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rohit890 · 2 years ago

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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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marketanalysisdata · 3 days ago

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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.

#In Vitro Diagnostics Market Share #In Vitro Diagnostics Market Analysis

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marketstudyreport · 3 days ago

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In Vitro Diagnostics Market 2030 Outlook by Growth Rate, Trends, Size and Opportunities

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market

Regional Insights:

North America In Vitro Diagnostics Market:

Europe In Vitro Diagnostics Market Trends:

Asia Pacific In Vitro Diagnostics Market Trends:

Latin America In Vitro Diagnostics Market Trends:

Middle East & Africa In Vitro Diagnostics Market Trends:

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:

Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics Market Share #In Vitro Diagnostics Market Analysis

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ashwetu · 4 days ago

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In Vitro Diagnostics Market Growth to Reach $116.28 Billion by 2031, at a CAGR of 5.3%

Increased demand for early disease diagnosis, personalized medicine, and point-of-care solutions drive IVD market growth.

According to a new report published by Meticulous Research®, the global in vitro diagnostics (IVD) market is poised for substantial growth, projected to reach $116.28 billion by 2031, expanding at a CAGR of 5.3% from 2024. The report, titled In Vitro Diagnostics (IVD) Market—Global Opportunity Analysis and Industry Forecast (2024-2031), delves into the key trends, technological advancements, and growth drivers shaping the IVD industry.

For detailed insights, request the sample report here: https://www.meticulousresearch.com/request-sample-report/cp_id=4858

Key Market Drivers and Growth Opportunities

The IVD market’s expansion is fueled by multiple factors, including a surge in chronic disease prevalence, a growing elderly population, and the rising incidence of infectious diseases. Increasing healthcare expenditure, advancements in genomics and proteomics, and rising awareness about early disease diagnosis have also significantly impacted market growth. The need for faster diagnostic solutions in clinical settings, particularly point-of-care (POC) diagnostics, has gained momentum in recent years, contributing to the rapid adoption of IVD technologies.

Furthermore, the growing interest in personalized medicine, especially in oncology and infectious disease management, has spurred demand for molecular diagnostics and advanced testing solutions. The availability of IVD products that can provide rapid, reliable results supports the increasing reliance on diagnostics for personalized treatment plans. The report offers an in-depth look at these market drivers and emerging opportunities.

For a more detailed analysis, you can download a sample report here: https://www.meticulousresearch.com/download-sample-report/cp_id=4858

Key Market Segments

Meticulous Research® segments the IVD market based on offering, technology, application, diagnostic approach, and end user:

Offering: The reagents & kits segment is projected to account for the largest share of the IVD market (81.1%) by 2024. The segment's prominence is attributed to the recurring use of assays and kits for chronic and infectious disease detection, as well as the increasing demand for self-testing solutions in emerging economies.

Technology: Molecular diagnostics is expected to be the leading technology segment, accounting for 23.1% of the market in 2024. The increasing prevalence of infectious diseases, coupled with advancements in automated diagnostic systems, has amplified the adoption of molecular diagnostics in clinical and research settings.

Application: The infectious diseases application segment is anticipated to dominate the market in 2024, with a 37.8% share. Heightened awareness around early diagnosis, government initiatives, and public health campaigns have all contributed to the growth of this segment.

For a customized view of the IVD market lndscape, tailored to specific business needs, visit: https://www.meticulousresearch.com/request-customization/cp_id=4858

Regional Market Analysis

The global IVD market spans major regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America is anticipated to lead the market, holding a 37.5% share in 2024. The region’s significant market share is driven by a high prevalence of chronic diseases, widespread adoption of diagnostic technologies, and robust funding for healthcare research. Advanced healthcare infrastructure and favorable government policies further support the region's market dominance.

In Asia-Pacific, the IVD market is also gaining momentum, with increasing healthcare expenditure and rising awareness about early disease detection in emerging economies. Countries like China, Japan, and India are projected to experience substantial growth due to increasing demand for POC diagnostic solutions and personalized medicine.

