Market Overview
The Global
Infectious Disease In-vitro Diagnostics Market is expected to reach a value of
USD 93.2 billion in 2023, and it is further anticipated to reach a market value of
USD 140.6 billion by 2032 at a
CAGR of 4.7%.
The global infectious disease in-vitro diagnostics (IVD) market refers to an industry that is concerned with the improvement, production, and distribution of diagnostic gear for detecting infectious sicknesses. It includes numerous diagnostic technologies (molecular diagnostics, immunoassays), product classes (reagents, gadgets), and addresses a wide variety of infectious illnesses.
This marketplace includes a diverse array of in-vitro diagnostic merchandise explicitly crafted for the identification of pathogens like microorganisms, viruses, fungi, and parasites, in conjunction with related biomarkers or
antibodies that characterize infectious processes. Ongoing studies and compliance with regulatory standards pressure innovation and ensure product safety. The marketplace operates globally, adapting to numerous healthcare infrastructures and financial conditions.
The global geriatric population is rapidly growing, creating significant opportunities for the infectious disease in-vitro diagnostics (IVD) market. According to World Bank data, there were approximately 779 million individuals aged 65 and older worldwide in 2022, with the population aged 80 and above expected to double by 2050.
This demographic shift drives demand for regular diagnostic testing to prevent severe infections among the elderly, a group highly susceptible to infectious diseases. Countries with higher aging populations, including Russia, Japan, Germany, and the U.S., are particularly poised for growth, as advanced IVD solutions address critical healthcare needs in these regions.
Key Takeaways
- Reagents stand as a cornerstone in the in-vitro diagnostics (IVD) infectious disease testing sector, holding dominance within the product segment as it holds 67.3% of the market share in 2023.
- Molecular diagnostics dominate the global infectious disease in-vitro diagnostics market in the technology segment as it holds 54.7% of the market share in 2023.
- Central laboratories stand out as dominant players in the infectious disease in-vitro diagnostics (IVD) market as they hold 57.2% of the market share in 2023.
- North America exerts its dominance in the global infectious disease in-vitro diagnostics (IVD) market as it holds 41.2% of the market share in 2023.
Market Dynamic
Technological improvements in molecular diagnostics, immunoassays, and automation power the improvement of greater accurate tools in this market. This market demonstrates adaptability, appreciably seen at some stage in the COVID-19 pandemic with speedy test development.
Regulatory environments affect, with stringent requirements impacting product development and market access. Globalization, especially in emerging markets, contributes to marketplace growth, and a trend toward customized remedies, particularly in molecular diagnostics, is obvious.
Decentralized trying out, especially point-of-care checking out (POCT), gains prominence for fast outcomes. Patient-centric
healthcare fashions emphasize diagnostics' function, increasing call for revolutionary solutions. Integration of diagnostic statistics with healthcare IT complements workflows, while monetary factors and healthcare spending impact generation adoption.
Government-led initiatives and issues approximately environmental monitoring and antimicrobial resistance shape the call for powerful diagnostic tools. The complex dynamics require stakeholders to navigate and adapt for competitiveness in addressing evolving healthcare desires.
Driving Factors
An increasing global burden of infectious diseases such as respiratory infections, sexually transmitted diseases and emerging viral outbreaks is driving growth for infectious disease in vitro diagnostics (IVD). Urbanization, globalization and climate change all play a part in spreading pathogens more widely. Governments and healthcare organizations emphasize early detection and containment measures which has created a demand for advanced diagnostic tools.
Molecular diagnostics combined with point of care testing significantly increases accuracy and speed for timely treatment, leading to market expansion. With increased awareness and investment in healthcare infrastructure, IVD solutions for infectious disease management continue to become more widely adopted; driving market expansion.
Trending Factors
The infectious disease IVD market is witnessing an impressive surge in adoption of
artificial intelligence (AI) and
machine learning (ML) capabilities in diagnostic solutions. AI enhanced algorithms improve precision and speed of data analysis, increasing diagnostic accuracy while decreasing human error. AI applications for digital pathology, image recognition, and predictive analytics improve workflows and enable personalized healthcare delivery.
