CPhI Worldwide, part of UBM Live’s Pharmaceutical Portfolio and a provider of exhibitions, conferences and online communities for pharmaceutical professionals, has found the R&D market is diversifying innovation in its Pharma Insights report on R&D.
The report shows this diversification is through increased out/in licensing of technology, partnerships and mergers. Improvements in evaluation also have been credited with helping the sector grow 8%, with long-term objectives now being considered at earlier stages within the development process.
According to the report, the industry is evolving its model, maintaining innovative output while also standardizing approaches to measuring effectiveness and, crucially, returns on investment—with 40% using QbD for analytical and tech, 18% using Six Sigma, 15% stage gate and 12% lean techniques to evaluate effectiveness.
Unsurprisingly, with the milestone nature of moving between clinical stages, balancing long and short-term goals was seen as a major challenge (53%) and improving efficiency (38%) also highlighted the growing efforts to improve ROI between stages. However, a clear trend has emerged from this, with more and more companies involving commercial side at an earlier and earlier stage, with 30% beginning in preclinical and another 30% prior to phase III.
Almost a quarter of respondents sighted cancer as a major focus area for 2014, followed by antibiotics (13%), cardiovascular (12%) and CNS (12%) targets. Additional evidence for the cancer focus also emerged from the novel areas companies are working on, with 37% researching combination drugs and 20% personalized medicines. Outside of cancer, it appears improved drug delivery mechanisms are targeted, as 17% are investing in nanotechnology and 12% directly in drug devices.
However, the source of innovation is increasingly diverse, with growing partnerships (75%), mergers (20%) and out/in-licensing of technology (55% and 60%, respectively). The report stated a major factor in competitiveness both now and in the future is access to technology, and the industry is seeing a more collaborative approach. This is an important trend and one that should enable the industry to continually innovate, with cross-pollination of projects, where even the smallest biotech can access crucial technology that enables projects to move forward.
“With product development processes being increasingly managed through quality and control methods, the cost of and access to technology will be the essential access point on many projects ultimate viability,” said Chris Kilbee, group director, pharma.
Highlighting the need for access to new techniques and technologies, 33% of respondents were partnering with research institutes, 15% with research-focused companies and 10% with universities.
The report concluded there is a clear desire among all companies to ensure future R&D spend is prudent and focused on bringing products to market faster, not just innovative targets. Monitoring processes more prescriptively and standardizing approaches should enable a quicker transfer between phases. Most interesting for the future, there now is an “open innovation approach” to technology—which will enable reduced R&D timelines and better results.
Kilbee said, “What we are now seeing is the maturation of the R&D sector, having gone through a period of change over the last few years with innovation moving downstream from big pharma. However, we now are at a point where innovation is coming from new and more diverse fields as different areas of science collaborate and bring new techniques into pharma production. This trend, coupled with a commitment to tackle long-term project viabilities alongside standardized methods for practice, should help reduce bottlenecks in the pipeline and bring more targets to market in a more cost-effective manner. It is a really exciting period for the R&D sector with new ideas, nanotechnology and manufacturing techniques and process bringing a new rigor and commercial focus to future projects.”