#In Vitro Diagnostics Market Analysis
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In Vitro Diagnostics Industry Research Report 2030 By Players, Regions, Types & Applications
The global in vitro diagnostics (IVD) market, valued at an estimated USD 80.71 billion in 2024, is anticipated to grow at a compound annual growth rate (CAGR) of 6.8% from 2025 to 2030. This projected growth is largely driven by the increasing utilization of IVD tools and technologies, a response to the rising incidence of both infectious and chronic diseases globally. The development and implementation of automated IVD systems in laboratories and hospitals further contribute to this expansion, offering healthcare providers tools to make diagnoses that are efficient, precise, and free from errors. Additionally, the continual launch of new IVD products by leading companies plays a significant role in fueling this market’s growth.
A noteworthy example of this innovation in IVD products is seen in ELITechGroup’s recent expansion of its diagnostic portfolio. In January 2024, ELITechGroup introduced the GI Bacterial PLUS ELITe MGB Kit, which received CE-IVDR certification. This product marks the beginning of the company’s Gastrointestinal (GI) assay panel and is designed to detect bacterial pathogens responsible for GI infections. ELITechGroup’s expansion plans include three more kits for launch within the next quarter, covering a broader spectrum of gastrointestinal infections. These new products aim to equip laboratories and healthcare professionals with advanced tools for precise diagnosis and improved management of GI conditions.
Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market
Regional Insights:
North America In Vitro Diagnostics Market:
The North American in vitro diagnostics (IVD) market led the global sector in 2024, holding a 42.28% share. The region is expected to maintain its dominance throughout the forecast period, largely driven by several key factors, including the growing prevalence of chronic diseases, the presence of established IVD companies, the frequent introduction of innovative diagnostic tests, and strong government funding support. For example, in January 2023, BD and CerTest Biotec obtained an Emergency Use Authorization (EUA) from the U.S. FDA for a PCR test to detect the Mpox virus, highlighting regulatory support for advanced diagnostics. The increasing demand for genetic testing, particularly for personalized treatments in diabetes and cancer, is further expected to support the growth of the IVD market in North America.
Europe In Vitro Diagnostics Market Trends:
The European IVD market is growing, driven by an emphasis on infectious disease testing, molecular diagnostics, and adherence to regulatory requirements like CE-IVDR. Following the COVID-19 pandemic, demand for infectious disease diagnostics surged, with companies like Siemens Healthineers introducing platforms such as the Atellica CI Analyzer for efficient testing. The molecular diagnostics sector is also expanding, with ELITechGroup’s CE-IVDR-certified GI Bacterial PLUS kit as a recent example, aimed at detecting gastrointestinal infections. Stringent IVDR standards in Europe foster innovation, improving diagnostic accuracy and safety across the continent.
Asia Pacific In Vitro Diagnostics Market Trends:
The Asia Pacific IVD market is projected to experience significant growth, with a CAGR of 8.59% over the forecast period. Key drivers include stabilizing economies, a rapidly growing middle class, supportive government policies, and rapid urbanization. For instance, in October 2023, Fapon partnered with Halodoc to boost IVD product sales and services in Indonesia. Major IVD players are also collaborating with regional partners to expand their reach in developing countries across Asia Pacific.
The Chinese IVD market is growing rapidly, fueled by rising demand for molecular diagnostics, point-of-care testing, and digital health integration. Molecular diagnostics are particularly in demand for infectious diseases and oncology, supported by public health initiatives and increased healthcare spending.
Japan’s IVD market growth is driven by an aging population and progress in personalized medicine. Key trends include a growing use of molecular diagnostics for oncology and genetic testing, which aid in identifying targeted treatments for age-related diseases
Latin America In Vitro Diagnostics Market Trends:
The IVD market in Latin America is expanding due to increased healthcare investments, a focus on disease prevention, and enhanced healthcare access. A prominent trend is the adoption of point-of-care testing for infectious diseases like dengue, Zika, and COVID-19, especially in remote areas. Demand for molecular diagnostics in oncology is also growing as awareness of personalized medicine rises. Public-private partnerships and government initiatives are building diagnostics infrastructure, making advanced testing technologies more accessible across the region.
Middle East & Africa In Vitro Diagnostics Market Trends:
The IVD market in the Middle East and Africa (MEA) is set for growth, driven by increased healthcare spending and the prevalence of infectious diseases. Major trends include the adoption of advanced molecular diagnostics and point-of-care testing to improve disease detection and management. Additionally, a focus on personalized medicine and government initiatives aimed at enhancing healthcare infrastructure are supporting market expansion. Collaborations between local and international players are fostering innovation, making diagnostic solutions more accessible across the region.
Browse through Grand View Research's Category Clinical Diagnostics Industry Research Reports.
The global saliva collection and diagnostics market size was estimated at USD 818.9 million in 2024 and is projected to grow at a CAGR of 4.7% from 2025 to 2030.
The global cholesterol testing products and services market size was estimated at USD 19.85 billion in 2024 and is projected to grow at a CAGR of 8.4% from 2025 to 2030.
Key Companies & Market Share Insights:
Among the prominent players in the IVD market are F. Hoffmann-La Roche Ltd., Abbott, Quest Diagnostics Incorporated, and Danaher. These companies actively pursue strategies like new product launches, mergers and acquisitions, and partnerships to strengthen and diversify their product offerings. These efforts are focused on expanding their product portfolios, introducing technologically advanced and innovative diagnostic tools, and improving their competitive positioning within the market.
