In Vitro Diagnostics Market Size to Expand USD 129.14 Bn by 2033

The global in vitro diagnostics market size was reached at USD 83.41 billion in 2024 and is expected to expand around USD 129.14 billion by 2033, with a CAGR of 4.97% from 2024 to 2033. The market is primarily influenced by the rising prevalence of conditions such as cancer, infections, and genetic disorders that require frequent or easy-to-use diagnostic solutions.

In Vitro Diagnostics Market: Exploring Transformation of Healthcare Sector

In vitro diagnostics tests are performed outside the patient's body in a controlled laboratory environment, typically using specialized equipment and techniques. These medical tests and procedures are conducted using biological samples such as tissue, bodily fluids, or other specimens obtained from a patient. Such tests are widely utilized in oncology, genetic, and age-related studies.

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As the in vitro diagnostics market largely facilitates oncological studies, the prevalence of cancer drives the growth of the market. In vitro diagnostic systems are used during clinical studies as well as therapeutic procedures to develop treatments or monitor the prognosis of the disease. Similar trends are observed for indicators such as cardiovascular diseases, genetic conditions, etc.

• According to the American Cancer Society report, an estimated 1.9 million new cancer cases were recorded in the U.S. Additionally, a report by the UICC revealed that 30% of cancers could be screened using IVDs.
• According to a report published by the CDC, congenital heart defects were the most common birth defects in the U.S., affecting approximately 1% of births every year.
• According to the Breast Cancer Research Foundation, in 2023, approximately 300,590 people are expected to be diagnosed with breast cancer in the U.S.

The regulatory landscape of a region greatly impacts it’s in vitro diagnostics market. Government entities have authority over trials related to medical devices and their presence in the market. Marketing authorities vary from region to region. The United States Food and Drugs Association (FDA) recommendations are followed on a larger scale, with regional medical associations or health ministry’s governing a smaller area.

• In May 2023, BD announced 510k clearance for its Methicillin-resistant Staphylococcus aureus (MRSA) imaging application that uses AI to eliminate the time-intensive task of determining bacterial growth manually.
• In December 2022, Agilent Resolution ctDx FIRST by Agilent Technologies Inc. received clearance from the U.S. FDA as a companion diagnostic tool for non-small cell lung cancer with KRAS G12C mutations. Such cases can benefit from treatment with KRAZATITM.
• 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.

Report Highlights

• North America IVD Market has captured highest revenue share of 43. 20% in 2023.
• Europe region has registered revenue share of 25.40% in 2023.
• Asia-Pacific has held revenue share of around 22.60%.
• By product, the reagents segment accounted for revenue share of 65.76% in 2023.
• By technology, the immunoassay segment accounted revenue share of 26% in 2023.

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Top Business Ventures in the In Vitro Diagnostics Market

Interaction between entities of the public and private sectors in the form of grants, investments, mergers, and acquisitions is responsible for the significant growth of the healthcare sector. Similarly, key participants of the in vitro diagnostics market are engaging in high-level strategic initiatives such as collaborations, partnerships, mergers, and acquisitions.

• In February 2023, a leading medical technology company, Siemens Healthineers, and a leading diagnostic services provider, Unilabs, announced today a multi-year agreement valued at over €200 million.
• In March 2023, Eli Lilly announced its partnership with Roche to further develop the latter's Elecsys Amyloid Plasma Panel (EAPP). This venture would benefit both by targeting an important area of unmet medical need.
• In January 2021, a world leader in serving science, Thermo Fisher Scientific Inc., announced its intention to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company.
• In June 2022, the European Commission invested approximately USD 203 million in a project named the AGLYC Project. AGLYC aims to develop a first-class blood-based biomarker for early detection of ischemia before the irreversible injury of the heart.

In Vitro Diagnostics Market’s Insights: Investments & Projections

Key Factors	Major Insights	Projection for Investors
Investments	In 2023, Roche invested $1 billion in R&D for advanced diagnostics.	Allotment of capital flow towards advanced diagnostics tools.
Technological Advancements	Abbott allocated $500 million in 2023 for Ai-driven tools for diagnostics.	Emphasis over diversification with new technologies for new revenue shares.
Consumer Shifts	Demand for accurate and at-home diagnostic solutions.	Planning strategic entries in evolving regions, especially for startups.

