In Vitro Diagnostics (IVD) Market Size, Share, Forecast, & Trends Analysis by Offering (Kits) Technology (Immunoassay, Molecular Diagnostics [PCR, NGS] Rapid Test) Application (Infectious Diseases, Oncology) Diagnostic Approach (Lab, POC) - Global Forecast to 2031

The In Vitro Diagnostics (IVD) Market was valued at $77 billion in 2023. This market is expected to reach $116.3 billion by 2031 from an estimated $80.9 billion in 2024, at a CAGR of 5.3% during the forecast period from 2024 to 2031.

IVD Market Size & Forecast

The growth of the In Vitro Diagnostics (IVD) market is driven by the rising prevalence of chronic diseases, the increasing occurrence of infectious diseases, increasing awareness of the importance of early disease diagnosis, the growing demand for point-of-care (POC) diagnostic & rapid diagnostic solutions, rising healthcare expenditures, and increasing investments in research and development. However, stringent technical requirements and regulatory processes for high/moderate-complexity tests, and variance in test results observed in rapid IVD tests restrain the growth of the market. Moreover, emerging economies, an inclination toward personalized medicine, and advancements in genomics & proteomics are expected to offer significant growth opportunities for market stakeholders. The evolving regulatory landscape poses a challenge to the growth of the market.

IVD Market Growth Drivers

Rising Prevalence of Chronic Diseases and Increasing Geriatric Population

The global incidence of chronic diseases and conditions, including cancer, diabetes, arthritis, and cardiovascular diseases, is escalating. The World Health Organization reports that chronic diseases are responsible for 41 million deaths annually, representing approximately 74% of global mortality. Contributing factors to this upward trend include an aging population and social behaviors such as tobacco and alcohol consumption, physical inactivity, and poor dietary habits. The International Diabetes Federation projects that the global prevalence of diabetes will increase to 11.3% of the population by 2030, up from 10.5% in 2021.

The majority of older adults are diagnosed with chronic diseases due to declining bodily functions and weakened immunity. According to the World Population Prospects, the population aged 65 and older is expanding at a faster rate than other age groups. In 2019, there were 703 million individuals in this age group globally, with projections indicating this number will double to 1.5 billion by 2050. Consequently, the increasing prevalence of chronic diseases, combined with the growing geriatric population, is expected to drive an increase in diagnostic testing and subsequently boost growth in the IVD market.

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Rising Awareness Regarding Early Disease Diagnosis

Early diagnosis of infectious diseases facilitates improved treatment and future care. It enables healthcare professionals and patients to make crucial medical decisions regarding care and support. Growing awareness of the benefits of early disease diagnosis underscores its importance. Detecting a disease in its early stages can lead to substantial cost savings in treatment. For example, the World Health Organization reports that, in certain high-income countries, early diagnosis of cancer can reduce treatment costs by two to four times. In addition, early diagnosis is often lifesaving for patients with critical conditions such as cancer.

Furthermore, key players and organizations in the IVD market are actively pursuing initiatives to enhance early diagnosis and reduce mortality rates associated with infectious diseases. For example, in June 2022, Illumina, Inc. (U.S.) and Ochsner Health System (U.S.) introduced new initiatives by providing multi-cancer early detection tests to patients at risk of cancer. Consequently, the increasing awareness of early disease diagnosis, combined with supportive initiatives, is anticipated to drive growth in the market.

IVD Market Trends

Increasing Applications of Next-generation Sequencing Technology

NGS (Next-Generation Sequencing) technology has transformed genetic disease diagnostics through its rapid, high-throughput, and cost-effective capabilities. NGS can concurrently analyze hundreds of genes, the entire exome, and even the whole genome, providing researchers with profound insights into the genetic diversity of rare diseases. It also facilitates the study of unknown species and complex conditions. Recently, NGS technology has gained significant traction in diagnosing infectious diseases, immunological disorders, and hereditary conditions. Additionally, it is extensively utilized for noninvasive prenatal diagnostics and for making therapeutic decisions in somatic cancers.

NGS testing is becoming increasingly integral to companion diagnostics. As cancer prevalence rises, precision or personalized medicine is gaining prominence in oncology, making the development of effective therapies a crucial focus for researchers. Moreover, ongoing technological advancements are anticipated to drive the creation of faster, more accurate, and portable NGS systems, thereby broadening their applications across medical, agricultural, ecological, and other domains. Improvements in sample preparation, liquid handling, bioinformatics, robotics, and miniaturization are expected to facilitate these advancements.

