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India
Today……….

   Compiled by:
     CK Shah




   Client Confidential
Shresth Pharma Nexus(SPN) is a business
consulting company active within the field
of Pharmaceuticals and Health Care. It
specialises in providing a Global network to
its customers, allowing them to choose from
the best in the market. The idea is to bring
the market to the customer, providing them
solutions and making business an easy task.
We work with organizations in the arena of
strategic management, which requires a
distinctive approach from operational
management.

                Client Confidential
Our key role is to build the road to your
               prosperity:




       We Lay Foundation for Future Growth
                   Client Confidential
Range of Services
                                     Business plan review
                                     Organizational review
             Market Assessment
                                                             Business Consultancy
             & Intelligence
                                                             For Merger, Acquisition
                                                             & Disposal




Registration of API/FF
                                 Shresth Pharma Nexus                  Strategic tie-ups
With DCGI, India




     Enterprise Risk                                               Project Evaluation
     Management

                                      CRAMs & Analytical
                                      Services

                                     Client Confidential
What We Offer
                                   Finished
    API
                                 Formulation
Manufacturer
                                 Manufacturer
Sourcing Intermediates
                                      Sourcing of API
  from India/China

  Sales & Marketing                 In & Out Licensing


  Custom Synthesis                        CRAMs

                                 Generic NDDS, Formulation
     Technology
                                          dossier

                                 Whole chain of analytical
  Turn Key Projects
                                        services.
           Client Confidential
Our Philosophy
    We comprehend our customers’ needs
    accurately and provide them with best
    business alternatives, as we believe that
    business should always be customer driven.
    However, we offer more than mere business.
    We help you make relations and partnership
    that lead towards triumph. We give
    importance      to      confidentiality    and
    transparency in our business. And that is our
    motive to deliver, with honesty and trust.
    Our key role is to build the road to your
    prosperity.


    “We Lay Foundation                        for
    Future Growth”
     Client Confidential
India
Today……….


   Client Confidential
Projected Growth of
                      Indian Pharmaceutical Market
        Currently                                                             Forecasted Growth for 2020
        • Total Worth $19billion                                              • Increase to $50billion
                 – Domestic Market: $11bn                                               – Domestic Market: $30bn
                 – Exports: $8bn                                                        – Exports: $20bn
        • Ranked 14th in World                                                • Will be one of top 10 markets




Source: PwC, Global pharma looks to India: Prospects for growth

                                                                  Client Confidential
India is expected to be the 7th largest
                market by 2020
                         Top Pharma Markets 2015* & 2020 (US$ bn)




                                                                    Source: BCG, Goldman Sachs,
                                                                    McKinsey Reports


However, among all Top 10 global markets of 2015 India shows the highest growth rate
among all countries analysed by McKinsey
                                        Client Confidential
Global API Manufacturer




Source: TR Newport Premium™   Client Confidential
Assessing the Capabilities of
                     API Manufacturers
Leading companies with business experience, regulatory, quality, non-infringing
processes, and track record of supplying regulated markets                               Established

Meet regulatory, quality, & other criteria for limited number of
                                                                                     Less
molecules. May be moving from older to new molecules, may supply
intermediates to Established companies.
                                                                                  Established

Companies usually make older molecules, may supply
                                                                        Potential
intermediates to Established companies, often working to
upgrade & forge links with dose firms in major markets                   Future

Companies serving their local markets. Lack
quality, regulatory, experience to supply major                 Local
markets


                                    Able to satisfy local markets                       Global markets

                                    Unregulated                                         cGMP, FDA Inspected

                                    Older molecules                                     New molecules



                                                  Client Confidential
Global API Manufacturer rated




Source: TR Newport Premium™   Client Confidential
API manufacturer-Emerging markets




Source: TR Newport Premium™
                              Client Confidential
2nd wave emerging API manufacturers rated




Source: TR Newport Premium™
                              Client Confidential
India’s API Plants




   Client Confidential
Indian API Manufacturer Ratings
                                       2004 to 2010
                             100                                                                  92

