Post on 14-Nov-2014
transcript
Tapping the generics Tapping the generics marketmarket
P N Karlekar P N Karlekar Atul LimitedAtul Limited
““Strategies for globalization and increasing Strategies for globalization and increasing
competitiveness of the Indian agrochemical competitiveness of the Indian agrochemical
industry”industry”
~ ~ Backdrop – global agrochemical industry.Backdrop – global agrochemical industry.
~ Generics - definition~ Generics - definition
~ Importance of generics~ Importance of generics
~ Strategies of major MNCs~ Strategies of major MNCs
~ Strategies of major generic companies~ Strategies of major generic companies
~ Indian industry - snapshot~ Indian industry - snapshot
““Strategies for globalization and increasing Strategies for globalization and increasing
competitiveness of the Indian agrochemical competitiveness of the Indian agrochemical
industry”industry”
~ Indian Industry – SWOT~ Indian Industry – SWOT
~ Generic market potential for Indian Industry~ Generic market potential for Indian Industry
~ Way ahead . . .~ Way ahead . . .
~ Must happen . . .~ Must happen . . .
BackdropBackdropGlobal agrochemical industry size : US$ 30 billion Global agrochemical industry size : US$ 30 billion (~Rs.135000 Cr.)(~Rs.135000 Cr.)
Six major MNCs cover 75% market : US$22 billion Six major MNCs cover 75% market : US$22 billion (~Rs.100000 Cr.)(~Rs.100000 Cr.)
Four major generic Cos. cover 10% market : US$ 3 Four major generic Cos. cover 10% market : US$ 3 billion (~Rs.13500 Cr.)billion (~Rs.13500 Cr.)
Balance 15% covered by hundreds of other Cos. : US$ 5 Balance 15% covered by hundreds of other Cos. : US$ 5 billion (~Rs.21500 Cr.)billion (~Rs.21500 Cr.)
US$ billion
0
10
20
30
40
1990 1995 2000 2005
Generics - definitionGenerics - definition
An active ingredient off-patent in the majority of its An active ingredient off-patent in the majority of its markets.markets.
A typical product life – cycle.A typical product life – cycle.
Gro
wth
0
50
100
Year20 3010 40
Proprietary Generic Commodity
Importance of GenericsImportance of Generics
Generics’ market share : 65% Generics’ market share : 65%
US$ 20 billion (~Rs.90000 Cr.)US$ 20 billion (~Rs.90000 Cr.)
MNCs dependence on generics : 40-50%MNCs dependence on generics : 40-50%
Generics’ market is growing…Generics’ market is growing…
~~ Products introduced in 1980s and 1990s are getting Products introduced in 1980s and 1990s are getting
off-patent now.off-patent now.
~~ NCEs have reduced considerably.NCEs have reduced considerably.
~~ Mature IndustryMature Industry
Generics - examplesGenerics - examples
The examples of a few generic molecules are as The examples of a few generic molecules are as under :under :
~~ Glyphosate – introduced in the year 1972 by Monsanto Glyphosate – introduced in the year 1972 by Monsanto and having a value of US$ 3185 million.and having a value of US$ 3185 million.
~~ Imidacloprid – introduced in the year 1991 by Bayer and Imidacloprid – introduced in the year 1991 by Bayer and having a value of US$ 820 million.having a value of US$ 820 million.
~~ Chloropyrifos – introduced in the year 1965 by Dow and Chloropyrifos – introduced in the year 1965 by Dow and having a value of US$ 390 million.having a value of US$ 390 million.
~~ Mancozeb – introduced in the year 1956 by Syngenta Mancozeb – introduced in the year 1956 by Syngenta and having a value of US$ 340 million.and having a value of US$ 340 million.
Strategies of major MNCs…Strategies of major MNCs…
ImageImage
Marketing… Marketing…
~~ BrandingBranding
~~ Geographic reachGeographic reach
~~ Newer formulationsNewer formulations
~~ Strategic alliances with local marketing companiesStrategic alliances with local marketing companies
Strategies of major MNCs…Strategies of major MNCs… Marketing… Marketing…
Combination products : Extend product life and offer solutions... a few Combination products : Extend product life and offer solutions... a few
examples..examples..
