In-Vitro Diagnostics (IVD) Market Overview
The global in-vitro diagnostics market was valued at USD 59,703.1 million in 2017, is expected to witness a CAGR of 4.9% over the period, 2018-2023 (henceforth, the forecast period). In-vitro diagnostics (IVD) involves medical devices and consumables that are utilized to perform in vitro tests on various biological samples. They are used for the diagnosis of various medical conditions, such as chronic diseases. In this report, a detailed analysis of the in vitro diagnostics market is presented, with specific attention toward diabetes and thalassemia. High prevalence of chronic diseases and increasing use of Point-of-care (POC) diagnostics are expected to boost the global market. North America accounts for the largest share of the In-vitro diagnostics market due to the factors like rising prevalence of chronic disorders such as respiratory disease and cancer.
Advanced Technologies Spurring the IVD Market
The field of in-vitro diagnostics has witnessed several changes and additions to its gamut of offerings in the recent past. There has been a paradigm shift from traditional diagnostics to a new generation diagnostics that work on the gene level. This was possible due to the inclusion of advanced technology, such as genetic testing, molecular diagnostics, Polymerase Chain Reaction (PCR), and Next-Generation Sequencing (NGS). Fast turnaround, reliability, user-friendliness, and predictability of predisposed diseases are few significant qualities, which helped these technologies attain their share in major offerings of diagnosis providers around the world. Increasing demand from the educated public for more information about their predisposition for serious diseases, and how these potential illnesses can be detected at an early stage, is driving the market for in-vitro diagnostics. High prevalence of chronic and infectious diseases, increasing use of point of care (POC) diagnostics, and surging number of private hospitals and independent testing laboratories are some of the other factors contributing to the growth of the market.
Cumbersome Reimbursement Procedure
The lack of proper reimbursement system around the globe poses to be a major restraining factor for the in-vitro diagnostics market. The process of securing reimbursement and funding for a diagnostic test on a global scale is extremely challenging. Stakeholders need to recognize what knowledge the payers/purchasers are looking for. This asks for extensive research and interpretation of a very large amount of data. Moreover, international reimbursement structures vary from country to country; hence, interested parties have to come up with new and effective strategies frequently, making it a cumbersome and tedious task hindering the market. Additionally, stringent regulations across the globe and limited budget of hospitals and laboratories in developing economies are also restraining the in-vitro diagnostics market.
Market Segmentation Insights for the In Vitro Diagnostics (IVD) Market
Insights on Product Segment
By Technique, the market is segmented into Immunochemistry, POC Diagnostics, Molecular Diagnostics, Hematology, Tissue Diagnostics, Microbiology, Self-blood Glucose Monitoring and other techniques. Molecular diagnostics has the largest share in the market, about 28% in 2017. Factors, such as large outbreaks of bacterial and viral epidemics in the world, increasing demand for point-of-care diagnostics, and rapidly evolving technology, are driving the growth of the molecular diagnostics segment. The point of care (POC) has the highest CAGR during the forecast period.
Under the Product segment, the Reagent sub-segment holds the largest market share with more than 80% market share and was valued at approximately USD 49 billion in 2017. The highest growth is also expected to be exhibited by Reagent sub-segment, with a CAGR of 5% over the forecast period. Given the high cost of many diagnostic platforms, it is common for manufacturers to lease equipment instead of selling technology outright to end users. In these arrangements, the lease is tied to contracts to purchase associated reagents or assays for the equipment over the life of the contract. Consequently, many diagnostic companies have in excess of 75% of sales from consumables such as assays and reagents, and such agreements guarantee the generation of cyclic revenues associated with the sale of reagents and other consumables. The above mentioned is a major driver for the growth of Reagent sub-segment at a global level in IVD market.
Insights into the usability segment, Reusable IVD Devices dominated the market share having 55% in 2017. The recent trend of precision and personalized medicines that usually require multi-marker diagnosis is driving the growth of the reusable IVD devices segment.
On the basis of application the market is segmented into infectious diseases, diabetes, cancer/oncology, cardiology, autoimmune disease, nephrology, drug testing, HIV/AIDS and others. Infectious disease dominated the market having a share of 26% due to the high prevalence of infectious diseases. However, cancer is growing with the highest CAGR during the forecast period.
