IVD Contract Manufacturing Market
Number of pages: 100 | Report Format: PDF | Published date: April 27, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023 to 2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 11.84 billion |
|
Revenue Forecast in 2031 |
US$ 23.85 billion |
|
CAGR |
7.6% |
|
Base Year for Estimation |
2022 |
|
Forecast Period |
2023 to 2031 |
|
Historical Year |
2021 |
|
Segments Covered |
Type, End User, and Region |
|
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global IVD contract manufacturing market was valued at US$ 11.84 billion in 2022 and is expected to register a revenue CAGR of 7.6% to reach US$ 23.85 billion by 2031.
IVD Contract Manufacturing Market Fundamentals
IVD contract manufacturers develop solutions that meet the needs of clinical testing. Outsourcing expedites the achievement of sales targets and the incorporation of new technologies into everyday manufacturing. The majority of in vitro diagnostic tests are based on molecular or immunodetection methods, such as polymerase chain reaction (PCR), enzyme-linked immunosorbent assays (ELISA), chemiluminescent immunoassays (CLIA), lateral flow, cytology, and immunohistochemistry. PCR and its variations are specific and sensitive detection technologies used to identify and amplify unique regions of DNA/RNA indicative of a pathogen or illness condition. Antibodies are coupled to a chromogenic enzyme in ELISA-based tests, which gives a quantitative, colorimetric signal in the presence of substrate. In CLIA, an enzyme transforms a substrate into a chemiluminescent signal released as visible or near-visible light. The amount of light generated is directly proportional to the target analyte in the sample.
From the design stage to product development and final production, concepts from biology, chemistry, physics, and engineering are applied. There is no assurance that an assay produced in R&D will be transferable to the production scale. When an assay is pushed to scale up, it frequently necessitates further development and reagent reformulations. Experienced diagnostic assay developers employ important fit-for-purpose components compliant with regulatory criteria and secure the supply chain to save substantial time and money by limiting deviations. Minimal maintenance requirements and onboard calibrations to ensure accurate test results, a user-friendly software interface, integration with laboratory and hospital information systems, and easy-to-use disposables containing all reagents for sample processing and testing are all desirable features of POC devices.
Although these standards appear straightforward, they pose several design and production hurdles for IVD firms. Several systems, for example, need more sophisticated disposable cartridges containing several chemicals to process only one patient sample at a time instead of simpler disposables in greater capacity laboratory devices. With this extra complexity, product development teams must collaborate to guarantee the seamless integration of disposable cartridges into the instrument design while minimizing costly redesigns. As a result, collaborating with a contract manufacturing partner that has experience combining disposable cartridge technologies with instrument design is the preferred alternative, driving the IVD contract manufacturing services market.
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IVD Contract Manufacturing Market Dynamics
The growing preference for point-of-care (POC) testing services drives the growth of the IVD contract manufacturing services market. There is a significant desire for IVD testing to move closer to the patient, whether at the hospital, clinic, physician's office, or home, to reduce result time and assist patients in making better-informed decisions about their health. Manufacturers (OEMs) face several design and manufacturing problems when producing customized PoC devices. For example, the capacity to process high-precision components involving reagents and fluids is one of the most important competencies OEMs desire, which specialist IVD CDMOs provide.
The increased need for advanced medical devices is one of the primary drivers of the IVD contract manufacturing services industry. The rising frequency of chronic illnesses and the need for early detection and treatment are driving the need for advanced medical equipment. Furthermore, the growing emphasis on individualized therapy is raising the demand for innovative medical gadgets.
Another driving force in the IVD contract manufacturing services industry is the requirement for efficient and cost-effective production methods. The rising strain on healthcare resources prompts providers to seek more cost-effective alternatives. Contract manufacturing is an efficient and cost-effective method of producing medical products.
The IVD contract manufacturing market is also influenced by the medical device industry's rigorous requirements. The regulations are intended to assure medical devices’ safety and efficacy. Due to the rigorous rules, manufacturers are forced to outsource medical equipment production to contract manufacturers. The IVD contract manufacturing services industry will likely expand rapidly in the next few years. The industry is driven by increased demand for advanced medical equipment and a greater emphasis on customized care.
