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Global Immuno Ivd Market
Market Size in USD Billion
CAGR :
%
USD
19.89 Billion
USD
28.89 Billion
2024
2032
Forecast Period
2025 –2032
Market Size(Base Year)
USD
19.89 Billion
Market Size (Forecast Year)
USD
28.89 Billion
CAGR
%
Major Markets Players
F. Hoffmann-La Roche Ltd
Danaher
Abbott
Siemens Healthcare Private Limited
Thermo Fisher ScientificInc.
Global Immuno In-Vitro Diagnostics (IVD) Market Segmentation, By Product Type (Reagents, Instruments, Data Management Software, and Services), Immunodiagnostics Technique (Enzyme-Linked Immunosorbent Assay, Rapid Tests, Enzyme-Linked ImmunoSpot Assays, Radioimmunoassay, and Western Blotting), Application (Infectious Diseases, Diabetes, Oncology, Cardiology, Drug Testing/Pharmacogenomics, HIV/AIDS, Autoimmune Diseases, Nephrology, and Others), End User (Hospital Laboratories, Clinical Laboratories, Point Of Care Testing, Patient Self-Testing, Academic Institutes, and Others) - Industry Trends and Forecast to 2032
Immuno In-Vitro Diagnostics (IVD) Market Size
The global Immuno In-Vitro Diagnostics (IVD) market size was valued at USD 19.89 billion in 2024 and is expected to reach USD 28.89 billion by 2032,at a CAGR of 4.78% during the forecast period
This growth is driven by factors such as increasing geriatric population
Immuno In-Vitro Diagnostics (IVD) Market Analysis
Immuno In-Vitro Diagnostics (IVD) are essential diagnostic tools used for the detection of diseases by analyzing samples such as blood, urine, or tissue outside the body. These diagnostics play a crucial role in the early detection, monitoring, and management of conditions such as infectious diseases, diabetes, cancer, and autoimmune disorders
The growing burden of chronic and infectious diseases, increased focus on personalized medicine, and advancements in diagnostic technologies are major drivers propelling the IVD market forward
North America is expected to dominate the Immuno IVD market with the largest market share of 48.98% due to well-established healthcare systems, high diagnostic test adoption, and the presence of leading market players such as Abbott, Danaher, and Thermo Fisher Scientific
Asia-Pacific is expected to be the fastest growing region in the Immuno In-Vitro Diagnostics (IVD) market during the forecast period due to improving healthcare infrastructure, rising healthcare awareness, and government support for early disease detection programs
Reagents segment is expected to dominate the market with a market share of 66.22% in 2025 due to its essential role in diagnostic and imaging processes, increasing adoption in ophthalmic testing procedures, and consistent demand for consumables in both clinical and research settings
Report Scope and Immuno In-Vitro Diagnostics (IVD) Market Segmentation
By Product Type: Reagents, Instruments, Data Management Software, and Services
By Immunodiagnostics Technique: Enzyme-Linked Immunosorbent Assay, Rapid Tests, Enzyme-Linked ImmunoSpot Assays, Radioimmunoassay, and Western Blotting
By Application: Infectious Diseases, Diabetes, Oncology, Cardiology, Drug Testing/Pharmacogenomics, HIV/AIDS, Autoimmune Diseases, Nephrology, and Others
By End User: Hospital Laboratories, Clinical Laboratories, Point Of Care Testing, Patient Self-Testing, Academic Institutes, and Others
Growing Adoption in Emerging Economies Due to Expanding Healthcare Infrastructure
Increasing Disposable Income
Value Added Data Infosets
In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include import export analysis, production capacity overview, production consumption analysis, price trend analysis, climate change scenario, supply chain analysis, value chain analysis, raw material/consumables overview, vendor selection criteria, PESTLE Analysis, Porter Analysis, and regulatory framework.
Immuno In-Vitro Diagnostics (IVD) Market Trends
“Expansion of Point-of-Care (POC) Testing for Rapid Diagnostics”
One major trend in the Immuno IVD market is the rapid expansion of Point-of-Care (POC) diagnostic solutions, which enable testing to be conducted closer to the patient, such as in clinics, pharmacies, or at home.
POC diagnostics allow for faster decision-making, especially in emergency and outpatient settings, improving patient management and reducing the burden on centralized labs
For instance, Abbott’s i-STAT Alinity system is gaining global adoption due to its handheld design and ability to deliver lab-accurate results in minutes, revolutionizing diagnostics in remote and resource-limited settings
This trend is transforming the IVD landscape by promoting accessibility, decentralization, and speed in diagnostics, especially in infectious disease screening and chronic disease monitoring
Immuno In-Vitro Diagnostics (IVD) Market Dynamics
Driver
“Rising Demand for Early Disease Detection and Personalized Medicine”
The increasing awareness and demand for early and precise disease detection, coupled with the global shift toward personalized healthcare, are key factors propelling the IVD market
Immunoassay-based diagnostics help detect biomarkers and monitor responses to therapies, supporting tailored treatment plans that improve patient outcomes
As governments and healthcare providers emphasize preventive care, the demand for immunodiagnostic tools across oncology, cardiology, and infectious diseases continues to rise
For instance, in August 2024, Roche launched its Elecsys GAAD panel for early detection of Alzheimer’s disease biomarkers, reinforcing the growing role of immunodiagnostics in neurodegenerative disease management
The market is witnessing substantial growth as immunodiagnostics align with the global movement toward precision medicine and predictive diagnostics
Opportunity
“Growing Adoption in Emerging Economies Due to Expanding Healthcare Infrastructure”
Emerging markets such as India, Brazil, and Southeast Asia present significant opportunities for Immuno IVD manufacturers, driven by rapid healthcare infrastructure development and increasing healthcare access
Governments are investing in national screening programs and public health campaigns to detect diseases such as HIV, TB, and hepatitis at earlier stages
Moreover, international collaborations and subsidies are encouraging the local availability and affordability of diagnostic solutions
For instance, in October 2024, India’s National Health Authority partnered with diagnostic companies to integrate immunodiagnostic tests under the Ayushman Bharat Digital Mission, aiming to broaden disease detection coverage
These developments open a lucrative avenue for global players to introduce cost-effective, scalable immunoassay technologies tailored to the needs of growing populations
Restraint/Challenge
“Stringent Regulatory Approvals and Compliance Hurdles”
The Immuno IVD industry is heavily regulated to ensure test accuracy, safety, and reliability, which can slow product launches and increase development costs
Navigating diverse regulatory frameworks across countries such as FDA (U.S.), EMA (Europe), and CDSCO (India) can be complex and time consuming for global manufacturers
In addition, the transition to IVDR compliance in the EU is pushing companies to reassess and relabel products, delaying market entry
For instance, in July 2024, multiple small IVD manufacturers reported delays in European launches due to the increased documentation and testing required under IVDR regulations
These regulatory hurdles can reduce agility in innovation, increase operational costs, and act as a significant barrier, especially for startups and small-scale diagnostic firms
Immuno In-Vitro Diagnostics (IVD) Market Scope
The market is segmented on the basis of product type, immunodiagnostics technique, application, and end user.
