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Understanding the Indian conundrum
and developing strategies to enhance its
vaccines market

Speaker:
Shubhendu Kumar Dash
Vice President
Lincoln Pharmaceuticals, India
S K DASH

                                       Vaccine marketing professional




Understanding the Indian Conundrum
     and developing strategies
  to enhance its vaccines market

    Customised presentation for World Vaccine Congress Asia,Singapore



                                 Folie 2
The vaccination delivery system in India
    Indian Pharma Mkt       Vaccine segment              Penetration(%)
         (USD bn)               (USD mn)
     10.5    (Gr=15 %)         271      (Gr=30 %)                  2.5

                                          Central Govt.               • GAVI / WHO /
                                                                      PATH / NTAGI / IAP
                                         (Univ. Immu. Prog)
                                                                      etc.
                 Public mkt
                USD 130 mn (48%)
                                            State Govt.               • Low priced vaccines
                                             (Rabies)
Vaccine                                                               • Dynamics does not
USD 271 mn                                                            stimulate sustainable
                                                                      demand
                                              Nursing Homes
                                              Corporate hosp
                Private mkt                     Physicians                   IAP
                USD 140 mn (52%)             Anti rabies clinics             APCRI

             Customised presentation for World Vaccine Congress Asia,Singapore

                                          Folie 3
Vaccines available in India
EPI vaccines under           IAP recommended                      IAP recommended
Universal Programme of       vaccines for routine use             vaccines-special
Immunisation (UIP)           (in addition to EPI)                 circumstances


BCG                          Typhoid                                             Rabies
OPV                          IPV                                         Influenza (Flu)
DTwP                         DTaP / Td                                       PPV-23
Measles                      PCV-7                                                JE
DT                           HPV                                        Meningococcal
TT                           Hep-A                                           Cholera
Hep B / (DPT+HB+Hib)         Varicella (Chicken Pox)                      Yellow fever
MMR                          Rotavirus
Hib

             Customised presentation for World Vaccine Congress Asia,Singapore

                                           Folie 4
Indian Vaccine Scenario                                                    (Fig in USD mn)
                                                                         Paed      GP / Phy    Other                Comment
Vaccine                          Total     Private        Public
                                                                          (%)        (%)        (%)

Total market                       271        139            132                                         Wt av. Gr is 30%
Rabies                              104         52            52             10      75       15-ARV     Very good potential
Oral Polio Vaccine                  36          2             34             90       10         -       Majority GOI purchase
Combination vaccines                19          18            1              90       10         -       Future promise for India (GOI)
Hepatitis-B                         12          4             8              60       30      10-Nephr   Shrinking market (GOI purch.)
Pneumococcal                         4          3             1              70       20      10-Nephr   Prevnar (Wyeth) dominant
Influenza (Seasonal)+ H1N1          20          9             11             70       20      10-Chest   H1N1 was an opportunity
Hib (monovalent)                     3          2             1              90       10         -       Trend towards combination
DPwT (monovalent)                    6          2             4              90       10         -       Trend towards combination
DPaT (monovalent)                    6          6             -              100      -          -       Good potential in metros
Varicella (Chicken pox)              7          6             1              80       20         -       Very good demand
Hepatitis-A                          4          4             -              50       40      10-PSM     Good potential in metros
Typhoid                              7          2             5              70       20      10-PSM     Potential unexploited
HPV (Cervical cancer)                8          8             -              10       30      60-Gyn     Very good promise
BCG                                  4          1             3              90       10         -       Majority GOI purchase
Meningococcal                        3          1             2              60       40         -       Majority Haj pilgrims
MMR / Measles / Rubella              5     2 /1 / - = 3   -/2/-=2            80       10      10-Gyn     Majority GOI purchase
JE (Japanese Encephalitis)           3          1             2              30       10      60-PSM     Majority GOI purchase
Rotavirus                            4          4             -              100      -          -       Future promise for India
Td / TD / TT / Oral Cholera         16          11            5              30      50       20-Gyn     Good potential for TT

                              Customised presentation for World Vaccine Congress Asia,Singapore
                                                                   Folie 5
Vaccination Schedule in India
           IAP IMMUNIZATION TIME TABLE
                                                        Some key facts:
Age                            Vaccines                 •West and South Zone contribute 60% of market
                                                        •Best season is Sept to Feb-70% business
Birth               BCG / OPV0 / HepB 1

6 weeks             DTwP1 / DTaP1 / OPV1/ IPV1 / Hib1 / HepB2 / PCV            Combination
                                                                               vaccines like
10 weeks            DTwP2 / DTaP2 / OPV2 / IPV2 / Hib 2 / Rotavirus            DPT+Hib+Hep-B
                                                                               or,
14 weeks            DTwP3 / DTaP3 / OPV3 / IPV3 / Hib3 / HepB3                 DPT+Hib+IPV
                                                                               preferred
9 months            Measles / Influenza

15-18 months        DTwP B1/DTaP B1/ OPV4 / IPVB1/ Hib B1/ MMR1/ Varicella / JE

2 years             Typhoid / Hep-A                                   Preference is for such
                                                                      companies which have
5 years             DTwP B2 / DTaP B2 / OPV5 / MMR2                   DPT / Hib / Hep-B / IPV
                                                                      cluster even though
10 years            Tdap / Td and HPV (Female)                        combination is unavailable

  Adults: Rabies / Hep-B / Hep-A / Influenza / MMR / Typhoid / HPV / Varicella

                 Customised presentation for World Vaccine Congress Asia,Singapore
                                              Folie 6
Market attractiveness in vaccines segment
                                                                                           PCV
High                                                         DPT+Hib+HB


                                                                                       Varicella
                                                                      Influenza
Growth




                                                                                   Hep-A
                                                                                            HPV
         30%




                                                         Rabies
                       Typhoid



                                      Hib
               OPV
                                                      Segments dominated by Indian companies
Low                    DPwT
                                   BCG

               Hep-B
                                                      Segments dominated by MNC


                         Low             Price / unit                      High
                                     USD 2 per dose

               Customised presentation for World Vaccine Congress Asia,Singapore

                                            Folie 7
Distribution channel in India
                                   • Cold chain is the life line of the vaccine and
           • Manufacturer          therefore differs substantially from Pharma
Company                            distribution network. Ingrained:”Colder is better”

           • Depot points in       •Most of the pediatric vaccines are handled through
             various states for    ‘vaccine dealers’ who directly supply to the doctors
  CFA        Tax implications
                                   (Pediatricians).This has a substantial impact on
                                   profitability leading to imperfections in system
                                       • MRP= USD 100 (Purchased by Subject)
           • Distributor in each        • Price to retailer / Doctor= USD 80
             city                       • Price to Stockist= USD 72
Stockist

                                   •Only mass-marketed vaccines like Rabies / Hep-A /
           • Pediatricians and     Influenza /TT have movement through conventional
             some physicians
             dispense vaccines     distribution system.
 Doctor

                                   •The distribution and cold-chain integrity costs have
                                   substantial financial impact
                      Customised presentation for World Vaccine Congress Asia,Singapore

                                                   Folie 8
Vaccine-Storage conditions: +20c to +80c




Customised presentation for World Vaccine Congress Asia,Singapore

                                            Folie 9
Major players in the Indian vaccine market
      Company                  Private mkt           Public mkt             Major revenue generators in
                               (% dependent)        (% dependent)                    trade mkt


GSK                                  92                     8          Rotavirus / DPaT+Hib / Varicella

Sanofi - Aventis                     70                     30         DPaT+Hib+IPV / Inflz / Rabies

Novartis / Chiron                    45                     55         DPwT+Hib+Hep-B / IPV /Rabies

MSD                                  90                     10         HPV

Serum Institute                      40                     60         (DPwT+Hep-B)+Hib / Hib / MMR

Bharat Biotech                       15                     85         DPwT+Hib+Hep-B / Rabies

Biological E Ltd.                    40                     60         TT

Wyeth                                40                     60         DPwT+Hib+Hep-B

VHB                                  80                     20         Varicella

Biomed                               70                     30         Typhoid / OPV

Wockhardt                            85                     15         Hep-A

IIL (Human Biolo)                    33                     67         Rabies

Zydus Cadila                         70                     30         Rabies / Influenza

                    Customised presentation for World Vaccine Congress Asia,Singapore

                                                 Folie 10
Major players-Sourcing strategy
      Company                          Major products in trade mkt                               Source

GSK                        Hep-A / Rotavirus / DPaT+Hib / Varicella / HPV           100% Imported

Sanofi - Aventis           DPaT+Hib+IPV / Inflz / Rabies / IPV / Varicella / DPaT   100% imported
                           / Pneumo

Novartis / Chiron          DPwT+Hib+Hep-B / IPV / Rabies / Hep-A                    Imported except Rabies and
                                                                                    DPwT+Hib+Hep-B

MSD                        HPV                                                      100% imported

Serum Institute            (DPwT+Hep-B)+Hib / Hib / MMR                             40% compo imported

Bharat Biotech             DPwT+Hib+Hep-B / Rabies                                  OPV contributing to 80% business
                                                                                    imported

Biological E Ltd.          TT                                                       Indigenous

Shantha Biotech            DPwT+Hib+Hep-B                                           DPwT imported

VHB                        Varicella                                                100% imported

Biomed                     Typhoid / OPV                                            Indigenous

Wockhardt                  Hep-A                                                    100% imported

IIL (Human Biolo)          Rabies                                                   Indigenous

Zydus Cadila               Rabies                                                   Indigenous

                 Customised presentation for World Vaccine Congress Asia,Singapore
                                                    Folie 11
Marketing dynamics in vaccines segment
• All the vaccines are cold chain products hence they are sold through predominantly
“vaccine dealers” who directly sell it to the pediatricians. Exceptions are Rabies and
TT which follow conventional distribution channel.

•In India, 80% of vaccines business (excepting Rabies and TT) is generated by
pediatricians, although adult vaccination is fast upcoming segment due to awareness

•The margin between MRP and “stockist price” is typically 60% to induce
dispensation by pediatricians. However, MNCs do not follow this principle.

•Pediatric vaccine market is slow to respond due to obsession with safety and
therefore requires a good franchisee for acceptance.

•Adult vaccination is fast growing with newer offerings and increased awareness.
Since dispensation profile is not there, margins are better and distribution channel is
more skewed to normal channel (through retailer) although cold chain is required.

              Customised presentation for World Vaccine Congress Asia,Singapore

                                            Folie 12
A look at Emerging Adult vaccination segment
• Demographic projections for 2026 indicates that there will be a huge shift from
Pediatric segment to Adults.
•Currently in India, the adult vaccination is in primitive shape, but is expected to take
shape in the years to come.
• Companies like Sanofi-Aventis, Novartis, MSD,GSK have taken the initiative of not
only identifying the segments of interest but at the same time they are increasing the
awareness level w.r.t the diseases in the adulthood & their consequences leading to
prevention through vaccination.
• Currently they are focusing on Influenza virus vaccine, Hepatitis-A+ B vaccines,
Varicella, HPV and other vaccines, thus preparing ground for future adult vaccines.

•The fastest growing segment in the adult vaccines area is Influenza vaccine. The
leading flu-vaccine manufacturers include Sanofi , Novartis, GSK and Baxter.

•The price realisation will also be better in the adult vaccination segment.


                 Customised presentation for World Vaccine Congress Asia,Singapore

                                            Folie 13
Demand drivers in Indian vaccines segment
                          • “Scare”: Swine Flu / Rabies / Hep B / HPV
VPD epidemiology          • Organised studies-Pneumococcal / IPV

                          • Urbanisation
  Affordability           • Disposable income rising

                          • GOI public spending-National Immu. Day (Polio)
  Accessability           • Corp Hosp / “Immun. Camp operators” /
                          • Cold chain integrity / power backups

                           • Increasing awareness- increase funnel size
                           • Harnessing propensity for “wellness”
  Acceptability            •Promotion beyond Pediatricians to GPs / CPs
                           •Organised marketing initiatives to increasing
                           compliance

          Customised presentation for World Vaccine Congress Asia,Singapore

                                     Folie 14
Marketing interventions to grow vaccine segment
                           • Create awareness and interest among physicians on
VPD epidemiology             vaccines through EIA / Advocacy studies

                           • Assistance to local producers for producing high end vaccines
   Affordability           • Introduce policy changes by involving Insurance sector for precluding
                             VPD from reimbursement


                           • Help entreprenuers-”Camp operators” into an
                             organised segment
  Accessability            • Focusing on innovative solutions- solar power packs
                             / thermostable vaccines

                            • Vaccine safety standards in private sector
                            •Organised marketing platform for adult vaccination
  Acceptability             •Developing primary care physicians to recognise
                            the importance of vaccination
                            •Focusing on private market by leveraging DTC