AI also facilitates the creation of advanced biosensors and automated platforms, leading to advances in real time disease monitoring and outbreak prediction. This trend highlights smart diagnostics as a path towards faster decision making and resource allocation in infectious disease management.
Restraining Factors
One major obstacle in the infectious disease IVD market is the high cost associated with advanced diagnostic technologies, including molecular diagnostics and next generation sequencing. These tools often require significant investments in equipment, reagents and skilled personnel; this may impede their adoption in low and middle income countries. Budget constraints in public healthcare systems and inadequate reimbursement policies impede market penetration.
Further compounding this challenge are logistical obstacles in resource limited settings where diagnostic infrastructure remains inconsistently available; affordability and accessibility must be prioritized to realize all of IVD technologies' potential.
Opportunity
The increased adoption of point of care (POC) testing solutions presents an attractive market opportunity in infectious disease IVD market. POC diagnostics provide fast and accurate disease detection at or near the patient site, decreasing turnaround time and improving clinical outcomes. This technology is particularly important in outbreak management situations and remote healthcare settings without adequate laboratory infrastructure.
Technological innovations, including portable PCR devices and immunoassay based kits, enhance the scalability and reliability of POC solutions. Collaborative efforts between diagnostic companies and healthcare providers can unlock unrealized market potential especially in emerging economies with increasing healthcare demands.
Research Scope and Analysis
By Product
Reagents stand as a cornerstone in the in-vitro diagnostics (IVD) infectious disease testing sector, holding dominance within the product segment as it holds
67.3% of the market share in 2023 for several vital reasons.
Serving as essential components in testing protocols, reagents play a fundamental role in detecting specific analytes indicative of infections. Continuous advancements in reagent formulations contribute to heightened test specificity and sensitivity, ensuring accuracy in results.
Their versatility across diagnostic platforms allows for adaptability and compatibility with various testing systems, offering flexibility to laboratories and healthcare facilities. The capability for multiplexing, customization for different pathogens, and their critical role in molecular diagnostics further accentuate the significance of reagents.
Ongoing innovation in reagent development, coupled with their cost-effectiveness, ease of storage, and widespread accessibility, solidify their dominant position in the IVD market. However, it is crucial to recognize the interdependence of different product categories, with instruments and software devices as they are working simultaneously with reagents throughout the diagnostic process, underscoring the collective success of infectious disease diagnostics.
By Technology
Molecular diagnostics dominate the global infectious disease in-vitro diagnostics market in the technology segment as it holds 54.7% of the market share in 2023 due to various key reasons. Molecular diagnostics dominance may be attributed to its high sensitivity and specificity, those techniques permit the accurate detection and amplification of unique nucleic acid sequences, ensuring reliable consequences.
Crucially, molecular diagnostics facilitate early detection of pathogens, often earlier than symptom onset, making an allowance for timely intervention and contamination management. Multiplexing capabilities, quantitative analysis, and the ability to detect genetic variants enhance efficiency, guide treatment decisions, and contribute to personalized medicine.
With rapid turnaround times, broad applicability to various infectious agents, and the development of point-of-care applications, molecular diagnostics have become integral to diagnostics.
Research and development focus, especially evident during global pandemics like COVID-19, underscores the continuous innovation in this field. However, it's essential to acknowledge the complementary roles of other diagnostic technologies, such as immunoassays, microbiology, hematology, and urinalysis, which are chosen based on factors like pathogen nature, clinical context, and specific diagnostic requirements.
By Test Location
Central laboratories stand out as dominant players in the infectious disease in-vitro diagnostics (IVD) market as they hold 57.2% of the market share in 2023 and are expected to show following growth in the forthcoming period of 2023 to 2032 for a multitude of reasons. The advanced infrastructure of central laboratories equipped with cutting-edge technologies and automated systems allows for efficient handling of large test volumes with high precision.
Offering a comprehensive menu of diagnostic tests, central laboratories cover a broad spectrum of infectious diseases, providing diverse testing options under one roof. Staffed with specialized professionals, including laboratory technicians and pathologists, these facilities ensure accurate interpretation of test results and maintain high diagnostic quality.
