B. Chemicals & Pharmaceuticals Ltd.

Pharmaceutical Industry

Growth in leaps and bound over last 50 years.

Major player in the global scenario

Leader in Pharma Market in Asian and Third World Countries

Self sufficient in most of the domestic needs of medicines

Constant growth in exports



Ind ia has emerged as a powerhouse of API production. Ind ian companies filed highest number of DMF with the USFDA, ahead of Italy , China, Israel .

Indian pharma industry has the highest number of plants approved by the USFDA outside the USA.

Indian pharma industry has bulk drug manufacturing base, availability of quality products at low manufacturing costs, skilled human resources, optimal use of process research skills.





Pharmaceutical companies in US and Europe are choosing to outsource:

Clinical trials and Bio-equivalence StudiesR&DManufacturingContract Research and Manufacturing




Outsourcing Clinical Trials and BE Studies

Costs of clinical trials in Ind ia much less than in US/Europe

Huge population and is genetically diverse

Incentives offered to clinical trial volunteers



Availability of medicines

Self sufficient in medicines . Self sufficiency in preventive therapy i.e. production of vaccinesSuccessful through preventive measures like vaccination, successfully erad icated small pox and making efforts to eradicate polio from the country.Indian Pharma Industry produces both d rug substances & drug products. These include biotech products also.Diagnostic industry has manufactured critical d iagnostic reagents HIV Kits, HVAC and Anti Malarial Kits to support National Health Program A lead ing private manufactruer of the country supplies to173 countries including world bodies like WHO, Unicef, UNIDO, PAHO etc.



Global Pharmaceutical Scenario

8717.8Rest of the world

1382.2Total

220.9Japan

730.4Europe

430.9North America

Share of population (%)

Share of production (%)

Country



Global Pharmaceutical Scenario

India s share in the global pharmaceutical market is less than 2%

North America, western Europe, Japan account for 80% of pharmaceutical market in value terms.These markets are recognised by strong IPR protection and significant R&D efforts.

Countries like Ind ia, Mexico, Brazil were characterised by weak IPR protection, generic drugs/ formulations, off patent formulations, presence of imitative drugs.



The US is the world s largest generics market with a 30% plus market share.In the next five years, it is estimated that d rugs with sales of $55-$65 billion will go off patent. Education excellence, skilled human resource, technical knowledge, infrastructural advances, strong IT support and knowledge of English gives Ind ia an added advantage.Opportunities for sales of generics, CROs and other outsourced business from USA / EU countries.With compliance to TRIPS and Patent Law, Ind ia is preferred for tie-ups.

Opportunities in Regulated MarketsOpportunities in Regulated Markets



Generic Drug Markets , 2004 (US $ Millions)

2480

057

0052

50

4100

3300

2500

1900

1300

1283

1241

788

628

609

582

229

0

5000

10000

15000

20000

25000

30000

US

A

Ind

ia

Ger

man

y

UK

Jap

an

Ital

y

Fra

nce

Ru

ssia

Net

her

lan

ds

Can

ada

Sp

ain

So

uth

Afr

ica

Bra

zil

Au

stra

lia

Sw

itze

rlan

d

Total Generic - $ 59.18 Billion



Opportunities in SemiOpportunities in Semi--Regulated MarketsRegulated Markets

Low registration cost

Faster registration

Comparatively less stringent regulatory requirements

Large volume of business



RussiaRussia and CIS Countriesand CIS Countries

Total market of approximately US $ 4-5 billion

Major CIS countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine & Uzbekistan.

Each CIS country has its own regulation for product registration. However regulations not as stringent as USA, EU.

Requirements : FSC, COPP, Formulation and analytical data, Drug toxicity report,Clinical trial report, BE stud ies, stability data, product samples etc.



Latin American Countries

Brazil, Mexico, Venezuela , Ecuador are major pharmaceutical markets

Brazil : Total market value of US $5.2 billion. Generic market of approx. US $1 billion. ANVISA has implemented generic law to facilitate generic market entry into the country

Product Registration :Apart from technical documents application for trademark and patent registration , contract with a local QC laboratory for QC, contract agreement for each product required

Mexico : Technical documents such as BMRs, Stability data , validation , samples in English / Spanish, legal documents like power of attorney, COPP, FSC etc.



Select Generic Companies Select Generic Companies Sales 2001 Sales 2001 -- 20032003 (US $ Millions)

Companies 2001 2002 2003Teva 2,077 2519 3276Sandoz 1,442 1817 2906Watson 1,161 1223 1458Ivax 1,215 1197 1420Merck KGaA 829 1077 1363Mylan 1,104 1269 1361Barr 1,172 895 1297Alpharma 975 1231 1297Ranbaxy 604 812 1042Andrx 724 744 959Pliva 465 659 859Stada 292 421 622Gedeon Richter 309 388 516Dr. Reddy's 349 374 438Cipla 268 299 418Total Sales 12,987 14,925 19,232 Y-O-Y Growth 33% 15% 29%

has a June 30 fiscal year end.



75% of world s population uses Herbal medicines as the primary therapy

India has climatic conditions conducive of growth of medicinal plants

Varied knowledge base

More scientific approach is now being developed towards Herbal Medicines

Herbal Medicines



Herbal Medicines

Great knowledge base but is more traditional

Methodical studies and data compilation needs to be done

Patent protection and IPR

Planned cultivation and research

GMP and quality monitoring systems

Marketing

Promotional incentives



THANK [email protected]


international pharmaceutical market opportunities for india...title: microsoft powerpoint -...

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