GBIME0067MR In Vitro Diagnostics Market to 2018 …In Vitro Diagnostics Market to 2018 - Consolidation, Decentralization and Demand for Genetic Testing to Shape the Competitive Landscape
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In Vitro Diagnostics Market to 2018 - Consolidation, Decentralization and Demand for Genetic Testing to Shape
the Competitive Landscape Reference Code: GBIME0067MR Publication Date: March 2012
In Vitro Diagnostics Market Forecast to Increase at a CAGR of XX% during 2011 – 2018
In Vitro Diagnostics Market, Global, Revenue ($bn), 2011–2018
2011 2018
Rev
enue
($bn
)
CAGR XX%
Source: GBI Research, Company Annual Reports, Interviews with Industry Expert and Key Opinion Leaders, Investor Presentations, News and Press Releases
The global In Vitro Diagnostics (IVD) market is forecast to grow at a Compounded Annual Growth Rate (CAGR) of XX% during 2011-2018 to reach a value of $XX billion by 2018. The IVD market will be driven by the shift to preventive healthcare from curative healthcare, the increase in the incidence of infectious diseases, the increase in the percentage of elderly people and technological advances.
Technological advances such as automation, biosensor technology, miniaturization, integration of workstations, and Information Technology (IT) optimizing laboratory workflow will lead to an increased demand for innovative technologies and drive the growth of the overall IVD market.
Emerging countries have huge potential for IVD and demand will be high in these countries.
Factors such as an increase in income levels, growing awareness among patients, an increase in the patient pool and the increased adoption of Point of Care (POC) testing will drive the market growth in these countries. The advantages of POC testing include reduced Turnaround Time (TAT), minimal infrastructure requirements and accessibility. These advantages will be major factors contributing to the increased demand for POC tests and will drive the growth of the overall IVD market.
The global In Vitro Diagnostics (IVD) market is forecast to grow at a Compounded Annual Growth Rate (CAGR) of XX% during 2011-2018 to reach a value of $XX billion by 2018
1 Table of Contents 1 Table of Contents...................................................................................................................5
1.1 List of Tables................................................................................................................9 1.2 List of Figures ............................................................................................................11
2 Introduction ..........................................................................................................................13 2.1 GBI Research Guidance.............................................................................................13
3 Global In Vitro Diagnostics Market: Market Characterization ..................................................14 3.1 Global in Vitro Diagnostics Market, Revenue ($bn), 2004–2011 ...................................14 3.2 Global In Vitro Diagnostics Market, Revenue ($bn), 2011–2018...................................16 3.3 Global In Vitro Diagnostics Market, Key Company Shares (%), 2010............................18 3.4 Global In Vitro Diagnostics Market: Key Market Trends................................................19
3.4.1 Growing Trend towards Preventive Healthcare is Driving the Growth of In Vitro Diagnostics .........................................................................................................19
3.4.2 Increased Use of Information Technology in IVD for Effective Workflow Management...........................................................................................................................20
3.4.3 Laboratory Consolidation is a Major Trend in the IVD Industry ..............................21 3.4.4 Demand for Decentralized Laboratory Testing is increasing Significantly Across the
World..................................................................................................................23 3.4.5 Consolidation Activity has Increased Significantly in the IVD Industry in Recent
Years..................................................................................................................23 3.4.6 Automation is the Key Technology Trend in IVD Market........................................24
3.5 Global In Vitro Diagnostics Market: Market Dynamics ..................................................26 3.5.1 Market Drivers.....................................................................................................26 3.5.2 Market Restraints ................................................................................................27
4 Global In Vitro Diagnostics Market: Market Category Analysis and Forecasts .........................28 4.1 In Vitro Diagnostics Market: Cross-Category Analysis..................................................28 4.2 Immunochemistry.......................................................................................................30