Leveraging economies of scale, central laboratories process tests at a lower per-unit cost, appealing to healthcare providers for routine and high-volume testing. Their commitment to rigorous standards, quality control measures, and adherence to regulatory guidelines ensures the consistency and reliability of results, instilling confidence in healthcare providers and regulatory authorities alike.
The Infectious Disease In Vitro Diagnostics Market Report is segmented on the basis of the following
By Product
- Reagents
- Instruments
- Software Devices
By Technology
- Molecular Diagnostics
- Polymerase Chain Reaction
- In Situ Hybridization
- Isothermal Nucleic Acid Amplification Technology (INAAT)
- Chips and Microarrays
- Transcription Mediated Amplification
- Others
- Immunoassay
- Microbiology
- Hematology
- Urinalysis
- Others
By Test Location
- Central laboratories
- Point of Care Testing Centers
- Hospital Laboratories
- Academic Institutes
- Clinical Laboratories
- Others
Regional Analysis
North America exerts its dominance in the global infectious disease in-vitro diagnostics (IVD) market as
it holds 41.2% of the market share in 2023 and is anticipated to show subsequent growth in the forthcoming period of 2023 to 2032.
This dominance may be attributed to numerous key factors. The place boasts a complicated healthcare infrastructure, excessive healthcare spending, and a robust emphasis on research and development, fostering innovation in infectious sickness diagnostic merchandise.
Early adoption of superior technologies, hooked-up regulatory surroundings, and a history of epidemic preparedness make contributions to the region's management. The massive and diverse market, coupled with industry collaborations and partnerships, complements North America's role. The presence of insurance and repayment mechanisms incentivizes healthcare vendors to include advanced diagnostic equipment, ensuring enormous accessibility.
Additionally, the worldwide presence of principal IVD agencies situated in North America in addition solidifies the location's dominance. While North America remains a pivotal player, different areas like Europe and Asia-Pacific also impact the evolving dynamics of the infectious disorder IVD marketplace, pushed by way of elements consisting of rising diseases, technological advancements, and shifts in healthcare policies.
By Region
North America
Europe
- Germany
- The U.K.
- France
- Italy
- Russia
- Spain
- Benelux
- Nordic
- Rest of Europe
Asia-Pacific
- China
- Japan
- South Korea
- India
- ANZ
- ASEAN
- Rest of Asia-Pacific
Latin America
- Brazil
- Mexico
- Argentina
- Colombia
- Rest of Latin America
Middle East & Africa
- Saudi Arabia
- UAE
- South Africa
- Israel
- Egypt
- Rest of MEA
Competitive Landscape
The international in-vitro diagnostics (IVD) market is characterized by the presence of important players, including Roche Diagnostics, Abbott Laboratories, Siemens Healthiers, Biomerix, and Becton, Dickinson & Company (BD), which have different diagnostic tools Collaboration and the use of partnerships in various ways to enhance production and geographic reach are common. Companies hold a global presence through robust distribution networks, making sure regulatory compliance and obtaining vital approvals.
Market enlargement, mergers, and acquisitions make a contribution to shaping competitive dynamics, and powerful customer support and service play a critical function in maintaining a strong competitive role. The aggressive panorama of this market stays exceedingly aggressive with ongoing tendencies influenced by technological advancements, regulatory changes, and evolving global health priorities.
Some of the prominent players in the Global Infectious Disease In Vitro Diagnostics Market are
COVID-19 Pandemic & Recession: Impact on the Global Infectious Disease In Vitro Diagnostics Market:
The COVID-19 pandemic and subsequent economic downturn have significantly impacted the global infectious diseases (IVD) market. The rise in the demand for diagnostic tests, especially for COVID-19 including PCR, antigen and antibody assessment has led to a significant increase in organizations engaged in their production. However, the disruption of world supply chains posed challenges in the manufacturing and distribution of various scientific devices, probably affecting the supply of IVD products.
The marketplace for non-COVID IVD products may also have suffered as sufferers postponed routine trying out, and financial recessions should have restrained healthcare budgets, impacting average market dynamics.
Despite those demanding situations, the pandemic has spurred accelerated innovation within the IVD area, with organizations investing in studies and improvement for advanced diagnostic gear now not most effective for COVID-19 but additionally for other infectious sicknesses. Additionally, there was a first-rate emphasis on point-of-care trying out, pushed through the want for speedy diagnostics in various settings.
