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

The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system

OECD International Futures Project on “The Bioeconomy to 2030: Designing a Policy Agenda”. Health Biotechnology to 2030

This is a report commissioned by the OECD. Innogen was asked to write a scenario report for the OECD International Futures Programme to consider the pathways that health biotechnologies could follow, the future trajectory of the bio-economy primarily in the context of human health and the likely societal, economic and policy impacts of these projected outcomes, focusing on the period 2015 to 2030 . We chose as a starting point a world health care system that, from the perspective of potential impacts of biotechnology, has been mainly under the influence of the innovation model of the multinational drug companies. To date the scope and inventiveness of this model has been constrained by the expensive and lengthy regulatory systems that act as a barrier to entry for small companies that could challenge the industry status quo and our report focuses on the need for regulatory change as a prelude to the emergence of a new, more radically innovative, health care sector. In the absence of such change our scenario predicts a health care sector that is increasingly populated by pharmaceutical commodity producers, research and development focused on incremental, piecemeal change, lack of both public and private sector funding, dysfunctional competition within and between companies and adversarial relationships with regulators. A radical change scenario on the other hand “Networked Health Care” would depend on regulatory agencies collaborating, as an integral component of the innovation system, in the proactive development of new, smarter regulatory approaches to the generation of benefits based on fundamental discoveries in life sciences. Our report describes the pre-conditions needed to lead to the more positive scenario and the roles of key actors in promoting or resisting such changes