REPORT SCOPE
INTRODUCTION
OBJECTIVES AND GOAL OF THE STUDY
This study provides the reader with a detailed analysis of the current application and consumption and future growth potential of immunoagents, gene probes, and molecular diagnostics. This study also analyzes the recent technological developments, future industry trends, and emerging business opportunities. Such information will facilitate the investment decisions and strategic planning for business managers.
Immunoassays are used to determine antibody or antigen levels in a variety of disease situations. Gene probes explore the DNA makeup of microorganisms causing infection and of the gene structure of cellular mutations involved in cancer diabetes, coronary disease, etc. Molecular diagnostics is an emerging science that studies cellular biomarkers that are related to gene expression and that also develops assays to serve as companion diagnostic tests to allow physicians to better structure treatment of diseases.
Major objectives of this study are to:
- Assess the technology developments and how they will impact this industry.
- Identify the driving forces for demand.
- Make available the most current and reliable information on consumption of probes and related biomolecules in enzyme immunoassays.
- Estimate a global supply and demand scenario broken down by applications and regions.
- Project the growth rate in demand.
- Estimate the projected demand and supply by applications and regions through 2016.
- Profile major companies involved in this business and their market shares.
REASONS FOR DOING THE STUDY
The segment of the diagnostic industry using immunoassays, gene probes, and molecular diagnostics has developed rapidly as scientific understanding of these systems has advanced in the past decade. This industry is undergoing rapid changes driven by the ongoing progress in biotechnology and medicine. This area is now experiencing major research and development (R&D) initiatives, which are leading to the development of new products, and to improvements in the sensitivities and performance of existing immunoassay products. This has direct impact on the demand, consumption, and future growth of the labeling and immunoagents, gene probes, and the developing market of molecular diagnostics.
This report provides a current and comprehensive global report on the scientific fields that make up diagnostic tests. This study provides a comprehensive analysis of the underlying influences brought about by rapid developments in diagnostic products, changes in governmental regulations, and the evolving economies of countries such as China, India, the Pacific Rim, Australia, Brazil, Russia, and the Middle East.
This study also looks at major global players in this field and provides an insight into their performance; in addition, it anticipates involvement in future technological trends and potential investment opportunities in the field.
SCOPE OF STUDY
The Scope of this study is to outline the international supply and demand for compounds used in immunoassays and in probes, including gene probes, and related chemicals employed in diagnostic tests and in the detection of various antigens/analytes. This study excludes separation and purification applications, which use some of these technologies.
The industries studied in this report are:
- In vitro diagnostics
- Research and development laboratories
- Point-of-Care Testing
- Doctor’s office
- Private medical laboratories
- Hospitaal bedside
- Home
- Molecular diagnostic testing
- In vivo diagnostics
- Immunoassay testing
- Monoclonal antibody therapy
- Blood banks
- Food Safety testing
- Bioterrorism detection
The large number of biochemical/chemical materials covered in this report is mainly due to the diversity of the immunological tests involved.
The immunological biochemical products covered include:
- Proteins
- Antibodies and antigens
- Cellular components
- Nucleic acids DNA, RNA
- Cellular receptors
- Gene structures
- Mutated genes involved in diseases
TARGETED AUDIENCE
This study will be of great interest to those involved with the reagents industry, either as manufacturers and suppliers of reagents or as manufacturers of diagnostics/detection tests. It will also be of interest to end users of diagnostics/detection tests as well as to government and regulatory bodies involved in setting standards and tests that use the immunoassay, gene probe, and molecular diagnostic technologies. Research scientists interested in pursuing diagnostics and molecular detections using immunoassays and gene probes also will find this study of value.
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 is vital for a variety of readers:
- Established companies in the industry will benefit from the contents, for corporate strategizing, sales and marketing, business development, and research and development.
- Emerging companies in this medical diagnostic segment must understand specific opportunities for out-licensing that originate from the elements of differentiation of their product or technology as compared to leading, competitive, and emerging diagnostic tests. Market forecasts can support investment provided a thorough and detailed substantiation is provided for the market forecast.
- 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 with detailed forecasts for the next 5 years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run. The readers are likely to hold positions in strategic planning, new business development, marketing, product management, sales, including purchasing agents, regulatory officers or analysts/investment advisors. These decision-makers will be better able to plan production, to develop new products, and to find new customers. Planners and marketers will gain insight for company and product positioning. Purchasers will locate new and additional suppliers.
Managers from several related industries will also find valuable information in the report. Distributors, test formulators, traders, and even test laboratory professionals can benefit from a better understanding of the tag/linkage business and how it influences competition in their own industries.
METHODOLOGY
In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts, and leading researchers in the field. The overall immunology market is comprised of a variety of fast-growing and independent segments. For completeness, the current and forecasted markets are comprised of the total market opportunity for each respective segment. Within each subsection there is a detailed forecast for each driving mechanism or relevant area of growth.
Information to prepare this report was obtained from participating and emerging companies in the immunoagent, gene probe, and molecular diagnostics areas. Information was gained from scientific publications like Nature Biotech, Genetic and Engineering News, Journal of Experimental Medicine, European Journal of Immunology, Immunology, Clinical and Diagnostic Laboratory Immunology, Immunobiology, Nature Immunology, and others.
Other information was from the World Health Organization (WHO) and other government agencies, literature searches, annual reports, 10-Ks, and others. Population estimates are based on those reported by the international database of the U.S. Census Bureau.
Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.
Major factors impacting the immunoassay, gene probe, and molecular diagnostic supply and demand are discussed. Government regulations, technology developments, patents and international trade are addressed.
ANALYST CREDENTIALS
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 consultancy where he focused on in-depth research; he also has worked at a large pharmaceutical company in a wide range of medical therapeutics in early and mid-stage drug development.
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DISCLAIMER
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.