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Sauman SINGH Aix-Marseille Université École Doctorale de Sciences Economiques et de Gestion d'Aix-Marseille N°372 Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale Aix-Marseille School of Economics Thèse pour le Doctorat ès Sciences Économiques Présenté et soutenue publiquement le 12 juillet 2018 par Sauman SINGH en vue de l'obtention du grade de docteur ès Sciences Economiques ENTRY AND OPERATION STRATEGIES OF INDIAN PHARMACEUTICAL FIRMS IN AFRICA UNDER THE DYNAMICS OF MARKETS AND INSTITUTIONS Composition du Jury : Bruno Boidin, Maître de Conférences, CLERSE, Université de Lille, Rapporteur Bruno Ventelou, Directeur de Recherche CNRS, AMSE, Aix-Marseille Université, Examinateur Fabienne Orsi, Chargée de recherche IRD, LPED, Aix-Marseille Université, Directrice de thèse Laurent Vidal, Directeur de Recherche IRD, SESSTIM, Représentant IRD au Sénégal, Examinateur Matthieu Montalban, Maître de Conférences, GREThA, Université de Bordeaux, Rapporteur Philippe Batifoulier, Professeur d’Université, CEPN, Université Paris 13, Sorbonne Paris Cité, Examinateur ii L’université d’Aix-Marseille n’entend ni approuver, ni désapprouver les opinions émises dans cette thèse. Elles doivent être considérées comme propres à leur auteur. iii To My Grandfather Dr. Phulgenda Sinha iv v Abstract The existing literature on the internationalization of Indian pharmaceutical firms has mainly focused on their penetration to highly regulated markets of economically advanced countries (Chapter 1). While this approach has enriched our knowledge of the strategies used by Indian firms in developed country settings, it considers the pharmaceutical markets in Sub-Saharan Africa only as an intermediate step in the broader process of internationalization. This dissertation opens the dialogue by asking, “What are the market entry and operation strategies of Indian pharmaceutical firms in Sub-Saharan Africa?” It employs a neo-institutional framework and looks at the problem from three different perspectives for a holistic picture of the phenomenon. Taking an empirical approach, the thesis starts the investigation by constructing a political economy narrative to highlight the importance of institutional factors behind internationalization rooted both inside and outside India (Chapter 2). It shows that the early protectionist environment put in place by the Indian government helped build a robust indigenous pharmaceutical industry. The simultaneous arrival of TRIPS and economic liberalization created both competitive and supportive push factors forcing Indian firms to look for new avenues of growth beyond national boundaries. Furthermore, generic supporting policies of African countries acted as pull factors for Indian firms to engage in these markets. It also demonstrates the pull created by the action of international organizations and the new governance of donor-funded markets through the cases of antiretroviral and antimalarial medicines. Next, the thesis explores the organization of the pharmaceutical market in Francophone West African countries through the case of Mali and examines the entry and operational strategies of Indian firms therein (Chapter 3). It relies on the analyses of two sets of semi-structured interviews conducted in Mali and India, a Malian pharmaceutical market authorization list, and pharmaceutical export data from the International Trade Centre. It shows that the pharmaceutical market is divided into four specific segments – government-funded public vi market, donor-funded public market, formal private market and the informal market – with different regulatory characteristics governing their functioning. Indian firms are using only export to operate in Francophone West African countries, but the organization of export as well as product portfolio varies according to the segment in which a firm intends to operate. Lastly, it studies the impact of strategic alliance of Indian firms with Product Development Partnerships (PDPs) and the regulatory framework put in place by international organizations on the market entry strategy (Chapter 4). It relies on the case study of Synriam, a new antimalarial medicine developed through the partnership between Medicines for Malaria Venture (MMV) and Ranbaxy. It shows that Ranbaxy used partnership for developing capabilities, accessing new markets and gaining legitimacy. The case also reflects that international organizations may create institutional barriers and influence the market entry strategy especially for medicines against diseases which have a substantial donor-funded market segment. To conclude, this thesis illustrates the richness and complexities of the African pharmaceutical market and shows that market entry and operation strategies of Indian firms are influenced by