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IVD Assay Development Market Size, Share, Forecast, & Trends Analysis by Offering (Assay Development, Packaging Development) Technology (Immunoassay, Molecular Diagnostics, Biochemistry) Application (Oncology, Diabetes) – Global Forecast to 2031
Report ID: MRHC - 1041354 Pages: 177 Oct-2024 Formats*: PDF Category: Healthcare Delivery: 2 to 4 Hours Download Free Sample ReportKey factors driving the growth of this market include the rising prevalence of chronic diseases & the increasing geriatric population, the high burden of infectious diseases, the growing focus on the development of POC IVD assays, and rising healthcare expenditures. Furthermore, emerging economies and the use of advanced technologies in IVD assay development are expected to generate growth opportunities for the stakeholders in this market.
Key Findings
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The prevalence of chronic diseases such as cancer, diabetes, arthritis, and heart disease is on the rise globally. According to the World Health Organization (WHO), chronic diseases account for 41 million deaths each year (around 74% of all deaths) globally. Growth in the geriatric population, tobacco & alcohol use, physical inactivity, and unhealthy diets are driving a steady increase in the prevalence of chronic diseases. According to the International Diabetes Federation (IDF), the global prevalence of diabetes is estimated to increase from 10.5% of the global population in 2021 to 11.3% in 2030. According to the IDF, in 2021, 537 million individuals were diagnosed with diabetes globally (Western Pacific accounted for 206 million cases, while Southeast Asia accounted for 90 million cases, the Middle East & North Africa for 73 million cases, Europe for 61 million cases, North America & the Caribbean for 51 million cases, South & Central America for 32 million cases, and Africa for 24 million cases). The number of diabetes cases is projected to reach 643 million in 2030 and 783 million in 2045.
Chronic diseases are often associated with the elderly population due to declining bodily functions and immunity in the population segment. Aging leads to progressive deterioration in the structure and functioning of organs, making the elderly population more prone to chronic diseases. According to World Population Prospects, the population aged 65 and over is growing more rapidly than other age groups. The percentage of the global population aged 65 years and over is expected to rise from 10% in 2022 to 16% in 2050. This remarkable growth in the elderly population is driven by declining fertility rates and improvements in longevity.
The WHO estimates that globally, 1 in 5 people develop cancer during their lifetime, and 1 in 8 men and 1 in 11 women die from the disease. As per WHO estimates, the global incidence of cancer is expected to increase from 19.2 million new cases in 2022 to 24.1 million new cases in 2030, while the global mortality from cancer is expected to increase from 9.7 million deaths in 2022 to 11.9 million deaths in 2030. This growing disease burden has increased the demand for IVD testing, resulting in IVD companies preferring to outsource the development of IVD assays to fulfill the growing demand for diagnostic assays while controlling production costs. These factors are driving the growth of the IVD assay development market.
Infectious diseases are caused by organisms such as bacteria, viruses, fungi, and parasites. Infectious diseases are transmitted from person to person or through bites from insects or animals. The burden of infectious diseases has increased globally, driving the need for safe and effective diagnostic assays. Hence, the demand for IVD assay development is expected to grow with the increasing utilization of diagnostic assays.
The following statistics indicate the high burden of infectious diseases:
Thus, the increasing burden of infectious diseases is expected to boost the need for diagnosis, driving the development of IVD assays.
IVD assays are developed using various technologies such as Polymerase Chain Reaction (PCR), Enzyme-linked Immunosorbent Assay (ELISA), Chemiluminescent Immunoassay (CLIA), Next-generation Sequencing (NGS), and proteomics. IVD assays are used to detect genomic variations in DNA. The use of genomic technologies has accelerated the shift toward precision medicine, wherein diagnostic tests and assays can be personalized to a person's genetic composition, enabling individualized treatment techniques based on each patient's unique genetic profile. Next-generation Sequencing (NGS) technology offers a comprehensive perspective of the human genome. Thus, it is used in IVD assay development to improve the accuracy of diagnosis, prognosis, and treatment selection.
In addition, High-throughput Sequencing (HTS) is used in the development of IVD assays for applications such as tumor profiling, HIV drug resistance detection, and early cancer detection. HTS provides multiple benefits, including retaining high precision while sequencing and sequencing millions of DNA molecules simultaneously. This can boost sequencing speed and provide more impactful conclusions by employing larger sample sizes.