~~ Metribuzin + CME (Canaopy) by DupontMetribuzin + CME (Canaopy) by Dupont
~~ MSM + Thifensulfuron + Tribenuron (Canvas) by DupontMSM + Thifensulfuron + Tribenuron (Canvas) by Dupont
~~ 2,4-D+Picloram (Tordon) by Dow2,4-D+Picloram (Tordon) by Dow
~~ Glyphosate + Picloram (Scout) by MonsantoGlyphosate + Picloram (Scout) by Monsanto
~~ Cymoxanil + Azoxytrobin (Quadris) by SyngentaCymoxanil + Azoxytrobin (Quadris) by Syngenta
~~ Difenconazole + Propiconazole (Amure) by SyngentaDifenconazole + Propiconazole (Amure) by Syngenta
~~ Imidacloprid + Azoxystrobin (Amistar admire) by BayerImidacloprid + Azoxystrobin (Amistar admire) by Bayer
Strategies of major MNCs…Strategies of major MNCs…
Marketing… Marketing…
Merging Biotechnology with generics…. Merging Biotechnology with generics….
The traits are designed in the crops in such a way that the The traits are designed in the crops in such a way that the
application of only specific generic brings the best results…..application of only specific generic brings the best results…..
~~ Monsanto’s Roundup ready soybean for GlyphosateMonsanto’s Roundup ready soybean for Glyphosate
~~ BASF’s Clear field project for Imidazolione group of products BASF’s Clear field project for Imidazolione group of products
(Imazathapyr etc..)… (Imazathapyr etc..)…
Strategies of major MNCs…Strategies of major MNCs…
PatentsPatents : :
~~ Supplementary protection certificatesSupplementary protection certificates
~~ Patent term extensionPatent term extension
~~ Novel formulation patentsNovel formulation patents
~~ Process patents (key intermediates, racemic mixtures)Process patents (key intermediates, racemic mixtures)
~~ Application patentsApplication patents
Strategies of major MNCs…Strategies of major MNCs…
Registrations :Registrations :
~~ Registration withdrawalsRegistration withdrawals
~~ Data protectionData protection
R&D thrustR&D thrust
Manufacturing alliances - Manufacturing alliances - Dupont recently acquired Khimprom to Dupont recently acquired Khimprom to
form Dupont Khimprom, a manufacturing venture in Russiaform Dupont Khimprom, a manufacturing venture in Russia
Safeguarding the access to critical intermediates.Safeguarding the access to critical intermediates.
Intermediates strategiesIntermediates strategies
Name of Name of MoleculeMolecule Key IntermediateKey Intermediate CompanyCompany
GlyphosateGlyphosate DiethanolamineDiethanolamine MonsantoMonsanto
PyrimiphosPyrimiphos DicyanodiamineDicyanodiamine SyngentaSyngenta
IndoxacarbIndoxacarb Cinchonine BaseCinchonine Base DuPontDuPont
PicloramPicloram 2-Cyanopyridine2-Cyanopyridine DowDow
ClodinafopClodinafop S-(-)2-Chloropropionic AcidS-(-)2-Chloropropionic Acid SyngentaSyngenta
CarbarylCarbaryl -Naphthol-Naphthol UCBUCB
Strategies of major generic Strategies of major generic companies…companies…
AlliancesAlliances
~~ M&A routeM&A route
Makhteshim-Agan is today one of the top ten agrochemical company based on Makhteshim-Agan is today one of the top ten agrochemical company based on
this strategy. The recent acquisitions by the company include :this strategy. The recent acquisitions by the company include :
~~ Farmoz in AustraliaFarmoz in Australia
~~ Mabeno in NetherlandsMabeno in Netherlands
~~ Biomarkt (70%) in HungaryBiomarkt (70%) in Hungary
~~ Control solutions incorporated (60%) in USA.Control solutions incorporated (60%) in USA.
