R&D Spending & Success: Key Trends, Issues & Solutions

Authors

  • Sanjay Kumar Rao

DOI:

https://doi.org/10.5912/jcb772

Keywords:

R&D, Clinical Trials, Analysis, Insights, Strategy

Abstract

Debates about rising bio/pharmaceutical prices are often predicated on the presumption that higher product prices are necessary for continuing funding of innovation. Recent trends only partially bear this out. While total spending on bio/pharmaceutical R&D has largely remained constant, costs for clinical trials have consumed a rising proportion of R&D budgets. More spending on clinical trials, however, has not yielded higher trial success rates.

 

Prior to product launch, clinical trials take up most of the financial resources attributed to a product in development, costing on average $75-$100M. While completing a full cycle of pre-clinical and clinical trials can take an average of 7.5 years, the probability of successful filing for marketing a drug after clinical trial testing has never exceeded 13-20%, despite advances in trial design and testing processes.

This article discusses key trends in R&D spending and productivity. It then lays out issues that prevent clinical trials from achieving higher success, and presents operational and strategic solutions that can be implemented to improve the effectiveness of increases in R&D spending.

Author Biography

Sanjay Kumar Rao

Since 1990 Dr. Rao’s projects have impacted product and portfolio development strategy, clinical trial investments, pharmaceutical brand development, new product commercialization, clinical and geographic market development, sales force design and optimization, product life cycle management, and new product and portfolio pricing, access and evolution strategies. In a special management consulting supplement, the Nov 2007 Issue of Pharmaceutical Executive profiles Dr. Rao as one the leading strategy consultants in the global bio/pharmaceutical industry. His publications have appeared in The Journal of Business Strategy, The Journal of Commercial Biotechnology, The Journal of New Product Innovation Management, Marketing Research, Marketing Insights, Marketing Health Services, Product Management Today, The Journal of Pharmaceutical Development & Regulation, PM360, Law360, Pharmaceutical Executive, Journal of Medical Marketing, Pharmaceutical Market Europe, Pharmaceutical Executive Europe and proceedings of the PMRG, the PMRG Institute, the PMSA, EPhMRA and the Oxford Outcomes PRO Conference. Dr. Rao has a Ph.D. in Marketing from The Wharton School of the University of Pennsylvania & a B’Tech in Aeronautical Engineering from The Indian Institute of Technology. He is part of the adjunct faculty in the marketing departments at the McDonough School of Business, Georgetown University & the Robert H. Smith School of Business at the University of Maryland.

References

Harper, Matthew (2013); How Much Does Pharmaceutical Innovation Cost, A Look At 100 Companies, Forbes, June 11

Rockoff, Jonathan D. & Ed Silverman (2015); Pharmaceutical Companies Buy Rivals’ Drugs, Then Jack Up Prices, April 26, The Wall Street Journal

Trends in Hospital Inpatient Drug Costs: Issues and Challenges, Final Report, October 11, 2016, NORC, University of Chicago

Trefis Team (2015); Why Are Generic Prices Shooting Up? Forbes, Feb. 27

DiMasi, J.A., Feldman, L., Seckler, A., & Wilson, A. (2010); Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs. Clinical Pharmacology and Therapeutics, 87(3).

Cost To Develop & Win Marketing Approval For A New Drug Is $2.6B; Tufts Center for the Study of Drug Development, Tufts University, Nov. 18, 2014

Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA Annual Membership Survey. Washington, DC: PhRMA; 2015.

Chamka, Justin, Gordon H. Sun, Jeffrey D. Steinberg, Stephen M. Sammut, and Reshma Jagsi (2014) Asia’s Ascent – Global Trends in Biomedical R&D Expenditures, NEJM, January 2nd

Graham, John (2014), Crisis In Pharma R&D: It Costs $2.6 Billion To Develop A New Medicine; 2.5 Times More Than In 2003; Forbes, Nov. 26

Thomas, David (2010), Clinical Trial Success Rates: Recent Study From Tufts, BioTech Now, Nov. 11

Measuring The Return From Pharmaceutical Innovation 2014: Turning A Corner? Deloitte, www.deloitte.co.uk

See http://www.medpagetoday.com/Neurology/MultipleSclerosis/52622, accessed Dec. 11, 2016

DiMasi, J., Hansen, R., & Grabowski, H. (2003). The price of innovation: new estimates of drug development costs; Journal of Health Economics, 22(2), 151-185.

Rao, Sanjay K. (2011); Strategic Priorities For Specialty Care Products, PM360, August

Mathieu, MP (1997); PAREXEL’s Pharmaceutical R&D Statistical Source Book; PAREXEL International Corporation, Waltham (MA)

Rao, Sanjay K., (2015); Trends In Market Access For Specialty Biologics: Challenges & Promises, Journal Of Commercial Biotechnology, April, v21, No. 2

Sertkaya, Aylin, Anna Birkenbach, Ayesha Berlind & John Eyraud (2014); Examination Of Clinical Trial Costs & Barriers For Drug Development, Eastern Research Group, July

Olson, C & S. Neeper (1997); Why Clinical Trials Fail? Brookwood Medical Publications, Richmond

Collier, R. (2009); Rapidly Rising Clinical Trial Costs Worry Researchers, Canadian Medical Association Journal, February, 180(3), 277-278.

Rao, Sanjay K., Re-Energizing A Product Portfolio: Case Study Of A Pharmaceutical Merger (2009), Journal Of Business Strategy, v30; No. 6

Published

2017-06-21

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