hERG screening Market report by 78398

hERG Screening Market Size Scope of the Study This report gives an insight into the hERG Screening market and its impact on drug development and discovery. The study provides global market analysis for hERG screening for sensitivity of potassium ion channel towards drugs. The study includes estimates and projections for the total global hERG screening market. Projections and estimates are also illustrated by geographic regions encompassing North America, Europe, Asia-Pacific, and Rest of World. Business profiles of 35 major companies are discussed in the report. The report serves as a guide to global hERG screening market, as it covers more than 180 companies that are engaged in hERG Screening R&D, discovery, testing and supply of products and services. Major Contract Research Organizations and Universities serving the market are also covered in the Corporate Directory section of this report. Information related to recent product releases, product developments, partnerships, collaborations, and mergers and acquisitions is also covered in the report. hERG Screening report is an ideal research tool providing strategic business intelligence to the corporate sector. This report may help strategists, investors, laboratories, pharmaceutical companies, contract research organizations, biotechnology companies and drug approval authorities in-

Gauging Competitive Intelligence

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Identifying Key Growth Areas and Opportunities

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Understanding Geographic Relevance to Product

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Knowing Regional Market Sizes and Growth Opportunities and Restraints

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Keeping Tab on Emerging Technologies

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Equity Analysis

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Tapping New Markets

Analytics and data presented in this report pertain to several parameters such as – 

Global And Regional Market Sizes, Market Shares, Market Trends

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Product (Global and Regional) Market Sizes, Market Shares, Market Trends

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Technology Trends

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Corporate Intelligence

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Key Companies By Sales, Brands, Products

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Consumer Behavioral Patterns

RITMIR013: hERG Screening – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Other Strategic Business Affecting Data

Research Methodology RI Technologies publishes business intelligence reports by going through a cycle of diligent research and analysis activity. Research is done using both online and offline resources. The study outline of this report is sketched on the following lines – global market analysis, regional market analysis, product segmentation, global and regional market analysis by product segment, market trends, M&A, R&D, competitive landscape, technology trends, and other key drivers. Current data helps in analyzing the future of the industry and is also helpful for doing market evaluations, and estimating the market size for the future.

This report is uniquely researched and the methodology includes: 

Need and Scope of Study

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Product Definitions

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Segmental Analysis

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Regional Analysis

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Exclusive Data Analytics

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Corporate Intelligence

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Feedback

Right from concept to final compilation of this report, both primary and secondary research methods are applied. We have provided exclusive feedback forms/pre-release questionnaires for this report to use the information for authentication of our own findings. Secondary research includes government publications, investment research reports, web based surveys, website information of both companies and markets, and other offline resources such as print publications and CDs. Our compilation of easy to navigate PDF reports are essential value addition resources for leading and growing companies.

RITMIR013: hERG Screening – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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II. REPORT SYNOPSIS This report gives an insight into the hERG Screening market and its impact on drug development and discovery. The study provides global market analysis for hERG screening for sensitivity of potassium ion channel towards drugs. The study includes estimates and projections for the total global hERG screening market. Projections and estimates are also illustrated by geographic regions encompassing North America, Europe, Asia-Pacific, and Rest of World. Business profiles of 37 major companies are discussed in the report. The report serves as a guide to global hERG screening market, covering more than 100 companies that are engaged in hERG Screening R&D, discovery, testing and supply of products and services. Major Contract Research Organizations and Universities serving the market are also covered in the Corporate Directory section of this report. Patents information too is provided. Information related to recent product releases, product developments, partnerships, collaborations, and mergers and acquisitions is also covered in the report.

