In vitro diagnostic tests - your guide to trends and revenue prospects
What's the future of in vitro diagnostic (IVD) testing? Visiongain's updated report predicts those revenues to 2023. There you find the best places for sales growth, also understanding trends, technologies, and opportunities.
That study gives you revenue forecasts to 2023 at overall world market, submarket, and national level. See what's happening for those technologies, finding how you can gain.
Read on to explore that industry and see what its future market could be worth.
Forecasts 2013-2023 and other analyses to help you understand IVD potential
Besides revenue forecasting to 2023, our new work shows recent results, growth rates, and market shares. There you find original analysis. See technological developments too. You also get 52 tables, 40 charts, and two interviews.
Many opportunities remain for those technologies and products. Now see how you can benefit your research, analyses, and decisions for IVD, also saving time.
You hear what's happening there and see where the money lies. That way you reduce your risk of missing out. Finding data you need there just got easier. Try our new report.
The following sections show, then, how you benefit from our new investigation and analysis.
Prospects from 2013 for the world market and submarkets
What are the secrets of that industry's progress? Along with prediction of the overall world market for IVD, our work shows you individual revenue forecasting of seven submarkets to 2023 at world level:
- Point-of-care testing
- Clinical chemistry
- Haematology-based applications (hematology)
- Microbiology-based tests
- Genetic-based testing
- Other systems (grouped forecast).
Our study gives you feel for what stimulates and restrains that industry and market. You see prospects for established and emerging technology and competition. That market will grow through the R&D, approval and launch of many products. See how you can benefit.
You also find that healthcare industry's geographical revenue prospects.
National markets - where will highest revenues and growth occur?
Our analyses show you individual revenue forecasts to 2023 for 11 national markets:
- United States (US)
- EU leaders - Germany, France, the UK, Italy, and Spain (EU5)
- BRIC countries - Brazil, Russia, India, and China.
There you assess the IVD industry's future - hear about developments and find their significance. Our work explains, exploring crucial issues.
Issues and events - what affects developers, producers and sellers?
The report lets you assess trends and outlooks for IVD companies. There, looking ahead, you find discussions of issues and developments:
- Regulations for approval and reimbursement
- Advances in technology benefiting IVD methods
- Competition driving consolidation and innovation
- Tests applying biomarkers.
- Immunoassays and automated systems
- Genetic testing, including direct-to-consumer (DTC) screening
- Cytogenetic tools
- Theranostics - targeting patients' needs through DNA testing.
Discover what its present and future hold.
Companies and 2017 market value - what happens next?
Our analysis predicts the world market for IVD products will reach $65.38bn in 2017, with high growth from 2013 to 2023.
That work also shows you what technologies and organisations hold greatest potential. See profiles of eight companies, including these:
- Abbott Laboratories
- Johnson & Johnson.
Information found nowhere else
In particular, then, our new study gives you these advantages:
- Revenues to 2023 for IVD products at world level, with forecasting of seven submarkets - assess prospects for investments and sales
- Forecasts to 2023 for 11 national markets in the Americas, Europe, and Asia - investigate countries for revenues and expected growth
- Prospects for established competitors, rising companies, and new entrants - explore activities, results, R&D, and outlooks for future success.
With that report you are less likely to fall behind in knowledge or miss sales opportunity. See there how you could benefit your research, analysis, and decisions. Explore progress and possibilities. Also find how you can save time and get recognition for insight.
Predictions for IVD sales - gain by ordering now
Our new report is for everyone investigating in vitro diagnostic technologies, reagents, and devices. There you discover revenue forecasts to 2023, with discussions. Avoid missing out - please order the report now.
