Infectious Disease In-vitro Diagnostics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

The global Infectious Disease In-Vitro Diagnostics (IVD) market has been steadily growing and valued at approximately US$64 billion in 2024. With a projected Compound Annual Growth Rate (CAGR) of 5% over the next decade, the market is poised to reach nearly US$92 billion by the end of 2031. This growth is driven by the increasing need for early detection and control of infectious diseases such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), Ebola, chikungunya, avian flu, swine flu, and Zika, which have imposed a significant epidemiological burden. This article delves into the factors driving this growth, key market players, and the impact of recent events like the COVID-19 pandemic.

Sales Analysis of Infectious Disease In-Vitro Diagnostics Market

The rising burden of infectious diseases across the globe has increased the demand for diagnostic products. Notably, electronic medical records (IVDs) play a crucial role in patient care, influencing around 70% of medical decisions. While the majority of the IVD market is concentrated in developed countries, the United States, Europe, and Japan account for over 80% of global sales.

The United States is expected to maintain its position as the largest contributor to the Infectious Disease In-Vitro Diagnostics Market during the forecast period, with a projected absolute dollar opportunity exceeding US$9.4 billion over the next decade.

Key Drivers of the Infectious Disease In-Vitro Diagnostics Market

1. Rising Global Healthcare Spending: Approximately 10% of the world's GDP is allocated to global healthcare spending, steadily increasing due to the growing healthcare needs of the population. In-Vitro Diagnostics, which influences over 60% of clinical decisions in healthcare, represents only 2% of total healthcare costs. This presents a significant opportunity for affordable in-vitro diagnostics.

2. Government Support: Government funding plays a pivotal role in driving research institutions to develop rapid diagnostic systems capable of diagnosing various diseases using various samples. For example, the European Union's "recovery plan" involves an investment of over US$250 billion by the end of 2026.

3. Point of Care (POC) Testing: The delocalization of diagnostics, including auto-diagnostics and home diagnostics, is rapidly growing. Major manufacturing companies are focusing on releasing quick, portable, easy-to-use tools suitable for use outside of traditional laboratories. This trend is expected to enhance the accessibility of diagnostics.

Impact of COVID-19 on the Infectious Disease In-Vitro Diagnostics Market

The COVID-19 pandemic has significantly reshaped the diagnostic landscape, making in-vitro testing a cornerstone in the diagnosis of the virus. Various test kits, often authorized under emergency use authorizations (EUA), have been developed globally to detect COVID-19. One of the primary In-Vitro Diagnostics assays for COVID-19 relies on real-time reverse transcriptase-polymerase chain reaction (RT-PCR), capable of identifying the virus within hours. The simplified nature of diagnostic products during the pandemic has expedited market growth.

Challenges and Restraints

1. Macroeconomic Vulnerability: The diagnostic industry is more susceptible to changes in the macroeconomic cycle compared to other healthcare sectors, primarily due to exposure to industrial end markets like food testing, which tend to have higher macroeconomic vulnerability.

2. Regulatory Hurdles: Different regions have varying regulations governing the production and sale of in-vitro diagnostic instruments, which can lead to delays in regulatory approvals. This can result in wasted R&D expenditures if diagnostic products are rejected.

3. Stringent Reimbursement Policies: Reimbursement policies have become more stringent, particularly for creators of novel diagnostics. The coverage evaluation process can be opaque, leading to increased R&D costs and inefficiencies in the development of new diagnostic products.

Regional Insights

North America's Dominance: North America is expected to dominate the Infectious Disease In-Vitro Diagnostics Market, with the National Institutes of Health contributing significantly to scaling up diagnostic test production through its Rapid Acceleration of Diagnostics initiative. The introduction of innovative products is making the market more competitive.

Country-wise Insights

U.S. Market Analysis: The United States is poised to contribute over US$28 billion to the global Infectious Disease In-Vitro Diagnostics Market by 2031. While the majority of the IVD market is in developed countries, the U.S. market accounts for less than 50% of the global share. Point of Care (POC) diagnostics is anticipated to make up 12% of the country's overall IVD market.

U.K. Market Analysis: The U.K. market is expected to experience steady growth from 2024 to 2031, presenting a significant opportunity for expansion.

Japan Market Analysis:

The Japanese market is anticipated to show strong growth from 2024 to 2031, providing a substantial opportunity for development.

Competitive Landscape

Key companies operating in the Infectious Disease In-Vitro Diagnostics Market include Abbott Laboratories, Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., bioMérieux SA, Siemens Healthineers AG, Danaher Corporation, Becton Dickinson and Company, PerkinElmer, Inc., Hologic, Inc., QIAGEN N.V., Grifols S.A., DiaSorin S.p.A, Bio-Rad Laboratories, Inc., Sysmex Corporation, Ortho Clinical Diagnostics Holdings plc, Quidel Corporation, Meridian Bioscience, Genetic Signatures Ltd., OraSure Technologies, Trinity Biotech Plc., Chembio Diagnostic Systems, Seegene, Inc., Co-Diagnostics, ELITechGroup, Epitope Diagnostics, Trivitron Healthcare, Meril Life Sciences Pvt. Ltd., InBios International, Vela Diagnostics, and Uniogen Oy.

Key Segments Covered in Infectious Disease In-Vitro Diagnostics Market Survey

By Product Type:

• Instruments
• Reagents
• Services

By Technology:

• Immunoassay
• Molecular Diagnostics
• Microbiology
• Other Technologies

By Application:

• MRSA
• Streptococcus
• Clostridium Difficile
• Respiratory Virus
• TB and Drug-resistant TB
• Gonorrhea
• HPV
• HIV
• Hepatitis C
• Hepatitis B
• COVID-19
• Other Applications

By End-use:

• Point of care
• Central Laboratories
• Other End-uses

By Region:

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

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