Biomarker Research
Report
Worldwide Trends
2014
Worldwide Trends
2014
What is a Biomarker?
• A biological marker, better
known as a “biomarker”, is
a characteristic that is
objectively measured and
evaluated as an indicator
of normal biological
processes, pathogenic
processes or
pharmacological responses
to a therapeutic
intervention.
Source: Drug Discovery World
http://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-trendssummer-10.html
Worldwide Trends
2014
History of Biomarkers
• Term ‘biomarker” first coined in the 1980’s.
• Biomarkers were developed as a response to
understand the relationship between environmental
factors and disease.
▫ Association or causation?
• Increase in the use of the term biomarker is a recent
one (the last fifty years).
• Use of the term and the characteristic continues to
grow today.
Source: The Environment and Disease: Association or Causation?
http://www.totalscientific.com/biomarkerblog/?p=55
Worldwide Trends
2014
Biomarker Uses and Applications
• Biomarkers include tools and
technologies that can aid in
understanding the
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Prediction
Cause
Diagnosis
Progression
Regression and
Outcome
of various diseases
Source: The Journal of the American Society for Experimental NeuroTherapeutics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/
Biomarker Uses and Applications
• Variety of Biomarkers
▫ Each body system has a specific
biomarker (i.e.-cardiovascular,
respiratory, lymphatic).
▫ Each biomarker is relatively easy to
measure.
▫ Each biomarker forms a piece of
routine medical examinations. (i.e.weight and BMI measurements to
predict obesity)
Source: News Medical
http://www.news-medical.net/health/Biomarker-What-is-a-Biomarker.aspx
Biomarker Uses and Applications
• Biomarkers can be:
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Specific cells
Molecules
Genes
Gene products
Enzymes
Hormones
Complex organ functions
General characteristic changes in
biological structures
Source: http://en.wikipedia.org/wiki/Biomarker_(medicine)
Biomarker Uses and Applications
• Ideal Biomarkers:
▫ Safe and easy to measure
 Create as little discomfort for patient (i.e.
blood sample, not invasive biopsy)
▫ Cost efficient to follow up
▫ Rapid return of results for early initiation
of treatment and monitoring effectiveness
▫ Modifiable with treatment
▫ Consistent across gender and ethnic
groups
 Highly reproducible among various clinical
laboratories.
Source: Coriell Institute for Medical Research
http://www.coriell.org/research-services/biomarkers/characteristics-of-the-ideal-biomarker
and
News Medical
http://www.news-medical.net/health/Biomarker-What-is-a-Biomarker.aspx
Biomarker uses and applications
• Biomarker identification and validation
▫ Applied to a wide variety of therapeutic areas
including:
 Neurological disease
 Metabolic disorders
 Immune dysregulation
▫ Most predominant field of application lies in
oncology.
Source: Drug Discovery World
http://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-trendssummer10.html
Worldwide Trends
2014
Types of Biomarkers
• Though many Biomarkers exist, there are two
major categories of Biomarkers:
▫ Biomarkers of exposure
▫ Biomarkers of disease
Source: The Journal of the American Society for Experimental NeuroTherapeutics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/
Types of Biomarkers
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Biomarkers of exposure
Used in risk prediction
Used in screening
Used in diagnostic tests
▫ All tests are well established, allowing for a
distinct advantage:
 improves sensitivity and specificity of the
measurement of the exposures or risk factors.
Source: The Journal of the American Society for Experimental NeuroTherapeutics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/
Types of Biomarkers
• Biomarkers of disease
▫ Used for screening or diagnosis that represent
surrogate manifestations of the disease.
▫ Distinct Advantage:
 Biomarkers depicting prodromal signs enable
earlier diagnosis or allow for the outcome of
interest to be determined a more primitive stage
of disease.
• Biomarkers of disease are used as an indicator
of a biological factor that represents either a
subclinical manifestation, stage of the
disorder, or a surrogate manifestation of the
disease.
Source: The Journal of the American Society for Experimental NeuroTherapeutics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/
e:
Worldwide Trends
2014
Biomarkers and Prostate Cancer
Detection
• Goal of Biomarkers in Prostate Cancer
Detection:
▫ Avoiding over-diagnosis in patients with
indolent (causing little or no pain) prostate
tumors.
 When patients with indolent diseases receive
aggressive treatments, negative effects result:
 Negative side effects occur
 Reduction in a patient’s quality of life
 Little to no benefit to the patient.
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745/
Biomarkers and Prostate Cancer
Detection
• One of the current clinical priorities is to develop
prognostic biomarkers to identify those with
indolent prostate diseases at low risk of
progressing
▫ Allows patients to better benefit from active
surveillance or watchful waiting, thus avoiding:
 unnecessary treatment (allowing for no unnecessary
adverse effects)
 unnecessary financial burden
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745
Biomarkers and Prostate Cancer
Detection
• Types of biomarkers in prostate cancer
prognosis:
▫ therapeutic response
▫ drug development
• Biomarkers can be used to predict:
▫ the expected course of a prostate disease (prognosis)
▫ help clinicians with making decisions about likelihood to
respond to a given drug (predictive)
▫ what dose might be most effective for severity and stage of
disease (pharmacodynamics).
