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The global in vitro diagnostics (IVD) market was valued at USD 55,533.2 million and is anticipated to grow at a CAGR of 6.7% over the forecast period from 2019 to 2028. The worldwide market for in vitro diagnostics continues to undergo robust grow despite financial and industrial difficulties. The United States and Europe are mature zones contributing nearly 67.2% of global revenue. Asia Pacific, on the other hand, continues to be the fastest growing IVD market where development is driven primarily by emerging markets like China and India.
The amount of industry support in the IVD market is medium. Government sponsored healthcare programs play a major part in the IVD industry. Although the government provides little direct help to the in-vitro diagnostics sector, the growing amount of government-funded healthcare programs represents a substantial amount of income in the IVD market. In the United States, Medicare and Medicaid accounted for 20.3% of diagnostic industry income in 2016. Such level of public support for users is even greater in European economies where the state-sponsored healthcare systems are more robust. Such events are anticipated to consistent in the coming years, as changes in health and welfare spending continue to be the focus of intensive discussion in the United States.
Key segments of the global In Vitro Diagnostic (IVD) market
Type Overview, 2015-2025 (USD Million)
Application Overview, 2015-2025 (USD Million)
Regional Overview, 2015-2025 (USD Million)
Reasons for the study
What does the report include?
Who should buy this report?
This study is suitable for industry participants and stakeholders in the IVD industry, who want an in-depth insight into the movement of the IVD market. The report will benefit:
POCT is becoming common in emergency rooms, operation theaters, cath laboratories, recovery rooms, and intensive care units due to the increasing need for fast testing. Physician clinics also have a keen interest in POCT owing to the ease of diagnosis, quicker outcomes and growing pool of patients ready to pay for the services. Given the potential of POCT platforms and their capacity to transform healthcare delivery, businesses are reinforcing their focus on POCT tools for improved results in research and development.
Participants in the IVD market also receive good support from industry organizations and activist organizations. These include the Medical Diagnostics Manufacturers Association (MDMA), the Association of Medical Device Manufacturers (AMDM) and the Advanced Medical Technology Association (AdvaMed). The AMDM brings together industry players and regulatory authorities, while the MDMA protects the interests of producers of medical devices by defending the sector from unnecessary or unreasonable regulation.
It was the MDMA that directed political attempts to abolish the 2.3% excise tax on purchases of medical devices introduced through the 2010 Patient Protection and Affordable Care Act that resulted in the tax being suspended until 31st December 2017. AdvaMed is the world's biggest association for medical technology, representing producers of medical devices worldwide, including medical equipment manufacturers, medical software and medical supplies. It operates to foster communication among lawmakers, regulators, and medical communities. AdvaMed also aims to guarantee fast product approval by regulators, sensible policies for reimbursement and coverage and fair access to worldwide markets.
On the one hand, governments in developed countries are adjusting the reimbursement rates to the reimbursement costs and proactively pushing them forward, as can be seen in France. Conversely, the final customer market was expanded by providing the populations with a wide coverage of health insurance. As a consequence of public reforms, more than 800,000 individuals were insured in the United States in January 2014. China is striving to guarantee full demographic coverage through continuing health system reform. Due to widespread regulatory hurdles, entry into the markets of some nations is made even more challenging. China already has an American FDA-like scheme.
Molecular diagnostics have emerged as one of the leading and fastest-growing sectors of the IVD industry. This development is fueled by the introduction of powerful techniques such as real-time polymerase chain reaction (PCR) and next generation sequencing (NGS), which allow the decoding and amplification of genetic and epigenetic information.
Quantitative real-time polymerase chain reaction (qPCR) is a method used to amplify genetic information encoded in RNA and DNA. This method is now used for diagnostics to rapidly detect nucleic acids of pathogens such as viruses and bacteria, cancer mutations and other genetic variations. The diagnosis of infectious diseases has been improved in particular. Quantitative real-time polymerase chain reaction allows the quantification and genotyping of viruses, such as the hepatitis B virus, by a characteristic melting curve without sequencing. Newly emerging pathogens, such as new strains of the influenza virus, can also be quickly discovered.
