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1、Lab Automation Markets Rures adquireret umbraculi, etiam tremulus matrimonii libere senesceret app March 2010 Kalorama Information A division of MarketR 38 East 29th Street Sixth Floor New York, New York 10016 212.807 .2660 t 800.298.5603 t 212.807 .2676 f THE WORLDWIDE MARKET FOR LAB AUTOMATION A
2、MARKET INTELLIGENCE ANALYSIS OF MANUFACTURERS AND SUPPLIERS OF LAB AUTOMATION SYSTEMS MARCH 2010 The Worldwide Market for Lab Automation has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of information services and research publication
3、s. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thorough presentation of essential data and concise analysis. Editor: Bruce Carlson Author: Joseph A. Constance Publication Date: January 2010 http:/www.KaloramaI E-MAIL:
4、 KLI2601060 COPYRIGHT 2010 Kalorama Information a division of MarketR, Inc. Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. TABLE OF CONTENTS 1.0 EXECUTIVE SUMMA
5、RY1 1.1 Perspective 1 1.1.1 Pressures to Automate in the Clinical Lab.5 1.1.1.1 Variety of Processes.5 1.1.2 Automating the Drug Discovery Lab6 1.1.2.1 Variety of Processes8 1.2 Emerging Trends9 1.3 Advantages and Trade-Offs12 1.4 World Market Summary13 1.5 Methodology15 2.0 INTRODUCTION17 2.1 Why A
6、utomate18 2.1.1 The Clinical Laboratory19 2.1.2 The Drug Discovery Laboratory20 2.2 An Evolving Market23 2.3 Key Issues24 2.3.1 Workflow28 2.3.2 Labor Issues32 2.3.3 Operating Costs36 2.3.4 Compatibility37 2.3.4.1 Middleware and Continuity40 2.4 Targets for Automation41 2.4.1 Specimen Handling42 2.4
7、.2 Automated Decapping44 2.4.3 Bar Coding44 2.4.4 Preanalytical Processing45 2.5 Healthcare Trends Impacting Automation47 Table of Contents ii Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any p
8、art, is strictly prohibited. 2.6 Automation Equipment Trends49 2.7 Total Lab Automation53 2.8 Modular Automation57 2.9 FDA Regulation60 2.10 Reimbursement60 3.0 RECENT MARKET DEVELOPMENTS65 3.1 Affymetrix, Beckman Coulter Join Forces65 3.2 Tecan, GE Healthcare Collaborate65 3.3 FDA Approval for Firs
9、t Fully Automated Blood Screening Test66 3.4 Beckman Coulter Acquisition67 3.5 Caliper Platform68 3.6 Robot Integration68 3.7 Electronic Notebook69 3.8 Automated Blood Sampling70 3.9 Automated Compound Plate Storage70 3.10 Assay Plate Production System Launched71 3.11 Liquid Handling Workstation72 3
10、.12 Open-Track Automation72 3.13 Cell Factory73 3.14 Benchtop Tube Sorting73 3.15 Automated Cell Culture73 4.0 MARKETS75 4.1 Overview75 4.2 Clinical Lab Automation Markets76 4.2.1 Sample Transport Systems83 4.2.2 Storage-Retrieval Systems85 4.2.3 Work Stations87 4.2.4 Specimen Handling Systems89 4.2
11、.5Clinical LIMS91 Table of Contents iii Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. 4.3 Drug Discovery Lab Automation Markets93 4.3.1 Plate Readers98 4.3.2 Au
12、tomated Liquid Handling Systems101 4.3.3 Robotics104 4.3.4 Dissolution Testing107 4.3.5 LIMS111 4.3.6 Storage-Retrieval Systems114 4.4 Total Market Share, Lab Automation Market 117 5.0 CORPORATE PROFILES119 5.1 Abbott Diagnostics.119 5.2 Affymetrix121 5.3 Agilent Technologies Inc. 122 5.4 Aurora Bio
13、technologies.123 5.5 Beckman Coulter Inc 124 5.6 BioTrove Inc. 127 5.7 Caliper Life Sciences.129 5.8 CyBio AG132 5.9 DKSH133 5.10 Dynacon Inc. 134 5.11 Eppendorf AG.136 5.12 Hamilton Storage Technologies Inc. 137 5.13 Hudson Robotics Inc. 138 5.14 InnovaSystems Inc 139 5.15 Labotix Automation Inc 14
14、0 5.16 LabVantage Solutions Inc 141 5.17 Magellan Biosciences Inc. 142 5.18 Molecular Devices143 5.19 Motoman Inc. 144 5.20 Olympus Corp. 146 5.21 PAA Ltd. 147 Table of Contents iv Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or her
15、eafter developed, in whole or in any part, is strictly prohibited. 5.22 PaR Systems Inc. 148 5.23 PerkinElmer Life and Analytical Sciences Inc. 149 5.24 F. Hoffmann-La Roche Ltd. 151 5.25 RTS plc 153 5.26 Siemens Healthcare155 5.27 Sotax157 5.28 The Automation Partnership159 5.29 Tecan Group Ltd. 16
16、2 5.30 ThermoFischer Scientific Inc 164 5.31 Xiril AG 167 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. 1.0 Executive Summary In recent years, manufacturing aut
17、omation processes have made a strong impact in certain areas of healthcare. They have helped to optimize clinical laboratories and corporate drug development laboratories. Laboratory automation systems and technologies involve any device, software or process that improves the efficiency of a laborat
18、ory. Over the years, many laboratories in North America, Europe and elsewhere have installed some sort of functional automation system. 1.1 Perspective Systems that automate the laboratory are indispensable for clinical and drug discovery laboratories facing market competition. Lab automation involv
19、es integrated hardware and software designed to process and analyze specimens. For clinical labs, automation can optimize workflow and speed the turnaround time for critical diagnostic tests. In the case of drug discovery, lab automation systems speed the identification of drug targets. Automation h
20、ardware can be installed in the form of a complete automation system total laboratory automation (TLA) - or as discreet hardware devices that perform specific tasks modular automation. The purpose of laboratory automation systems is to improve the quality and efficiency of laboratory operations. The
21、se systems may provide a solution to the quality demands and staff shortages faced by todays clinical laboratories. On the drug discovery front, lab automation has facilitated drug development by reducing the Executive Summary 2 Copyright 2010 Kalorama Information Reproduction without prior written
22、permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. potential for error and by facilitating high throughput screening (HTS). Several vendors offer automation systems for both markets. With the advent of new technologies, such as microarr
23、ays, microfluidics and lab-on-a-chip, not only the amount of throughput but also the way in which data are generated have changed the face of drug discovery and clinical diagnostics. Automated arrayed assay systems integrating several assay and detection methods are major competitors to established
24、clinical analyzers both for point-of-care and clinical laboratory applications. From the benchtop point of view, the trend is toward implementing modular automation - small work cells that can be rapidly configured, installed, brought into operation, and reconfigured when the need arises. The benefi
25、ts of automation in the clinical laboratory are well documented. Automation can replace manual, potentially dangerous, error-prone steps with automated processes that require minimal operator intervention. This approach can increase productivity, decrease turnaround time, improve staff safety, minim
26、ize errors, improve the handling of specimens, and allow labs to reallocate personnel to more important and productive tasks. Furthermore, by turning around critical tests rapidly, tracking specimens, and preventing errors in specimen aliquoting, the benefits of automation can reach outside the clin
27、ical laboratory to provide a positive impact on patient safety. For drug discovery, bringing a new drug to market has been both a very time- intensive, laborious and expensive undertaking. Thousands of compounds are typically identified in the drug discovery process, but only a few make it to clinic
28、al trials with human subjects. Once a drug reaches clinical testing, another three to six years on average are needed to complete the commercialization process. Developing and introducing a new drug to the market costs about $900 million per drug and takes about 15 years. Given such lengthy developm
29、ent cycles and high research costs, big pharma is always interested in more cost-effective and timely approaches to drug discovery. Lab automation can be used throughout the pre-clinical drug discovery process, involving microtiter plates, automated analyzers, HTS, robotics and liquid handling syste
30、ms, among other systems. Automation is not always harnessed to lower Executive Summary 3 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. labor costs, but also to
31、improve experimental accuracy and work flow efficiency. In drug development, scientists test many samples to measure a drugs characteristics so the quality of results is crucial. Automation allows highly qualified researchers to properly analyze results or develop new areas for research rather than
32、undertaking the laborious and repetitive manual steps of an experimental set-up. 1.1.1 Pressures to Automate in the Clinical Lab Many clinical laboratories are facing a number of issues that are challenging their ability to remain competitive. These challenges have been caused by the reduction of go
33、vernment reimbursement rates for laboratory tests, cost-restraint measures established by the managed care industry, and the continuing trend toward containment of national health care costs. As pressures increase for clinical labs to become more productive and cost efficient, their management must
34、examine more closely their labs internal processes to find ways to increase productivity with limited funds on hand. In order to survive in the future, it will be necessary for labs to run more tests; test in fewer sites; operate with less equipment; maintain lower operating costs; hire less skilled
35、 labor; and harness additional automation. Most clinical laboratories must become more efficient. The quest for efficiency, however, is confronted with the decreasing availability of trained laboratory technologists and an expanding menu of diagnostic testing protocols. Often, increased efficiency m
36、eans increasing or maintaining the timely output of test results with the same number or fewer technologists. The overused and sometimes misused solution in the quest for efficiency has been automation. Automation in the laboratory usually means optimizing work flow to increase output, shortening tu
37、rn-around time in reporting test results, and utilizing less labor. Attempts to accomplish these objectives have focused on applying instrumentation and computers. Automation, however, has not achieved for all laboratories the expected improvements in efficiency. Consequently, automation does not al
38、ways mean replacing every manual activity in the laboratory. This problem is further compounded by the inability of Executive Summary 4 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is
39、 strictly prohibited. instrumentation systems to accommodate changes in the daily work flow patterns of the laboratory. In addition, a thorough analysis of work flow patterns is generally neglected before attempts are made to enhance work flow. Automation will increasingly become crucial for clinica
40、l laboratories that want to achieve higher productivity levels and cost efficiency. Automation helps streamline the work flow and results in a more reproducible process with less hands-on interaction, which can significantly reduce costs and errors, and decrease the need for skilled labor. Automatio
41、n can help alleviate pending labor shortages caused by retirement. Current professionals are reaching retirement age in disproportionate numbers. About 40% of medical laboratory employees are between the ages of 46 and 66 according to the American Society for Clinical Pathology, and nearly half of t
42、he current workforce are about ready for retirement. The US Department of Labors Bureau of Labor Statistics estimates that 13,800 medical laboratory professionals are needed each year through 2012 to fill vacant positions. One of the main motivators for harnessing automation in laboratories involves
43、 minimizing those non-value-added steps, including such processes as sorting tubes, decapping, centrifugation, loading analyzers, and prepping and sorting materials for storage. Non-value-added steps usually can be addressed by automated systems. This frees up a medical technicians time. Because lab
44、or accounts for more than 60% of the cost of producing test results, automation and better information management systems effectively can reduce the manual, hands-on procedures in a lab and optimize the efficiency of labor in the laboratory. Automating a lab increases the available time for value-ad
45、ded steps - the tasks that technologists perform that help make a difference in the quality of the test results and a diagnosis - such activities as reviewing critical results and deciding whether to rerun or perform reflex testing based on a specific result. When the trend toward clinical laborator
46、y automation first began, in the early to mid-1990s, much of the talk about automation focused on automating all lab functions total laboratory automation (TLA). Targeted to the largest, highest- volume laboratories, TLA requires a major financial commitment several millions of dollars - and the spa
47、ce for installing equipment. But TLA is not an affordable nor Executive Summary 5 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. practical solution for the major
48、ity of small to mid-sized hospital and other diagnostic laboratories. The trend for most clinical labs, and for many automation system manufacturers, is toward modular automation, which includes consolidated and integrated analyzers, independent work cells or self-contained work stations, and automa
49、tion for transport, handling, and pre- and postanalytical processes. The concept of TLA has not grown beyond some larger laboratories. Only the minority of labs is suitable for TLA. In the US, only about 7% of the laboratories are considered to be able to benefit from TLA. A 500 bed hospital or smaller is not suitable for TLA, unless it has a large outpatient business. Usual