Generic OCP manufacturers

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Generic Contraceptive Manufacturers

Can subtitle here Add They Help Increase Access To Affordable Products In The Developing World?

Abt Associates Inc. in partnership with:Data Management Services Inc. Dillon Allman and Partners. LLC Family Health International Forum One Communications Global Microenterprise Initiatives IntraHealth International London School of Hygiene and Tropical Medicine OHanlon Consulting Population Services International Tulane University School of Public Health and Tropical Medicine

PSP-One industry primern

Purposen

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To increase knowledge about the generic industry To explore partnership opportunities Literature review Interviews with procurement and industry experts Assessment trip to India

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Methodologyn n

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Key facts about Hormonal contraceptivesn

Manufacturing:n n n

Economies of scale are essential Complex quality/safety issues Importance of local regulatory environment R&D companies lead worldwide Wide range of formulations, many off-patent Fast-growing generic industry Key differences between developed and developing markets

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Marketing and distribution:n n n n

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Two different types of marketsn

Developed marketsn

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Developing marketsn

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Strong regulatory environments Innovation-driven, commercial markets Strong R&D presence2 Growing use of Bioequivalent generics

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Weak regulatory environments Limited product choice Large government and donorfunded programs Generics limited to NBE copy products

Hormonal contraceptive manufacturersn

R&D companies:n

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Mostly Western-based with large international presence Focus on product innovation in developed markets Require high margins for marketing and R&D Need economies of scale to control costs Favor large single-product contracts for developing countries

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Hormonal contraceptive manufacturersn

R&D companies:n n n n n

Organon (Netherlands) Ortho McNeil (USA) Pfizer (USA) Schering (Germany) Wyeth (USA)

Hormonal contraceptive manufacturersn

Schering:n n

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Annual revenues: 4.9 billion Contraceptive products represent 30% of business Best-known brands: Microgynon, Diane 35, Yasmin Leader in worldwide commercial markets Large institutional business (donors and governments)

Hormonal contraceptive manufacturersn

Generic manufacturers:n

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Catch-all definition for non R&D manufacturers Two types of generic products: bioequivalent and NBE copy products Manufacturers differ widely in product quality, corporate strategies and marketing capability

Hormonal contraceptive manufacturersn

Bioequivalent generics:n

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Pharmaceutical products that have demonstrated the same quality, safety and therapeutic efficacy as the originator brand Only the most developed markets are currently enforcing bioequivalence regulations Many generic contraceptives sold around the world have not been tested for bioequivalence

Hormonal contraceptive manufacturersn

Bioequivalent generic manufacturers:n n n n n n

Aspen Pharmacare (SA) Barr laboratories (USA) Watson Pharmaceuticals (USA) Teva Pharmaceutical Industries (Israel) Gedeon Richter (Hungary) Cipla (India)

Hormonal contraceptive manufacturersn

Barr Laboratories:n

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Largest US generic contraceptive supplier Sells predominantly to pharmacy chains Annual revenue: $1 Billion 22 generic OC products Limited portfolio of proprietary brands: Plan B, Loestrin, Seasonale, Nordette

Generic productsProduct development cycleFDA approval NDA Submitted FDA review Extensive human clinical studies Clinical effectiveness studies Clinical safety studies Laboratory & animal studies 2 Yrs 3 Yrs 2 Yrs 1 Yr 3 Yrs Safety and efficacy established by clinical trials of innovator 1-2 Yrs -1 Yrs FDA approval NDA Submitted FDA review Extensive human clinical studies

Innovator product

Generic product

Source: Barr Pharmaceuticals - http://www.barrlabs.com/pages/induhist.html

Hormonal contraceptive manufacturersn

Non-bioequivalent (NBE)n n

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Typically located in Asia and Latin America Two major types: manufacturers of branded generics, and contract manufacturers Two different business models: commercial and institutional

Commercial modelMarketing Products

Manufacturer

Field sales force

Distributor

Healthcare providers

Wholesaler

Patient

Retailer

Institutional modelBid/contract Products

Manufacturer

Procurement tender or trade marketing

Client warehouses

Generic contraceptive manufacturersManufacturers of branded generics (commercial model)

Generic contraceptive manufacturersn

Laboratorios Silesia (Chile)n

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Large portfolio of NBE contraceptive formulations Competes directly with R&D brands Multiple therapeutic areas Extensive commercial distribution in Latin America

Generic contraceptive manufacturersContract Manufacturers (institutional model)

Generic contraceptive manufacturersn

Famy care (India)n

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Limited portfolio of OCs No other therapeutic area Trade brands, not commercially marketed Major supplier of OCs and IUDs to government programs

Generic contraceptive manufacturersn

Famy care (India)COMBINED PILLSame Composition ORALCON 0.15 mg Levonorgestrel + 0.03 mg Ethinylestradiol LEVONYL 0.15 mg Levonorgestrel + 0.05 mg Ethinylestradiol LO-LEVONYL 0.125 mg Levonorgestrel + 0.03 mg Ethinylestradiol FAMYNON 0.25 mg Levonorgestrel + 0.05 mg Ethinylestradiol LO-FAMYNON 0.25 mg Levonorgestrel + 0.03 mg Ethinylestradiol FAMYNOR 0.50 mg Levonorgestrel + 0.05 mg Ethinylestradiol LUSIA 0.30 mg Levonorgestrel + 0.03 mg Ethinylestradiol PHASIC / SEQUENTIAL PILLSName Compostion TRIGESTREL 0.05 mg of Levonorgestrel + 0.03 mg of Ethinylestradiol 0.075 mg of Levonorgestrel + 0.04 mg of Ethinylestradiol 0.125 mg of Levonorgestrel + 0.03 mg of Ethinylestradiol DIALZA 0.15 mg of Levonorgestrel + 0.03 mg of Ethinylestradiol 0.20 mg of Levonorgestrel + 0.04 mg of Ethinylestradiol PROGESTAGEN ONLY PILL / MINIPILL HYAN 0.03 mg Levonorgestrel FAMYREL 0.075 mg Norgestrel LO-FAMYREL 0.070 mg Norgestrel Composition

EMERGENCY CONTRACEPTION PILL Composition PREGNON 0.75 mg Levonorgestrel

What role for generic manufacturers?n

Three potential areasn n n

Supplying government and donor programs Supplying NGOs and SMOs Competing on commercial markets

Government/donor marketn n

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Key factors: price, quality and capacity Contract manufacturers best positioned to capture this market Barriers:n n

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Registration costs Concerns about product quality Donor prequalification requirements (such as FDA registration)

NGO/SMO marketn n

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Key factors: price, quality, marketing capacity Contract and branded generic manufacturers well positioned to capture this market Barriers:n n

Registration costs Concerns about product quality

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Commercial marketn n

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Key factor: Marketing capacity Branded generic manufacturers best positioned to capture low-end market Potential barriers:n

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Registration and marketing costs Low demand and ability to pay Competition from subsidized brands

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Are branded generics cheaper?Profit And Loss Statement For R&D And Generic Brands

Opportunity matrix

Opportunity matrix

Conclusionsn n n n n n n

Generic manufacturers are not a homogenous group Bioequivalent generic manufacturers are most likely to focus on developed markets Opportunities exist for contract and branded generic manufacturers in developing countries Prequalification requirements are main barrier in the public and NGO sector Competition from subsidized products is the main barrier in commercial markets Activities involving generic manufacturers should be consistent with their business model