Get more info on this report!The Clinical Laboratory Services Market (Growth Opportunities,Competitive Analysis and Compet...
The issues and trends which are fueling growth:A trend towards preventive and risk factor testing has been noted in severa...
Additional InformationInterview Re: Clinical Lab Services with Kalorama Information Publisher BruceCarlsonCan you elaborat...
healthcare exchanges as part of the bill. As they come „on line‟ with insurance, thosefirst years of doctor visits are goi...
We noticed slightly higher growth overall in the market in 2009 then had anticipated in2007 when we did the last report on...
specialty testing and a review of the latest trends driving growth. Forecasts through2014 and profiles of major players in...
o   Physician-office Laboratories       o   Independent Clinical Laboratories    Incidence of Diseases    Demographics    ...
o   Key Acquisitions, Alliances, and Partnerships       o   Products and Services       o   Growth Strategy       o   Loca...
APPENDIX: COMPANY DIRECTORY                         LIST OF EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARY     Figure 1-1: U.S. Cl...
Table 2-21: Leading Commercial Insurance Providers, 2008    Table 2-22: Quest and LabCorp Service Contracts for Leading In...
Figure 4-5: U.S. Clinical Laboratory Market Analysis by General Test Type,       (Routine vs. Specialty) 2009       Table ...
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Clinical Laboratory Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles), The

  1. 1. Get more info on this report!The Clinical Laboratory Services Market (Growth Opportunities,Competitive Analysis and Competitor Profiles)February 1, 2010Clinical laboratories are an essential part of the health industry. It is estimated thatapproximately 80% of physicians diagnoses are a result of laboratory tests. Theconstant pressure to reduce healthcare spending is shifting healthcare utilization infavor of the laboratory, making it an ever more valuable part of the treatment plan. Ashospital stays are shortened, contact between the physician and patient is reduced,which places a larger role on labs to gather, interpret, and deliver accurate informationto the physician in a timely manner. We can expect to see an increase in the number ofclinical labs, particularly in the independent sector, as these trends continue to influencethe industry.Since the last time Kalorama Information studied this market two years ago, there havebeen substantial changes in the industry, including changes in market share as majorcompanies eat into regional labs, new competitors enter the marketplace, and newspecialty tests are developed and priced. Clinical Laboratory Services (Markets, GrowthOpportunities, Competitive Analysis and Competitor Profiles), provides an in-depthmarket overview, a total market analysis, analysis by laboratory type, and by routineand specialty testing and a review of the latest trends driving growth. Revenues andforecasts presented are for the U.S. market. Key international markets are discussed aswell.Key market data provided includes: Hospital, Physician and Independent Lab Statistics Major Tests Performed by Clinical Lab Companies Disease Incidence and Trends Driving Lab Business Market Forecast to 2014 Market Breakdown by Lab Type (Hospital, Physician, Independent) Market Breakdown by Test Type (Specialty, Routine) Market Share of Competitors Competitive Analysis of Leading clinical Lab Providers
  2. 2. The issues and trends which are fueling growth:A trend towards preventive and risk factor testing has been noted in several disciplines,particularly in the areas of oncology, endocrinology, and gynecology. Physicians inthese areas are taking full advantage of testing for early detection and diseaseprevention. Some of the other issues and trends explored in this study include: U.S. Demographics Types of Specialty Tests Growing Competition Increasing Life Expectancy Growing Incidence of Disease New Product Offerings Regulatory Environment Insurance and Reimbursement Payer Types Developments in Personalized MedicineA competitive analysis of leading clinical laboratory providers includes: Quest Diagnostics, Inc. Laboratory Corporation of America (LabCorp) Genomic Health Genoptix, Inc. Genzyme Corporation DaVita Clarient, Inc. Spectra Laboratories Bio-Reference LaboratoriesOur methodology:The information in this report is the result of interviews with executives and marketexperts, as well as thorough research of secondary sources such as company literature,trade publications and medical and business journals. The emphasis Kalorama puts onprimary research guarantees that new insights will be uncovered that are not availablefrom any other source. The most important part of Kaloramas efforts is its superioranalysis of company activities and their true significance in the marketplace.All market data pertains to the world market at the manufacturers‟ level. The base yearfor data was 2009. Historical data was provided for the years 2006, 2007 and 2008, withforecast data provided for 2010 through 2014. Compound annual growth rates (CAGRs)are provided for the 2006-2009 and 2009-2014 periods for each segment covered. Acompetitive analysis is provided for the year 2009. The forecasted market analysis for2010-2014 was largely based on demographic trends, new developments, companyperformance trends, mergers and acquisitions, and national expansion.
  3. 3. Additional InformationInterview Re: Clinical Lab Services with Kalorama Information Publisher BruceCarlsonCan you elaborate on what is behind the growth in the specialty testing market?Better, more useful technologies that give results clinicians want - FISH,immunohistochemistry and molecular tests among them. They represent tests wherespecialty knowledge and equipment is needed that generally the hospital doesn‟t have,Advanced services such as immunohistochemistry, flow cytometry, and moleculargenetics technologies, and thus these tests can command a higher price There is also alarge volume of these tests, and so we expect growth the continue. While fees for sometests have been reduced, Centers for Medicare and Medicaid show that FISH manualtesting increased.Reimbursement of tests. A test is only going to be a successful product if it isreimbursed and increasingly insurance companies are showing a willingness toreimburse. Pharmacodiagnostic tests that can help to limit the use of treatements thatdon‟t work on a given paitent, will be favored by governments and insurancecompanes..Of course sadly more incidence of cancer and other diseases for which speciality testsare needed is a growth factor. But also because these tests require knowledge andtechnology not commonly found in the hospital setting, there is a premium charge forthese tests.What are key trends that you expect to see more of in the near future?IVD companies performing tests and marketing new tests as a service rather thanmerely selling kits. A trend we‟ve seen develop over the last decade and,. Given thegrowth rates of companies who pursue this type of strategy, we expect others willfollow. This would also lead us to believe that there will be more acquisitions ofcompanies who have this competency.What impact do you expect the health care reform law to have on clinical labs?Generally good impact. The legislation introduced taxes and fees to other industries butleft diagnostics - both kit sellers and service sellers alone for the most part, so „no harmdone‟ is good news there. Testing benefits from health care reform. In general terms,more patients with insurance will mean more doctor visits; less visits skipped for lack offinancing. Doctor visits will lead testing. Near term may see the best result - As asignificant group of people who were uninsured become insured between Medicaid and
  4. 4. healthcare exchanges as part of the bill. As they come „on line‟ with insurance, thosefirst years of doctor visits are going to have to be test - rich, as doctors likely will beseeing patients who have not had a physicial for some time. This should help LabCorpand Quest. But this is not without challenges. For a test to be ordered, there has to be adoctor‟s visit, and if there is a doctor shortage or long waiting line, the promised testvolumes may not arrive. We will also see over the next few years, the governmentstolerance for reimbursing all these tests.What is impacted are high cost tests. With the government as a key payor and with a lotof attention on cost cutting, there will be pressure to negotiate lower reimbursement ontests. So far though, FDA has shown a willingness to reimburse a test where it works;the Oncotype DX is an example. Even the high-cost tests can get dollars if they canshow they limit more expensive treatment in cases where treatment will not be effective.What emerging technologies do you expect will impact the clinical lab businessin the near term?Getting results to patients in a high-tech way is an interesting trend. In an evolving effortto more efficiently connect with patients and physicians, several clinical laboratorieshave developed electronic test result distribution. This is not a novel concept but it hasbeen an area of focus for companies in the past several years, especially as newelectronic technologies and the internet have become used extensively. Companies inthe industry have seen that efficiently communicating results with clients is an essentialpart of the job, and may be just as important as providing leading test menus in cutting-edge areas of lab testing.For example, patients registered with a Google Health account, may view lab resultsonline if they were ordered through Quest Diagnostics. The two companies paired up in2008, after Google started the personal healthcare management system. The argumentfor this system is increased efficiency. In some cases it may also help people manage,or be more proactive with their health.Were any findings in your report surprising?A very scattered market. The top eight or so companies make 10BN, the others makeabout 37BN. Most healthcare markets are 80-20 or roughly so, with the top fewcompanies owning 80%. This reperesents the regional nature of a market that serviceshospitals and physicians.Quest‟s considerable growth between 07 and 09 - 9.8%. Genomic Health‟s fast rise andsuccessful business model leading to 82% growth 2007-9. It is not so much a surpriseto us as we‟ve been watching the service trend but for your readers it may be, andcertainly the large IVD companies are noticing. While these small companies are nowhere near Quest or Lab Corps revenue, they can affect the growth rate of thosecompanies by competing in the high-growth sector of speciality testing.
  5. 5. We noticed slightly higher growth overall in the market in 2009 then had anticipated in2007 when we did the last report on this subject, market 54BN vs our 2007 of 50BN.TESTING INCREASINGLY IMPORTANT, REPORT FINDSNew York, February 4, 2010 — About eighty percent of physicians‟ diagnoses resultfrom a lab test. This bodes well for clinical lab service providers, especially the twomajor players Quest and LabCorp who provide lab services to hospitals, according tohealthcare market research publisher Kalorama Information, which recently publishedClinical Laboratory Services Market (Growth Opportunities, Competitive Analysisand Competitor Profiles).In today‟s cost cutting reality, there is a shift taking place in healthcare that includesshortened hospital stays. The average length of hospital stays in the U.S. is 4.7 daystoday, down from about 5.4 days in 1995 and 4.9 days in 2000. As a result, clinical labshave been pressured to improve the turnaround of test results so they can pick up theslack and help doctors to continue providing proper healthcare. This means they havealso become a more valuable part of the treatment plan and are improving a physician‟sability to treat patients like never before.“As hospital stays are shortened, contact between the physician and patient is reduced,which places a larger role on labs to gather, interpret, and deliver accurate informationto the physician in a timely manner,” notes Melissa Elder, an analyst with KaloramaInformation. “We expect to see an increase in the number of clinical labs, particularly inthe independent sector, as these trends continue to influence the industry.”In the report, Kalorama estimates the clinical lab services market in the U.S. was about$52.7 billion in 2009 and will grow at an annual rate of 4.1% to reach $61.9 billion by2014. New technologies in testing will likely continue to fuel growth in combination withan aging population, increasing disease incidence and prevalence, a greater focus onprevention and early detection, and new trends in personalized medicine. Some keyareas of growth include genomic and esoteric testing, anatomic pathology, andspecialized testing in oncology and infectious disease.The clinical lab services market in the U.S. is highly competitive with a large number ofplayers. However, two big players, Quest Diagnostics and LabCorp, dominate theindustry with combined lab service revenues of nearly $12 billion in 2009. No otherplayers approach these two, but smaller companies have achieved noticeable growth inthe past two years, especially in the area of specialty testing where they have cut intothe pricing and volume of the major companies. Overall, the specialty segments enjoyedhigher growth in test volume than the routine segments in 2009.Kalorama Information‟s Clinical Laboratory Services Market (Growth Opportunities,Competitive Analysis and Competitor Profiles) provides an in-depth marketoverview, a total market analysis, analysis by laboratory type, and by routine and
  6. 6. specialty testing and a review of the latest trends driving growth. Forecasts through2014 and profiles of major players in the industry are also included.About Kalorama InformationKalorama Information supplies the latest in independent market research in the lifesciences, as well as a full range of custom research services.Table of ContentsCHAPTER ONE: EXECUTIVE SUMMARY Industry at a Glance Scope and Methodology Size and Growth of the Market Key Issues and Trends Affecting the Market Leading Market ParticipantsCHAPTER TWO: INDUSTRY OVERVIEW, REGULATION AND TRENDS Clinical Laboratory Description Testing and Services Routine Testing o Blood Cell Count o Cholesterol Level Testing o HIV Testing o Anti-HIV-1 Oral Specimen Collection Device o Anti-HIV-1 Testing Service o Nucleic Acid Testing o Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay) o Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay) o Pap Testing o Pregnancy Testing o Substance Abuse Testing o Urinalysis Specialty Testing o Endocrinology o Esoteric Testing o Genetics o Immunology and Molecular Microbiology o Oncology o Serology o Toxicology Industry Structure o Hospital-based Laboratories
