Number of pages: 120 | Report Format: PDF | Published date: October 01, 2021
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global in-vitro diagnostics market was valued at US$ 112.87 billion in 2022 and is expected to register a revenue CAGR of 4.3% to reach US$ 164.87 billion by 2031.
In-Vitro Diagnostics Market Fundamentals
In-vitro diagnostics refers to medical tests and procedures performed on samples derived from the human body, such as blood, urine, or tissue, to provide information about a person's health condition. These tests are conducted outside of the living organism (in vitro) in a laboratory or other controlled environment. In-vitro diagnostics play a crucial role in disease diagnosis, monitoring, and management, providing healthcare professionals with valuable information to guide treatment decisions. Common examples of in-vitro diagnostics tests include blood tests, genetic testing, urine analysis, and molecular diagnostics.
In-Vitro Diagnostics Market Dynamics
The increasing prevalence of cardiovascular disorders, cancer, diabetes, and infectious diseases creates a demand for precise and early diagnostic solutions, thereby driving growth in-vitro diagnostics market. According to the WHO, around 17.9 million deaths are caused by cardiovascular diseases each year. It is the leading cause of death globally. The aging population is more susceptible to chronic diseases and requires frequent diagnostic testing. As the global population continues to age, according to the WHO, around 1 billion people worldwide are 60 or older; thus, demand for in-vitro diagnostics tests has risen. Advancements in technologies such as molecular diagnostics, point-of-care testing, and automation have improved the speed, accuracy, and efficiency of in-vitro diagnostics tests, which is increasing the in-vitro diagnostics market demand. The increased awareness about the importance of early disease detection and preventive healthcare measures has led to a higher need for screening and diagnostic tests. In-vitro diagnostics tests are essential in identifying risk factors and detecting diseases at an early stage, these in-vitro diagnostics industry trend is contributing to market growth. The in-vitro diagnostics market outlook is positive as in-vitro diagnostics tests, including genetic testing and companion diagnostics, are instrumental in facilitating personalized medicine, which aims to customize medical treatment based on an individual's unique characteristics, including their genetic profile. Favorable regulations and reimbursement policies by governments and healthcare authorities encourage the adoption of in-vitro diagnostics tests. These policies provide an impetus for developing and commercializing innovative in-vitro diagnostics products, which is also expected to boost the growth of the in-vitro diagnostics market.
However, the in-vitro diagnostics industry is subject to stringent regulatory frameworks and approval processes. Compliance with these regulations can be time-consuming and costly, restricting the growth of the in-vitro diagnostics market. As genetic testing and other advanced in-vitro diagnostics technologies continue to advance, ethical and legal concerns around privacy, informed consent, and data protection arise, which is also expected to hamper the growth of the in-vitro diagnostics market.
In-Vitro Diagnostics Market Ecosystem
The global in-vitro diagnostics market is analyzed from five perspectives: products & services, technology, application, end user, and region.
In-Vitro Diagnostics Market by Products & Services
Based on the products & services, the global in-vitro diagnostics market is segmented into instruments, kits & reagents, and services.
The kits & reagent segment accounted for the largest in-vitro diagnostics market share, with a 60% share of the market. Kits and reagents are fundamental components required for performing in-vitro diagnostics tests. They consist of specific substances, chemicals, antibodies, probes, and other materials necessary for sample processing and analysis. These kits and reagents enable accurate and reliable test results. Kits and reagents are utilized across a broad spectrum of in-vitro diagnostics tests, including clinical chemistry, immunoassays, molecular diagnostics, and hematology. They cater to diverse diagnostic needs, allowing for the detection and measurement of various analytes and biomarkers. The kits and reagents segment has a well-established market presence, with numerous manufacturers specializing in producing and supplying these products. This segment has a mature market structure, established distribution networks, and customer relationships. Kits and reagents offer flexibility and compatibility with various laboratory instruments and platforms. They are designed to work seamlessly with specific diagnostic systems, ensuring accurate and standardized testing procedures across different laboratories. In many cases, purchasing kits and reagents is more cost-effective than developing in-house assays or investing in specialized equipment. The ready-to-use nature of these products reduces the need for extensive research, development, and quality control processes, making them more accessible and cost-efficient for laboratories.
In-Vitro Diagnostics Market by Technology
Based on the technologies, the global in-vitro diagnostics market is segmented into immunoassay, molecular diagnostics, hematology, urinalysis, microbiology, and others.
The molecular diagnostics segment accounted for a considerable revenue share, with a 38.2% share of the in-vitro diagnostics market. Molecular diagnostics offer high precision and accuracy in detecting and analyzing genetic material, such as DNA and RNA. They enable the identification of specific genetic mutations, pathogens, and biomarkers associated with various diseases, allowing for precise diagnosis and personalized treatment selection. Molecular diagnostics have various applications across different medical fields, including infectious diseases, oncology, genetic disorders, and pharmacogenetics. They are used for disease diagnosis, monitoring treatment response, detecting drug resistance, and guiding targeted therapies. Molecular diagnostics have benefited from significant technological advancements, such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and microarray techniques. These technologies have improved molecular tests' sensitivity, speed, and scalability, driving their adoption in clinical settings. The increasing prevalence of infectious diseases and genetic disorders necessitates accurate and early detection. Molecular diagnostics have attracted substantial research and development investments from both private and public sectors. These investments fuel innovation, developing new assays, platforms, and technologies in the molecular diagnostics segment, further driving its dominance.