Advances in DNA sequencing have also revolutionized the industry. Since the first human genome was sequenced in 2001 at a cost of around USD 3 billion, the technology has become much quicker and further economical. Next generation sequencing (NGS) has empowered molecular biologists to sequence a human genome within a day at a cost of approximately USD 1,000. In amalgamation with powerful bioinformatics, genomics is able to diagnose genetic diseases and disorders, particularly when it comes to finding the cause of rare diseases.
North America is a mature market and the largest contributor to the global IVD market. Despite several economic and industry challenges, the IVD market continues to show stable and robust growth in this region. The use of data-driven healthcare, automation and modernization of laboratories, unifying technology investments along with internal and external mergers are currently trending in North America.
The U.S. contributes the largest revenue share in North America. In 2017, the U.S. Food and Drug Administration launched 46 medical devices with premarket approvals as compared to 39 premarket approvals in 2016. The MedTech companies here, are acclimatizing to complex regulatory and reimbursement policies, and are advancing in clinical studies to ascertain the safety and efficacy of their medical devices. An upsurge in the adoption of communication technology in IVD devices in the U.S. also signifies progress in mhealth. The region’s IVD market performance is expected to face strong competition from growth in venture capital investment in emerging economies like China, Brazil and India, alongside growing local investor interest in developing economies. Additionally, implications of the Medical Device Excise Tax (MDET), unfortunate reimbursement procedures and extra fees for grouping of unique medical devices by FDA’s De Novo pathway are evident barriers for companies to enter this market.
The Canadian market is sophisticated and mature, with a robust demand for advanced IVD technologies with superior quality. Its vigorous manufacturing and health industries along with favorable policies for the growth of advanced digital technologies, are the key drivers for IVD market in this country. Approximately, 80% of the Canadian medical device market consists of imported goods, such as diagnostics, orthopedic, prosthetics and dental equipment. This trend is an ideal opportunity to attract foreign investors; however, manufacturers outside North America will face high competitive rivalry from the U.S. companies, which cover more than 50% of the Canadian medical devices market.
The global in vitro diagnostics (IVD) market was valued at USD 55,533.2 million and is anticipated to grow at a CAGR of 6.7% over the forecast period from 2019 to 2028. The worldwide market for in vitro diagnostics continues to undergo robust grow despite financial and industrial difficulties. The United States and Europe are mature zones contributing nearly 67.2% of global revenue. Asia Pacific, on the other hand, continues to be the fastest growing IVD market where development is driven primarily by emerging markets like China and India.
The amount of industry support in the IVD market is medium. Government sponsored healthcare programs play a major part in the IVD industry. Although the government provides little direct help to the in-vitro diagnostics sector, the growing amount of government-funded healthcare programs represents a substantial amount of income in the IVD market. In the United States, Medicare and Medicaid accounted for 20.3% of diagnostic industry income in 2016. Such level of public support for users is even greater in European economies where the state-sponsored healthcare systems are more robust. Such events are anticipated to consistent in the coming years, as changes in health and welfare spending continue to be the focus of intensive discussion in the United States.
Key segments of the global In Vitro Diagnostic (IVD) market
Type Overview, 2015-2025 (USD Million)
Application Overview, 2015-2025 (USD Million)
Regional Overview, 2015-2025 (USD Million)
Reasons for the study
What does the report include?
Who should buy this report?
