In-vitro diagnostics (IVD) are tests done on samples such as blood or tissue to detect diseases or other conditions. It is used to monitor a person’s overall health to help cure, treat, or prevent diseases. Cost savings, scalability, technology know-how, and risk mitigation offered by IVD contract manufacturers drive OEM's decision to outsource to IVD CDMOs.
Growing Preference for Point-of-Care (POC) Testing Services Fuels the growth of IVD Contract Manufacturing Services Market
In an endeavor to cut result time and help patients make better-informed decisions about their health, there is considerable demand for IVD testing to move closer to the patient i.e. point-of-care (POC) diagnostics whether in the hospital, clinic, physician's office, or home.
Manufacturing of specific PoC devices presents manufacturers (OEMs) with a variety of design and manufacturing challenges. For instance, the ability to process high-precision components that involve reagents and fluids are the most relevant capabilities sought by OEMs, which are accomplished by specialized IVD CDMOs.
IVD Diagnostic Kits Demand Triggered by Covid-19 Bolsters the IVD Contract Manufacturing Services Market
Ever since the outbreak of Covid-19, the demand for IVDs has exploded, which in turn has fueled the demand for IVD Contract Manufacturing Services. There are several types of SARS-CoV-2 and COVID-19 related IVDs. For instance:
- Diagnostic Tests: This includes molecular tests and antigen tests. These tests can detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus
- Serology/Antibody and Other Adaptive Immune Response Tests: These tests can detect antibodies to the SARS-CoV-2 virus or measure a different adaptive immune to the SARS-CoV-2 virus
- Tests for Management of COVID-19 Patients: These tests are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions
Government Support to Scale Up Production of IVD Kits in the Wake of Covid-19 Spurs the IVD Contract Manufacturing Services Market
Government interventions to scale up the production of IVD kits during the pandemic further propelled the demand for IVD contract manufacturing services. Regulators enacted several new measures to expedite access to IVD kits. Regulators issued guidance to assist and clarify new or relaxed requirements under the emergency provisions for IVDs to help accelerate their development. Expedited approval processes for IVDs played a pivotal role in combating the Covid-19 pandemic.
IVD manufacturers including contract manufacturers also worked relentlessly to address the crisis with a rapid ramp-up of IVD testing kits for Covid-19. IVD testing is considered the most critical to containing Covid-19.
Cost Savings, Scalability, Technology Know-how and Risk Mitigation Offered By IVD Contract Manufacturers Drives Their Demand
By partnering with IVD contract manufacturers, OEMs can save costs on labor, automation and can achieve economies of scale at a relatively lower cost. OEMs prefer IVD CDMOs for their scalability, reliability, and cost-effective manufacturing capabilities. OEMs look for IVD CDMOs who have sound technical capabilities that are not part of their core competency. Mitigation of regulatory risks & supply disruption risks is other pivotal factors that urge OEMs to partner with IVD CDMOs.
Growing Incidence of Cancer and Infectious Diseases & Role of IVDs Drives the IVD Contract Manufacturing Services Market
IVD plays a critical role in driving clinical decision-making for cancer screening, diagnosis, and treatment. IVD testing provides insights related to a patient’s health status such as risk or predisposition for developing certain cancer; the stage of disease, and the prognosis for progression/remission after therapy.
IVDs are also used to analyze human samples such as blood and saliva. It helps in measuring the concentration of specific substances/analytes, detects the presence or absence of a particular marker or set of markers in response to infection. Clinicians frequently use IVDs to diagnose infectious diseases, guide treatment decisions and even mitigate or prevent future diseases.
Continuously rising cases of cancer and infectious diseases are likely to spur the IVD contract manufacturing services market.
“Rising demand for point-of-care IVD devices is a key driver for growth. Recently launched point-of-care IVD instruments and devices are convenient to use and efficient. Manufacturing of specific PoC devices presents manufacturers (OEMs) with a variety of design and manufacturing challenges, which is addressed by IVD CDMOs.” - Director, Leading IVD OEM, United States
Competitive Landscape Analysis: IVD Contract Manufacturing Services Market
The IVD Contract Manufacturing Services market is marked by the presence of key players such as Jabil, STRATEC, Celestica, Sanmina Gerresheimer, Phillips-Medisize, Plexus, Röchling, KMC Systems, Cenogenics Corporation, Savyon Diagnostics, Nova Biomedical, Cone Bioproducts, Invetech, Inc., Thermo Fisher Scientific Inc., Avioq, Inc., LRE Medical, Coris BioConcept, Meridian Bioscience, Inc., Maxim Biomedical, Inc., among others.
Key Strategic Questions Addressed
- What is the market size & forecast of the IVD Contract Manufacturing Services Market?
- What are historical, present, and forecasted market shares and growth rates of various segments and sub-segments of the IVD Contract Manufacturing Services Market?
- What are the key trends defining the IVD Contract Manufacturing Services market?
- What are the major factors impacting the market?
- What are the opportunities prevailing in the IVD Contract Manufacturing Services market?
- Which region has the highest share in the global market? Which region is expected to witness the highest growth rate in the next 5 years?
- Who are the major players operating in the market?
- What are the key strategies adopted by players?
The study has been compiled based on the extensive primary and secondary research.
Secondary Research (Indicative List)
To validate research findings (market size & forecasts, market segmentation, market dynamics, competitive landscape, key industry trends, etc.), extensive primary interviews were conducted with both supply and demand side stakeholders.
Supply Side Stakeholders:
- Senior Management Level: CEOs, Presidents, Vice-Presidents, Directors, Chief Technology Officers, Chief Commercial Officers
- Mid-Management Level: Product Managers, Sales Managers, Brand Managers, R&D Managers, Business Development Managers, Consultants
Demand Side Stakeholders:
- Stakeholders in Medical Device OEMs.
Breakdown of Primary Interviews
Market Size Estimation
Both ‘Top-Down and Bottom-Up Approaches’ were used to derive market size estimates and forecasts.
Research findings derived through secondary sources & internal analysis was validated with Primary Interviews, Internal Knowledge Repository and Company’s Sales Data.