IVD Reagents Market Size, Share, Forecast, & Trends Analysis by Type (Antibodies, Proteins, Oligonucleotides, Nucleic Acid Probes) Technology (Immunoassay, Biochemistry, Microbiology, Hematology) Use (Clinical, RUO) End User - Global Forecast to 2031

IVD Reagents Market Size & Forecast

The IVD Reagents Market is expected to reach $79.76 billion by 2031, at a CAGR of 5.3% from 2024 to 2031. The growth of the IVD reagents market can be attributed to several factors, including the increasing prevalence of infectious diseases, increasing funding for research activities, the rising adoption of advanced diagnostic technologies, the growth in proteomics & genomics research studies, and the growing number of clinical laboratories offering advanced diagnostic testing menus. Moreover, emerging economies and the growing demand for protein therapeutics & personalized medicines are expected to offer growth opportunities for the players operating in this market.

IVD Reagents Market Growth Drivers

Increasing Prevalence of Infectious Diseases

Infectious diseases are mainly caused by organisms such as bacteria, viruses, fungi, and parasites. Some infectious diseases get transmitted from person to person or through bites from insects or animals. The burden of infectious diseases has increased globally, driving the demand for safe and effective diagnostic assays. Hence, the demand for IVD reagents is expected to grow with the increased utilization of diagnostic assays. The following statistics indicate the increased prevalence of infectious diseases:

• In 2021, 39 million people had HIV globally, of which 1.5 million were children. There were 20.8 million (53%) people with HIV in eastern and southern Africa, 5 million (13%) in western and central Africa, 6.5 million (15%) in Asia and the Pacific, and 2.3 million (5%) in Western and Central Europe and North America.
• According to an article published in the United Nations digital magazine Africa Renewal in July 2022, the risk of outbreaks caused by zoonotic pathogens such as the Ebola & monkeypox viruses that originate in animals and infect humans is rising. There has been a 63.0% increase in the number of zoonotic disease outbreaks in Africa from 2012–2022 compared to 2001– 2011 (Source: WHO).
• According to the WHO, about 1.6 million people died from tuberculosis in 2021. The disease was the 13th leading cause of death globally. In 2021, there were 10.6 million new cases of tuberculosis, of which 3.4 million were women and 1.2 million were children. The burden of drug-resistant TB (DR-TB) increased by 3% between 2020 and 2021, with 450,000 new cases of rifampicin-resistant TB (RR-TB) recorded in 2021.

Thus, the increasing prevalence of infectious diseases is expected to boost the need for diagnosis, driving the demand for IVD reagents.

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Increase in Proteomics and Genomics Research Studies

In recent years, there has been a significant increase in proteomics and genomics-based research studies driven by technological advancements and the need to understand the genetic and molecular bases of various diseases. Proteomics and genomics are employed to identify proteins and genes, their structures, functions, and modifications across various research areas, particularly in medical research, drug discovery, and diagnostics. Researchers are currently utilizing multiple antibodies, including polyclonal, monoclonal, recombinant, and mono-specific antibodies, due to their high target specificity and strong affinity for target molecules.

Traditionally, proteomics and genomics studies were conducted using conventional Sanger sequencing technology, which sequenced and analyzed single genes, amplicon targets, genomic fragments, and short tandem repeats. However, according to the National Human Genome Research Institute, Sanger sequencing can produce inaccurate results, offer low throughput, and be time-consuming. Consequently, it has recently been largely replaced by Next-Generation Sequencing (NGS).

NGS can analyze 100 genes simultaneously, requires a lower amount of input material, and is cost-effective. Sanger sequencing costs about USD 500 per 1,000 bases, while NGS costs around USD 0.50 per 1,000 bases. This significant cost difference has prompted researchers to adopt more sophisticated and specific techniques. Advanced genomics and proteomics methods leverage antibody-based research for biomarker identification and drug development. For instance, the monoclonal antibody inhibitor trastuzumab (ErbB2, HER-2) has been used as a monotherapy in women with HER-2 overexpressing metastatic breast cancer.

Thus, the transition to new genomics and proteomics techniques is enhancing the precision and efficiency of research, supporting advances in biomarker identification and drug development.

IVD Reagents Market Trends

Growing Use of IVD Reagents in DNA Sequencing & Next-generation Sequencing

DNA sequencing determines a DNA molecule's precise order of nucleotides (adenine, guanine, cytosine, and thymine). DNA sequencing is a fundamental technique in molecular biology, genetics, and genomics and has revolutionized many areas of biological research. Next-generation sequencing (NGS) is a large-scale DNA high-throughput technology that can parallel sequence millions of small DNA fragments. Hence, the technology is also referred to as massively parallel sequencing. It can sequence entire genomes, including all 22,000 coding genes or small numbers of individual genes. NGS has well-known applications in various life sciences, such as oncology, forensic sciences, functional genomics, transcriptomics, medicine, and evolutionary biology. NGS has enabled the analysis of multiple genome regions in one single reaction and is a cost-effective and efficient tool in investigating patients with Mendelian diseases. Consequently, NGS methods have provided a great impetus to discovering genetic aberrations and their establishment as prognostic and predictive markers of diseases.

