医療機器アウトソーシング市場レポート：サービス、治療薬、用途、地域別、2024年～2032年

世界の医療機器アウトソーシング市場規模は2023年に1,262億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに2,582億米ドルに達し、2024年から2032年の間に8.1%の成長率（CAGR）を示すと予測しています。医療費全体の削減ニーズの高まり、厳しい規制要件や品質基準の導入、ウェアラブル医療機器の採用拡大、個別化医療に対する需要の急増などが、市場成長を促す主な要因となっています。

医療機器のアウトソーシングとは、医療機器製品のライフサイクルのさまざまな側面を処理するために、外部の企業やサービスプロバイダーと契約または提携することを指します。これらの外部パートナーは通常、専門の受託製造業者、設計開発会社、規制コンサルタント、ロジスティクス・プロバイダー、または医療機器業界に精通したその他のサービス・プロバイダーです。このようなサービスは、コスト削減、専門知識へのアクセス、業務効率の向上、より効果的に市場の需要に適応する能力など、いくつかのメリットを企業に提供します。また、医療機器メーカーは、研究開発、マーケティング、戦略立案などのコアコンピタンスに集中する一方で、製品ライフサイクルのその他の重要な側面を処理するために外部パートナーの能力を活用することができます。

同市場は、医療疾患の増加や質の高いヘルスケアサービスに対するニーズの高まりにより、大きな成長を遂げています。加えて、アウトソーシングは医療機器メーカーに、市場の需要に応じて生産量を拡大できる柔軟性を提供します。この適応性は、製品需要の変動、特に季節変動のある機器や予期せぬ市場の変化に対応するために不可欠です。さらに、個別化医療に対する需要の急増、ウェアラブル医療機器の採用拡大、低侵襲外科手術の人気の高まり、在宅医療、遠隔医療、医療ツーリズムの傾向の高まりは、市場を推進しているその他の要因の一部です。また、国際的な事業を展開する受託製造業者は、多様な市場へのアクセスを提供し、輸出入規制を回避することができるため、新たな地域へのスムーズな進出が容易になり、市場の成長に影響を与えています。

医療機器アウトソーシング市場動向/促進要因：

医療費削減ニーズの高まり

医療機器のアウトソーシングは、ヘルスケアプロバイダーや医療機器企業にコスト削減をもたらします。専門メーカーやサービスプロバイダーと契約することで、社内でオペレーションを維持するよりもコスト効率が高まる。外部パートナーは確立された生産設備、スケールメリット、合理化されたプロセスを持っているため、より低コストで医療機器を生産することができます。さらに、製造や物流などの非中核業務をアウトソーシングすることで、医療機器メーカーは資源配分を最適化することができます。定型的な業務を外部のパートナーに任せることで、企業は社内のリソースを研究開発やイノベーションといったコアコンピタンスに集中させることができ、より費用対効果の高い競争力のある製品を生み出すことができます。

厳しい規制要件と品質基準の導入

厳しい規制の導入は、医療機器企業とそのアウトソーシング・パートナーの双方に、より高いコンプライアンス負担を強いることになります。委託製造業者は、OEMと同じ規制基準を遵守し、製造する医療機器が要求される安全性と品質の基準を満たすようにしなければならないです。そのためには、厳格な文書化、品質管理システム、適正製造規範（GMP）の遵守が必要となります。さらに、規制当局の監視が厳しくなるにつれ、医療機器のアウトソーシング・プロセスでは品質保証が最重要課題となっています。受託製造業者は現在、製造プロセスにおける潜在的な問題を特定し、軽減するための強固な品質管理対策とリスク管理戦略の実施を迫られています。

ウェアラブル医療機器の採用拡大

ウェアラブル医療機器には、高度なセンサー、ワイヤレス接続、高度なデータ分析機能が組み込まれていることが多いです。このような技術集約型機器の開発・製造には、専門的な知識とリソースが必要となるため、高度なエレクトロニクスやソフトウェア開発に精通したアウトソーシング・パートナーの需要が高まっています。さらに、医療機器はユーザーのコンプライアンスと長期的な装着性を確保するため、軽量で快適、人間工学的に設計されている必要があります。小型化技術や材料選択に関する専門知識を持つ製造委託先は、こうした設計要件を実現する上で重要な役割を果たしています。

