In Vitro Diagnostics Market Size Estimated to Reach USD 124.65 Bn by 2032| Precedence Research

OTTAWA, ON, Dec. 8, 2023 /PRNewswire/ — The global in vitro diagnostics (IVD) market size is estimated to reach around USD 124.65 billion by 2032, increasing from USD 107.76 billion in 2023.

The global in vitro diagnostics (IVD) market size was estimated at USD 115.48 billion in 2022 and the sector has been growing at a CAGR of 1.6% between 2023 and 2032. The U.S. in vitro diagnostics market size is projected to hit around USD 40.66 billion by 2032.

The North America in vitro diagnostics (IVD) market size was estimated at USD 48.98 billion in 2022 and is projected to reach around USD 50.29 billion by 2032, with a CAGR of 1.1% between 2023 and 2032.

The Europe in vitro diagnostics (IVD) market size was valued at USD 30.60 billion in 2022 and is estimated to surpass around USD 32.38 billion by 2032, with a CAGR of 1.4% between 2023 and 2032.

The Asia Pacific in vitro diagnostics (IVD) market size was estimated at USD 26.73 billion in 2022 and is projected to reach around USD 31.88 billion by 2032, with a CAGR of 2.6% between 2023 and 2032.

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Global In Vitro Diagnostics Market, by Product Type ($ Million)

Global In Vitro Diagnostics Market, by Technology ($ Million)

Global In Vitro Diagnostics Market, by Application ($ Million)

In vitro diagnostic (IVD) tests are medical devices used for diagnosing, monitoring, screening, and evaluating predispositions to diseases. These tests involve conducting assays in a controlled environment, such as a test tube, outside the organism, thus adding valuable medical information to a patient’s available health data. In vitro diagnostics (IVD) incorporate tests conducted on samples such as blood or tissue derived from the human body. These tests help monitor a person’s general health to cure, treat, or prevent diseases since they can identify diseases or other disorders. Furthermore, in identifying patients most likely to benefit from treatments or therapies, in vitro diagnostics are essential in precision medicine. Next-generation sequencing tests are among these diagnostics; these analyze the DNA of an individual to find genetic changes. Some tests are conducted in a lab or by other health professionals.

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The In Vitro Diagnostics (IVD) market is undergoing a transformative shift towards increased automation and efficiency, particularly within central diagnostic labs. Manufacturers are focusing on their devices’ workflow automation features in response to the increasing volume of samples. Roche’s Cobas 8100, for instance, simplifies pre-analytical activities. This trend aims to reduce laboratory testing errors and meet the growing demand, boosting productivity. Meanwhile, there has been a noticeable change in consumables, with a shift toward specialized consumables made to function well in diagnostic workflow automation systems

Moreover, the IVD market is experiencing a convergence of workflow automation and Short Turnaround Time (STAT) test capabilities in response to the changing needs of diagnostic labs. On-demand testing is increasingly important; manufacturers respond to this need by adding functionality. One such analyzer that provides priority processing for samples entering its designated STAT port is Roche’s Cobas 6000. This integration represents a turning point in addressing the changing needs of central diagnostic laboratories by striking a balance between the advantages of workflow automation and the requirement for rapid diagnostic results.

Furthermore, the IVD market is segmented based on product, test location, technology, application, end-user, and region. Factors such as an increase in chronic and infectious disease, increased popularity of personalized medicine and prevention, healthcare spending growth and resiliency, government support and EU funds, increasing adoption of rapid diagnostics, and rise in demand for point of care testing (POCT) are driving the growth of the market. However, the uncertain regulatory environment, shortage, and variable cost of raw materials, purchasing centralization and payback on medical devices are limiting the growth of the market.

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Global In Vitro Diagnostics Market, by Region ($ Million)

In 2022, the Europe region was valued at USD 30,607.72 million and is expected to grow faster during the forecast period due to the stringent regulatory environment, technological advancements, and a growing focus on personalized medicine and disease management. Transparency and quality in the development of diagnostic tests are given the highest priority under the In Vitro Diagnostic Regulation (IVDR). Accurate diagnosis is made more accessible by innovations like point-of-care testing, laboratory automation, and molecular diagnostics. Smaller innovators and more established firms compete in the market, which drives research and development.

Product Insights

Based on product, the instrument segment held a revenue of 28.95 USD Billion in 2022. Technological developments and the need for more advanced and effective diagnostic instruments are driving significant developments in the Instruments segment of the In Vitro Diagnostics (IVD) market. The introduction of automated instruments that optimize laboratory workflows and drastically increase testing throughput results from the increasing importance placed on automation and efficiency. The focus on point-of-care testing has accelerated the development of small, lightweight diagnostic devices, which has led to their widespread use. Interoperability and data management are improved when these tools are integrated with healthcare information systems.