                              90

                              80
Number of Corporate Groups




                              70
                                                                                           56
                              60

                              50
                                                                              40
                              40                                                                           2004
                                                        24                                                 2010
                              30
                                             18
                                                                     17
                              20

                              10

                               0

                                         Established          Less Established          Potential Future
                                              Corporate API Rating Assessed by Thomson Reuters


                             Source: Newport Premium™             Client Confidential
Capabilities of
                   Indian API Manufacturers
 24 corporate groups, 34 API sites
                                                                                  Established
 e.g., Cipla, Dr. Reddy’s


40 corporate groups, 47 API sites                                             Less
e.g., MSN, Hetero                                                          Established

92 corporate groups, 91 API sites                                    Potential
e.g., Emcure, Sai Advantium                                           Future

480 corporate groups, 492 API sites
e.g., SMILAX Laboratories                                    Local



                                    Able to satisfy local markets                Global markets

                                    Unregulated                                  cGMP, FDA Inspected

                                    Older molecules                              New molecules



                                               Client Confidential
Comparing the Ability of Indian and
                              Chinese Manufacturers to Supply
                                    Regulated Markets
                             160                                                                             150

                             140
Number of Corporate Groups




                             120

                                                                                                      92
                             100

                             80
                                                                                                                      India
                             60                                                                                       China
                                                                           40
                                                                                  34
                             40
                                               24
                                                       12
                             20

                              0
                                             Established              Less Established             Potential Future

                                                    Corporate Rating Assessed by Thomson Reuters


                                   Source: Newport Premium™
                                                                     Client Confidential
DMFs & COS by India & China




           Client Confidential
Year wise US DMFs Submitted by India & China

  2009                                  94
                                                                                            350

  2008                                        119
                                                                                                  382

  2007                                        122
                                                                                      331

  2006                            64
                                                                                283

  2005                       52
                                                                          257
                       33
  2004                                                    184                                       China
                        35
  2003                                       114                                                    India
  2002             25
                                  63

  2001        5
                            44

  2000            15
                       31

  1999        5
                   23

          0                            100                 200                  300                400
                                                    Number of US DMFs

 Source: Newport Premium™
                                                    Client Confidential
COSs Granted 2000 to 2009 to
  India, Italy, China & ROW (includes US)
                            2000                              2009
                                                                         India
                                                                         24%




                                                                                China
                                                                                10%
                                                       ROW
                                                       54%
                                                                        Italy
                                                                        12%

                           459 COS                           2722 COS


Source: Newport Premium™             Client Confidential
US ANDAs Held by Indian
                                                 Companies
                                 180

                                 160
                                                                                       17    29

                                 140
            Number of US ANDAs




                                                                                 21
                                 120

                                 100

                                 80                                                                     Tentative
                                                                          19           147
                                                                                             139
                                                                                                        Approved
                                 60                                              117
                                                                  10
                                                                                                   11
                                 40
                                                                          63
                                 20                               42                               38
                                                 14   12   18
                                       0    10
                                  0    2




                                                                Year



Source: Newport Premium™
                                                           Client Confidential
Increase in Indian Holders
                                                                of US ANDAs
                                                180                                                                    30
                                                                                                            168
                                                                                                      164
                                                160
          Number US ANDAs by Indian Companies




                                                                                                                            Number of India Based ANDA Holders
                                                                                                                       25
                                                                                                138
                                                140

                                                120                                                                    20

                                                100
                                                                                          82                           15
                                                 80

                                                 60                              52                                    10
                                                                                                                  49

                                                 40
                                                                                                                       5
                                                                          18
                                                 20             14   12
                                                           10
                                                      2
                                                 0                                                                     0




Source: Newport Premium™

                                                                          Client Confidential
Top Ten Paragraph IV Challengers
                                           by Volume
                                 160   149
                                 140
      Number of PIV Challenges




                                 120

                                 100

                                 80          75   72
                                                       57        55
                                 60
                                                                            42    39
                                 40                                                    32   30   27
                                 20