Strategies of major generic Strategies of major generic companies…companies…
AlliancesAlliances
Other major M&A for the year 2005 were as under Other major M&A for the year 2005 were as under ::
~~ Aryta’s acquisition of 50% share of Volcano in SouthAryta’s acquisition of 50% share of Volcano in Southafrica.africa.
~~ Atanor’s acquisition of a Syngenta plant (fungicide) in Brazil.Atanor’s acquisition of a Syngenta plant (fungicide) in Brazil.
~~ Cheminova’s acquisition of Ospray (Australia) and Croptec (Colombia)Cheminova’s acquisition of Ospray (Australia) and Croptec (Colombia)
~~ Nufarm’s acquisition of Agrogen (Colombia) and Nuturf to C K Life SciencesNufarm’s acquisition of Agrogen (Colombia) and Nuturf to C K Life Sciences(Australia)(Australia)
~~ UPL’s acquisition of Reposo (Argentina) and Cequisa (Spain)UPL’s acquisition of Reposo (Argentina) and Cequisa (Spain)
Strategies of major generic Strategies of major generic companies…companies…
AlliancesAlliances
Marketing alliances – a few recent examples… Marketing alliances – a few recent examples…
~~ Cheminova and MAI entered into an agreement with Bayer for the worldwide Cheminova and MAI entered into an agreement with Bayer for the worldwide
distribution of Imidaclopriddistribution of Imidacloprid
~~ Valent enterd into distribution arrangement with Bayer for Fluopicolide for US Valent enterd into distribution arrangement with Bayer for Fluopicolide for US
and Canadaand Canada
~~ Arysta got the distribution rights for Clothianidin from Sumitomo for US market.Arysta got the distribution rights for Clothianidin from Sumitomo for US market.
~~ MAI entered into an agreement with Bayer for the distribution of Tebuconazole MAI entered into an agreement with Bayer for the distribution of Tebuconazole
in USA.in USA.
Strategies of major generic Strategies of major generic companies…companies…
AlliancesAlliances
Acquire marketing rights for products divested by major Acquire marketing rights for products divested by major
MNCs…MNCs…
~~ Amvac acquired Phorat from BASF.Amvac acquired Phorat from BASF.
~~ Nufarm acquired Imazamethabenz from BASF.Nufarm acquired Imazamethabenz from BASF.
~~ Sumitomo acquired Trifone from BASF Sumitomo acquired Trifone from BASF
Contract R&D and manufacturing with Major MNCsContract R&D and manufacturing with Major MNCs
Strategies of major generic Strategies of major generic companies…companies…
RegistrationRegistration
~~ Task force entry for US registration.Task force entry for US registration.
~~ Registration in high priced markets like EU, Brazil Registration in high priced markets like EU, Brazil
and Canada.and Canada.
R&D thrustR&D thrust
Indian industry - snapshotIndian industry - snapshot
Domestic market : Rs.3500 Cr. (~US$ 750 million)Domestic market : Rs.3500 Cr. (~US$ 750 million)
Exports : Rs.2000 Cr. (US$450 million)Exports : Rs.2000 Cr. (US$450 million)
Market share of MNCs : 50%+Market share of MNCs : 50%+
The balance is shared between :The balance is shared between :
~~ Basic manufacturing company (approx..100)Basic manufacturing company (approx..100)
~~ Formulators/ repackers/marketing companies (approx..200)Formulators/ repackers/marketing companies (approx..200)
Indian industry - SWOT Indian industry - SWOT
Strengths :Strengths :
Exports to a large no. of countries.Exports to a large no. of countries.
Managerial / Technical pool of professionals. Managerial / Technical pool of professionals.
Low cost manufacturing base.Low cost manufacturing base.
Quality – at par with the MNCs.Quality – at par with the MNCs.
Development of new and eco-friendly formulations.. Development of new and eco-friendly formulations..
WDG, SC, EW etc..WDG, SC, EW etc..
