USD 117.8 billion
Global In-Vitro Diagnostics Market Size, Share, Growth Analysis, By Product & Service(Reagents & Kits, Instruments), By Technology(Clinical chemistry, Molecular diagnostics), By Application(Infectious diseases, Diabetes), By End-User(Standalone laboratories, Hospitals) - Industry Forecast 2024-2031
Report ID:
SQSG35G2015 |
Region:
Global |
Published Date: February, 2024
Pages:
157
|
Tables:
124 |
Figures:
77
Global In-Vitro Diagnostics Market Insights
Global In-Vitro Diagnostics (IVD) Market size was valued at USD 117.8 billion in 2019 and is poised to grow from USD 121.69 billion in 2023 to USD 157.78 billion by 2031, growing at a CAGR of 3.3% during the forecast period (2024-2031).
The growing opportunities in unexploited emerging markets with enhanced health infrastructure, rising unfulfilled medical needs, increasing prevalence of chronic diseases, and more demand for cutting-edge testing methodologies have been predicted to serve as the driving force behind the proliferation of the in vitro diagnostics market. The emergence of personalized medicine as an individualized treatment approach tailored to patient’s specific genetic, molecular, and clinical contexts is also a contributing factor that is shaping the IVD market. On the spectrum of IVDs, companion diagnostics, a unique subset, take an active part in assessing patients appropriate for therapies or those at risk of adverse drug reactions or toxicity. These individualized interventions not only increase the treatment efficacy but also contain the healthcare costs by avoiding wasteful treatments, thus emphasizing market expansion.
IVD industry operates in a regulated environment to confirm patient safety and accuracy of the test. Getting regulatory approvals for an innovative IVD test may be time-consuming and be resource intensive. The rigorous regulatory standards, imposed by the regulatory institutions like the FDA and similar bodies worldwide, might slow down the rapid entrance of new tests and technologies, which in turn may become an obstacle in the growth path of the IVD market. It is forecasted that the market will face growth due to the arrival of products that have improved versatility. For instance, in June 2022, Agilent Technologies introduced IVD-compliant instruments, kits, and reagents that follow the new European Union IVDR regulation and further and greater the demand for and usage of IVD devices. This growth is also supported by increased investment from leading industrial actors aimed at research and development projects to develop new products and explore new applications of IVD technologies. For instance, in February 2022 Thermo Fisher Scientific Inc. introduced the Renvo Rapid PCR Test, which is aimed at airborne viruses, including SARS-CoV-2 pathogens. The test is performed on samples collected using the Aerosol Sense Sampler. Therefore, their immediate coming onto the market can be expected not only to encourage the rise of the IVD market but also to become its major drivers.
US In-Vitro Diagnostics Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
Reagents & Kits, Services
Fastest Growth
Reagents & Kits, Services
Growth Rate
3.3% CAGR
Global In Vitro Diagnostics Market ($ Bn)
Country Share for North America Region (%)
Global In Vitro Diagnostics Market By Product ($ Bn)
Global In Vitro Diagnostics Market By Product (%)
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Global In-Vitro Diagnostics Market Segmental Analysis
Global In Vitro Diagnostics Market is segmented by Product, Application, Technology, End User and region. Based on Product, the market can be segmented into Reagents & Kits, Services, Instruments and Data Management Software. Based on Application, the market is segmented into infectious diseases, Diabetes, Drug Testing/ Pharmacogenomics, Autoimmune diseases, Oncology and Others. Based On Technology, the market is segmented into Immunoassay/ Immunochemistry, Clinical chemistry, Hematology, Molecular diagnostics, Microbiology, and Others. Based on End User, the market is segmented into Hospital laboratories, Point-of-care testing centres, Academic institutes, Clinical laboratories and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
In-Vitro Diagnostics Market Analysis by Product
In the in vitro diagnostics market size in 2022, the reagents and kits segment held the largest share, and it is expected to be the leader throughout the forecast period as well. This long-term dominance is due to a variety of reasons including persistent demand for diagnostic solutions testing, on-going development of innovative and specialized reagents, and the increase in the number of patients needing accurate diagnostic procedures. In contrast, instruments section is expected to have the highest CAGR in the forecast period. This development is mainly due to progress in automation and technology in the field, growing popularity of in vitro diagnostic testing, and the need for faster and more efficient diagnostic processes both in clinics and hospitals.
In 2023, the instrument segment which is the second largest in the market accounted for around 30% of the overall demand. Moreover, the emergence of precision medicine will drive the requirement of novel reagents and consumables which can support precision medicine. In addition to that, the rising acceptance of novel IVD instruments will also contribute to the increased size of this market segment. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the US FDA to get a rapid AST (Antimicrobial Susceptibility Testing) system, VITEK REVEAL, approved. Organizations are cleverly launching equipment for screening purposes to be able to cope with the increasing demand for the worldwide genetic testing. Similarly, in March 2022, Thermo Fisher Scientific came up with the Ion Torrent Genexus Dx Integrated Sequencer for the market and it would serve both research and diagnostic needs. This agreement with genetic testing standards shows the industry's willingness to further precision medicine and improve diagnostics.