Some of the recent key developments in this market are as follows:
Based on offering, the global IVD assay development market is segmented into IVD assay development services, IVD packaging development services, IVD assay stability testing, regulatory support, and other offerings. In 2024, the into IVD assay development services segment is estimated to account for the largest share of the global IVD assay development market. The large share of this segment is attributed to the trend of outsourcing IVD assay design and development among IVD companies, the high demand for IVD assays in drug discovery, increasing partnerships between manufacturers and research institutes to promote innovation and develop new assays, and the high prevalence of infectious diseases.
Assay development includes the designing of assays, proof of concept, feasibility studies with reagent formulation, prototype development, and complete assay development. The assay format is designed based on the analyte and the intended level of specificity and sensitivity. Many In Vitro Diagnostic (IVD) assays are developed using methods such as Enzyme-linked Immunosorbent Assay (ELISA), Polymerase Chain Reaction (PCR), lateral flow, cytology, Chemiluminescent Immunoassay (CLIA), and immunohistochemistry.
In addition, the rising use of IVD assays in drug discovery is driving the demand for IVD assay development services. IVD assays are critical in evaluating medication candidates, detecting biomarkers, guiding treatment decisions, and identifying patients for specific therapies. With pharmaceutical companies’ shift toward personalized medicine and precision therapeutics, the demand for high-quality IVD assays is growing rapidly.
However, the IVD assay stability testing segment is projected to register the highest CAGR during the forecast period of 2024 to 2031. IVD Stability testing assesses the consistency of IVD assays in various storage conditions, including humidity, temperature, and light exposure, to ensure consistent results. IVD assay stability testing improves product reliability and accuracy, increasing clients’ reliance on the product over time. These factors are expected to drive the segment’s growth during the forecast period.
In 2024, North America is estimated to account for the largest share of the global IVD assay development market. North America’s significant market share in the IVD assay development market is primarily attributed to the presence of leading IVD assay development companies in the region, the high prevalence of various infectious diseases and chronic diseases, the well-developed healthcare sector, awareness regarding early disease diagnosis, early adoption of advanced innovative diagnostic products, and significant research funding for the development of advanced diagnostic technologies.
However, the market in Asia-Pacific is projected to register the highest CAGR during the forecast period. This market's growth is attributed to factors like ongoing improvements in healthcare infrastructure and increasing government investment in the IVD sector. Accelerated economic growth in many Asia-Pacific countries has led governments to invest more in the healthcare sector to enhance accessibility to healthcare facilities and improve infrastructure. Additionally, growing awareness of health and treatment options, an expanding middle-class population with higher disposable income, increased health insurance penetration, and a rising aging population are further boosting the market’s growth in Asia-Pacific.
The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market players over the past three years (2021-2024).
The key players profiled in the global IVD assay development market report are Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), Creative Biolabs, Inc (U.S.), Maxim Biomedical, Inc. (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), PeploBio Ltd (U.K.), ICON plc (Ireland), NeoDx Biotech Labs Pvt. Ltd. (India), Eclevar Medtech (France), Savyon Diagnostics (Israel), Promega Corporation (U.S.), and Future Diagnostics Solutions B.V. (Netherlands).
Particulars |
Details |
Number of Pages |
177 |
Format |
|
Forecast Period |
2024–2031 |
Base Year |
2023 |
CAGR (Value) |
7.9% |
Market Size (Value) |
USD 8.39 Billion by 2031 |
Segments Covered |
By Offering
By Technology
By Application
|
Countries Covered |
North America (U.S., Canada), Europe (Germany, France, U.K., Italy, Spain, Rest of Europe), Asia-Pacific (China, Japan, India, South Korea, Australia, Rest of Asia-Pacific), Latin America (Brazil, Mexico, Rest of Latin America), and the Middle East & Africa |
Key Companies |
Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), Creative Biolabs, Inc (U.S.), Maxim Biomedical, Inc. (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), PeploBio Ltd (U.K.), ICON plc (Ireland), NeoDx Biotech Labs Pvt. Ltd. (India), Eclevar Medtech (France), Savyon Diagnostics (Israel), Promega Corporation (U.S.), and Future Diagnostics Solutions B.V. (Netherlands). |
The global IVD assay development market size was valued at $4.60 billion in 2023.