目次

第1章 序文

第2章 調査範囲と調査手法

• 調査の目的
• ステークホルダー
• データソース
  • 一次情報
  • 二次情報
• 市場推定
  • ボトムアップアプローチ
  • トップダウンアプローチ
• 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

• 概要
• 主要業界動向

第5章 世界の医療機器アウトソーシング市場

• 市場概要
• 市場実績
• COVID-19の影響
• 市場予測

第6章 市場内訳：サービス別

• 規制コンサルティング
  • 市場動向
  • 市場予測
• 製品設計と開発
  • 市場動向
  • 市場予測
• 製品テストと滅菌
  • 市場動向
  • 市場予測
• 製品の実装
  • 市場動向
  • 市場予測
• 製品のアップグレード
  • 市場動向
  • 市場予測
• 製品メンテナンス
  • 市場動向
  • 市場予測

第7章 市場内訳：治療薬

• 心臓病学
  • 市場動向
  • 市場予測
• 診断画像
  • 市場動向
  • 市場予測
• 整形外科
  • 市場動向
  • 市場予測
• 体外診断
  • 市場動向
  • 市場予測
• 眼科
  • 市場動向
  • 市場予測
• 一般外科および形成外科
  • 市場動向
  • 市場予測
• ドラッグデリバリー
  • 市場動向
  • 市場予測
• 歯科
  • 市場動向
  • 市場予測
• 内視鏡検査
  • 市場動向
  • 市場予測
• 糖尿病ケア
  • 市場動向
  • 市場予測

第8章 市場内訳：用途別

• クラスI
  • 市場動向
  • 市場予測
• クラス II
  • 市場動向
  • 市場予測
• クラスIII
  • 市場動向
  • 市場予測

第9章 市場内訳：地域別

• 北米
  • 米国
  • カナダ
• アジア太平洋
  • 中国
  • 日本
  • インド
  • 韓国
  • オーストラリア
  • インドネシア
  • その他
• 欧州
  • ドイツ
  • フランス
  • 英国
  • イタリア
  • スペイン
  • ロシア
  • その他
• ラテンアメリカ
  • ブラジル
  • メキシコ
  • その他
• 中東・アフリカ
  • 市場動向
  • 市場内訳：国別
  • 市場予測

第10章 SWOT分析

• 概要
• 強み
• 弱み
• 機会
• 脅威

第11章 バリューチェーン分析

第12章 ポーターのファイブフォース分析

• 概要
• 買い手の交渉力
• 供給企業の交渉力
• 競合の程度
• 新規参入業者の脅威
• 代替品の脅威

第13章 価格分析

第14章 競合情勢

• 市場構造
• 主要企業
• 主要企業のプロファイル
  • Celestica Inc.（Onex Corporation）
  • Charles River Laboratories International Inc.
  • Flex Ltd.
  • Freyr Inc.
  • Heraeus Holding GmbH
  • ICON plc
  • Integer Holdings Corporation
  • IQVIA Inc.
  • Plexus Corp.
  • Sanmina Corporation
  • TE Connectivity
  • West Pharmaceutical Services Inc.