In-Vitro Diagnostics Market Analysis by End User
The hospitals segment was the leading revenue earner in 2023, due to the ever-increasing number of hospitalizations needing prompt diagnostic help. Furthermore, the continuous advancement in healthcare infrastructure and the implementation of government-friendly initiatives are expected to increase the existing hospital capabilities and hence enhance demand for hospital-based IVD testing. The majority of IVD devices are purchased by hospitals and used in considerable quantities. In the United States, as of 2023, there are over 6,129 hospitals that trust the accuracy and speed of IVD technology.
However, the homecare segment is anticipated to experience an impressive CAGR from 2024 to 2030 mainly due to the growing older population and the increasing demand for home care IVD devices. In December, the American Hospital Association opposed the FDA from enforcing their regulations on hospitals' Laboratory Developed Tests (LDTs). The demand for the development of molecular diagnostic and immunoassay platforms that can be performed by the patients themselves is growing. For instance, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first OTC home diagnostic test that can discriminate between influenza A and B, as well as SARS-CoV-2 which is the virus responsible for COVID-19.
Global In Vitro Diagnostics Market By Product, 2023 (%)
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Global In-Vitro Diagnostics Market Regional Insights
In 2022, North America contributed to the major share of the in vitro diagnostics market, and it is considered to maintain its top position during the market forecast period. Therefore, the main reason for their dominance is that many of the leading players are involved. Apart from this, the region also has witnessed technological upgrades in manufacturing sector for in vitro diagnostics which is another driving factor for this market.
The Asia-Pacific area is expected that to have the most rapidly growth rate in the in vitro diagnostics market over the forecast period. This growth can be explained by the increased demand arising from countries that have a large population and abundant purchasing power of the population. Also, the expanding tendency for the personalised medicine, and application of the innovative production methods to improve the manufacturing of the in vitro diagnostics products create a favourable environment for unstoppable development of this market in this region. For Instance, In October 2023 Fapon and Halodoc have united being a part of a strategic partnership to promote sales and services in vitro diagnostic products in Indonesia. Furthermore, the leading players have chosen partnerships with local partners to take their presence deeper into developing countries emerging in the Asia Pacific region.
Global In Vitro Diagnostics Market By Region, 2024-2031
- Largest
- Fastest
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Global In-Vitro Diagnostics Market Dynamics
In-Vitro Diagnostics Market Driver
Rising Burden of Chronic Diseases to Augment Market Growth
- The growing pressure of chronic diseases, majorly discussed by organizations is a major issue that is being seen as a challenge to all the global healthcare systems. Non-Communicable Diseases (NCDs) including cardiovascular diseases, cancer, chronic respiratory diseases and diabetes are responsible for a significant proportion of the global morbidity and mortality. In-Vitro Diagnostics (IVD) contribute to the early diagnosis of such diseases while allowing healthcare professionals to immediately provide an adequate treatment. Through the prompt determination of disease, IVD technologies enables early treatment that in turn ensures positive patient outcomes as well as helps to lower the overall pressure on the healthcare system. However, in its September 2022 brochure the World Health Organization emphasizes the overwhelming burden of NCDs. These conditions are responsible for a very high number of deaths worldwide. Coronary heart disease and other cardiovascular diseases, however, become the first reason for death among all diseases, in front of cancer cases, chronic respiratory ones and diabetes. Data evidence the need for effective strategies that can collectively address these diseases.
Government Regulations and Investments
- The government and the agencies are the main entities that encourage IVD’s adoption through awareness campaigns and thereby, expansion of the markets. To streamline the disease prioritization process based on their burden and prevalence, the World Health Organization (WHO) put out a model list of Essential In Vitro Diagnostics for primary healthcare facilities and clinical laboratories. The latter represents general IVDs and those which are related to or caused by diseases. In addition, the emergence of research efforts as well as governmental support is accelerating innovations in IVD products, and this is what further enables the market to experience growth.
Restraints
Regulatory and legal Frameworks
- There are some changes in the regulatory landscape of in vitro diagnostic industry, including test kits used for infectious diseases, but gradual tightening of the regulatory requirements in both the US and European countries. In the USA, federal law demands that manufacturers of devices file a 510(k) application for any major changes in the device's properties. This entails updates of software or the installation of new software on existing gadgets, as well as any other changes made on devices.