           Customised presentation for World Vaccine Congress Asia,Singapore

                                      Folie 15
The regulatory framework / entry strategy
Activity timeline                                 Year-1    Year-2       2012   Low risk model approach
                                                  Q Q Q Q   Q Q Q Q Q Q Q Q
                                                  1 2 3 4   1 2 3 4 1 2 3 4
Registration of vendor                                                          •Finished & packed formulations will
                                                                                save on time-to-market.
Obtaining test-licence and planning trial
protocol
                                                                                •Once licenced, lead time in-toto will
Phase III (non-inferiority) trial for licensure
                                                                                be reduced to 4 months cycle time
Import licence on submission of dossier
                                                                                •Most MNCs and Indian companies
Import of consignment and CDL-Kasauli                                           follow this business model
testing
India licensure obtained                                                        •Field force can be deployed in a
                                                                                phased manner-South & West ,then
10 Managers to be recruited for product                                         North and then East.
registration at imp institutions / hospitals
Field force recruitment begins 50 MR+10
Managers / training / deployment
Revenue generation starts

Business development activities start for
long-term plans in vaccines


                    Customised presentation for World Vaccine Congress Asia,Singapore

                                                              Folie 16
India now requires entry of new players for growing the
vaccine segment


                         WELCOME




        Customised presentation for World Vaccine Congress Asia,Singapore

                                   Folie 17

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Indian Vaccine scenario by S K DASH

