#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.

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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%.

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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.

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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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Global Genotyping Assay Market Report 2032

Global Genotyping Assay Market is projected to witness a CAGR of 14.85% during the forecast period 2025-2032, growing from USD 20.99 billion in 2024 to USD 63.54 billion in 2032. The market demand for genotyping assays is anticipated to thrive drastically in the forecast years due to the rising prevalence of genetic disorders, chronic diseases, and technological advancements in genomic technologies.

Genotyping analysis is a method used in the laboratory to determine the body’s genetic composition (genetic type) by analyzing the DNA. In a specific place of the genome, genetic mutations are identified, such as individual nucleotide multiple type single nucleotide polymorphisms (SNPs), insertions, deletions, or other mutations. The genetic analysis market grows significantly due to an increase in the rate of genetic disorders, the accurate medical field, and the growing demand for personalized healthcare solutions. The market is promoted by the extensive introduction of advanced technology, such as the next-generation microchip sequence (NGS), the polymerase chain reaction (PCR), and the analysis of accurate and effective genetic analysis. Leading companies are focusing on product innovation, strategic alliances, and application expansion in areas such as pharmacogenomics, oncology, infectious disease diagnostics, etc., driving the market growth. For instance, in October 2024, LGC Biosearch Technologies Limited launched Amp-Seq One, a revolutionary one-step amplicon sequencing workflow for commercial breeding. With a 120-minute turnaround time and no liquid handling equipment needed, it minimizes hands-on time, reduces consumables, lowers contamination risks, doubles throughput, and delivers unmatched speed and precision in agricultural genomics.

Increasing Prevalence of Genetic Disorders

The growing incidence of genetic diseases is a significant growth factor for the global genotyping assay market. Increasing cases of cancer, cystic fibrosis, sickle cell anemia, and cardiovascular diseases necessitate early and accurate diagnostic tools. Genotyping assays can accurately identify the genetic mutations to allow early intervention and targeted therapy. There is now increased awareness about hereditary and somatic mutations, further increasing demand for genotyping in clinical as well as research areas. Awareness about genetic testing is also increased by both healthcare providers and patients with the implementation of genetic diagnostics in routine medical care, the adoption of genotyping assays market growth in the forecast period. For instance, in October 2024, Revvity, Inc. announced the launch of the in-vitro diagnostic EURORealTime APOE assay in CE-marked European countries. This assay enables precise apolipoprotein E (APOE) gene genotyping to assess Alzheimer’s patients’ risk for adverse side effects from anti-amyloid therapies, which is crucial for personalized treatment plans and managing potential amyloid-related imaging abnormalities-related risks.

Advancements in Genotyping Technologies

Advancement in genotyping technologies is poised to witness significant growth in the genotyping market; the increasing prevalence of genetic disorders is fueling the demand for accurate and efficient genotyping methods, particularly in the field of personalized medicine and drug development. Advanced technologies such as next-generation sequencing and polymerase revolutionized genetic analysis that guarantees quick and accurate detection of genetic fluctuations in various uses. These technological innovations enhance the effectiveness of genotyping analysis, reduce costs, and make it more affordable for researchers and medical workers. Additionally, increasing collaborations between academic institutions and biotech companies are helping to create an environment conducive to innovation, thereby expanding market growth.  For instance, in June 2024, MGI Tech Co., Ltd. announced a new automated workflow for large-scale Low-pass Whole Genome Sequencing (WGS) Solutions for Agriculture. The solution streamlines molecular breeding with tools for extraction, library prep, sequencing, and SNP/InDel calling. The MGIEasy Large-scale polymerase chain reaction Free FS Library Prep Set simplifies library construction with a plate-based design, cutting steps, time, and consumables.