                                  0




Source: Newport Premium™

                                                            Client Confidential
Innovation

                        Zydus Cadila                          6                                  4                1   10

                              Orchid                                            12                                         1       10

                         Sun Pharma               3           010

                               Lupin                  4                    2                2        1   1

                              Biocon                              7                         0    2       1        1
                                                                                                                                                 Pre-Clinical
                  Jubilant Organosys 0       2        0       2
                                                                                                                                                 Phase I
                              Torrent                 4                1       1 0
                                                                                                                                                 Phase II
                          Wockhardt                   4                1            2           10
                                                                                                                                                 Phase III
                    Nicholas Piramal        1 0
                                                                                                                                                 Review
                           Glenmark                       5                             3                    4         0

         Ranbaxy [now Daiichi Sankyo]                         6                             2        1   10

                          Dr Reddy's                                           11                                              4             2    1    1

                    Ipca Laboratories       1 0

                                        0                                  5                                 10                         15                   20
                                                                      Number of Compounds



Source: Newport Premium Deals Module™ Confidential
                                  Client
Acquisitions by Foreign Companies
                      of Indian Targets
                                         80                                                            76
                                                                                        72
                                         70                                                       68
                                                                             65
                Number of Acquisitions




                                         60                                                  56

                                         50             47
                                                   45
                                                             43      42
                                         40   38


                                         30


                                         20


                                         10


                                          0




                                                                      Year


Source: Newport Premium Deals Module™
                                                                  Client Confidential
Significant Foreign Acquisitions of
               Indian Companies
   Mylan’s acquisition of Matrix (2006)

   Daiichi’s acquisition of Ranbaxy (2008)

   Hospira’s acquisition of Orchid’s injectable business
    (2009)

   Abbott’s acquisition of Piramal’s Healthcare Solutions
    Business (2010)




Source: Company websites

                              Client Confidential
Indian Acquisitions of Foreign Companies

 Sun acquired Caraco (2004) & ICN Hungary (2005)
 Dr Reddys acquired Betapharm Arzneimittel GmbH (2006)

 Strides acquired Diaspa SpA (2007)

 Lupin acquired Kyowa Pharmaceutical Industry co Ltd (2007)

 Dishman acquired Solvay Pharmaceuticals BV - Fine Chemical & Vitamin Business
  (2007)

 Sun acquired Chattem’s controlled substance facility (2008)

 Piramal acquired Minrad International (2008)




 Source: Company websites

                                    Client Confidential
Biotech Capabilities Among Top Indians
      Company                  Recombinant                     Monoclonal         Vaccines           Launches
                               Proteins                        Antibodies
      Biocon                               FP                             FP                             EPO, MAb

      Shantha                              FP                             UD                             INF, GCSF

      Intas                                FP                             UD                          GCSF, INF, EPO

      Panacea                                                                             FP             Vaccines

      Lupin                                FP
      Zydus                                FP                             FP
      Torrent                              FP                                                             Insulin

      Wockhardt                            FP                             UD                         Insulin, INF, CGSF,
                                                                                                            EPO
      Glenmark                                                            UD              FP            Novel only

      Bharat                               UD                                             FP
      Shasun                               FP

Source: TR Research   Key: FP = Full Production, UD = Under Development
                                                                               Client Confidential
Thank You




