In-Vitro Diagnostics Market to Reach USD 160.68 Billion by 2033, Driven by Aging Population and Tech Advancements

In-Vitro Diagnostics Market Analysis

The market for in-vitro diagnostics is anticipated to grow at a compound annual growth rate (CAGR) of 5.70% from 2025 to 2033, from US$97.56 billion in 2024 to US$160.68 billion by 2033. The aging population, rising infectious illness rates, continuous technological advancements, and shifting consumer preferences toward customized medication are the primary factors driving the in vitro diagnostics market share.

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The In-Vitro Diagnostics (IVD) market involves medical tests performed outside the body, typically using blood, urine, or tissue samples to detect diseases, conditions, or infections. This market plays a crucial role in diagnosing diseases, monitoring health, and making treatment decisions. The growth of the global IVD market is driven by an aging population, the increasing prevalence of chronic diseases, and advancements in technology, such as point-of-care testing and molecular diagnostics. The need for quick diagnostic tests was further increased by the COVID-19 epidemic.

The increasing geriatric population is becoming a significant factor in the growth of the global in vitro diagnostics (IVD) market. By 2050, the percentage of people in the world who are 60 and older is predicted to almost double, from 12% in 2015 to 22%. By that year, approximately 80% of elderly individuals will be living in low- and middle-income countries. This rise in life expectancy has led to a substantial increase in the percentage of geriatric patients. Moreover, geriatrics is often accompanied by various health issues such as cancer, diabetes, cardiovascular diseases, and neurodegenerative disorders, including Alzheimer's disease. These conditions are on the rise, coinciding with a greater incidence of the aforementioned diseases. They necessitate the frequent use of diagnostic tests for early detection and ongoing management, which further drives the demand for IVD products.

Key information covered in the report

• Base Year - 2024
• Historical Period - 2020-2024
• Market Forecast - 2025-2033
• Market - US$ Billion

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Most geriatric patients will require comprehensive health assessments that include a wide range of diagnostic tests, such as molecular diagnostics, immunoassays, and clinical chemistry tests. These tests, which help identify disease markers and evaluate treatment responses, play a crucial role in improving health outcomes for this age group. In the USA, the in vitro diagnostics market is expanding due to significant advancements in diagnostic technology, as well as the prevalence of chronic and infectious diseases. There is a growing demand for early and accurate disease detection, which has driven interest in newer diagnostic tools. The rapid growth of point-of-care testing is expected to improve patient outcomes in a timelier manner.

Additionally, the increasing number of elderly individuals is one of the factors that heightens the risk of chronic illnesses and necessitates more frequent diagnostics. Research indicates that the population aged 65 and older in the United States is projected to double over the next 40 years, reaching approximately 80 million by 2040. Furthermore, developments in personalized medicine and companion diagnostics present new opportunities for targeted therapies. Policy initiatives and reimbursement measures to support national diagnostic testing are also enhancing market access.

Market Drivers

Growing Chronic Illness Prevalence to Fuel Market Expansion

The rising incidence of acute and chronic disorders, such as cardiovascular, genetic, and neurological diseases, is driving the demand for in-vitro diagnostic (IVD) products. The effective use of IVDs in the early diagnosis of these conditions enables healthcare providers to implement appropriate treatments swiftly.

According to statistics published by the U.S. Centers for Disease Control and Prevention (CDC) in 2022, the number of tuberculosis (TB) cases in the U.S. increased by 5%, reaching 8,300 cases in that year. Furthermore, a 2023 article from the National Centers for Biotechnology Information (NCBI) estimated that the global prevalence of chronic Hepatitis B virus (HBV) infection was approximately 3.2%, equivalent to 257 million cases.

In addition, the growing geriatric population, which is increasingly susceptible to health issues such as liver diseases, hypertension, cardiovascular disorders, and kidney diseases, is expected to contribute to market growth. For example, according to 2023 statistics from Time Magazine, about 297 million people in China are aged 60 and older. This trend is projected to enhance the growth of the global in-vitro diagnostics (IVD) market in the coming years.

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Increasing Funding and Government Support for IVD Device Development

There is a rising focus on raising awareness among government organizations, agencies, and associations that promote the use of IVD products through various initiatives. It is anticipated that this tendency will propel market expansion. The WHO published a model list of necessary in-vitro diagnostics for primary healthcare and medical facilities with clinical laboratories in order to make clear the order of diseases according to their burden and prevalence. IVDs are divided into both general and disease-specific groups in this list.

In October 2023, the WHO published its 2023 Essential Diagnostics List (EDL), which serves as an evidence-based register of IVDs to assist countries in making informed national diagnostic choices. Additionally, increasing research and development initiatives aimed at funding are expected to contribute significantly to product development, further boosting market growth.

All things considered, the market is expected to develop due to the previously listed variables as well as the increasing number of IVD product launches.

How Do High Equipment and Maintenance Costs Impede the Growth of the In Vitro Diagnostics Market?

High costs associated with equipment and maintenance are significant barriers to the growth of the in vitro diagnostics (IVD) market. As of 2022, the average price for a high-end molecular diagnostic system range from $100,000 to $500,000. Additionally, annual maintenance costs typically represent 10-15% of the initial purchase price of the equipment. A 2022 healthcare cost analysis estimates that upkeep of IVD equipment costs smaller labs between $150,000 and $200,000 annually.

Another challenge is the lack of skilled labor, which also hinders market growth. The American Society for Clinical Laboratory Science reported a 7% vacancy rate for laboratory positions in 2022. Additionally, in the same year, the Bureau of Labor Statistics reported a shortfall of almost 25,000 laboratory professionals. The training costs for each laboratory technician averaged between $40,000 and $60,000 in 2021.

Furthermore, stringent regulatory requirements and reimbursement challenges affect the industry's growth. The FDA reported that the average time for IVD device approvals extended to 9-12 months in 2022. Regulatory compliance costs rose by 25% between 2020 and 2022, with companies spending an average of $250,000 to $500,000 per IVD device on regulatory submissions in 2022. Medicare reduced reimbursement rates for certain diagnostic tests by 15-20% that year. According to data from the Centers for Medicare & Medicaid Services (CMS), laboratory test reimbursements decreased by an average of 10% between 2020 and 2022, while insurance claim denials for diagnostic tests increased by 23% in 2021 compared to 2020.

Recent Developments in In-Vitro Diagnostics Market

In February 2025, ABL Diagnostics will begin manufacturing and commercializing a comprehensive range of UltraGene PCR tests, which it has acquired from its parent company, Advanced Biological Laboratories. These tests will cover over 100 pathogens, thus supporting the diagnosis of various infectious diseases. The company's goal is to integrate PCR technology with its DeepChek sequencing products, further establishing its presence in the field of precision medicine.

In January 2025, QIAGEN received U.S. FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, a targeted syndromic test designed for diagnosing bacterial and viral gastrointestinal infections. The company is planning to launch this product as part of an effort to expand its syndromic testing portfolio, thereby offering more comprehensive and targeted diagnostic options for both inpatient and outpatient settings.

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