Medical Device Analytical Testing Outsourcing Market
Number of pages: 100 | Report Format: PDF | Published date: May 31, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023 to 2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 5.23 billion |
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Revenue Forecast in 2031 |
US$ 10.15 billion |
|
CAGR |
7.64% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023 to 2031 |
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Historical Year |
2021 |
|
Segments Covered |
Service, Application, End User, and Region |
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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 medical device analytical testing outsourcing market was valued at US$ 5.23 billion in 2022 and is expected to register a revenue CAGR of 7.64% to reach US$ 10.15 billion by 2031.
Medical Device Analytical Testing Outsourcing Market Fundamentals
Medical device analytical testing outsourcing refers to the practice of contracting external laboratories or testing facilities to perform various analytical tests on medical devices. It involves engaging third-party service providers to conduct a range of testing activities to evaluate the safety, quality, performance, and compliance of medical devices with regulatory requirements. Medical device analytical testing outsourcing can encompass various types of tests, including physical, chemical, biological, and performance testing. These tests assess factors such as material composition, sterility, biocompatibility, functionality, durability, electrical safety, and packaging integrity of medical devices.
Medical Device Analytical Testing Outsourcing Market Dynamics
Increasing prevalence of chronic diseases among the people across the globe is one of the major drivers in the global medical devices analytical testing outsourcing market. For instance, according to ‘Diabetes Research Institute’ article, in 2019, approximately 283,000 children and adolescents younger than age group of 20 years were diagnosed diabetes. This includes 244,000 with type 1 diabetes. Additionally, medical devices are becoming increasingly complex, incorporating advanced technologies, materials, and interconnected systems. Analyzing the safety, functionality, and performance of these complex devices requires specialized expertise and sophisticated testing methodologies. Moreover, cost optimization is a significant driver for medical device manufacturers. Outsourcing analytical testing services allows them to avoid capital investments in expensive testing equipment, maintenance costs, and overhead expenses associated with maintaining in-house testing facilities. The medical device industry is experiencing globalization, with manufacturers expanding their presence in international markets. For instance, in August 2022, Pace Life Sciences LLC acquired Meridian BioGroup (Meridian). This strategic acquisition was done to develop and maintain biopharmaceutical operations and quality management systems that meet regulatory requirements. Each country or region may have unique regulatory requirements and standards for medical device testing. Outsourcing testing to local laboratories with expertise in regional regulations can help manufacturers navigate global market entry and compliance challenges effectively. Rapid advancements in analytical testing technologies, such as high-performance liquid chromatography (HPLC), mass spectrometry, and genetic testing, are driving the need for specialized expertise and equipment. Ensuring the quality and safety of medical devices is a top priority for manufacturers. Outsourcing analytical testing to accredited laboratories that follow stringent quality control and assurance protocols can help manufacturers maintain high standards of quality.
Medical device manufacturers may have concerns about protecting their proprietary information and intellectual property when outsourcing analytical testing. Ensuring robust confidentiality agreements and intellectual property protection measures between the manufacturer and the testing service provider is crucial to mitigate this risk. Medical device testing involves sensitive data, including patient information and confidential test results. Ensuring data security and privacy during the outsourcing process is essential. Manufacturers should carefully evaluate the information security measures and data protection protocols implemented by the outsourcing service provider to mitigate the risk of data breaches or unauthorized access. Manufacturers should establish robust quality control processes, including clear specifications, standard operating procedures (SOPs), and quality assurance protocols, to maintain consistency in testing outcomes across various outsourcing engagements. Diversifying outsourcing partners or having contingency plans in place can help mitigate this risk. While outsourcing analytical testing can offer cost advantages, it is essential to carefully evaluate the overall cost-benefit analysis. Factors such as pricing structures, hidden costs, long-term contracts, and potential additional expenses for retesting or troubleshooting should be considered. Manufacturers should conduct thorough cost analyses and consider the potential impact on their budget and profitability.
Medical Device Analytical Testing Outsourcing Market Ecosystem
The global medical device analytical testing outsourcing market has been analyzed from the following perspectives: by service, application, end user, and region.
Medical Device Analytical Testing Outsourcing Market by Service
Based on the service, the global medical device analytical testing outsourcing market is segmented into extractable and leachable, bioburden testing, physical testing, material characterization, sterility testing, and other.
Material characterization accounts for a significant revenue share of more than 19.40%. Material characterization provides essential data on the physical and chemical properties of medical device materials. This information is crucial for assessing the safety, efficacy, and performance of medical devices. Material characterization tests help identify potential risks associated with material degradation, leachable, extractables, and interactions with biological systems. Material characterization plays a significant role in product development and quality assurance processes. Understanding the properties and behavior of materials helps manufacturers select appropriate materials, design and optimize product formulations, and ensure consistent quality during production. It aids in identifying potential issues early in the development process, leading to improved product performance and reduced risks. Biocompatibility testing is a critical component of material characterization for medical devices. It involves evaluating the interactions between device materials and living tissues or biological systems. This assessment is essential to ensure that medical devices do not cause adverse reactions, tissue damage, or systemic toxicity when used in clinical settings. By understanding material properties, compatibility, and performance characteristics, manufacturers can make informed decisions about material selection, ensuring the chosen materials meet the required specifications and regulatory standards. Material characterization encompasses tests that evaluate the mechanical, thermal, electrical, and chemical properties of medical device materials. These tests assess factors such as strength, flexibility, heat resistance, electrical conductivity, corrosion resistance, and stability. This information helps manufacturers understand how materials will perform under real-world conditions and ensure device reliability and durability.
Medical Device Analytical Testing Outsourcing Market by Application
Based on the application, the global medical device analytical testing outsourcing market is segmented into cardiology, diabetes care, orthopedic, IVD, ophthalmology, dental, drug delivery, endoscopy, and others.
The cardiology segment dominates the global market with a more than 22.06% of revenue share. Cardiovascular diseases, including heart disease and stroke, are leading causes of death globally. The high prevalence of these conditions creates a significant demand for medical devices used in cardiology, such as pacemakers, stents, and defibrillators. For instance, according to ‘American Heart Association,’ it was noted that in 2020, nearly 19.1 million deaths were caused due to cardiovascular diseases globally. While in 2019 there was approximately 874,613 deaths in the United States due to cardiovascular diseases. As a result, there is a greater need for analytical testing of these cardiology devices to ensure their safety, efficacy, and compliance with regulatory standards. The field of cardiology has seen rapid advancements in medical device technology. Innovations such as minimally invasive procedures, implantable devices, and remote monitoring systems have improved patient outcomes and expanded the range of available cardiology devices. These advancements require rigorous analytical testing to evaluate their performance, durability, and safety, driving the demand for outsourcing analytical testing services. These regulations necessitate comprehensive testing to demonstrate the safety, efficacy, and quality of medical devices before they can be approved for commercial use. Outsourcing analytical testing to specialized service providers helps manufacturers meet these regulatory requirements efficiently. Outsourcing analytical testing allows medical device manufacturers to leverage the expertise and resources of specialized testing laboratories without incurring substantial costs associated with setting up an in-house testing facility. Cardiology devices often require complex and specialized testing procedures, which can be efficiently handled by dedicated testing service providers. This enables manufacturers to focus on their core competencies while ensuring the quality and compliance of their cardiology devices.
Medical Device Analytical Testing Outsourcing Market by End User
Based on the end user, the global medical device analytical testing outsourcing market is segmented into hospitals, homecare settings, diagnostic centers, and others.
The hospital segment registered for the largest in the global market with more than 86.05% of revenue share. Hospitals, as end-users of medical devices, have a responsibility to comply with these regulations. Hospitals may lack the specialized equipment, infrastructure, and skilled personnel necessary to conduct in-house analytical testing for medical devices. Maintaining an in-house testing facility with advanced equipment, skilled personnel, and compliance with regulatory standards can be expensive. By outsourcing, hospitals can avoid the upfront investment and ongoing operational costs associated with establishing and maintaining an in-house testing capability. Testing laboratories often have access to state-of-the-art equipment, advanced analytical techniques, and specialized knowledge in medical device testing. By partnering with these laboratories, hospitals can benefit from the latest technologies and methodologies without having to invest in them themselves.
Medical Device Analytical Testing Outsourcing Market by Region
Based on the region, the global medical device analytical testing outsourcing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America accounts for a notable revenue share in the global market. North America has a well-established regulatory framework for medical devices. North America boasts a robust healthcare infrastructure with advanced hospitals, research institutions, and specialized testing laboratories. The presence of a well-developed healthcare system enables the region to support a thriving market for medical device analytical testing outsourcing. North America is known for its advancements in medical technology and innovation. The region is home to many leading medical device manufacturers and research institutions, which drive the need for analytical testing to ensure the quality and safety of their products. This creates a favorable environment for outsourcing analytical testing services. North America has a well-trained and highly skilled workforce in the field of medical device testing and analysis. This talent pool comprises scientists, engineers, and technicians who have expertise in conducting analytical testing and interpreting the results accurately. The availability of skilled professionals further supports the growth of the outsourcing market in the region. North America has a significant market demand for medical devices due to its large population and high healthcare expenditure. The size of the medical device industry in the region, along with the stringent regulatory requirements, contributes to the demand for analytical testing services. This, in turn, drives the growth of the outsourcing market.
Competitive Landscape
The prominent players operating in the global medical device analytical testing outsourcing market are:
Strategic Developments
Medical device analytical testing outsourcing refers to the practice of contracting external laboratories or testing facilities to perform various analytical tests on medical devices.
SGS SA, Toxikon Inc., Eurofins Scientific, and Charles River Laboratories International Inc. are some of the major market players in the global medical device analytical testing outsourcing market.
Issues related to data security and privacy and problems related to quality control and consistency are some of the restraints obstructing the growth of the global market.
Cardiology segment dominated the global medical device analytical testing outsourcing market in 2022
Growing technological advancement and rising complexity of medical devices are some of the major factors driving the global market.
*Insights on financial performance are subject to the availability of information in the public domain