#In Vitro Diagnostic (IVD) market size

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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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United States In-Vitro Diagnostics Market will be US$ 56.52 Billion in 2030

In vitro diagnostics (IVD) entails laboratory-based medical assessments performed outside of a living organism, making use of additives extracted from the human body or other resources. Vital for healthcare, IVD aids in disease analysis, treatment, and monitoring with the aid of studying samples like blood, urine, and tissues. It encompasses diverse technologies along with molecular diagnostics,…

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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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The global in vitro diagnostics quality control market size was USD 84.7 Billion in 2020 and is expected to register a CAGR of 19.30% during the forecast period.

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

The global in vitro diagnostics (IVD) market, valued at an estimated USD 80.71 billion in 2024, is anticipated to grow at a compound annual growth rate (CAGR) of 6.8% from 2025 to 2030. This projected growth is largely driven by the increasing utilization of IVD tools and technologies, a response to the rising incidence of both infectious and chronic diseases globally. The development and implementation of automated IVD systems in laboratories and hospitals further contribute to this expansion, offering healthcare providers tools to make diagnoses that are efficient, precise, and free from errors. Additionally, the continual launch of new IVD products by leading companies plays a significant role in fueling this market’s growth.

A noteworthy example of this innovation in IVD products is seen in ELITechGroup’s recent expansion of its diagnostic portfolio. In January 2024, ELITechGroup introduced the GI Bacterial PLUS ELITe MGB Kit, which received CE-IVDR certification. This product marks the beginning of the company’s Gastrointestinal (GI) assay panel and is designed to detect bacterial pathogens responsible for GI infections. ELITechGroup’s expansion plans include three more kits for launch within the next quarter, covering a broader spectrum of gastrointestinal infections. These new products aim to equip laboratories and healthcare professionals with advanced tools for precise diagnosis and improved management of GI conditions.

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

Regional Insights:

North America In Vitro Diagnostics Market:

The North American in vitro diagnostics (IVD) market led the global sector in 2024, holding a 42.28% share. The region is expected to maintain its dominance throughout the forecast period, largely driven by several key factors, including the growing prevalence of chronic diseases, the presence of established IVD companies, the frequent introduction of innovative diagnostic tests, and strong government funding support. For example, in January 2023, BD and CerTest Biotec obtained an Emergency Use Authorization (EUA) from the U.S. FDA for a PCR test to detect the Mpox virus, highlighting regulatory support for advanced diagnostics. The increasing demand for genetic testing, particularly for personalized treatments in diabetes and cancer, is further expected to support the growth of the IVD market in North America.

Europe In Vitro Diagnostics Market Trends:

The European IVD market is growing, driven by an emphasis on infectious disease testing, molecular diagnostics, and adherence to regulatory requirements like CE-IVDR. Following the COVID-19 pandemic, demand for infectious disease diagnostics surged, with companies like Siemens Healthineers introducing platforms such as the Atellica CI Analyzer for efficient testing. The molecular diagnostics sector is also expanding, with ELITechGroup’s CE-IVDR-certified GI Bacterial PLUS kit as a recent example, aimed at detecting gastrointestinal infections. Stringent IVDR standards in Europe foster innovation, improving diagnostic accuracy and safety across the continent.

Asia Pacific In Vitro Diagnostics Market Trends:

The Asia Pacific IVD market is projected to experience significant growth, with a CAGR of 8.59% over the forecast period. Key drivers include stabilizing economies, a rapidly growing middle class, supportive government policies, and rapid urbanization. For instance, in October 2023, Fapon partnered with Halodoc to boost IVD product sales and services in Indonesia. Major IVD players are also collaborating with regional partners to expand their reach in developing countries across Asia Pacific.

The Chinese IVD market is growing rapidly, fueled by rising demand for molecular diagnostics, point-of-care testing, and digital health integration. Molecular diagnostics are particularly in demand for infectious diseases and oncology, supported by public health initiatives and increased healthcare spending.

Japan’s IVD market growth is driven by an aging population and progress in personalized medicine. Key trends include a growing use of molecular diagnostics for oncology and genetic testing, which aid in identifying targeted treatments for age-related diseases

Latin America In Vitro Diagnostics Market Trends:

The IVD market in Latin America is expanding due to increased healthcare investments, a focus on disease prevention, and enhanced healthcare access. A prominent trend is the adoption of point-of-care testing for infectious diseases like dengue, Zika, and COVID-19, especially in remote areas. Demand for molecular diagnostics in oncology is also growing as awareness of personalized medicine rises. Public-private partnerships and government initiatives are building diagnostics infrastructure, making advanced testing technologies more accessible across the region.

