Analysing stratified medicine business models and value systems: innovation- regulation interactions (original) (raw)
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Trends in Biotechnology, 2011
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.
Shifting paths of pharmaceutical innovation: Implications for the global pharmaceutical industry
The modern pharmaceutical industry has always been dominated by a few large pharmaceutical companies, or ‘big pharma’. Until recent times, big pharma has enjoyed success through its integrated approach of exploiting growing scientific and technological know-hows and commercialising high value blockbuster drugs. However, a number of external and internal forces are influencing the value of pharmaceutical innovation, and making big pharma’s growth through integrated innovation model, unsustainable. To sustain growth, big pharma is adapting its innovation pathway, and complementing its model of creating value through new drugs and new markets with one that deliver the perceived value to users including patients, physicians, payers and policy makers. This paper maps the shifting paths of pharmaceutical innovation by examining big pharma’s responses to the forces that are affecting their innovation models. The shifting paths of pharmaceutical innovation have important implications for th...
Technological Forecasting and Social Change, 2012
An industry's dominant logic is the general scheme of value creation and capture shared by its actors. In high technology fields, technological discontinuities are not enough to disrupt an industry's dominant logic. Identifying the factors that might trigger change in that logic can help companies develop strategies to enable them to capture greater value from their innovations by disrupting that logic. Based on analyzing the changes that biotechnologies and bioinformatics have brought to the drug industry, we identify and characterize three triggers of change that can create disruptive business models. We suggest that, in mature industries experiencing strong discontinuities and high technological uncertainty, entrants' business models initially tend to fit into the industry's established dominant logic and its value chains remain unchanged. But as new technologies evolve and uncertainty decreases, disruptive business models emerge, challenging dominant industry logics and reshaping established value chains.
Objectives: The aim of this study was to investigate how innovation is defined with respect to new medicines. Methods: MEDLINE, Embase, and EconLit databases were searched for articles published between January 1, 2010 and May 25, 2016 that described a relevant definition of innovation. Identified definitions were analyzed by mapping the concepts described onto a set of ten dimensions of innovation. Results: In total, thirty-six articles were included, and described a total of twenty-five different definitions of innovation. The most commonly occurring dimension was therapeutic benefit, with novelty and the availability of existing treatments the second and third most common dimensions. Overall, there was little agreement in the published literature on what characteristics of new medicines constitute rewardable innovation. Conclusions: Alignment across countries and among regulators, health technology assessment bodies and payers would help manufacturers define research policies that can drive innovation, but may be challenging, as judgements about what aspects of innovation should be rewarded vary among stakeholders, and depend on political and societal factors.
International Journal of Healthcare Technology and Management
The emergence of more targeted molecular therapies has contributed to accelerated growth within the oncology market. Projected to become the leading therapeutic area by 2017, forecast spends are expected to be in the range of $74-84 billion. Coupled with its many specificities around pricing, insurance implications, and ethics, we argue that the oncology segment may best inform future pharmaceutical value network design characteristics-in supporting the sustainable manufacture and supply of next-generation medicines. Through exploration of future state scenarios and opportunities areas, driven by the adoption of emerging process and digital technologies, a base framework is extended to enable a systematic assessment of a series of candidates representative of the wider oncology market. These include niche, low volume drugs on-patent with high QALYs (quality-adjusted life years), through to higher volume generics with a history of supply shortages. A series of emerging product-process 'archetypes' in oncology are proposed-classified as 'New Niche', 'Old Niche' and 'Established Generics'-with associated models for reconfiguration, based on the clustering of potential supply benefits. A key application of this systems approach is the potential of informing economies of drug 'repurposing', through its extension from commercial to drug discovery, development and clinical trial contexts, and in matching emerging process capabilities to future adaptive supply requirements-for the sustainable provision of next-generation medicines.