Emerging companies in the IVD sector, including Llusern Scientific, Biocartis Group NV, ARUP Laboratories, Veracyte, and Exact Sciences Corp, are also making strides. These companies concentrate on developing novel and accurate IVD testing products, contributing to overall healthcare improvements. They frequently collaborate with research institutions, governmental bodies, and global leaders to expand their product reach and presence in new, high-potential markets.
Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.
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In Vitro Diagnostics Market 2030 Outlook by Growth Rate, Trends, Size and Opportunities
The global in vitro diagnostics (IVD) market, valued at an estimated USD 80.71 billion in 2024, is anticipated to grow at a compound annual growth rate (CAGR) of 6.8% from 2025 to 2030. This projected growth is largely driven by the increasing utilization of IVD tools and technologies, a response to the rising incidence of both infectious and chronic diseases globally. The development and implementation of automated IVD systems in laboratories and hospitals further contribute to this expansion, offering healthcare providers tools to make diagnoses that are efficient, precise, and free from errors. Additionally, the continual launch of new IVD products by leading companies plays a significant role in fueling this market’s growth.
A noteworthy example of this innovation in IVD products is seen in ELITechGroup’s recent expansion of its diagnostic portfolio. In January 2024, ELITechGroup introduced the GI Bacterial PLUS ELITe MGB Kit, which received CE-IVDR certification. This product marks the beginning of the company’s Gastrointestinal (GI) assay panel and is designed to detect bacterial pathogens responsible for GI infections. ELITechGroup’s expansion plans include three more kits for launch within the next quarter, covering a broader spectrum of gastrointestinal infections. These new products aim to equip laboratories and healthcare professionals with advanced tools for precise diagnosis and improved management of GI conditions.
Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market
Regional Insights:
North America In Vitro Diagnostics Market:
The North American in vitro diagnostics (IVD) market led the global sector in 2024, holding a 42.28% share. The region is expected to maintain its dominance throughout the forecast period, largely driven by several key factors, including the growing prevalence of chronic diseases, the presence of established IVD companies, the frequent introduction of innovative diagnostic tests, and strong government funding support. For example, in January 2023, BD and CerTest Biotec obtained an Emergency Use Authorization (EUA) from the U.S. FDA for a PCR test to detect the Mpox virus, highlighting regulatory support for advanced diagnostics. The increasing demand for genetic testing, particularly for personalized treatments in diabetes and cancer, is further expected to support the growth of the IVD market in North America.
Europe In Vitro Diagnostics Market Trends:
The European IVD market is growing, driven by an emphasis on infectious disease testing, molecular diagnostics, and adherence to regulatory requirements like CE-IVDR. Following the COVID-19 pandemic, demand for infectious disease diagnostics surged, with companies like Siemens Healthineers introducing platforms such as the Atellica CI Analyzer for efficient testing. The molecular diagnostics sector is also expanding, with ELITechGroup’s CE-IVDR-certified GI Bacterial PLUS kit as a recent example, aimed at detecting gastrointestinal infections. Stringent IVDR standards in Europe foster innovation, improving diagnostic accuracy and safety across the continent.
Asia Pacific In Vitro Diagnostics Market Trends:
The Asia Pacific IVD market is projected to experience significant growth, with a CAGR of 8.59% over the forecast period. Key drivers include stabilizing economies, a rapidly growing middle class, supportive government policies, and rapid urbanization. For instance, in October 2023, Fapon partnered with Halodoc to boost IVD product sales and services in Indonesia. Major IVD players are also collaborating with regional partners to expand their reach in developing countries across Asia Pacific.
The Chinese IVD market is growing rapidly, fueled by rising demand for molecular diagnostics, point-of-care testing, and digital health integration. Molecular diagnostics are particularly in demand for infectious diseases and oncology, supported by public health initiatives and increased healthcare spending.
Japan’s IVD market growth is driven by an aging population and progress in personalized medicine. Key trends include a growing use of molecular diagnostics for oncology and genetic testing, which aid in identifying targeted treatments for age-related diseases
Latin America In Vitro Diagnostics Market Trends:
The IVD market in Latin America is expanding due to increased healthcare investments, a focus on disease prevention, and enhanced healthcare access. A prominent trend is the adoption of point-of-care testing for infectious diseases like dengue, Zika, and COVID-19, especially in remote areas. Demand for molecular diagnostics in oncology is also growing as awareness of personalized medicine rises. Public-private partnerships and government initiatives are building diagnostics infrastructure, making advanced testing technologies more accessible across the region.
Middle East & Africa In Vitro Diagnostics Market Trends:
The IVD market in the Middle East and Africa (MEA) is set for growth, driven by increased healthcare spending and the prevalence of infectious diseases. Major trends include the adoption of advanced molecular diagnostics and point-of-care testing to improve disease detection and management. Additionally, a focus on personalized medicine and government initiatives aimed at enhancing healthcare infrastructure are supporting market expansion. Collaborations between local and international players are fostering innovation, making diagnostic solutions more accessible across the region.
Browse through Grand View Research's Category Clinical Diagnostics Industry Research Reports.
The global saliva collection and diagnostics market size was estimated at USD 818.9 million in 2024 and is projected to grow at a CAGR of 4.7% from 2025 to 2030.
The global cholesterol testing products and services market size was estimated at USD 19.85 billion in 2024 and is projected to grow at a CAGR of 8.4% from 2025 to 2030.
Key Companies & Market Share Insights:
Among the prominent players in the IVD market are F. Hoffmann-La Roche Ltd., Abbott, Quest Diagnostics Incorporated, and Danaher. These companies actively pursue strategies like new product launches, mergers and acquisitions, and partnerships to strengthen and diversify their product offerings. These efforts are focused on expanding their product portfolios, introducing technologically advanced and innovative diagnostic tools, and improving their competitive positioning within the market.
