In Vitro Diagnostics Market

The global in vitro diagnostics market in terms of revenue was estimated to be worth $85.2 billion in 2024 and is poised to reach $119.4 billion by 2029, growing at a CAGR of 6.9% from 2024 to 2029. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Growth in the in vitro diagnostics (IVD) market is driven by growing prevalence of chronic & infectious diseases, the increasing geriatric population in developed and developing regions, and rising demand for point-of-care testing.

However, an unfavorable reimbursement scenario will restrain the growth of the IVD market to a certain extent during the forecast period.

In Vitro Diagnostics Market Size, Dynamics & Ecosystem

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In Vitro Diagnostics Industry Dynamics

DRIVER: Increasing geriatric population and subsequent rise in chronic & infectious diseases

With the rapid growth in the geriatric population globally, the prevalence of age-associated diseases is expected to increase significantly. According to the United Nations Department of Economic and Social Affairs (UN DESA) at the world level in 2022, approximately 10 per cent of people worldwide are aged 65 or over. The proportion of older persons in the world is projected to reach nearly 12 per cent in 2030 and 16 per cent in 2050.

With age, the risk of developing diseases increases proportionately—for instance, nearly 80% of the elderly population in the US suffers from at least one chronic condition (Source: CDC). According to the National Council On Aging (NCOA) research, 94.9% percent of adults aged 60 and older have at least one condition, while 78.7% have two or more.

Having high blood cholesterol raises the risk for heart disease, the leading cause of death, and for stroke, the fifth leading cause of death. Diabetes is another chronic disease that affects the senior population since this population is prone to endocrine disorders due to hormonal fluctuations. Hence, the growth in the geriatric population is expected to increase the prevalence of several chronic conditions worldwide and drive the growth of the IVD market.

RESTRAINT: Unfavourable reimbursement

Medicare does not currently provide genetic testing coverage for individuals without a history of cancer. Similarly, according to MedPAC (Medicare Payment Advisory Commission), medical testing has seen a 40% decline in reimbursement over the last 40 years. This decline and additional budgetary concerns among healthcare systems will be a major obstacle to implementing novel diagnostic techniques in clinical laboratories. Besides, the rules governing reimbursement have been tightened in a number of European nations. The restrictions are severe, particularly for creators of innovative diagnostics whose coverage assessment procedure is opaque and differs throughout insurers. The standards for the caliber of evidence required for reimbursement are unclear to inventors of novel diagnostics. This has led to inefficiencies in the creation of innovative diagnoses and a commensurate rise in needless R&D expenses. These changes in the reimbursement scenario are expected to adversely affect growth of the IVD market.

OPPORTUNITY: Growth opportunities in emerging markets

Major players in the IVD industry should expect growth opportunities from developing economies including India, Brazil, China, South Korea, Turkey, Russia, South Africa, and Mexico. This can be attributed to the high disease prevalence, large patient population, improved healthcare infrastructure, increasing disposable income, and growing medical tourism in these countries.

The incidence of tropical diseases, such as Zika, malaria, and chikungunya, has increased significantly in these countries, with South American nations accounting for the highest number of cases. However, the Asia Pacific has emerged as an adaptive and business-friendly hub due to its relatively less-stringent regulations and data requirements. Currently, China is one of the largest investors in R&D. Moreover, various market players are strategically expanding their product portfolios across emerging countries through product launches & approval, collaborations, and expansion. This will support the installation of diagnostic systems in laboratories and contribute to the adoption of IVD.

CHALLENGE: Operational Barriers

Clinical laboratories across major markets are still evolving; technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as NGS and lab-on-a-chip PCR devices. Laboratory space also needs to be reconfigured to meet the requirements of conducting specific diagnostic tests used for pathogen detection to avoid cross-contamination and ensure efficient time management. This results in considerable cost escalation to maintain and operate advanced molecular diagnostic instruments, particularly those capable of handling a single sample type.

However, the shortage of skilled laboratory technicians to operate advanced diagnostic products has hindered overall adoption of in vitro diagnostics, particularly in emerging markets.