   www.shresthpn.com
     Client Confidential

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Spn report on india today

  • 1. India Today………. Compiled by: CK Shah Client Confidential
  • 2. Shresth Pharma Nexus(SPN) is a business consulting company active within the field of Pharmaceuticals and Health Care. It specialises in providing a Global network to its customers, allowing them to choose from the best in the market. The idea is to bring the market to the customer, providing them solutions and making business an easy task. We work with organizations in the arena of strategic management, which requires a distinctive approach from operational management. Client Confidential
  • 3. Our key role is to build the road to your prosperity: We Lay Foundation for Future Growth Client Confidential
  • 4. Range of Services Business plan review Organizational review Market Assessment Business Consultancy & Intelligence For Merger, Acquisition & Disposal Registration of API/FF Shresth Pharma Nexus Strategic tie-ups With DCGI, India Enterprise Risk Project Evaluation Management CRAMs & Analytical Services Client Confidential
  • 5. What We Offer Finished API Formulation Manufacturer Manufacturer Sourcing Intermediates Sourcing of API from India/China Sales & Marketing In & Out Licensing Custom Synthesis CRAMs Generic NDDS, Formulation Technology dossier Whole chain of analytical Turn Key Projects services. Client Confidential
  • 6. Our Philosophy We comprehend our customers’ needs accurately and provide them with best business alternatives, as we believe that business should always be customer driven. However, we offer more than mere business. We help you make relations and partnership that lead towards triumph. We give importance to confidentiality and transparency in our business. And that is our motive to deliver, with honesty and trust. Our key role is to build the road to your prosperity. “We Lay Foundation for Future Growth” Client Confidential
  • 7. India Today………. Client Confidential
  • 8. Projected Growth of Indian Pharmaceutical Market Currently Forecasted Growth for 2020 • Total Worth $19billion • Increase to $50billion – Domestic Market: $11bn – Domestic Market: $30bn – Exports: $8bn – Exports: $20bn • Ranked 14th in World • Will be one of top 10 markets Source: PwC, Global pharma looks to India: Prospects for growth Client Confidential
  • 9. India is expected to be the 7th largest market by 2020 Top Pharma Markets 2015* & 2020 (US$ bn) Source: BCG, Goldman Sachs, McKinsey Reports However, among all Top 10 global markets of 2015 India shows the highest growth rate among all countries analysed by McKinsey Client Confidential
  • 10. Global API Manufacturer Source: TR Newport Premium™ Client Confidential
  • 11. Assessing the Capabilities of API Manufacturers Leading companies with business experience, regulatory, quality, non-infringing processes, and track record of supplying regulated markets Established Meet regulatory, quality, & other criteria for limited number of Less molecules. May be moving from older to new molecules, may supply intermediates to Established companies. Established Companies usually make older molecules, may supply Potential intermediates to Established companies, often working to upgrade & forge links with dose firms in major markets Future Companies serving their local markets. Lack quality, regulatory, experience to supply major Local markets Able to satisfy local markets Global markets Unregulated cGMP, FDA Inspected Older molecules New molecules Client Confidential
  • 12. Global API Manufacturer rated Source: TR Newport Premium™ Client Confidential
  • 13. API manufacturer-Emerging markets Source: TR Newport Premium™ Client Confidential
  • 14. 2nd wave emerging API manufacturers rated Source: TR Newport Premium™ Client Confidential
  • 15. India’s API Plants Client Confidential