Emerging companies in the IVD sector, including Llusern Scientific, Biocartis Group NV, ARUP Laboratories, Veracyte, and Exact Sciences Corp, are also making strides. These companies concentrate on developing novel and accurate IVD testing products, contributing to overall healthcare improvements. They frequently collaborate with research institutions, governmental bodies, and global leaders to expand their product reach and presence in new, high-potential markets.
Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.
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The Future of Health: Navigating the Growing In Vitro Diagnostics Market
Market Size Overview
The In Vitro Diagnostics Market is projected to be valued at approximately USD 95.59 billion in 2024, with expectations to reach around USD 125.61 billion by 2029, reflecting a compound annual growth rate (CAGR) of 5.62% during the forecast period from 2024 to 2029.
Market Overview
The In Vitro Diagnostics (IVD) industry is experiencing significant growth driven by advancements in technology, an increasing prevalence of chronic diseases, and a rising demand for personalized medicine. As healthcare systems evolve, the emphasis on early disease detection and monitoring further propels the market forward.
Key Trends
Technological Advancements: Innovations in molecular diagnostics, point-of-care testing, and automation are enhancing the accuracy and efficiency of diagnostic procedures.
Rising Demand for Home Testing: The trend toward at-home diagnostic kits is on the rise, fueled by consumer preference for convenience and privacy, especially post-pandemic.
Personalized Medicine: Increasing adoption of targeted therapies necessitates precise diagnostic tools, driving demand for specific IVD tests tailored to individual patient needs.
Regulatory Changes: Evolving regulatory frameworks are influencing market dynamics, as companies adapt to new compliance requirements to ensure product safety and efficacy.
Global Health Initiatives: Government investments in healthcare infrastructure and disease prevention programs are enhancing access to diagnostic services, particularly in emerging markets.
Challenges
Despite its promising growth, the IVD market faces challenges such as stringent regulatory requirements, high costs of advanced diagnostic technologies, and the need for continuous innovation to keep pace with rapid scientific advancements. Additionally, competition from established players and emerging startups can impact market entry for new companies.
Conclusion
The In Vitro Diagnostics industry is poised for robust growth, driven by technological advancements and a heightened focus on early disease detection. While challenges exist, the overall outlook remains positive, suggesting that stakeholders should remain agile and innovative to capitalize on emerging opportunities in this dynamic market.
#In Vitro Diagnostics industry#In Vitro Diagnostics market#In Vitro Diagnostics market size#In Vitro Diagnostics market share#In Vitro Diagnostics market trends#In Vitro Diagnostics market analysis#In Vitro Diagnostics market growth#In Vitro Diagnostics industry overview
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In Vitro Diagnostics Market Size and Regional Outlook Analysis 2024 - 2030
The global in vitro diagnostics market size is expected to reach USD 101.58 billion by 2030, according to a new report by Grand View Research, Inc. It is estimated to register a CAGR of 4.4% over the forecast period driven by the increasing geriatric population, COVID-19 pandemic, and technological advancements in diagnostics that are supporting its adoption. Technological advancements in terms of portability, accuracy, and cost-effectiveness are projected to be one of the high-impact rendering drivers. Technological advancements were further accelerated by the launch of COVID-19 IVD diagnostics and enhanced the adoption of instruments and consumables for technologies, such as PCR. Competitors in the market are increasingly adopting agreement and partnership strategies to maintain a constant flow of business for manufacturers & diagnostics for users.
These agreements are also a result of the harsh price containment strategies for government laboratories, which lowers the price in government settings. For instance, in April 2021, the Italian subsidiary of Seegene, Inc. received a USD 108.25 million tenders for public procurement for the supply of extraction reagents, as well as 7.15 million SARS-CoV-2 diagnostic tests. However, it increases the multiparty nature and complexity of the supply chain. The high prevalence of cancer and Cardiovascular Diseases (CVDs) globally is anticipated to drive diagnostic innovation to facilitate early diagnosis and meet the constantly evolving needs of consumers. Novel technologies, such as plasmonic PCR, are anticipated to commercially enter the market during the forecast period, influencing the business of existing products adversely.
Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market
Detailed Segmentation:
Market Characteristics
Market growth stage is medium, and the pace of the market growth is decelerating. Decreasing demand for COVID-19 tests is hampering the growth. The market is characterized by a high degree of innovation owing to the increasing introduction of novel molecular diagnostics and immunoassay tests for multiple disease indications. Moreover, increasing demand for patient-centric tests is encouraging market players to develop technologically advanced products.
Product Insights
The reagents segment held the largest share of 65.88% of the overall revenue in 2023. The segment is expected to retain its dominance growing at the fastest CAGR from 2024 to 2030 owing to the extensive R&D initiatives undertaken by major players to develop novel reagents and test kits. For instance, in February 2023, BD received the market approval for the BD Onclarity HPV Assay to be used with the ThinPrep Pap Test in the U.S. The increasing R&D activities to enable faster cancer detection and precision medicine are allowing companies to focus on niche profitable areas in the IVD business. For instance, in March 2023, QIAGEN partnered with Servier to develop a companion diagnostic test for TIBSOVO, indicated for treating the blood cancer acute myeloid leukemia.
Technology Insights
The immunoassay segment accounted for the largest revenue share in 2023. Increasing incidence of chronic & communicable diseases and rising need for early diagnosis are among the key factors leading to an increase in demand for immunological methods, including different types of Enzyme-Linked Immunosorbent Assays (ELISAs). Moreover, key players are focused on R&D pertaining to development of new immunological diagnostic instruments and tests for IVD applications. For instance, in October 2023, Sysmex Corporation and Fujirebio Holdings, Inc. collaborated to enhance their R&D, production, clinical development, and marketing activities in immunoassay.