Reagents and Kits Segment to Dominate the Genotyping Assay Market 

The reagents and kits segment is anticipated to dominate the genotyping assay market primarily because of its role in ensuring accurate results, as well as reproducible results, across various genotyping applications. The segment further benefits from the increasing adoption of ready-to-use kits, which simplify the workflow and reduce procedural errors in research and clinical settings. Due to the increasing demand for high-throughput genotyping, innovations in reagent formulation for technologies like next-generation sequencing and polymerase chain reaction and microarrays enhance the segment’s growth prospects. Additionally, this contributes to a continuous flow of revenue, making the segment fuel the market growth. For instance, in June 2024, Omixon Inc. launched HoloGRAFT ONE, a simplified digital polymerase chain reaction kit for monitoring donor-derived cell-free DNA (dd-cfDNA) in transplant research. Its single-use, dry reagent format eliminates handling errors and streamlines workflows. The assay offers direct, absolute quantification of donor-specific genetic markers for improved transplant monitoring.

North America Dominates Genotyping Assay Market 

The overall market for genotyping assays worldwide is dominated by North America, due to the excellent infrastructural facilities for healthcare available here, high research and development activity, and extensive adoption of advanced genomic technologies. Notable biotechnology and pharmaceutical firms, as well as huge government spending on genomics research, make further enhancements in the market. The increasing incidence of chronic diseases, personalized medicine initiatives, and the increasing demand for precision diagnostics have created a strong demand for genotyping assays in the region. For instance, in May 2024, F. Hoffmann-La Roche AG launched an HPV self-collection solution that received FDA approval, offering an accessible screening option. Individuals can collect vaginal samples in a healthcare setting, then analyze them using Roche’s Cobas molecular instrument. Positive results lead to further care with a healthcare provider, enabling early detection of cervical cancer risks.

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Future Market Scenario (2025-2032F)

The future market scenario for the global genotyping assay market looks very promising, as rapid advancement in genomic technologies and the adoption of precision medicine are driving this market. Emerging trends such as artificial intelligence and machine learning integration in genomic data analysis are expected to streamline workflows and enhance diagnostic accuracy. The increasing incidence of genetic diseases, along with the increased demand for pharmacogenomics and personalized medicines, will fuel further growth in the market. In addition, the increased focus on agricultural genomics and animal breeding is expected to create new growth opportunities. Increased access to cost-effective, high-throughput genotyping platforms is sustainable growth in the market. For instance, in March 2024, Nucleus Genomics, Inc. launched DNA analysis and whole genome sequencing services for personalized genetic risk and health reports. Customers can upload existing microarray DNA data to gain insights into diseases like type 2 diabetes and breast cancer, with analysis incorporating lifestyle factors like age, body mass index, and cholesterol.

Report Scope

“Genotyping Assay Market Assessment, Opportunities and Forecast, 2018-2032F”, is a comprehensive report by Markets and Data, providing in-depth analysis and qualitative and quantitative assessment of the current state of global genotyping assay market, industry dynamics, and challenges. The report includes market size, segmental shares, growth trends, opportunities, and forecasts between 2025 and 2032. Additionally, the report profiles the leading players in the industry, mentioning their respective market share, business models, competitive intelligence, etc.

Click here for full report- https://www.marketsandata.com/industry-reports/genotyping-assay-market

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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.

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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%.

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Medical Device Testing Outsourcing: $3.5B in 2023 to $7.2B by 2033 (7.5% CAGR)

Medical Device Analytical Testing Outsourcing Market offers specialized services provided by third-party organizations to rigorously test and analyze medical devices. These services ensure compliance with regulatory standards, enhance product safety and efficacy, and support manufacturers in accelerating time-to-market while reducing operational costs.

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Key Market Drivers

The market is experiencing robust growth, driven by:

Increasing Regulatory Scrutiny: Rising emphasis on product safety and efficacy has amplified the need for comprehensive testing.

Cost-Efficiency: Outsourcing helps manufacturers optimize resources and focus on core competencies.

Technological Advancements: The growing complexity of medical devices necessitates specialized and advanced testing capabilities.

Market Insights

The chemical characterization segment leads the market, accounting for 38% of the share in 2023, driven by stringent safety standards and the necessity for thorough material analysis.

Microbiology and sterility testing follow closely with a 32% share, underscoring the importance of ensuring device sterility and patient safety.

Biocompatibility testing holds a 30% share, reflecting the demand for evaluating device compatibility with biological systems.

In 2023, the global market recorded approximately 1.2 billion tests conducted, showcasing the growing reliance on outsourced testing services.

Regional Highlights

North America dominates the market due to advanced healthcare infrastructure and the high concentration of medical device manufacturers.

Europe follows, supported by a robust regulatory framework and a rising demand for innovative medical technologies.

The United States and Germany stand out as leading contributors, reflecting significant demand for outsourced testing services in these regions.

Market Segmentation

By Type: Chemical Testing, Physical Testing, Microbiological Testing, Biocompatibility Testing, Stability Testing, Electromagnetic Compatibility Testing, Packaging Testing By Product: Instruments, Reagents, Consumables By Services: Method Development, Method Validation, Extractables and Leachables Testing, Material Characterization, Batch Release Testing, Product Life Cycle Testing By Technology: Chromatography, Spectroscopy, Polymerase Chain Reaction (PCR), Flow Cytometry, Mass Spectrometry, Electrophoresis, Microscopy By Component: Sensors, Transducers, Microfluidics By Application: Cardiology Devices, Orthopedic Devices, In Vitro Diagnostic Devices, Ophthalmic Devices, Dental Devices, Drug Delivery Devices By Device: Wearable Devices, Portable Devices, Stationary Devices By Process: Preclinical Testing, Clinical Testing, Post-Market Surveillance By End User: Medical Device Manufacturers, Research Laboratories, Academic Institutions

Leading Market Players

Key players such as Eurofins Scientific, SGS SA, and Charles River Laboratories drive the market with their advanced technologies and robust testing capabilities, maintaining a competitive edge in this dynamic industry.

#MedicalDevices #AnalyticalTesting #OutsourcingServices #MedicalInnovation #HealthcareSafety #RegulatoryCompliance #BiocompatibilityTesting #ChemicalCharacterization #SterilityTesting #AdvancedTechnologies #GlobalHealthcare #PatientSafety #DeviceTesting #ResearchAndDevelopment #QualityAssurance

The Medical Device Analytical Testing Outsourcing Market is set to expand further as advancements in medical device technologies and stringent regulatory requirements fuel the demand for precise, specialized testing services.

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Meticulous Research® Unveils New Report: Africa IVD Market Poised to Reach $1.65 Billion by 2031

[Redding, California] — Meticulous Research®, a global leader in market research and consulting, has released a new report titled ‘Africa IVD Market Size, Share, Forecast & Trends Analysis by Offering, Technology (Immunoassay, PoC, Molecular Diagnostics, Coagulation), Application (Infectious Diseases, Diabetes, Oncology), Diagnostic Approach (Lab, OTC, PoCT), End User – Forecast to 2031.’ According to the latest findings, the Africa in vitro diagnostics (IVD) market is projected to grow at a compound annual growth rate (CAGR) of 3.1%, reaching $1.65 billion by 2031.

Download Sample Report Here : https://www.meticulousresearch.com/download-sample-report/cp_id=5415 Market Growth Drivers and Challenges

The expansion of the Africa IVD market is driven by multiple factors, including the rising prevalence of chronic and infectious diseases, increased investments from IVD companies, growing demand for point-of-care (PoC) and rapid diagnostics, and a burgeoning geriatric population. Furthermore, supportive government initiatives aimed at bolstering Africa's healthcare sector and increasing healthcare expenditure are playing a significant role in the market's development.

