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IVD Assay Development Market to be Worth $8.39 Billion by 2031--Exclusive Report by Meticulous Research®
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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 ).
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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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, the IVD stability testing segment is slated to register the highest CAGR of 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.
, the molecular diagnostics segment is slated to register the highest CAGR of 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.
, the infectious disease segment is slated to register the highest CAGR of 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.
, Asia-Pacific is slated to register the highest CAGR of 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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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
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https://www.meticulousresearch.com/pressrelease/1269/ivd-assay-development-market
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