Recent Developments
- In April 2023, Oxford Nanopore and bioMérieux formed a strategic partnership for infectious disease diagnostics using innovative nanopore sequencing which aims to enhance global health outcomes through rapid, cost-effective pathogen characterization and diagnostic solutions.
- In June 2023, Sysmex launched the PA-100 AST System in Europe, a groundbreaking Point-of-Care Testing System detecting antimicrobial susceptibility in 30 minutes, revolutionizing infection diagnosis, promoting proper antimicrobial use, and addressing global antimicrobial resistance.
- In November 2022, Thermo Fischer Scientific launched the rapid RT-PCR Accula Flu A and Flu B specifically designed to enable healthcare providers to detect and differentiate influenza A and B in about 30 minutes.
- In July 2022, F. Hoffmann-La Roche Ltd introduced the Elecsys HCV Duo, a novel dual antigen and antibody diagnostic test for hepatitis C. This groundbreaking immunoassay test is among the first commercially available options that enable the simultaneous and independent determination of the hepatitis C virus strain using a single human plasma or serum sample.
- In February 2022, SEEGENE received the CE-IVD mark from the EU regulatory authority for their Allplex SARS-CoV-2 rapid MDx Assay. Designed for efficiency, this assay is suitable for deployment in airports, schools, and other large-scale institutions, as it can deliver results in less than 30 minutes.
Report Details
| Report Characteristics |
| Market Size (2023) |
USD 93.2 Bn |
| Forecast Value (2032) |
USD 140.6 Bn |
| CAGR (2023-2032) |
4.7% |
| Historical Data |
2018 – 2023 |
| Forecast Data |
2024 – 2033 |
| Base Year |
2023 |
| Estimate Year |
2024 |
| Report Coverage |
Market Revenue Estimation, Market Dynamics, Competitive Landscape, Growth Factors and etc. |
| Segments Covered |
By Product (Reagents, Instruments, and Software
Devices), By Technology (Molecular Diagnostics,
Immunoassay, Microbiology, Hematology, Urinalysis,
and Others), By Test Location (Central laboratories,
Point of Care Testing Centers, Hospital Laboratories,
Academic Institutes, Clinical Laboratories, and
Others) |
| Regional Coverage |
North America – The US and Canada; Europe – Germany, The UK, France, Russia, Spain, Italy, Benelux, Nordic, & Rest of Europe; Asia- Pacific– China, Japan, South Korea, India, ANZ, ASEAN, Rest of APAC; Latin America – Brazil, Mexico, Argentina, Colombia, Rest of Latin America; Middle East & Africa – Saudi Arabia, UAE, South Africa, Turkey, Egypt, Israel, & Rest of MEA
|
| Prominent Players |
QIAGEN, Abbott, F. Hoffmann-La Roche Limited,
Becton Dickinson & Company (BD), bioMérieux SA,
Hologic Inc. (Gen-Probe), Quidel Corporation,
Siemens Healthineers AG, Bio-Rad Laboratories Inc.,
Danaher Corporation, OraSure Technologies Inc, and
Other Key Players |
| Purchase Options |
We have three licenses to opt for: Single User License (Limited to 1 user), Multi-User License (Up to 5 Users), and Corporate Use License (Unlimited User) along with free report customization equivalent to 0 analyst working days, 3 analysts working days and 5 analysts working days respectively. |
Frequently Asked Questions
The Global Infectious Disease In-vitro Diagnostics Market size is estimated to have a value of USD 93.2
billion in 2023 and is expected to reach USD 140.6 billion by the end of 2032.
North America has the largest market share for the Global Infectious Disease In-vitro Diagnostics Market
with a share of about 41.2% in 2023.
Some of the major key players in the Global Infectious Disease In-vitro Diagnostics Market are QIAGEN,
BD, bioMérieux SA, F. Hoffmann-La Roche, Ltd., Hologic Inc. (Gen-Probe), Abbott, and many others.
The Infectious Disease In-vitro Diagnostics market is growing at a CAGR of 4.7% over the forecasted period.