Edited by Marian V Jones, Colin Wheeler and Pavlos Dimitratos
Chapter 4: Small Pharmaceutical Firms Building Capabilities to Compete Along the Global Research and Development Pipeline
Lisette Pregelj, Martie-Louise Verreynne and Damian Hine INTRODUCTION Entrepreneurial small firms use their innovations to penetrate markets and then to sustain themselves in those markets. These firms are viewed worldwide as major contributors to national economies and to the industry sectors in which they operate, due to their significant contribution to GDP, employment and market growth. In more mature industries their role is less defined and their support more tenuous. In the pharmaceutical industry and the related life sciences industry, however, their role has been viewed as the generators of lead candidates emanating from their research. It has been regarded as the role of the multinational, powerful, large firms, Big Pharma, to take those candidates and develop them into products for the market. As a result, the focus of policy makers, industry analysts and academics alike has been on Big Pharma. Questions remain over the ability of small firms to compete in an area that appears to advantage economies of scale and well developed resources, due to very high development costs. There has been a gradually dawning crisis in the global pharmaceuticals industry owing to ever-strengthening concerns about research and development (R&D) productivity, the belief that the cost of bringing products to market is rising and that the time taken to bring those products to market is increasing. The purported cause is the stringent regulatory requirements of the United States (US) Food and Drug Administration (FDA), the de facto world industry-standard in pharmaceuticals, including biopharmaceuticals, drugs and vaccines. Big...
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