 Emphasis on Artificial Intelligence (AI) and Automation: Creating New Opportunities for the In Vitro Diagnostics Market

AI has shown significant success in integration in several sectors, including healthcare. AI, along with machine learning (ML), is acknowledged as the main driver for the routinization of precision medicine, personalized treatment, and accurate treatments. The in vitro diagnostics market has well-established protocols and methods supported by a plethora of specialized instrumentation. These instruments have been thoroughly tested and supported by intensely studied case studies.

• AI and ML algorithms can be used as adjuvant to the already-established diagnostic tools for accuracy, automation, bulk processing, and duration. Diagnostic processes can be automated, needing little to no human interference. This considerably increases the accuracy of the diagnostic while greatly reducing the margin for error.
• Advancements in technologies also allow the processing of multiple samples in a single cycle in settings like hospitals, diagnostic labs, or point-of-care centers. The predictive features of AI can also allow data interpretation and personalized treatment recommendations.

• In September 2022, Sysmex Corporation launched its UD-1500 Fully Automated Urine Particle Analyzer for testing urine sediments.

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AI can improve digital communications by offering personalized health advice, scheduling reminders, and suggesting the next steps for patients. Moreover, companies investing in AI-based solutions for personalized or precision medicine are expected to contribute to the market's growth. As a result, the integration of AI in healthcare solutions, from detection tools to accurate methods for customizing treatment plans, promises improved health outcomes and enhanced patient engagement.

Report Scope

Report Coverage	Details
IVD Market Size in 2025	USD 87.57 Billion
IVD Market Size in 2033	USD 129.14 Billion
IVD Market CAGR	4.97%
IVD Market, Dominant Region	North America
IVD Market, High Growth Region	Asia-Pacific

North America to Dominate: Favourable Healthcare Landscape

North America leads the global in vitro diagnostics market. This dominance is attributed to the region's increasing healthcare expenditure, well-established infrastructure, growing senior population, and a large pool of patients suffering from infectious diseases and cancer. The growing geriatric population, especially, is a major driver for North America’s healthcare sector. This age group is associated with a number of separate conditions that require long-term monitoring. Specialized point-of-care centers or at-home diagnostic solutions are considered ideas here.  Moreover, senior citizens are susceptible to infectious diseases and thus require better care.

• According to the 2020 United Nations report, there were about 727 million people above the age of 65. Furthermore, the number of individuals aged 80 and above is projected to double by 2050 to over 1.5 billion.

Considering government efforts, the U.S. government provides generous funding to healthcare enterprises. Furthermore, both the public and commercial sectors have successfully embraced advanced in vitro diagnostics solutions. The U.S. has remained a leader in the region, largely due to persistently high funding for basic, long-term research. The presence of several major players, such as F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., Illumina, Inc., InterVenn Biosciences, and others, and advancement in manufacturing technology of in vitro diagnostics in the region drive the growth of the market.

• Health spending in the U.S. increased by 4% in 2022 to USD 4.5 trillion or USD 13,493 per capita. 

Asia Pacific Potential: Growing Demand and Government Initiatives

Hosting some of the most populated nations in the world, Asia Pacific has a huge consumer base for markets related to the healthcare sector. The rising concern of infectious disease is much more prevalent in countries like India, China, and Pakistan. To cater to these growing needs, the market is continuously evolving. Personalized medicine and the adoption of high-tech processing help improve the production of in vitro diagnostic products. The increasing number of technological advancements, coupled with the enthusiasm and efforts of entrepreneurs, offers the region an opportunity to tackle some of its longstanding issues in delivering quality.

• In June 2024, a prominent player in the healthcare industry, Cupid Limited, launched a comprehensive distribution network for its rapid in vitro diagnostic kits in the Indian market. 

Top Companies in the In Vitro Diagnostics Market

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

Strict Compliance and Rigid Regulatory Framework Hamper the Market’s Growth

The regulatory landscape of a region greatly impacts it’s in vitro diagnostics market. Several organizations dedicated to the development of the healthcare sector and public interest exercise their authority over the in vitro diagnostics market. Clinical trials are related to medical devices and monitor the safety and efficacy of these devices in the market. Clinical trials for in vitro diagnostics are regulated with strict rules and compliance requirements. Permission and trial-related costs often outweigh the estimated profitability. Combined with limited leeway with regard to safety standards, newer companies are often discouraged from participating.