IVD Contract Manufacturing Market Ecosystem
The global IVD contract manufacturing is analyzed from the following perspectives by type, services, technology, and region.
IVD Contract Manufacturing Market by Type
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Based on type, the global IVD contract manufacturing market is segmented into IVD consumables and IVD equipments.
The IVD consumables had a considerable segment share. The increased usage of consumables to identify different chronic illnesses, the increased amount of testing for infectious diseases such as COVID-19 and influenza, and the rise in demand for molecular and immunoassay reagents throughout the world all contribute to the expansion of contract manufacturing of consumables.
IVD Contract Manufacturing Market by Services
Based on services, the global IVD contract manufacturing market is segmented into manufacturing services, assay manufacturing services, and others.
The manufacturing services segment will likely show significant growth during the forecast period. Manufacturing services offer ISO-certified manufacturing facilities and can handle comprehensive project and production management, quality and regulatory assistance, and scale and process flexibility, resulting in rising demand for manufacturing services.
IVD Contract Manufacturing Market by Technology
Based on technology, the global IVD contract manufacturing market is segmented into immunoassay, clinical diagnostics, molecular diagnostics, microbiology, and hematology.
During the projection period, the Immunoassay segment is expected to increase at the fastest CAGR. This market's significant growth may be attributed to the popularity of advanced diagnostic immunoassay formats and the increased demand for this approach for immune diagnostics tests due to its high-level accuracy standards, inherent specificity, high throughput, and high sensitivity. Additionally, immunoassay-based diagnostics are becoming increasingly used across the world. Public awareness initiatives aiming at detecting the signs of infectious illnesses and measures to prevent them play a critical role in disease control. As a result of greater patient awareness, immunoassays are in high demand. The application of antibodies in immunoassays is based on immunological responses to a specific microorganism's antigen. On the other hand, nucleic acid probes are based on unique genetic composition in molecular diagnostics. As a result, molecular diagnostic tests will likely expand throughout the forecast period.
IVD Contract Manufacturing Market by Region
Based on region, the global IVD contract manufacturing market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The IVD contract manufacturing market is rapidly expanding, with Asia Pacific being the fastest-growing region. The increased need for diagnostic tests, technical improvements, and an increasing number of mergers and acquisitions (M&As) in the IVD sector are driving the expansion of the IVD contract manufacturing market. The Asia Pacific IVD contract manufacturing market is predicted to develop at the fastest revenue CAGR during the projected period. This market's expansion may be ascribed to increased demand for diagnostic tests, rising illness prevalence, and an increased number of M&As in the IVD business. This region's countries are experiencing substantial growth in the elderly population, boosting the demand for diagnostic services. Furthermore, one factor that is boosting the market in the area is the increasing use of modern laboratory methods and processes for speedier investigation and diagnosis of infectious and chronic conditions. Furthermore, the launch of molecular kits and increased demand for diagnostic reagents are important drivers driving the market.
The rising incidence of patients suffering from chronic disorders, high levels of unhealthy eating and drinking habits among people living in the United States, the rising incidence of cancer cases, and the rising technological advancement associated with medical devices are some of the factors driving the growth of the North America IVD contract manufacturing market. The United States is a significant market in the North American area. An increase in cancer patients is one of the primary causes driving the rising demand for medical devices that aid in the detection and treatment of cancer, increasing the overall growth of the IVD contract manufacturing market.
IVD Contract Manufacturing Market Competitive Landscape
Some of the prominent market players in the global IVD contract manufacturing market include,
IVD Contract Manufacturing Market Strategic Development
IVD contract manufacturers develop solutions that meet the world's clinical testing needs. Outsourcing expedites the achievement of sales targets and the incorporation of new technologies into everyday manufacturing.
Asia Pacific is the key growth region in the global IVD contract manufacturing market.
The estimated market size of the IVD contract manufacturing Market in 2031 will be US$ 23.85 billion.
The revenue CAGR of the IVD contract manufacturing market during the forecast period will be 7.6%.
Some prominent IVD contract manufacturing market players include Savyon Diagnostics KMC Systems, Inc., Cenogenics Corporation Nova Biomedical, and Cone Bioproducts.
*Insights on financial performance are subject to the availability of information in the public domain