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745
Biomarkers and Prostate Cancer
Detection
• Red color denotes
types of biomarker
• Blue color denotes
the biomarker-based
decision making
• Green color indicates
the exemplary
actions or events
▫ PSA=prostatespecific antigen
▫ DRE=digital rectal
examination
▫ TRUS= transrectal
ultrasound
▫ PD= biomarker,
pharmacodynamic
biomarker.
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745
Biomarkers and Prostate Cancer
Detection
• The previous graph shows the specificity of drug
development for prostate cancer in respect to the
actual treatment necessary for the cancer.
• Biomarkers allow for proper treatment of the
cancer, dismissing over-diagnosis.
Biomarkers and Prostate Cancer
• Black boxes
Detection
denote conceptual
breakthroughs
• Blue boxes
denote biomarker
advances
• Green boxes
denote therapeutic
and technological
outlook.
▫ PAP= prostatic
acid phosphatase
▫ PSA= prostatespecific antigen
▫ FDA= US Food
and Drug
Administration
▫ CTC= circulating
tumor cells
▫ NGS= nextgeneration
sequencing
▫ miRNA=
microRNA.
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745
Biomarkers and Prostate Cancer
Detection
• The previous timeline depicts the advances of
prostate cancer detection and diagnosis.
• It is clear that biomarkers are leading to
technologically therapeutic advances, allowing for
the proper prevention and treatment of prostate
cancer as the years progress.
• Personalized cancer prevention will ensue as
technological advancements in biomarkers
continues.
Worldwide Trends
2014
Key Players
• Discovery and development of biomarkers is
very costly and extremely time consuming.
▫ However. application of biomarkers in drug
discovery and development reduces overall cost of
the entire drug development process
 Therefore, demand for novel biomarkers is expected
to increase in the next five years
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Key Players
• Due to the immense cost
and time commitment of
the development of
biomarkers, many
companies are
combining forces to
ensure that biomarkers
are created in the most
cost efficient of manners
as a main market
strategy.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Key Players
• Companies such as:
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Thermo Fisher Scientific, Inc. (U.S.)
QIAGEN N.V. (Netherlands)
Hologic, Inc. (U.S.)
Roche Diagnostics Limited (Switzerland)
Johnson & Johnson (U.S.)
Siemens Healthcare (Germany)
Abbott Laboratories, Inc. (U.S.) and
Bio-Rad Laboratories, Inc. (U.S.)
are all actively adopting strategies of partnerships and
collaborations, to ensure their growth in the
biomarkers market.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
and
PR News Wire
http://www.prnewswire.com/news-releases/biomarkers-market---discovery-technologies--validation-services-applications--diseases---global-trends--forecasts-2013---2018-244202091.html
Other Key Players
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Abcodia Ltd
Affymetrix Inc
Agilent Technologies Inc
Amgen Inc
Astrazeneca Plc
Augurex Life Sciences Corp
Aushon Biosystems Inc
BGI
Bayer Ag
Beckman Coulter Inc
Biocrates Life Sciences AG
Biomarkers Strategies
Biosystems International
Bristol-Myers Squibb
Caprion Proteomics Inc
Crescendo Bioscience
Eisai Co Ltd
Epiontis GMBH
Epistem Holdings PLC
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Eurogentec SA
Evotec AG
Glaxosmithkline PLC
Ipsen
Merck & Co
Micromedic Technologies Ltd
Myriad Genetics Inc
Nextgen Sciences Inc
Novartis International AG
Ocimum Biosolutions Ltd
Pacific Biomarkers Inc
Pfizer Inc
Pronota NV
Proteome Sciences Plc
Quintiles Transnational Corporation
Sanofi-Aventis
Trans-Hit Biomarkers Inc
Vermillion Inc
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Worldwide Trends
2014
Market Growth
• Factors increasing usage of biomarkers:
▫ rising demand for personalized medicine
▫ companion diagnostics
• Global biomarkers market is expected to grow at
a CAGR (Compounded Annual Growth Rate) of
18.5% from 2013 to 2018
• Expected CAGR of $40.8 billion by 2018.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Other Factors Increasing Market
Growth
• Omics technology such as:
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Proteomics
Genomics
Transcriptomics
Metabolomics
serve as the largest segment of the global
biomarkers discovery technology market
• Advancement in discovery technologies such as
genome sequencing is the prime factor
contributing to the growth of this market.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Worldwide Trends
2014
Future of Biomarkers
• The future appears bright for the
development of biomarkers as
personalized solutions for cancer
prevention and treatment
increase in medicine
• Global upward trends in respect
to utilization of biomarkers are
promising as biomarkers
continue to serve as central hub
in cancer detection, treatment,
and prevention.
Future of Biomarkers
• The next breakthroughs in therapeutics and
biomarkers?
▫ Only can occur with in-depth understanding of
fundamental disease mechanisms
 I.E. prostate cancer initiation and progression,
response to therapy, and mechanisms of action of
anticancer agents.
• Such “disease orientation” will require a greater
collaboration between industry, academia,
regulatory agencies, and patients (revert to the
idea of cost and resource efficiency).
Source: Prostate Cancer- A biomarker perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745/
Future of Biomarkers
• The integrative, interdisciplinary systems
biology approach, along with omics
technologies, offers potential in next-generation
biomarkers.
• The decades approaching will allow for proper
identification, qualification, and application of
novel biomarkers.
• Biomarkers will remain a focal point of patient
care and the drug discovery paradigm for not
only prostate cancer, but all disease.
Source: Prostate Cancer- A biomarker perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745