5 Global In Vitro Diagnostics Market: Country Analysis and Forecasts ......................................64 5.1 In Vitro Diagnostics Market: Cross-Country Analysis....................................................64 5.2 Historic and Forecast Revenue, By Country ................................................................66
5.2.1 In Vitro Diagnostics Market, The US, Revenue ($m), 2004–2011 ..........................66 5.2.2 In Vitro Diagnostics Market, the US, Revenue ($m), 2011–2018 ...........................67 5.2.3 In Vitro Diagnostics Market, Canada, Revenue ($m), 2004–2011..........................68 5.2.4 In Vitro Diagnostics Market, Canada, Revenue ($m), 2011–2018..........................69 5.2.5 In Vitro Diagnostics Market, the UK, Revenue ($m), 2004–2011 ...........................70 5.2.6 In Vitro Diagnostics Market, the UK, Revenue ($m), 2011–2018 ...........................71 5.2.7 In Vitro Diagnostics Market, Germany, Revenue ($m), 2004–2011........................72 5.2.8 In Vitro Diagnostics Market, Germany, Revenue ($m), 2011–2018........................73 5.2.9 In Vitro Diagnostics Market, France, Revenue ($m), 2004–2011 ...........................74 5.2.10 In Vitro Diagnostics Market, France, Revenue ($m), 2011–2018 ...........................75 5.2.11 In Vitro Diagnostics Market, Italy, Revenue ($m), 2004–2011 ...............................76 5.2.12 In Vitro Diagnostics Market, Italy, Revenue ($m), 2011–2018 ...............................77 5.2.13 In Vitro Diagnostics Market, Spain, Revenue ($m), 2004–2011.............................78 5.2.14 In Vitro Diagnostics Market, Spain, Revenue ($m), 2011–2018.............................79 5.2.15 In Vitro Diagnostics Market, Japan, Revenue ($m), 2004–2011 ............................80 5.2.16 In Vitro Diagnostics Market, Japan, Revenue ($m), 2011–2018 ............................81 5.2.17 In Vitro Diagnostics Market, China, Revenue ($m), 2004–2011.............................82 5.2.18 In Vitro Diagnostics Market, China, Revenue ($m), 2011–2018.............................83 5.2.19 In Vitro Diagnostics Market, India, Revenue ($m), 2004–2011 ..............................84 5.2.20 In Vitro Diagnostics Market, India, Revenue ($m), 2011–2018 ..............................85 5.2.21 In Vitro Diagnostics Market, Australia, Revenue ($m), 2004–2011 ........................86 5.2.22 In Vitro Diagnostics Market, Australia, Revenue ($m), 2011–2018 ........................87 5.2.23 In Vitro Diagnostics Market, Brazil, Revenue ($m), 2004–2011 .............................88 5.2.24 In Vitro Diagnostics Market, Brazil, Revenue ($m), 2011–2018 .............................89
6 Global In Vitro Diagnostics Market: Competitive Assessment .................................................90 6.1 Key Market Participants..............................................................................................91
6.1.1 F. Hoffmann–La Roche Ltd..................................................................................91 6.1.2 Siemens Healthcare (Subsidiary of Siemens AG).................................................92 6.1.3 Abbott Laboratories .............................................................................................93 6.1.4 Beckman Coulter, Inc. (Subsidiary of Danaher Corporation) .................................94 6.1.5 Ortho–Clinical Diagnostics Inc. (Subsidiary of Johnson & Johnson) ......................95 6.1.6 bioMerieux S.A. (Subsidiary of Merieux Alliance group) ........................................95
6.1.7 Sysmex Corporation (Sysmex).............................................................................96 6.1.8 Becton, Dickinson and Company .........................................................................97 6.1.9 Bio–Rad Laboratories, Inc. (Bio–Rad) ..................................................................98 6.1.10 Alere Inc. (formerly Inverness Medical Innovations, Inc.).......................................99
7 Global In Vitro Diagnostics Market: Product Pipeline Analysis ..............................................100 7.1 In Vitro Diagnostics Market: Pipeline Products Summary ...........................................100
7.2 In Vitro Diagnostics Market: Profiles of Key Pipeline Products....................................109 7.2.1 ImmProCon Technology ....................................................................................109 7.2.2 RAPIDPoint 500 System – Lactate Assay ..........................................................109 7.2.3 Sali – Chek Reader ...........................................................................................109 7.2.4 Point-of-Care Diagnostic Device ........................................................................110 7.2.5 ACE Alera Clinical Chemistry System – Direct A1c Assay...................................110 7.2.6 Advia 120 Hematology System – IRF Test .........................................................110 7.2.7 Advia 2120 Hematology System – MPC Test .....................................................111 7.2.8 AIA–600 II – D–dimer Test.................................................................................111