End-use Insights
The hospitals segment held the largest revenue share in 2023 owing to a rise in the rate of hospitalizations that require support from faster diagnostics. Moreover, the ongoing development of healthcare infrastructure and favorable initiatives taken by government bodies are anticipated to enhance the existing hospital facilities. Thus, the demand for hospital-based IVD tests is increasing. Most IVD devices are purchased by hospitals and used in significant volumes. In 2023, there are over 6,129 hospitals in the U.S. that require constant aid from IVD for critical decision-making, as IVD tests provide faster and more accurate results.
Test Location Insights
The others (lab-based tests) segment accounted for the largest revenue share in 2023. A large number of test analyses at one time and the higher accuracy of laboratory-based tests make them more reliable compared to PoC and home tests, giving segment a competitive edge over the other two segments. Moreover, the availability of tests that allow for sample collection at home and sending it to the laboratories for testing makes testing highly convenient for patients.
Application Insights
The infectious diseases segment dominated the market in 2023. The outbreak of the COVID-19 pandemic increased the segment share significantly in recent years. Moreover, key players are introducing novel testing products to improve access to high-quality, innovative laboratory services for patients & healthcare providers. For instance, in February 2023, BD received EUA from the U.S. FDA for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV). Such initiatives by key players to strengthen their presence are expected to drive market growth.
Regional Insights
North America dominated the market and accounted for a share of 42.28% in 2023. The region is estimated to retain its leading market position throughout the forecast period. The market in this region is collectively driven by factors, such as the rising incidence of chronic diseases, presence of strong players, increasing number of novel test launches, and supportive government funding. For instance, in January 2023, BD and CerTest Biotec received EUA from the U.S. FDA for a PCR test for Mpox virus detection in the U.S. Moreover, the increasing requirement for genetic testing for personalized health care, such as that for diabetes and cancer, is expected to drive market growth in North America.
Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.
• The global hepatitis diagnostic market size was valued at USD 3.82 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030.
• The global hematology diagnostics market size was valued at USD 7.54 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030.
Key Companies & Market Share Insights
Some of the key players operating in the in vitro diagnostics market include F. Hoffmann-La Roche Ltd.; Abbott; Quest Diagnostics Inc.; and Danaher. Market players are adopting various strategies, such as new product launches, mergers & acquisitions, and partnerships, to strengthen their product portfolios and offer diverse technologically advanced & innovative products.
Key In Vitro Diagnostics (IVD) Companies:
• Abbott
• bioMérieux SA
• QuidelOrtho Corporation
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Qiagen
• Sysmex Corporation
• Charles River Laboratories
• Quest Diagnostics Incorporated
• Agilent Technologies, Inc.
• Danaher Corporation
• BD
• F. Hoffmann-La Roche Ltd.
In Vitro Diagnostics Market Segmentation
Grand View Research has segmented the global in vitro diagnostics (IVD) market report based on product, technology, application, end-use, test location, and region:
IVD Product Outlook (Revenue, USD Million, 2018 - 2030)
• Instruments
• Reagents
• Services
IVD Technology Outlook (Revenue, USD Million, 2018 - 2030)
• Immunoassay
o Instruments
o Reagents
o Services
• Hematology
o Instruments
o Reagents
o Services
• Clinical Chemistry
o Instruments
o Reagents
o Services
• Molecular Diagnostics
o Instruments
o Reagents
o Services
• Coagulation
o Instruments
o Reagents
o Services
• Microbiology
o Instruments
o Reagents
o Services
• Others
o Instruments
o Reagents
o Services
IVD Application Outlook (Revenue, USD Million, 2018 - 2030)
• Infectious Diseases
• Diabetes
• Oncology
• Cardiology
• Nephrology
• Autoimmune Diseases
• Drug Testing
• Others
IVD Test Location Outlook (Revenue, USD Million, 2018 - 2030)
• Point of Care
• Home-care
• Others
IVD End-use Outlook (Revenue, USD Million, 2018 - 2030)
• Hospitals
• Laboratory
• Home-care
• Others
IVD Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
o U.S.
o Canada
• Europe
o UK
o Germany
o France
o Spain
o Italy
o Russia
o Denmark
o Sweden
o Norway
• Asia Pacific
o Japan
o China
o India
o South Korea
o Australia
o Thailand
o Singapore
• Latin America
o Brazil
o Mexico
o Argentina
• Middle East and Africa (MEA)
o South Africa
o Saudi Arabia
o UAE
o Kuwait
Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.
Recent Developments
• In December 2023, ARUP Laboratories and Medicover collaborated to provide diagnostic and healthcare services in Europe. ARUP Laboratories has developed AAV5 DetectCDx in collaboration with BioMarin Pharmaceutical Inc. to select therapies for severe hemophilia A patients
• In November 2023, Veracyte joined Illumina to develop molecular tests for decentralized IVD applications. Companies are focusing on the development of Prosigna breast cancer and Percepta nasal swab tests of Veracyte
• In October 2023, Promega Corporation announced its plan to develop and commercialize companion diagnostics kits with GSK Plc to identify cancer patients with MSI-H solid tumors
• In February 2023, Unilabs announced investing over USD 200 million in Siemens Healthineers' technology and acquiring more than 400 laboratory analyzers to strengthen its laboratory infrastructure
• In February 2023, F. Hoffmann-La Roche Ltd. collaborated with Janssen Biotech Inc. to develop companion diagnostics for targeted therapies. Companion diagnostic technologies include digital pathology, NGS, PCR, immunoassays, and immunohistochemistry
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The In Vitro Diagnostics Market in 2023 is US$ 121.38 billion, and is expected to reach US$ 176.89 billion by 2031 at a CAGR of 4.82%.
