North America and Europe Preclinical Medical Device Testing Services Market Size, Share, Segmentation Analysis, 2030

According to Nova one advisor,  the North America And Europe Preclinical Medical Device Testing Services market size was estimated at USD 1.40 billion in 2021 and is expected to surpass around USD 2.99 billion by 2030 and poised to grow at a compound annual growth rate (CAGR) of 8.9% during the forecast period 2022 to 2030.

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COVID-19 has created a huge demand for medical devices and this trend is going to be followed in the coming years. The main driver of this market is the growing stringent regulations for medical devices that are expected to help in the formation of precise and innovative devices.

There has been an increase in the number of players operating in the market over the last decade. Due to this large number, it has witnessed fierce competition. To sustain the market, a mix of defensive and offensive marketing strategies is used. For instance, extensive R&D, competitive pricing, new product launches, collaborative development, regional expansion, and mergers and acquisitions.

COVID-19 has created a huge demand for these services. During the first half, the growth was not drastic, but it increased in the second half as the industry learned to operate amid the pandemic. Various projects that were postponed due to COVID have resumed and there has been a spike in production and testing of Personal Protective Equipment (PPE). There are many other medical devices in high demand during the pandemic, which shifted the focus from the devices required during surgery. The major products experiencing a surge in demand are the COVID-19 vaccines, ventilators, and pulse oximeters.

Moreover, in such an intensely competitive environment, companies must reduce the time to market from the developmental phase. Considering that the approval processes for medical devices are not simple, companies need to have a sound knowledge of updated regulatory norms and protocols. As a result, medical device companies prefer to outsource it to a specialized firm.

During the COVID-19 pandemic, the preclinical medical device testing services industry is anticipated to expand profitably. The new players who have entered this market during the past ten years are its key drivers. The market for preclinical medical device testing services has benefited from the ongoing COVID-19 pandemic. Growth started more slowly in the first quarter, but it quickened in the second as companies adapted to the pandemic.

Due to the decline in demand for surgical medical devices brought on by the COVID-19 pandemic, personal protective equipment (PPE) is the main piece of equipment being tested. As medical device manufacturers scramble to prepare for the new EU-MDR, which was expected to go into effect as of May 2021, advisory services with testing companies are booked. A rise in demand is also being seen for ventilators and COVID-19 medical diagnostic kits.

The European Commission has adopted revised harmonized standards to expedite the production of gloves, medical face masks, sterilization devices & disinfectants, and containers for intravenous injections, as well as to alter the specific requirements for emergency & transport ventilators. In collaboration with the European Committee for Electro Technical Standardization (CENELEC) and the European Committee for Standardization (CEN), the European Commission has agreed to make several harmonized standards freely available.

Most medical devices are classified by the FDA as Class II or Class III. These classes require higher control and monitoring. Class II devices need pre-market notification, whereas Class III devices need pre-market approval (PMA) from the regulatory bodies. Apart from this special compliance, the basic ones include labeling requirements, manufacturing plant-established registration, medical device listing, quality systems regulation, and Medical Device Reporting (MDR). The FDA’s Center for Devices and Radiological Health (CDRH) mandates the framework and standards regarding the manufacturing, labeling, packaging, and storage of imported devices sold in the U.S.

Report Scope of the North America And Europe Preclinical Medical Device Testing Services Market

Key Takeaways:

• By Services, the U.S. Preclinical Medical Device Testing Services market was valued at USD 775.2 million in 2021 and expected to witness growth at a CAGR of 9.4% from 2022 to 2030.
• Microbiology & Sterility Testing segment dominated the market with a revenue share of 34.3% in 2021. It is one of the major tests included in pre-clinical medical device testing. These examinations aid in identifying any microorganisms that could be present in the apparatus
• Based on test type, sterility test and validation led the market with a revenue share of 45.7% in 2021
• North America led the global market in 2021 and is projected to witness the fastest CAGR of 8.8% during the forecast years
• In Europe, the market held a considerable revenue share of 36.6% in 2021. This is due to the rising demand for cost-cutting and increasing complexity in product designing, which is supporting the growth of the region

Market Dynamics

Market Driver Analysis

• Complexity in Product design
• Intensifying Competition
• Increase in number of small medical device lacking in-house testing capabilities
• Strict Approval Norms

Market Restraint Analysis

• Legal and Regulatory Issues
• Delays in contractual obligation

Industry Challenges

Market Analysis Tools

• Industry Analysis - Porter's
• PESTEL Analysis

COVID-19 pandemic impact on clinical trial activity

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Some of the prominent players in the North America And Europe Preclinical Medical Device Testing Services market include:

Regional Insights

North America led the market for preclinical medical device testing services, with the largest revenue share of 63.4% in 2021. This is largely due to the presence of a large number of players in this region. It is also the top manufacturing hub for complex, highly reliable, and high-end medical devices. There is a rapid increase in the manufacturing of medical devices to meet the rising demand for efficient and cost-effective healthcare in this region. Besides this, the presence of the FDA is fueling the growth of the market for medical device testing services.

In Europe, the preclinical medical device testing service is expected to witness a CAGR of 8.5% during the forecast period. This is due to the rising demand for cost-cutting and increasing complexity in product design, which has a high impact on the rendering drivers for the medical device analytical testing outsourcing market in European nations. A steady increase in the outsourcing of services for contract manufacturers and component suppliers has been observed in the last two decades. However, notified bodies such as the European Medical Device Regulation (EMDR) are also involved in the scrutiny of outsourced medical devices.

Some of the prominent players in the North America And Europe Preclinical Medical Device Testing Services market include:

• SGS SA
• Toxikon, Inc.
• Eurofins Scientific
• Pace Analytical Services LLC
• Intertek Group Plc
• WUXI APPTEC
• TÜV SÜD AG
• Sterigenics International LLC
• Nelson Labs
• North American Science Associates, Inc.
• American Preclinical Services
• Charles River Laboratories International, Inc.

Segments Covered in the Report

This report forecasts revenue growth at regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2018-2030. For this study, Nova one advisor has segmented North America And Europe Preclinical Medical Device Testing Services market based on services and region:

• Service
  • Biocompatibility Tests
  • Chemistry Test
  • Microbiology & Sterility Testing
    • Bioburden Determination
    • Pyrogen & Endotoxin Testing
    • Sterility Test and Validation
      • Ethylene Oxide (EO) gas sterilization                             
      • Gamma-irradiation                        
      • E-beam sterilization                       
      • X-ray sterilization
    • Antimicrobial Activity Testing
    • Others
  • Package Validation
• Regional
  • North America
    • U.S.
    • Canada
  • Europe
    • France
    • Germany
    • U.K.
    • Italy
    • Spain
    • Netherlands
    • Belgium
    • Switzerland
    • Russia
    • Sweden

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Key Benefits for Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the North America And Europe Preclinical Medical Device Testing Services industry analysis from 2022 to 2030 to identify the prevailing North America And Europe Preclinical Medical Device Testing Services industry opportunity.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the North America And Europe Preclinical Medical Device Testing Services industry segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the U.S. market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
• The report includes the analysis of the regional as well as North America And Europe Preclinical Medical Device Testing Services industry trends, key players, market segments, application areas, and market growth strategies.

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