8 Global In Vitro Diagnostics Market: Consolidation Landscape ..............................................112 8.1 Deals by Number, 2008–2011...................................................................................112 8.2 In Vitro Diagnostics Market: Key Deals, 2008–2011...................................................120
8.2.1 Roche Completes Acquisition of mtm laboratories ..............................................120 8.2.2 bioMerieux Acquires Argene..............................................................................120 8.2.3 Thermo Fisher Completes Acquisition of Phadia.................................................120 8.2.4 Quest Diagnostics Completes Acquisition of Athena Diagnostics ........................121 8.2.5 Danaher Completes Acquisition of Beckman Coulter ..........................................121 8.2.6 Laboratory Corporation of America Completes Acquisition of Genzyme Genetics
From Genzyme .................................................................................................122 8.2.7 Merck Completes Acquisition of Millipore ...........................................................122 8.2.8 Thermo Fisher Scientific Completes Acquisition of Ahura Scientific .....................122 8.2.9 Inverness Medical Innovations Acquires 78.13% Stake in Standard Diagnostics..123 8.2.10 Quidel Completes Acquisition of Diagnostic HYBRIDS .......................................123 8.2.11 Danaher Completes Acquisition of Genetix Group ..............................................123 8.2.12 QIAGEN Completes Acquisition of DxS..............................................................123 8.2.13 Thermo Fisher Scientific Completes Acquisition of B.R.A.H.M.S. ........................124 8.2.14 Laboratory Corporation of America Holdings Completes Acquisition of Monogram
Biosciences.......................................................................................................124 8.2.15 Inverness Medical Innovations Completes Acquisition of Concateno From Marwyn
Figure 61: Cardiovascular Devices Market, Mergers and Acquisitions, Number of Deals, Global, 2008–2011..............................................................................................................112
2 Introduction In Vitro Diagnostics (IVD) includes all diagnostic tests that are performed in laboratories or other health professional settings using body fluids such as urine, blood and tissues derived from the human body. The tests are done to diagnose disease, provide disease screening, to monitor therapy and to ensure safety during blood transfusions. The IVD tests are also used for monitoring disease progression and to target patients for specific drugs.
Major IVD market categories include: clinical chemistry, immunochemistry, microbiology culture, hematology, cytology and histology, genetic testing and infectious immunology. IVD companies supply instruments and reagents for these categories.
The global IVD market is highly fragmented with a large number of companies operating in the market. Increased Merger and Acquisition (M&A) activities in the past few years have resulted in companies expanding their product portfolios through inorganic means. Increased demand for advanced tests such as genetic tests, combined with the growing demand for IVD in emerging countries, have increased the focus of IVD companies in these areas.
Companies are expanding their test menu as well as their geographic presence in emerging countries. The IVD market is expected to grow at a moderate rate of XX% to 2018.
2.1 GBI Research Guidance This report begins with an executive summary which captures the key categories and factors
driving and restraining the growth of the global IVD market. This chapter also outlines the major categories and companies operating in the IVD market.
Chapter two provides an introduction to IVD and an overview of the market.
Chapter three provides information on the historic size of the market during 2004–2011 and the expected market size during the forecast period 2011–2018. It also includes information related to market trends and dynamics. In the market dynamics section, comprehensive information is provided on market drivers and restraints, as well as the competitive landscape for the overall IVD market.
Chapter four includes category level details of the IVD market. Market size information for the historic (2004–2011) and forecast (2011–2018) periods are discussed for each category, in addition to market dynamics and competition.
Chapter five provides historic (2004–2011) and forecast (2011–2018) information on the IVD market for the US, Canada, The UK, France, Germany, Italy, Spain, Japan, China, India, Australia and Brazil.
Chapter six provides a competitive assessment of the market, and profiles of the leading IVD companies and their product portfolios.
Chapter seven focuses on the pipeline products for the various market categories. Key pipeline products are listed and discussed in detail. Product approval and expected launch dates are also provided for a number of products.
Chapter eight discusses the consolidation landscape in the IVD industry. This chapter looks at the total number of deals that took place during 2004–2011.
3.3 Global In Vitro Diagnostics Market, Key Company Shares (%), 2010
Figure 3: Global In Vitro Diagnostics Market, Key Company Shares (%), 2010
F. Hoffmann-La Roche Ltd.
Siemens Healthcare
Abbott Laboratories
Beckman Coulter, Inc.
Ortho-Clinical Diagnostics Inc.
bioMerieux S.A.
Sysmex Corporation
Becton, Dickinson and Company
Bio-Rad Laboratories, Inc.
Alere Inc.
Others
Source: GBI Research, Company Annual Reports, Interviews with Industry Expert and Key Opinion Leaders, Investor Presentations, News and Press Releases
Table 3: Global In Vitro Diagnostics Market, Key Company, Revenue ($m) 2010 Company Name Revenue ($m)
F. Hoffmann-La Roche Ltd.
Siemens Healthcare
Abbott Laboratories
Beckman Coulter, Inc.
Ortho-Clinical Diagnostics Inc.
bioMerieux S.A.
Sysmex Corporation
Becton, Dickinson and Company
Bio-Rad Laboratories, Inc.
Alere Inc.
Others
Total
Source: GBI Research, Company Annual Reports, Interviews with Industry Expert and Key Opinion Leaders, Investor Presentations, News and Press Releases
In 2010, F. Hoffmann-La Roche Ltd was the market leader in the IVD market and was closely followed by Siemens Healthcare, each with a market share of XX%
Source: GBI Research, Company Annual Reports and Interviews with Industry Experts and Key Opinion Leaders
The histology and cytology market is expected to grow at a CAGR of XX% during 2011–2018 to reach a value of $XXm by 2018. The increase in the number of cancer cases and technological advances, such as automation and use of advanced digital imaging techniques, are expected to drive the market growth.
9 Appendix 9.1 Definitions In Vitro Diagnostics (IVD) include analyzers and reagents which are used in the diagnosis of disease or other health conditions, and also tests to determine the state of health, in order to treat or prevent disease. Such reagents, instruments and systems are used in the processes such as sample collection, sample preparation, and examination of samples taken from the human body.
9.1.1 Clinical Chemistry Clinical chemistry includes reagents, test kits and devices that determine the concentration and/or protein activity, carbohydrates, lipids, electrolytes, enzymes or small bio molecules in human body fluids such as blood, plasma, serum, or urine. Immuno chemical reagents are not included under this category and are tracked separately under Immunochemistry. This category comprises of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for all enzyme, metabolite and electrolyte analysis and instruments used for clinical chemistry diagnosis are also covered in this category.
9.1.1.1 Enzyme Chemistry Reagents
Reagents and test kits used for quantification and detection of enzymes that act as a marker for identification and determination of disease states and bodily functions. Examples of enzymes tracked include acid phosphatase, alkaline phosphatase, creatine kinase, and lactate dehydrogenase.
9.1.1.2 Metabolite Chemistry Reagents
Reagents used for the quantification of metabolites for assessment of bodily functions and disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin and bilirubin.
9.1.1.3 Electrolyte Chemistry Reagents
Reagents used to quantify or detect electrolytes such as sodium, potassium, chloride, bicarbonate, magnesium, and calcium from the extra cellular fluids of the body.
9.1.1.4 Clinical Chemistry Rapid Tests & POC
Clinical chemistry rapid tests provide the test results immediately. These tests are used in low resource settings with the help of test strips, tablets, and solutions. Urine testing, feces testing, blood gas electrodes are tracked in this segment. Blood glucose tests strips are not tracked in this segment.
9.1.1.5 Clinical Chemistry Analyzers
Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry, metabolite chemistry, electrolyte chemistry. Clinical chemistry analyzers can be fully automated or semi automated.
Automated Clinical Chemistry Analyzers
A fully automated clinical chemistry analyzer has software that enables the operator to feed in most test parameters. The tasks associated with performing the test such as dispensing the reagents and incubation are automated and require minimum manual work.
Semi–Automated Clinical Chemistry Analyzers
A semi–automated clinical chemistry analyzer requires an operator to perform the reagent dispensing, incubation and other tasks manually.