The wide range of diagnostic platforms that cover clinical chemistry, immunoassays, and molecular diagnostics enable medical professionals to treat a wide range of diseases. Modern devices that facilitate genetic sequencing and molecular profiling are becoming necessary for precise diagnosis and individualized treatment due to the rising incidence of complex diseases. Furthermore, ongoing investments in R&D indicate continuous initiatives that meet the changing needs of healthcare professionals and tackle new healthcare concerns.

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End Use Insights

The standalone laboratory segment has captured a 40% revenue share in 2022. The segment growth is primarily driven by its specialization in specific testing services. These labs, which are known for their adaptability and independence, are essential for delivering specialty diagnostics like genetic and molecular testing. Their growing popularity is further fueled by the trend of outsourcing diagnostic tests to independent laboratories due to access to knowledge and cost-effectiveness. Standalone labs are expected to play a major role in the IVD market’s expansion as it develops, satisfying the growing need for specialized and individualized diagnostic services.

Market Dynamics

Driver: The rise of innovative technologies, particularly lateral flow testing and wireless monitoring, is a major driver in the In Vitro Diagnostics (IVD) market. Lateral flow technology, generally active in clinical Point-of-Care settings for glucose and pregnancy testing, continues to grow into new applications like flu and strep, offering simplified sample collection and rapid results. Real-time data transmission and analysis are made more accessible by the trend toward wireless monitoring, which is represented by wearables and continuous monitoring devices. This shift not only improves diagnostic capabilities for specific medical conditions but also supports “wellness” diagnostics, influencing lifestyle decisions. These technical developments indicate IVD transformation, driving innovation and reshaping the healthcare industry to provide more proactive and individualized care.

Restraint: Cost and affordability remain significant obstacles in the In Vitro Diagnostics (IVD) market, particularly for advanced technologies like molecular diagnostics and next-generation sequencing. Adoption is hindered by high initial prices and continuing consumables-related charges, particularly in environments with limited resources. The accessibility of modern diagnostics is further impacted by global differences in financial capacity, which raises obstacles to their widespread deployment. As budget considerations become more critical to healthcare decision-makers when adopting new IVD solutions, it becomes essential to demonstrate these technologies’ economic value and affordability to get market adoption.

Opportunity: The growing need for precision and personalized medicine presents a major opportunity for the In Vitro Diagnostics (IVD) market. Personalized diagnostic solutions are in high demand due to the awareness of individual genetic variants and the progress made in genome sequencing. IVD producers are able to profit from this development by creating advanced systems and tests that are specific to the requirements of specific patients. Furthermore, integrating AI and machine learning in diagnostics presents the potential for improved data analysis, which is consistent with the increasing focus on precision medicine in healthcare.

Browse More Insights:

Microbiology Testing Market: The global microbiology testing market size reached USD 4.9 billion in 2022 and is projected to be worth around USD 11.76 billion by 2032, expanding at a CAGR of 9.2% from 2023 to 2032.

Infectious Respiratory Disease Diagnostics Market: The global infectious respiratory disease diagnostics market size was estimated at USD 41.6 billion in 2022.

Rapid Microbiology Testing Market: The global rapid microbiology testing market size was estimated at USD 5.2 billion in 2022 and is projected to be worth around USD 12.37 billion by 2032, registering a CAGR of 9.1% during the forecast period 2023 to 2032.

DNA Diagnostics Market: The global DNA diagnostics market size was reached at USD 12.46 billion in 2022 and it is projected to hit around USD 20.1 billion by 2032, registering a CAGR of 4.9% during the forecast period 2023 to 2032.

Gene Expression Market: The global gene expression market size accounted for USD 12.19 billion in 2022, and it is projected to be worth around USD 32.85 billion by 2032, with a compound annual growth rate (CAGR) of 10.42% from 2023 to 2032.

Mass Spectrometry Market: The global mass spectrometry market size was estimated at USD 6.39 billion in 2022, and it is expected to hit around USD 14.47 billion by 2032, registering a CAGR of 8.52% from 2023 to 2032.

Biotechnology Instruments Market: The global biotechnology instruments market was valued at USD 81 billion in 2022 and is expected to hit over USD 119.32 billion by 2032, poised to grow at a CAGR of 4% from 2023 to 2032.

MicroRNA Market: The global microRNA market size was valued at USD 1,252.80 million in 2022, and it is projected to surpass around USD 7,757.01 million by 2032, poised to grow at a CAGR of 20% during the forecast period 2023 to 2032.