In the end-user segment the market is segmented into laboratories, hospitals, academia, POC testing and others. Hospitals has the largest share in the market due to the increasing incidences of hospital-acquired infections and the associated molecular diagnostic procedures in the hospitals which are expected to drive the hospital segment revenues. However, POC testing has recorded the highest CAGR in the market.
Insights on Geography Segment
North America is the most prominent regional market in terms of revenue in 2017 due to rising chronic disease and rapid adoption of innovative IVD methods, such as digital PCR, mass spectrophotometry, chromosome analysis, tissue microarrays, next-generation sequencing, and cell signalling pathway testing in the regions.
The Asia-Pacific region is expected to grow with the fastest compounded annual growth rate of about 5.6% over the forecast period. The fastest growing market will be the regional market of China in the Asia-Pacific region, while Japan region holds the largest market share in the current market.
By the end of the forecast period, the China market is expected to grow to have the largest market share in the IVD market of the Asia-Pacific region. The growth of the market in China is due to the upsurge of the geriatric population and the increasing prevalence of chronic diseases, like diabetes, cancer, and CVD. Additionally, between 2014 & 2018, in order to shorten and standardize IVD approval periods, many Japanese authorities improved collaboration between Japanese regulators and industries.
Key Developments in the In Vitro Diagnostics (IVD) Market
- February 2015: Roche acquired Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer.
- May 2018: Beckman Coulter Diagnostics announced the global launch of next-generation software to support new and existing DxH 500 hematology analyzers.
- Jun 2018: Beckman Coulter Diagnostics announced that it received 510(k) clearance from the US Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay.
Major companies include BioMérieux, Danaher Corporation, Roche Diagnostics, Becton, Dickinson and Company, Bio-Rad Laboratories Inc., Abbott Laboratories, Arkray Inc., Sysmex Corporation, Ortho-Clinical Diagnostics, Siemens AG, Thermo Fisher Scientific Inc., and Qiagen N.V., among others.
In Vitro Diagnostics (IVD) Market Segmentation
In Vitro Diagnostics (IVD) Market by Technique
- POC Diagnostics
- Molecular Diagnostics
- Tissue Diagnostics
- Self-Blood Glucose Monitoring
In Vitro Diagnostics (IVD) Market by Product
- Data Management
In Vitro Diagnostics (IVD) Market by Usability
- Disposable IVD Devices
- Reusable IVD Devices
In Vitro Diagnostics (IVD) Market by Application
- Infectious Disease
- Autoimmune Disease
- Drug Testing
- Other Application
In Vitro Diagnostics (IVD) Market by End Users
- POC Testing
- Other End-Users
In Vitro Diagnostics (IVD) Market by Region
- North America
- Asia Pacific
- South Korea
- Middle East and Africa
- South Africa
- South America
Country-Level Data Points Coverage and Deliverables for In Vitro Diagnostics (IVD) Market
In Vitro Diagnostics (IVD) Market Report Summary
In Vitro Diagnostics (IVD) Market
(2015 – 2023)
Segmentation by Technique includes Immunochemistry, POC Diagnostics, Molecular Diagnostics, Hematology, Tissue Diagnostics, Microbiology, Self-blood Glucose Monitoring, and Other techniques;
Segmentation by Product includes Instrument, Reagent, and Data Management System;
Segmentation by Usability includes Disposable IVD Devices and Reusable IVD Devices;
Segmentation by Application includes Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, Drug Testing, HIV/AIDS, and Other applications;
Segmentation by End-Users includes Laboratory, Hospital, Academia, POC Testing, and Other End-users.
North America (US, Canada, Mexico), Europe (UK, Germany, France, Italy Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Australia, South Korea and Rest of Asia Pacific), Middle East & Africa (GCC, South Africa and Rest of MEA) and South America (Brazil, Argentina and Rest of South America)
February 2015: Roche acquired Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer.
Danaher Corporation, Roche Diagnostics, Becton, Dickinson and Company, Bio-Rad Laboratories Inc., and Abbott Laboratories, Arkray Inc., among others.
In Vitro Diagnostics (IVD) Market offers latest trends, growth prospects, industry competitiveness, major players, regional share of market and forecast to 2023.
