North America Medical Device Outsourcing Market – Industry Trends and Forecast to 2031

Análise e tamanho do mercado de outsourcing de dispositivos médicos da América do Norte

O mercado de outsourcing de dispositivos médicos está a sofrer um avanço significativo, impulsionado pela integração dos mais recentes métodos e tecnologias. Esta tendência estimula o aumento da eficiência e da inovação nos processos de fabrico, melhorando a qualidade e a funcionalidade dos dispositivos médicos. Tais avanços não só melhoram os cuidados prestados aos doentes, como também promovem oportunidades de crescimento no setor do outsourcing, refletindo um cenário dinâmico preparado para uma maior expansão e desenvolvimento.                               

O tamanho do mercado de outsourcing de dispositivos médicos da América do Norte foi avaliado em 62,69 mil milhões de dólares em 2023, deverá atingir 164,32 mil milhões de dólares até 2031, com um CAGR de 12,8% durante o período de previsão de 2024 a 2031. Isto indica que o valor de mercado. Além dos insights sobre cenários de mercado, tais como valor de mercado, taxa de crescimento, segmentação, cobertura geográfica e grandes players, os relatórios de mercado com curadoria da Data Bridge Market Research incluem também análise especializada aprofundada, epidemiologia de pacientes, análise de pipeline, análise de preços, e quadro regulamentar.

Âmbito do relatório e segmentação de mercado

Definição de mercado

A externalização de dispositivos médicos refere-se à prática de delegar o design, fabrico, testes e distribuição de equipamentos médicos a fornecedores ou empreiteiros externos. Esta estratégia permite às empresas concentrarem-se nas competências essenciais, ao mesmo tempo que tiram partido de conhecimentos especializados, reduzem custos e aceleram o desenvolvimento de produtos. O outsourcing pode abranger várias fases do ciclo de vida do dispositivo, garantindo qualidade, conformidade e entrega atempada no setor da saúde.

Dinâmica do mercado de outsourcing de dispositivos médicos da América do Norte

Motoristas

• Acesso a expertise especializada

O outsourcing no setor dos dispositivos médicos catalisa o crescimento do mercado, oferecendo acesso a conhecimentos especializados e tecnologias inatingíveis internamente. Por exemplo, uma empresa focada em dispositivos de monitorização cardíaca pode não ter experiência no fabrico de sistemas microeletromecânicos (MEMS). Ao externalizar este processo especializado para uma empresa com experiência em tecnologia MEMS, a empresa pode melhorar as capacidades e a competitividade do produto, impulsionando a expansão do mercado.

• Foco nas competências essenciais

A externalização de funções não essenciais, como o fabrico, a montagem e a embalagem, permite que as empresas de dispositivos médicos se concentrem em competências essenciais, como a investigação, o desenvolvimento e a inovação. Este foco estratégico impulsiona o mercado, acelerando a inovação de produtos e aumentando a vantagem competitiva. Por exemplo, uma empresa especializada na inovação de dispositivos cardíacos pode alocar mais recursos à investigação e desenvolvimento, conduzindo a avanços em tecnologias que salvam vidas.

Oportunidades

• Conformidade Regulamentar e Garantia de Qualidade

A externalização na indústria de dispositivos médicos é impulsionada pela necessidade de conformidade regulamentar e garantia de qualidade. Os parceiros externos possuem sistemas de gestão da qualidade robustos e conhecimentos regulamentares, garantindo a adesão a normas rigorosas, como os regulamentos da FDA. Por exemplo, uma empresa de dispositivos médicos que colabora com um fabricante contratado beneficia do seu historial comprovado no cumprimento dos requisitos regulamentares, melhorando a competitividade do mercado e a confiança dos clientes.

• Aumento da flexibilidade e escalabilidade

Outsourcing in the medical devices sector offers unparalleled flexibility and scalability, enabling companies to swiftly adjust production levels according to market demand without hefty infrastructure investments. For instance, a medical device start up can seamlessly ramp up production during a sudden surge in demand for a new lifesaving device, without being burdened by the costs of expanding their own manufacturing facilities. 

Restraints/Challenges

• Intellectual Property Protection

Intellectual Property Protection presents a formidable obstacle in the medical devices outsourcing market. Entrusting third-party manufacturers with proprietary technologies heightens the risk of IP theft and compromise. This challenge stifles market growth, engendering mistrust and reluctance among companies to outsource critical manufacturing processes. 

• Dependency on Outsourcing Partners

Over-reliance on outsourcing partners for crucial manufacturing processes can jeopardize market stability. If vendors face financial issues, change ownership, or breach contracts, disruptions occur, impacting supply chains and product availability. Such dependencies heighten vulnerability, amplifying risks without clear solutions.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In May 2023, Emergo partnered with the Shanghai Center for Medical Testing and Inspection (CMTC) to conduct ongoing usability tests for medical devices in China. This collaboration aimed to ensure adherence to Human Factors Engineering (HFE) guidelines set by China’s National Medical Products Administration (NMPA), enhancing the usability and safety of medical devices in the region
• In September 2022, North American Science Associates, LLC (NAMSA), and InspireMD, Inc. formed a strategic outsourcing partnership aimed at expediting the development and commercialization of medical devices. This collaboration leveraged NAMSA's expertise in regulatory compliance and InspireMD's innovative technology to accelerate the market entry of new medical solutions
• In July 2021, BREATHE and IQVIA initiated a collaborative effort to expedite the early detection and treatment of respiratory ailments in the U.K. This strategic partnership aimed to enhance health outcomes and improve the quality of life for individuals grappling with respiratory conditions by leveraging advanced diagnostic tools and healthcare insights provided by IQVIA

North America Medical Device Outsourcing Market Scope

The market is segmented on the basis of services, product, device type, application, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Services

• Quality Assurance
• Regulatory Affairs Services
• Product Design and Development Services
• Product Testing and Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Raw Material Services
• Medical Electrical Equipment Services
• Contract Manufacturing
• Materials and Chemical Characterization

 Product

• Finished Goods
• Electronics
• Raw Materials

Device Type

• Class I
• Class II
• Class III

 Application

• Cardiology
• Diagnostic Imaging
• Orthopaedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

 End User

• Small Medical Device Company
• Medium Medical Device Company
• Large Medical Device Company
• Others

North America Medical Device Outsourcing Market Regional Analysis/Insights

The market is analysed and market size insights and trends are provided by country, services, product, device type, application, and end user as referenced above.

The countries covered in the market report are U.S., Canada and Mexico.

U.S. is expected to dominate the medical device outsourcing in North America, sustained by FDA-approved services, escalating demand for chronic wound treatments, growing medical device outsourcing trends, and a growing elderly demographic. These factors position the nation as a hub for innovative, reliable, and compliant medical outsourcing solutions.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and North America Medical Device Outsourcing Market Share Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• Pace Analytical Services, LLC (U.S.)
• North American Science Associates, LLC (U.S.)
•  Sterigenics U.S., LLC (U.S.)
• Charles River Laboratories (U.S.)
•  Celestica Inc. (Canada)
• Integer Holdings Corporation (U.S.)
• Nortech Systems, Inc. (U.S.)
• Plexus Corp. (U.S.)
• Sanmina Corporation (U.S.)
• Parexel International (MA) Corporation (U.S.)
• Labcorp Drug Development (U.S.)
• Tecomet, Inc. (U.S.)
•  IQVIA (U.S.)
•  Jabil Inc. (U.S.)
• Syneos Health (U.S.)
•  PROVIDIEN LLC (U.S.)
• East West Manufacturing (U.S.)

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