Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • From the Analyst's Couch
  • Published:

Valuation of biomarkers

Nature Reviews Drug Discovery volume 10, pages 253–254 (2011)Cite this article

Subjects

Although many factors need to be considered before making an investment decision, a good place to start is consideration of return on investment. At a minimum, the benefits accruing from an investment should be greater than its cost. Furthermore, a dollar spent on a biomarker programme today is not fully offset by a dollar earned from a sale of a drug 5 years from now. Therefore, both costs and expected benefits need to be discounted to the present, using the cost of capital currently available to the company.

There are many types of biomarkers2, but much of the current literature is devoted to those designed to predict either efficacy or toxicity of a drug treatment. Of these two, estimation of financial impact is more straightforward for those purporting to predict efficacy. For example, lowering of blood pressure is now accepted by regulatory authorities as a surrogate biomarker for subsequent development of clinically meaningful end points such as stroke, myocardial infarction and renal failure. However, the value equation is different for the vast majority of efficacy biomarkers that have not been validated to a degree necessary for acceptance as primary end points by regulatory authorities.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Peck, R. W. Driving earlier clinical attrition: if you want to find the needle, burn down the haystack. Considerations for biomarker development. Drug Discov. Today 12, 289–294 (2007).

    Article  CAS  Google Scholar 

  2. Hurko, O. The uses of biomarkers in drug development. Ann. NY Acad. Sci. 180, 1–10 (2009).

    Article  Google Scholar 

  3. Paul, S. M. et al. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nature Rev. Drug Discov. 9, 203–214 (2010).

    Article  CAS  Google Scholar 

  4. DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–185 (2003).

    Article  Google Scholar 

  5. Fleming, T. R. & DeMets, D. L. Surrogate end points in clinical trials: are we being misled? Ann. Int. Med. 125, 605–613 (1996).

    Article  CAS  Google Scholar 

  6. Prentice, R. L. Surrogate endpoints in clinical trials: definition and operational criteria. Stat. Med. 8, 431–440 (1989).

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Orest Hurko is at Biologics Consulting Group, 400 North Washington Street, Suite 100, Alexandria, Virginia 22314-2353, USA.,

    Orest Hurko

  2. Graham K. Jones is at Pfizer, Groton, Connecticut, USA.,

    Graham K. Jones

Authors
  1. Orest Hurko
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Graham K. Jones
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Orest Hurko.

Ethics declarations

Competing interests

Orest Hurko is a full-time employee of the Biologics Consulting Group, 400 North Washington Street, Alexandria, Virginia 22314–2353, USA. Biologics Consulting Group is an international consultancy that provides support with regulatory submissions to the US Food and Drug Administration. Graham K. Jones is a full-time employee at Pfizer.

Supplementary information

Supplementary information Box S1

Details of model and analysis (PDF 333 kb)

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hurko, O., Jones, G. Valuation of biomarkers. Nat Rev Drug Discov 10, 253–254 (2011). https://doi.org/10.1038/nrd3417

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd3417

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research