Micro Array Technology and Markets

Trends in the Market Opportunities for
Microarray Technologies
Kenneth G Krul, MBA, PhD
Barcelona, Spain --- May 2008
KGK Associates, Ltd

www.kgkassociates.com.
Trends in the Market Opportunities for Microarray
Technologies
Goals
 1. Provide a view on how and where microarrays are

being used.
Technologies
Goals

being used.
 2. Provide a perspective on where opportunities in

microarray applications may be over the next ten years.
Technologies
Goals

being used.
 2. Provide a perspective on where opportunities in

microarray applications may be over the next ten years.
 3. Provide a point of reference in terms of market

potential for microarray applications over the next few
years.
Technologies
Laboratory Use of Features
 Almost all laboratories using microarrays use oligo

features for sequencing and/or SNP analysis.
Technologies

 Only 7% of laboratories using microarrays use protein

arrays.
Technologies

 Only 7% of laboratories using microarrays use protein

arrays.
 Very few laboratories use tissue or small-molecule

microarrays.
Technologies
Laboratories Using Microarrays
 Based on Laboratory Population

 Academic Laboratories: 75% - 80%
 Industrial/Commercial Laboratories: 20% - 25%
Technologies
Laboratories Using Microarrays
 Based on Laboratory Population

 Based on Microarray Features Used

Technologies
Custom-Spotted –vs- Off-the-Shelf

Microarrays
 80% of the laboratory population spots their own

microarrays
Technologies

Microarrays
 80% of the laboratory population spots their own

microarrays
 20% of the laboratory population uses off-the-shelf

microarrays
Technologies

Microarrays
 The overlap usage (custom and off-the-shelf) is not

known
Technologies
Custom-Spotted vs. Off-the-Shelf

Microarrays
 The overlap usage (custom and off-the-shelf) is not

known
 The trend is toward more off-the-shelf usage

Technologies
Primary Reasons for the Use of Custom-

Spotted vs. Off-the-Shelf Microarrays
 Custom Spotting
 Increased flexibility
 Lower array costs
Technologies
Primary Reasons for the Use of Custom-

Spotted vs. Off-the-Shelf Microarrays
 Custom Spotting
 Increased flexibility
 Lower array costs
 Off-the-Shelf-Arrays
 Specific technology
 Convenience and speed
Technologies
Reasons for the Use of 90

Custom-Spotted vs. 80
70
Off-the-Shelf
% Laboratories
60
Microarrays 50
40
30
20
10
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Off-the-Shelf Custom
Technologies
Materials Used for 70

Custom-Spotted 60
Microarrays 50
% Laboratories
40
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Technologies
Patterns of Microarray Use

Technologies
Seven Basic Areas of Microarray Analysis
 Sequence Analysis
Technologies
 Gene Expression Analysis
Technologies
 Comparative Genomic Hybridization
Technologies
 Drug Discovery
Technologies
 Drug Discovery
 Tissue Microarrays
Technologies
 Drug Discovery
 Protein Microarrays (Immunoassays and Receptor Assays)
Technologies
 Drug Discovery
 Protein Microarrays (Immunoassays and Receptor Assays)
 DNA Computing
Technologies
Markets Considered Opportunities for Microarrays
Molecular Diagnostics
Up-Side
6. Wide range of current and potential assays

7. Multidisciplinary
8. Rapidly expanding market ($117 billion market potential in the
seven major world healthcare markets by 2016 --- excluding
pharmacogenomics/pharmacogenetics)
9. Strong technology base
Technologies
Molecular Diagnostics
Down-Side
6. Very few tests, if any, required in such volume as to justify

microarray analysis; potential market essentially ZERO
7. Major suggested application, prenatal screening for inborn errors
of metabolism appears opportune but has faults
3 million live births per year (USA) X 400 errors = 1.2 billion features
@ 12,000 features per array (20x400) = 100,000 arrays/year
10. Cost-benefit analysis does not justify a shotgun approach
Technologies
Blood Banking
Up-Side
6. Limited number of tests, but high volume and secure demand

7. Well-defined market
8. Market motivated to cost-cutting
14 million units/yr in USA –Tested by pools of 9 = 1.6 million panels/yr
80% of USA testing in 7 major regional centers = 1.3 million panels/yr, or
186,000 panels/center/year = 3,600 panels/wk
Six tests per panel (HAV, HBV, HCV, HIV, HTLV, WNV)
~21,000 features (6x3,600)
Technologies
Blood Banking
Up-Side
6. Current USA potential market ~$970 million, reaching ~1.5 billion

by 2010
7. Current potential market in the seven major world healthcare
markets, ~$2 billion, expected to grow to $3 billion by 2012
Technologies
Blood Banking
Down-Side
6. Well-established and aggressive competition

7. Conservatism of blood bankers
8. Instrument/array package a must
9. Instrument will most probably have to be a loss-leader
Technologies
Genotype Screening/Disease Susceptibility

Up-Side
6. Claimed health benefits in terms of preventive medicine

7. Large population of potential test subjects
8. Highly promoted by the healthcare/life insurance industry willing
to invest
Technologies
Genotype Screening/Disease Susceptibility