  • 16. Indian API Manufacturer Ratings 2004 to 2010 100 92 90 80 Number of Corporate Groups 70 56 60 50 40 40 2004 24 2010 30 18 17 20 10 0 Established Less Established Potential Future Corporate API Rating Assessed by Thomson Reuters Source: Newport Premium™ Client Confidential
  • 17. Capabilities of Indian API Manufacturers 24 corporate groups, 34 API sites Established e.g., Cipla, Dr. Reddy’s 40 corporate groups, 47 API sites Less e.g., MSN, Hetero Established 92 corporate groups, 91 API sites Potential e.g., Emcure, Sai Advantium Future 480 corporate groups, 492 API sites e.g., SMILAX Laboratories Local Able to satisfy local markets Global markets Unregulated cGMP, FDA Inspected Older molecules New molecules Client Confidential
  • 18. Comparing the Ability of Indian and Chinese Manufacturers to Supply Regulated Markets 160 150 140 Number of Corporate Groups 120 92 100 80 India 60 China 40 34 40 24 12 20 0 Established Less Established Potential Future Corporate Rating Assessed by Thomson Reuters Source: Newport Premium™ Client Confidential
  • 19. DMFs & COS by India & China Client Confidential
  • 20. Year wise US DMFs Submitted by India & China 2009 94 350 2008 119 382 2007 122 331 2006 64 283 2005 52 257 33 2004 184 China 35 2003 114 India 2002 25 63 2001 5 44 2000 15 31 1999 5 23 0 100 200 300 400 Number of US DMFs Source: Newport Premium™ Client Confidential
  • 21. COSs Granted 2000 to 2009 to India, Italy, China & ROW (includes US) 2000 2009 India 24% China 10% ROW 54% Italy 12% 459 COS 2722 COS Source: Newport Premium™ Client Confidential
  • 22. US ANDAs Held by Indian Companies 180 160 17 29 140 Number of US ANDAs 21 120 100 80 Tentative 19 147 139 Approved 60 117 10 11 40 63 20 42 38 14 12 18 0 10 0 2 Year Source: Newport Premium™ Client Confidential
  • 23. Increase in Indian Holders of US ANDAs 180 30 168 164 160 Number US ANDAs by Indian Companies Number of India Based ANDA Holders 25 138 140 120 20 100 82 15 80 60 52 10 49 40 5 18 20 14 12 10 2 0 0 Source: Newport Premium™ Client Confidential
  • 24. Top Ten Paragraph IV Challengers by Volume 160 149 140 Number of PIV Challenges 120 100 80 75 72 57 55 60 42 39 40 32 30 27 20 0 Source: Newport Premium™ Client Confidential
  • 25. Innovation Zydus Cadila 6 4 1 10 Orchid 12 1 10 Sun Pharma 3 010 Lupin 4 2 2 1 1 Biocon 7 0 2 1 1 Pre-Clinical Jubilant Organosys 0 2 0 2 Phase I Torrent 4 1 1 0 Phase II Wockhardt 4 1 2 10 Phase III Nicholas Piramal 1 0 Review Glenmark 5 3 4 0 Ranbaxy [now Daiichi Sankyo] 6 2 1 10 Dr Reddy's 11 4 2 1 1 Ipca Laboratories 1 0 0 5 10 15 20 Number of Compounds Source: Newport Premium Deals Module™ Confidential Client
  • 26. Acquisitions by Foreign Companies of Indian Targets 80 76 72 70 68 65 Number of Acquisitions 60 56 50 47 45 43 42 40 38 30 20 10 0 Year Source: Newport Premium Deals Module™ Client Confidential
  • 27. Significant Foreign Acquisitions of Indian Companies  Mylan’s acquisition of Matrix (2006)  Daiichi’s acquisition of Ranbaxy (2008)  Hospira’s acquisition of Orchid’s injectable business (2009)  Abbott’s acquisition of Piramal’s Healthcare Solutions Business (2010) Source: Company websites Client Confidential
  • 28. Indian Acquisitions of Foreign Companies  Sun acquired Caraco (2004) & ICN Hungary (2005)  Dr Reddys acquired Betapharm Arzneimittel GmbH (2006)  Strides acquired Diaspa SpA (2007)  Lupin acquired Kyowa Pharmaceutical Industry co Ltd (2007)  Dishman acquired Solvay Pharmaceuticals BV - Fine Chemical & Vitamin Business (2007)  Sun acquired Chattem’s controlled substance facility (2008)  Piramal acquired Minrad International (2008) Source: Company websites Client Confidential
  • 29. Biotech Capabilities Among Top Indians Company Recombinant Monoclonal Vaccines Launches Proteins Antibodies Biocon FP FP EPO, MAb Shantha FP UD INF, GCSF Intas FP UD GCSF, INF, EPO Panacea FP Vaccines Lupin FP Zydus FP FP Torrent FP Insulin Wockhardt FP UD Insulin, INF, CGSF, EPO Glenmark UD FP Novel only Bharat UD FP Shasun FP Source: TR Research Key: FP = Full Production, UD = Under Development Client Confidential
  • 30. Thank You www.shresthpn.com Client Confidential