Technical competence…Technical competence…
Chemistry Expertise Thru’ Existing Chemistry Expertise Thru’ Existing MoleculesMolecules
CategoryCategory: : PyrethroidsPyrethroids
Technological AspectTechnological Aspect::
– Optical ResolutionOptical Resolution
– Asymmetric SynthesisAsymmetric Synthesis
– Grignard reactionsGrignard reactions
Examples: Examples: Deltamethrin, Lambda CyhalothrinDeltamethrin, Lambda Cyhalothrin
CategoryCategory: : NeonicotinoidsNeonicotinoids
Technological AspectTechnological Aspect::– High Temperature Catalytic ChlorinationHigh Temperature Catalytic Chlorination
– CyanationCyanation
– CyclizationCyclization
Examples: Examples: Imidacloprid, Acetamiprid, ThiamethoxamImidacloprid, Acetamiprid, Thiamethoxam
CategoryCategory: : CarbamatesCarbamates
Technological AspectTechnological Aspect::
– Multistep Synthesis using Catalytic ChlorinationMultistep Synthesis using Catalytic Chlorination
– Asymmetric InductionAsymmetric Induction
– Hydride ReactionsHydride Reactions
Examples: Examples: Carbofuran, BPMC, IndoxacarbCarbofuran, BPMC, Indoxacarb
CategoryCategory: : Sulfonyl UreaSulfonyl Urea
Technological AspectTechnological Aspect::– High Temperature selective phosgenationHigh Temperature selective phosgenation
– CyclizationCyclization
– Selective HalogenationSelective Halogenation
– ThioethylationThioethylation
Examples: Examples: Sulfosulfuron,Sulfosulfuron, Chlorimuron Methyl, Metsulfuron Methyl, Chlorimuron Methyl, Metsulfuron Methyl, Tribenuron MethylTribenuron Methyl
Chemistry Expertise Thru’ Existing Chemistry Expertise Thru’ Existing MoleculesMolecules
CategoryCategory: : PhenoxyPhenoxyTechnological AspectTechnological Aspect::
– High Temperature Selective HalogenationHigh Temperature Selective Halogenation– PhosgenationPhosgenation– Asymmetric SynthesisAsymmetric Synthesis– Fluorine ChemistryFluorine Chemistry
Examples: Examples: 2,4-Dichlorophenoxys, MCPA2,4-Dichlorophenoxys, MCPA
CategoryCategory: : Amino AcidsAmino Acids
Technological AspectTechnological Aspect::
– High Temperature Catalytic Chlorination with Exotic MOCHigh Temperature Catalytic Chlorination with Exotic MOC
– Catalytic OxidationCatalytic Oxidation
– Microbial OxidationMicrobial Oxidation
– High Temperature PhosphochlorinationHigh Temperature Phosphochlorination
Examples: Examples: Glufosinate, Glyphosate, PicloramGlufosinate, Glyphosate, Picloram
Chemistry Expertise Thru’ Existing Chemistry Expertise Thru’ Existing MoleculesMolecules
Indian industry - SWOTIndian industry - SWOT
WeaknessWeakness::
ImageImage
Infrastructure / labour laws.Infrastructure / labour laws.
Unhealthy competition Unhealthy competition
Global access : low price & low margin countries.Global access : low price & low margin countries.
Limited knowledge :Limited knowledge :
~~ High price marketsHigh price markets
~~ PatentsPatents
Indian industry - SWOTIndian industry - SWOT
WeaknessWeakness::
Limited financial musclesLimited financial muscles
Highly fragmented industry and hence powerless.Highly fragmented industry and hence powerless.
Lack of teamwork – a major drawback.Lack of teamwork – a major drawback.
Some important technologies are untouched.Some important technologies are untouched.