The market is projected to grow from $4.93 billion in 2024 to $8.39 billion by 2031.
The IVD assay development market analysis indicates substantial growth, with projections indicating that the market will reach $8.39 billion by 2031 at a compound annual growth rate (CAGR) of 7.9% from 2024 to 2031.
The key companies operating in this market include Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), Creative Biolabs, Inc (U.S.), Maxim Biomedical, Inc. (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), PeploBio Ltd (U.K.), ICON plc (Ireland), NeoDx Biotech Labs Pvt. Ltd. (India), Eclevar Medtech (France), Savyon Diagnostics (Israel), Promega Corporation (U.S.), and Future Diagnostics Solutions B.V. (Netherlands).
Emerging economies and the use of advanced technologies in IVD assay development are expected to generate growth opportunities for market stakeholders.
By offering type, the IVD assay development services segment is forecasted to hold the largest market share during 2024-2031.
By application, the infectious diseases segment is expected to dominate the market during 2024-2031.
By technology, the immunoassay/immunochemistry segment is expected to dominate the market during 2024-2031.
By geography, North America is anticipated to hold the major market share during 2024-2031.
By region, North America holds the largest IVD assay development market share in 2024. However, the market in Asia-Pacific is expected to witness the highest growth rate, driven by continuous improvements in healthcare infrastructure and increasing government investment in the IVD sector. Moreover, accelerated economic growth in many Asia-Pacific countries has led governments to invest more in the healthcare sector to enhance accessibility to healthcare facilities and improve infrastructure in countries such as China, India, and South Korea.
Key factors driving the growth of this market include the rising prevalence of chronic diseases & the increasing geriatric population, the high burden of infectious diseases, the growing focus on the development of POC IVD assays, and rising healthcare expenditures.
Global IVD Assay Development Market Will Grow at A CAGR of 7.9% during the Forecast Period to Reach $8.39 Billion by 2031, Says “Meticulous Research®”
IVD assay development is the process of creating, refining, and verifying diagnostic assays that identify and quantify pathogens, biomarkers, and other substances present in biological samples. In healthcare settings, these tests are utilized for the diagnosis, monitoring, and management of various diseases and conditions.
The growth of this market is driven by the rising prevalence of chronic diseases & the increasing geriatric population, the high burden of infectious diseases, the growing focus on the development of POC IVD assays, and rising healthcare expenditures. Additionally, emerging economies and the use of advanced technologies in IVD assay development are expected to offer significant market growth opportunities.
Here are the top 13 companies operating in the global IVD assay development market:
Creative Biolabs, Inc. (U.S.)
Founded in 2005 and headquartered in New York, U.S., Creative Biolabs, Inc. provides distinctive pharmaceutical and biotechnology services that address the complete range of biotechnology demands, including early discovery and drug development. The company focuses on the development of novel antibodies or their equivalents that possess suitable specificity and affinity for applications in research, therapeutics, and diagnostics.
The company provides a comprehensive range of services, including Phage Display Library Construction, Phage Display Library Screening, Magic Anti-Membrane Protein Antibody Discovery, Hybridoma Services, Anti-idiotype Antibody Discovery, Single Domain Antibody (sdAb) Discovery, Native Antibody Discovery, De Novo Antibody Sequencing, Antibody Humanization, Antibody Affinity Maturation, Post-translational Modification (PTM) Specific Antibody Discovery, as well as IVD Antibody Development Platforms, IVD Kit Development, IVD Materials and Reagents Development Services, Custom Antibody Array Development Services, Custom IVD Antibody Production Services, Custom Formulation Development Services, Custom Assay Development Services, and Biomarker Analysis Services. Additionally, the company offers platforms such as the Membrane Protein Platform, Phage Display Platform, Hyperdoma Platform, and B-Cell Sorting Platform to government and academic research laboratories, as well as pharmaceutical and biotechnology companies worldwide.
