Specific Cell-Types “On-Demand”

Est. Market Size - $7 B.

PRODUCT CONSTITUENT

•     Frozen pluripotent adult derived stem cells of a known genotype.

•     Stem cells provided in 96 or 386 well automation friendly microassay plates

•     Differentiation factors.  (For liver it is a tiny section of liver scaffold.  The three-dimensionality is important.)

•     Non-Serum based, differentiation-free culture media.

These plates would be a use-once and throw away.  The genotypic specific cells can be replaced an unlimited number of times.

Market Need?

Cell-based primary screening assays tend to have a high hit rate and to identify compounds with nonspecific effects.  The use of living human cells strengthens the predictive value of preclinical screening, reducing the number of failures in drug discovery and improving pipelines.  Using cell-based assays for compound screening should decrease costs, increase success rates, and identify failures during discovery and preclinical development.

There are Limitations in the Cell Lines Presently used

Although it is obvious that using human cells for the drug discovery process would be best, the technology for reasonably priced and reliable cell-assays is only just coming on line.  Most of these cell-based assays are being used have their own unique challenges. 

Limitations of Cell-Based Assays:

•     Reliable source of cells.

•     Timely cell delivery.

•     A need for consistent batches of cell.

•     Most primary cells have a short live time in plates, less than two weeks for most cells.

•     Immortalized cells are either virally transformed or cancer cell.

•     Regulatory issues of cell culture media containing non-human products, such as Bovine serum.  There is a possibility of disease cross over such as rabies and BSE.

•     There is a world wide shortage of bovine serum.

When compared to the use of primary hepatocytes (liver cells) to immortalized (viral modified) human hepatocyte cell lines have the following advantages:

•     An unlimited supply of cells

•     Reproducible P450 induction

•     Adaptability to a multi-well format

•     Utility for studying cell-based toxicity.

Still, there is a concern for the changes from a Natural state that has occurred when the cells were transformed and immortalized.   By definition, immortalized are not nature, normal terminally differentiated cells, the problems is, does it matter to the drug discovery test being run.  Unfortunately, the answer to that question is usually unanswered until the compound is injected into a living human body.  The whole point of the cell-based assay, though was to have answers before it gets to that point.

Despite these concerns, a Front Line's strategic market report projects that the worldwide cellular assay market will dramatically grow over the next five years as pharmaceutical and biotechnology companies seek ways of increasing the efficiency of their drug discovery effort.  Such estimates are confirmed by market activity.  CMT (Phillipsburg, NJ) is a contract research organization that provides cell for cell-based assays on a custom basis.  They state that 60% to 80% of their client's screens are cell-based.  They also stated that the increases they are experiencing in requests for cell production has placed a strain on their cell culture capacity

MARKET SIZE – Est. $7 Billion

Generalized Cell-Base Assays

The estimates of the general cellular assay market include both hand done and automated tests used for both the research market as well as the drug discovery process.  The cellular assays market is expected to have a AAGR of 8.3% for the next few years. 

In dollars for a world wide market it was $470M in 2004 to grow to an estimated $700M by 2009.

Specialized Cell-based Assays

There are specialized markets that use cell-based assays that have their own market.  For example:

            Specialized Tests                                                          $$

Immortalized Human Liver Cell Toxicity Kit      $3.7B world wide

non-tumorigenic, highly metabolic

ADME                                                                         $1.5B

(Absorption, Degradation, Metabolism, Excretion)

Toxicity                                                                        $1.5 B

Drug Discovery

The existing primary and secondary screening processes in drug discovery have been isolated and broken out to be just about equal in size for the year 2003.

Primary Screen             $610.5M  

Secondary screen         $667.5M   

These figures represent mostly the reagents and supplies consumed by these processes.  The instrumentation utilized in this process is considered in capital equipment budgets.

$$$$$

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Last modified: 04/24/2008