Development of Smartphone-based Detection Platforms for Rapid Diagnostic Tests

The demand for high-quality medical services is continuously increasing. Technological innovations, such as portable devices designed for home use or in remote and resource-limited environments, significantly enhance both the quantity and quality of medical care. Smartphone-based platforms are being utilized in various fields, including tele-imaging, food technology, and education, demonstrating their versatility and broad range of medical applications. Rapid diagnostics are crucial for effective patient screening across healthcare settings. Given the high costs of traditional diagnostic methods and the limited availability of benchtop readers in remote areas, the demand for smartphone-based rapid diagnostics is growing. Many companies in the rapid diagnostics market are developing or have already developed smartphone-based, end-to-end platforms that integrate with mobile applications to provide test results efficiently in point-of-care settings.

Smartphone-based detection methods offer automated result detection and analysis, complementing human expertise. Patient data transactions are secured using blockchain technology to ensure privacy and integrity. Companies are actively engaged in developing and launching smartphone-based platforms. For example, in August 2021, Becton, Dickinson, and Company (U.S.) received FDA Emergency Use Authorization (EUA) for the BD Veritor At-Home COVID-19 Test. This rapid antigen test utilizes the Scanwell Health Mobile App to interpret and provide reliable results within 15 minutes.

IVD Market Opportunity

Emerging Economies

Countries like India, Malaysia, Bangladesh, China, South Korea, Argentina, and Brazil are recognized as emerging economies due to their expanding GDPs and high rates of new technology adoption. These emerging economies are driving the demand for healthcare services and treatments, fueled by factors such as rapid urbanization, advancements in healthcare infrastructure, increased healthcare expenditures, broader healthcare insurance coverage, rising disposable incomes, and the growing prevalence of both non-communicable and infectious diseases.

Increasing urbanization and rising GDP per capita in emerging economies are driving the demand for healthcare services and treatments. Urbanization often results in higher wages, enhanced quality of life, and improved access to healthcare services. Consequently, as urbanization progresses in these economies, it is anticipated to stimulate the development of healthcare systems, leading to the expansion of hospitals, clinics, and diagnostic laboratories. This expansion will improve access to healthcare services and create lucrative opportunities for companies operating in the IVD market.

IVD Market Study: Key Findings

The Reagents & Kits Segment to Account for the Largest Share of this Market in 2024

Based on offering, the IVD market is segmented into reagents and kits, systems, and software & services. In 2024, the kits & reagents segment is expected to account for the largest share of 81.1% of the IVD market. The substantial market share of this segment is due to the frequent use of reagents and kits for detecting a variety of chronic diseases, as well as the wide availability of a diverse range of reagents and consumables for diagnosing different conditions.

Furthermore, the kits and reagents segment is slated to register the highest CAGR of 5.0% during the forecast period. The increased volume of testing for infectious diseases and the rising awareness among the general population about self-testing kits drive this segment's growth.

The Molecular Diagnostics Segment to Account for the Largest Share of this Market in 2024

Based on technology, the IVD market is segmented into immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular diagnostics, point-of-care (POC) diagnostics, whole blood glucose monitoring, microbiology, hematology, coagulation/hemostasis, urinalysis, and other technologies. In 2024, the molecular diagnostics segment is expected to account for the largest share of 23.1% of the IVD market. The large market share is due to the growing prevalence of infectious diseases and the superior sensitivity of molecular diagnostics for detecting infectious agents.

Moreover, the molecular diagnostics segment is expected to record the highest CAGR during the forecast period. The high sensitivity of various technologies, low sample volume requirements, and cost-effectiveness drive this segment's growth.

The Infectious Diseases Segment to Account for the Largest Share of this Market in 2024

Based on application, the IVD market is segmented into infectious diseases, oncology, diabetes, cardiology, nephrology, autoimmune disorders, and other applications. In 2024, the infectious diseases segment is expected to account for the largest share of 37.8% of IVD market. The large market share of this segment is attributed to the increasing prevalence of infectious diseases, government initiatives to promote awareness and testing, and global outbreaks of infectious diseases.