Visiongain is a trading partner with the US Federal Government
CCR Ref number: KD4R6
1.1 Highlights from the Study
1.2 Aims, Scope and Format of the Report
1.3 Chapter Outlines
1.4 Research and Analysis Methods
2. INTRODUCTION TO IN VITRO DIAGNOSTICS
2.1 What are In Vitro Diagnostic (IVD) Tests?
2.2 Classifying In Vitro Diagnostics
2.2.1 The US Classification
2.2.2 The EC (European Commission) Classification
2.2.3 Regulatory Issues in the IVD Market
188.8.131.52 Regulation of IVD Tests
184.108.40.206 Lack of Clarity Can Be Costly
2.3 What are the Different Types of IVD Tests?
2.3.1 Point Of Care Diagnostics- The Most Prominent Type
2.3.2 Clinical Chemistry Is Not to Be Discounted
220.127.116.11 Regulatory Differences With IVD Microbiology Tests
2.3.6 Genetic Testing
3. THE GLOBAL IN VITRO DIAGNOSTICS MARKET, 2013-2023
3.1 In Vitro Diagnostics Market, 2012 - Nothing Radically Different
3.2 Global IVD Market Forecast, 2013-2023 - Three Sectors Dominate
3.2.1 Expected IVD Industry Trends Over 2013-2023
18.104.22.168 Advances in Technology Driving the IVD Market
22.214.171.124 Decentralisation Will Play its Part Too
126.96.36.199 Increased Awareness of Need for IVD Tests
4. LEADING NATIONAL IVD MARKETS, 2013-2023
4.1 Regional Breakdown of the Global IVD Market, 2012
4.2 The Global IVD Market: Regional Forecast, 2013-2023
4.3 The US Market - Still the Global Leader
4.3.1 Increased Levels of Molecular Testing in the US
4.3.2 Increased Use of Mobile Applications
4.3.3 Centralisation of Testing Facilities and the Impact of the Patient Protection and Affordable Care Act (PPACA)
4.4 The EU5 - Europe's Engine
4.4.1 Germany and France - In the Centre of Europe
4.4.2 United Kingdom - Still a Major Player
4.4.4 Italy - Still Reeling
4.5 The Japanese Market - The Sun Keeps on Rising
4.6 The BRIC Nations - Today's Growth Engines, Tomorrow's Leaders?
4.6.1 The Brazilian Market
4.6.2 The Russian Market - Many Growth Opportunities Exist for Sales
4.6.3 The Indian Market - A Massive Expansion is Expected
4.6.4 The Chinese Market - A Cut Above the Rest
5. IN VITRO DIAGNOSTICS MARKET SECTORS, 2013-2023
5.1 Point-of-Care Diagnostics - A Revolution in the Making?
5.1.1 POC Diagnostics Market, 2012
5.1.2 POC Diagnostics: Market Forecast, 2013-2023
5.1.3 POC Diagnostics: Market Trends, 2013-2023
188.8.131.52 New Tests Targeting Biomarkers Will Be Crucial
184.108.40.206 Competition Driving Consolidation and Product Innovation
220.127.116.11 Infectious Diseases Prompting Growth of POC
18.104.22.168 Other Factors Influencing the Influencing the POC Segment
5.1.4 Profile: Roche's Accutrend Plus System
5.2 Clinical Chemistry Still Going Strong
5.2.1 Clinical Chemistry: Market Forecast, 2013-2023
5.2.2 Clinical Chemistry: Market Trends, 2013-2023
5 .2.3 Profile: Siemens' ADVIA 2400 Chemistry System
5.3 Immunochemistry - Attack of the Antibodies
5.3.1 Immunochemistry: Market Forecast, 2013-2023
5.3.2 Immunochemistry: Market Trends, 2013-2023
22.214.171.124 Immunoassays and Automated Systems Prompting Market Growth
126.96.36.199 Strong Growth in China and India
5.3.3 Profile: Roche's Elecsys Anti-HBc IgM Immunoassay
5.4 Haematology - An Ever Present Medical Need
5.4.1 Haematology: Market Forecast, 2013-2023
5.4.2 Haematology: Market Trends, 2013-2023
5.4.3 Profile: Sysmex's XN Series
5.5 Microbiology - A Declining Segment?
5.5.1 Microbiology: Market Forecast, 2013-2023
5.5.2 Microbiology: Market Trends, 2013-2023
5.5.3 Profile: bioMerieux's Vitek 2 System
5.6 Genetic Testing - The Future of the Industry?
5.6.1 Genetic Testing: Market Forecast, 2013-2023
5.6.2 Genetic Testing: Market Trends, 2013-2023
188.8.131.52 Cytogenetic Tests to Drive Market Growth
184.108.40.206 Direct-To-Consumer (DTC) Genetic Screening
220.127.116.11 Theranostics: Targeting Unmet Needs Through DNA Tests
5.6.3 Profile: Qiagen's TheraScreen KRAS RGQ PCR Kit
6. LEADING COMPANIES IN THE IVD MARKET, 2013
6.1 A Fragmented Market, But a Few Major Player Dominate
6.2 IVD Market: Breakdown by Company, 2012
6.3 Roche Continues to Dominate
6.3.1 Sales and Recent Performance Analysis, 2012
18.104.22.168.Roche Diagnostics - More Growth From Emerging Markets
6.4 Danaher - A Strong Competitor
6.4.1 Sales and Recent Performance Analysis, 2012
22.214.171.124 Life Sciences & Diagnostics - Danaher's Revenue Generator
6.5 Siemens - A Highly Diversified Company
6.5.1 Sales and Recent Performance Analysis, 2012
126.96.36.199 Healthcare Sector
6.6 Abbott Laboratories Make a Major Contribution
6.6.1 Sales and Recent Performance Analysis, 2012
6.7 Johnson & Johnson - The World's Largest Med Tech Company
6.7.1 Sales and Recent Performance Analysis, 2012
188.8.131.52 Medical Devices and Diagnostics Segment
6.8 Other Companies to Watch Out For
6.8.1 Agilent Technologies Inc. - A Future Leader?
6.8.2 Life Technologies - One to Take Note Of
6.8.3 Myriad Genetics - Well Placed for the Genetic Revolution
7. SWOT AND STEP ANALYSIS OF THE IVD MARKET, 2013
7.1 In Vitro Diagnostics: Industry Trends
7.2.1 Patient Demographics Will Be a Major Driver
7.2.2 Technological Advancements Will Continue
7.3.1 Regulatory Board Approvals May Be Problematic
7.3.2 Reimbursement Issues Could Restrain Growth
7.4.1 Globalisation is making the World Smaller
7.4.2 Molecular Diagnostics Will Have Increased Prominence
7.5.1 Medical Device Excise Tax
7.6 STEP Analysis
8. OPINIONS FROM OUR SURVEY
8.1 Dr Catharina Boehme, Chief Executive Officer, Foundation for Innovative New Diagnostics (FIND)
8.1.1 On Major Challenges in Creating New Diagnostics for Developing World Diseases
8.1.2 On FIND's Recent Successes
8.1.3 On Unmet Medical Needs in Poor Nations
8.1.4 On the Most Promising Type of IVD Tests to Meet Developing World Needs
8.1.5 On Regulatory Requirements for IVD Products in Developing Nations
8.1.6 On Any Other Point of Interest
8.2 Mr David Yizhar, Chief Executive Officer, Adaltis
8.2.1 On Current Unmet Needs Facing the IVD Industry
8.2.2 On Which Therapeutic Areas Will Show the Greatest Demand
8.2.3 On the Future Geographical Focus
8.2.4 On the European Economic Environment
8.2.5 On Key Challenges in Developing IVD Products
8.2.6 On Any Other Point of Interest
9.2 Point-of-Care (POC) Testing Will Remain the Largest Segment
9.3 Prominent Companies in the Market
9.4 World Market Forecasting and Trends to 2023
9.5 Future Outlook and Concluding Remarks
LIST OF FIGURES
Figure 3.1 IVD Market Shares (%) by Sector, 2012
Figure 3.2 IVD Market Shares (%) by Sector, 2023
Figure 3.3 Global IVD Market Forecast ($bn), 2012-2023
Figure 4.1 IVD Market Shares (%) by Country, 2012
Figure 4.2 IVD Market Shares (%) by Country, 2023
Figure 4.3 The US: IVD Market Forecast ($bn), 2012-2023
Figure 4.4 EU5: IVD Market Shares (%) by Country, 2012
Figure 4.5 EU5: IVD Market Forecasts ($bn), 2012-2023
Figure 4.6 Germany and France: IVD Market Forecasts ($bn), 2012-2023
Figure 4.7 The UK: IVD Market Forecast ($bn), 2012-2023
Figure 4.8 Spain: IVD Market Forecast ($bn), 2012-2023
Figure 4.9 Italy: IVD Market Forecast ($bn), 2012-2023
Figure 4.10 Japan: IVD Market Forecast ($bn), 2012-2023
Figure 4.11 BRIC Nation Market Shares (%), Within the BRIC Bloc, 2012
Figure 4.12 BRIC IVD Market Forecast ($bn), 2012-2023
Figure 4.13 Brazil: IVD Market Forecast ($bn), 2012-2023
Figure 4.14 Russia: IVD Market Forecast ($bn), 2012-2023
Figure 4.15 India: IVD Market Forecast ($bn), 2012-2023
Figure 4.16 China: IVD Market Forecast ($bn), 2012-2023
Figure 5.1 POC Diagnostics Market Shares (%) by Test Type, 2012
Figure 5.2 Point-of-Care (POC) Diagnostics: Market Forecast ($bn), 2012-2023
Figure 5.3 Clinical Chemistry: Market Forecast ($bn), 2012-2023
Figure 5.4 Immunochemistry: Market Forecast ($bn), 2012-2023
Figure 5.5 Haematology: Market Forecast ($bn), 2012-2023
Figure 5.6 Microbiology: Market Forecast ($bn), 2012-2023
Figure 5.7 Genetic Testing: Market Forecast ($bn), 2012-2023
Figure 6.1 Leading Companies in the IVD Market by Market Shares (%), 2012
Figure 6.2 Roche Revenue Shares (%) by Business Segment, 2012
Figure 6.3 Roche Diagnostics Revenue Shares (%) by Product Line, 2012
Figure 6.4 Danaher Revenue Shares (%) by Business Segment, 2012
Figure 6.5 Siemens Revenue Share (%), by Business Sectors, 2012
Figure 6.6 Siemens' Diagnostics Revenue Share (%) within its Healthcare Sector, 2012
Figure 6.7 Abbott Revenue Shares (%), by Sector, 2012
Figure 6.8 Johnson & Johnson Revenue Shares (%) by Business Segment, 2012
Figure 6.9 Johnson & Johnson Franchise Revenue Shares (%) within the Medical Devices and Diagnostics Business Segment, 2012
Figure 6.10 Agilent Technologies Revenue Shares (%), by Business Segment, 2012
Figure 6.11 Life Technologies Revenue Shares (%), by Business Segment, 2012
Figure 6.12 Myriad Genetics Revenue Shares (%), by Business Segment, 2012
Figure 9.1 Projected IVD Market Revenues ($bn) by Sector, 2013, 2017 and 2023
Figure 9.2 Projected Total IVD Market Size ($bn), 2013, 2017 and 2023
Center for Devices and Radiological Health (CDRH) [part of US FDA]
European Commission (EC)
European Diagnostic Manufacturers Association (EDMA)
European Medicines Agency (EMA)
Foundation for Innovative and New Diagnostics (FIND)
Fujirebio Diagnostics Inc.
Gene Chip Research Centre, Tianjin, China
Hai Kang Life Corporation
Human Genetics Commission
Innova Biotechnology Co.
Japanese Ministry of Health and Welfare
Johnson & Johnson
Miraca Life Sciences
National Institute of Clinical Excellence (UK NICE)
Ortho Clinical Diagnostics
Pharmaceutical and Medical Devices Agency, Japan (PMDA)
SeraCare Life Sciences
Suzhou Ribo Life Sciences
Targeted Diagnostics & Therapeutics
Transasia Bio Medicals
United Nations (UN)
US Food and Drug Administration (FDA)
World Health Organization (WHO)
Genetic Testing: Market Trends, 2013-2023
Genetic testing is the newest category of IVD tests to be added to the global market. As a result, this sector is still in its infancy, representing only a 3.2% market share in 2012. However, the uptake and growth rate of this sector is expected to exceed that of any other IVD submarket.