hERG Screening Human Ether-a-go-go Related Gene (hERG gene) (KCNH2) is an encoder of the potassium ion channel that depolarizes IKr current in the heart. It consists of 6 transmembrane domains which are serially numbered from S1-S6. The abnormalities resulting in this channel can either lead to Long QT syndrome (LQT2) or Short QT syndrome causing loss of function mutations and gain of function mutations respectively. Both of these are considered as potentially fatal cardiac arrhythmia caused due to depolarization disturbances of the cardiac action potential. This channel remains sensitive to drug binding and reduction in extracellular potassium levels. These are believed to result in a decrease in channel function or otherwise termed as acquired long QT syndrome. The drugs that are considered to possess the potential of causing QT prolongation include typical antiarrhythmic varieties like Class 1A and Class III, certain varieties of antibiotics like quinolones and macrolides and few anti-psychotic agents. Scientific advancements are now greatly aiding in knowing ion channel structure-function relationships and understanding disease-causing mutations in ion channel genes. The importance of ion channel proteins in health and disease has opened up markets for ion channel targets and has great research potential in the multi-billion dollar drug discovery industry. Ion channel screenings are increasingly focusing on throughput and enhancing information content of assays through electrophysiological approaches. Studies of ion channels through voltage clamps and time, voltage and state dependent drug interactions with enhanced throughput will eventually go ahead to play a crucial role in the development of innovative and safe ion channel targeted drugs. Ion channels require efficient high resolution techniques for screening efforts and research targeting. The patch clamp technique is the conventional standard which is a high resolution but low efficiency technique. The Patch Clamp Technique discovered by Professors Bert Sakmann and Erwin Neher in 1970s is designed for analyzing ion channel function. The technique allows measuring of the single channel currents including the overall current in the whole cell membrane directly.

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The patch clamp technique is highly effective in application with molecular biological techniques. The patch clamp allows expressing the specific ion channels in cultured cell lines facilitating effective characterization of their biophysical as well as pharmacological properties. Sophion Bioscience developed an automated ion channel screening technology system, the QPatch 16 and QPatch HT, compatible Patch Clamp Technique for high throughput screening of numerous data points each day. For in-vitro screening of drugs two different cell lines are mostly used for hERG Screening - HEK 293 and CHO `s. Introduction of a new drug in the market is not only expensive but also an extremely complicated process. The process of drug discovery is fraught with several risks. The number of new drug launches each year has remained relatively constant over the past few years; whereas, the cost of pharmaceutical research and development has sky-rocketed. This reveals that the success rate of a drug candidate overcoming the several hurdles is at best 1 in 10. Advanced technologies, superior R&D facilities have not greatly contributed to the success rates of lead compounds in drug discovery. Also, the concerning factor is that most drug candidates in development on which large investments have already been made have little probability of returning. ADMET (absorption, distribution, metabolism, excretion and toxicology) profiles of drug candidates are the stumbling blocks. Along with the FDA, all countries have stringent rules for drug introductions. In this wake, the regulatory authorities are paying great emphasis on testing of all new drugs on hERG channels for side effects. Consequently, a lot number of whole cell recordings are performed on these grounds. hERG Screening has attracted great attention due to its role in cardiac arrhythmia and the LQT-syndrome. The hERG (human ether-à-go-go-related gene) potassium channel has evoked great scientific interest in recent years due to its kinetics and its affiliation with arrhythmia and sudden death. The blocking of hERG finds place in both antiarrhythmic pharmacotherapy and the pathogenesis of familial and acquired long QT syndrome (LQTS). Also, Short QT syndrome (SQTS), muscular atrophy and many forms of cancer have been associated with hERG as a target. There are molecular models of hERG channel blockers and pharmacophores that reveal methods to design hERG liability out of potential drug molecules. Research on synthesis of preclinical data on hERG with other criteria to determine net arrhythmogenic risk will mould future developments. Moreover, the molecular actions of hERG and its genetics are to be studied in detail to allow for clinical risk reductions.

RITMIR013: hERG Screening – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Global Market Analysis Global hERG Screening market is projected to reach about US$XX.XX billion by 2020 from an estimated US$ XX.XX billion in 2012, growing at a high compounded annual growth rate (CAGR) of XX.XX % during the analysis period 2005-2020. Exhibit 1. hERG Screening – Global Market Estimations & Predictions (2005 – 2020) in US$ Million Year

Value

2005

XX.XX

2006

XX.XX

2007

XX.XX

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2009

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CAGR %

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US$ Million

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

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III. MARKET DYNAMICS

Market Overview hERG Screening has its major role in the pharmaceutical field in drug release process. Some drugs may prolong the QT interval in normal and healthy individuals and result in QT Syndrome. This side effect has promoted majority of pharmaceutical companies to screen compounds for hERG channel activity in early stages of drug discovery and development process. Many companies are developing cell lines such as HEK 293, and CHO to aid in vitro screening for hERG channel activity.

Global Market Analysis Global market for hERG Screening is projected to reach about US$ XX.XX billion by 2020 from an estimated US$ XX.XX billion in 2012, growing at a Compounded Annual Growth Rate (CAGR) of XX.XX % during the analysis period, 2005-2020. Global hERG Screening market for 2012 is estimated at US$ XX.XX billion. North America is estimated as the largest market for hERG Screening in 2012 with a share of XX.XX % valued at US$ XX.XX million and is projected to reach US$ XX.XX billion by 2020 to retain its position with a share of XX.XX %. Europe is projected to be the second largest (XX.XX % market share in 2020) and second fastest growing (XX.XX % during 2005-2020) market during the same analysis period, while Asia-Pacific is projected to be the fastest growing (XX.XX % during 2005-2020) market.

RITMIR013: hERG Screening â&#x20AC;&#x201C; A Market Insight Report, July 2013 ÂŠ RI Technologies - www.researchimpact.com

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Exhibit 2. hERG Screening– Global Market Estimations & Predictions (2005-2020) in US$ Million by Geographic Region for North America, Europe, Asia-Pacific, and Rest of World Year/Region

North America

Europe

Asia-Pacific

Rest of World

Total

2005

XX.XX

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US$ Million

2005

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2011 Europe

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Asia-Pacific

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Rest of World

The pharmaceutical industry sees the screening of test compounds and the examination of genetically created ion channel mutants as the most important domains of automated patch clamp devices. Highthroughput automation may even lead to testing changes in the numbers and functions of ion channels after stress or in animal models of human diseases such as epilepsy, high blood pressure, or arrhythmia.

RITMIR013: hERG Screening – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Since ion channels gate the movement of charged particles and mediate the flow of electrical currents over the cell membrane, they determine how cells exchange information in all tissues. Also, they are easily accessible for drugs as they are membrane proteins and can connect the outer world of the cell with both the inner realm and the lipid membranes. However, ion channels can also be adversely affected by drugs which have been designed for totally unrelated targets. If the hERG channel is fully or partially blocked, potassium ions cannot be released from the cell, which is then unable to relax resulting in malfunction in cardiac excitability, clinically ex-pressed as either cardiac arrhythmia (torsades des pointes) or long QT syndrome, a ventricular fibrillation. Long QT syndrome can be induced by a wide range of drugs that unintentionally block ion channels; and hence, several drugs have been withdrawn from the market since 1997, including Seldane, an antihistamine; sertindole, an antipsychotic; cisapride, a gastric prokinetic; and even the antibiotic grepafloxacin. Such side effects have laid the ground for the International Conference on Harmonization’s guidelines for nonclinical toxicology and pharmacology testing and clinical trials, which were adopted in June 2004. Regulatory organizations such as FDA and the European Medicines Agency require drug testing of known ion channels, especially hERG, to rule out possible side effects before clinical trials are performed. Exhibit 3.hERG Screening Antibodies and Cell Lines - Estimated Market Shares By Company for 2010 Company

Market Share (%)

Sigma-Aldrich Corporation

Aurora Biomed, Inc.

Santa Cruz Biotechnology, Inc.

Abnova Corporation

AVIVA Biosciences Corporation

Lifespan Biosciences, Inc.

Novus Biologicals, Inc.

