#ivd market analysis

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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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Exploring the Growth of the In Vitro Diagnostic (IVD) Market: Key Trends and Insights

The In Vitro Diagnostic (IVD) market is projected to be valued at USD 95.59 billion in 2024, with expectations to grow to USD 125.61 billion by 2029, reflecting a compound annual growth rate (CAGR) of 5.62% during the forecast period from 2024 to 2029

The In Vitro Diagnostic (IVD) market has been experiencing robust growth, fueled by advancements in medical technology, an aging population, and increasing demand for early diagnosis and precision medicine. IVD refers to tests conducted on biological samples such as blood, urine, and tissues to diagnose diseases, monitor health conditions, or predict treatment outcomes. These diagnostic tests are critical in guiding clinical decisions and improving patient care.

Key Drivers of the IVD Market

Technological Advancements Cutting-edge technologies like molecular diagnostics, next-generation sequencing (NGS), and point-of-care (POC) testing are revolutionizing the IVD market. Molecular diagnostics, in particular, allow for the detection of specific genetic markers, enabling early detection of diseases such as cancer and genetic disorders. NGS is enhancing personalized medicine by identifying precise mutations in a patient’s DNA, making treatments more targeted and effective.

Aging Population and Chronic Diseases The global aging population is contributing to the rise in chronic diseases such as diabetes, cardiovascular conditions, and cancer. As these conditions require continuous monitoring and management, the demand for IVD tests has increased. For instance, diabetes patients rely on glucose monitoring systems, which are a significant segment of the IVD market. This trend is expected to drive further growth in the coming years.

Rising Demand for Point-of-Care Testing POC testing, which allows for rapid diagnostic results at the patient’s bedside or in non-laboratory settings, is becoming increasingly popular. This technology enables quicker decision-making, especially in emergency situations, and reduces the need for centralized lab facilities. With advancements in POC technology, tests for conditions like COVID-19, diabetes, and infectious diseases are becoming more accessible and efficient.

Personalized Medicine and Companion Diagnostics The shift towards personalized medicine is one of the most significant trends in healthcare today. Companion diagnostics, a segment of IVD, plays a crucial role in determining the suitability of specific therapies based on a patient’s genetic makeup. This approach not only enhances treatment effectiveness but also minimizes adverse drug reactions, improving patient outcomes.

COVID-19 Impact The pandemic significantly boosted the IVD market, particularly in the areas of molecular diagnostics and POC testing. The urgent need for COVID-19 testing drove innovations in rapid testing kits, which have now become a critical part of pandemic management. As healthcare systems around the world continue to prioritize pandemic preparedness, this surge in demand for infectious disease testing is expected to persist.

Challenges Facing the IVD Industry

Despite the positive growth trajectory, the IVD market faces several challenges:

Regulatory Hurdles: IVD products must undergo stringent regulatory approvals before being brought to market, which can delay commercialization. Different regions have varying regulatory requirements, adding complexity for companies operating globally.

Reimbursement Issues: Securing reimbursement for IVD tests, especially in the case of novel diagnostics, can be a barrier to widespread adoption. In many markets, healthcare systems may be slow to integrate these tests into routine care due to cost concerns.

Data Privacy Concerns: As more IVD tests incorporate digital platforms and patient data, concerns over data security and privacy have risen. Ensuring that patient information is protected is critical to maintaining trust in IVD technologies.

Regional Insights

North America: The largest market for IVD, driven by well-established healthcare infrastructure, high adoption of advanced diagnostic technologies, and favorable government policies supporting innovation.

Europe: Strong growth is anticipated, particularly in molecular diagnostics and cancer testing. Countries such as Germany, France, and the UK are leading in research and development within the field.

Asia-Pacific: The fastest-growing region due to the rising prevalence of chronic diseases, increasing healthcare expenditure, and improving healthcare infrastructure in countries like China and India.

Future Outlook

The future of the IVD market looks promising, with continued advancements in technology and an increasing focus on precision medicine. The integration of artificial intelligence (AI) and machine learning into diagnostic tools is expected to improve the accuracy of tests and allow for the analysis of large datasets in real-time. Additionally, the ongoing emphasis on personalized healthcare will drive demand for companion diagnostics and genetic testing.

With the global healthcare landscape rapidly evolving, the In Vitro Diagnostic market is well-positioned for sustained growth. Companies investing in innovation, regulatory compliance, and expanding access to diagnostics in emerging markets will be the key players shaping the future of this dynamic industry.

Conclusion

The In Vitro Diagnostic market is a vital part of modern healthcare, providing the tools needed for accurate and timely diagnosis of diseases. As new technologies emerge and patient demand for personalized care grows, the IVD industry is set to expand further, offering innovative solutions that enhance healthcare outcomes and improve the quality of life for patients worldwide.

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In Vitro Diagnostics (IVD) 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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IVD Assay Development Market to be Worth $8.39 Billion by 2031: Size, Share, Forecast, & Trends Analysis

Meticulous Research®, a leading market research firm, has published a new report titled IVD Assay Development Market Size, Share, Forecast, & Trends Analysis by Offering (Assay Development, Packaging Development), Technology (Immunoassay, Molecular Diagnostics, Biochemistry), Application (Oncology, Diabetes) – Global Forecast to 2031. According to the findings, the global IVD assay development market is projected to reach $8.39 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.9% from 2024 to 2031.

Download Research Report Sample @ https://www.meticulousresearch.com/download-sample-report/cp_id=6037

The growth of the IVD assay development market is driven by the increasing prevalence of chronic diseases, a rising geriatric population, the high burden of infectious diseases, and a growing emphasis on the development of point-of-care (POC) IVD assays. Additionally, increasing healthcare expenditures are fueling the demand for more advanced diagnostic solutions. However, the evolving regulatory landscape remains a key challenge to the market’s growth.

Furthermore, emerging economies and advancements in IVD assay technologies present significant growth opportunities for market participants. Challenges related to maintaining product quality and safeguarding proprietary information also pose potential obstacles to market expansion.

Key Players:

The key players profiled in the IVD assay development market report are Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), Creative Biolabs, Inc (U.S.), Maxim Biomedical, Inc. (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), PeploBio Ltd (U.K.), ICON plc (Ireland), NeoDx Biotech Labs Pvt. Ltd. (India), Eclevar Medtech (France), Savyon Diagnostics (Israel), Promega Corporation (U.S.), and Future Diagnostics Solutions B.V. (Netherlands). The market is segmented by offering, technology, and application. The report also provides a comprehensive analysis of market competitors and regional trends.

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Market Segmentation:

By Offering: In 2024, the IVD assay development services segment is expected to hold the largest share, accounting for 45.1% of the market. This segment encompasses various stages of assay development, including raw material selection, feasibility studies, optimization of assay parameters, and clinical sample testing. The demand for IVD assays in drug discovery, particularly in assessing pharmaceutical candidates and detecting biomarkers, is driving the need for these services. As personalized medicine and precision therapies become more widespread, the demand for high-quality, customized IVD assays continues to rise, further strengthening this segment’s position.

By Technology: The immunoassay/immunochemistry segment is projected to dominate the IVD assay development market in 2024, capturing a share of 42.3%. Immunoassay technologies leverage antigen-antibody reactions to detect causative agents, offering high specificity and throughput. The growing use of immunoassays in point-of-care (PoC) testing for infectious diseases and the increasing global demand for novel assays are driving the segment’s growth. The aging population and the continued innovation in immunoassay formats are additional factors contributing to the dominance of this technology.

By Application: The infectious diseases application segment is anticipated to hold the largest market share in 2024. The rapid spread of infectious diseases makes accurate and early diagnosis crucial to preventing transmission. IVD assays have proven to be essential tools in diagnosing infectious diseases, driving demand for these diagnostic products. Government initiatives, advancements in diagnostic techniques, and recent global outbreaks have heightened awareness and spurred investment in diagnostic solutions. For instance, the World Health Organization (WHO) reported nearly 40 million cases of HIV globally at the end of 2023, up from 25.6 million cases in 2021, further underscoring the need for robust diagnostic tools.

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Regional Insights:

The report also provides a detailed regional analysis, highlighting key markets such as North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

By Region: North America is expected to dominate the IVD assay development market in 2024, with a share of 37.8%. This dominance can be attributed to favorable government investments in disease prevention and investigation, a high prevalence of infectious and chronic diseases, a well-established healthcare infrastructure, and a high degree of awareness regarding early disease diagnosis. Furthermore, North America’s early adoption of advanced diagnostic technologies and its strong base of key industry players contribute significantly to the region’s market leadership.

Overall, the IVD assay development market is poised for significant growth, driven by advancements in diagnostic technology, increased healthcare spending, and rising demand for early and accurate disease detection. The report offers valuable insights for stakeholders looking to capitalize on the opportunities in this evolving market.

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From Lab-on-a-Chip to Industrial Innovation: Milestones in Microfluidic Technology

The global market for microfluidic products surged to $9.98 billion in 2019, with microfluidic devices accounting for $3.48 billion of this figure. A notable trend in the industry is the ongoing acquisition of microfluidic companies by larger enterprises, signaling a trajectory of accelerated growth through capital infusion.

