Coagulation Self-Testing to 2020

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1 Greystone Research Associates June 2015 Coagulation Self-Testing to 2020 Devices, Products, Markets, and Forecasts Contents A Comprehensive Market Analysis Report Scope & Overview 2 Table of Contents 3 Report Summary 4 Methodology 5 How to Order 6

2 2 An Evolving Demand Picture The size and future potential of the coagulation self-testing market has been evolving over the past 24 months as two competing forces work to inject uncertainty into future demand. Demographic and incidence data indicate a definite upward trend in the clinical and managed care demand for anticoagulation therapeutics. But the commercialization of novel oral anticoagulants (NOACs) a new class of drugs that does not require routine coagulation monitoring will work to reduce demand for coagulation self-testing. The result will be a muddled global market where demand among countries and regions will vary based on individual market factors. To minimize risk and fully engage addressable markets, participants must commit to a comprehensive understanding of the key markets in which they currently, or plan to, compete. The value we provide to our clients and subscribers is best illustrated by our ability to consistently provide strategic direction and market knowledge that contributes to their tactical and strategic decision process Tailored Research Market-driven Product Strategies As technology and products evolve, the level of precision in management decisions required to enable effective company performance is increasing. Such precision cannot be achieved without timely and accurate data about the company's macroscopic operating environment. The information that you and your management team require to execute your business and market strategies is unique to your organization and business model. This is why - in addition to the multi-client reports you will find on our site - we offer client-specific research services that start with customer-defined needs and culminate in assessments and analysis that answer the questions that represent risk to your business strategy. To discuss Greystone's Customer Defined Research services, we invite you to contact us. A longer life span is expected to translate to a growing number of patients diagnosed with chronic conditions. To counteract the financial and medical infrastructure implications of this trend, pressure from the public sector and managed care organizations will place a premium on therapeutic self-testing and management. In this environment, healthcare sector participants have come to realize that commercial success no longer depends solely on the product itself but also on achieving a consumercompatible form of packaging and operation.

3 Table of Contents Executive Summary 2 Anticoagulation Therapy Market Dynamics Anticoagulation Healthcare Economics Oral Anticoagulation Therapy Monitoring Prothrombin Time Competing Coagulation Tests Key Factors in Patient Compliance Market Drivers Industry Alignment and Competitive Landscape Coagulation Self-Testing Device Design Factors Standardization of PT/INR Testing Accuracy and Precision Sampling Method Endpoint Detection Patient/User Interface Wireless Technology Commercialization Factors Managed Care and Reimbursement Third-party Patient Training & Support Proprietary Technology Market Factors Indications and Market Segments Novel Oral Anticoagulants Patient Demographics Regulations and Standards Patient/Consumer Sentiment Patient Self-Testing Product Assessments Commercial Products CoaguChek CoaguSense InRatio i-stat Development-Stage Devices iline Microsystems Microvisk Universal Biosensors FlexLife Health Market Analysis, Data and Forecasts North America Western Europe Eastern Europe Asia MENA South America The availability of selftesting monitors provides patients with an opportunity to self-test and avoid frequent caregiver visits. Compared to blood glucose monitoring, OAT self-testing presents a higher level of complexity and risk, placing a premium on patient education. A number of companies are now providing services to patients wishing to selftest, acting as a first-line patient resource and assisting with device selection and patient training. Wirelesslyenabled devices that allow patients to share readings with physicians electronically provide an additional safety and compliance benefit. Company Profiles

4 2 Greystone Research Associates Our reports are carefully researched and written to provide timely and insightful analysis of key factors and developments shaping the commercial marketplace. The focused nature of our publications is designed to allow readers to identify emerging demand and growth opportunities in selected markets. Numerous charts, tables and graphs complement the text, with evaluations and assessments of current and probable future market developments, technology issues and business factors - information necessary to compete effectively in the global marketplace. What You Will Learn What are the marketed patient self-testing devices for measuring and monitoring anticoagulation drug therapy? What is the status and prospects of coagulation self-test devices currently in development? What is the market potential and commercialization risks and opportunities for coagulation self-test devices? What are the key patient self-test device design issues and evolving market factors for coagulation self-testing? What is the impact of coagulation self-test technology and devices on coagulation management markets? What is the role and impact of third-party PT/INR self-test services on device demand and patient acceptance? Who are the market participants in the coagulation self-test segment, and what are their technology and market strategies? Who are the market leaders, what is the size of the market today, and what will it be in 2020? What is the impact of novel oral anticoagulants on the future commercial growth of coagulation self-test devices? Report Value Chain Who Should Read this Report Development Industry Market Drug Developers Device Suppliers CMOs Components/APIs Testing/Validation Clinical Trial Mgmt Pharma Managers Biotech Managers Drug Marketers Industry Strategists Financial Analysts Management Consultants Clinical Managers Drug Distributors Pharma Regulators FDA Consultants Managed Care Managers

5 5 Greystone Research Associates Report Format and Availability This report is available electronic format. Single user licenses as well as licenses for multiple users are available. Custom licensing options to address specific company user requirements are available by calling client services at , or by ing The Power of Insight Find us on the Web: Methodology Research methodology is based on primary research in the form of indepth interviews with key market participants, technology developers, distributors, industry experts, and market influencers, a list that includes regulatory officials, industry trade groups, and materials standards organizations. Primary data is evaluated and normalized against secondary sources including trade journal articles, technical literature, industry publications, company data sheets and published information, and statistical data from government agencies and trade associations. Forecasts and projections of market demand and future market activity are derived using standard statistical techniques. Greystone Research Associates Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

6 6 How to Order Orders may be placed via postal mail, or fax. Orders not accompanied by a purchase order must contain a telephone number for verification, and clearly indicate the physical shipping address. Orders which are not prepaid must indicate the billing address. There is no charge for handling and shipping for destination addresses within the continental US. Payment We accept the following forms of payment: Company Check: Please make checks payable to Greystone Associates Credit Cards: We accept MasterCard, Visa and American Express Wire Transfers: See Wire Transfers below for more information Fax to: or to clientservices@greystoneassociates.org Orders Outside the U.S. Orders must be prepaid via credit card, company check in US funds and drawn on a US bank, or wire transfer. Wire Transfers: TD Bank 300 Franklin Street Manchester, NH (Call for Account Information) Mailing Address: Greystone Research Associates Client Services P.O. Box 1362 Amherst, NH Coagulation Self-testing to 2020 Devices, Products, Markets, and Forecasts Select Format License Price (U.S. funds) Total PDF Single User $3, PDF Site License $5, PDF Global License $7, Total Payment (U.S. funds) Method of Payment: Company Check Wire Transfer Card Number: Name on Card Expiration Date: Card CVV Signature Billing Information Name: Title: Company: Street Address: City, State/Province: Country/Postal Code: Phone: Fax: Shipping Information Click here if same as Billing Information Name: Title: Company: Street Address: City,State/Province: Country/Postal Code: Phone: Fax: 98 Route 101A P.O. Box 1362 Amherst, NH (F) reports@greystoneassociates.org