Companion Diagnostics: Technologies and Global Markets

Countries covered: Global Oncotype Dx, although not FDS-approved, is still a lead product in the breast cancer diagnosis sector. Oncotype Dx is reimbursed by most insurance companies and therefore enjoys an increase in its sales number every year. Valued at $170 million in 2010, analysts believe that by 2015, Oncotype Dx for breast cancer risk recurrence and drug regimen may reach $300 million, a compound annual growth rate (CAGR) of 12%. The approval of Selzentry for first time HIV patients is creating new opportunity for the assay Trofile, a companion diagnostic to Selzentry (Celsentri outside U.S.). As a result, Trofile is expected to reach an estimated $34 million by 2015, from $24 million in 2010, a compound annual growth rate (CAGR) of 7.2%.

Additional Information

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This BCC Research report, Companion Diagnostics: Technologies and Global Markets, provides an overview of the current state of development in the companion diagnostics field, existing products on the market, and detailed analysis of the competitive environments, including new potential markets for current industry trends. The study includes information about significant current players in this field of study, trends, and challenges, and other information affecting assay development in this space of personalized medicine.

REASONS FOR DOING THIS STUDY

When the human genome project was finally completed in 2003, the idea of testing the specific genetic signature for every human individual became a reality. In addition to the fast development of proteomic approaches and array technology, a new trend in personalized medicine started to evolve as part of the healthcare system. Personalized medicine became more and more embraced by healthcare providers, the pharmaceutical industry and even insurance companies, in an attempt to reduce unnecessary expenses and costs for patients’ treatments. Indeed, a new organization was formed called the Personalized Medicine Coalition (PMC), a nonprofit advocacy group that keeps close track of all the recent developments and propositions in this field.

Companion diagnostics is part of the “personalized medicine revolution.” The field evolved as a continuation of biomarker studies and diagnostics testing. And although this area of industry is still young, it becomes more and more complicated and developed, with a number of successful FDA-approved products.

This study will provide knowledge of the current state of the companion diagnostics industry, new technologies in assay development, and more importantly, will describe potential novel commercial venues in this area of the healthcare industry.

SCOPE OF REPORT

Personalized medicine is relatively new to the market research report format and provides business tools to evaluate new commercial opportunities in diagnostics and biomarker fields. The geographic scope of this study covers U.S. and global companies. The report identifies major commercial sectors in companion diagnostics: oncology related products vs. cardiovascular diseases and other segments. This study describes current products in each area, identifies current market participants and, most importantly, notes the trends that are going to affect further product development in this area. The report also provides information about less-developed sectors of this market, and gives a list of current companies that have new companion diagnostics products in development.

METHODOLOGY AND INFORMATION SOURCES

Both primary and secondary research methodologies were used in preparing this study. The methodology employed a triangulating approach, which aids in validity.

Initially, a comprehensive and exhaustive search of the literature on assay development and already-marketed products was conducted. These secondary sources included assay development and science-related journals, textbooks, press releases, marketing literature, other product/promotional literature, annual reports, security analyst reports, and other publications. A patent search and analysis were also conducted.

In a second phase, a series of semistructured interviews were conducted with company representatives, bench scientists, marketing representatives, and other personnel at biotech and pharmaceutical companies. Other resources included academics, technology and consulting companies, which were rich sources of data. Subsequent analysis of the documents and interview notes was performed thoroughly.

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