There are several factors driving growth of the genetic testing market – pharmacogenomics and personalisation of medical treatment are the most significant growth drivers. Pharmacogenomics describes a branch of pharmacology that determines the influence of genetic variation on a patient’s drug response, by correlating the patient’s genetic expression with the drug’s efficacy or toxicity. This method of testing offers a new form of personalised medical care, by not only identifying which patients are most likely to respond (or develop resistance) to a particular drug, but also which patients will require modifications to their dosage, thereby reducing the risk of possible adverse drug effects. It is these features of pharmacogenomics testing which is set to propel the genetic testing IVD market during the forecast period. Furthermore, one of the primary uses of pharmacogenomic testing is to provide an accurate prognosis and diagnosis of infectious diseases, including AIDS and HIV. As the global incidence of these conditions continues to escalate towards pandemic levels (especially in regions such as sub-Saharan Africa), visiongain predicts a strong demand for pharmacogenomic testing, that will allow earlier indications of possible infection. While there is no currently available HIV vaccine, such tests can prompt the initiation of antiviral therapy, which although may not cure the patient or prevent the infection returning, but early application can significantly reduced the risk of death. This not only allows the patient to being preventative treatment before the onset of symptoms but also allows them to manage their won healthcare, which may prompt them to adopt certain lifestyle changes that can delay the onset or lessen the severity of the infection/disease. Therefore genetic testing has tremendous market value.
The genetic testing market is expected to grow as the medical understanding of the relationship between genes and diseases increases. Growth is expected to be particularly strong in the area of cancer diagnostics, as tests are able to determine whether a patient is likely to develop a certain form of cancer. It has been predicted, however, that the majority all future medical treatment (where applicable) will be designed in conjunction with, and based upon, the results of the patient’s genetic tests. As a result visiongain predicts their use will continue to expand during the forecast period of this report.
Cytogenetic Tests to Drive Market Growth
Cytogenetics forms an important part of the genetic testing market. The technique describes the study of the structure and function of cell, most notably the chromosomes, and the results can help assess abnormalities in chromosome structure (a key feature of several genetic diseases such as cancer, Down’s syndrome and infertility.
One example of a cytogenetic test is FISH (Fluorescence In Situ Hybridisation), where fluorescent probes are used to detect and localise specific DNA sequences on chromosomes. While this technique can be used for important life decisions (for example, parents wanting to understand their child’s developmental disability, before deciding to have another child), the primary application of FISH tests is to establish a diagnosis, or evaluate remission, of cancer. Traditional genetic tests are particularly time and labour consuming and significantly require dividing cells. Furthermore, they are often unable to identify the subtle differences in chromosome structure that are evident in different forms of cancer. FISH tests however, are able to elucidate these differences as they do not require living cells and results can be quantified automatically.
The application of FISH tests is likely to provide strong market growth for the overall genetic testing market, owing to the valuable diagnostic information offered by the technique especially with regards to cancer diagnosis. The ability to distinguish between different forms of cancer is one particular feature of this technique that will be highly useful in future diagnoses, as it will allow the oncologist to initiate the appropriate treatment plan for that specific form of cancer. It is this ability, coupled with the global rise in the incidence of cancer, which will sustain growth of the genetic testing market during the forecast period of this report.
The material was prepared in October, 2013.