9.1.1.6 Urine Analysis
Urine analysis is the analysis of urine for the diagnosis of disease or for detecting the presence of a specific substance.
Urine Analyzers
Urine analyzers are analytical laboratory equipment used in qualitative and semi–quantitative tests done using urine sample.
Urine analyzer reagents are the reagents used in urine analyzers.
9.1.2 Immunochemistry Test Reagents The immunochemistry category includes reagents, instruments and test kits used for the analysis of antigen–antibody interactions in any of the bodily fluids. The category includes both test kits and reagents for quantification and detection of specific proteins, hormones, drug moieties and non infectious diseases.
9.1.2.1 Specific Proteins
Reagents and test kits used to quantify and detect protein molecules from bodily fluids.
9.1.2.2 Endocrinology Tests
Reagents used for quantification and detection of endocrine hormones secreted in the human body.
Thyroid Function Hormones
Reagents used for quantification and detection of hormones secreted by the thyroid gland. Reagents used to test TSH, T3 and T4 are included in this segment.
Fertility or Pregnancy Hormones
Pregnancy test system is intended for the early detection of pregnancy by measurement of Human Chronic Gonadotropin (HCG), a placental hormone, in plasma or urine.
Individual and Specified Hormones
Reagents are used for a quantitative measurement of specific hormones from human specimens such as blood, plasma and urine. All human hormones tested for any other purpose other than pregnancy and thyroidal hormones are included here. They include reagents for testing of hormones such as Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, and Aldosterone.
9.1.2.3 Drug Related Testing
Reagents used to determine the presence or quantity of drug compounds in a patient's blood sample.
Therapeutic Drug Monitoring
Reagents and test kits intended to measure different types of therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for measurement of both proteins based and chemical based therapeutic drugs. This include tests for antibiotics, anti analgesics, anti–inflammatory, antipyretic and menstrual drugs.
Drugs of Abuse/Toxicology
Test kits for measurement of drugs of abuse from blood, serum or urine. They are systems used for testing of depressants, narcotics, stimulants and hallucinogens.
9.1.2.4 Disease Specific Immunochemistry
Auto–Immune Diseases Tests used in the diagnosis of immune system disorders and other disease states to detect auto antibodies, which are antibodies produced against the body's own tissues.
Tumor markers
Tests that detect specific antibody/antigen produced by the tumor itself or by the body in response to the tumor. The tests can assay markers from samples of blood, urine, or body tissue.
Cardiac markers
Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and other acute coronary syndromes. The tests include assays for proteins and chemicals such as Creatine Kinase–MB (CK–MB), myoglobin, homocysteine, C–Reactive Protein (CRP), troponin T (cTnT), and troponin I (cTnI), associated with heart diseases.
Rheumatoid – Inflammatory diseases markers are antigen/antibodies that detect specific antigen/antibody produced by the bone, cartilage or inflammatory disease activity.
9.1.2.5 Organ Function Assays
Test systems for evaluating the wellness of a specific organ through an assay of the organ metabolites. These include liver function tests and kidney function tests.
9.1.2.6 Immunochemistry Rapid Tests
Spot test kits intended generally for rapid diagnosis, with immediate results, through immunoassays.
9.1.2.7 Immunochemistry Analyzers
Analytical laboratory equipment used to perform both routine and special immunochemistry tests.
Chemiluminescence Analyzers
Chemiluminescence analyzers analyze NO, NOX, NO2 and NH3 concentrations within a gaseous sample.
Radioimmunoassay Analyzers
Radioimmunoassay analyzers are used to measure concentrations of antigens (for example, hormone levels in the blood) without the need to use a bioassay.
Immunofluorescence Analyzers
Immunofluorescence analyzers are used to label the antibodies or antigens by visualizing the sub cellular distribution of biomolecules of interest.
ELISA Instruments
ELISA Instruments are used in enzyme–linked immuno sorbent assay. These Instruments include Micro plate readers and ELISA washers.
9.1.3 Hematology Hematology includes reagents, rapid tests and instruments used for determination and diagnosis of both physiological and pathological aspects of blood and its components. The category also includes immune relates reagents used for analysis of blood and its components.
9.1.3.1 Hematology Reagents
Reagents are provided for substantially lysing red blood cells in a whole blood sample prior to hematology analysis.
Hematology Analyzer Reagents
Hematology analyzer reagents are exclusively used in the blood lysing techniques.
Slide Stainers
Slide stainers are reagents used in staining of the slides and smears.
9.1.3.2 Hematology Analyzers
Analytical laboratory equipment used to perform tests related to blood and its components
9.1.3.3 Hemostasis
Analyzers that conduct blood coagulation related tests.
General Coagulation Tests
Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or PTT), bleeding time, and plasma thrombin time.
Special Coagulation Tests
Special coagulation tests are used to provide quantitative determination of anticoagulant activities of heparin and thrombin formation.
Tests used in the determination of cytokines belonging to the chemokine family.
Coagulation Analyzers
Automated laboratory equipment used in clotting assay, chromogenic assay, and hemostasis profile.
9.1.3.4 Hematology Cell Counters
Blood counters for complete blood count determination in routine examinations.
Hemoglobin meters
Instruments used to measure the percentage of hemoglobin in a blood sample.
Differential Counters
Instruments used in detection of the count of white cell types.
9.1.3.5 Immuno Hematology
Immuno Hematology studies antigen–antibody reactions and analogous phenomena as they relate to the pathogenesis and clinical manifestations of blood disorders.
ABO Typing
Reagents used for detecting blood types into four categories of Type A, Type B, Type AB, Type O.
Rhesus Typing
Test to detect Rh factor (antigen) on the surface of the red blood cells.
Antibody Detection
Antibody detection is done for the differential diagnosis of many different pathological conditions. Determination of specific antibodies to bacterial and viral pathogens as well as to parasites enabled the correct therapeutic measures to be taken.
9.1.3.6 Hematology Rapid Tests
Spot tests that generate results immediately and can be done in low resource setting
Cytology is the examination and study of cells and its related structures. In this segment flow cytometers are tracked.
Flow Cytometers
Flow cytometers are electronic detection apparatus used is a technique for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid.
9.1.5 Microbiology Culture This category includes reagents used for the preparation of growth medium for microbial organisms.
9.1.5.1 Blood Culture
Culture media used for the preparation of medium capable of supporting the growth of mycobacterium. They are generally in solid/liquid forms or only solid and liquid forms with constituents specific to the bacteria.
9.1.5.2 Mycobacteria Culture
Culture media used for the preparation of medium capable of supporting the growth of mycobacterium.
Reagents used to test the sensitivity of bacteria towards an antimicrobial substance.
9.1.5.4 Immunological Culture Identification
Reagents used to test Streptococci grouping, Staphylococci, and Meningitis.
9.1.5.5 Parasitology Culture
Culture media used for the preparation of medium capable of supporting growth of blood parasites such as plasmodium and pneumocystis.
9.1.5.6 Mycology Culture
Reagents for preparation of medium that is capable of supporting growth of fungi
9.1.5.7 Microbiology Analyzers
Analytical laboratory equipment used to perform routine and special microbiology tests. Microbiology analyzers can be fully automated or semi automated.
Automated Microbiology Analyzers
A fully automated clinical chemistry analyzer is connected to a software program that allows the user to feed in most test parameters. The tasks associated with performing the test such as dispensing the reagents and incubation are automated and require minimum manual work.
Semi–Automated Microbiology Analyzers
A semi–automated clinical chemistry analyzer requires an operator to perform the reagent dispensing, incubation and other tasks manually.
9.1.6 Infectious Immunology Reagents, instruments and test kits used for the analysis of antigen–antibody interactions for the detection or quantification of bacteria and viruses.
9.1.6.1 Bacteriology
Reagents, instruments and test kits to detect the pathogenicity of the bacteria such as Chlamydia, Gonococci, Syphilis, Helicobacter Pylori, and Salmonella.
9.1.6.2 Hepatitis Viruses
Diagnostic kits used to detect the hepatitis virus such as HAV, HBV, HCV, and HbsAg.
Diagnostic kits used to detect the antigen/antibody of HIV and HTLV.
9.1.6.4 Other Virology
Diagnostic kits used to confirm the antigen/antibody of Rubella, Cytomegalovirus, Herpes Simplex Virus, and Epstein Barr Virus.
