#In Vitro Diagnostic (IVD) market forecast

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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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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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The Business Research Company offers in vitro diagnostics ivd quality control market research report 2023 with industry size, share, segments and market growth

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In Vitro Diagnostics (IVD) Quality Control Market Analysis, Demand & Forecast to 2020 – Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK)

Market Overview

The global in vitro diagnostics quality control market was valued at USD 1.5 billion in 2021 and it is anticipated to grow further up to USD 2.2 billion by 2031, at a CAGR of 3.7% during the forecast period.

The effectiveness of in vitro diagnostic tests, including those for pathogen identification using in vitro nucleic acid testing, healthcare-associated illnesses (HAIs) such as pneumonia, urinary tract infections, and others, is assessed using IVD quality controls. These products primarily concentrate on defect detection, quality control, and validation panels like the Blood Culture (BCID) Control Panel, Human Papillomavirus (HPV) Control Panel, and others to support in the implementation and monitoring of the performance of clinical and research laboratories, blood diagnostic centers, and IVD manufacturers.

View Detailed Report Description: https://www.globalinsightservices.com/reports/in-vitro-diagnostics-ivd-quality-control-market/

Market Dynamics

As the burden of various diseases increases globally, so has the number of laboratory tests. The number of laboratories in both the public and private sectors has increased in response to this need. With the start of the COVID-19 pandemic in December 2019, the demand for diagnostic tests has skyrocketed. Many government organizations have established new laboratories in response to this epidemic and to increase laboratory testing capacity. The majority of nations need clinical laboratories to get regulatory body accreditation before performing diagnostic tests. Additionally, accreditation to ISO 15189:2012 and other comparable standards is turning into a requirement in many nations. Authorities assess a laboratory’s competency and quality system during the accreditation process using predetermined standards. While some European nations, including Belgium, France, Hungary, Ireland, and Lithuania, require accreditation for a variety of laboratory tests, others, like Finland, the Netherlands, Sweden, Switzerland, and the UK, have practically finished the process.

It costs a lot of money to set up a QC process in a clinical laboratory. Additionally, laboratories must keep a specialized staff on hand to oversee the QC system. Moreover, regardless of the number of tests conducted, QC procedures are expensive. As a result, QC methods are particularly expensive to adopt for clinical laboratories that perform few diagnostic tests. This is predicted to lead to a lesser adoption of QC procedures, along with budgetary restrictions in many hospitals and laboratories in developed and emerging nations.

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The key players studied in the global in vitro diagnostic quality control market are Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), Abbott Laboratories (US), Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), and Helena Laboratories Corporation (US) among others.

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In Vitro Diagnostics Industry Research Report 2030 By Players, Regions, Types & Applications

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

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

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

Regional Insights:

North America In Vitro Diagnostics Market:

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

Europe In Vitro Diagnostics Market Trends:

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

Asia Pacific In Vitro Diagnostics Market Trends:

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

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

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

Latin America In Vitro Diagnostics Market Trends:

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

Middle East & Africa In Vitro Diagnostics Market Trends:

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

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

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

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

Key Companies & Market Share Insights:

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

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

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

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

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

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

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

Regional Insights:

North America In Vitro Diagnostics Market:

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

Europe In Vitro Diagnostics Market Trends:

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

Asia Pacific In Vitro Diagnostics Market Trends:

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

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

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

Latin America In Vitro Diagnostics Market Trends:

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

Middle East & Africa In Vitro Diagnostics Market Trends:

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

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

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

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

Key Companies & Market Share Insights:

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

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

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

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

Market Size Overview

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

Market Overview

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

Key Trends

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

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

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

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

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

Challenges

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

Conclusion

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

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In Vitro Diagnostics Market Size and Regional Outlook Analysis 2024 - 2030

The global in vitro diagnostics market size is expected to reach USD 101.58 billion by 2030, according to a new report by Grand View Research, Inc. It is estimated to register a CAGR of 4.4% over the forecast period driven by the increasing geriatric population, COVID-19 pandemic, and technological advancements in diagnostics that are supporting its adoption. Technological advancements in terms of portability, accuracy, and cost-effectiveness are projected to be one of the high-impact rendering drivers. Technological advancements were further accelerated by the launch of COVID-19 IVD diagnostics and enhanced the adoption of instruments and consumables for technologies, such as PCR. Competitors in the market are increasingly adopting agreement and partnership strategies to maintain a constant flow of business for manufacturers & diagnostics for users.