This study is suitable for industry participants and stakeholders in the IVD industry, who want an in-depth insight into the movement of the IVD market. The report will benefit:
Chapter 1. Executive Summary
Chapter 2. Research Methodology
2.1. Research approach
2.2. Scope, definition, and assumptions
2.3. Data sources
Chapter 3. Market Outlook
3.1. Introduction
3.2. Key trends
3.2.1. Market drivers
3.2.2. Market restraints
3.2.3. Market opportunities
3.3. Porter’s Five Forces’ analysis
3.4. Value chain analysis
3.5. Market share of top 10 players (2016-2018)
3.6. Average Gross Margin (2016-2018)
Chapter 4. In Vitro Diagnostic (IVD) Market Overview, By Type
4.1. Global In Vitro Diagnostic (IVD) market share, by type, 2018 & 2028
4.2. Immunodiagnostics
4.2.1. Market size and projections, 2013 - 2028
4.3. Chemistry Diagnostics
4.3.1. Market size and projections, 2013 – 2028
4.4. Molecular Diagnostics
4.4.1. Market size and projections, 2013 – 2028
4.5. Point of Care Testing (POCT)
4.5.1. Market size and projections, 2013 – 2028
4.6. Others
4.6.1. Market size and projections, 2013 – 2028
Chapter 5. In Vitro Diagnostic (IVD) Market Overview, By Application
5.1. Global In Vitro Diagnostic (IVD) market share, by application, 2018 & 2028
5.2. Hospitals
5.2.1. Market size and projections, 2013 - 2028
5.3. Laboratories
5.3.1. Market size and projections, 2013 – 2028
5.4. Research and Academics
5.4.1. Market size and projections, 2013 – 2028
Chapter 6. In Vitro Diagnostic (IVD) Market Overview, By Region
6.1. Global In Vitro Diagnostic (IVD) market share, by region, 2018 & 2028
6.1.1. North America
6.1.1.1. Market size and projections, 2013-2028
6.1.1.2. Market size and projections, by type, 2013-2028
6.1.1.3. Market size and projections, by application, 2013-2028
6.1.1.4. Market size and projections, by country, 2013-2028
6.1.1.5. U.S.
6.1.1.5.1. Market size and projections, by type, 2013-2028
6.1.1.5.2. Market size and projections, by application, 2013-2028
6.1.1.6. Canada
6.1.1.6.1. Market size and projections, by type, 2013-2028
6.1.1.6.2. Market size and projections, by application, 2013-2028
6.1.1.7. Mexico
6.1.1.7.1. Market size and projections, by type, 2013-2028
6.1.1.7.2. Market size and projections, by application, 2013-2028
6.1.2. Europe
6.1.2.1. Market size and projections, 2013-2028
6.1.2.2. Market size and projections, by type, 2013-2028
6.1.2.3. Market size and projections, by application, 2013-2028
6.1.2.4. Market size and projections, by country, 2013-2028
6.1.2.5. Germany
6.1.2.5.1. Market size and projections, by type, 2013-2028
6.1.2.5.2. Market size and projections, by application, 2013-2028
6.1.2.6. U.K.
6.1.2.6.1. Market size and projections, by type, 2013-2028
6.1.2.6.2. Market size and projections, by application, 2013-2028
6.1.2.7. France
6.1.2.7.1. Market size and projections, by type, 2013-2028
6.1.2.7.2. Market size and projections, by application, 2013-2028
6.1.2.8. Italy
6.1.2.8.1. Market size and projections, by type, 2013-2028
6.1.2.8.2. Market size and projections, by application, 2013-2028
6.1.2.9. Spain
6.1.2.9.1. Market size and projections, by type, 2013-2028
6.1.2.9.2. Market size and projections, by application, 2013-2028
6.1.2.10. Russia
6.1.2.10.1. Market size and projections, by type, 2013-2028
6.1.2.10.2. Market size and projections, by application, 2013-2028
6.1.2.11. Benelux
6.1.2.11.1. Market size and projections, by type, 2013-2028
6.1.2.11.2. Market size and projections, by application, 2013-2028
6.1.2.12. Rest of Europe
6.1.2.12.1. Market size and projections, by type, 2013-2028
6.1.2.12.2. Market size and projections, by application, 2013-2028
6.1.3. Asia Pacific
6.1.3.1. Market size and projections, 2013-2028
6.1.3.2. Market size and projections, by type, 2013-2028
6.1.3.3. Market size and projections, by application, 2013-2028
6.1.3.4. Market size and projections, by country, 2013-2028
6.1.3.5. Japan
6.1.3.5.1. Market size and projections, by type, 2013-2028
6.1.3.5.2. Market size and projections, by application, 2013-2028
6.1.3.6. China
6.1.3.6.1. Market size and projections, by type, 2013-2028
6.1.3.6.2. Market size and projections, by application, 2013-2028
6.1.3.7. India
6.1.3.7.1. Market size and projections, by type, 2013-2028
6.1.3.7.2. Market size and projections, by application, 2013-2028
6.1.3.8. Korea
6.1.3.8.1. Market size and projections, by type, 2013-2028
6.1.3.8.2. Market size and projections, by application, 2013-2028
6.1.3.9. South East Asia
6.1.3.9.1. Market size and projections, by type, 2013-2028
6.1.3.9.2. Market size and projections, by application, 2013-2028
6.1.3.10. Australia
6.1.3.10.1. Market size and projections, by type, 2013-2028
6.1.3.10.2. Market size and projections, by application, 2013-2028
6.1.3.11. Rest of APAC
6.1.3.11.1. Market size and projections, by type, 2013-2028
6.1.3.11.2. Market size and projections, by application, 2013-2028
6.1.4. South America
6.1.4.1. Market size and projections, 2013-2028
6.1.4.2. Market size and projections, by type, 2013-2028
6.1.4.3. Market size and projections, by application, 2013-2028
6.1.4.4. Market size and projections, by country, 2013-2028
6.1.4.5. Brazil
6.1.4.5.1. Market size and projections, by type, 2013-2028
6.1.4.5.2. Market size and projections, by application, 2013-2028
6.1.4.6. Argentina
6.1.4.6.1. Market size and projections, by type, 2013-2028
6.1.4.6.2. Market size and projections, by application, 2013-2028
6.1.4.7. Colombia
6.1.4.7.1. Market size and projections, by type, 2013-2028
6.1.4.7.2. Market size and projections, by application, 2013-2028
6.1.4.8. Chile
6.1.4.8.1. Market size and projections, by type, 2013-2028
6.1.4.8.2. Market size and projections, by application, 2013-2028
6.1.4.9. Peru
6.1.4.9.1. Market size and projections, by type, 2013-2028
6.1.4.9.2. Market size and projections, by application, 2013-2028
6.1.4.10. Rest of South America
6.1.4.10.1. Market size and projections, by type, 2013-2028
6.1.4.10.2. Market size and projections, by application, 2013-2028
6.1.5. Middle East & Africa
6.1.5.1. Market size and projections, 2013-2028
6.1.5.2. Market size and projections, by type, 2013-2028
6.1.5.3. Market size and projections, by application, 2013-2028
6.1.5.4. Market size and projections, by country, 2013-2028
6.1.5.5. Egypt
6.1.5.5.1. Market size and projections, by type, 2013-2028
6.1.5.5.2. Market size and projections, by application, 2013-2028
6.1.5.6. Saudi Arabia
6.1.5.6.1. Market size and projections, by type, 2013-2028
6.1.5.6.2. Market size and projections, by application, 2013-2028
6.1.5.7. South Africa
6.1.5.7.1. Market size and projections, by type, 2013-2028
6.1.5.7.2. Market size and projections, by application, 2013-2028
6.1.5.8. Nigeria
6.1.5.8.1. Market size and projections, by type, 2013-2028
6.1.5.8.2. Market size and projections, by application, 2013-2028
6.1.5.9. UAE
6.1.5.9.1. Market size and projections, by type, 2013-2028
6.1.5.9.2. Market size and projections, by application, 2013-2028
6.1.5.10. Rest of MEA
6.1.5.10.1. Market size and projections, by type, 2013-2028
6.1.5.10.2. Market size and projections, by application, 2013-2028