In-Vitro Diagnostics Market by Application
Based on the applications, the global in-vitro diagnostics market is segmented into infectious diseases, oncology, cardiology, nephrology, diabetes, gastrointestinal diseases, and others.
The infectious diseases segment accounted for the prominent revenue share of the in-vitro diagnostics market in 2022. Infectious diseases pose a significant global health challenge, with a high prevalence and impact on population health. The need for accurate and timely diagnosis of infectious diseases is critical for effective disease management and public health interventions, driving the demand for in-vitro diagnostics tests. According to statistics provided by ReAct (a SIDA-funded organization), bacterial infection was responsible for 7.7 million deaths worldwide. That accounts for 13.6%, or 1 in 8, of all deaths worldwide. Many countries implement screening and surveillance programs for infectious diseases, especially those with significant public health implications, such as HIV, hepatitis, tuberculosis, and sexually transmitted infections. In-vitro diagnostics tests are central to these programs, facilitating early detection, prevention, and control of infectious diseases. The infectious diseases segment encompasses various testing methods, including immunoassays, molecular diagnostics, serology tests, and microbiology culture techniques. This diversity of testing methods allows for comprehensive and targeted diagnosis of different types of infectious diseases. The constant threat of emerging infectious diseases and the evolution of pathogens necessitate ongoing research and development efforts in diagnostic technologies. Continued innovation in assay development, multiplex testing, and rapid detection methods further bolsters the dominance of the infectious diseases segment.
In-Vitro Diagnostics Market by End User
Based on the end users, the global in-vitro diagnostics market is segmented into hospitals, clinical laboratories, academics/research institutes, point-of-care testing, and others.
The clinical laboratories segment accounted for the highest revenue share of the in-vitro diagnostics market in 2022. Clinical laboratories possess the necessary infrastructure, facilities, and trained personnel to perform a wide range of diagnostic tests. They have the equipment, instrumentation, and quality control systems required for accurate and reliable testing, making them a central hub for in-vitro diagnostics services. Clinical laboratories offer a comprehensive range of diagnostic tests across different disciplines, including clinical chemistry, hematology, microbiology, immunology, molecular diagnostics, and pathology. They cater to diverse healthcare needs and provide a one-stop solution for various testing requirements. Clinical laboratories often act as centralized testing hubs, receiving samples from healthcare providers, hospitals, and clinics for analysis. They process a large volume of samples and handle a broad spectrum of tests, enabling efficient and timely diagnosis for a significant number of patients. Clinical laboratories adhere to stringent quality assurance measures and obtain accreditation from regulatory bodies. These quality standards ensure accurate and reliable testing, establishing trust among healthcare providers and patients. Clinical laboratories are integral to healthcare systems, collaborating closely with providers, physicians, and hospitals. They play a crucial role in disease diagnosis, treatment monitoring, and patient management, making them a vital part of the healthcare ecosystem.
In-Vitro Diagnostics Market by Region
Geographically, the global in-vitro diagnostics market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region has the largest in-vitro diagnostics market size in terms of revenue generation accounting for around 38.7% share of the market. North America is at the forefront of technological advancements in in-vitro diagnostics. The region has a strong focus on research and development, leading to the introduction of innovative diagnostic technologies and platforms. Advancements in areas such as molecular diagnostics, point-of-care testing, and digital health solutions drive regional growth. North America has a high burden of chronic diseases, including cardiovascular disorders, cancer, diabetes, and respiratory diseases. The need for accurate and early diagnosis of these conditions fuels the demand for in-vitro diagnostics tests. The market benefits from the region's strong healthcare infrastructure and focus on disease management. According to the CDC, in 2021, around 4.6% of people in the U.S. were diagnosed with COPD, emphysema, or chronic bronchitis. There is a growing emphasis on preventive healthcare in North America, driven by factors such as rising healthcare costs and an aging population. Screening and early detection of diseases are vital components of preventative care, and in-vitro diagnostics tests play a crucial role in identifying risk factors and enabling timely interventions.
In-Vitro Diagnostics Competitive Landscape
The prominent players operating in the global in-vitro diagnosticsmarket are:
In-Vitro Diagnostics Strategic Developments
In-vitro diagnostics refers to medical tests and procedures performed on samples derived from the human body, such as blood, urine, or tissue, to provide information about a person's health condition.
Asia Pacific can be considered the key growth region due to the surge in in-vitro diagnostics industry trends in China, Japan, and the Indian subcontinent.
The prominent global in-vitro diagnostics market players are Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers, Bio-Rad Laboratories Inc., and F. Hoffmann-La Roche Ltd.
The global in-vitro diagnostics market growth is estimated to be at a revenue CAGR of 4.3% during the forecast period from 2023 to 2031.
The estimated size of the global in-vitro diagnostics market in 2031 is US$ 164.87 billion.
*Insights on financial performance are subject to the availability of information in the public domain