#In Vitro Diagnostics Market#In Vitro Diagnostics Market Analysis#In Vitro Diagnostics Market Overview
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Exploring the Growth of the In Vitro Diagnostic (IVD) Market: Key Trends and Insights
The In Vitro Diagnostic (IVD) market is projected to be valued at USD 95.59 billion in 2024, with expectations to grow to USD 125.61 billion by 2029, reflecting a compound annual growth rate (CAGR) of 5.62% during the forecast period from 2024 to 2029
The In Vitro Diagnostic (IVD) market has been experiencing robust growth, fueled by advancements in medical technology, an aging population, and increasing demand for early diagnosis and precision medicine. IVD refers to tests conducted on biological samples such as blood, urine, and tissues to diagnose diseases, monitor health conditions, or predict treatment outcomes. These diagnostic tests are critical in guiding clinical decisions and improving patient care.
Key Drivers of the IVD Market
Technological Advancements Cutting-edge technologies like molecular diagnostics, next-generation sequencing (NGS), and point-of-care (POC) testing are revolutionizing the IVD market. Molecular diagnostics, in particular, allow for the detection of specific genetic markers, enabling early detection of diseases such as cancer and genetic disorders. NGS is enhancing personalized medicine by identifying precise mutations in a patient’s DNA, making treatments more targeted and effective.
Aging Population and Chronic Diseases The global aging population is contributing to the rise in chronic diseases such as diabetes, cardiovascular conditions, and cancer. As these conditions require continuous monitoring and management, the demand for IVD tests has increased. For instance, diabetes patients rely on glucose monitoring systems, which are a significant segment of the IVD market. This trend is expected to drive further growth in the coming years.
Rising Demand for Point-of-Care Testing POC testing, which allows for rapid diagnostic results at the patient’s bedside or in non-laboratory settings, is becoming increasingly popular. This technology enables quicker decision-making, especially in emergency situations, and reduces the need for centralized lab facilities. With advancements in POC technology, tests for conditions like COVID-19, diabetes, and infectious diseases are becoming more accessible and efficient.
Personalized Medicine and Companion Diagnostics The shift towards personalized medicine is one of the most significant trends in healthcare today. Companion diagnostics, a segment of IVD, plays a crucial role in determining the suitability of specific therapies based on a patient’s genetic makeup. This approach not only enhances treatment effectiveness but also minimizes adverse drug reactions, improving patient outcomes.
COVID-19 Impact The pandemic significantly boosted the IVD market, particularly in the areas of molecular diagnostics and POC testing. The urgent need for COVID-19 testing drove innovations in rapid testing kits, which have now become a critical part of pandemic management. As healthcare systems around the world continue to prioritize pandemic preparedness, this surge in demand for infectious disease testing is expected to persist.
Challenges Facing the IVD Industry
Despite the positive growth trajectory, the IVD market faces several challenges:
Regulatory Hurdles: IVD products must undergo stringent regulatory approvals before being brought to market, which can delay commercialization. Different regions have varying regulatory requirements, adding complexity for companies operating globally.
Reimbursement Issues: Securing reimbursement for IVD tests, especially in the case of novel diagnostics, can be a barrier to widespread adoption. In many markets, healthcare systems may be slow to integrate these tests into routine care due to cost concerns.
Data Privacy Concerns: As more IVD tests incorporate digital platforms and patient data, concerns over data security and privacy have risen. Ensuring that patient information is protected is critical to maintaining trust in IVD technologies.
Regional Insights
North America: The largest market for IVD, driven by well-established healthcare infrastructure, high adoption of advanced diagnostic technologies, and favorable government policies supporting innovation.
Europe: Strong growth is anticipated, particularly in molecular diagnostics and cancer testing. Countries such as Germany, France, and the UK are leading in research and development within the field.
Asia-Pacific: The fastest-growing region due to the rising prevalence of chronic diseases, increasing healthcare expenditure, and improving healthcare infrastructure in countries like China and India.
Future Outlook
The future of the IVD market looks promising, with continued advancements in technology and an increasing focus on precision medicine. The integration of artificial intelligence (AI) and machine learning into diagnostic tools is expected to improve the accuracy of tests and allow for the analysis of large datasets in real-time. Additionally, the ongoing emphasis on personalized healthcare will drive demand for companion diagnostics and genetic testing.
With the global healthcare landscape rapidly evolving, the In Vitro Diagnostic market is well-positioned for sustained growth. Companies investing in innovation, regulatory compliance, and expanding access to diagnostics in emerging markets will be the key players shaping the future of this dynamic industry.
Conclusion
The In Vitro Diagnostic market is a vital part of modern healthcare, providing the tools needed for accurate and timely diagnosis of diseases. As new technologies emerge and patient demand for personalized care grows, the IVD industry is set to expand further, offering innovative solutions that enhance healthcare outcomes and improve the quality of life for patients worldwide.
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#In Vitro Diagnostics (IVD) Market Size in 2022 : Share#Trends#Opportunities Analysis Forecast Report By 2028 | 181 Pages Report#intellectualmarketinsights
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Global Medical Device Testing and Certification Market Is Estimated To Witness High Growth Owing To Stringent Regulatory Standards
The global Medical Device Testing and Certification Market is estimated to be valued at US$ 9,687.7 Mn in 2022 and is expected to exhibit a CAGR of 4.3% over the forecast period 2023-2030, as highlighted in a new report published by Coherent Market Insights. Market Overview: Medical device testing and certification are critical processes to ensure the safety, efficacy, and quality of medical devices. These tests and certifications are performed to comply with regulatory standards and ensure that the devices meet quality and performance requirements. The need for medical device testing and certification arises from the growing complexity of medical devices, increased regulatory scrutiny, and the need to mitigate risks associated with device failures. The advantages of medical device testing and certification include improved patient safety, increased market access, enhanced product quality, and compliance with regulatory standards. Market key trends: One key trend in the medical device testing and certification market is the increasing demand for testing and certification services due to stringent regulatory standards. Regulatory authorities such as the Food and Drug Administration (FDA) require manufacturers to comply with rigorous testing and certification procedures to ensure that medical devices are safe and effective for use. This trend is driven by the need to prevent device malfunctions, recalls, and adverse events, which can have serious implications for patients and manufacturers. For example, in 2020, the FDA issued more than 200 device recalls due to safety concerns. As a result, there is a growing emphasis on testing and certification to ensure compliance with regulatory requirements. PEST Analysis: Political: The political environment plays a crucial role in shaping the medical device testing and certification market. Governments worldwide are enacting regulations to ensure patient safety and enhance the quality of medical devices. For example, the European Union implemented the Medical Devices Regulation (MDR) to strengthen the regulatory framework for medical devices, ensuring their safety and effectiveness. Economic: The economic factors influencing the medical device testing and certification market include healthcare expenditure, reimbursement policies, and healthcare infrastructure. As healthcare spending continues to rise globally, there is an increased focus on ensuring the quality and reliability of medical devices through testing and certification. Social: Social factors such as the aging population, increasing prevalence of chronic diseases, and rising awareness about patient safety are driving the demand for reliable and safe medical devices. This, in turn, fuels the need for rigorous testing and certification. Technological: Advancements in technology, such as the development of complex medical devices and the integration of artificial intelligence and Internet of Things (IoT) in healthcare, present new challenges and opportunities for testing and certification. Technological advancements require comprehensive testing procedures to ensure the reliability and functionality of these advanced medical devices. Key Takeaways: 1. The Global Medical Device Testing And Certification Market Demand is expected to witness high growth, exhibiting a CAGR of 4.3% over the forecast period. This growth can be attributed to increasing regulatory standards and the need to ensure patient safety. 2. North America is expected to dominate the market due to stringent regulatory requirements, advanced healthcare infrastructure, and a strong presence of key players.
#Medical Device Testing and Certification Market#Medical Device Testing and Certification Market Insights#Medical Device Testing and Certification Market Outlook#Medical Device Testing and Certification Market Growth#Medical Device Testing and Certification Market Analysis#Medical Device Testing and Certification Market Values#Medical Device Testing and Certification#medical devices#healthcare devices#In Vitro Diagnostic Directive#Medical Device Directive#Coherent Market Insights
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The Business Research Company offers in vitro diagnostics ivd quality control market research report 2023 with industry size, share, segments and market growth
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In Vitro Diagnostics (IVD) Quality Control Market Analysis, Demand & Forecast to 2020 – Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK)
Market Overview
The global in vitro diagnostics quality control market was valued at USD 1.5 billion in 2021 and it is anticipated to grow further up to USD 2.2 billion by 2031, at a CAGR of 3.7% during the forecast period.
The effectiveness of in vitro diagnostic tests, including those for pathogen identification using in vitro nucleic acid testing, healthcare-associated illnesses (HAIs) such as pneumonia, urinary tract infections, and others, is assessed using IVD quality controls. These products primarily concentrate on defect detection, quality control, and validation panels like the Blood Culture (BCID) Control Panel, Human Papillomavirus (HPV) Control Panel, and others to support in the implementation and monitoring of the performance of clinical and research laboratories, blood diagnostic centers, and IVD manufacturers.
View Detailed Report Description: https://www.globalinsightservices.com/reports/in-vitro-diagnostics-ivd-quality-control-market/
Market Dynamics
As the burden of various diseases increases globally, so has the number of laboratory tests. The number of laboratories in both the public and private sectors has increased in response to this need. With the start of the COVID-19 pandemic in December 2019, the demand for diagnostic tests has skyrocketed. Many government organizations have established new laboratories in response to this epidemic and to increase laboratory testing capacity. The majority of nations need clinical laboratories to get regulatory body accreditation before performing diagnostic tests. Additionally, accreditation to ISO 15189:2012 and other comparable standards is turning into a requirement in many nations. Authorities assess a laboratory’s competency and quality system during the accreditation process using predetermined standards. While some European nations, including Belgium, France, Hungary, Ireland, and Lithuania, require accreditation for a variety of laboratory tests, others, like Finland, the Netherlands, Sweden, Switzerland, and the UK, have practically finished the process.
It costs a lot of money to set up a QC process in a clinical laboratory. Additionally, laboratories must keep a specialized staff on hand to oversee the QC system. Moreover, regardless of the number of tests conducted, QC procedures are expensive. As a result, QC methods are particularly expensive to adopt for clinical laboratories that perform few diagnostic tests. This is predicted to lead to a lesser adoption of QC procedures, along with budgetary restrictions in many hospitals and laboratories in developed and emerging nations.
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The key players studied in the global in vitro diagnostic quality control market are Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), Abbott Laboratories (US), Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), and Helena Laboratories Corporation (US) among others.
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In Vitro Diagnostics Market Growth Trends and Strategies 2024 - 2030
The global in vitro diagnostics (IVD) market size was estimated at USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030.
The growth can be attributed to increasing adoption of IVD owing to a rise in the incidence of infectious and chronic diseases. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel market growth. The rising number of IVD products being launched by key players is also fueling market growth. For instance, in November 2023, ARUP Laboratories received a CE mark from EU-IVDR for AAV5 DetectCDx, a companion diagnostic to select the eligibility of severe hemophilia A-affected patients for BioMarin’s new gene therapy, Roctavian.