Down-Side
 IT WILL NEVER FLY! No market potential

 Cost-prohibitive
Current cost of human genome analysis = $100,000 genome
Semi-realistic estimate of future cost = $12,000 genome
Totally unrealistic estimate of future cost = $1,000 genome
11. Major moral, legal, ethical and privacy issues
Technologies
Personalized Medicine
Up-Side
 POTENTIALLY a very large market (opening at $250 million in

the USA by 2015 – not counting current ad hoc tests)
 Companion diagnostics in therapy backed by both the
pharmaceutical industry AND the FDA (which is pushing the
companion diagnostics issue)
 Theory supported by current practice (Herceptin and Gleevec)
 Defined markets by need (cancer, psychiatric disorders,
cardiovascular drugs)
Technologies
Personalized Medicine
Down-Side
 Current companion diagnostics are ad hoc; that is, they were

developed after the therapeutic reached the market; not used in
drug development of clinical trial design
 The coordinated therapeutic/diagnostic development concept has
yet to be validated
 The more closely a single gene is associated with a single drug,
the less likely there will be a market for microarrays
 Not a short-term prospect
Technologies
Bioterrorism
Up-Side
6. Relatively large opportunity but primarily linked to continued

development
7. Focused market
8. Huge unmet need
Technologies
Bioterrorism
Down-Side
6. Basically, a single customer outlet

7. Highly competitive
8. Market size unknown/contracted
Technologies
Others
5. Agriculture
6. Animal husbandry
7. Animal health
8. Ecological
9. Food industry
Technologies
SUMMARY
 Microarray markets are highly slanted to academic laboratories.

 Genomics present the major use of microarrays at this time, with
custom-spotted oligos most prevalent.
 Custom-spotted arrays are the preferred method of operation for
most laboratories.
 Two-thirds of all laboratories using custom-spotted microarrays
spot human genetic material and just over one-half spot murine
genetic material.
Technologies
SUMMARY
 We looked at five areas of opportunity for microarrays: molecular

diagnostics, blood banking, genotype screening, personalized
medicine and biowarfare.
 Blood banking presents the most immediate opportunity for
microarray technology.
 Genotype screening for disease susceptibility prediction hasn’t
the chance of a snowflake in a blast furnace.
Technologies
SUMMARY
 Personalized medicine and companion diagnostics may present a

good opportunity for microarray technology, but it will be seven
years, perhaps more, before the volume of testing justifies the
use of microarrays --- and only if a small number of genes can be
defined as controlling the metabolism of a large number of drugs.
 Biowarfare defense is a powerful market and could benefit greatly
from microarray technology, but may be a difficult market to
crack.
 Ecological, agricultural, animal and food industries hold only
limited potential due to the level of technology in these non-
research laboratories.

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Trends in the Market Opportunities for

Kenneth G Krul, MBA, PhD

Barcelona, Spain --- May 2008

KGK Associates, Ltd

 1. Provide a view on how and where microarrays are

 1. Provide a view on how and where microarrays are

 2. Provide a perspective on where opportunities in

 1. Provide a view on how and where microarrays are

 2. Provide a perspective on where opportunities in

 3. Provide a point of reference in terms of market

Laboratory Use of Features

 Almost all laboratories using microarrays use oligo

Laboratory Use of Features

 Almost all laboratories using microarrays use oligo

 Only 7% of laboratories using microarrays use protein

Laboratory Use of Features

 Almost all laboratories using microarrays use oligo

 Only 7% of laboratories using microarrays use protein

 Very few laboratories use tissue or small-molecule

Laboratories Using Microarrays

 Based on Laboratory Population

Laboratories Using Microarrays

 Based on Laboratory Population

 Based on Microarray Features Used

Custom-Spotted –vs- Off-the-Shelf

 80% of the laboratory population spots their own

Custom-Spotted –vs- Off-the-Shelf

 80% of the laboratory population spots their own

 20% of the laboratory population uses off-the-shelf

Custom-Spotted –vs- Off-the-Shelf

 The overlap usage (custom and off-the-shelf) is not

Custom-Spotted vs. Off-the-Shelf

 The overlap usage (custom and off-the-shelf) is not

 The trend is toward more off-the-shelf usage

Primary Reasons for the Use of Custom-

Primary Reasons for the Use of Custom-

Reasons for the Use of 90

Materials Used for 70

Patterns of Microarray Use

Seven Basic Areas of Microarray Analysis

Seven Basic Areas of Microarray Analysis

Seven Basic Areas of Microarray Analysis

Seven Basic Areas of Microarray Analysis

Seven Basic Areas of Microarray Analysis

Seven Basic Areas of Microarray Analysis

Seven Basic Areas of Microarray Analysis

Markets Considered Opportunities for Microarrays

6. Wide range of current and potential assays

Markets Considered Opportunities for Microarrays

6. Very few tests, if any, required in such volume as to justify

Markets Considered Opportunities for Microarrays

6. Limited number of tests, but high volume and secure demand

Markets Considered Opportunities for Microarrays

6. Current USA potential market ~$970 million, reaching ~1.5 billion

Markets Considered Opportunities for Microarrays

6. Well-established and aggressive competition

Markets Considered Opportunities for Microarrays

Genotype Screening/Disease Susceptibility

6. Claimed health benefits in terms of preventive medicine

Markets Considered Opportunities for Microarrays

Genotype Screening/Disease Susceptibility

 IT WILL NEVER FLY! No market potential

Markets Considered Opportunities for Microarrays

 POTENTIALLY a very large market (opening at $250 million in