Cancer Molecular Diagnostics: On the Critical Path to
Personalized Medicine
Dr. Sudeep Basu, Senior Analyst
Drug Discovery & Clinical Diagnostics
July 24, 2008
2
Presentation Focus Points
� Industry Participants
� Hot Topics
� Market Challenges
� Growth Drivers and Restraints
� Market Coverage and Definitions
� Revenue Forecast
3
Market Coverage and Definitions
Forecast Period: 2008 – 2014
Base Year: 2007
Region: United States
U.S. Cancer Molecular Diagnostics Markets
• U.S. Breast Cancer Molecular Diagnostics Market
• U.S. Prostate Cancer Molecular Diagnostics Market
• U.S. Colorectal Cancer Molecular Diagnostics Market
• U.S. Other Cancers Molecular Diagnostics Market
• U.S. Cancer Companion Diagnostics Market
4
Industry Participants
5
Market Challenges, Growth Drivers and Restraints
2004 – 2007:
• Growth of Cancer Molecular Diagnostics
• New Entrants, M&A
• First Commercial Launch of FDA Approved IVDMIA: MammaPrint
2008 – 2014:
• What applications/new opportunities will drive the U.S. cancer molecular
diagnostics market?
• What is the main barrier to the U.S. cancer molecular diagnostics market?
• Will the U.S. cancer molecular diagnostics market continue to grow?
• How will the market play out in the future with regards to M&A ?
• What is the timeline for new market entrances?
• How will the regulatory environment affect the market?
6
Role of Venture Capital
• Venture Backed Start-Ups in Cancer Molecular Diagnostics
• Major Concerns of the VC Firms
• Listing of Key VC Firms Investing in Cancer Molecular Diagnostic
• Key Pointers for VC Funding for Cancer Molecular Diagnostics
• Price point considerations
• High cost low volumes vs. low cost high volume models
• FDA regulations
• Therapeutic implications in cancer molecular diagnostic
7
FDA Regulation in Cancer Molecular Diagnostics
2008 – 2014:
• FDA Draft Guidelines on IVDMIA
• CLIA vs. IVD Routes for Test Commercialization
• Case Study Based Discussion of the Models
• Effect of Regulation on M&A
• Strategic Recommendations
8
Effect of Regulation: FDA vs. CLIA On Growth Rates
U.S. Cancer Mol Diagnostics (FDA)
U.S. Cancer Mol Diagnostics (CLIA)
2007 20
08 2009 20
10 2011 20
12
Year
Total U.S. Cancer Molecular Diagnostics Market
For illustrative purposes
2007
2014
9
Biomarkers and Companion Diagnostics
BIOMARKER
DISCOVERY
FDA’s CONCEPT
PAPER
WILL THE FDA MOVE ON K- RAS ?
COMPANION--
DIAGNOSTICS
IS EUROPE (EMEA) AHEAD OF THE U.S. (FDA) ?
10
How Quickly Will The Market Grow?
• FDA Regulations
• Physician Awareness and Adoption
• Rate of Biomarker Discovery and Validation
• Technology as a Driver
• The SPECS and PACCT Programs(NIH-NCI)
• Companion Diagnostics (?)
• Reimbursement Policies and Coverage
Scenario A
(Minimal Companion Diagnostics)
Scenario B
(Growth in Companion Diagnostics)
US CANCER MOLECULAR DIAGNOSTICS MARKET
0.0
200.0400.0
600.0800.0
1,000.0
1,200.01,400.0
1,600.01,800.0
2,000.0
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Year
$ M
illi
on
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
Gro
wth
Rate
TOTAL
Growth
11
How Will The M&A Landscape Change ?
• 2008 – 2014:
• Noteworthy Deals
• Who Are The Acquirers?
•
• Who Are The Target Companies?
• How Will Platform Technology Companies Enter The Space?
• Will Pharma Integrate Diagnostics?
• How Will Consolidation Effect The Market?