Reimbursement Situation that is not Favourable
- The reimbursement framework imposes considerable difficulty, most notably to a few pathology tests that do not have Healthcare Common Procedure Coding System codes, thus they are usually paid using typical codes. In these cases, the Medicare Administrative Contractors (MACs) use regional jurisdictions to determine the payment rates. Besides, lack of money and fund shortage impedes the implementations of the modern diagnostic methodologies of clinical laboratories. These adjustments in payment mechanisms are viewed as likely to have a negative impact on the US molecular and genetic testing market, and therefore might lead to a slowdown in the industry's in-vitro diagnostics (IVD) segment.
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Global In-Vitro Diagnostics Market Competitive Landscape
The global in vitro diagnostics (IVD) market presents a dynamic competitive landscape characterized by a diverse array of players ranging from established multinational corporations to innovative startups. The companies continuously engage in research and development activities to introduce innovative diagnostic solutions, expand their market reach, and strengthen their competitive position. However, the market also sees vigorous competition from niche players specializing in specific diagnostic segments or cutting-edge technologies, fostering innovation and driving market growth.
In-Vitro Diagnostics Market Top Player's Company Profiles
- Roche Diagnostics
- Siemens Healthineers
- Abbott Laboratories
- Danaher Corporation
- Thermo Fisher Scientific
- Sysmex Corporation
- bioMerieux SA
- Becton, Dickinson and Company
- Ortho-Clinical Diagnostics
- QIAGEN N.V.
- Beckman Coulter, Inc.
- Hologic, Inc.
- Bio-Rad Laboratories
- Agilent Technologies
- Illumina, Inc.
- Cepheid
- PerkinElmer, Inc.
- Bruker Corporation
- Luminex Corporation
- DiaSorin S.p.A.
In-Vitro Diagnostics Market Recent Developments
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In December 2022, Agilent Technologies Inc. revealed that the U.S. Food and Drug Administration (FDA) granted approval for Agilent Resolution ctDx FIRST as a companion diagnostic (CDx). This designation allows for the identification of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who might derive therapeutic benefits from KRAZATITM (adagrasib) treatment.
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In November 2022, Thermo Fisher Scientific, introduced the Accula Flu A/Flu B Test, a rapid RT-PCR assay specifically developed to facilitate the prompt detection and differentiation of influenza A and B viruses, providing results in approximately 30 minutes, thus aiding healthcare providers in swift diagnosis.
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In September 2022, Sysmex Corporation introduced the UF-1500 Fully Automated Urine Particle Analyzer (UF-1500) designed specifically for urine sediment testing. This new system inherits the advanced functionality and user-friendly features of its predecessor, the UF-5000 Fully Automated Urine Particle Analyzer (UF-5000).
Global In-Vitro Diagnostics Key Market Trends
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Shift towards Sustainable and Resilient Infrastructure: The increase in the burden of diseases has urged medical device companies to speed up the design of highly advanced diagnostic devices. In addition, hospitals and laboratories are mainly relying on point-of-care devices due to their capability to provide immediate and real-time data. Point-of-Care (PoC) testing is a diagnostic method which is performed close to the patient, with minimal blood volume needed, and which offers rapid test results crucial for clinical decision making, making the physician to initiate timely treatment without waiting for the central laboratory results. Therefore, the demand for these instruments will increase, which will lead to an increase in the need for the in vitro diagnostics devices. Moreover, an increase in the launch of new and advanced products are set to drive the industry development. For example, In January 2023, FUJIFILM Sonosite, Inc. came up with the new Sonosite PX ultrasound system in India to replace the traditional system. The aim is to enhance clinician ergonomics and streamline efficiency.
Global In-Vitro Diagnostics Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our analysis, the global in vitro diagnostics (IVD) market is experiencing robust growth driven by the escalating prevalence of chronic and infectious diseases, increasing demand for personalized medicine, and advancements in technology. The market encompasses a wide array of diagnostic tests and devices used for early disease detection, diagnosis, monitoring, and management, spanning various healthcare settings from hospitals and laboratories to point-of-care facilities. Factors such as the growing geriatric population, rising healthcare expenditure, and expanding access to healthcare services in emerging economies further contribute to market expansion. Additionally, ongoing developments in molecular diagnostics, immunoassays, and point-of-care testing are driving innovation and diversification within the IVD market, fostering competition among key players and fuelling continuous research and development efforts to address evolving healthcare needs globally.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 117.8 billion |
| Market size value in 2031 | USD 157.78 billion |
| Growth Rate | 3.3% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
| Historical Year | 2019 |
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Global In-Vitro Diagnostics Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Global In-Vitro Diagnostics Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Global In-Vitro Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global In-Vitro Diagnostics Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Global In-Vitro Diagnostics Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Global In-Vitro Diagnostics Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Global In-Vitro Diagnostics Market Report Snapshots
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