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Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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Biomarker Research Report Worldwide Trends 2014
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Page 1: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarker Research Report Worldwide Trends 2014

Page 2: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

What is a Biomarker?Worldwide Trends2014

Page 3: 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

Page 4: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

History of BiomarkersWorldwide Trends2014

Page 5: Biomarker Research Report Worldwide Trends 2014. 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

Page 6: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarker Uses and Applications

Worldwide Trends2014

Page 7: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarker Uses and Applications

•Biomarkers include tools and technologies that can aid in understanding the▫Prediction▫Cause▫Diagnosis▫Progression▫Regression and▫Outcome

of various diseasesSource: The Journal of the American Society for Experimental NeuroTherapeuticshttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/

Page 8: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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

Page 9: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarker Uses and Applications •Biomarkers can be:

▫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)

Page 10: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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

Page 11: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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 Worldhttp://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-

trendssummer-10.html

Page 12: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Types of BiomarkersWorldwide Trends2014

Page 13: Biomarker Research Report Worldwide Trends 2014. 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 NeuroTherapeuticshttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/

Page 14: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Types of Biomarkers

•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 NeuroTherapeuticshttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/

Page 15: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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:

Page 16: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarkers and Prostate Cancer Detection Worldwide Trends2014

Page 17: Biomarker Research Report Worldwide Trends 2014. 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/

Page 18: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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

Page 19: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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

Page 20: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarkers and Prostate Cancer Detection

Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745

• Red color denotes types of biomarker

• Blue color denotes the biomarker-based decision making

• Green color indicates the exemplary actions or events▫ PSA=prostate-

specific antigen▫ DRE=digital rectal

examination▫ TRUS= transrectal

ultrasound▫ PD= biomarker,

pharmacodynamic biomarker.

Page 21: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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.

Page 22: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Biomarkers and Prostate Cancer Detection

Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745

• Black boxes denote conceptual breakthroughs

• Blue boxes denote biomarker advances

• Green boxes denote therapeutic and technological outlook. ▫ PAP= prostatic

acid phosphatase▫ PSA= prostate-

specific antigen▫ FDA= US Food

and Drug Administration

▫ CTC= circulating tumor cells

▫ NGS= next-generation sequencing

▫ miRNA= microRNA.

Page 23: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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.

Page 24: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Key Players in Biomarker IndustryWorldwide Trends 2014

Page 25: Biomarker Research Report Worldwide Trends 2014. 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 Webhttp://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Page 26: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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 Webhttp://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Page 27: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Key Players• Companies such as:

▫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 Webhttp://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

Page 28: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Other Key Players• 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

• 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 Webhttp://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Page 29: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Market GrowthWorldwide Trends2014

Page 30: Biomarker Research Report Worldwide Trends 2014. 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 Webhttp://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Page 31: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Other Factors Increasing Market Growth• Omics technology such as:

▫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 Webhttp://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Page 32: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

Future of BiomarkersWorldwide Trends2014

Page 33: Biomarker Research Report Worldwide Trends 2014. 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.

Page 34: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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 perspectivehttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745/

Page 35: Biomarker Research Report Worldwide Trends 2014. Worldwide Trends 2014.

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 perspectivehttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745


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