Table 2.1 Advantages and Disadvantages of POC Diagnostics, 2013
Table 2.2 Types of Genetic In Vitro Diagnostic Tests Currently Available, 2013
Table 3.1 IVD Global Market Revenues ($bn) and Market Shares (%) by Sector, 2012
Table 3.2 Global IVD Market Forecast ($bn), by Sector, 2012-2023
Table 3.3 Global IVD Market: Drivers and Restraints, 2013-2023
Table 4.1 IVD Market Revenues ($bn) and Market Shares (%) by Country, 2012
Table 4.2 IVD Market Forecast ($bn) by Country, 2012-2023
Table 4.3The US: IVD Market Forecast ($bn), 2012-2023
Table 4.4 US: IVD Market Drivers and Restraints, 2013-2023
Table 4.5 The EU5: IVD Market Forecasts ($bn), 2012-2023
Table 4.6 EU5: IVD Market Drivers and Restraints, 2013-2023
Table 4.7 Germany and France: IVD Market Forecasts ($bn), 2012-2023
Table 4.8 The UK: IVD Market Forecast ($bn), 2012-2023
Table 4.9 Spain: IVD Market Forecast ($bn), 2012-2023
Table 4.10 Italy: IVD Market Forecast ($bn), 2012-2023
Table 4.11 Japan: IVD Market Forecast ($bn), 2012-2023
Table 4.12 Japan: IVD Market Drivers and Restraints,2013-2023
Table 4.13 BRIC Countries: IVD Market Forecasts ($bn), 2012-2023
Table 4.14 BRIC: IVD Market Drivers and Restraints, 2013-2023
Table 4.15 Brazil: IVD Market Forecast ($bn), 2012-2023
Table 4.16 Russia: IVD Market Forecast ($bn), 2012-2023
Table 4.17 India: IVD Market Forecast ($bn), 2012-2023
Table 4.18 China: IVD Market Forecasts ($bn), 2012-2023
Table 5.1 POC Diagnostics Revenues ($bn) & Market Shares (%) by Test, 2012
Table 5.2 Point-of-Care (POC) Diagnostics: Market Forecast ($bn), 2012-2023
Table 5.3 Point-of-Care (POC) Diagnostics Drivers and Restraints, 2013-2023
Table 5.4 Clinical Chemistry: Market Forecast ($bn), 2012-2023
Table 5.5 Clinical Chemistry Drivers and Restraints, 2013-2023
Table 5.6 Immunochemistry: Market Forecast ($bn), 2012-2023
Table 5.7 Immunochemistry Drivers and Restraints, 2013-2023
Table 5.8 Haematology: Market Forecast ($bn), 2012-2023
Table 5.9 Haematology Drivers and Restraints, 2013-2023
Table 5.10 Microbiology: Market Forecast ($bn), 2012-2023
Table 5.11 Microbiology Drivers and Restraints, 2013-2023
Table 5.12 Genetic Testing: Market Forecast ($bn), 2012-2023
Table 5.13 Genetic Testing Drivers and Restraints, 2013-2023
Table 6.1 Leading Companies in the IVD Market, Revenues ($bn) and Market Shares (%), 2012
Table 6.2 Roche Revenues ($bn) & Revenue Shares (%) by Business Segment, 2012
Table 6.3 Roche Diagnostics Revenues ($bn) and Revenue Share (%) by Product Line, 2012
Table 6.4 Danaher Total Revenues ($bn) and Revenue Shares (%) by Business Segments, 2012
Table 6.5 Siemens Revenues ($bn) & Revenue Shares (%) by Business Sectors, 2012
Table 6.6 Siemens' Diagnostics Revenue Share (%) Relative to Total Revenues ($bn) and Healthcare Sector Revenues ($bn), 2012
Table 6.7 Abbott Revenues ($bn) and Revenue Shares (%), by Sectors, 2012
Table 6.8 Johnson & Johnson Revenues ($bn) and Revenue Shares (%), by Business Segment, 2012
Table 6.9 Johnson & Johnson Revenues ($bn) by Franchise ($bn), Proportional to Business Segment Revenues (%) and Total Company Revenues (%), 2012
Table 6.10 Selected Other Companies Operating in the IVD Market, 2013
Table 6.11 Agilent Technologies Revenues ($bn) and Revenue Shares (%), by Business Segment, 2012
Table 6.12 Life Technologies Revenues ($bn) and Revenue Shares (%), by Business Segment, 2012
Table 6.13 Myriad Genetics Revenues ($m) and Revenue Shares (%), by Business Segment, 2012
Table 7.1 SWOT Analysis of the Global IVD Market, 2013-2023
Table 7.2 STEP Analysis of the Global IVD Market, 2013-2023
Table 9.1 IVD Market Forecasts ($bn) by Sector In 2013, 2017 and 2023