Medical Device Outsourcing Market: The global medical device outsourcing market size was valued at USD 65.82 billion in 2022 and is predicted to reach USD 224.42 billion by 2032 with registering a CAGR of around 13.10% from 2023 to 2032.

Medical Device Contract Manufacturing Market: The global medical device contract manufacturing market size was valued at USD 72.89 billion in 2022 and is expected to reach USD 211.66 billion by 2032, with a noteworthy CAGR of 11.3% from 2023 to 2032.

Medical Devices Market: The global medical devices market was valued at USD 570 billion in 2022 and is expected to reach around USD 996.93 billion by 2032, poised to grow at a compound annual growth rate (CAGR) of 5.8% from 2023 to 2032.

Recent Developments:

• In July 2023, Thermo Fisher Scientific announced that the FDA has approved a blood test that aids doctors in identifying individuals at a heightened risk of experiencing severe pre-eclampsia. This potentially hazardous complication arises in approximately one out of every 25 pregnancies.
• May 2023, Thermo Fisher announced the partnership with Pfizer to expand access to next-generation sequencing (NGS) testing for lung and breast cancer patients in over 30 countries across Latin America, Africa, the Middle East, and Asia. This collaboration aims to overcome previous limitations and make advanced genomic testing available in regions where it was previously restricted. Local NGS testing enables quicker analysis of relevant genes, assisting healthcare providers in selecting the most suitable therapy for individual patients.
• May 2023, Siemens Healthineers announced the launch of next gen hematology analyzers which remove workflow barriers in hematology testing. These analyzers offer intuitive interfaces and automation connectivity to achieve fast throughput and provide results faster. Integrated rules-based testing enables efficient interpretation of complex patient results. These solutions address the need for high-volume hematology testing and help deliver critical information reliably, despite staffing limitations in labs.
• May 2023, QuidelOrtho Corporation has received FDA clearance for its Sofia 2 SARS Antigen+ FIA, the first rapid antigen test for COVID-19 to be granted market approval. This test is designed for point-of-care use and requires a prescription.
• May 2023, QuidelOrtho, in collaboration with BARDA, has received FDA authorization for its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total and IgG tests. These high-throughput, automated antibody tests are the first of their kind to be permitted for marketing in the US through a traditional premarket review process.
• May 2023, Hologic Inc. announced an agreement with newly selected NFL cornerback Kelee Ringo and his mother, breast cancer survivor Tralee Hale, to inform women about the value of scheduling yearly mammograms and other crucial health exams
• Feb 2023, Siemens Healthineers and Unilabs have entered into an agreement worth over €200 million. Unilabs will invest in Siemens Healthineers’ advanced technology, acquiring over 400 laboratory analyzers to enhance its laboratory infrastructure and provide exceptional service to its customers.
• Nov 2022, Abbott has introduced the Panbio HIV Self-Test, a convenient at-home testing solution available online in Hong Kong. This over-the-counter test provides users with results in just 15-20 minutes, enabling them to obtain accurate HIV testing outcomes anytime and anywhere.
• Jan 2022, Sysmex Corporation has announced the successful completion of a declaration of conformity to the European In Vitro Diagnostic (IVD) Directive for their assay kit. This kit is designed to measure Amyloid Beta (Aβ) levels in the blood and is compatible with their automated immunoassay system, HISCL-5000/HISCL-800.
• Feb 2022, Thermo Fisher announced the partnership with Mylab, a startup to source RT-PCR kits for infectious diseases.

Market Key Players:

• Alere, Inc.
• Hoffmann-La Roche Ltd.
• Arkray
• Beckman Coulter
• Becton Disckinson
• Bio-Rad laboratories
• Danaher
• Sysmex Corporation
• Abbott Laboratories

Key Market Segments:

By Product

• Reagents
• Instruments
• Services

By Test Location

• Point of Care
• Home Care
• Others

By Technology

• Immunoassay
• Instruments
• Reagents
• Services
• Hematology
• Instruments
• Reagents
• Services
• Clinical Chemistry
• Instruments
• Reagents
• Services
• Molecular Diagnostics
• Instruments
• Reagents
• Services
• Coagulation
• Instruments
• Reagents
• Services
• Microbiology
• Instruments
• Reagents
• Services
• Others
• Instruments
• Reagents
• Services

By Application

• Diabetes
• Cardiology
• Nephrology
• Infectious Disease
• Oncology
• Drug Testing
• Autoimmune Diseases
• Others

By End User

• Standalone Laboratories
• Hospitals
• Academic & Medical Schools
• Point-of-Care
• Others

By Regional

• North America
• Europe
• Asia Pacific
• Middle East & Africa
• Latin America

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