In 2025, the reagents is projected to dominate the market with a largest share in product type segment
The reagents segment is expected to dominate the Immuno In-Vitro Diagnostics (IVD) market with the largest share of 66.22% in 2025due to its essential role in diagnostic and imaging processes, increasing adoption in ophthalmic testing procedures, and consistent demand for consumables in both clinical and research settings.
The infectious diseases is expected to account for the largest share during the forecast period in application segment
In 2025, the infectious diseases segment is expected to dominate the market, due to the rising global burden of infectious outbreaks, increasing demand for early and accurate diagnostics, and expanding public health initiatives aimed at controlling disease spread.
“North America Holds the Largest Share in the Immuno In-Vitro Diagnostics (IVD) Market”
North America dominates the Immuno In-Vitro Diagnostics (IVD) market with the largest market share of , driven by its robust healthcare infrastructure, rapid adoption of advanced diagnostic tools, and presence of major IVD manufacturers
The U.S. contributes significantly due to its strong focus on preventive healthcare, growing geriatric population, and high prevalence of chronic and infectious diseases requiring accurate diagnostic testing
Favorable reimbursement policies, increased healthcare spending, and consistent technological advancements in immunodiagnostics further enhance regional growth
The presence of leading market players, ongoing research initiatives, and strategic collaborations between public and private sectors continue to propel innovation and market expansion in the region
“Asia-Pacific is Projected to Register the Highest CAGR in the Immuno In-Vitro Diagnostics (IVD) Market”
The Asia-Pacific region is expected to witness the highest growth rate in the Immuno In-Vitro Diagnostics (IVD) market, driven by due to rising healthcare awareness, increasing investments in diagnostics, and government support for healthcare reforms
Countries such as China, India, South Korea, and Japan are driving regional growth owing to increasing incidence of infectious and lifestyle-related diseases, improved access to healthcare services, and the development of diagnostic laboratories
China’s expanding healthcare infrastructure and India’s rapid adoption of point-of-care testing and self-diagnosis solutions are significantly contributing to the rising demand for IVDs
Japan remains a leader in diagnostic technology adoption, while Southeast Asian nations are witnessing a surge in immunodiagnostic testing as part of national disease control programs
Immuno In-Vitro Diagnostics (IVD) Market Share
The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.
The Major Market Leaders Operating in the Market Are:
Latest Developments in Global Immuno In-Vitro Diagnostics (IVD) Market
In February 2025, ABL Diagnostics announced it would begin manufacturing and commercializing a comprehensive range of UltraGene PCR tests acquired from its parent company, Advanced Biological Laboratories, covering more than 100 pathogens for infectious disease diagnostics across various conditions, and plans to integrate these with its DeepChek sequencing tools to expand its footprint in precision medicine, thereby reinforcing its position in advanced molecular diagnostics
In January 2025, QIAGEN received U.S. FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, a targeted syndromic test designed to detect bacterial and viral gastrointestinal infections, with a planned product launch aimed at broadening QIAGEN's syndromic testing capabilities in both inpatient and outpatient settings, enhancing its market presence in precision diagnostics
In October 2024, Becton, Dickinson and Company (BD) obtained Health Canada approval for its Onclarity HPV Assay to be used with self-collected vaginal samples, enabling at-home human papillomavirus (HPV) testing, which improves accessibility to early cervical cancer screening solutions
In June 2024, bioMérieux announced that its BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini received FDA Special 510(k) clearance and a CLIA waiver, offering a point-of-care multiplex PCR solution that can detect five common respiratory and sore throat pathogens in approximately 15 minutes using relevant swab samples, thus enhancing rapid diagnostic capabilities in clinical settings
In January 2024, ELITechGroup expanded its in-vitro diagnostics portfolio by launching the CE-IVDR-certified GI bacterial PLUS ELITe MGB kit, capable of identifying bacterial pathogens linked to gastrointestinal infections, aiming to boost adoption of advanced diagnostics in GI testing
In January 2024, HORIBA Medical introduced its CE-IVDR-certified 2.0 high-throughput automated hematology platform, engineered to deliver high-quality and scalable analytical performance for clinical laboratories, supporting improved efficiency and reliability in hematology testing
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