Segments Insights

The reagents segment established dominance over the market in 2024

By product type, the in vitro diagnostics market can be segmented into instruments, reagents, and services. Reagents are a crucial part of the overall market. In 2024, the reagents segment accounted for the largest market share on account of the growing prevalence of infectious diseases and associated research and development activities.A rising demand for better healthcare solutions has been observed worldwide in the wake of the recent pandemic. Pharmaceuticals are increasing their efforts to meet these demands via increased production and R&D activities.

• In June 2024, Roche launched its in-situ hybridization (ISH) cocktail. This in vitro diagnostic test allows pathologists to differentiate a B-cell malignancy from a normal reactive response to an infection.

The molecular diagnosis segment led the market globally

By technology, the in vitro diagnostics market is bifurcated into several segments. In recent years, molecular diagnostics has been gaining prevalence in the healthcare industry. The molecular diagnostics segment is expected to maintain its dominance in the coming years due to increased R&D activities in the field of genomics and proteomics. These efforts have led to the compilation of a huge portfolio of biomarkers that can be targeted in preventive and diagnostic procedures. The revolutionary potential of molecular diagnostics can be further enhanced by the integration of AI technologies and automation to sort and simplify complex data. Rising investment by the government and other key players further promotes market participation.

• In November 2023, Roche launched the LightCycler® PRO System to meet the growing clinical demands for molecular diagnostics using qPCR technology. The system will allow users to develop their own tests and will also enable a portfolio of more than 200 LightMix Modular research assays.

The point-of-care segment is expected to continue its dominance over the global market

By test location, the in vitro diagnostics market is classified into home care, point of care, and others. The point-of-care segment has held a significant share of the market due to the recent decentralization of healthcare services. Outsourcing procedures to separate facilities enables large patient traffic and data analysis. A point-of-care setting is often preferred in chronic conditions such as genetic, congenital, and age-related conditions. Established players such as Roche, Siemens Healthcare, Abbott, and Danaher are focusing their resources on developing better solutions.

• In January 2023, Cipla announced the launch of its point-of-care testing device, Cippoint. Cippoint offers testing for a wide variety of various non-communicable diseases and other medical conditions.
• In April 2024, Roche Diagnostics, a field of in vitro diagnostics, launched its first groundbreaking localized R&D product, Elecsys CA 242. Elecsys is meant to help physicians to monitor the prognosis of colorectal cancer and pancreatic cancer.

In 2024, the infectious disease segment led the market by a considerable margin

In the aftermath of COVID-19, infectious diseases have been under scrutiny by the medical community. The prevalence of conditions such as tuberculosis, influenza, HIV, etc., has been a major cause of concern globally due to the associated mortality trend. Influenza and pneumonia, ranked 12^th as a cause of death globally, have led to 47,052 deaths in 2022 alone. This is equivalent to about 14 deaths per 100,000 individuals. Competitors in the market are pooling their resources to combat any upcoming threats.

• In April 2023, Cepheid, a subsidiary of Danaher, announced a plan to introduce novel tests for a range of infectious diseases, including respiratory diseases and tuberculosis.

In Vitro Diagnostics Market News

• In September 2023, a Bengaluru-based startup, NeoDx Biotech Labs, launched an in vitro diagnostic kit to empower healthcare services to improve their testing capabilities. This kit uses real-time PCR to diagnose various inflammatory disorders, including Ankylosing Spondylitis (AS), inflammatory bowel disease, reactive arthritis, and psoriasis.
• In March 2021, a pioneer and global leader in cell-free DNA testing, Natera, Inc., was granted FDA approval for its two breakthrough device designations covering new intended uses of the Signatera molecular residual disease test.

Segments Covered in the Report

By Product

• Reagents
• Instruments
• Services

By Test Location

• Point of care
• Home care
• Others

By Technology

• Immunoassay
• Hematology
• Clinical chemistry
• Molecular diagnostics
• Coagulation
• Microbiology
• Others

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 Region

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

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