However, the cardiology segment is anticipated to record the highest CAGR during the forecast period. This segment's growth is driven by the increasing incidence of cancer and the rising number of diagnostic laboratories.

The Lab Testing Segment to Account for the Largest Share of this Market in 2024

Based on diagnostic approach, the IVD market is segmented into laboratory testing, OTC/self-testing, and point-of-care testing. In 2024, the laboratory testing segment is expected to account for the largest share of the IVD market. This segment’s large market share is attributed to the higher accuracy & reliability of lab testing compared to point-of-care testing, low costs, the availability of a wide range of IVD tests, and the presence of robust quality assurance programs.

However, the point-of-care testing segment is projected to record the highest CAGR during the forecast period. This segment's growth is driven by quick results, the ability to be performed by non-healthcare professionals, shorter hospital stays, easy sample collection, and rapid medical decisions.

The Hospitals & Clinics Segment to Account for the Largest Share of this Market in 2024

Based on end user, the IVD market is segmented into diagnostic laboratories, hospitals & clinics, home healthcare, and other end users, which includes nursing homes, academic & research institutes, ambulatory care centers, and transfusion laboratories. In 2024, the hospitals & clinics segment is expected to account for the largest share of the IVD  market. This segment's substantial market share is due to hospitals and clinics being the primary contact points for patients with health conditions, the expansion of diagnostic capabilities during the COVID-19 pandemic, and the significant global burden of chronic diseases.

Moreover, the hospitals & clinics segment is projected to record the highest CAGR during the forecast period. This segment's growth is driven by the increasing number of tests, government funding, the increasing hospitalization rate, and the increasing demand for diagnostic products.

Geographical Analysis

In 2024, North America is expected to account for the largest share of 37.5% of the IVD market. The key factors contributing to the large share of this regional market include the rising prevalence of chronic and infectious diseases, increased awareness about early disease diagnosis, growing adoption of advanced diagnostic products, and heightened funding activities combined with novel advancements in diagnostic technologies.

However, Asia-Pacific is poised to record the highest CAGR during the forecast period. This segment's growth is driven by continuous improvements in healthcare infrastructure, the rising number of hospitals, increasing governments in this sector, rapid urbanization, the growing burden of infectious diseases, and efforts to improve the accessibility of diagnostic services to enhance the prevention of infectious diseases by developing diagnostic products or platforms.

IVD Market: Key Companies

The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market participants over the past three to four years. The key players profiled in the IVD market report are Abbott Laboratories (U.S.), Becton, Dickinson and Company (U.S.), bioMérieux SA (France), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), Illumina, Inc. (U.S.), QIAGEN N.V. (Netherlands), Shenzhen Mindray Bio-Medical Electronics Co., Ltd (China), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (U.S.), Wama Diagnostica (Brazil), Wiener Laboratorios SAIC (Argentina), Ortho-Clinical Diagnostics, Inc. (U.S.), Agilent Technologies Inc. (U.S.), DiaSorin S.p.A. (Italy), Hologic, Inc. (U.S.), Abcam Plc (U.K.), Raybiotech, Inc. (U.S.), Oy Medix Biochemica Ab (Finalnd), InBios International, Inc. (U.S.), Dextra Laboratories Ltd. (U.K.), Genecopoeia, Inc. (U.S.), Sakura Finetek USA, Inc. (U.S.), and Edvotek, Inc. (U.S.).

IVD Market Industry Overview: Latest Developments from Key Industry Players

•  In January 2023, Becton, Dickinson, and Company (U.S.) and CerTest Biotec (Spain) received Emergency Use Authorization (EUA) from the US FDA for their molecular polymerase chain reaction (PCR) assay, VIASURE Monkeypox Virus Real-Time PCR Reagent.
• In January 2023, Beckman Coulter Inc. (U.S.), a subsidiary of Danaher Corporation (U.S.), partnered with MeMed Diagnostics Ltd (Israel) to commercialize and develop the MeMed BV test. This test, which differentiates between viral and bacterial infections, is intended for use with Immunoassay Analyzers.
• In September 2022, Becton, Dickinson and Company (U.S.) launched its cloud-based software solution, BD Research Cloud. This platform is designed to streamline and enhance the workflow of flow cytometry, enabling faster and higher-quality experiments.

IVD Market Research Summary

Key questions answered in the IVD market report: