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.

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

A. High Market Penetration Assays
B. Recently Validated Assays
C. Assays under Development

IV. High-priority Molecular Targets for Assay Development

V. Competitive Analysis

A. Early Entrants
B. Dominant Competitors
C. Recent Market Players

VI. Analysis of Grant Rates / Trends in Funding

A. Trailing 5 Year Analysis
B. Projected 5 Year Analysis

VII. Market Size Determination for Pharmacodynamic Assays
 

A. Methods
B. Worldwide Annual Market Size
C. U.S. Annual Market Size

VIII. Market Growth Rates & Trend Analysis

A. Experimental Approach
B. Growth Rates
C. Trend Analysis

IX. Market Projections
 

X. Product Development Opportunities & Suggestions

A. Pre-Clinical Applications (Research-Use Only)
 

1. Angiogenesis
2. DNA Damage/Apoptosis
3. Other

B. Clinical Applications