San Francisco, 28 February 2030: The Report U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Application (Cardiology, Diagnostic Imaging, IVD), By Class, And Segment Forecasts, 2023 - 2030

The U.S. medical device outsourcing market size is expected to reach USD 58.5 billion by 2030, expanding at a CAGR of 11.5% during the forecast period, according to a new report by Grand View Research, Inc. This market is growing as a result of increased offshore trends, a rise in demand for high-tech medical devices, and stringent regulation for medical devices in the U.S.

The medical device industry has always been highly competitive, and categories such as coronary stents, orthopedic devices, and wound care are moving toward maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, smaller companies are gaining market share by offering low prices and introducing innovative business models. Due to the convergence of mounting challenges and changing market dynamics, medical device manufacturers are likely to opt for outsourcing business models to reduce costs, manage business risks, and improve service delivery. This factor is expected to propel market growth over the forecast period.

The government authorities have escalated funds for the research and development of essential devices, thus driving the market. The majority of clinical research globally devices are conducted in the U.S. alone according to Clinical Trials .gov. In case of the medical device also significant studies are conducted in the U.S.

For instance, as of February 2023, over 25033, research for medical devices was registered in the Clinical Trials .gov. Medical device companies are conducting research in the country owing to the availability of skilled labor and advanced infrastructure, as well as the presence of a significant number of CROs offering quality services. All these factors are expected to support the market in the post-Pandemic period.

The high demand for technologically advanced medical devices in the country, the increasing focus among medical device companies to focus on their core competencies and outsourcing non-core activities, and the growing demand to reduce costs associated with the research and manufacturing of medical devices are some of the major factors promoting the growth of the U.S. medical device outsourcing industry.

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The COVID-19 pandemic in 2020 delayed medical procedures, thereby creating a challenging environment for manufacturers. Many companies had temporarily ceased their research and development activities due to complete lockdowns. This led to a severe disruption in the supply chain, which caused shortages and a slowdown in production.

U.S. Medical Device Outsourcing Market Report Highlights

• The quality assurance services are projected to exhibit the fastest CAGR of 13.7% over the forecast period. This is due to the necessity of maintaining an effective quality management system, which has become an integral part of the production of every medical device
• Cardiology segment has held the largest share of 21.8% in 2022, based on application owing to the growing demand for cardiac devices due to the rising disease burden in the country
• Based on class, the Class II segment is expected to grow at the fastest CAGR of 11.8% over the forecast period, owing to the high complexity in developing these devices that are promoting the demand for an expert team to conduct development and manufacturing of these devices

However, in the post-pandemic period, the situation has changed. The pipeline of medical devices has witnessed a steady rise from the third quarter of 2022. The medical devices pipeline in the U.S. accounted for 39.0% of the global medical device outsourcing market. A significant number of medical devices in the pipeline are expected to support the industry growth in the post-pandemic period.

Associated benefits, such as reduction in production cost and focus on core competencies by the medical device companies, are expected to propel the market growth over the forecast period. The medical device industry is currently facing challenging headwinds. Sharp cutbacks in public spending in the U.S. are a major issue faced by medical device manufacturers.

Increasing prices, profitability pressure, and growing competition coupled with a high degree of industry maturity have a great impact on this market. Amendments in the ISO standards are expected to boost the demand for quality assurance and regulatory affairs service providers in the U.S. as Small & Medium-sized Enterprises (SMEs) would require third-party assistance to comply with new ISO standards.