Technological areas yet to be Technological areas yet to be exploredexplored
Many intermediates/products not made in India due to lack of Many intermediates/products not made in India due to lack of attention to certain technological areasattention to certain technological areas
- Ammoxidation- Ammoxidation – Aromatic & Heterocyclic Nitrites – Aromatic & Heterocyclic Nitrites– Enzymetic ReactionsEnzymetic Reactions – Selective Hydrolysis, Esterification – Selective Hydrolysis, Esterification
Etc.Etc.– OxidationOxidation (Metal Catalyzed)- Aromatic Aldehydes, (Metal Catalyzed)- Aromatic Aldehydes,
metaphenoxy benzaldehydemetaphenoxy benzaldehyde– PhosphorylationPhosphorylation (High Temperature) – Methyl Phosphorus (High Temperature) – Methyl Phosphorus
Chloride, GlyphosinateChloride, Glyphosinate– Effluent Treatment Effluent Treatment (Microbial) – Selective towards (Microbial) – Selective towards
PHENOLICS, CYANIDES, CHLORINATED PRODUCTSPHENOLICS, CYANIDES, CHLORINATED PRODUCTS– Mercaptans Mercaptans – Ethyl, t-Butyl– Ethyl, t-Butyl
New Molecules through Biochemical ApproachNew Molecules through Biochemical Approach
– AVERMECTIN (AVERMECTIN (Insecticide, AcaricideInsecticide, Acaricide))
– VALIDOMYCIN (VALIDOMYCIN (FungicideFungicide))
– SPINOSAD (SPINOSAD (InsecticideInsecticide))
Biochemical Molecules Biochemical Molecules (Microbial Synthesis)(Microbial Synthesis)
Indian industry - SWOTIndian industry - SWOT
OpportunitiesOpportunities
Large untapped Indian market.Large untapped Indian market.
Peak product introduction was in mid 1980s Peak product introduction was in mid 1980s
to mid 1990s. A no. of them are getting off-to mid 1990s. A no. of them are getting off-
patent in the near future.patent in the near future.
Special advantage of introducing products Special advantage of introducing products
patented before 1995 even if the patent is patented before 1995 even if the patent is
internationally valid.internationally valid.
Indian industry - SWOTIndian industry - SWOT
OpportunitiesOpportunities
Product divestment by the MNCs.Product divestment by the MNCs.
For example… at the formation of Syngenta, from Novartis and For example… at the formation of Syngenta, from Novartis and
Zeneca in 2000…..Zeneca in 2000…..
~ ~ the combined number of the active ingredients of the two the combined number of the active ingredients of the two
companies totaled 121 active ingredientscompanies totaled 121 active ingredients
~ ~ by end 2002 this had been reduced to 89by end 2002 this had been reduced to 89
~ ~ the target has been to reduce this to just 76 by 2005the target has been to reduce this to just 76 by 2005
The phasing out/divestment of these brands is likely to make The phasing out/divestment of these brands is likely to make
approximately US$220 million to generic playersapproximately US$220 million to generic players
Indian industry - SWOTIndian industry - SWOT
OpportunitiesOpportunities
Indian industry’s technical competence can Indian industry’s technical competence can
be harnessed for manufacturing the products be harnessed for manufacturing the products
that have recently come out of patent or will that have recently come out of patent or will
be off-patent in the near future.be off-patent in the near future.
InsecticidesInsecticides
Existing Chemistry New
Carbofuran Asymmetric Induction Bifenthrin
Deltamethrin High Temperature Phosgenation
Gamma Cyhalothrin
Lambda CyhalothrinSelective Halogenation
(including Fluorination)
Thiochloprid
Thiamethoxam
Optical Resolution
Fipronil
Imidacloprid
Cyanation
Tefluthrin
Grignard Reaction on Bulk Scale
Indoxacarb
Lufenuron
FungicidesFungicides
Existing Chemistry New
Phosgenation Cyproconazole
Hexaconazole Fluorination Fluazinam
Propiconazole Friedel Craft’s Synthesis
Fludioxonil
TebuconazoleOxirane Synthesis Difenoconazole
Epoxidation Epoxyconazole
HerbicidesHerbicides
Existing Chemistry New
Chlorimuron Ethyl High Temperature Phosgenation
Thifensulfuron
Tribenuron Methyl ThioethylationNicosulfuron
SulfosulfuronPyrimidine Chemistry
Primisulfuron & Methyl
Metsulfuron MethylSelective Chlorination
Bensulfuron
Fluorination
Rimsulfuron
Friedel Craft’s Synthesis
Clethodim
Difiufenican
HerbicidesHerbicides(Oxacetamide, Chloroacetamide, Anilides, Acyalanines)(Oxacetamide, Chloroacetamide, Anilides, Acyalanines)
(Imidazolinone / Isoxazolidinone)(Imidazolinone / Isoxazolidinone)
Existing Chemistry New
Acylation Dimethanamide
Butachlor
Mefenacet
Alachlor
High Temperature pyridine chlorination
Clomazone
Metalaxyl
Cyanide ChemistryImuzaquin
Pyridine Chemistry Imazethapyr
Asymmetric Synthesis
Pretilachlor
Chemistry New
Picloram
Chloropyriphor
Pyrethroids
Existing
Herbicides (Phenoxy)Herbicides (Phenoxy)
Existing Chemistry New
Selective Chlorination
Clodinafop - P
2,4-D Derivatives
Fenoxaprop
MCPA Phosgenation
2,4-D B Asymmetric Synthesis
Technologies common to Technologies common to existing molecules & genericsexisting molecules & generics
Existing Chemistry New
Metsulfuron methylPhosgenation
Indoxacarb
2,4-D Acid
Cyanation
Primisulfuron Methyl
Imidacloprid
Halogenation (including Fluorination)
Chlorothalonil
Carbofuran
Epoxidation
ThiochlopridFriedel Craft’s synthesis
Clodinafop PropargylAsymmetric induction
Gamma Cyhalothrin
Bifenthrin
Chlorimuron methyl
Hexaconazole
Deltamethrin
Pretilachlor
Picloram
Pyrimidine reactions
Grignard reaction on industrial scale
High Temp. pyridine chlorination
Fermentation/ microbeal reaction
Avermectin
Clomazone
Indian industry - SWOTIndian industry - SWOT
ThreatsThreats
Low price competition from China.Low price competition from China.
Defense strategies of majors.Defense strategies of majors.
Impact of BiotechnologyImpact of Biotechnology
Resistance buildingResistance building
Obsolesces of product and technologyObsolesces of product and technology
Generic market potential for Indian Generic market potential for Indian companies…companies…
Generic market : US$20 billion (~ Rs 90000 Cr) Generic market : US$20 billion (~ Rs 90000 Cr)
Indian companies share in the generic market : Indian companies share in the generic market :
4% - US$800 million (~ Rs 3600 Cr)4% - US$800 million (~ Rs 3600 Cr)
MNCs share US$11.25 billion (~Rs 50,000 Cr)MNCs share US$11.25 billion (~Rs 50,000 Cr)
Major generics share US$3 billion (~Rs 13,500 Cr)Major generics share US$3 billion (~Rs 13,500 Cr)
Way ahead..Way ahead.. MarketMarket accessaccess....
~~ Choice of market / product.Choice of market / product.
~~ Image creation and branding.Image creation and branding.
~~ Global tie-ups and marketing alliances.Global tie-ups and marketing alliances.
~~ Overseas offices and stock points..Overseas offices and stock points..
RegistrationRegistration
~~ Data generationData generation
~~ Obtaining registration in the developed marketsObtaining registration in the developed markets
TechnologyTechnology
~~ Developing the difficult technologies for the products getting Developing the difficult technologies for the products getting
off-patent.off-patent.
~~ Mastering the art of making quality products with the lowest Mastering the art of making quality products with the lowest
input cost.input cost.
Synergistic Synergistic
partnershipspartnerships
Strategic alliancesStrategic alliances
Must happen…Must happen…
Paradigm shift in the image of our country Paradigm shift in the image of our country
for quality and the industry as a solution for quality and the industry as a solution
provider provider
Support from the Government authorities.Support from the Government authorities.
Synergistic partnershipsSynergistic partnerships
Thanks…Thanks…