CreaCell

Other Companies

Total

100%

RITMIR013: hERG Screening – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com

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Exhibit 4. Patch Clamp Technology - Estimated Market Value by Company in US$ Million for 2010 Company

Market

Sophion Bioscience A/S

Molecular Devices, Inc.

Cytocentrics AG

flyion GmbH

Fluxion Biosciences, Inc.

Nanion Technologies GmbH

Cellectricon AB

Other

Total

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IV. PRODUCT/TECHNOLOGY RESEARCH Even though there are potential targets for adverse effects of the cardiac organs the major types of drugs associated with acquired QT prolongation is believed to interact effectively with hERG potassium channel. The main cause of this phenomenon is the presence of larger inner vestibule of the hERG channel which is responsible for providing more space for different drug classes to bind and block the potassium channel. The potential hazard owing to the use of these QT drugs has prompted the regulatory authorities to issue directions for ensuring cardiac safety during preclinical drug development phases. The researchers involved in the research involving hERG believe that the preclinical studies of hERG should be carried out in a GLP environment. The hERG gene found in human beings is believed to be homologous to that of the Ether-a-go-go gene found in the Drosophila fly. It was observed that when these Drosophila flies with mutations in their gene are given anesthesia with ether, their legs start trembling and dancing in an intoxicated condition. This was named Ether-a-go-go by William D. Kaplan in the 1960s. Exhibit 5. Diseases Involving Ion Channel Function S. No

Disease

S. No

Disease

Dry Mouth Syndrome

Osteoporosis (CIC7)

Cystic Fibrosis (CFTR)

Epilepsy (CHRNA4 ,KCNQ)

Long QT (KCNQ)

Tinnitus

Hypertension

Kidney Stones (CIC5)

Diarrhea

Myotonia (CIC/1)

Cancer

Deafness (KCNQ4)

Incontinence

Migraine (CACN1A)

Multiple Sclerosis

Dry Mouth Syndrome

Exhibit 6. Companies Developing Cell lines for hERG Screening Company

Region

Web Site

Profile

AVIVA Biosciences Corporation

USA

www.avivabio.com

Electrophysiology research, ion channel drug screening and rare-cell isolation

Aurora Biomed,Inc

Canada

www.aurorabiomed.com

hERG Assays, SA Channel Assay, CA Channel assay, NaK-ATPase Assay, ion channel cell line licensing. cardiac safety screening, in vivo QT prolongation studies,

Invitrogen Corporation

USA

www.invitrogen.com

hERG ion channel cell lines for cardiac safety screening

Millipore Corporation

USA

www.millipore.com

hERG selectivity profiling, hERG-HEK293 & hERG-CHO K1 Recombinant Cell Lines

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Company

Region

Web Site

Profile

CreaCell

France

www.creacell.com

HEK293 hERG Recombinant Cell Line, CHO hERG Recombinant Cell Line

Wisconsin Alumni Research Foundation (WARF)

USA

www.warf.ws

hERG CDNA with Native PolyA Tail ,hERG-1 Transfected HEK 293 Cell Line

HERG SCREENING -THE MARKET OUT LOOK What is currently the need of the hour is a true pharmacological approach to define the issue. Cardiovascular dysfunction has to be properly understood and also the key to being able to address this issue is important for cardiovascular liability. As per FDA’s new recommendations, a growing number of whole-cell recordings will be performed on hERG, and special assays are already in the market. This development is an important breakthrough for automated high-throughput patch clamp devices. Currently, about 10 companies offer such tools (mostly in Europe; only two are in the United States). The new rules also open markets for providers of screening services, who offer safety tests on ion channels. This would eventually lead to new orders for the manufacturers. Multichannel devices pose the strongest competition which register 15 or more target channels. On the other hand, single-channel devices are mainly used for routine tests on specific ion channels……………………………………………………………………….

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

Identifying Key Growth Areas and Opportunities



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

Knowing Regional Market Sizes and Growth Opportunities and Restraints

Sample Page - 11



Keeping Tab on Emerging Technologies



Equity Analysis



Tapping New Markets

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