In the industrial landscape, in vitro diagnostics (IVD) stands out as the primary sector for microfluidic applications, driven by its lucrative returns. Demographic shifts, particularly aging populations, contribute to an escalating demand for microfluidic chips. Moreover, governmental policies prioritize the advancement of the microfluidics industry, a focus that has intensified amidst the backdrop of the pandemic. Moving forward, the critical hurdles facing microfluidic chip technology revolve around manufacturing costs and scalability. Achieving scalable production processes and cost reduction measures while maintaining product standardization and minimizing variations are imperative objectives.

The evolution of modern technology emphasizes miniaturization, integration, and intelligence. Microelectromechanical systems (MEMS) have played a pivotal role in this evolution, enabling the transition from bulky electronic systems to compact integrated circuit chips and handheld devices like smartphones. Similarly, microfluidic chips, often referred to as Lab-on-a-Chip technology, epitomize the manipulation of fluids at micro- and nanoscales. These chips condense essential laboratory functionalities, such as sample preparation, reaction, separation, and detection, onto a compact chip, typically a few square centimeters in size. The hallmark of microfluidic chips lies in their capacity for flexible integration and scaling of diverse unit technologies within a controllable microplatform.

Originating from MEMS technology, early microfluidic chips underwent fabrication processes on substrates like silicon, metals, polymers, glass, and quartz. These processes yielded microstructure units such as fluid channels, reaction chambers, filters, and sensors, with dimensions ranging from micrometers to sub-millimeters. Subsequent fluid manipulation within these microstructures enabled automated execution of biological laboratory procedures, including extraction, amplification, labeling, separation, and analysis, or cell manipulation and analysis.

In the early 1990s, A. Manz et al. demonstrated the potential of microfluidic chips as analytical chemistry tools by achieving electrophoretic separation—a technique previously confined to capillaries—on chips. Subsequently, spurred by the U.S. Department of Defense's requisition for portable biochemical self-test equipment, research in microfluidic chips burgeoned globally. Throughout the 1990s, microfluidic chips primarily served as platforms for analytical chemistry, often interchangeably referred to as "Micro Total Analysis Systems" (u-TAS). Consequently, these chips found applications across diverse fields, including biomedical diagnostics, food safety, environmental monitoring, forensics, military, and aerospace sciences.

Key milestones in the advancement of microfluidic chips include G. Whitesides et al.'s 2000 publication on PDMS soft lithography and S. Quake et al.'s 2002 article on "large-scale integration of microfluidic chips" featuring microvalve and micropump controls. These seminal works propelled microfluidic chips beyond the confines of traditional analytical systems, unlocking their potential for significant scientific and industrial applications. For instance, microfluidic chips enable the execution of combinatorial chemical reactions or droplet techniques, facilitating drug synthesis, high-throughput screening, and large-scale nanoparticle or microsphere production. In essence, microfluidic chips pave the way for the realization of a "chemical plant or pharmaceutical lab on a chip."

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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.

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

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In Vitro Diagnostics (IVD) Industry In-depth Analysis and Forecast Report, 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…

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

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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

[savibangar]

IVD Assay Development Market Size, Share, Forecast, & Trends Analysis by Offering (Assay Development, Packaging Development) Technology (Immunoassay, Molecular Diagnostics, Biochemistry) Application (Oncology, Diabetes) – Global Forecast to 2031

[healthcare-skyquest]

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.

[blueweave]

 United States In-Vitro Diagnostics (IVD) Market size at USD 33.50 billion in 2023. During the forecast period between 2024 and 2030, BlueWeave expects United States In-Vitro Diagnostics (IVD) Market size to expand at a CAGR of 5.70% reaching a value of USD 49.10 billion by 2030. The growing elderly population and the increasing incidence of both communicable and non-communicable diseases are key drivers of United States in-vitro diagnostics (IVD) market. The number of point-of-care tests is also rising along with the use of automation in labs and automated equipment, which is expected to provide United States in-vitro diagnostics (IVD) market enormous potential for expansion over the period in analysis.

Opportunity - Rising adoption of automation in IVD labs

The increasing adoption of automated instruments and automation in laboratories is anticipated to present lucrative growth opportunities for United States In-Vitro Diagnostics (IVD) Market. Automated instruments provide several benefits, such as higher performance levels, enhanced productivity, data accuracy, and meeting safety protocols. As a result, many industry players are developing and launching automated instruments that offer higher efficiency and effectiveness in diagnostic tests. The increasing test volumes and shortage of skilled lab personnel are anticipated to boost automation in laboratories, thus, in turn, driving the growth of United States In-Vitro Diagnostics (IVD) Market.

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