  7. 7. o Physician-office Laboratories o Independent Clinical Laboratories Incidence of Diseases Demographics o Population Over Age 65 o Life Expectancy Regulatory Overview o Certificate of Waiver o Certificate of Provider-Performed Microscopy Procedures (PPMP) o Certificate of Compliance and Certificate of Accreditation o States Exempt from Federal Clinical Laboratory Improvements Amendments (CLIA) of 1988 Insurance and Reimbursement o Laboratory Service Payer Types o Trends in Medicare Reimbursement o Commercial Insurance Providers New Developments in Information Technology International Markets and TrendsCHAPTER THREE: LEADING MARKET PARTICIPANTS Summary Quest Diagnostics, Inc. o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Business Locations Laboratory Corporation of America o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations Genzyme Corporation o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations DaVita, Inc. o Company Overview o Performance Review
  8. 8. o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations Clarient, Inc. o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations Spectra Laboratories o Company Overview o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations Bio-Reference Laboratories o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations Genomic Health, Inc. o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o Locations Genoptix, Inc. o Company Overview o Performance Review o Key Acquisitions, Alliances, and Partnerships o Products and Services o Growth Strategy o LocationsCHAPTER FOUR: MARKET ANALYSIS Market Overview Market Analysis by Laboratory Type Market Analysis by Test Type Competitive Analysis
  9. 9. APPENDIX: COMPANY DIRECTORY LIST OF EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARY Figure 1-1: U.S. Clinical Laboratory Market Analysis: 2006-2013CHAPTER TWO: INDUSTRY OVERVIEW Table 2-1: Laboratory Reference Parameters for CBC Table 2-2: High Cholesterol Risk Categories Table 2-3: HIV Testing Products/Services Approved by the FDA Table 2-4: HCG Levels in Pregnant Women by Days Past Ovulation Table 2-5: Substance Detection Periods by Test Method Table 2-6: Normal Reference Levels in a Medical Urinalysis Figure 2-1: Growth in Clinical Laboratories, 1997-2008 Table 2-7: U.S. Registered Hospitals by Type, 2006 compared to 2008 Table 2-8: Leading For-Profit U.S. Hospital Chains, 2006, 2007, 2008 Figure 2-2: Trend in For-Profit U.S. Hospital Facilities, 2006-2008 Figure 2-3: Trend in For-Profit U.S. Hospital Licensed Beds, 2006-2008 Figure 2-4: Trend in For-Profit U.S. Hospital Inpatient Admissions, 2006-2008 Table 2-9: Physicians in the US by Specialty, 1970-2008 Table 2-10: Leading U.S. Independent Laboratory Groups, 2008 Table 2-11: U.S. Prevalence of Selected Medical Conditions Figure 2-5: U.S. Prevalence of Selected Medical Conditions Table 2-12: The U.S. Population, 1980-2020 Figure 2-6: The US Population, 1980-2020 Table 2-13: Percent U.S. Population Over Age 65 by Year Figure 2-7: Estimated Population by Age Group, 2000 and 2050 Table 2-14: Average U.S. Life Expectancy in Years 1980, 2004, 2006 and 2008 Figure 2-8: Average U.S. Life Expectancy in Years 1980 and 2008 Table 2-15: Selected CLIA Waived Laboratory Tests Table 2-16: Provider-Performed Microscopy Procedures Figure 2-9: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), December 2008 Table 2-17: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), December 2008 Figure 2-10: Clinical Laboratory Certificates Issued by Selected State (non- exempt laboratories only), December 2008 Figure 2-11: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), December 2008 Table 2-18: CLIA Exempt States, Number of Laboratories, 2008 Table 2-19: Health Insurance Trends in the United States, Estimated 2007* Table 2-20: Clinical Laboratory Clients and Payers by Type Figure 2-12: Clinical Laboratory Clients and Payers by Type Table 2-21: Laboratory Fee Schedule for Common CPT Codes in Specialty Testing, 2007-2009
  10. 10. Table 2-21: Leading Commercial Insurance Providers, 2008 Table 2-22: Quest and LabCorp Service Contracts for Leading Insurance ProvidersCHAPTER THREE: LEADING MARKET PARTICIPANTS Table 3-1: Corporate Details of Quest Diagnostics Figure 3-1: Quest Diagnostics‟ Clinical Testing Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions) Table 3-2: Corporate Details of Laboratory Corporation of America Figure 3-2: Laboratory Corporation of America‟s Sales to Third Parties, 2006- 2008 and Estimated 2009 ($millions) Table 3-3: Corporate Details of Genzyme Corporation Figure 3-3: Genzyme Corporation Testing Service Sales to Third Parties, 2006- 2008 and Estimated 2009 ($millions) Table 3-4: Corporate Details of DaVita Figure 3-4: DaVita‟s Laboratory Service Revenues, 2006-2008 and Estimated 2009 ($millions) Table 3-5: Corporate Details of Clarient Figure 3-5: Clarient‟s Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions) Table 3-6: Corporate Details of Fresenius Medical Care AG Table 3-7: Corporate Details of Bio-Reference Laboratories Figure 3-6: Bio-Reference‟s Sales to Third Parties, 2006-2009 ($millions) Table 3-8: Corporate Details of Genomic Health, Inc. Figure 3-7: Genomic Health‟s Sales to Third Parties, 2006-2008 and estimated 2009 ($millions) Table 3-9: Corporate Details of Genoptix, Inc. Figure 3-8: Genoptix Sales to Third Parties, 2006-2008 and Estimated 2009 ($millions)CHAPTER FOUR: ANALYSIS Table 4-1: U.S. Clinical Laboratory Market Analysis, 2006-2013 Figure 4-1: U.S. Clinical Laboratory Market Analysis: 2006-2013 Table 4-2: U.S. Clinical Laboratory Market Analysis by Type, (Hospital-Based, Physician, Other) 2006-2013 Figure 4-2: U.S. Clinical Laboratory Market Analysis by Type, (Hopsital-Based, Phyisican, Other) 2006-2013 Figure 4-3: U.S. Clinical Laboratory Market Share by Type, (Hopsital-Based, Phyisican, Other) 2009 Figure 4-4: U.S. Clinical Laboratory Market Share by Type, (Hopsital-Based, Phyisican, Other) 2013 Table 4-3: U.S. Clinical Laboratory Market Analysis by General Test Type, (Routine vs. Specialty) 2009
  11. 11. Figure 4-5: U.S. Clinical Laboratory Market Analysis by General Test Type, (Routine vs. Specialty) 2009 Table 4-4: Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2007 and 2009 Figure 4-6: Estimated Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers 2009 Figure 4-7: Estimated Laboratory Service Revenues for Leading Clinical Laboratory Providers 2007 and 2009 Figure 4-7: Rate of Growth: Lab Corp and Quest Diagnostics 2007 and 2009Available immediately for Online Download athttp://www.marketresearch.com/product/display.asp?productid=2565239US: 800.298.5699UK +44.207.256.3920Intl: +1.240.747.3093Fax: 240.747.3004

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