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

The IVD Assay Development Market was valued at $4.60 billion in 2023. This market is projected to reach $8.39 billion by 2031 from an estimated $4.93 billion in 2024, at a CAGR of 7.9% during the forecast period of 2024-2031.

IVD Assay Development Market Size & Forecast

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. 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

• By Offering: The IVD Assay Development Services Segment to Dominate the IVD Assay Development Market in 2024
• By Technology: In 2024, the Immunoassay/Immunochemistry Segment is Expected to Dominate the IVD Assay Development Market
• By Application: In 2024, the Infectious Diseases Segment is Expected to Account for the Largest Share of the IVD Assay Development Market
• By Geography: North America Dominates the IVD Assay Development Market in 2024

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IVD Assay Development Market Drivers

Rising Prevalence of Chronic Diseases Associated with the Increasing Geriatric Population

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.

High Burden of Infectious Diseases

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:

• In 2023, 39.9 million individuals had HIV globally, of which 1.4 million were children. There were 20.8 million individuals with HIV in Eastern and Southern Africa, 5.1 million in Western and Central Africa, 6.7 million in Asia and the Pacific, and 2.3 million in Western and Central Europe and North America (Source: HIV.gov).
• According to the WHO, in 2022, an estimated 254 million individuals had chronic Hepatitis B, and 50 million individuals had Hepatitis C globally. A significant number of those chronically infected develop cirrhosis or liver cancer. HCV leads to approximately 242,000 deaths annually, largely due to cirrhosis and hepatocellular carcinoma.
• 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% increase in the number of zoonotic disease outbreaks in Africa from 2012–2022 compared to 2001– 2011 (Source: WHO).
• The outbreak of COVID-19 stopped almost all economic activity around the globe. According to the WHO, as of July 2, 2023, there were 767 million confirmed COVID cases, with 6.9 million deaths.
• The epidemiological burden of sepsis has increased globally in the past few years. According to data published by the WHO in May 2024, in 2020, sepsis affected 48.9 million individuals globally, leading to 11 million sepsis-related deaths.
• According to the WHO, in 2022, 10.6 million new cases of tuberculosis were recorded globally, of which 5.8 million were men, 3.5 million were women, and 1.3 million were children. Also, approximately 1.3 million individuals died from tuberculosis in 2022.

Thus, the increasing burden of infectious diseases is expected to boost the need for diagnosis, driving the development of IVD assays.

IVD Assay Development Market Opportunities

Use of Advanced Technologies in IVD Assay Development

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:

• In September 2024, Seegene Inc. (South Korea) expanded its partnership with Springer Nature Group (Germany) by launching Nature Awards MDx Impact Grants for the development of PCR diagnostic assays.
• In April 2023, SpinChip Diagnostics AS (Norway) raised USD 6.20 million (NOK 65.4 million) in funding for a testing and sample comparison study and a follow-up investigation of 3,600 frozen patient samples. The funds were also used for the development of novel assays, clinical trials, ISO 13485 certification, and other operating expenses.

IVD Assay Development Market Analysis: Top Market Opportunity

By Offering: In 2024, the IVD Assay Development Services Segment is Expected to Dominate the IVD Assay Development Market

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.

Geographical Analysis

North America Dominates the IVD Assay Development Market in 2024

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.

Key Companies

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).

IVD Assay Development Industry Overview: Latest Developments from Key Industry Players

• In May 2023, Promega Corporation signed an agreement with Axxam S.p.A. (Italy) to develop smart assays for drug discovery services.
• In March 2023, Creative Biolabs launched comprehensive contract ELISA kit development services for R&D and IVD organizations, aiming to reduce the need for regulatory approval submissions.
• In April 2021, Bio-Techne rebranded Pharma Assay Services as Professional Assay Services to meet the growing demand for its assay offerings at its Newark, CA laboratory.
• In January 2021, Merck acquired AmpTec GmbH, a German mRNA contract development and manufacturing organization (CDMO). This acquisition enhances Merck’s capabilities in mRNA manufacturing, supporting the development of vaccines, therapies, and diagnostics.

IVD Assay Development Market Research Summary

Key questions answered in the IVD assay development market