The company engages in the IVD assay development market by providing various services, including radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), lateral-flow immunochromatographic assay (LFIA), western blot (WB), latex particle-enhanced turbidimetric immunoassay (LETIA), immunohistochemistry (IHC), and flow cytometry (FC). Creative Biolabs maintains a global presence with offices and distributors located in the U.K., the U.S., China, Germany, Australia, Belgium, Chile, France, Japan, South Korea, the Netherlands, Switzerland, Spain, South Africa, Singapore, and Italy. The company provides a comprehensive EU, GMP, USP, and FDA-compliant testing laboratory, offering analytical and bioassay services.
Avioq, Inc. (U.S.)
Founded in 2007 and headquartered in North Carolina, U.S., Avioq, Inc. is engaged in the development, production, and distribution of IVD devices and products. The company offers services for IVD assay development, IVD contract manufacturing, cell culture development, companion diagnostics, and direct-to-consumer testing. The company operates in the IVD assay development market by offering a range of IVD assay development services. It has established a presence through manufacturing sites, distributors, and offices in the U.S. and Europe.
Bio-Techne Corporation (U.S.)
Founded in 1976 and headquartered in Minnesota, U.S., Bio-Techne Corporation develops, manufactures, and sells life science reagents, instruments, and services within the research and clinical diagnostic markets. The company provides services, including custom controls and calibrators, assay development, IVD manufacturing, technology transfer, packaging development, regulatory support, technical support, and stability programs. BioTechne operates in two segments: Protein Sciences and Diagnostics & Genomics, with its involvement in the IVD assay development market occurring through the Diagnostics & Genomics segment.
The Genomics & Diagnostics segment develops and manufactures diagnostic products, including calibrators, controls, and diagnostic assays for regulated diagnostics, advanced tissue-based in-situ hybridization, exosome-based molecular diagnostic assays for spatial genomic and tissue biopsy analysis, and genetic and oncology kits for clinical and research applications.
The company maintains a direct presence through subsidiaries, manufacturing sites, sales offices, and distributors across the U.K., U.S., Canada, China, India, and France. Notable subsidiaries involved in the IVD assay development market include Bionostics, Inc. (U.S.), Bio-Techne China Co. Ltd (China), Bio-Techne SAS (France), Bio-Techne GmbH (Germany), Bio-Techne France (France), Bio-Techne AG (Switzerland), Bio-Techne srl (Italy), and Bio-Techne Ireland Limited (Ireland)
Thermo Fisher Scientific Inc. (U.S.)
Founded in 1956 and headquartered in Massachusetts, U.S., Thermo Fisher Scientific Inc. is a biotechnology company focused on life sciences research, enhancing patient diagnostics, and boosting laboratory productivity. The company operates through four reportable segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products & Biopharma Services.
The Specialty Diagnostics segment consists of five business categories: Clinical Diagnostics, ImmunoDiagnostics, Microbiology, Transplant Diagnostics, and Healthcare Market Channel. The company participates in the IVD assay development market through its Clinical Diagnostics business, offering detection assays, liquid and lyophilized ready-to-use immunodiagnostic reagent kits, calibrators, controls, proteins, and instruments.
Key brands within Thermo Fisher include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company maintains a direct presence through regional offices and manufacturing facilities located in the U.S., Mexico, Brazil, Germany, Belgium, Austria, the U.K., Italy, the Netherlands, South Africa, the UAE, India, China, Japan, Australia, and the Republic of Korea. Notable subsidiaries active in the IVD assay development market comprise Thermo Fisher Scientific Operating Company LLC (Delaware), Fisher Clinical Services Japan K.K. (Japan), Fisher Clinical Services (Korea) Co., Ltd (Korea), and Thermo Fisher Scientific SL (Spain).
NeoDx Biotech Labs Pvt. Ltd. (India)
Incorporated in 2020 and headquartered in Karnataka, India., NeoDx Biotech Labs Pvt. Ltd. is engaged in developing, designing, and manufacturing IVD kits and provides services for diagnosing infectious diseases. The company’s in vitro diagnostic products encompass kits, reagents, and devices for both infectious and noninfectious diseases. Additionally, it offers various self-test kits such as NeoCheck to test for infectious disorders and Hana Health for women seeking fertility solutions.
The company offers various services, such as contract research, assay development, quality and regulatory, OEM manufacturing contract research, and manufacturing services. It operates in the IVD assay development market by offering assay development services.
