After years of low productivity, R&D in leading pharmaceutical and biotech companies is starting to deliver on its promises; the number of New Molecular Entities (NMEs) approved by the US FDA has leveled out and biotech companies’ share prices are rising, indicating profitable business models. Now is the time for launch. Arthur D. Little’s (ADL) latest viewpoint, ‘Launch Excellence for New Medicines,’ assesses the key success factors for the successful launch of new medicines.
Based upon ADL’s extensive project experience, Launch Excellence has the power to shorten time-to-market by four to six months and it can deliver additional incremental annual sales of up to €50m. In the past, it seemed natural for multinational pharma companies to launch NMEs in known business areas and territories. However, due to global market access challenges, companies need to transform their launch approach.
Healthcare delivery is undergoing a transformation due to the convergence of new developments in IT, telecommunications and medicine. Communications through social media, collaborations with telecommunications companies and joint software development with IT companies will become an integral part of future sales processes within the pharmaceutical industry. In addition, each local market has its characteristics with different purchasing power and regulations for patient access to medicines issued by governments and payers. So how do companies manage the complexity of global product launch in a dynamic environment of emerging markets, new technologies and changing market access requirements?
“Launch organization is key,” say ADL’s Healthcare practitioners. “Companies need to establish a launch governance, a culture of transparency and information exchange; and provide the appropriate structures and tools. The launch status should be constantly tracked to avoid delays.”
To be successful in NME launches, a holistic approach to market analysis is required to go beyond an analysis of epidemiology, competitors, prescribers and previous ramp-up curves. Instead, launching companies should finalize the value proposition of the drug five years prior to launch. To prepare for the successful market entry, R&D teams need to be integrated with the commercial and operational teams and a launch plan must be tracked. Finally, companies need to engage with stakeholders well in advance of the actual launch to ensure the new therapy will meet their requirements.
The report can be downloaded at:
www.adl.com/Launch_excellence