12
Conclusion
2008 – 2014:
Rapid Growth in the U.S. Cancer Molecular Diagnostics
Market
Near Term: More Clarity in Regulations
Long Term:
Growth of Companion Diagnostics
Market Consolidation via M&A
13
Personalized Medicine
Clinical Diagnostics and Drug Discovery Technologies:The Next Generation of Growth Opportunities
laboratoryautomation
multiplexassays
compoundscreening
innovativeresearch tools
workflowsystems
cancer
infectiousdisease
geneticdisorders
drugmetabolism
diseaseprognostics
expressionprofiling
genotyping
cytogenetics
epigenetics
sequencing
M O L E C U L A R D I A G N O S T I C S
P H A R M A C O G E N O M I C S
C O M P A N I O N D I A G N O S T I C S
P O I N T OF C A R E D I A G N O S T I C S
G E N O M I C S & P R O T E O M I C S
Personalized Medicine
Clinical Diagnostics and Drug Discovery Technologies:The Next Generation of Growth Opportunities
Personalized Medicine
Clinical Diagnostics and Drug Discovery Technologies:The Next Generation of Growth Opportunities
laboratoryautomation
multiplexassays
compoundscreening
innovativeresearch tools
workflowsystems
cancer
infectiousdisease
geneticdisorders
drugmetabolism
diseaseprognostics
expressionprofiling
genotyping
cytogenetics
epigenetics
sequencing
M O L E C U L A R D I A G N O S T I C S
P H A R M A C O G E N O M I C S
C O M P A N I O N D I A G N O S T I C S
P O I N T OF C A R E D I A G N O S T I C S
G E N O M I C S & P R O T E O M I C S
laboratoryautomation
multiplexassays
compoundscreening
innovativeresearch tools
workflowsystems
cancer
infectiousdisease
geneticdisorders
drugmetabolism
diseaseprognostics
expressionprofiling
genotyping
cytogenetics
epigenetics
sequencing
laboratoryautomation
multiplexassays
compoundscreening
innovativeresearch tools
workflowsystems
laboratoryautomation
multiplexassays
compoundscreening
innovativeresearch tools
workflowsystems
cancer
infectiousdisease
geneticdisorders
drugmetabolism
diseaseprognostics
cancer
infectiousdisease
geneticdisorders
drugmetabolism
diseaseprognostics
expressionprofiling
genotyping
cytogenetics
epigenetics
sequencing
expressionprofiling
genotyping
cytogenetics
epigenetics
sequencing
M O L E C U L A R D I A G N O S T I C S
P H A R M A C O G E N O M I C S
C O M P A N I O N D I A G N O S T I C S
P O I N T OF C A R E D I A G N O S T I C S
G E N O M I C S & P R O T E O M I C S
M O L E C U L A R D I A G N O S T I C S
P H A R M A C O G E N O M I C S
C O M P A N I O N D I A G N O S T I C S
P O I N T OF C A R E D I A G N O S T I C S
G E N O M I C S & P R O T E O M I C S
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Industry Expertise
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StrategicExpert Analysis
ComprehensiveSupply-side Analysis
RobustEnd-user Analysis
Through Detailed Market Intelligence
and Inquiry Time with Analysts,
Our Team of Industry Experts Will Help You
•Identify High-Growth Segments in Molecular Diagnostics
•Establish Investment Criteria for Pharmacogenomics
•Predict IVDMIA Regulations’ Impact on New Diagnostic Tests
•Determine how the Drug—DiagnosticsCo-Development Model will Evolve
•Understand the Role of Reimbursementin Personalized Medicine
•Evaluate the Influence that Partnershipsand M&A Activity will have on the
Competitive Landscape
•Examine the ways Platform TechnologyProviders Position Themselves Relative to
Biomarker and Diagnostic Development
15
Total Rapid Microbiology Tests Market:
Percent of Revenues by Market Segment (U.S.), 2007
Manufacturing
Tests
18.8%
Rapid Clinical
Tests
Rapid
Bioterroism
Tests
15.2%
0.0
2.0
4.0
6.0
8.0
10.0
12.0
Re
ven
ue
s (
$ b
illio
ns
)
EsotericTesting
Rapid growth expected for esoteric testing. It is expected to reach $10.6 billion by 2014 from $5.1 billion in 2007 at a CAGR of 11.0%
2007
2014
Total Esoteric Testing Market:Revenue Forecasts (U.S.), 2007-2014
0.0
2.0
4.0
6.0
8.0
10.0
12.0
Re
ven
ue
s (
$ b
illio
ns
)
0.0
2.0
4.0
6.0
8.0
10.0
12.0
Re
ven
ue
s (
$ b
illio
ns
)
EsotericTesting
Rapid growth expected for esoteric testing. It is expected to reach $10.6 billion by 2014 from $5.1 billion in 2007 at a CAGR of 11.0%
EsotericTesting
Rapid growth expected for esoteric testing. It is expected to reach $10.6 billion by 2014 from $5.1 billion in 2007 at a CAGR of 11.0%
2007
2014
2007
2014
Total Esoteric Testing Market:Revenue Forecasts (U.S.), 2007-2014
0.0
200.0
400.0
600.0
800.0
1000.0
1200.0
1400.0
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
Total qRT-PCR Markets:Revenue Forecasts (U.S.), 2002-2012
Year
Reven
ues
($ M
illio
n)
Gro
wth
Rate
(%)
Revenues
Growth
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
0.0
200.0
400.0
600.0
800.0
1000.0
1200.0
1400.0
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
Total qRT-PCR Markets:Revenue Forecasts (U.S.), 2002-2012
Year
Reven
ues
($ M
illio
n)
Gro
wth
Rate
(%)
Revenues
Growth
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
Market Engineering Research
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Measurement-based strategies developed
through our exclusive market engineering
methodology – presents an accurate picture of
the current and future marketplace, opportunities
for growth, challenges, and market drivers.
“We have relied on Frost & Sullivan’s strategic research studies for
reliable insights into several competitive markets. Their ability to identify
and analyze industry-specific trends gives their clients not only a clear
indication of where markets are going, but why they are going there.”
- Gen-Probe
• Cancer Molecular Diagnostics Markets
• Pharmacogenomics Markets
• Epigenetics and MicroRNA Markets
• Established Infectious Disease Molecular Diagnostics Markets
• Emerging Infectious Disease Molecular Diagnostics Markets
• Genetic Testing and Genomic Profiling Markets
• Rapid Microbiology Testing Markets
• Nucleic Acid Isolation and Purification Markets
16
Customer Research
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Specialized Insight into:
• Researcher and Physician Utilization
• Laboratory and Hospital
Implementation
• Reimbursement Policies
• Regulations
• Healthcare Privacy Laws
17
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For Additional Information
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Corporate Communications
North American Analyst Briefing Coordinator
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