In Vitro Diagnostics Market Segmentation & Geographical Spread

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Blood, serum, and plasma segment accounted for the largest share of the in vitro diagnostics industry in 2023, by specimen.

Based on specimen, the IVD market is segmented into blood, serum, and plasma, urine, saliva, and other specimens. The blood, serum, and plasma segment accounted for the largest share in the IVD market in 2023. The significant share of the segment can be attributed to the growing number of blood donations. Also, blood is the most widely collected sample for IVD diagnostic procedures, and these are preferred for overall health screening as they provide information on various health conditions, such as genetic disorders, cardiovascular diseases, cancer, and diabetes.

Hospital & clinics segment accounted for the largest share in the in vitro diagnostics industry in 2023, by end user.

Based on end user, the IVD market is segmented into hospital & clinics, clinical laboratories, blood banks, home care settings, pharmaceutical & biotechnology companies, academic institutes, and other end users. In 2023, hospital & clinics accounted for the largest share in the IVD market. Rising number of patient admissions due to infectious diseases have increased the adoption and use of in vitro diagnostic tests across hospital laboratories, thereby driving the market growth.

North America accounted for the largest share of the in vitro diagnostics industry in 2023.

Based on region, the IVD market is segmented into six major regions—North America, Europe, Asia Pacific, Latin America, Middle East & Africa, and the GCC Countries. In 2023, North America accounted for the largest share in the IVD market. The large share of this region in the global IVD market is mainly attributed to the highly developed healthcare system in the US and Canada, the presence of many leading national clinical laboratories, and the easy accessibility to technologically advanced instruments. However, healthcare coverage expansions made by Medicare, Medicaid, and private health insurance companies in the region are also expected to play a significant role in fuelling the growth of the IVD market.

The major players in this market are Roche Diagnostics (Switzerland), Abbott Laboratories (US, Danaher Corporation (US), Siemens Healthineers (Germany), and Thermo Fisher Scientific.These players’ market leadership is due to their comprehensive product portfolios and expansive global footprint. These dominant market players have several advantages, including strong research and development budgets, strong marketing and distribution networks, and well-established brand recognition.

Scope of the In Vitro Diagnostics Industry

This research report categorizes the In Vitro Diagnostics Market to forecast revenue and analyze trends in each of the following submarkets:

By Region

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

By Product & Service

• Reagents & Kits
• Instruments
• Data Management Software and Services

By Technology

• Immunoassays
• Clinical Chemistry
• Molecular Diagnostics
• Hematology
• Microbiology
• Coagulation & Hemostasis
• Urinalysis
• Chromatography & Mass Spectrometry

By Specimen

• Blood, Serum, and Plasma
• Saliva
• Urine
• Other Specimens

By Application Split

• Infectious Diseases
• Oncology
• Endocrinology
• Cardiology
• Blood Screening
• Genetic Testing
• Autoimmune Diseases
• Allergy Diagnostics
• Drug Monitoring & Testing
• Bone & Mineral Disorders
• Coagulation Testing
• Blood Group Typing
• Other Applications

By End User

• Hospital & Clinics
• Clinical Laboratories
• Blood Banks
• Home Care Settings
• Pharmaceutical & Biotechnology Companies
• Academic Institutes
• Other End Users

Recent Developments of In Vitro Diagnostics Industry:

• In December 2023, Thermo Fisher launched the applied Biosystems MagMAX Dx Viral/Pathogen NA Isolation Kit and the Thermo Scientific KingFisher Apex Dx, an automated nucleic acid purification device, for the separation and purification of bacterial and viral pathogens from respiratory biological specimens.
• In November 2023, Roche launched a Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus (HEV) infections in countries accepting the CE mark .
• In July 2023, Siemens received FDA clearance and launched its Atellica CI Analyzer for immunoassay and clinical chemistry in the world’s major markets.
• In August 2022, Roche launched a Digital LightCycler System, a digital polymerase chain reaction (PCR) system. This system is a powerful new diagnostics platform combatting cancer and other diseases.
• In November 2022, Danaher Corporation launched the Xpert Xpress MVP, a multiplexed PCR test.

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