Metabolomics. A GlobalMarketOverview. TechnologiesandApplications. ReportCode:BT004 Pages:508 Charts:306 Price:Sample

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1 I I Biotechnology Metabolomics TechnologiesandApplications A GlobalMarketOverview Thereportreviews,analyzesandprojects theglobalmarketformetabolomictechnologies andapplicationsfortheperiod Published:Nov2014 ReportCode:BT004 Pages:508 Charts:306 Price:Sample 2014IndustryExperts,alrightsreserved industry-experts.com

2 Product Outline What is Metabolomics? Metabolomics, a relatively new entrant into the -omics arena and in several ways related to genomics and proteomics, is concerned with the rapid and high-throughput characterization of the small molecule metabolites found in an organism. Metabolomics provides the exceptional prospect of looking into genotypephenotype as well as genotype-envirotype relationships due to the fact that the metabolome is closely linked to the genotype of an organism, its physiology and its environment. The utilization of metabolomics has been growing in a range of health applications, such as pharmacology, pre-clinical drug trials, toxicology, transplant monitoring, newborn screening and clinical chemistry. Despite these advances, the field of metabolomics has been limited by the fact of inadequacy in the characterization of the human metabolome. Metabolomics enables in the detection and quantification of metabolites or low molecular weight molecules, which are constituents of the metabolome and are produced by active and living cells under different conditions and times in their life cycles. Due to its capability of observing mixtures of small molecules in living cells or in cell extracts, nuclear magnetic resonance (NMR) is critical to the concept of metabolomics. Though the words metabolomics and metabonomics are very often used synonymously, there has been an endeavour to specify the meaning of each. Metabolomics is associated with cataloguing and quantifying the multitude small molecules that are present in biological fluids under different conditions. In contrast, metabonomics involves scrutinizing alterations in the metabolic profile of a complex biological system as a consequence of stresses, such as disease, changes in diet or exposure to toxins. A Brief History of Metabolomics The notion of biological fluids reflecting the health of an individual has been in existence for times immemorial. Doctors in ancient China made use of ants for evaluating patients urine and ascertaining the presence of high glucose content in order to confirm diabetes. The middle ages witnessed the use of urine charts for associating the colors, tastes and smells of urine to a range of medical conditions that were of metabolic origin. In the late 1940s, Roger Williams was instrumental in introducing the idea of individuals possessing a metabolic profile capable of being reflected in the composition of their biological fluids. He made use of paper chromatography in proposing that typical metabolic patterns in urine and saliva had an association with diseases, such as schizophrenia. However, technological advancements witnessed in the 1960s and 1970s were of immense help in the quantitative, as against the qualitative, measurement of metabolic profiles. Metabolic profiles was a term coined by Horning in 1971 after establishing that gas chromatography-mass spectrometry (GC-MS) could be utilized for measuring compounds present in human urine and tissue extracts. During the 1970s, groups of researchers were engaged in developing GC-MS techniques for monitoring the metabolites present in urine. During the same time, NMR spectroscopy, developed in the 1940s, was also going through rapid technological advancements. By the 1980s, this technique gained enough sensitivity for the identification of metabolites in unmodified biological samples. -3-

3 APPLICATION ANALYSIS OF METABOLOMICS Major application areas of Metabolomics include biomarker discovery, drug discovery, nutrigenomics, toxicology testing and other applications. The report aslso analyzes the key therapeutic areas of Metabolomics. Biomarker discovery is projected to be the largest and the fastest growing market for Metabolomics interms of application areas with market worth US$xxx.x million in 2014 and projected to touch US$xxx million by The CAGR for the period is expected to record at xx.x%. Chart 3: Trending of Market for Applications of Metabolomics (2014 & 2020) in USD Million Biomarker Discovery Application Area %CAGR Biomarker Discovery xxxxxxx xxxxxxx xxxxxx Drug Discovery xxxxxxx xxxxxxx xxxxxx Nutrigenomics xxxxxxx xxxxxxx xxxxxx Toxicology Testing xxxxxxx xxxxxxx xxxxxx Other Applications xxxxxxx xxxxxxx xxxxxx Total xxxxxxx xxxxxxx xxxxxx Biomarker Discovery Drug Discovery Nutrigenomics Toxicology Testing Other Applications The use of metabolomics in identifying biomarkers for disease diagnosis, prognosis and risk detection has been growing at a rapid pace. Biomarkers can be defined as objectively measurable biological characteristics that can be used to diagnose, monitor or predict the risk of disease. Some examples of biomarkers include BRCA1 mutations ass genetic markers for breast cancer risk, blood glucose as a standard chemical biomarker for diabetes monitoring, serum creatinine as a chemical marker for kidney function and prostate specific antigen (PSA) as a protein biomarker for prostate cancer. The emergence of -omics technologies, such as proteomics, transcriptomics and metabolomics has offered the potential of measuring, as well as using multiple biomarkers simultaneously for predicting or diagnosing disease. Physicians have been known to commonly use multiple physiological biomarkers for improving the sensitivity and specificity of clinical diagnosis. One illustration of this is assessing the risk of cardiac disease by studying an individual s age, body mass index (BMI), triglyceride level and cholesterol level. -15-

4 KEY MARKET TRENDS Plasma Metabolites as Biomarkers in Predicting Alzheimer s Disease Notwithstanding the research efforts being undertaken across the world for better understanding it, the diagnosis of Alzheimer s disease (AD) has still remained quite complex. Some approaches have required researchers to target the brain itself for investigating the chemistry around the formation of the amyloid proteins and their precursors in a bid to garner any diagnostic clues. Yet other approaches, primarily from researchers in China, have taken the recourse of metabolomics for finding out whether the lowmolecular-mass metabolites in the body could be of assistance in signaling the onset of AD. Though conceding that the application of metabolomics in AD is not a new concept, this group has emphasized that previous studies have either involved a limited number of patients or targeted a relatively small number of metabolites. These approaches have been modified to measure as many metabolites as possible in an attempt to find the most appropriate ones that get altered due to this crippling degenerative disease. In addition to AD, the researchers have also directed focus on amnestic mild cognitive impairment (amci) that can eventually lead to full-blown Alzheimer's. amci affects about 5%-20% of the older population, with typical symptoms being minor problems in day-today memory, planning, language and impaired attention span. The research has shed light on two distinct groups of metabolites found in human plasma, which offer the possibility of distinguishing between patients with Alzheimer s disease or amci and healthy individuals that could be of potential use in the early diagnosis of both conditions. The study has collected plasma from 57 people with Alzheimer's disease, 58 with amci and 57 healthy volunteers of average ages 74, 72 and 72 years, respectively. The complementary techniques of GC- MS and LC-MS were used for studying the metabolites, with both being conducted in time-of-flight instruments that can simultaneously record data from several compounds. The GC-MS technique has uncovered 545 chromatographic peaks, from which 85 have been identified from their retention times and mass spectra. The LC-MS technique has found 12,705 peaks, leading to the identification of 238 metabolites. Following statistical analysis, it was shown that 31 and 40 metabolites had altered abundances in Alzheimer's and amci patients, respectively. These comprised saturated and unsaturated fatty acids that were less in abundance and amino acids, some with reduced and some with increased abundance. Further whittling down of these compounds has been done by using ROC analysis and logistic regression to obtain a more manageable number for creating a panel of biomarkers for each condition. This has resulted in selecting arachidonic acid, N,Ndimethylglycine, thymine, glutamine, glutamic acid and cytidine for AD and arachidonic acid, N,Ndimethylglycine, thymine, 2-aminoadipic acid and 5,8-tetradecadienoic acid for amci. -31-

5 KEY GLOBAL PLAYERS AGILENT TECHNOLOGIES (UNITED STATES) 5301 Stevens Creek Blvd, Santa Clara, CA United States Phone: , Fax: Website: Key People William P. (Bill) Sullivan - President and Chief Executive Officer, Agilent Didier Hirsch - Senior Vice President, Agilent Chief Financial Officer Ronald S. Nersesian - Executive Vice President, Agilent President and Chief Executive Officer, Keysight Technologies Mark Doak - Senior Vice President, Agilent President, Agilent CrossLab Group Lon Justice - Vice President and General Manager, Agilent Chemical Analysis Group Sales, Marketing and Operations Mike McMullen - Senior Vice President, Agilent President, Chemical Analysis Group John Pouk - Vice President and General Manager, Agilent Life Sciences Sales Shiela Barr Robertson - Senior Vice President, Agilent Corporate Development and Strategy Darlene J. S. Solomon - Chief Technology Officer Life Sciences and Diagnostics Labs Fred Strohmeier - Senior Vice President, Agilent President, Life Sciences and Diagnostics Group Key Financial Data ($ in Millions) Business Overview Year 2014 (Nine Months Ended) Total Revenue 5,176 6,782 6,858 6,615 Income before taxes ,043 1,032 Income before taxes % 10.8 % 12.7% 15.2% 15.6% Net Income ,153 1,012 Incorporated in 1999 with headquarters in Santa Clara, CA, Agilent Technologies provides core bio-analytical and electronic measurement solutions for the life sciences, diagnostics and genomics, chemical analysis, communications and electronics industries. In September 2013, Agilent separated into two publicly traded companies, one comprising the life sciences, diagnostics and chemical analysis businesses, which will retain the Agilent name; and the other comprising the electronic measurement business ("EM"). The Life sciences and diagnostics business provides application-focused solutions such as reagents, instruments, software, consumables, and services that enable customers in identifying, quantifying and analyzing physical and biological properties of substances and products. Agilent key products include: liquid chromatography mass spectrometry ("LCMS") systems; liquid chromatography ("LC") systems, columns and components; laboratory automation and robotic systems; laboratory software and informatics systems; dissolution testing; nucleic acid solutions; Nuclear Magnetic Resonance ("NMR"), Magnetic Resonance Imaging ("MRI"), and X-Ray Diffraction ( XRD ) systems; services and support for the aforesaid products; -53-

6 Market Overview by Metabolomics Analytical Technique Cornering an estimated 2014 share of xx.x% or US$xxx.x million, Separation Techniques dominate the analytical techniques used in Metabolomics, the market for which is also expected to record the fastest CAGR of xx.x% in reaching a projected US$xx.x billion by 2020 from a forecast US$ xx.x million in The global market for Detection Techniques for Metabolomics is likely to sustain a marginally slower CAGR of xx.x % over the similar period and reach a projected US$ xx.x billion by 2020 from an estimated US$ xx.x million in 2014 and a forecast US$ xx.x million in Chart 6: Global Metabolomics Market Analysis ( ) by Analytical Technique Separation Techniques and Detection Techniques in USD Million Year Separation Techniques Detection Techniques Total 2010 xxxxxxx xxxxxxx xxxxxxx 2011 xxxxxxx xxxxxxx xxxxxxx 2012 xxxxxxx xxxxxxx xxxxxxx 2013 xxxxxxx xxxxxxx xxxxxxx 2014 xxxxxxx xxxxxxx xxxxxxx 2015 xxxxxxx xxxxxxx xxxxxxx 2016 xxxxxxx xxxxxxx xxxxxxx 2017 xxxxxxx xxxxxxx xxxxxxx 2018 xxxxxxx xxxxxxx xxxxxxx 2019 xxxxxxx xxxxxxx xxxxxxx 2020 xxxxxxx xxxxxxx xxxxxxx % CAGR ( ) xxxxxxx xxxxxxx xxxxxxx Separation Techniques Detection Techniques -132-

7 Neurology Neurology is likely to emerge as the slowest growing indication area for Metabolomics globally, with the prospect to sustaining a compounded annual rate of xx.x% between 2014 and 2020 to reach a projected US$xxxx million by 2020 from an estimated US$xxx million in 2014 and a forecast US$xxxx million in Europe, estimated to account for a share of xxx% in 2014 translating into US$xxx million, forms the largest global market for Metabolomics in Neurology. Forecast to be US$xxx million in 2015, the European market for Metabolomics in Neurology is further likely to reach US$xxxx million by 2020 at a CAGR of xxx%. Fastest growth in the market for Metabolomics in Neurology is expected to be recorded by Asia-Pacific, compounding at an annual rate of xxx% over in reaching a projected US$xxxx million by 2020 from an estimated US$xxx million in 2014 and a forecast US$xxx million in In contrast, North America s market for Metabolomics in Neurology is slated to sustain the slowest similar period CAGR of xx.x% and reach a projected US$xxx million by 2020 from an estimated US$xxx million in 2014 and a forecast US$xxx million in Chart 42: Global Market for Metabolomics in Neurology ( ) by Geographic Region North America, Europe, Asia-Pacific and Rest of World in USD Million Year North America Europe Asia-Pacific Rest of World Total 2010 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2011 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2012 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2013 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2014 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2015 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2016 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2017 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2018 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2019 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx 2020 xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx % CAGR ( ) xxxxxx xxxxxx xxxxxx xxxxxx xxxxxxx North America Europe Asia-Pacific Rest of World -168-

8 Market Overview by Geographic Region The United States, accounting for an estimates share of xxx% equating to US$xxxx million in 2014, is the leading of the two North American markets for Metabolomics. Forecast to be US$xxx million in 2015, the region s Metabolomics market is further projected to reach US$xxx million by 2020 at a CAGR of xxx% between 2014 and The Canadian market for Metabolomics is likely to maintain a slower CAGR of xxx% in reaching a projected US$xxx million by 2020 from an estimated US$xxxx million in 2014 and a forecast US$xxx million in Chart 52: North American Metabolomics Market Analysis ( ) by Geographic Region United States and Canada in USD Million Year United states Canada Total 2010 xxxxxx xxxxx xxxxxxx 2011 xxxxxx xxxxx xxxxxxx 2012 xxxxxx xxxxx xxxxxxx 2013 xxxxxx xxxxx xxxxxxx 2014 xxxxxx xxxxx xxxxxxx 2015 xxxxxx xxxxx xxxxxxx 2016 xxxxxx xxxxx xxxxxxx 2017 xxxxxx xxxxx xxxxxxx 2018 xxxxxx xxxxx xxxxxxx 2019 xxxxxx xxxxx xxxxxxx 2020 xxxxxx xxxxx xxxxxxx % CAGR ( ) xxxxxx xxxxx xxxxxxx United states Canada -178-

9 Market Overview by Metabolomics Application Area By application area, the European market for Metabolomics is dominated by Biomarker Discovery in terms of both size and fastest growth. Estimated at US$xxx million in 2014 (xxx % share) and forecast to be US$ xxx million in 2015, the region s market for Metabolomics in Biomarker Discovery is further likely to register a CAGR of about xxx % between 2014 and 2020 to reach a projected US$ xxx million by On the other hand, the European market for Metabolomics in Toxicology Testing is anticipated to register the slowest CAGR of xxx %, thereby reaching a projected US$ xxx million in 2020 from an estimated US$ xxx million in 2014 and a forecast US$ xxx million in Chart 139: European Metabolomics Market Analysis ( ) by Application Area Biomarker Discovery, Drug Discovery, Nutrigenomics, Toxicology Testing and Other Applications in USD Million Year Biomarker Discovery Drug Discovery Nutrigenomics Toxicology Testing Other Applications Total 2010 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2011 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2012 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2013 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2014 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2015 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2016 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2017 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2018 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2019 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx 2020 xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx % CAGR ( ) xxxxxx xxxxxx xxxxxx xxxxxx xxxxx xxxxxxx Biomarker Discovery Drug Discovery Nutrigenomics Toxicology Testing Other Applications -310-