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Indian Pharmaceutical Industry Evolution, Trends

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Local companies begin to make an impact. Phase III Development Phase. Process development ... Teva acquired an Indian co in 2003, setting up new development centre ... – PowerPoint PPT presentation

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Title: Indian Pharmaceutical Industry Evolution, Trends


1
Indian Pharmaceutical Industry Evolution, Trends
Opportunities
  • CHLA
  • September 21, 2006
  • Akshay Lal
  • Vice President, Strategic Licensing Sourcing
  • Pharmascience Inc.

2
Presentation Structure
  • Indian Pharmaceutical Evolution
  • India Advantage
  • Emerging Trends Opportunities
  • Key Partnership Considerations

3
Indian Pharmaceutical Evolution
  • Phase V
  • Innovation and Research
  • New IP law
  • Discovery Research
  • Convergence
  • Phase IV
  • Growth Phase
  • Rapid expansion of domestic market
  • International market development
  • Research orientation
  • Phase III Development Phase
  • Process development
  • Production infrastructure creation
  • Export initiatives
  • Phase II
  • Government Control
  • Indian Patent Act 1970
  • Drug prices capped
  • Local companies begin to make an impact
  • Phase I
  • Early Years
  • Market share domination by foreign companies
  • Relative absence of organized Indian companies

1970
1980
1990
2000
2010
4
Moving up the Value Chain
VALUE
Innovative Products
Specialty Products
Generic exports to developed countries
Generic exports to under-developed developing
countries
API Exports
TIME
5
India Advantage
  • Large skill base
  • Experts in process chemistry
  • Long history of reverse engineering
  • Vast talent pool
  • Sheer number of scientists
  • Motivated English speaking
  • Large number of trained Indians returning home
    from North America and Europe
  • Unmatched cost competitiveness
  • Lower cost of infrastructure and skilled manpower
  • Vertical integration

6
India Advantage cont.
  • Strong local industry
  • Growing expertise with international regulatory
    compliance
  • High quality manufacturing with abundant
    capacities
  • Speed
  • Very strong entrepreneurial spirit
  • Hungry for growth and recognition
  • Quick learners and fast movers
  • Availability of capital
  • Stock market has seen unprecedented growth in the
    last decade
  • Continues to be bullish on the pharma industry

7
Emerging Trends Opportunities
  • Geographic Convergence
  • Established and growing destination for Generic
    product development and manufacturing
  • Leading Indian companies seeking overseas markets
    and global scale
  • Generic Innovator Convergence
  • Leading Indian companies trying to climb the
    value chain into innovative research
  • India developing into a Drug Discovery services
    outsourcing destination

8
Generic Product Development Manufacturing
Destination
  • Leader in API DMF filings in the US
  • Jan-Jun 2006 175 of the 601 DMFs filed were by
    Indian companies
  • 2005 - 313 of the 946 DMFs filed were by Indian
    companies
  • Leader in capital investments - largest number of
    US FDA approved manufacturing facilities (outside
    the US)
  • Almost 20 of ANDA filings in the US
  • No place like India for generics RD and
    manufacturing of APIs formulations
  • Indias biggest assets cost, speed scientists
    churning out generics faster than you can say
    copy
  • In 5 years, 30-35 of the global demand for
    generic products is expected to be met by India

9
Generic Product Development Manufacturing
Destination cont.
  • Leading global/regional generic players
    establishing a presence
  • Teva acquired an Indian co in 2003, setting up
    new development centre another manufacturing
    facility
  • Sandoz development centre, 3 manufacturing
    facilities, more than 1000 employees
  • Actavis - development centre, acquired CRO
    (Lotus)
  • Mylan acquired controlling stake in Matrix last
    month for US 736 mn
  • Ratiopharm development centre, manufacturing
    facilities

10
Indian companies seeking overseas marketsand
global scale
  • Aggressive Growth Strategies
  • For building a global scale Ranbaxy aims to be
    one of the Top 5
  • For market entry acquiring local co or setting
    up subsidiaries
  • Recent MA activity size of deals growing
  • Ranbaxy going after acquisitions in US Europe
  • Acquired 3 companies in Europe in March/April
    2006
  • Terapia (Romania) for US 324 million
  • Raising 1.5 billion to fund further acquisitions
  • Dr. Reddys
  • Acquired Betapharm (Germany) for US 570 million
    in March 2006
  • Matrix (now part of Mylan)
  • Acquired Docpharma (Belgium) for US 263 million
    in 2005.

11
Indian companies seeking overseas markets
cont.
  • Partnership opportunities
  • Large number of large and mid-sized Indian
    companies with world-class generic product
    development and manufacturing capabilities and
    facilities
  • Lot of under-utilized manufacturing capacities
  • These companies prefer focusing attention
    resources on some key markets (US/EU) and look
    for partners in other markets
  • Opportunities for supplementing pipelines,
    filling pipeline gaps and reducing/optimizing
    cost of development and cost of goods
  • In-licensing products
  • Dossier and API development
  • Contract Manufacturing
  • Contract Research pilot pivotal
    bio-equivalence studies
  • Opportunities for out-licensing and supplying
    products to leading Indian companies for other
    markets

12
Generic Innovator convergence
  • Increasing number of Indian companies moving up
    the value chain from generic to NDDS/NCE research
  • Low cost development/manufacturing to Low cost
    innovation
  • Some examples
  • Ranbaxy
  • 1 project in Phase II
  • 1 project in Phase I
  • 7 projects in Pre-Clinical 2 with GSK
  • Dr. Reddys
  • 3 projects in Phase II
  • 2 projects in Phase I
  • 4 projects in Pre-Clinical
  • Glenmark
  • 2 projects in Phase II deals with US 190
    million signed
  • 4 projects in Pre-Clinical
  • Opportunities for in-licensing out-licensing

13
Drug Discovery Services Outsourcing
  • Global outsourcing market
  • US 15-20 billion Manufacturing
  • US 3-4 billion Research (informatics,
    chemistry services chemical custom synthesis)
  • Big pharma is entering into deals with Indian
    companies to lower their cost of RD
  • Collaborative RD GSK - Ranbaxy
  • Service outsourcing - Wyeth GVK, Jubilant,
    Lilly Suven
  • Global discovery services companies are looking
    at India to retain their cost advantages
  • Albany Molecular Nektar have already
    established a presence
  • Indian industry hoping to see 3-4 global
    discovery services companies emerging out of India

14
Drug Discovery Services Outsourcing
  • Leading Indian Service Providers
  • Contract Manufacturing Jubilant, Shasun, Divis
  • Clinical Research Syngene (Biocon), Aurigene
    (Reddys), Synchron
  • Bio-informatics other IT services TCS,
    Satyam, Infosys, GVK Bio, Jubilant
  • Drug Discovery/Medicinal Chemistry Aurigene,
    Divis, Syngene, Suven, GVK Bio
  • Pre-clinicals Vimta, Lambda
  • Central laboratory services SRL Ranbaxy, Vimta

15
Key Partnership Considerations
  • Supplier/Partner mapping/selection
  • Capability / Keenness / Reliability /
    Competitiveness
  • Key team members development, regulatory
    commercial
  • Optimal Number of Partners
  • Strategic markets/product lines
  • Opportunistic product specific
  • Relationship management
  • Relationship oriented culture
  • Contract negotiation
  • Clear distribution of responsibilities and
    timelines
  • Demand performance - penalties for not meeting
    deliverables
  • Project management
  • Regular visits and video/teleconferences a must

16
Closing Comment
  • India is an acquired taste
  • Give it some time it will grow on you

17
  • Thank you!
  • Merci!
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