In addition, clinical laboratories are increasingly adopting NGS testing, which requires IVD reagents as a standard for diagnosing hereditary disorders, such as phenylketonuria, congenital myopathy, cystic fibrosis, and periodic paralysis syndromes. Further, the adoption of NGS-based IVD tests, which require IVD reagents, is likely to increase in the future, thereby broadening the adoption of IVD reagents detecting a wide array of diseases.

Additionally, the continuous advancements in DNA sequencing have led to the emergence of fourth-generation sequencing, which incorporates nanopore technology into single-molecule sequencing (SMS). This technology performs real-time sequencing without amplification and repeated cycles by eliminating synthesis. The fourth-generation sequencing, also known as in situ sequencing technology, has widened the applications of DNA sequencing, which requires IVD reagents to identify the order of nucleotides in fixed cells and tissues.

IVD Reagents Market Opportunity

Growing Demand for Protein Therapeutics and Personalized Medicines

Protein therapeutics is a branch of medicine that can serve patients needing novel therapies. Advances in protein-engineering technologies (such as mass spectrometry), molecular genetics, and production technologies are key drivers of protein therapeutic practices. Drug developers are exploiting the functional characteristics of desired proteins to maintain and enhance product safety or efficacy. The fastest-growing class of therapeutic proteins is an antibody that includes bispecific mAbs, multispecific fusion proteins, and mAbs conjugated with small-molecule drugs designed to treat cancers, immune disorders, infections, and other diseases.

According to a research article published in F1000Research, recent advances in protein purification technologies and expression systems have increased the production of therapeutic peptides while maintaining product safety or efficacy or both at the same time. Further, government initiatives supporting the development of personalized medicines (which largely include monoclonal antibodies) have boosted antibody production.

In March 2020, scientists in South Africa developed a new antibody technology for precision medicine. A group of researchers from the University of Cape Town’s Medical Biotechnology and Immunotherapy Research Unit published a paper explaining how certain proteins based on antibodies, called SNAP-tag fusion proteins, may help reduce the cost and time needed to develop new personalized therapies. The fact that antibodies have these specific targets is important in developing targeted therapies. Scientists can generate new protein combinations for various applications by rearranging genetic material such as antibody genes. An example of precision medicine is using antibody technologies to identify breast cancer patients treated with trastuzumab.

Thus, the increasing demand for therapeutic proteins and personalized medicines and the increase in approvals are expected to create growth opportunities for the players operating in the IVD reagents market.

Growth in Emerging Economies

Emerging economies in Asia-Pacific and Latin America are expected to offer market growth opportunities due to the rising demand for antibodies and oligonucleotides, increasing funding for R&D, rising healthcare expenditures, and ongoing developments in healthcare infrastructure. Countries such as China, India, Brazil, and Mexico have significantly contributed to revenue generation for various stakeholders in this market, mainly due to the increasing number of research institutes, clinical and diagnostic laboratories, and pharmaceutical and biopharmaceutical companies. Additionally, growth in public and private R&D funding and contract research supports market growth in these countries.

According to the United Nations, Asia-Pacific is witnessing rapid growth in its aging population. In 2022, 12.7% of the population in Eastern and Southeastern Asia was aged 65 years or older, and the percentage is projected to increase to 25.7% by 2050. Thus, the prevalence of age-related disorders, such as cancer, is rising in Asia-Pacific.

Moreover, the increasing healthcare expenditures in emerging economies from Asia-Pacific and South and Central America are enabling physicians to diagnose a wide range of diseases through advanced testing and examination techniques requiring specific reagents. Most market players are focused on emerging economies due to the increasing prevalence of infectious and chronic diseases.

IVD Reagents Market Analysis: Key Findings

By Type: In 2024, the Antibodies Segment to Dominate the IVD Reagents Market

Based on types, the market is segmented into antibodies, purified proteins and peptides, oligonucleotides, nucleic acid probes, and other IVD reagents. In 2024, the antibodies segment is expected to account for the largest share of 22.1% of the IVD reagents market. Antibodies are glycoproteins produced by plasma cells in response to an antigen stimulus. These antibodies are highly specific to target molecules. Antibodies are necessary reagents for research and in vitro diagnostic (IVD) applications and specifically bind to a specific biomolecule or a protein of interest. The large share of the segment is attributed to factors such as inherent specificity, high throughput, high sensitivity, and low cost, which drive the growth of this technology segment. Further, the increasing use of immunoassays in POC & infectious disease testing, the development of novel tests, and the rising demand for immunoassay-based tests also contribute to the large share.

