Profitable Opportunities in Pharmacodynamic Assay Development

Published Date : 30 October 2009

Pharmacodynamic Assays

Overview: Pharmacodynamic assays are assays that provide methods for quickly screening cell samples for a pharmacodynamic effect to a drug or test agent. These assays inform drug development decisions by providing evidence of drug action on molecular targets.

Pharmacodynamic assay development has become an increasingly lucrative area of product development for research supply companies, as demand for the assays has risen following recent introduction of Phase 0 trials by the FDA. Phase 0 trials are known as human microdosing studies and are designed to speed up the development of promising drugs by establishing early on whether they interact with their expected targets.

The NCI recently requested that qualified small businesses submit proposals to develop pharmacodynamic assays for measuring a number of high-priority molecular targets. (For a list of the targets of interest to NCI, see: http://sbir.cancer.gov/). NCI's goal is to support development of new rigorous, validated assays to measure molecular-level response to treatment, especially real-time assays that could be used to rapidly assess response to treatment during clinical trials.

This market report characterizes the rapidly growing pharmacodynamic assays market, including:

Market segmentation by application
Examination of validated assays and assays under development
Quantitative U.S. and International market size analysis
Analysis of market growth rates and future projections
In-depth analysis of emerging trends and opportunities
A critique of high-priority molecular targets for assay development
Research product opportunities & suggestions

In summary, it provides detailed guidance for companies that wish to develop pharmacodynamic assays to supplement their traditional research supply or bio-pharmaceutical product development.

Table of Contents :

I. Pharmacodynamics Assays

A. Definition
B. History

1. Impact of Phase 0 Legislation
2. SBIR Support of Pharmacodynamic Assay Development

C. Increasing Participation from Research Supply Companies

1. Natural Extension of Product Lines
2. A Response to Potential Profits

II. Market Segmentation of by Application

A. Streamlined Drug Development Processes for Pharmaceutical Companies
B. Phase 0 Clinical Trials
C. Patient Stratification during Clinical Trials (Phase I-IV)
D. Prediction of Cancer Re-Occurrence
E. Insights into the Basis of Cytotoxic Response to Existing Cancer Therapies
F. Pharmacodynamic Monitoring of Immunosuppressive Drugs

III. Market Environment