Technological advancements in terms of accuracy, portability, and cost-effectiveness are expected to be one of the high-impact rendering drivers of this market. Introduction of novel and highly accurate clinical laboratory tests is boosting the adoption of novel IVD tests worldwide. In June 2023, Toray Industries, Inc. received marketing approval from Japan’s Ministry of Health, Labour and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer. Moreover, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S. Increasing approvals of IVD tests for life-threatening diseases are expected to create new opportunities in the untapped market.
Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market
In Vitro Diagnostics Market Report Highlights
• Molecular diagnostics is anticipated to grow at the fastest CAGR from 2024 to 2030 owing to the rising adoption and usage rate
• Reagents held the largest market share owing to the surge in demand for genetic testing and enhanced availability of technologically advanced diagnostic tests in lower and middle-income countries with unmet clinical needs
• The infectious diseases application segment held the largest market share owing to the large volume of testing for infectious diseases globally
• North America dominated the global market in 2023 owing to the high demand for novel technologies, a large pool of key players, high prevalence of diseases, and advanced healthcare infrastructure
Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.
• The global hepatitis diagnostic market size was valued at USD 3.82 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030.
• The global hematology diagnostics market size was valued at USD 7.54 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030.
In Vitro Diagnostics Market Segmentation
Grand View Research has segmented the global in vitro diagnostics (IVD) market report based on product, technology, application, end-use, test location, and region:
IVD Product Outlook (Revenue, USD Million, 2018 - 2030)
• Instruments
• Reagents
• Services
IVD Technology Outlook (Revenue, USD Million, 2018 - 2030)
• Immunoassay
o Instruments
o Reagents
o Services
• Hematology
o Instruments
o Reagents
o Services
• Clinical Chemistry
o Instruments
o Reagents
o Services
• Molecular Diagnostics
o Instruments
o Reagents
o Services
• Coagulation
o Instruments
o Reagents
o Services
• Microbiology
o Instruments
o Reagents
o Services
• Others
o Instruments
o Reagents
o Services
IVD Application Outlook (Revenue, USD Million, 2018 - 2030)
• Infectious Diseases
• Diabetes
• Oncology
• Cardiology
• Nephrology
• Autoimmune Diseases
• Drug Testing
• Others
IVD Test Location Outlook (Revenue, USD Million, 2018 - 2030)
• Point of Care
• Home-care
• Others
IVD End-use Outlook (Revenue, USD Million, 2018 - 2030)
• Hospitals
• Laboratory
• Home-care
• Others
IVD Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
o U.S.
o Canada
• Europe
o UK
o Germany
o France
o Spain
o Italy
o Russia
o Denmark
o Sweden
o Norway
• Asia Pacific
o Japan
o China
o India
o South Korea
o Australia
o Thailand
o Singapore
• Latin America
o Brazil
o Mexico
o Argentina
• Middle East and Africa (MEA)
o South Africa
o Saudi Arabia
o UAE
o Kuwait
Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.
#In Vitro Diagnostics Market#In Vitro Diagnostics Market size#In Vitro Diagnostics Market share#In Vitro Diagnostics Market analysis#In Vitro Diagnostics Industry
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https://rollbol.com/blogs/1789654/In-Vitro-Diagnostics-Market-Size-Analysis-and-Forecast-2031
The In Vitro Diagnostics Market in 2023 is US$ 121.38 billion, and is expected to reach US$ 176.89 billion by 2031 at a CAGR of 4.82%.
#In Vitro Diagnostics Market#In Vitro Diagnostics Market Analysis#In Vitro Diagnostics Market Forecast
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Philippines Medical Device and Pharmaceutical Market Analysis, Demand & Opportunity 2024-2032
Philippines Medical Device and Pharmaceutical Market Overview
Base Year: 2023
Historical Years: 2018-2023
Forecast Years: 2024-2032
Market Growth Rate: 7.60% (2024-2032)
The Philippines Medical Device and Pharmaceutical Market is poised for significant growth, driven by increasing healthcare demands, government initiatives to enhance healthcare access, and a rising emphasis on innovative medical technologies and pharmaceuticals. According to the latest report by IMARC Group, The Philippines medical device and pharmaceutical market is projected to exhibit a growth rate (CAGR) of 7.60% during 2024-2032.
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Philippines Medical Device and Pharmaceutical Market Trends and Drivers:
The Philippines medical device and pharmaceutical market is expanding rapidly, owing to several interconnected factors. Primarily, the market is driven by increased healthcare spending, a growing prevalence of chronic illnesses, as well as the initiatives of the government authorities to boost healthcare accessibility. Besides this, the "Universal Health Care Act" of the government bodies seeks to lower the cost and increase access to healthcare services, which has increased demand for necessary drugs, medical equipment, and diagnostic tools. In line with these factors, international collaborations and investments from major pharmaceutical and med-tech companies are further boosting the Philippines medical device and pharmaceutical market by enhancing local manufacturing capabilities and supply chains. Additionally, the Philippines is witnessing a shift toward digital health and telemedicine, with devices such as remote monitoring tools gaining traction, especially following the COVID-19 pandemic.
Key trends in the Philippines medical device and pharmaceutical market include a growing emphasis on locally manufactured, affordable generic drugs to address the needs of low- to middle-income patients and reduce dependence on imports. In addition to these factors, the demand for advanced medical devices, such as minimally invasive surgical instruments and diagnostic imaging equipment, is also on the rise as hospitals upgrade their facilities. Furthermore, the market is witnessing increased adoption of mobile health applications and wearable devices, providing Filipinos with better tools for managing chronic conditions. With these dynamics, the medical device and pharmaceutical market in the Philippines is expected to grow significantly, aligning with the country's goals of improving healthcare outcomes and expanding access across all socioeconomic groups. Consequently, the convergence of these factors is anticipated to propel the expansion of the Philippines medical device and pharmaceutical market in the coming years.
