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

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

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 global IVD assay development market is projected to reach $8.39 billion by 2031 at a CAGR of 7.9% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities. 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. However, the evolving regulatory landscape restrains the growth of this market.

Furthermore, the emerging economies and the use of advanced technologies in IVD assay development are expected to generate growth opportunities for the players operating in this market. However, maintaining product quality & protecting proprietary information are major challenges impacting market growth.

The report offers a competitive landscape based on an extensive assessment of the leading players’ offerings and geographic presence and the key growth strategies adopted by them over the past few years (2021–2024). The key players operating in the global IVD assay development market 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).

Among the offerings covered in this report, the IVD stability testing segment is projected to register the highest CAGR of over 8.1% during the forecast period of 2024-2031. This growth is driven by the benefits of stability testing, which helps identify potential breakdowns or alterations in performance over time. Stability testing enables companies to detect and manage risks related to factors that can affect the effectiveness of IVD assays, including light exposure and temperature variations.

Among the technologies covered in this report, in 2024, the immunoassay /immunochemistry segment is expected to account for the largest share of the IVD assay development market. The segment’s large market share is attributed to the higher preference for immunodiagnostics compared to other technologies due to its inherent specificity and high throughput, and the emergence of advanced diagnostic immunoassay formats.

Among the applications covered in this report, in 2024, the infectious diseases segment is expected to account for the largest share of the IVD assay development market. The large market share of this segment can be attributed to the increasing prevalence of HIV and the growing availability of rapid diagnostic assays for HIV.

An in-depth analysis of the geographical scenario of the global IVD assay development market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. In 2024, North America is expected to account for the largest share of over 37.8% of the IVD assay development market. Within this region, the U.S. is expected to account for the largest share of the IVD assay development market in 2024. The country’s large market share is attributed to the increasing prevalence of infectious diseases, favorable government investments and funding for disease investigation & prevention, and rising healthcare expenditure.

Scope of the Report:

IVD Assay Development Market–by Offering

IVD Assay Development Services
IVD Packaging Development Services
IVD Assay Stability Testing
Regulatory Support
Other Offerings

(Note: Other offerings include technology transfer, technical support services, and custom QA & QC testing)

IVD Assay Development Market–by Technology

Immunoassay/Immunochemistry
Molecular Diagnostics
Clinical Chemistry/Biochemistry
Hematology
Microbiology
Urinalysis

IVD Assay Development Market–by Application

Infectious Diseases
Oncology
Diabetes
Cardiology
Other Applications

(Note: Other applications include nephrology, coagulation tests, and neurological disorders.)

IVD Assay Development Market—by Geography

North America
U.S.
Canada
Europe
Germany
France
U.K.
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Latin America
Brazil
Mexico
Rest of Latin America
Middle East & Africa

IVD Assay Development Market - Report Summary

Report Metrics	Details
Years Considered	2022 - 2031
Base Year	2023
Forecast Period	2024-2031
Page Count	177
Units Referenced	Value (USD Billion)
Segments/Key Topics	Market by Offering, Technology, Application, and Geography
Regions Covered	North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa
Key Companies Mentioned	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).

FAQs About the Report

How big is the IVD assay development market?

The global IVD assay development market size was valued at $4.60 billion in 2023.

At what rate is the IVD assay development market projected to grow?

The market is projected to grow from $4.93 billion in 2024 to $8.39 billion by 2031.

What is the forecast for the IVD assay development Market?

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.

Who are the leading players in the IVD assay development market?

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).

What are the opportunities in the IVD assay development market?

Emerging economies and the use of advanced technologies in IVD assay development are expected to create market growth opportunities.

Which segments will hold large market shares in the IVD assay development market during 2024-2031?

By offering, 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, the North America segment is anticipated to hold the largest market share during 2024-2031.

What are the regional trends in the IVD assay development market?

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. 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.

What are the major drivers of the IVD assay development market?

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.