However, market growth is being restrained by the high costs of advanced IVD products, variations in test results for rapid diagnostics, and the stringent regulatory requirements for high-complexity diagnostic tests. On the other hand, advancements in genomics and proteomics, heightened awareness of early diagnosis, and the increasing adoption of personalized medicine are expected to create significant opportunities for market players. Despite these promising trends, uneven access to healthcare and a shortage of trained healthcare professionals remain critical challenges.

Check complete table of contents with list of table and figures: https://www.meticulousresearch.com/product/africa-ivd-market-5415

Market Segmentation and Key Insights

The report provides detailed insights into the market, segmented by offering, technology, application, diagnostic approach, and end user:

By Offering: The market is segmented into reagents & kits, instruments, and software & services. The reagents & kits segment is expected to grow at the highest CAGR of 3.3% during the forecast period, driven by increased diagnostic test volumes for infectious diseases, particularly malaria and tuberculosis, and various initiatives aimed at improving healthcare access across Africa.

By Technology: In 2024, the immunoassay/immunochemistry segment is projected to account for the largest market share at 34.5%. This is largely due to immunoassay technology's efficient and accurate diagnostics for highly prevalent diseases such as HIV, malaria, and dengue in Africa, along with its cost-effectiveness and continuous development of new biomarkers.

By Application: The infectious diseases segment is expected to dominate the market in 2024, fueled by the widespread prevalence of diseases like COVID-19, dengue, and HIV. Increasing awareness of diagnostic testing and the availability of low-cost rapid test kits are key factors driving this segment’s growth.

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By Diagnostic Approach: Point-of-care testing (PoCT) is projected to witness the highest growth during the forecast period, driven by the rising demand for immediate diagnostic results, especially in remote and underserved regions.

By End User: Hospitals and clinics are expected to grow at the highest CAGR between 2024 and 2031. Factors such as the increasing number of hospitalizations for chronic diseases, rising healthcare expenditure, and the willingness of hospitals to adopt advanced diagnostic tools are contributing to this growth.

Geographic Insights

The report also provides an in-depth analysis of various African countries, including South Africa, Nigeria, Egypt, Algeria, Morocco, Kenya, Tunisia, Côte d’Ivoire, Tanzania, Cameroon, and the Rest of Africa. South Africa is projected to grow at the highest CAGR of 8.3% during the forecast period. The growth in South Africa is driven by increased healthcare expenditure, expanded access to diagnostic tools through partnerships and collaborations, and favorable government policies aimed at enhancing healthcare infrastructure.

Competitive Landscape

Key players in the Africa IVD market include Abbott Laboratories (U.S.), Becton, Dickinson and Company (U.S.), bioMérieux SA (France), Danaher Corporation (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), QIAGEN N.V. (Netherlands), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Illumina, Inc. (U.S.), and Shenzhen Mindray Bio-Medical Electronics Co., Ltd (China). These industry leaders continue to invest in the region, driving innovation and expanding their presence in the African market.

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Key Questions Addressed in the Report:

What is the current revenue generated by IVD products in Africa? What are the projected growth rates for the Africa IVD market over the next 5–7 years? What are the key drivers, opportunities, and challenges affecting this market? Which market segments are generating the most traction in terms of offering, technology, and application? Which countries in Africa offer significant growth opportunities for market participants? Who are the leading players, and what products and strategies are they employing in the Africa IVD market? What recent developments are shaping the competitive landscape?

Contact Information

Meticulous Research® Email: sales@meticulousresearch.com Phone: +1-646-781-8004 LinkedIn: Connect with us

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Pediatric Allergy Diagnostics Market Outlook On The Basis Of Product, Allergen, Test, Region And Forecast To 2030: Grand View Research Inc.

San Francisco, 29 Nov 2024: The Report Pediatric Allergy Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables), By Allergen (Food, Inhaled, Drug), Test (In Vivo Test, In Vitro Test), By Region, And Segment Forecasts, 2024 – 2030 The global pediatric allergy diagnostics market is anticipated to reach USD 4.68 billion by 2030 and is projected to grow at a…