IMARCs report provides a deep dive into the Philippines medical device and pharmaceutical market analysis, outlining the current trends, underlying market demand, and growth trajectories.
Philippines Medical Device and Pharmaceutical Market Report Segmentation:
The report has segmented the market into the following categories:
Medical Device and Pharmaceutical Insights:
Medical Device
Breakup by Product Type
Orthopedic Devices
Cardiovascular Devices
Diagnostic Imaging
In Vitro Diagnostics
Minimally Invasive Surgery
Wound Management
Diabetes Care
Ophthalmic
Dental
Nephrology
General Surgery
Others
Breakup by End User
Hospitals and ASCs
Clinics
Others
Pharmaceutical
Breakup by Type
Drugs
Cardiovascular Drugs
Dermatology Drugs
Gastrointestinal Drugs
Genito-Urinary Drugs
Hematology Drugs
Anti-Infective Drugs
Metabolic Disorder Drugs
Musculoskeletal Disorder Drugs
Central Nervous System Drugs
Oncology Drugs
Ophthalmology Drugs
Respiratory Diseases Drugs
Biologics
Monoclonal Antibodies (MAbS)
Therapeutic Proteins
Vaccines
Breakup by Routes of Administration
Oral
Topical
Parenteral
Others
Breakup by Distribution Channel
Hospital Pharmacy
Retail Pharmacy
Online Pharmacy
Others
Breakup by End User
Hospitals and ASCs
Clinics
Others
Regional Insights:
Luzon
Visayas
Mindanao
Competitive Landscape:
The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.
Other key areas covered in the report:
COVID-19 Impact on the Market
Porter’s Five Forces Analysis
Strategic Recommendations
Market Dynamics
Historical, Current and Future Market Trends
Market Drivers and Success Factors
SWOT Analysis
Value Chain Analysis
Comprehensive Mapping of the Competitive Landscape
Top Winning Strategies
Recent Industry News
Key Technological Trends & Development
Note: If you need specific information that is not currently within the scope of the report, we will provide it to you as a part of the customization.
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From Lab-on-a-Chip to Industrial Innovation: Milestones in Microfluidic Technology
The global market for microfluidic products surged to $9.98 billion in 2019, with microfluidic devices accounting for $3.48 billion of this figure. A notable trend in the industry is the ongoing acquisition of microfluidic companies by larger enterprises, signaling a trajectory of accelerated growth through capital infusion.
In the industrial landscape, in vitro diagnostics (IVD) stands out as the primary sector for microfluidic applications, driven by its lucrative returns. Demographic shifts, particularly aging populations, contribute to an escalating demand for microfluidic chips. Moreover, governmental policies prioritize the advancement of the microfluidics industry, a focus that has intensified amidst the backdrop of the pandemic. Moving forward, the critical hurdles facing microfluidic chip technology revolve around manufacturing costs and scalability. Achieving scalable production processes and cost reduction measures while maintaining product standardization and minimizing variations are imperative objectives.
The evolution of modern technology emphasizes miniaturization, integration, and intelligence. Microelectromechanical systems (MEMS) have played a pivotal role in this evolution, enabling the transition from bulky electronic systems to compact integrated circuit chips and handheld devices like smartphones. Similarly, microfluidic chips, often referred to as Lab-on-a-Chip technology, epitomize the manipulation of fluids at micro- and nanoscales. These chips condense essential laboratory functionalities, such as sample preparation, reaction, separation, and detection, onto a compact chip, typically a few square centimeters in size. The hallmark of microfluidic chips lies in their capacity for flexible integration and scaling of diverse unit technologies within a controllable microplatform.
Originating from MEMS technology, early microfluidic chips underwent fabrication processes on substrates like silicon, metals, polymers, glass, and quartz. These processes yielded microstructure units such as fluid channels, reaction chambers, filters, and sensors, with dimensions ranging from micrometers to sub-millimeters. Subsequent fluid manipulation within these microstructures enabled automated execution of biological laboratory procedures, including extraction, amplification, labeling, separation, and analysis, or cell manipulation and analysis.
In the early 1990s, A. Manz et al. demonstrated the potential of microfluidic chips as analytical chemistry tools by achieving electrophoretic separation—a technique previously confined to capillaries—on chips. Subsequently, spurred by the U.S. Department of Defense's requisition for portable biochemical self-test equipment, research in microfluidic chips burgeoned globally. Throughout the 1990s, microfluidic chips primarily served as platforms for analytical chemistry, often interchangeably referred to as "Micro Total Analysis Systems" (u-TAS). Consequently, these chips found applications across diverse fields, including biomedical diagnostics, food safety, environmental monitoring, forensics, military, and aerospace sciences.
Key milestones in the advancement of microfluidic chips include G. Whitesides et al.'s 2000 publication on PDMS soft lithography and S. Quake et al.'s 2002 article on "large-scale integration of microfluidic chips" featuring microvalve and micropump controls. These seminal works propelled microfluidic chips beyond the confines of traditional analytical systems, unlocking their potential for significant scientific and industrial applications. For instance, microfluidic chips enable the execution of combinatorial chemical reactions or droplet techniques, facilitating drug synthesis, high-throughput screening, and large-scale nanoparticle or microsphere production. In essence, microfluidic chips pave the way for the realization of a "chemical plant or pharmaceutical lab on a chip."
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