These agreements are also a result of the harsh price containment strategies for government laboratories, which lowers the price in government settings. For instance, in April 2021, the Italian subsidiary of Seegene, Inc. received a USD 108.25 million tenders for public procurement for the supply of extraction reagents, as well as 7.15 million SARS-CoV-2 diagnostic tests. However, it increases the multiparty nature and complexity of the supply chain. The high prevalence of cancer and Cardiovascular Diseases (CVDs) globally is anticipated to drive diagnostic innovation to facilitate early diagnosis and meet the constantly evolving needs of consumers. Novel technologies, such as plasmonic PCR, are anticipated to commercially enter the market during the forecast period, influencing the business of existing products adversely.

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

Detailed Segmentation:

Market Characteristics

Market growth stage is medium, and the pace of the market growth is decelerating. Decreasing demand for COVID-19 tests is hampering the growth. The market is characterized by a high degree of innovation owing to the increasing introduction of novel molecular diagnostics and immunoassay tests for multiple disease indications. Moreover, increasing demand for patient-centric tests is encouraging market players to develop technologically advanced products.

Product Insights

The reagents segment held the largest share of 65.88% of the overall revenue in 2023. The segment is expected to retain its dominance growing at the fastest CAGR from 2024 to 2030 owing to the extensive R&D initiatives undertaken by major players to develop novel reagents and test kits. For instance, in February 2023, BD received the market approval for the BD Onclarity HPV Assay to be used with the ThinPrep Pap Test in the U.S. The increasing R&D activities to enable faster cancer detection and precision medicine are allowing companies to focus on niche profitable areas in the IVD business. For instance, in March 2023, QIAGEN partnered with Servier to develop a companion diagnostic test for TIBSOVO, indicated for treating the blood cancer acute myeloid leukemia.

Technology Insights

The immunoassay segment accounted for the largest revenue share in 2023. Increasing incidence of chronic & communicable diseases and rising need for early diagnosis are among the key factors leading to an increase in demand for immunological methods, including different types of Enzyme-Linked Immunosorbent Assays (ELISAs). Moreover, key players are focused on R&D pertaining to development of new immunological diagnostic instruments and tests for IVD applications. For instance, in October 2023, Sysmex Corporation and Fujirebio Holdings, Inc. collaborated to enhance their R&D, production, clinical development, and marketing activities in immunoassay.

End-use Insights

The hospitals segment held the largest revenue share in 2023 owing to a rise in the rate of hospitalizations that require support from faster diagnostics. Moreover, the ongoing development of healthcare infrastructure and favorable initiatives taken by government bodies are anticipated to enhance the existing hospital facilities. Thus, the demand for hospital-based IVD tests is increasing. Most IVD devices are purchased by hospitals and used in significant volumes. In 2023, there are over 6,129 hospitals in the U.S. that require constant aid from IVD for critical decision-making, as IVD tests provide faster and more accurate results.

Test Location Insights

The others (lab-based tests) segment accounted for the largest revenue share in 2023. A large number of test analyses at one time and the higher accuracy of laboratory-based tests make them more reliable compared to PoC and home tests, giving segment a competitive edge over the other two segments. Moreover, the availability of tests that allow for sample collection at home and sending it to the laboratories for testing makes testing highly convenient for patients.

Application Insights

The infectious diseases segment dominated the market in 2023. The outbreak of the COVID-19 pandemic increased the segment share significantly in recent years. Moreover, key players are introducing novel testing products to improve access to high-quality, innovative laboratory services for patients & healthcare providers. For instance, in February 2023, BD received EUA from the U.S. FDA for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A+B, and Respiratory Syncytial Virus (RSV). Such initiatives by key players to strengthen their presence are expected to drive market growth.

Regional Insights

North America dominated the market and accounted for a share of 42.28% in 2023. The region is estimated to retain its leading market position throughout the forecast period. The market in this region is collectively driven by factors, such as the rising incidence of chronic diseases, presence of strong players, increasing number of novel test launches, and supportive government funding. For instance, in January 2023, BD and CerTest Biotec received EUA from the U.S. FDA for a PCR test for Mpox virus detection in the U.S. Moreover, the increasing requirement for genetic testing for personalized health care, such as that for diabetes and cancer, is expected to drive market growth in North America.

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

• The global hepatitis diagnostic market size was valued at USD 3.82 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030.

• The global hematology diagnostics market size was valued at USD 7.54 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030. 

Key Companies & Market Share Insights

Some of the key players operating in the in vitro diagnostics market include F. Hoffmann-La Roche Ltd.; Abbott; Quest Diagnostics Inc.; and Danaher. Market players are adopting various strategies, such as new product launches, mergers & acquisitions, and partnerships, to strengthen their product portfolios and offer diverse technologically advanced & innovative products.

Key In Vitro Diagnostics (IVD) Companies:

• Abbott

• bioMérieux SA

• QuidelOrtho Corporation

• Siemens Healthineers AG

• Bio-Rad Laboratories, Inc.

• Qiagen

• Sysmex Corporation

• Charles River Laboratories

• Quest Diagnostics Incorporated

• Agilent Technologies, Inc.

• Danaher Corporation

• BD

• F. Hoffmann-La Roche Ltd.

In Vitro Diagnostics Market Segmentation

Grand View Research has segmented the global in vitro diagnostics (IVD) market report based on product, technology, application, end-use, test location, and region:

IVD Product Outlook (Revenue, USD Million, 2018 - 2030)

• Instruments

• Reagents

• Services

IVD Technology Outlook (Revenue, USD Million, 2018 - 2030)

• Immunoassay

o Instruments

o Reagents

o Services

• Hematology

o Instruments

o Reagents

o Services

• Clinical Chemistry

o Instruments

o Reagents

o Services

• Molecular Diagnostics

o Instruments

o Reagents

o Services

• Coagulation

o Instruments

o Reagents

o Services

• Microbiology

o Instruments

o Reagents

o Services

• Others

o Instruments

o Reagents

o Services

IVD Application Outlook (Revenue, USD Million, 2018 - 2030)

• Infectious Diseases

• Diabetes

• Oncology

• Cardiology

• Nephrology

• Autoimmune Diseases

• Drug Testing

• Others

IVD Test Location Outlook (Revenue, USD Million, 2018 - 2030)

• Point of Care

• Home-care

• Others

IVD End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Hospitals

• Laboratory

• Home-care

• Others

IVD Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

o U.S.

o Canada

• Europe

o UK

o Germany

o France

o Spain

o Italy

o Russia

o Denmark

o Sweden

o Norway

• Asia Pacific

o Japan

o China

o India

o South Korea

o Australia

o Thailand

o Singapore

• Latin America

o Brazil

o Mexico

o Argentina

• Middle East and Africa (MEA)

o South Africa

o Saudi Arabia

o UAE

o Kuwait

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

Recent Developments

• In December 2023, ARUP Laboratories and Medicover collaborated to provide diagnostic and healthcare services in Europe. ARUP Laboratories has developed AAV5 DetectCDx in collaboration with BioMarin Pharmaceutical Inc. to select therapies for severe hemophilia A patients

• In November 2023, Veracyte joined Illumina to develop molecular tests for decentralized IVD applications. Companies are focusing on the development of Prosigna breast cancer and Percepta nasal swab tests of Veracyte

• In October 2023, Promega Corporation announced its plan to develop and commercialize companion diagnostics kits with GSK Plc to identify cancer patients with MSI-H solid tumors

• In February 2023, Unilabs announced investing over USD 200 million in Siemens Healthineers' technology and acquiring more than 400 laboratory analyzers to strengthen its laboratory infrastructure

• In February 2023, F. Hoffmann-La Roche Ltd. collaborated with Janssen Biotech Inc. to develop companion diagnostics for targeted therapies. Companion diagnostic technologies include digital pathology, NGS, PCR, immunoassays, and immunohistochemistry

[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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[healthcare-skyquest]

In Vitro Diagnostics Market: Revolutionizing Healthcare with Advanced Diagnostics

The In Vitro Diagnostics (IVD) market plays a pivotal role in the healthcare industry, offering essential tools for disease diagnosis, treatment monitoring, and overall patient care. With advancements in diagnostic technology and the rising demand for personalized medicine, the IVD market is experiencing rapid growth. This article provides a detailed overview of the market trends, segmentation, key drivers, and leading companies in the IVD industry, offering valuable insights for decision-makers.