Merck KGaA (Germany)
Founded in 1668 and headquartered in Darmstadt, Germany, Merck KGaA is a science and technology company that aims to improve people's health and well-being and advance their lives through science and technology. The company operates in three reportable segments: Healthcare, Life Science, and Electronics. The Life Science segment has three categories: Process Solutions, Life Science Services, and Science & Lab Solutions. The company operates in the IVD assay development market through the Science & Lab Solutions category by offering lateral flow assay development services.
The company's Life Science business segment has more than 55 manufacturing sites worldwide and over 100 distribution centers. The company has corporate offices, manufacturing units, and distributors in Argentina, Germany, Malaysia, Singapore, France, Romania, Australia, New Zealand, Sweden, Switzerland, the U.K., Colombia, Japan, Brazil, Belgium, the Netherlands, Croatia, the U.S., and Iraq.
Some of its subsidiaries operating in the IVD assay development market are Merck Life Science Germany GmbH (Germany), Merck Millipore Ltd. (Ireland), Merck Life Science S.L.U. (Spain), Sigma-Aldrich International GmbH (Switzerland), Sigma-Aldrich Biochemie GmbH (Germany), Merck Life Science S.r.l. (Italy), and Merck Life Science AS (Norway).
PeploBio Ltd (U.K)
Incorporated in 2021 and headquartered in Guildford, U.K., PeploBio Ltd is a clinical diagnostic laboratory and full-service contract research organization (CRO) that offers a comprehensive range of products and services to facilitate the development of medical therapeutics and devices. Their service offerings include clinical trials, product development, report preparation, immune monitoring, as well as genomic, proteomic, and diagnostic services.
The company specializes in Research Use Only (RUO), Laboratory-developed Tests (LDT), IVD, and CDx assays, and emerging technologies such as PCR, cell-based assays, flow cytometry, sanger sequencing, ELISA, and lateral flow. It offers diagnostic testing solutions in the fields of infectious disease, oncology, serology, and more.
ICON plc (Ireland)
Founded in 1990 and headquartered in Dublin, Ireland. ICON plc offers outsourced development services to biotechnology, pharmaceutical, medical devices, and government/public health organizations. The company operates within a single reportable segment focused on delivering these outsourced development services.
The company maintains a direct presence in over 40 countries, operating 39 offices in Europe, including 10 in the U.K., five in the Netherlands, four in both Germany and Spain, two each in France, Ireland, Hungary, Poland, Sweden, Russia, Turkey, and Ukraine, and one each in Belgium, Belarus, Bulgaria, Georgia, the Czech Republic, Israel, Latvia, Romania, Italy, and Slovakia.
In North America, the company has 33 offices, with 29 located in the U.S., two in Canada, and two in Mexico. In Asia, there are 16 offices, including five in China (with one in Hong Kong), three in India, two each in Japan and Singapore, and one each in South Korea, Thailand, Taiwan, and the Philippines. Additionally, the company operates two offices in Australia and five offices in South America, with one office each in Argentina, Chile, Brazil, Colombia, and Peru, as well as one office in South Africa.
Several of its subsidiaries operating in the IVD assay development market include ICON Clinical Research Austria GmbH (Austria), ICON Laboratory Services, Inc. (U.S.), ICON Chile Limitada (Chile), ICON CRO Malaysia Sdn. Bhd. (Malaysia), ICON Clinical Research Korea Limited (South Korea), ICON Life Sciences Canada Inc. (Canada), and ICON Clinical Research Services Philippines, Inc. (Philippines).
Savyon Diagnostics (Israel)
Founded in 1984 and headquartered in Ashdod, Israel, Savyon Diagnostics specializes in the development and manufacturing of diagnostic tests for point-of-care, clinical laboratories, and home use. Its Analytical Unit provides a comprehensive suite of services to the pharmaceutical, biotech, IVD, and life sciences sectors, including assay development, contract manufacturing, logistics, and quality assurance & regulatory consulting. The company also maintains a global network of over 80 distributors.
Maxim Biomedical, Inc. (U.S.)
Founded in 2005 and headquartered in Maryland, U.S., Maxim Biomedical, Inc. is a diagnostic healthcare company that develops and manufactures diagnostic solutions. The company provides a comprehensive range of testing solutions for HIV surveillance, screening, confirmation, and diagnosis. Additionally, it specializes in custom IVD assay development for both government and private sector clients.
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