REDDING,
Calif., June 26, 2024 /PRNewswire/ -- According to
a new market research report, 'IVD Contract Manufacturing
Services Market by Type (Assay Development,
Manufacturing), Category (Reagents, Systems), Technology
(Immunoassay, Molecular Diagnostics, Clinical Chemistry,
Hematology, Microbiology, Urinalysis)–Global Forecast to
2031', published by Meticulous Research®, the
IVD contract manufacturing services market is projected to reach
$25.80 billion by 2031, at a CAGR of
7.8% from 2024 to 2031.
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IVD contract manufacturing services allow organizations to
outsource manufacturing processes. Companies outsource a product or
a part of a product. This is often used to increase production
rates or to expand product offerings without investing in new
equipment and machinery.
The growth of the IVD contract manufacturing services market is
driven by several factors, including the rising prevalence of
infectious diseases, a shift in focus from centralized laboratories
to point-of-care testing services, regulatory complexities faced by
IVD companies, and the need for cost-effective manufacturing of IVD
tests. Factors such as high economic growth and increased
outsourcing in emerging countries are opportunities that would help
grow the market in the future. The lack of skilled professionals
could be considered a challenge for the IVD contract manufacturing
services market. However, maintaining product quality and
protection of proprietary information restrains 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 contract manufacturing services market has
witnessed several organic and inorganic strategic developments. The
key players profiled in the IVD contract manufacturing services
market report are Cenogenics Corporation (U.S.), In-Vitro
Diagnostic Developers, Inc. (IDxDI) (U.S.), Savyon Diagnostics
(Israel), KMS Systems, Inc.
(U.S.), Nova Biomedical (U.S.), LRE Medical (Germany), Cone Bioproducts (U.S.), Invetech,
Inc. (Australia), Avioq, Inc.
(U.S.), TCS Biosciences Ltd. (U.K.), Affinity Life Sciences, Inc.
(U.S.), Coris BioConcept (Belgium), Meridian Bioscience, Inc. (U.S.),
Affinity Biologicals, Inc. (Canada), Biokit S.A. (Spain), Merck KgaA (Germany), Thermo Fisher Scientific, Inc.
(U.S.), and Maxim Biomedical, Inc. (U.S.).
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Regulatory Complexities Faced by IVD Companies
Although IVD holds excellent potential for early diagnosis, the
regulatory approval processes for these devices or tests are
tedious. Regulatory approvals include a review of the clinical
data, calibration, manufacturing methods, quality control, risk
assessment, and other factors to ensure the reproducibility and
safety of the devices/tests. Despite this, the primary regulatory
hurdle for diagnostic devices is complexity. The monitoring and
controlling of the quality of components and assembly during the
transition of diagnostic assays to full-scale production is
important. Also, supply chain management and risk mitigation
strategies become critical. To keep the final assay product
compliant and sellable, quality management systems (QMS) and
careful documentation of production processes according to ISO and
other regulatory guidelines become necessary. To verify safety and
quality compliance, government bodies conduct scheduled and
unscheduled audits of all manufacturing facilities.
Manufacturers found that developing tests for point-of-care
settings is difficult compared to laboratory tests due to the high
standards of the FDA. For instance, the FDA determines CLIA status
through a point scoring system (1-3, low to high complexity).
Devices with a cumulative score greater than 12 are categorized as
high-complexity devices. Devices with an aggregate score of less
than 12 are classified as moderate-complexity devices.
Low-complexity tests can be used in any POC setting due to the low
risk of enormous results. On the other hand, it is mandated by the
FDA that high and moderate complexity tests must be performed in
CLIA-certified labs by qualified personnel. Thus, manufacturers
find the bar high and, hence, difficult to develop POC tests.
IVD companies are trying to optimize resources due to regulatory
complexities, prompting industry participants to adopt innovative,
integrated business models. In such situations, contract
manufacturing services are positioning themselves as one-stop-shop
solution providers. Their services help IVD companies overcome
regulatory complexities, thus driving market growth.
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The IVD contract manufacturing services market is segmented by
Type (Assay Development Services, Manufacturing Services, and
Other Services), Category (Reagents & Consumables and
Instruments & Systems), Technology (Immunoassay, Molecular
Diagnostics, Clinical Chemistry, Hematology, Microbiology, and
Urinalysis), and Geography. The study also evaluates industry
competitors and analyzes the regional and country-level
markets.
Based on type, in 2024, the manufacturing services segment is
expected to account for the largest share of the market.
Manufacturing services are FDA-registered and include ISO-certified
manufacturing facilities that allow them to provide everything,
from small-scale pilot batch manufacture to full commercial
production. These facilities carry out full project and production
management, quality and regulatory support, and flexibility in
scale and process, which results in an increased demand for
manufacturing services, hence driving the growth of the
segment.
Based on category, in 2024, the reagents & consumables
segment is expected to account for the largest share of
the market. Reagents & consumables provide high standards
of innovation and quality in R&D and manufacturing of IVD
assays. This results in laboratory efficiency and better
clinical outcomes for patients, therefore driving the growth of the
market. Apart from this, the rising prevalence of infectious
diseases and the growing demand for POC diagnostic kits also
consequently increase the use of reagents & consumables used in
diagnosis.
Based on technology, in 2024, the immunoassay segment is
expected to account for the largest share of the market.
Immunoassay technologies utilize antigen-antibody reactions for the
detection of causative agents. Radioimmunoassay and ELISA are the
most widely used immunoassay techniques for the diagnosis of
infectious diseases. These tests are used frequently for
immunodiagnostics owing to their inherent specificity, high
throughput, and the emergence of advanced diagnostic immunoassay
formats. Furthermore, the increasing use of immunoassays in Point
of Care (PoC) infectious disease testing and the rising trend of
automation in immunoassay instruments is propelling the growth of
this segment.
Based on geography, in 2024, the market in North America is expected to account for the
largest share of the market. The growth of this regional
market is primarily driven by the rising prevalence of various
infectious diseases, the growing healthcare sector, increasing
awareness regarding early disease diagnosis, the growing adoption
of advanced diagnostic products, and increasing funding activities
coupled with novel advanced diagnostic technologies.
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Scope of the Report:
IVD Contract Manufacturing Services Market—by Type
- Manufacturing Services
- Assay Development Services
- Other Services
(Other Services primarily include product design and
lyophilization)
IVD Contract Manufacturing Services Market—by
Category
- Reagents & Consumables
- Instruments & Systems
IVD Contract Manufacturing Services Market—by
Technology
- Immunoassay
- Molecular Diagnostics
- Clinical Chemistry
- Hematology
- Microbiology
- Urinalysis
IVD Contract Manufacturing Services Market—by
Geography
- North America
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe (RoE)
- Asia-Pacific
- China
- Japan
- India
- Rest of APAC (RoAPAC)
- Latin America
- Middle East & Africa
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