the underlying institutional environment. Keywords: Indian pharmaceutical firms; internationalization; market entry; firm strategy; Sub-Saharan Africa; pharmaceutical markets; international organizations; Product Development Partnerships vii Résumé La littérature existante sur l'internationalisation des firmes pharmaceutiques indiennes s'est principalement concentrée sur leur pénétration dans les marchés hautement réglementés des pays avancés (Chapitre 1). Bien que cette approche ait enrichi notre connaissance des stratégies utilisées par les firmes indiennes dans les pays développés, elle considère les marchés pharmaceutiques en Afrique subsaharienne seulement comme une étape intermédiaire dans le processus d'internationalisation. Cette thèse essaie de répondre à la question suivante : « quelles sont les stratégies d'entrée sur le marché et de fonctionnement des firmes pharmaceutiques indiennes en Afrique subsaharienne ? ». À travers un cadre néo-institutionnel, cette problématique est abordée selon trois perspectives différentes afin d'obtenir une image holistique du phénomène. Notre démarche est avant tout empirique. La thèse débute par une mise en évidence l'importance des facteurs institutionnels que sous-tendent l'internationalisation à la fois à l'intérieur et à l'extérieur de l'Inde (Chapitre 2). Cela démontre que l'environnement protectionniste mis en place par le gouvernement indien a contribué à bâtir une industrie pharmaceutique solide. L'arrivée simultanée de l'Accord ADPIC et de la libéralisation économique a créé des « push factors » à la fois compétitifs et favorables, obligeant les firmes indiennes à chercher de nouvelles voies de croissance au-delà des frontières nationales. En outre, les politiques de soutien des pays africains en faveur des génériques ont induits des « pull factors » permettant aux firmes indiennes de s'engager davantage sur ces marchés. Cette thèse montre également que le « pull » a été créé par l'attraction des organisations internationales et de la nouvelle gouvernance des marchés financés par les bailleurs de fonds. La thèse explore ensuite l'organisation du marché pharmaceutique et les stratégies d'entrée et d'exploitation des firmes indiennes dans les pays francophones d'Afrique de l'Ouest à travers le cas du Mali (Chapitre 3). Une analyse de deux séries d'entretiens semi-directifs menés au Mali et en Inde a été complétée par l’analyse d'une liste d'autorisations de mise sur le marché des produits pharmaceutiques au Mali et de données sur les exportations de produits viii pharmaceutiques du Centre du Commerce International. Cette enquête montre que le marché pharmaceutique en Afrique de l’Ouest francophone est divisé en quatre segments spécifiques – le marché public financé par l'État, le marché public financé par des donateurs, le marché privé formel et le marché informel – avec des réglementations différentes régissant leur fonctionnement. Les firmes indiennes n'utilisent que l'exportation pour opérer dans ces pays, mais leur organisation ainsi que le portefeuille de produits varient selon le segment dans lequel une firme a l'intention de s’implanter. Enfin, l'alliance stratégique des firmes indiennes avec les partenariats de développement de produits (PDP) a été étudiée tout en s’intéressant au cadre réglementaire mis en place par les organisations internationales concernant la stratégie d'entrée sur le marché (Chapitre 4). Cette recherche s'appuie sur l’étude du Synriam, un nouvel antipaludéen développé dans le cadre du partenariat entre Medicines for Malaria Venture (MMV) et Ranbaxy. Les résultats montrent que Ranbaxy a utilisé ce partenariat pour développer ses capacités, accéder à de nouveaux marchés et gagner en légitimité. Cette étude a mis également en évidence le fait que les organisations internationales peuvent créer des barrières institutionnelles et influencer la stratégie d'entrée sur le marché. En conclusion, cette thèse illustre la richesse et la complexité du marché pharmaceutique africain et démontre également que les stratégies d'entrée sur le marché et d'exploitation des firmes indiennes sont influencées par l'environnement institutionnel sous-jacent. Mots-clés : Firmes pharmaceutiques indiennes; internationalisation; entrée sur le marché; stratégie des firmes; Afrique subsaharienne; marchés pharmaceutiques; organisations internationales; partenariats pour le développement de produits ix Acknowledgements Past four and half years have been an incredible journey and I couldn’t have made it all alone. First and foremost, I would like to thank my advisor Dr. Fabienne Orsi for her unfettered support, absolute trust, and honest criticism. This thesis would not have been possible without your guidance and encouragement. You have helped me become a
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