  • 1. Understanding the Indian conundrum and developing strategies to enhance its vaccines market Speaker: Shubhendu Kumar Dash Vice President Lincoln Pharmaceuticals, India
  • 2. S K DASH Vaccine marketing professional Understanding the Indian Conundrum and developing strategies to enhance its vaccines market Customised presentation for World Vaccine Congress Asia,Singapore Folie 2
  • 3. The vaccination delivery system in India Indian Pharma Mkt Vaccine segment Penetration(%) (USD bn) (USD mn) 10.5 (Gr=15 %) 271 (Gr=30 %) 2.5 Central Govt. • GAVI / WHO / PATH / NTAGI / IAP (Univ. Immu. Prog) etc. Public mkt USD 130 mn (48%) State Govt. • Low priced vaccines (Rabies) Vaccine • Dynamics does not USD 271 mn stimulate sustainable demand Nursing Homes Corporate hosp Private mkt Physicians IAP USD 140 mn (52%) Anti rabies clinics APCRI Customised presentation for World Vaccine Congress Asia,Singapore Folie 3
  • 4. Vaccines available in India EPI vaccines under IAP recommended IAP recommended Universal Programme of vaccines for routine use vaccines-special Immunisation (UIP) (in addition to EPI) circumstances BCG Typhoid Rabies OPV IPV Influenza (Flu) DTwP DTaP / Td PPV-23 Measles PCV-7 JE DT HPV Meningococcal TT Hep-A Cholera Hep B / (DPT+HB+Hib) Varicella (Chicken Pox) Yellow fever MMR Rotavirus Hib Customised presentation for World Vaccine Congress Asia,Singapore Folie 4
  • 5. Indian Vaccine Scenario (Fig in USD mn) Paed GP / Phy Other Comment Vaccine Total Private Public (%) (%) (%) Total market 271 139 132 Wt av. Gr is 30% Rabies 104 52 52 10 75 15-ARV Very good potential Oral Polio Vaccine 36 2 34 90 10 - Majority GOI purchase Combination vaccines 19 18 1 90 10 - Future promise for India (GOI) Hepatitis-B 12 4 8 60 30 10-Nephr Shrinking market (GOI purch.) Pneumococcal 4 3 1 70 20 10-Nephr Prevnar (Wyeth) dominant Influenza (Seasonal)+ H1N1 20 9 11 70 20 10-Chest H1N1 was an opportunity Hib (monovalent) 3 2 1 90 10 - Trend towards combination DPwT (monovalent) 6 2 4 90 10 - Trend towards combination DPaT (monovalent) 6 6 - 100 - - Good potential in metros Varicella (Chicken pox) 7 6 1 80 20 - Very good demand Hepatitis-A 4 4 - 50 40 10-PSM Good potential in metros Typhoid 7 2 5 70 20 10-PSM Potential unexploited HPV (Cervical cancer) 8 8 - 10 30 60-Gyn Very good promise BCG 4 1 3 90 10 - Majority GOI purchase Meningococcal 3 1 2 60 40 - Majority Haj pilgrims MMR / Measles / Rubella 5 2 /1 / - = 3 -/2/-=2 80 10 10-Gyn Majority GOI purchase JE (Japanese Encephalitis) 3 1 2 30 10 60-PSM Majority GOI purchase Rotavirus 4 4 - 100 - - Future promise for India Td / TD / TT / Oral Cholera 16 11 5 30 50 20-Gyn Good potential for TT Customised presentation for World Vaccine Congress Asia,Singapore Folie 5
  • 6. Vaccination Schedule in India IAP IMMUNIZATION TIME TABLE Some key facts: Age Vaccines •West and South Zone contribute 60% of market •Best season is Sept to Feb-70% business Birth BCG / OPV0 / HepB 1 6 weeks DTwP1 / DTaP1 / OPV1/ IPV1 / Hib1 / HepB2 / PCV Combination vaccines like 10 weeks DTwP2 / DTaP2 / OPV2 / IPV2 / Hib 2 / Rotavirus DPT+Hib+Hep-B or, 14 weeks DTwP3 / DTaP3 / OPV3 / IPV3 / Hib3 / HepB3 DPT+Hib+IPV preferred 9 months Measles / Influenza 15-18 months DTwP B1/DTaP B1/ OPV4 / IPVB1/ Hib B1/ MMR1/ Varicella / JE 2 years Typhoid / Hep-A Preference is for such companies which have 5 years DTwP B2 / DTaP B2 / OPV5 / MMR2 DPT / Hib / Hep-B / IPV cluster even though 10 years Tdap / Td and HPV (Female) combination is unavailable Adults: Rabies / Hep-B / Hep-A / Influenza / MMR / Typhoid / HPV / Varicella Customised presentation for World Vaccine Congress Asia,Singapore Folie 6
  • 7. Market attractiveness in vaccines segment PCV High DPT+Hib+HB Varicella Influenza Growth Hep-A HPV 30% Rabies Typhoid Hib OPV Segments dominated by Indian companies Low DPwT BCG Hep-B Segments dominated by MNC Low Price / unit High USD 2 per dose Customised presentation for World Vaccine Congress Asia,Singapore Folie 7
  • 8. Distribution channel in India • Cold chain is the life line of the vaccine and • Manufacturer therefore differs substantially from Pharma Company distribution network. Ingrained:”Colder is better” • Depot points in •Most of the pediatric vaccines are handled through various states for ‘vaccine dealers’ who directly supply to the doctors CFA Tax implications (Pediatricians).This has a substantial impact on profitability leading to imperfections in system • MRP= USD 100 (Purchased by Subject) • Distributor in each • Price to retailer / Doctor= USD 80 city • Price to Stockist= USD 72 Stockist •Only mass-marketed vaccines like Rabies / Hep-A / • Pediatricians and Influenza /TT have movement through conventional some physicians dispense vaccines distribution system. Doctor •The distribution and cold-chain integrity costs have substantial financial impact Customised presentation for World Vaccine Congress Asia,Singapore Folie 8
  • 9. Vaccine-Storage conditions: +20c to +80c Customised presentation for World Vaccine Congress Asia,Singapore Folie 9
  • 10. Major players in the Indian vaccine market Company Private mkt Public mkt Major revenue generators in (% dependent) (% dependent) trade mkt GSK 92 8 Rotavirus / DPaT+Hib / Varicella Sanofi - Aventis 70 30 DPaT+Hib+IPV / Inflz / Rabies Novartis / Chiron 45 55 DPwT+Hib+Hep-B / IPV /Rabies MSD 90 10 HPV Serum Institute 40 60 (DPwT+Hep-B)+Hib / Hib / MMR Bharat Biotech 15 85 DPwT+Hib+Hep-B / Rabies Biological E Ltd. 40 60 TT Wyeth 40 60 DPwT+Hib+Hep-B VHB 80 20 Varicella Biomed 70 30 Typhoid / OPV Wockhardt 85 15 Hep-A IIL (Human Biolo) 33 67 Rabies Zydus Cadila 70 30 Rabies / Influenza Customised presentation for World Vaccine Congress Asia,Singapore Folie 10