Middle East & Africa In Vitro Diagnostics Market Trends:

The IVD market in the Middle East and Africa (MEA) is set for growth, driven by increased healthcare spending and the prevalence of infectious diseases. Major trends include the adoption of advanced molecular diagnostics and point-of-care testing to improve disease detection and management. Additionally, a focus on personalized medicine and government initiatives aimed at enhancing healthcare infrastructure are supporting market expansion. Collaborations between local and international players are fostering innovation, making diagnostic solutions more accessible across the region.

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

The global saliva collection and diagnostics market size was estimated at USD 818.9 million in 2024 and is projected to grow at a CAGR of 4.7% from 2025 to 2030.

The global cholesterol testing products and services market size was estimated at USD 19.85 billion in 2024 and is projected to grow at a CAGR of 8.4% from 2025 to 2030.

Key Companies & Market Share Insights:

Among the prominent players in the IVD market are F. Hoffmann-La Roche Ltd., Abbott, Quest Diagnostics Incorporated, and Danaher. These companies actively pursue strategies like new product launches, mergers and acquisitions, and partnerships to strengthen and diversify their product offerings. These efforts are focused on expanding their product portfolios, introducing technologically advanced and innovative diagnostic tools, and improving their competitive positioning within the market.

Emerging companies in the IVD sector, including Llusern Scientific, Biocartis Group NV, ARUP Laboratories, Veracyte, and Exact Sciences Corp, are also making strides. These companies concentrate on developing novel and accurate IVD testing products, contributing to overall healthcare improvements. They frequently collaborate with research institutions, governmental bodies, and global leaders to expand their product reach and presence in new, high-potential markets.

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

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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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Saudi Arabia IVD Market will be US$ 1.48 Billion in 2030

According to Renub Research, the Saudi Arabia IVD Market is forecasted to reach approximately US$ 1.48 Billion by 2030. Saudi Arabia is poised to become the world’s fastest-growing major economy in 2022, surpassing other Middle Eastern countries and major emerging economies. In vitro diagnostics (IVD) play a crucial role in monitoring overall health. These tests involve examining samples such as…

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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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The Future of Health: Navigating the Growing In Vitro Diagnostics Market

Market Size Overview

The In Vitro Diagnostics Market is projected to be valued at approximately USD 95.59 billion in 2024, with expectations to reach around USD 125.61 billion by 2029, reflecting a compound annual growth rate (CAGR) of 5.62% during the forecast period from 2024 to 2029.

Market Overview

The In Vitro Diagnostics (IVD) industry is experiencing significant growth driven by advancements in technology, an increasing prevalence of chronic diseases, and a rising demand for personalized medicine. As healthcare systems evolve, the emphasis on early disease detection and monitoring further propels the market forward.

Key Trends

Technological Advancements: Innovations in molecular diagnostics, point-of-care testing, and automation are enhancing the accuracy and efficiency of diagnostic procedures.

Rising Demand for Home Testing: The trend toward at-home diagnostic kits is on the rise, fueled by consumer preference for convenience and privacy, especially post-pandemic.

Personalized Medicine: Increasing adoption of targeted therapies necessitates precise diagnostic tools, driving demand for specific IVD tests tailored to individual patient needs.

Regulatory Changes: Evolving regulatory frameworks are influencing market dynamics, as companies adapt to new compliance requirements to ensure product safety and efficacy.

Global Health Initiatives: Government investments in healthcare infrastructure and disease prevention programs are enhancing access to diagnostic services, particularly in emerging markets.

Challenges

Despite its promising growth, the IVD market faces challenges such as stringent regulatory requirements, high costs of advanced diagnostic technologies, and the need for continuous innovation to keep pace with rapid scientific advancements. Additionally, competition from established players and emerging startups can impact market entry for new companies.

Conclusion

The In Vitro Diagnostics industry is poised for robust growth, driven by technological advancements and a heightened focus on early disease detection. While challenges exist, the overall outlook remains positive, suggesting that stakeholders should remain agile and innovative to capitalize on emerging opportunities in this dynamic market.

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In Vitro Diagnostics (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.