By Technology: In 2024, the Immunoassay/Immunochemistry Segment to Dominate the IVD Reagents Market

Based on technologies, the market is segmented into immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation/hemostasis, urinalysis, and other IVD technologies. In 2024, the immunoassay/immunochemistry segment is expected to account for the largest share of 30.8% of the IVD reagents market. Immunoassay/immunochemistry is a bioanalytical method in which the quantitation of the analyte depends on the reaction of an antigen and antibody. The large share of the segment is attributed to factors such as the increasing use of immunoassays in POC and infectious disease testing, the development of novel tests, the increasing usage of miniaturized devices, and the rising demand for immunoassay-based tests.

By Use: In 2024, the Clinical Use Segment to Dominate the IVD Reagents Market

Based on uses, the market is segmented into clinical use, research use only (RUO), and analyte-specific reagents (ASR). In 2024, the clinical use segment is expected to account for the largest share of the IVD reagents market. IVD reagents are critical components in clinical laboratories. Without these reagents, these laboratories cannot generate the information required for patient diagnosis, monitoring, and treatment. Chemical, biochemical, and immunochemical reagents are the types of reagents used in clinical applications. Initiatives by manufacturers for developing advanced IVD clinical applications, ongoing clinical trials, and exemption from the investigational device (IDE) requirements are the factors contributing to the largest share of this segment.

By End User: the IVD Manufacturers Segment to Dominate the IVD Reagents Market

Based on end users, the market is segmented into IVD manufacturers, reference laboratories, academic institutes & research laboratories, and hospital laboratories. In 2024, the IVD manufacturers segment is expected to account for the largest share of 35% of the IVD reagents market. In-vitro diagnostic (IVD) reagents are critical components in clinical and special chemistry testing laboratories. These labs generate the information required for patient diagnosis, monitoring, and treatment using IVD reagents. The large share of the segment is attributed to factors such as increasing demand for innovative products, growing incidence of chronic diseases, increasing demand for pharmaceutical & biopharmaceutical products from emerging countries, and initiatives undertaken by IVD manufacturers.

Geographical Analysis

By Geography: North America to Dominate the IVD Reagents Market

In 2024, North America is expected to account for the largest share of 37.7% of the IVD reagents market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The largest share of the segment is primarily due to the growing awareness regarding early disease diagnosis, expanding healthcare sector, high prevalence of infectious and chronic diseases, rising funding activities coupled with the development of novel advanced diagnostic technologies, and growing adoption of advanced diagnostic products.

However, Asia-Pacific is slated to register the highest CAGR of 7.8% during the forecast period. This is attributed to factors such as rapid urbanization, increasing investments by healthcare providers towards infrastructure improvement, the presence of key IVD reagent companies in countries like China, India, Singapore, and South Korea, and government investments in research and development activities. Furthermore, the need to manage the growing burden of infectious diseases, growing accessibility to healthcare services & advanced products, growing income levels of the middle-class population, and increasing number of hospitals and clinics contribute to the growth of this market.

IVD Reagents Market: Key Companies

The report offers a competitive analysis based on an extensive assessment of the leading players’ product portfolios, geographic presence, and key growth strategies adopted in the last 3–4 years. Some of the key players operating in the IVD reagents market are Thermo Fisher Scientific (U.S.), Becton, Dickinson and Company (U.S.), Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), Abcam plc (U.K.), Hologic Inc. (U.S.), InBios International, Inc. (U.S.), SDIX, LLC (U.S.), BioTechne Corporation (U.S.), Bio-Synthesis Inc. (U.S.), RayBiotech, Inc. (U.S.), Sino Biological Inc. (China), Oy Medix Biochemica Ab (Finland), QIAGEN N.V. (Netherlands), and Beckman Coulter, Inc. (U.S.).

IVD Reagents Industry Overview: Latest Developments from Key Industry Players

• In April 2023, Beckman Coulter, Inc. received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification to help prepare labs for IVDR.
• In April 2022, Becton, Dickinson and Company launched AI-based D Horizon RealYellow 586 Reagents for flow cytometry. These reagents help researchers to increase improved data resolution and larger insights from samples compared to traditional fluorochromes.
• In January 2022, Beckman Coulter, Inc. received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for more than 200 flow cytometry reagents developed and manufactured at their Marseille, France facility.

IVD Reagents Market Research Summary

Key questions answered in the IVD reagents market report: