《In Vitro Diagnostics in a Recessionary Economy.pdf》由会员分享，可在线阅读，更多相关《In Vitro Diagnostics in a Recessionary Economy.pdf（119页珍藏版）》请在三一文库上搜索。
1、In Vitro Diagnostics in a Recessionary Economy May 2009 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 Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media
2、now in existence or hereafter developed, in whole or in any part, is strictly prohibited IVD IN A RECESSIONARY ECONOMY In Vitro Diagnostics Markets in a Recessionary Economy has been prepared by Kalorama Information. We serve business and industrial clients in the United States and abroad with a com
3、plete line of information services and research publications. 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. Author: Shara Rosen Publication Date: May 2009 38
4、 East 29th Street New York, New York 10016 (800) 298-5699 Outside the U.S. (212) 807-2657 FAX: (212) 807-2676 www.KaloramaI E-MAIL: Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is st
5、rictly prohibited TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY1 Scope and Methodology .1 Market Trends.2 World Demand for Diagnostics4 Keys to Success.7 CHAPTER TWO: INTRODUCTION.11 Background.11 Marketing in a recession what the experts say about the 4Ps13 Obamas new deal boom and bust.15 Musin
6、gs on what form a reformed U.S. system might take19 Status quo and future impressing investors in a bear market.21 CHAPTER THREE: MARKET TRENDS/DEMAND ANALYSIS.27 Hospital Financing27 The role of the new deal for the insured, uninsured and underinsured30 Payer Response to Economic Stress.32 Demand f
7、or esoteric Tests 35 World demand for IVD Tests and Services36 United States of America40 Europe.42 Japan .44 China.45 CHAPTER FOUR: MARKET OVERVIEW/SUPPLY ANALYSIS49 Market Analysis, revenue estimates 20092014 49 IVD Sectors.52 IVD Events53 New Tests and Technologies53 Acquisitions, Mergers.56 Coll
8、aborations.59 Market Expansion Activities.60 Lab Services62 Lab Information Technology63 CHAPTER FIVE: COMPANY PROFILES.65 Abbott Diagnostics66 Atherotech.67 Beckman Coulter Inc68 Becton, Dickinson and Company (BD)70 bioMerieux Inc72 Celera Corporation74 Cellestis Ltd76 Cepheid.77 iv IVD in a Recess
9、ionary Economy Copyright 2009 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 Clarient Inc. (formerly ChromaVision)79 deCode Genetics Inc.80 Genomic Health81 Gen-Probe Inc.82 Imm
10、ucor, Inc.83 Inverness Medical Innovations.85 Luminex Corporation87 Monogram Biosciences, Inc89 Nanogen91 Ortho Clinical Diagnostics (OCD)93 Qiagen N.V.95 Quidel Corporation.97 Roche Diagnostics 98 Seegene, Inc100 Sequenom, Inc.101 Siemens Medical Solutions Diagnostics.103 Sysmex Corporation104 Verm
11、illion/Ciphergen Biosystems Inc106 CHAPTER SIX: CONCLUSION.107 Marketing Strategies for Now and the Future.107 Keep Your Pricing Stable.107 Strengthen the Marketing Budget.109 Evidence-Based Medicine is Here to Stay109 Conclusion110 Table of Contents v Copyright 2009 Kalorama Information Reproductio
12、n without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY Figure 1-1: IVD Market 2009 and 2014.5 Figure 1-2: Growth Rates in Various Countries/Regions Compared.7 CHAPTER T
13、WO: INTRODUCTION Table 2-1: Selected IVD Venture Investments24 CHAPTER THREE: MARKET TRENDS/DEMAND ANALYSIS Table 3-1: Number of People Worldwide Who Get Chronic Diseases Every Year.35 Table 3-2: Percent Change in Industrial Productivity, by Country or Region,.37 Table 3-3: Worldwide In Vitro Diagno
14、stic Reagent Sales by Country, 2009-2014 40 Table 3-4: Europe Unemployment Rates and % change in GDP .43 CHAPTER FOUR: MARKET OVERVIEW/SUPPLY ANALYSIS Table 4-1: Worldwide In Vitro Diagnostic Reagent Sales by Product Market, 2009-2014 ($ million).50 CHAPTER SIX: CONCLUSION Table 6-1: Pricing Structu
15、res That Create Value for the Customer.108 Copyright 2009 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 CHAPTER ONE Executive Summary SCOPE AND METHODOLOGY This report discusse
16、s some of the nuances of how our current economic conditions play out in marketing IVD products. It also presents actions that IVD companies can take to assure growth in uncertainty. The report focuses on developments at work in the United States since this is the largest single market for IVD produ
17、cts and also the epicenter of the economic meltdown that is having repercussions across the globe. The economic problems that began slowing the U.S. economy in the fall of 2007 keep spreading, with Europe and Japan following America into recession. The source of global economic woes and unemployment
18、 is partly related to Americas huge appetite for imported goods. With spending down so goes the market for imports. U.S. imports from China dropped 5% over the past year, a far cry from the recent rapid growth. But U.S. imports from Germany and Japan fell a whopping 12% and 19%, respectively. The re
19、port looks at the market for IVD products in the developed markets of North America, the European Union and Japan, and provides some insight to opportunities in emerging nations, primarily China, India, Asia and Latin America. Market analysis in this report covers world markets for in vitro diagnost
20、ics, however the reader will find a bias toward the developed areas of the globe - North America, Japan and Western Europe. However public health and infectious disease are a growing global problem and where possible the report covers IVD products related to the globalization of diseases. 2 IVD in a
21、 Recessionary Economy Copyright 2009 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 The information presented in this report is derived on publicly available information sources
22、 such as company, government, and medical organization reports. The analysis is based on the authors industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics, imaging industries and cardiologists. Major informati
23、on sources include but are not limited to the following: American Association for Clinical Chemistry, www.aacc.org EDMA (the European Diagnostic Manufacturers Association), www.edma-ivd.be FDA, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), www.fda.gov/cdrh/oivd/index.html Medica
24、l Test Kits Information Directory, www.medical-test- M, Reuters Healthcare, The Henry Kaiser Family Foundation, Daily Reports, www.kaisernetwork.org/Daily_Reports The Wall Street Journal, Health Edition Online, http:/ Yahoo Medical and Pharmaceutical News, http:/ MARKET TRENDS Compared to the aut
25、omotive or housing sectors, there is a general consensus that healthcare and diagnostics (as a part of the healthcare industry) are fairly recession- proof. Better yet the IVD industry can look forward to steady growth. There have been decreases in discretionary spending, but not all types of medica
26、l care can be put off. Heart disease, cancer, diabetes, autoimmune disease, and many other diseases strike regardless of the economic environment. At this time, a routine battery of tests would still be required. In fact there is some speculation that more people are likely to get sick this time rou
27、nd than during past downturns because the population is older and more obese. Chapter One: Executive Summary 3 Copyright 2009 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 This
28、 may seem as an obvious conclusion people get sick and will still need care, in spite of the state of the economy. This is true, however, the safe haven status that the IVD industry may enjoy is only relative to that of other industries. And in spite of the current stock market upturn, we are not qu
29、ite out of the woods. In fact there is evidence that some patients are cutting back on care. A study conducted by the Associated Press and reported in the April 13, 2009 edition of the New York Daily News found that people with diabetes increasingly are cutting back on doctor visits, treatment and t
30、esting during the economic recession, thus risking complications like amputation, vision loss, stroke and death. Hospital funding is in jeopardy. A major source of hospital funding derives from investment income. Some 80% of hospital asset financing is rooted in equity investments. With the constric
31、tion of the stock market, analysts estimate that most hospitals now have at least 50% less money to spend. The result is also a decrease in the level of their days cash on hand. This more precarious financial position leads to a less enviable credit rating and increases the rate at which many hospit
32、als can borrow money. The total effect of this liquidity crunch limits the flexibility of hospitals and their ability to carry on with strategic plans that may include discretionary spending on large capital expenditures. As cost management pressures continue to increase, private and public payers,
33、worldwide, make their decision whether or not to reimburse a new product based on its impact on patient care. No new test or test service can expect to be reimbursed simply because it appears to provide a technological improvement over the status quo. Therefore, payers of services, worldwide serve a
34、s gatekeepers to access to molecular testing, pharmacodiagnostics and all measure of specialized tests and services. Nevertheless, the market for IVD products appears to be holding its own: Demand for new tests continues to be strong and new tests continue to gain acceptance. Demand remains strong f
35、or cost effective diagnostics. Reimbursement continues to be favorable for new tests and procedures despite payers rhetoric about cost reduction. Product innovation continues via new collaborations and research and development. 4 IVD in a Recessionary Economy Copyright 2009 Kalorama Information Repr
36、oduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited WORLD DEMAND FOR DIAGNOSTICS The analysis presented throughout this report supports Kaloramas view that it is primarily status quo for the IVD industry ove
37、r the next 3-5 years. The world market for in vitro diagnostics will approach $47 billion in 2009. North America, Europe, Japan and Western Europe with 44%, 26% and 11% respectively make up 81% of the total IVD market. By 2014, their portion of the market is expected to decrease to 75%. There are ma
38、ny reasons for this rationale: In vitro diagnostics were the first products targeted for cutbacks in the major markets the U.S., Europe and Japan. Since the late 1980s healthcare payers have systematically frozen reimbursement rates for the existing group of tests and have imposed strict utilization
39、 guidelines for the adoption of new tests. The IVD industry did not experience the explosive growth seen in some medical devices. In the U.S. the American Hospital Association estimates that at least 70% of hospitals are members of a hospital system or participate in a group purchasing organization.
40、 Thus the majority of labs located in the largest single market for IVD products, the U.S., acquire their instruments, reagents and supplied for routine tests at rock bottom and discounted prices. New healthcare initiatives proposed by the new U.S. administration under the guidance of President Bara
41、ck Obama further bolster the use of IVDs. Demand for healthcare and thus diagnostic tests in all the major markets is driven by aging populations and increased incidence of conditions such as: cancer, diabetes, cardiovascular disease, arthritis and obesity. There is an emerging menu of specialized t
42、ests for these diseases, but routine tests are used as the first line of diagnosis. Chapter One: Executive Summary 5 Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibite
43、d Figure 1-1 IVD Market 2009 and 2014. Emerging markets, primarily China and India, will still experience market growth of 10-14%. This is fuelled by privatization and health insurance initiatives by governments and employers. But even at 15% market growth, IVD expenditures in China, L. America and
44、India add only $2,640,000 dollars (5%) to the world market for IVDs in 2009. The routine test segmentschemistry/immunoassay workstations, hematology, coagulation and routine microbiologymake up some 50% of the dollar value of hospital-based IVD market and about 70% of the market test wise. These tes
45、ts make up the basic investigation of any disease and it is not anticipated that there can be much of a cutback on these tests. Further, in vitro diagnostics were the first products targeted for cutbacks in the major markets the U.S., Europe and Japan. Since the late 1980s healthcare payers have sys
46、tematically frozen reimbursement rates for the $46,815 $63,255 $0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000 $70,000 20092014 6 IVD in a Recessionary Economy Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed,
47、in whole or in any part, is strictly prohibited existing group of tests and have imposed strict utilization guidelines for the adoption of new tests. The IVD industry did not experience the explosive growth seen in some medical devices. By 2014 more expensive nucleic acid, pharmacodiagnostic tests a
48、nd immunoassays for cancer, cardiovascular diseases and infectious diseases begin to gain market share. Some of these test segments may see some decreased utilization in the short term. But cost benefit analysis, technological innovation and investment in new test applications lead to increasing market share for other segments. Cancer research will spur g