From maturity to value-added innovation: lessons from the pharmaceutical and agro-biotechnology industries

Analysing stratified medicine business models and value systems: innovation-regulation interactions

“…The Innogen Centre has proposed a set of principles that could be implemented to deliver smarter regulatory approaches for the life sciences sector [2,29,48,52], including:…”

“…This challenge is similar to that faced by the agro-biotechnology industry in the 1980s [3] and is leading to a productivity crisis in which year-on-year increases in R&D investment have not been matched by an equivalent increase in product approvals [2,4]. Although there is debate around the nature and extent of the socalled 'innovation deficit' [5][6][7], there is no doubt that, since the early 1990s companies have not been generating enough new high value compounds to sustain growth [8].…”

“…The emergence of stratified medicine can be best understood in the context of a pharmaceutical industry that has reached a level of maturity with small-molecule treatments, having struggled for at least two decades to sustain a blockbuster innovation model in the face of social, economic and technological challenges [1,2]. The maturity problem, put simply, arises from the fact that companies are finding it increasingly difficult to discover, develop and market novel products that are effective enough to compete with existing product ranges, safe enough to meet regulatory requirements, cheap enough to manufacture, and cost-effective enough to meet payers' demands.…”

Bioeconomy and the global economy: industrial policies and bio-innovation

“…The model, as practiced and honed over half a century is characterised by: identifying promising new blockbuster drugs; conducting large multi-phase clinical trials; and, an extensive marketing and sales presence. During the 1980s and 1990s, big pharmaceutical firms had relatively integrated and complementary R&D strategies (Mittra et al 2010). The top ten firms were large multinationals, all based in the USA (companies like Pfizer, Bristol Myers Squibbs and Johnson and Johnson) or Europe (with Glaxo Smith Kline, Astra-Zeneca and Sanofi).…”

“…It is becoming harder to find truly new drugs in spite of continuing high R&D expenditure. Pharmaceutical company profit rates are falling, although volumes are massive and keep big pharmaceutical firms in the top global companies worldwide (Mittra et al 2010). Another indicator of instability is that large companies are constantly attempting to restructure: cutting in-house R&D units, such as Pfizer's decision in 2011 to close a set of R&D units (Mittra et al 2011); shaving costs through mergers (Mittra 2007); outsourcing R&D to universities and specialist biotechnology firms; and, organisational changes such as encouragement of smaller 'fleetfooted' innovation units within big pharma companies.…”