Market Overview

According to SkyQuest's In Vitro Diagnostics Market report, the global market is currently valued at USD 87.93 Billion in 2023, with a projected CAGR of 5.3% over the forecast period. The market is driven by the increasing prevalence of chronic diseases, advancements in diagnostic technologies, and the growing demand for early and precise disease detection.

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Market Segmentation

By Product Type:

Reagents and Kits: Essential components used in diagnostic procedures across a range of diseases.

Instruments: Include advanced diagnostic tools like analyzers, molecular diagnostic machines, and point-of-care devices.

Software & Services: Diagnostic software for accurate test results and integrated solutions for laboratories.

By Technology:

Immunoassays: Widely used for infectious diseases and cancer diagnosis.

Molecular Diagnostics: Key in genetic testing and precision medicine applications.

Clinical Chemistry: Essential for routine testing and biomarker identification.

Microbiology: Used to identify pathogens and guide antibiotic therapies.

Hematology: Focuses on blood-related diagnostics such as complete blood count (CBC).

Others: Encompasses emerging technologies like proteomics and metabolomics.

By Application:

Infectious Diseases: Dominating the market due to the global rise in bacterial, viral, and fungal infections.

Oncology: Growing demand for early cancer diagnostics and targeted treatments.

Cardiology: Vital in diagnosing cardiovascular diseases and risk factors.

Diabetes: Includes blood glucose monitoring and HbA1c testing for diabetes management.

Other Applications: Includes diagnostics for autoimmune diseases, nephrology, and neurology.

By End-User:

Hospitals and Clinics: Major centers for diagnostic testing and patient care.

Diagnostic Laboratories: Specializing in high-volume testing across various disease areas.

Homecare Settings: Growing segment due to increasing demand for at-home diagnostic kits.

Academic and Research Institutes: Driving innovation in diagnostic tools and techniques.

Key Growth Drivers

Rising Prevalence of Chronic Diseases: Increasing cases of cancer, diabetes, and cardiovascular diseases fuel the demand for diagnostic tools.

Advancements in Technology: Development of rapid, accurate, and minimally invasive diagnostic methods is boosting the market.

Growing Demand for Personalized Medicine: The focus on tailored treatments and early diagnosis is driving the adoption of molecular diagnostics.

Expansion of Point-of-Care Testing (POCT): The shift towards decentralized testing is increasing the demand for portable and easy-to-use diagnostic devices.

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

Leading Companies in the Market

SkyQuest’s In Vitro Diagnostics Market report identifies key players that are shaping the market, including:

Roche Diagnostics

Abbott Laboratories

Siemens Healthineers

Danaher Corporation

Thermo Fisher Scientific

bioMérieux SA

Becton, Dickinson and Company

QIAGEN

Sysmex Corporation

Agilent Technologies

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Challenges and Opportunities

The IVD market faces challenges such as stringent regulatory frameworks and high costs of diagnostic devices, especially in emerging markets. However, opportunities lie in the growing adoption of telemedicine, increased government funding for healthcare infrastructure, and technological advancements that enable faster and more precise diagnostic results.

Future Outlook

The In Vitro Diagnostics Market is expected to experience robust growth as healthcare providers increasingly rely on advanced diagnostics for effective patient care. Companies that invest in innovation and cater to the rising demand for point-of-care and home-based testing will have a competitive edge in this dynamic market.

As diagnostics play a critical role in healthcare, the In Vitro Diagnostics Market is poised for significant growth. Decision-makers should stay informed about emerging trends and technological advancements to leverage the full potential of this market. For more detailed insights and strategies, consult SkyQuest’s comprehensive In Vitro Diagnostics Market report.

[marketingreportz]

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.

[tamanna31]

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

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.

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

BD

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.

[marketanalysisdata]

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.