9.1.7 Genetic Testing Genetic testing reagents used for identifying the specific syndrome present and can improve the accuracy of the diagnostic tests leading to a better treatment.
9.1.7.1 Inborn Gene or Chromosome Alterations
Genetic tests to detect monogenetic disorders, polygenetic disorders, chromosomal disorders, and polymorphisms
Acquired Gene or Chromosome Alterations
Genetic tests to detect cancer causing genes/related alterations.
9.1.7.2 Other Genetic Tests
Other genetic tests include pharmaco-genomics and other tests.
9.2 Sources American Association for Clinical Chemistry
American Diabetes Association
Annual reports and SEC filings
Center for Disease Control
Company websites
World Health Organization, 2011, Fact sheet N 310. Updated June 2011. URL: http://www.who.int/mediacentre/factsheets/fs310/en/index.html.
BIOMERIEUX, 2011, A World Leader in ‘In Vitro Diagnostics’. A report from Biomerieux. URL: ttp://www.biomerieux.com/upload/bioMerieux%20discovery%20december%202011-1.pdf [Accessed on Feb, 15, 2012]
Economist Intelligence Unit (Sponsored by Roche), 2010, Broadening healthcare access in Brazil through innovation. A report from the Economist. URL:Intelligence Unit http://www.managementthinking.eiu.com/sites/default/files/Roche_Healthcare_WEB_English.pdf [Accessed on Feb, 10, 2012]
José Cech (2011). Living Longer and Better in Brazil: Challenges and Opportunities Faced by a Graying Society. Available from: http://journal.aarpinternational.org. [Accessed on Feb, 20, 2012]
IFCC the International Federation of Clinical Chemistry
ISO: the International Standardization Organization
IUPAC: International Union of Pure and Applied: Chemistry
LIS/HIS: Lab Information Systems and Hospital Information Systems
MEMS: Microelectromechanical Systems
NCCLS: National Committee for Clinical Laboratory Standards
NHS: National Health Service
OR: Operation Rooms
POCT: Point Of Care Rapid Tests
RIA: Radioimmunoassay
WHO: the World Health Organization
9.4 Research Methodology GBI Research’s dedicated Research and Analysis Teams consists of experienced professionals with a pedigree in marketing, market research, consulting background in the medical devices industry and advanced statistical expertise.
GBI Research adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and the Society of Competitive Intelligence Professionals (www.scip.org).
All GBI Research databases are continuously updated and revised. The following research methodology is followed for all databases and reports.
9.4.1 Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and SEC Filings.
Industry trade journals, scientific journals and other technical literature.
Internal and external proprietary databases.
Relevant patent and regulatory databases.
National government documents, statistical databases and market reports.
Procedure registries.
News articles, press releases and web-casts specific to the companies operating in the market.
9.4.2 Primary Research GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:
It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook etc.
Helps in validating and strengthening the secondary research findings.
Further develops the Analysis Team’s expertise and market understanding.
Primary research involves e-mail correspondence, telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies.
The participants who typically take part in such a process include, but are not limited to:
Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers.
Hospital stores, laboratories, pharmacies, distributors and para-medics.
Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets.
Key opinion leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.
9.4.3 Models Where no hard data is available GBI Research uses modeling and estimates in order to produce comprehensive data sets. The following rigorous methodology is adopted:
Available hard data is cross referenced with the following data types to produce estimates:
Demographic data: population, split by segment.
Macro-economic indicators: GDP, inflation rate. .
Healthcare Indicators: health expenditure, physicians base, healthcare infrastructure and facilities.
Selected epidemiological and procedure statistics.
Data is then cross checked by the expert panel.
All data and assumptions relating to modeling are stored and are available to clients on request.
9.4.4 Forecasts GBI Research uses proprietary forecast models. The following four factors are used in the forecast models:
Historic growth rates.
Macro indicators such as population trends and healthcare spending.
Forecast epidemiological data.
Qualitative trend information and assumptions.
Data is then cross checked by the Expert Panel.
9.4.5 Expert Panels GBI Research uses a panel of experts to cross verify its databases and forecasts.
GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies.
Historic data and forecasts are relayed to GBI Research’s Expert Panel for feedback and adjusted in accordance with this feedback.
9.6 Disclaimer All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.