Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Therapeutic Area (Cardiology, General & Plastic Surgery), And Segment Forecasts, 2019 - 2026

Industry Insights

The global medical device outsourcing market size was valued at USD 94.2 billion in 2018. It is expected to witness a CAGR of 10.5% over the forecast period. Increasing demand for medical devices combined with rising price competition and requirement to reduce cost is expected to drive the growth during the forecast period.

In addition, rising difficulties in product engineering along with the number of new entrants is anticipated to shape the future of the market. High prevalence of chronic disorders is boosting the demand for healthcare equipment. This, in turn, is working in favor of the market. Implantable Medical Devices (IMDs) are being used increasingly to improve medical outcome of patients. IMD designers have to balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation from non-core activities and therefore are outsourcing these activities to launch efficient devices.

Amendments in the ISO standards are expected to boost the demand for quality assurance and regulatory affairs service providers in U.S. and Europe as Small and Medium-sized Enterprises (SME) would require third-party assistance to comply with new ISO standards. Subcontractors and Original Equipment Manufacturers (OEM) in developed countries like U.S, Canada, Japan, and European Union (EU) countries are expected to adopt these new standards earlier than those in the developing countries.

Apart from this, recent regulatory changes in Europe pertaining to a medical device is also anticipated to boost the demand for regulatory affairs, and quality assurance services, thus contributing to the regional market growth. For instance, the application of In Vitro Diagnostic Regulation (IVDR) and Medical Devices Regulation (MDR) is projected to increase the demand for Quality Management System (QMS) service providers, thereby supplementing the growth.

Service Insights

On the basis of service, the medical device outsourcing market is categorized into contract manufacturing, product design and development, product maintenance, quality assurance, product upgrade, product implementation, product testing, and regulatory consulting. Contract manufacturing held the leading market share of over 55.0% in 2018 and is expected to remain dominant until 2026. Increasing focus on controlling the production cost of production is augmenting the segment growth. Alternatively, quality assurance service segment is projected to register the fastest CAGR of 12.9% throughout the forecast period.

Application Insights

On the basis of application, the market is segregated into diabetes care, cardiology, ophthalmic, diagnostic imaging, endoscopy, In-vitro Diagnostic (IVD), general and plastic surgery, orthopedic, drug delivery, dental, and others. Cardiology segment led the market in 2018 and is likely to remain dominant throughout the forecast period owing to the increasing prevalence of associated conditions.

IVD devices is estimated to be the most promising segment over the forecast period. As a large number of devices are approved by the U.S. Food and Drug Administration (FDA) and many of them are outsourced including kits for the disposable items, packaging development, and filling and capping equipment.

Regional Insights

Asia Pacific led with approximately 41.0% of the overall market share in 2018. This can be attributed to the lower cost and increased availability of skilled human resources. In addition, local presence of market players and competitive pricing are other supporting factors anticipated to drive the regional market. Also, increasing demand for medical devices owing to growing prevalence of chronic diseases is fueling the regional market growth.

North America represented a sizeable market share in 2018, attributed to well establish manufacturing hubs for high-end, consistent, and complex medical devices. Also, existence of technologically advanced electronic sector is helping North America edge over other regions.

Medical Device Outsourcing Market Share Insights

Some of the players operating in the market are Eurofins Scientific; Integer; Plexus; Pace Analytical Services; Tecomet; Intertek Group; Jabil; MAPI; Flextronics; PPD; Celestica; Freyr Solutions; Sanmina; Wuxi Apptec; Toxikon Inc.; and SGS SA.

Many new companies are anticipated to venture into this space due to the increasing demand for medical devices around the globe. This is projected to boost the competition level in in the global arena.

Additionally, collaborations among existing players and niche service offerings to boost quality is likely fuel growth over the forecast period. Established players in the market are expected to broaden their portfolio and provide one-stop solutions to withstand aggressive competition. For instance,in March 2016, WuXi AppTeclaunched a life science innovation hub in South Korea. This expansion is anticipated to enhance geographical footprints and strengthen R&D capabilities.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2015 to 2026.For the purpose of this study, Grand View Research, Inc. has segmented the global medical device outsourcing market report on the basis of service, application, and region:

• Service Outlook (Revenue, USD Billion, 2015 - 2026)

  • Quality Assurance

  • Regulatory Affairs Services

    • Clinical trials applications and product registrations

    • Regulatory writing and publishing

    • Legal representation

    • Other

  • Product Design and Development Services

    • Designing & engineering

    • Machining

    • Molding

    • Packaging

  • Product Testing & Sterilization Services

  • Product Implementation Services

  • Product Upgrade Services

  • Product Maintenance Services

  • Contract Manufacturing

    • Accessories manufacturing

    • Assembly manufacturing

    • Component manufacturing

    • Device manufacturing

• Application Outlook (Revenue, USD Billion, 2015 - 2026)

  • Cardiology

    • Class I

    • Class II

    • Class III

  • Diagnostic imaging

    • Class I

    • Class II

    • Class III

  • Orthopedic

    • Class I

    • Class II

    • Class III

  • IVD

    • Class I

    • Class II

    • Class III

  • Ophthalmic

    • Class I

    • Class II

    • Class III

  • General and plastic surgery

    • Class I

    • Class II

    • Class III

  • Drug delivery

    • Class I

    • Class II

    • Class III

  • Dental

    • Class I

    • Class II

    • Class III

  • Endoscopy

    • Class I

    • Class II

    • Class III

  • Diabetes care

    • Class I

    • Class II

    • Class III

  • Others

    • Class I

    • Class II

    • Class III

• Regional Outlook (Revenue, USD Billion, 2015 - 2026)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Italy

    • Spain

    • Switzerland

    • France

    • Sweden

    • Netherlands

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Singapore

    • Malaysia

    • Thailand

    • Taiwan

    • Korea

    • Indonesia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • Israel

    • UAE