REDDING, Calif., Oct. 24, 2024 /PRNewswire/ -- According to a new market research report, '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, published by Meticulous Research®
The IVD assay development market is projected to reach $8.39 billion by 2031, at a CAGR of 7.9% from 2024 to 2031.
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In vitro diagnostics (IVD) assay development services provide comprehensive, end-to-end contracting solutions. These services include assay design and proof of concept, feasibility studies, prototype development, packaging design, stability testing, regulatory support, and more. The assay development process involves several phases, including the selection and screening of key raw materials, preliminary feasibility assessments, optimization of assay parameters, verification of assay designs, and clinical sample testing.
The growth of IVD assay development 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 market growth is restrained by an evolving regulatory landscape.
Moreover, the emerging economies and the use of advanced technologies in IVD assay development are expected to generate growth opportunities for market stakeholders. Maintaining product quality & protecting proprietary information pose challenges to the growth of the market.
The report also includes an extensive assessment of the product portfolio, geographic analysis, and key growth strategies adopted by leading market players in the last three to four years. In recent years, the IVD assay development market has witnessed several organic and inorganic strategic developments. The key players profiled in the 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.n (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.
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Growing Focus on the Development of POC IVD Assays
Point-of-care (POC) testing is used for diagnosis at or near the site where the patient is located. POC assays have been approved for the diagnosis of infectious diseases, such as chlamydia, gonorrhea, and influenza, and help medical professionals in initiating treatment early. In decentralized setups, POC assays help physicians monitor infectious diseases and improve clinical workflows. Furthermore, POC assays allow for rapid turnaround, helping medical professionals make timely treatment decisions, which is especially important for patients in remote places, emergencies, and instances where immediate action is required. POC IVD assays enable better patient outcomes by allowing for speedier treatment and evaluation. Early disease identification, monitoring, and treatment plan adjustments based on real-time outcomes improve patient care.
Moreover, companies are focusing on product approvals to expand their offerings. For instance, in December 2023, QuidelOrtho Corporation (U.S.) received the U.S. FDA's 510(K) clearance for its Savanna Multiplex Molecular Platform and SavannaHSV 1+2/VZV PCR Assay. This assay is used for the detection and differentiation of the Herpes Simplex Virus Type 1 (HSV-1). Thus, the growing focus on point-of-care diagnostics is boosting the development of POC diagnostic assays, supporting market growth.
The IVD assay development market is segmented by Offering (IVD assay development services, IVD packaging development services, IVD assay stability testing, regulatory support, and other offerings), Technology (immunoassay/immunochemistry, molecular diagnostics, clinical chemistry/biochemistry, hematology, microbiology, urinalysis, and other technologies), Application (infectious diseases, oncology, diabetes, cardiology, and other applications). The report also provides a comprehensive analysis of the IVD assay development market in North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.
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Based on offerings, the IVD stability testing segment is slated to register the highest CAGR of 8.1% during the forecast period. IVD stability testing evaluates the extent to which an IVD assay maintains its performance characteristics over time, which is critical for tests utilized in ongoing research or the tracking of chronic diseases. Furthermore, stability testing is a vital component of quality assurance processes in IVD assay development, as it helps detect any possibility of breakdown or alterations in performance over time. Stability testing allows companies to detect and manage risks associated with conditions that alter the effectiveness of IVD assays, including light exposure and temperature changes. Also, stability testing delivers data useful for product formulation & packaging, optimizing storage conditions, and assessing product shelf-life are factors expected to support the segment's high growth.
Based on technologies, the molecular diagnostics segment is slated to register the highest CAGR of 8.8% during the forecast period. Continuous advancements in molecular diagnostics technology have improved assay specificity, sensitivity, and multiplexing ability. Next-generation sequencing can perform gene-specific selective or complete genome sequencing with high accuracy. NGS has enabled the analysis of multiple regions of the genome in one single reaction and has been increasingly used in applications such as genetic disorders diagnosis, cancer diagnosis, and mutation target/biomarker identification to check the feasibility of targeted therapies are factors expected to support the segment's high growth.
Based on applications, the infectious disease segment is slated to register the highest CAGR of 8.9% during the forecast period. The growing need to detect and treat infectious diseases has led to the emergence of new technologies, such as molecular and Point-of-care (POC) systems. The growing number of infectious disease cases and integration of advanced technologies in IVD assay development are factors expected to support the segment's high growth.
Based on geographies, Asia-Pacific is slated to register the highest CAGR of 9.1% during the forecast period. Rapid urbanization, the need to manage the rising burden of infectious diseases, and initiatives aimed at increasing access to diagnostic services. 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 factors expected to support the segment's high growth.
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Scope of the Report:
IVD Assay Development Market-by Offering
- Equipment 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
- Other Technologies
(Note: Other technologies include whole blood glucose monitoring and coagulation/hemostasis.)
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
- Switzerland
- Netherlands
- 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
Browse More Related Reports -
Latin American IVD Market is expected to grow at a CAGR of 5.5% during forecast period 2023-2030 to reach $6.45 billion by 2030
Nepal IVD Market is expected to grow at a CAGR of 12.3% from 2022 to 2029 to reach $62.7 million by 2029
Africa IVD Market to reach $1.65Bn by 2031, growing at 3.1% CAGR from 2024 https://www.meticulousresearch.com/product/africa-ivd-market-5415
Europe IVD Market to reach $39.77Bn by 2030 with a 3.7% CAGR
Asia-Pacific IVD Market is expected to reach $36.02 billion by 2031 at a CAGR of 7% from 2024 to
IVD Assay Development Market Research Summary
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. and Canada), Europe (Germany, France, |
Key Companies | Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), |
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