To access a comprehensive breakdown of regional market dynamics, you can download the https://www.meticulousresearch.com/download-sample-report/cp_id=4858

Challenges and Opportunities

While the IVD market is positioned for significant growth, challenges persist. Regulatory hurdles and technical complexities in developing high/moderate-complexity tests can impede market progress. Inconsistencies in rapid test results and shifting regulatory landscapes pose additional challenges for manufacturers. However, with the rising need for accurate, fast diagnostics, companies are investing in research and development to overcome these obstacles and improve product quality.

Opportunities exist for expanding into untapped markets in developing regions, where healthcare infrastructure is evolving, and demand for diagnostic solutions is increasing. Additionally, advances in genomics and proteomics open new pathways for targeted diagnostics and treatment, benefiting both patients and healthcare providers.

For an in-depth examination of market challenges and strategic growth opportunities, https://www.meticulousresearch.com/request-sample-report/cp_id=4858

Competitive Landscape

The report also provides a detailed analysis of the competitive landscape, highlighting key players shaping the IVD market:

Abbott Laboratories (U.S.)

Becton, Dickinson and Company (U.S.)

bioMérieux SA (France)

Danaher Corporation (U.S.)

F. Hoffmann-La Roche Ltd. (Switzerland)

Thermo Fisher Scientific Inc. (U.S.)

Siemens Healthineers AG (Germany)

These companies are at the forefront of innovation, leveraging partnerships, acquisitions, and advanced diagnostic technologies to enhance their market presence. For instance, in 2022, QIAGEN N.V. launched the therascreen EGFR RGQ PCR Kit for detecting EGFR mutations, showcasing how new products continue to drive growth within the IVD sector. Strategic alliances, regional expansions, and R&D investments are common among these market leaders as they aim to address evolving diagnostic needs.

Future Outlook for the IVD Market

The future of the IVD market is promising, with technological advancements driving innovation across applications and use cases. The increasing adoption of digital and automated diagnostic solutions, including artificial intelligence in diagnostics, is expected to enhance the accuracy and speed of diagnostic testing. These advancements, coupled with a growing emphasis on personalized medicine, position the IVD market for sustained growth over the next decade.

Furthermore, as healthcare providers worldwide prioritize early diagnosis and preventive healthcare, the demand for advanced diagnostic tools will likely continue to rise. This growth trajectory presents substantial opportunities for both established players and emerging companies seeking to innovate within the sector.

Download the full report to gain in-depth insights into the trends, drivers, and future outlook of the global in vitro diagnostics market: https://www.meticulousresearch.com/download-sample-report/cp_id=4858

Contact Us: Meticulous Market Research Pvt. Ltd. 1267 Willis St, Ste 200 Redding, California, 96001, U.S. Email- [email protected] USA: +1-646-781-8004 Europe: +44-203-868-8738 APAC: +91 744-7780008 Visit Our Website: https://www.meticulousresearch.com/ For Latest Update Follow Us: LinkedIn- https://www.linkedin.com/company/meticulous-research Meticulous Blog | Top Market Research Reports Blog - https://meticulousblog.org/

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latestmarketresearchnews · 11 days ago

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In Vitro Diagnostics (IVD) Industry Sales, Demand, Regional Outlook And Supply Chain Analysis till 2030

The global in vitro diagnostics (IVD) market reached an estimated size of USD 77.92 billion in 2023, with expectations for a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This market growth is primarily driven by the increasing use of IVD tools due to rising cases of infectious and chronic diseases worldwide. Automated IVD systems are becoming more common in hospitals and laboratories, as they provide accurate, fast, and error-free diagnoses, helping meet the growing demand for efficient healthcare services. Additionally, IVD market expansion is fueled by frequent product launches from key industry players. For example, in November 2023, ARUP Laboratories received a CE mark from the EU-IVDR for AAV5 DetectCDx, a companion diagnostic that helps identify eligibility for severe hemophilia Some patients to receive BioMarin’s gene therapy, Roctavian.

Major companies in the IVD market are employing various strategies to strengthen their position and bring more advanced and diverse products to their customers. New product launches and partnerships are among the most common tactics. For instance, in March 2023, BD received FDA 510(k) clearance for the BD Vaginal Panel on its BD COR System, a tool designed to detect infectious causes of vaginitis. In another instance, in August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These partnerships and product developments highlight how key players are focused on expanding their diagnostic offerings to meet growing healthcare needs.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Supportive initiatives from government and non-governmental bodies are also contributing to the market's growth by enhancing access to essential diagnostic tools. In October 2023, the World Health Organization (WHO) released an updated Essential Diagnostics List (EDL), a comprehensive catalog of vital IVD products that aids countries in making informed decisions on diagnostic tools. This list provides evidence-based recommendations, ensuring that essential diagnostic products are accessible to the people who need them most. Additionally, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve access to diagnostic tests across the African continent. Such initiatives are expected to further support the expansion of the IVD market, especially in regions with limited healthcare resources.

The global aging population, coupled with growing awareness of early disease detection, has led to an increase in routine check-ups. This trend is particularly relevant because the majority of deaths due to infections and chronic conditions occur in people over 75. According to the UK's Office for Budget Responsibility, healthcare costs have seen a significant rise, which can place economic strain on countries with rapidly aging populations. However, these increased expenditures are likely to boost the IVD market, as diagnostic testing becomes essential in managing the healthcare needs of older adults.

End-use Segmentation Insights:

Hospitals represented the largest revenue share in the IVD market in 2023, largely due to an increase in hospital admissions requiring rapid diagnostic support. The continuous development of healthcare infrastructure, supported by government initiatives, is further improving hospital facilities, thereby increasing demand for hospital-based IVD testing. IVD tests are frequently purchased by hospitals and are utilized in large volumes due to their critical role in providing fast, accurate results for patient care. In the U.S. alone, there are over 6,129 hospitals, all of which rely on IVD tests for essential decision-making in patient care.

In December 2023, the American Hospital Association advocated to the FDA that regulatory requirements for devices should not apply to hospitals' laboratory-developed tests (LDTs), which could allow hospitals greater flexibility in their use of in-house diagnostic tools. Meanwhile, the homecare segment is anticipated to see high growth from 2024 to 2030, driven by the aging population and increasing demand for at-home diagnostic devices. There is a particular need for novel molecular diagnostic and immunoassay platforms that enable patients to perform self-tests conveniently at home. For example, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first over-the-counter (OTC) home diagnostic test capable of distinguishing between influenza A, influenza B, and SARS-CoV-2 (the virus causing COVID-19). This authorization demonstrates the shift towards providing individuals with more autonomy in managing their health through accessible at-home testing solutions.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Research #In Vitro Diagnostics (IVD) Market Forecast

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researchreportinsight · 11 days ago

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In Vitro Diagnostics (IVD) Industry Growth Analysis & Forecast Research Report, 2030

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

End-use Segmentation Insights:

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Research #In Vitro Diagnostics (IVD) Market Forecast

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mordorintelligencemarketresearch · 22 days ago

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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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industrynewsupdates · 1 month ago

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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

#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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healthcare-skyquest · 1 month ago

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In Vitro Diagnostics Market: Revolutionizing Medical Testing

The In Vitro Diagnostics (IVD) Market is at the forefront of medical diagnostics, enabling healthcare providers to detect diseases and conditions through tests performed outside the body. As demand for early detection and accurate diagnostic tools increases, the IVD market is witnessing rapid growth. This article delves into the market segmentation, key growth drivers, and leading companies shaping the industry, providing valuable insights for decision-makers.

Market Overview

According to SkyQuest’s In Vitro Diagnostics Market report, the global IVD market is valued at USD 87.93 Billion in 2023 and is projected to grow at a CAGR of 5.3%. The market’s expansion is driven by the rising prevalence of chronic diseases, the growing importance of early disease detection, and technological advancements in diagnostics.

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Market Segmentation

By Product Type:

Reagents & Kits: Essential for a wide variety of diagnostic tests, including immunoassays and molecular diagnostics.

Instruments: Diagnostic tools such as analyzers and automated systems used in laboratories and healthcare settings.

Software & Services: Used for managing data, improving accuracy, and ensuring compliance with regulatory standards.

By Application:

Infectious Diseases: A leading segment, especially with the demand for COVID-19 diagnostics.

Cancer: Rising incidence of cancer has fueled the need for accurate diagnostic tools.

Cardiology: IVD tools for cardiovascular diseases are seeing growing demand due to an increasing global burden.

Diabetes: Blood glucose monitoring systems dominate this segment, with widespread use among diabetic patients.

Autoimmune Diseases: IVD tests play a crucial role in diagnosing autoimmune disorders.

By End-User:

Hospitals & Clinics: Major users of IVD tools, especially for infectious diseases and chronic conditions.

Diagnostic Laboratories: Central hubs for conducting a wide range of tests with high accuracy and reliability.

Research & Academic Institutions: Key in driving innovation and new test development.

Homecare Settings: Growing segment with the rise in at-home diagnostic tools, particularly for chronic conditions.

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Key Growth Drivers

Increasing Prevalence of Chronic Diseases: Rising cases of cancer, diabetes, and cardiovascular diseases are driving the demand for IVD tests.

Technological Innovations: Advancements in molecular diagnostics, AI-driven analysis, and automation are enhancing the efficiency and accuracy of diagnostic tools.

Demand for Personalized Medicine: IVD plays a pivotal role in tailoring treatments to individual patients, fueling market growth.

Aging Population: As the global population ages, the demand for diagnostic tests for age-related diseases like Alzheimer’s and cardiovascular conditions is on the rise.

Leading Companies in the Market

SkyQuest’s In Vitro Diagnostics Market report highlights the following key players in the industry:

Roche Diagnostics

Abbott Laboratories

Thermo Fisher Scientific Inc.

Danaher Corporation

Siemens Healthineers

Bio-Rad Laboratories, Inc.

Becton, Dickinson and Company

bioMérieux SA

Qiagen N.V.

Sysmex Corporation

Read More at: - https://www.skyquestt.com/report/in-vitro-diagnostics-market

Challenges and Opportunities

While regulatory hurdles and high costs of advanced diagnostic tools remain challenges, the IVD market offers numerous opportunities. The increasing focus on point-of-care testing and the integration of AI in diagnostics present significant growth avenues for industry players.

Future Outlook

The In Vitro Diagnostics Market is set to experience robust growth as healthcare shifts towards early detection and preventive care. Companies that invest in cutting-edge technologies and innovative diagnostic solutions will be well-positioned to lead in this evolving market.

The In Vitro Diagnostics Market is transforming the healthcare landscape, offering essential tools for early diagnosis and effective treatment planning. Decision-makers who stay ahead of trends and leverage technological advancements will thrive in this rapidly growing industry. For more detailed insights, explore SkyQuest’s In Vitro Diagnostics Market report.

#healtcare innovation #health #healthcare #in vitro diagnostics market #in vitro diagnostics #ivd

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saudiarabia12 · 2 months ago

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Mastering European IVD CE Marking Compliance with Operon Strategist

Navigating the complexities of CE marking for in vitro diagnostic (IVD) devices under the new IVDR 2017/746 regulations can be challenging. Operon Strategist provides expert guidance and customized support for European IVD CE marking, ensuring compliance with stringent EU standards and facilitating smooth market access. Learn how our specialized services can help you achieve regulatory success.

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market-spy · 2 months ago

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Pediatric Medical Devices Market Analysis, Size, Share & Trends | 2031

In recent years, the global Pediatric Medical Devices Market has witnessed a dynamic shift, influenced by changing consumer preferences, technological advancements, and a growing emphasis on sustainability. The Research report on Pediatric Medical Devices Market presents a complete judgment of the market through strategic insights on future trends, growth factors, supplier landscape, demand landscape, Y-o-Y growth rate, CAGR, pricing analysis. It also provides and a lot of business matrices including Porters Five Forces Analysis, PESTLE Analysis, Value Chain Analysis, 4 Ps' Analysis, Market Attractiveness Analysis, BPS Analysis, Ecosystem Analysis. Get Your Free Sample Report Here @ https://www.skyquestt.com/sample-request/pediatric-medical-devices-market

The global pediatric medical devices market reached a valuation of approximately USD 28.4 billion in 2023. Projections indicate that the market is poised to experience steady growth over the next decade, with a projected compound annual growth rate (CAGR) of 7.8% from 2024 to 2031. The new study offers a brief evaluation of the Pediatric Medical Devices Market statistics, which are subdivided into the regions, countries as well as subregions. This report is helpful to remark the possible estimations and projection regarding the growth strategies of the global Pediatric Medical Devices Market. It also summarizes possible profit opportunities, sales/demand, production as well as consumption analysis, in involvement to Pediatric Medical Devices industry share in each nation and sub-region. The geographical segment of the Pediatric Medical Devices Market report illustrates the industry share as well as growth rates of each region during the estimated period from 2024 to 2031. Global urbanization and rapid industrialization have increased the need for new market Growth. This has prompted a rise in the use of Pediatric Medical Devices. Additionally, massive amounts of money are being spent by governments and the private sector globally on Pediatric Medical Devices industry, which is further boosting the market's expansion. The amount that regional governments are investing to improve the current investment is increasing as part of their global market plans. The whole research report on the Pediatric Medical Devices Market concentrated on the valuable data and various other factors. Additionally, the report delivers a comprehensive overview, pie charts, tables, diagrams, and tables to assist the growth of the Pediatric Medical Devices Market. Market Segments covered: By Product - Cardiology Devices, In Vitro Diagnostic (IVD) Devices, Diagnostic Imaging Devices, Anesthesia & Respiratory Care Devices, Neonatal ICU Devices, Others By End-user - Hospitals, Pediatric Clinics, Ambulatory Surgical Centers, Others By Regional - North America, Europe, Asia Pacific, Latin America

To establish the important thing traits, Ask Our Experts @ https://www.skyquestt.com/speak-with-analyst/pediatric-medical-devices-market

Profitable players of the Pediatric Medical Devices Market are: TSE MEDICAL Ningbo David Medical Device Co. Ltd Hamilton Medical GE Healthcare Fritz Stephan GmbH Phoenix Medical Systems Pvt Ltd Novonate Inc. Trimpeks Atom Medical Corporation Abbott Medtronic PLC

Essential regions of the Pediatric Medical Devices Market are: Pediatric Medical Devices North America Market includes (Canada, Mexico, USA) Pediatric Medical Devices Europe Market includes (Germany, France, Great Britain, Italy, Spain, Russia) Pediatric Medical Devices Asia-Pacific Market includes (China, Japan, India, South Korea, Australia) Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa) Pediatric Medical Devices South America Market includes (Brazil, Argentina) FAQs: - What are the sales, production, consumption, imports, and exports of the global market (North America, Europe, Asia-Pacific, South America, Middle East, and Africa)? Who are the major manufacturers who dominate the world market? What are their current capacity, production, sales, pricing, cost, gross, and revenue operating levels? What are the market's risks and opportunities? What's more, it likewise covers the request and give of the promoting research concentrate in the assessed figure time frame. Explained investigation of the market players with their profile, deals examination and serious scene is given in the report. Besides, organization, joint effort and consolidations in the business are referenced for the accommodation of the investigation of the global Pediatric Medical Devices industry.

Take Action Now: Secure Your Pediatric Medical Devices Market Today - https://www.skyquestt.com/buy-now/pediatric-medical-devices-market Pivotal questions answered in the global Pediatric Medical Devices Market report: What are the major value propositions of the Pediatric Medical Devices Market? What are the new strategical frameworks that are mobilized among players to accomplish resilience in the wake of the COVID-19 pandemic? What technologies are expected to adopt the new regulations in Pediatric Medical Devices report? What are the key collaborations generated by the vendors to consolidate their position in the Pediatric Medical Devices Market? What are the vital offerings new entrants concentrate on to implement unique positioning strategies? What are the futuristic prospects of the Pediatric Medical Devices Market across the globe? Looking ahead, the Pediatric Medical Devices Market is poised for continued growth, driven by evolving consumer preferences and ongoing innovations. The trend towards sustainability is expected to strengthen, with more consumers seeking products that align with their values. Additionally, the integration of advanced technologies and digital platforms will likely further enhance market accessibility and consumer engagement. The global Pediatric Medical Devices Market is a dynamic and evolving landscape, shaped by a confluence of trends and factors. Get Complete Report Pediatric Medical Devices Market 2024 for Better Understanding @ https://www.skyquestt.com/report/pediatric-medical-devices-market

Contact: Mr. Jagraj Singh Skyquest Technology 1 Apache Way, Westford, Massachusetts 01886 USA (+1) 351–333–4748 Email: [email protected] Visit Our Website: https://www.skyquestt.com/ About Us: SkyQuest is an IP focused Research and Investment Bank and Accelerator of Technology and assets. We provide access to technologies, markets and finance across sectors viz. Life Sciences, CleanTech, AgriTech, NanoTech and Information & Communication Technology. We work closely with innovators, inventors, innovation seekers, entrepreneurs, companies and investors alike in leveraging external sources of R&D. Moreover, we help them in optimizing the economic potential of their intellectual assets. Our experiences with innovation management and commercialization have expanded our reach across North America, Europe, ASEAN and Asia Pacific.

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marketanalysisdata · 25 days ago

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In Vitro Diagnostics (IVD) Industry Size, Trends, Value, Sales and Forecast 2030

The global in vitro diagnostics (IVD) market was valued at approximately 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. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Share #In Vitro Diagnostics (IVD) Market Trends #In Vitro Diagnostics (IVD) Market Growth

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marketstudyreport · 25 days ago

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In Vitro Diagnostics (IVD) Market Growth Analysis & Forecast Research Report, 2030

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Product Segmentation Insights:

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

#In Vitro Diagnostics (IVD) Industry #In Vitro Diagnostics (IVD) Market Share #In Vitro Diagnostics (IVD) Market Trends #In Vitro Diagnostics (IVD) Market Growth

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ashwetu · 4 days ago

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In Vitro Diagnostics Market Growth to Reach $116.28 Billion by 2031, at a CAGR of 5.3%

Increased demand for early disease diagnosis, personalized medicine, and point-of-care solutions drive IVD market growth.

For detailed insights, request the sample report here: https://www.meticulousresearch.com/request-sample-report/cp_id=4858

Key Market Drivers and Growth Opportunities

For a more detailed analysis, you can download a sample report here: https://www.meticulousresearch.com/download-sample-report/cp_id=4858

Key Market Segments

Meticulous Research® segments the IVD market based on offering, technology, application, diagnostic approach, and end user:

For a customized view of the IVD market lndscape, tailored to specific business needs, visit: https://www.meticulousresearch.com/request-customization/cp_id=4858

Regional Market Analysis

To access a comprehensive breakdown of regional market dynamics, you can download the https://www.meticulousresearch.com/download-sample-report/cp_id=4858

Challenges and Opportunities

For an in-depth examination of market challenges and strategic growth opportunities, https://www.meticulousresearch.com/request-sample-report/cp_id=4858

Competitive Landscape

The report also provides a detailed analysis of the competitive landscape, highlighting key players shaping the IVD market:

Abbott Laboratories (U.S.)

Becton, Dickinson and Company (U.S.)

bioMérieux SA (France)

Danaher Corporation (U.S.)

F. Hoffmann-La Roche Ltd. (Switzerland)

Thermo Fisher Scientific Inc. (U.S.)

Siemens Healthineers AG (Germany)

Future Outlook for the IVD Market

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marketingreportz · 2 months ago

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Companion Diagnostics Market - Forecast(2024 - 2030)

Companion Diagnostic Market Overview:

The Harvard University, while addressing the risk associated with reactions of new drugs prescription, has stated some overwhelming facts. According to their findings, even properly prescribed drugs causes about 1.9 million hospitalizations a year and about 128,000 people die from drugs prescribed to them.[1] Such epidemic condition is being tailgated by the need of safe and effective and specific use of the drug. Owing to such demands, companion diagnostic drug market is poised for exponential growth. Companion diagnostics is an in-vitro diagnostic tool that assists physicians in optimizing treatment decisions for their patients and is crucial for myriad of cancer and other therapies. Riding on the back of economic burden of global healthcare and with abundant potential to restrict the liability, companion diagnostic market size is estimated to be $2,950 million as of 2018.

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Companion Diagnostic Market Outlook:

Companion diagnostic (CDx) is a diagnostic test used as an associate to a therapeutic drug to regulate its applicability to an individual person. It involves multiple monitoring methods including immunohistochemistry (IHC), polymerase chain Reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), and gene sequencing. The companion diagnostics uses technologies such as molecular biology technique, drug and diagnostic technology, and oncology therapy for the treatment of colorectal cancer, breast cancer, and other chronic diseases.

An acute analysis of the region-wise companion diagnostic market share concluded with reckoning North America as the most lucrative market for CDx. This region with cutting-edge healthcare technology in the United States and Canada generates 41% of the global companion diagnostic market demand for alarming need for cancer diagnosis and treatment. According to the American Cancer Society, prostate cancer is the most common cancer among males (19%), followed by lung (14%) and colorectal (9%) cancers and among females, breast (30%), lung (12%), and colorectal (8%) cancers are the most common. Increasing instances of cancer along with neurological disorders, infectious diseases, Hepatitis A is augmenting the North American companion diagnostic market.

Companion diagnostic market with abundant potential as an effective tool for personalized medicine has found a tremendous scope of application in pharmaceuticals, laboratories, research institutes and hospitals. Hospital as an end-user industry is the leading segment progressing with an application CAGR of 12.5% going through 2025. Hospitalized patients account for a total of 2.74 million serious adverse drug reactions. Each CDx test is specifically designed to be corresponding with an exact drug. Such tests can also save significant hospital expenditure by targeting specific patients with the most effective therapy.

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Companion Diagnostic Market Trends and Growth Drivers:

· The necessity for personalized therapeutics for the cumulative geriatrics population and the increasing figure of diagnostics centers in both the developed and developing economies is predominant to determine profits in the global companion diagnostics market.

· FDA had issued "Guidance for Industry: In Vitro Companion Diagnostic Devices," to assist syndicates recognize the necessity for companion diagnostics at an initial stage in the drug development procedure and to strategize for co-development of the drug and companion diagnostic test.

On July 15, 2016, FDA introduced the draft regulation, "Principles for Co-development of an In Vitro Companion Diagnostic Device with a Therapeutic Product." This guidance text is envisioned to be a practical guide to support therapeutic product promoters and IVD sponsors in evolving a therapeutic product and an associated IVD companion diagnostic. The scientific progressions in the in-situ hybridization and automated silver-enhanced in-situ hybridization (SISH) for the monitoring of genes is trending in the global companion diagnostics market.

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Companion Diagnostic Market Players Perspective:

Some of the key players influencing the global market are:- Abbott Laboratories, Agilent Technologies, biomerieux, Bio-Genex Laboratories, Danaher Corporation, GE Healthcare, Myriad Genetics, Inc., QIAGEN N.V., R-Biopharm AG, and Roche Diagnostics.

In April 2017, Abbott acquired Alere for a new price of about $5.3 billion. Alere is the global leader in point of care diagnostics focused on the areas of infectious disease, molecular, cardiometabolic and toxicology. The collective business will offer the biggest point of care menu of infectious disease, molecular, cardiometabolic and toxicology testing. Abbott's platforms will be expanded to comprise benchtop and rapid strip tests.

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Companion Diagnostic Market Research Scope:

The base year of the study is 2018, with forecast done up to 2025. The study presents a thorough analysis of the competitive landscape, taking into account the market shares of the leading companies. It also provides information on unit shipments. These provide the key market participants with the necessary business intelligence and help them understand the future of the companion diagnostic market. The assessment includes the forecast, an overview of the competitive structure, the market shares of the competitors, as well as the market trends, market demands, market drivers, market challenges, and product analysis. The market drivers and restraints have been assessed to fathom their impact over the forecast period. This report further identifies the key opportunities for growth while also detailing the key challenges and possible threats. The key areas of focus include the various diagnostics in companion diagnostic market, and their specific advantages.

#companion diagnostics market #companion diagnostics market size #companion diagnostics market share #companion diagnostics market forecast #companion diagnostics market report #drugs #chronic diseases #treatment #">

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tamanna31 · 3 months ago

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New Study: 2024-2030 In Vitro Diagnostics Market Trend and Forecast Report

In Vitro Diagnostics Industry Overview

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.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market

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.

Key players in the market undertake various strategies to strengthen their position and offer their customers diverse, technologically advanced & innovative products. New product launches and partnerships are the most prominently adopted by companies to attract more customers. For instance, in March 2023, BD received 510(k) clearance for BD Vaginal Panel on the BD COR System to detect infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) formed a partnership with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for the diagnosis of cancer in Northern Ireland.

Favorable initiatives undertaken by government and non-government bodies to improve overall healthcare services are anticipated to increase market growth. In October 2023, the WHO published the Essential Diagnostics List (EDL), a comprehensive list of IVD products that helps countries make decisions regarding diagnostic tools. It provides evidence-based recommendations and ensures the accessibility of essential products for target people. Moreover, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to increase access to diagnostic tests across Africa. Such initiatives are expected to boost market growth.

A rise in the geriatric population and growth in knowledge regarding early testing have led to a surge in the number of regular check-ups, as a majority of deaths due to infections and chronic conditions occur in the population aged over 75 years. As per the Office for Budget Responsibility, UK, healthcare costs have risen exponentially, which can create economic pressure on nations with rapidly growing geriatric population. However, this expenditure is anticipated to translate positively for the IVD industry, driving market growth.

Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.

• The global point of care infectious disease testing market size was valued at USD 11.40 billion in 2023 and is projected to grow at a CAGR of 4.3% from 2024 to 2030.

• The global transplant diagnostics market size was valued at USD 5.97 billion in 2023 and is projected to grow at a CAGR of 7.3% from 2024 to 2030.

Key Companies & Market Share Insights

Llusern Scientific, Biocartis Group NV, ARUP Laboratories, Veracyte, and Exact Sciences Corp are some of the emerging market participants in the market. Emerging companies are actively involved in developing novel and accurate IVD testing products to improve overall health services. Moreover, these companies are collaborating with research institutes, government bodies, and global leaders to increase the range of their products in potential markets.

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

F. Hoffmann-La Roche Ltd

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

Order a free sample PDF of the In Vitro Diagnostics Market Intelligence Study, published by Grand View Research.

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