Reasons to Purchase the In Vitro Diagnostics (IVD) Market Report
- Current and future of In Vitro Diagnostics (IVD) Market outlook in the developed and emerging markets
- Analysis of various perspectives of the market with the help of Porter’s five forces analysis
- The segment that is expected to dominate the market
- Regions that are expected to witness the fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
- 3-month analyst support, along with the market estimate sheet (in Excel)
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1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. In vitro Diagnostics Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Products and Services
5.2.5 Competitive Rivalry within the Industry
6. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
6.1 In vitro Diagnostics Market Drivers
6.1.1 High Prevalence of Chronic and Infectious Diseases
6.1.2 Increasing Use of Point of Care (POC) Diagnostics Fueling the IVD Market
6.1.3 Advanced Technologies
6.1.4 Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics
6.2 In vitro Diagnostics Market Restraints
6.2.1 Stringent Regulations
6.2.2 Cumbersome Reimbursement Procedures
6.3 In vitro Diagnostics Market Opportunities
6.4 In vitro Diagnostics Market Key Challenges
7. Market Segmentation
7.1 In vitro Diagnostics Market By Technique
7.1.2 POC Diagnostics
7.1.3 Molecular Diagnostics
7.1.5 Tissue Diagnostics
7.1.7 Self-Blood Glucose Monitoring
7.2 In vitro Diagnostics Market By Products
7.2.3 Data Management Systems
7.3 In vitro Diagnostics Market By Usability
7.3.1 Disposable IVD Devices
7.3.2 Reusable IVD Devices
7.4 In vitro Diagnostics Market By Application
7.4.1 Infectious Diseases
7.4.5 Autoimmune Diseases
7.4.7 Drug Testing
7.5 In vitro Diagnostics Market By End Users
7.6 In vitro Diagnostics Market By Geography
7.6.1 North America In vitro Diagnostics Market Size (2018-2023)
22.214.171.124 United States In vitro Diagnostics Market Size (2018-2023)
126.96.36.199 Canada In vitro Diagnostics Market Size (2018-2023)
188.8.131.52 Mexico In vitro Diagnostics Market Size (2018-2023)
7.6.2 Europe In vitro Diagnostics Market Size (2018-2023)
184.108.40.206 France In vitro Diagnostics Market Size (2018-2023)
220.127.116.11 United Kingdom In vitro Diagnostics Market Size (2018-2023)
18.104.22.168 Germany In vitro Diagnostics Market Size (2018-2023)
22.214.171.124 Italy In vitro Diagnostics Market Size (2018-2023)
126.96.36.199 Spain In vitro Diagnostics Market Size (2018-2023)
188.8.131.52 Rest of Europe
7.6.3 Asia-Pacific In vitro Diagnostics Market Size (2018-2023)
184.108.40.206 India In vitro Diagnostics Market Size (2018-2023)
220.127.116.11 China In vitro Diagnostics Market Size (2018-2023)
18.104.22.168 Japan In vitro Diagnostics Market Size (2018-2023)
22.214.171.124 Australia In vitro Diagnostics Market Size (2018-2023)
126.96.36.199 South Korea In vitro Diagnostics Market Size (2018-2023)
188.8.131.52 Rest of Asia-Pacific
7.6.4 Middle East & Africa In vitro Diagnostics Market Size (2018-2023)
184.108.40.206 GCC In vitro Diagnostics Market Size (2018-2023)
220.127.116.11 South Africa In vitro Diagnostics Market Size (2018-2023)
18.104.22.168 Rest of Middle East & Africa
7.6.5 South America In vitro Diagnostics Market Size (2018-2023)
22.214.171.124 Brazil In vitro Diagnostics Market Size (2018-2023)
126.96.36.199 Argentina In vitro Diagnostics Market Size (2018-2023)
188.8.131.52 Rest of South America
8. In vitro Diagnostics Market Competitive Landscape
8.1 Mergers & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches
9. In vitro Diagnostics Market Key Players
9.2 Danaher Corporation
9.3 Roche Diagnostics
9.4 Becton, Dickinson and Company
9.5 Bio-Rad Laboratories, Inc.
9.6 Abbott Laboratories
9.8 Arkray, Inc.
9.9 Sysmex Corporation
9.10 Ortho Clinical Diagnostics
9.11 Siemens AG
9.12 Thermo Fisher Scientific
*List not Exhaustive
10. Future of the In vitro Diagnostics Market