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Therapies and Biomarkers for Inflammatory Bowel Disease

  • January 2013
  • -
  • BCC Research
  • -
  • 115 pages

Summary

Table of Contents

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This BCC Research report, Therapies and Biomarkers for Inflammatory Bowel Disease, provides a detailed analysis of the products and technologies that define the market space and summarizes the composition and dynamics of individual companies in the competitive environment. The study also includes an overview of the relevant regulatory issues, patent landscapes and strategic partnerships that will play substantial roles in shaping the market in the future.

REASONS FOR DOING THE STUDY

Inflammatory bowel diseases (IBDs), notably Crohn’s disease (CD) and ulcerative colitis (UC), are estimated to affect more than four million people globally. The precise etiology of these diseases is under active investigation, but the clinical observation that many IBD patients respond to anti-inflammatory medications with concomitant U.S. Food and Drug Administration (FDA) approval for alternative indications (e.g., infliximab [Remicade], a chimeric IgG1k monoclonal antibody targeted against TNF-alpha) makes IBD a disease class with broad market appeal to the pharmaceutical and biotechnology industries. In addition, the clinical removal of biopsy samples from IBD patients is a routine part of the standard of care in many cases, and thus the widespread availability of tissue samples from the site of active disease makes IBD a disease class in which the potential for disease and therapeutic biomarker discovery has a practical basis. Clinical biomarkers, whether used to assess IBD disease severity or to inform treatment regimens, represent a significant market segment in IBD management.

Despite the existence of diagnostics and therapeutics for IBD, the pharmaceutical, medical and payor market sectors are keeping up the demand for the development of better technologies. With the upcoming patent expiry of the biologic drug Remicade, the most efficacious treatment for Crohn’s and UC, the recent approval of several other biologic therapies for IBD, along with a shift in the clinical setting to toward treating with biologic therapies earlier in the course of disease, the market for IBD therapeutics is in a state of heavy flux.

SCOPE OF REPORT

The study scope of this report includes commercialized products used in the diagnosis and treatment of IBD, as well as novel products and technologies that may be commercially viable by 2017. Important IBD disease mechanisms, technologies for biomarker discovery, industry structure, and key players and factors influencing demand for IBD therapeutics are discussed. Suppliers of IBD diagnostic and therapeutic products are discussed, with the market for IBD therapeutics analyzed based on product types and regions. In addition to an in-depth analysis of the intellectual property landscape for major industry players, this report highlights recent industrial shifts (e.g., strategic alliances, mergers and acquisitions, major venture capital deals) in the IBD diagnostic and therapeutic space. Forecasted market growth from 2012 through 2017 is presented.

In addition to examining larger and more-established producers in IBD diagnostic and therapeutic product market segments, BCC Research profiled numerous smaller specialized market players in this report. Market segmentation within the areas of therapeutic class and geographical areas are highlighted. Each technology is analyzed by application type and in the context of relevant technological and regulatory forces to determine its current market status and forecasted growth through 2017.

Recent industrial alliances and acquisitions affecting producer market penetration and dominance are also discussed.

Topics that are specifically excludedfrom this study, as they are considered beyond the scope of this report, include a detailed market analysis for IBD diagnostic procedures (e.g., colonoscopy, endoscopy, radiology) and IBD classes with lower incidence and prevalence rates (e.g., ischemic, diversionary, Bechet’s). A detailed market analysis for products used for the palliative care of IBD and non-laboratory diagnostics for IBD detection were also excluded from this study.

INTENDED AUDIENCE

This report will be of general interest to business professionals in the pharmaceutical, biotechnology and investment fields. Both producers and consumers of IBD diagnostics and therapeutics will benefit from the comprehensive summary of relevant technologies and industrial profiles contained within this study.
Consultants, strategic and market analysts, and investors working within the pharmaceutical, clinical and biotechnology industries will also find this report particularly useful. In addition, business development professionals, as well as those in sales, marketing, information sciences and competitive intelligence fields of biotechnology, will benefit from the information contained in this report.

METHODOLOGY AND INFORMATION SOURCES

The market assessments presented in this report were derived from publicly available information up to and including September 2012 in conjunction with primary source interviews. Using 2010 as the base year, forecast data are provided through 2017. In cases where data for 2012 were incomplete or not readily available, figures were extrapolated from 2011 statistics, half-year figures for 2012 and historical trends between 2010 and 2012. Market figures are based on current U.S. dollars with no adjustments for inflation made in the projections.

The information contained in this report has been assembled from both primary and secondary data sources. Primary research was conducted via telephone or e-mail correspondence with industry professionals, research scientists, physicians, researchers and laboratory heads to discover the most recent developments in their fields of interest. Secondary data were collected via a comprehensive search of the scientific, peer-reviewed literature; clinical trial reports and databases; industry trade media; company websites; annual reports; intellectual-property databases; and industry press releases.

ANALYST CREDENTIALS

Dr. Willem Westra brings more than a decade of experience as an analyst in diverse areas of biomedical science, including basic research, intellectual property and investor relations, to BCC Research. He is the author of several peer-reviewed scientific articles and book chapters, and he actively works with major domestic and international pharmaceutical and biotechnology companies to evaluate potential biomarkers for autoimmune diseases. In addition to his pharmaceutical industry experience, Dr. Westra has served as an intellectual property/patent consultant, held visiting faculty positions in academia and has worked as a professional ski instructor. Dr. Westra has earned both a B.S. in Pharmacological Chemistry and a Ph.D. in Biomedical Science from the University of California, San Diego.

REPORT HIGHLIGHTS

This report provides:
- An overview of the global market for therapies and biomarkers for inflammatory bowel disease (IBD)
- Analyses of global market trends, with data from 2011, estimates for 2012, and projections of compound annual growth rates (CAGRs) through 2017
- Discussion of the types of IBD, including Crohn's disease, ulcerative colitis, and other (ischemic, diversionary, Bechet's)
- Examination of the types of IBD diagnostics, such as stool cultures, blood tests, and colonoscopy, endoscopy and radiology; and therapies, such as clinical guidelines for managing the disease, drugs, and surgery
- A breakdown of research and development, the current drugs approved for treatment, and current clinical trials of drugs
- Industry structure, key competitive factors, and growth drivers and obstacles
- Comprehensive company profiles of key players.

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