Applied Clinical Research, Clinical Trials and Regulatory Affairs

Satish Chandra
Tawam Hospital
Al Ain


Big Pharma's Recent Challenges

Author(s): Harish Dureja, Neelam Dalal and Swagat Tripathy

Affiliation: Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, India.


The golden era of drug discovery and development began to show cracks as research productivity has started to slump for such reasons that business analyst finds difficult to trace any specific point. To sort out this problem, this paper highlights not only few areas that are really exacerbating the situation such as imminent patent expiry of drugs, shrinking pipeline of NME, challenges from Regulatory Agencies, changing disease state and ageing population, worsened risk/reward ratio for research and development outlays, narrowing Return on Investment (ROI) for the Pharmaceutical R&D Industry and the related rise of cheaper generic alternatives, but also few approaches such as mergers and acquisitions, consolidation, diversification, in licensing, and strategic alliances that Industry is following to make Pharma business environment sustainable.

Keywords: Aging population, branded generics, mergers and acquisition, new molecular entity, outsourcing, patent, pay for delay, personalised medicines, product hopping, regulatory challenges, return of investment, risk-reward ratio, technology-led discovery.

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Article Details

Page: [28 - 36]
Pages: 9
DOI: 10.2174/2213476X114016660001