Biomarkers: Technologies and Global Markets

• Publication date: March 2011

In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 at a 5-year compound annual growth rate (CAGR) of 19.8%.Of all segments, genomics will continue as the largest, at 2010 revenue of $5.1 billion, growing to $16.9 billion in 2015, a compound annual growth rate (CAGR) of 26.9%. Genomics has been and will continue to be the fastest-growi...

In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 at a 5-year compound annual growth rate (CAGR) of 19.8%.

Of all segments, genomics will continue as the largest, at 2010 revenue of $5.1 billion, growing to $16.9 billion in 2015, a compound annual growth rate (CAGR) of 26.9%. Genomics has been and will continue to be the fastest-growing driver of biomarker technology.

Imaging, as a modality, completed 2010 with $4.2 billion in revenue. The next 5 years will continue to see growth, slightly outpacing proteomics, at a 14.8% compound annual growth rate (CAGR) from 2010 to 2015 to reach a value of $8.4 million in 2015. 
 



INTRODUCTION

STUDY GOALS AND OBJECTIVES

This study provides a comprehensive analysis of biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the market for products and services in the biomarkers segment. Individual product-types are forecast on a global basis, as are overall segments. Forecasts and trends are developed from a cross-reference of data points, gleaned from proprietary industry sources, company publications, industry benchmarking, and other divergent data sources to arrive at a cogent and coordinated forecast.

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 biomarkers market presents the largest of all opportunities in representative disease subsegments. This study investigates one of the most important market drivers: the introduction of combination therapies, which are expected to continue to contribute substantially to market growth through the forecast period. This report analyzes emerging markets, by disease segment. Continued growth is expected in emerging geographies, driven by the growing middle class in emerging countries such as India, China, Brazil, and Russia.

This report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and technologies, strategies for accessing emerging markets, and specific disease segments and geographies in order to allocate resources and make effective decisions.

SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2010 to 2015) are discussed. As well, new products approved in 2009 and 2010 by the FDA, and those products expected to be approved within the forecast period are projected. 2010 is an estimated figure, except where actual results have been reported, due to the release timing of the report. For all areas, including the very large markets segments such as infectious disease and cardiovascular specific mechanisms of action are discussed in detail.

The report includes analysis of leading and emerging competitors in the current worldwide biomarkers market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define their specific product strategies employed. This 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 and technologies are influencing the current standard of care. Detailed profiles of current market leaders are discussed, as well as companies with innovative products poised to advance within the forecast period.

Market figures are based on revenues at the manufacturers’ level and are projected at 2010-dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence, diagnosis, and scripting rates for certain diseases.

Included in this report are forecasts by product, product category, and by company from 2009 through 2015. The study is arranged to offer an overview of the biomarkers market accompanied by product, company, geography, and mechanism of action with forecasts broken down and covered by geographic region or country. Virtually the entire globe is covered to include prevalence data, for each disease subsegment.

Excluded from this report are over-the-counter (OTC) medications, and other consumables that do not require a physician’s prescription.

Sales 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.

INTENDED AUDIENCE

This 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 biomarkers market, its products, its industry participants, and its future.

The importance of identifying overall market trends, product opportunities, emerging geographies, 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 biotechnology players in the segment must understand specific opportunities for out-licensing, originating from the elements of differentiation of their biomarker product or technology as compared to leading, competitive, and emerging therapies. As well, market forecasts can support investment, provided a 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 5 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

Both primary and secondary research methodologies were used in preparing this study. In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts, and leading medical practitioners in the field.

The overall biomarkers sector 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. Each sub-section contains detailed forecasts for each driving mechanism, or relevant area of growth.

Information to prepare this report was obtained from participating and emerging companies in the biomarkers area; American Heart Association, the National Heart, Lung and Blood Institute and the National Heart, Lung, and Blood Institute; articles published in medical journals such as American Heart Journal, Circulation, Journal of Biomarkers Pharmacology, Lancet, and others; the World Health Organization and other government agencies; literature searches; annual reports; 10Ks; and others. Population estimates are based on those reported by the international data-base 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.

Global Genomics Industry

CHAPTER ONE: INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

METHODOLOGY AND INFORMATION SOURCES

RELATED REPORTS

BCC ONLINE SERVICES

DISCLAIMER

CHAPTER TWO: SUMMARY

SUMMARY TABLE GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2015 ($ MILLIONS)

SUMMARY FIGURE GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2015 ($ MILLIONS)

TABLE 1 GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010 ($ MILLIONS)

FIGURE 1 CUMULATIVE COST OF CLINICAL DRUG DEVELOPMENT

FIGURE 2 AVOIDABLE COST OF $177.4B OF DRUG-RELATED MORBIDITY AND MORTALITY

FIGURE 3 VARIANCE ANALYSIS OF INCREASED COST ORIGINATING FROM DRUG-RELATED MORBIDITY AND MORTALITY

FIGURE 4 DECISION TREE AND ECONOMICS FOR BIOMARKERS AT POINT OF CARE

FIGURE 5 PRICE, COST, ADOPTION PERCENT FOR BIOMARKER ENVIRONMENT

FIGURE 6 BREAKEVEN LEVEL FOR ADOPTION OF BIOMARKER

TABLE 2 NOVEL SAFETY / TOXICOLOGY BIOMARKERS USED IN CANCER, CARDIO AND RENAL

TABLE 3 NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE

TABLE 4 PATIENT OUTCOME MEASUREMENTS BIOMARKERS

TABLE 6 GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2015 ($ MILLIONS)

TABLE 7 FDA GUIDELINES FOR BIOMARKER APPLICATIONS

TABLE 8 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S., EUROPE, JAPAN, THROUGH 2010

TABLE 9 CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2010 ($ MILLIONS)

TABLE 10 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY

TABLE 11 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN U.S., EUROPE, JAPAN

TABLE 12 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2010 ($ MILLIONS)

TABLE 13 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY

TABLE 14 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY

TABLE 15 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER

TABLE 16 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER

TABLE 17 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT MELANOMA

TABLE 18 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: CARDIOVASCULAR

TABLE 19 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR

TABLE 20 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE

TABLE 21 CLINICAL BIOMARKERS IN CYP2D6 FAMILY FOR CNS DISEASE

TABLE 22 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY

TABLE 23 GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH 2015 ($ MILLIONS)

TABLE 24 2015 GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2015 ($ MILLIONS)

TABLE 25 GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL USE BY REGION, THROUGH 2015 ($ MILLIONS)

TABLE 26 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKER AND DRUG DEVELOPMENT COMPANIES

TABLE 27 PRINCIPAL FOCUS OF BIOMARKERS: PHARMACEUTICAL COMPANIES BY THERAPEUTIC AREA

TABLE 28 ABBOTT REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 29 ASTRAZENECA REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 30 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 31 ELI LILLY REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 32 GSK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 33 MERCK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 34 NOVARTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 35 PFIZER REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 36 ROCHE REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

TABLE 37 SANOFI-AVENTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS