Biomarkers are measurable and quantifiable biological indicators that can be used to diagnose or predict disease, monitor disease progression, indicate what treatment options may be most effective in an individual patient’s case and predict treatment response. They play a role both in new drug R&D and in predicting the outcome of treatment in the medical setting. They are important tools for understanding disease mechanism, developing more effective treatments and improving the quality of patient care.
The report examines the role of CNS biomarkers in early discovery, in drug development and for future diagnostics. The global CNS biomarker market is discussed, and forecasts are made for this segment of the industry for the five-year period from 2012 to 2017. The technological segments of the market (genomics, proteomics and molecular diagnostics) are discussed by application, technology and geographic region. Individual disease segments are also discussed and describe gaps in treatment and limitations of current methods of diagnosis. The process of developing biomarkers from discovery to commercialization is described along with the forces in the industry that play an integral role, such as payers, providers and suppliers. Growth drivers and inhibitors that can affect CNS biomarker development and adoption are also discussed.
STUDY GOALS AND OBJECTIVES
- Assess the various technologies used for CNS biomarker discovery and future diagnostics.
- Understand the process of CNS biomarker development from discovery to commercialization and the path towards adoption.
- Examine the regulatory landscape and government’s role.
- Examine the future advances that need to be made in the diagnosis and treatment of various CNS disorders.
- Determine current and future CNS biomarker markets.
REASONS FOR DOING THE STUDY
For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.
The CNS biomarker market presents an increasingly significant part of the overall pharmaceutical product market worldwide. The study investigates the specific classes of biomarkers involved in CNS disease and the current and potential future pharmaceutical products associated with them. Existing drug products and potential drugs in the pipelines of the major pharmaceutical players in this market are reviewed.
CNS disorders exist in all countries worldwide. Growing health concerns in developing countries are expected to continue to contribute substantially to market growth through the forecast period (2012 to 2017). The report analyzes existing research, emerging markets and biomarker technology categories. Continued growth is expected in emerging geographies, driven by the increase in health awareness of the growing middle class in emerging countries such as the BRIC countries: Brazil, Russia, India, China.
The report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and products, strategies for accessing emerging markets, specific disease prevalence and geographies in order to allocate resources and make effective decisions.
SCOPE OF REPORT
Current and projected product forecasts during the forecast period of 2012 to 2017 are discussed. New product launches will be discussed. Revenue figures for 2011 are actual figures. Revenue figures for 2012 are actual figures except where actual results have not been reported, due to the timing of the release of the report.
The report includes an analysis of leading and emerging CNS biomarkers and related drugs for each CNS disorder. Profiles of producers of leading products and their specific products are provided. The report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products will alter the quality of life of patients receiving CNS biomarker diagnostics and treatment with associated drugs.
Market figures are based on revenues at the manufacturers’ level and are projected at a 2012-dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, for new product introductions, expanded markets for existing products and other factors affecting the market.
Included in this report are forecasts by product, product category and by company from 2012 through 2017. The study is arranged to offer an overview of existing biomarker technology, drug markets for CNS diseases, drug and disease mechanism of action and companies, with forecasts broken down and covered by geographic region or country.
Patent and clinical trial information is reviewed for various candidate biomarkers. The status of approval by the FDA and regulatory agencies in other countries of biomarker diagnostics in each segment is reviewed.
Figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.
All market share data presented is on a global basis, unless specifically noted.
The report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants and anyone interested in the biomarker and CNS drug markets, its products, its industry participants and its future.
The importance of identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities and insights that provide guidance for sales growth or defensive moves cannot be overstated for a variety of constituents, including:
Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development and R&D.
Emerging players in the segment must understand specific opportunities for out-licensing originating from the elements of differentiation of their product or technology as compared to leading, competitive and emerging products. In addition, market forecasts can support investment, provided thorough and detailed substantiation is provided for the market forecast, as is found in this study.
Investment firms evaluating candidates for venture capital or hedged investments will gain insights as to the opportunity and risks that are being encountered in the industry, in a product and company specific analysis.
Equity analysts are provided detailed forecasts for the next five years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.
METHODOLOGY AND INFORMATION SOURCES
In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts and leading individuals in the field.
The CNS biomarker and drug markets comprise drug products for treatment of a number of specific diseases afflicting both men and women. For completeness, the current and forecasted markets comprise the total market opportunity for each respective segment.
Information to prepare this report was obtained from participating and emerging companies in the biomarker and CNS drug areas and from the following institutes within the National Institutes of Health (NIH): National Institute of Mental Health (NIMH), the National Institute of Aging (NIA), the National Institute of Neurological Diseases and Stroke (NINDS), National Human Genomic Research Institute (NHGRI), the NIH’s Center of Information Technology (CIT) and the National Library of Medicine (NLM).
Additional information was obtained from a variety of medical and technical journals on the various specialties within biomarker and CNS applications. Other sources included the New York Times, Wall Street Journal, Washington Post, other newspapers, company documents and Internet websites. Population estimates are based on those reported by the International Data Base of the U.S. Census Bureau. Statistical data was obtained from the World Health Organization (WHO) and the Collaborating Centre for Drug Statistics Methodology (Norway).
Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.
Jackson Highsmith is a life sciences research consultant with more than 16 years of research experience. Jackson has been consulting with specialty pharmaceuticals and large pharmaceutical industry players since 2007. Prior to that, he worked at a large research and consulting firm where he focused on in-depth research; he also has worked at a large pharmaceutical company involved a wide range of medical therapeutics in early- and mid-stage drug development.
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The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal or accounting advice, nor should it serve as a corporate policy guide, laboratory manual or an endorsement of any product, as much of the information is of a speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or from its use.
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