Chapter 7. Company Profiles
7.1. F. Hoffmann-La Roche Ltd.
7.1.1. Company overview
7.1.2. Product portfolio
7.1.3. Key developments
7.1.4. Financial performance
7.1.5. SWOT Analysis
7.2. Abbott Laboratories, Inc.
7.2.1. Company overview
7.2.2. Product portfolio
7.2.3. Key developments
7.2.4. Financial performance
7.2.5. SWOT Analysis
7.3. Danaher Corporation
7.3.1. Company overview
7.3.2. Product portfolio
7.3.3. Key developments
7.3.4. Financial performance
7.3.5. SWOT Analysis
7.4. Siemens Healthineers Inc.
7.4.1. Company overview
7.4.2. Product portfolio
7.4.3. Key developments
7.4.4. Financial performance
7.4.5. SWOT Analysis
7.5. Thermo Fisher Scientific Inc.
7.5.1. Company overview
7.5.2. Product portfolio
7.5.3. Key developments
7.5.4. Financial performance
7.5.5. SWOT Analysis
7.6. Sysmex Corporation
7.6.1. Company overview
7.6.2. Product portfolio
7.6.3. Key developments
7.6.4. Financial performance
7.6.5. SWOT Analysis
7.7. bioMérieux SA
7.7.1. Company overview
7.7.2. Product portfolio
7.7.3. Key developments
7.7.4. Financial performance
7.7.5. SWOT Analysis
7.8. Ortho-Clinical Diagnostics Inc.
7.8.1. Company overview
7.8.2. Product portfolio
7.8.3. Key developments
7.8.4. Financial performance
7.9. Becton, Dickinson and Company
7.9.1. Company overview
7.9.2. Product portfolio
7.9.3. Key developments
7.9.4. Financial performance
7.9.5. SWOT Analysis
7.10. Bio-Rad Laboratories Inc.
7.10.1. Company overview
7.10.2. Product portfolio
7.10.3. Key developments
7.10.4. Financial performance
7.10.5. SWOT Analysis
7.11. Hologic Inc.
7.11.1. Company overview
7.11.2. Product portfolio
7.11.3. Key developments
7.11.4. Financial performance
7.11.5. SWOT Analysis
7.12. Illumina Inc.
7.12.1. Company overview
7.12.2. Product portfolio
7.12.3. Key developments
7.12.4. Financial performance
7.12.5. SWOT Analysis
7.13. QIAGEN
7.13.1. Company overview
7.13.2. Product portfolio
7.13.3. Key developments
7.13.4. Financial performance
7.14. Myriad Genetics Inc.
7.14.1. Company overview
7.14.2. Product portfolio
7.14.3. Key developments
7.14.4. Financial performance
7.15. Guangzhou Wondfo Biotech Co., Ltd.
7.15.1. Company overview
7.15.2. Product portfolio
7.15.3. Key developments
7.15.4. Financial performance
7.16. Shanghai Kehua Bio-engineering Co., Ltd (KHB)
7.16.1. Company overview
7.16.2. Product portfolio
7.16.3. Key developments
7.16.4. Financial performance
7.17. DAAN Gene Co., Ltd.
7.17.1. Company overview
7.17.2. Product portfolio
7.17.3. Key developments
7.17.4. Financial performance
7.18. Beijing Leadman Biochemistry Co., Ltd.
7.18.1. Company overview
7.18.2. Product portfolio
7.18.3. Key developments
7.18.4. Financial performance
7.19. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
7.19.1. Company overview
7.19.2. Product portfolio
7.19.3. Key developments
7.19.4. Financial performance
7.20. Biosino Bio-Technology and Science Incorporation
7.20.1. Company overview
7.20.2. Product portfolio
7.20.3. Key developments
7.20.4. Financial performance
7.21. SDIX, LLC
7.21.1. Company overview
7.21.2. Product portfolio
7.21.3. Key developments
7.21.4. Financial performance
7.22. Capricorn Products LLC
7.22.1. Company overview
7.22.2. Product portfolio
7.22.3. Key developments
7.22.4. Financial performance
7.23. Nittobo America Inc.
7.23.1. Company overview
7.23.2. Product portfolio
7.23.3. Key developments
7.23.4. Financial performance
7.24. Randox Laboratories Ltd.
7.24.1. Company overview
7.24.2. Product portfolio
7.24.3. Key developments
7.24.4. Financial performance