  • 11. Major players-Sourcing strategy Company Major products in trade mkt Source GSK Hep-A / Rotavirus / DPaT+Hib / Varicella / HPV 100% Imported Sanofi - Aventis DPaT+Hib+IPV / Inflz / Rabies / IPV / Varicella / DPaT 100% imported / Pneumo Novartis / Chiron DPwT+Hib+Hep-B / IPV / Rabies / Hep-A Imported except Rabies and DPwT+Hib+Hep-B MSD HPV 100% imported Serum Institute (DPwT+Hep-B)+Hib / Hib / MMR 40% compo imported Bharat Biotech DPwT+Hib+Hep-B / Rabies OPV contributing to 80% business imported Biological E Ltd. TT Indigenous Shantha Biotech DPwT+Hib+Hep-B DPwT imported VHB Varicella 100% imported Biomed Typhoid / OPV Indigenous Wockhardt Hep-A 100% imported IIL (Human Biolo) Rabies Indigenous Zydus Cadila Rabies Indigenous Customised presentation for World Vaccine Congress Asia,Singapore Folie 11
  • 12. Marketing dynamics in vaccines segment • All the vaccines are cold chain products hence they are sold through predominantly “vaccine dealers” who directly sell it to the pediatricians. Exceptions are Rabies and TT which follow conventional distribution channel. •In India, 80% of vaccines business (excepting Rabies and TT) is generated by pediatricians, although adult vaccination is fast upcoming segment due to awareness •The margin between MRP and “stockist price” is typically 60% to induce dispensation by pediatricians. However, MNCs do not follow this principle. •Pediatric vaccine market is slow to respond due to obsession with safety and therefore requires a good franchisee for acceptance. •Adult vaccination is fast growing with newer offerings and increased awareness. Since dispensation profile is not there, margins are better and distribution channel is more skewed to normal channel (through retailer) although cold chain is required. Customised presentation for World Vaccine Congress Asia,Singapore Folie 12
  • 13. A look at Emerging Adult vaccination segment • Demographic projections for 2026 indicates that there will be a huge shift from Pediatric segment to Adults. •Currently in India, the adult vaccination is in primitive shape, but is expected to take shape in the years to come. • Companies like Sanofi-Aventis, Novartis, MSD,GSK have taken the initiative of not only identifying the segments of interest but at the same time they are increasing the awareness level w.r.t the diseases in the adulthood & their consequences leading to prevention through vaccination. • Currently they are focusing on Influenza virus vaccine, Hepatitis-A+ B vaccines, Varicella, HPV and other vaccines, thus preparing ground for future adult vaccines. •The fastest growing segment in the adult vaccines area is Influenza vaccine. The leading flu-vaccine manufacturers include Sanofi , Novartis, GSK and Baxter. •The price realisation will also be better in the adult vaccination segment. Customised presentation for World Vaccine Congress Asia,Singapore Folie 13
  • 14. Demand drivers in Indian vaccines segment • “Scare”: Swine Flu / Rabies / Hep B / HPV VPD epidemiology • Organised studies-Pneumococcal / IPV • Urbanisation Affordability • Disposable income rising • GOI public spending-National Immu. Day (Polio) Accessability • Corp Hosp / “Immun. Camp operators” / • Cold chain integrity / power backups • Increasing awareness- increase funnel size • Harnessing propensity for “wellness” Acceptability •Promotion beyond Pediatricians to GPs / CPs •Organised marketing initiatives to increasing compliance Customised presentation for World Vaccine Congress Asia,Singapore Folie 14
  • 15. Marketing interventions to grow vaccine segment • Create awareness and interest among physicians on VPD epidemiology vaccines through EIA / Advocacy studies • Assistance to local producers for producing high end vaccines Affordability • Introduce policy changes by involving Insurance sector for precluding VPD from reimbursement • Help entreprenuers-”Camp operators” into an organised segment Accessability • Focusing on innovative solutions- solar power packs / thermostable vaccines • Vaccine safety standards in private sector •Organised marketing platform for adult vaccination Acceptability •Developing primary care physicians to recognise the importance of vaccination •Focusing on private market by leveraging DTC Customised presentation for World Vaccine Congress Asia,Singapore Folie 15
  • 16. The regulatory framework / entry strategy Activity timeline Year-1 Year-2 2012 Low risk model approach Q Q Q Q Q Q Q Q Q Q Q Q 1 2 3 4 1 2 3 4 1 2 3 4 Registration of vendor •Finished & packed formulations will save on time-to-market. Obtaining test-licence and planning trial protocol •Once licenced, lead time in-toto will Phase III (non-inferiority) trial for licensure be reduced to 4 months cycle time Import licence on submission of dossier •Most MNCs and Indian companies Import of consignment and CDL-Kasauli follow this business model testing India licensure obtained •Field force can be deployed in a phased manner-South & West ,then 10 Managers to be recruited for product North and then East. registration at imp institutions / hospitals Field force recruitment begins 50 MR+10 Managers / training / deployment Revenue generation starts Business development activities start for long-term plans in vaccines Customised presentation for World Vaccine Congress Asia,Singapore Folie 16
  • 17. India now requires entry of new players for growing the vaccine segment WELCOME Customised presentation for World Vaccine Congress Asia,Singapore Folie 17