List of Figures

• Figure 1: Global: Medical Device Outsourcing Market: Major Drivers and Challenges
• Figure 2: Global: Medical Device Outsourcing Market: Sales Value (in Billion US$), 2018-2023
• Figure 3: Global: Medical Device Outsourcing Market Forecast: Sales Value (in Billion US$), 2024-2032
• Figure 4: Global: Medical Device Outsourcing Market: Breakup by Service (in %), 2023
• Figure 5: Global: Medical Device Outsourcing Market: Breakup by Therapeutics (in %), 2023
• Figure 6: Global: Medical Device Outsourcing Market: Breakup by Application (in %), 2023
• Figure 7: Global: Medical Device Outsourcing Market: Breakup by Region (in %), 2023
• Figure 8: Global: Medical Device Outsourcing (Regulatory Consulting) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 9: Global: Medical Device Outsourcing (Regulatory Consulting) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 10: Global: Medical Device Outsourcing (Product Design and Development) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 11: Global: Medical Device Outsourcing (Product Design and Development) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 12: Global: Medical Device Outsourcing (Product Testing and Sterilization) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 13: Global: Medical Device Outsourcing (Product Testing and Sterilization) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 14: Global: Medical Device Outsourcing (Product Implementation) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 15: Global: Medical Device Outsourcing (Product Implementation) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 16: Global: Medical Device Outsourcing (Product Upgrade) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 17: Global: Medical Device Outsourcing (Product Upgrade) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 18: Global: Medical Device Outsourcing (Product Maintenance) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 19: Global: Medical Device Outsourcing (Product Maintenance) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 20: Global: Medical Device Outsourcing (Cardiology) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 21: Global: Medical Device Outsourcing (Cardiology) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 22: Global: Medical Device Outsourcing (Diagnostic Imaging) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 23: Global: Medical Device Outsourcing (Diagnostic Imaging) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 24: Global: Medical Device Outsourcing (Orthopedic) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 25: Global: Medical Device Outsourcing (Orthopedic) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 26: Global: Medical Device Outsourcing (IVD) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 27: Global: Medical Device Outsourcing (IVD) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 28: Global: Medical Device Outsourcing (Ophthalmic) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 29: Global: Medical Device Outsourcing (Ophthalmic) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 30: Global: Medical Device Outsourcing (General and Plastic Surgery) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 31: Global: Medical Device Outsourcing (General and Plastic Surgery) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 32: Global: Medical Device Outsourcing (Drug Delivery) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 33: Global: Medical Device Outsourcing (Drug Delivery) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 34: Global: Medical Device Outsourcing (Dental) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 35: Global: Medical Device Outsourcing (Dental) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 36: Global: Medical Device Outsourcing (Endoscopy) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 37: Global: Medical Device Outsourcing (Endoscopy) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 38: Global: Medical Device Outsourcing (Diabetes Care) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 39: Global: Medical Device Outsourcing (Diabetes Care) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 40: Global: Medical Device Outsourcing (Class I) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 41: Global: Medical Device Outsourcing (Class I) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 42: Global: Medical Device Outsourcing (Class II) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 43: Global: Medical Device Outsourcing (Class II) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 44: Global: Medical Device Outsourcing (Class III) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 45: Global: Medical Device Outsourcing (Class III) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 46: North America: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 47: North America: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 48: United States: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 49: United States: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 50: Canada: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 51: Canada: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 52: Asia-Pacific: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 53: Asia-Pacific: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 54: China: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 55: China: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 56: Japan: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 57: Japan: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 58: India: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 59: India: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 60: South Korea: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 61: South Korea: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 62: Australia: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 63: Australia: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 64: Indonesia: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 65: Indonesia: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 66: Others: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 67: Others: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 68: Europe: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 69: Europe: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 70: Germany: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 71: Germany: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 72: France: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 73: France: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 74: United Kingdom: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 75: United Kingdom: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 76: Italy: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 77: Italy: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 78: Spain: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 79: Spain: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 80: Russia: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 81: Russia: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 82: Others: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 83: Others: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 84: Latin America: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 85: Latin America: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 86: Brazil: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 87: Brazil: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 88: Mexico: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 89: Mexico: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 90: Others: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 91: Others: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 92: Middle East and Africa: Medical Device Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 93: Middle East and Africa: Medical Device Outsourcing Market: Breakup by Country (in %), 2023
• Figure 94: Middle East and Africa: Medical Device Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 95: Global: Medical Device Outsourcing Industry: SWOT Analysis
• Figure 96: Global: Medical Device Outsourcing Industry: Value Chain Analysis
• Figure 97: Global: Medical Device Outsourcing Industry: Porter's Five Forces Analysis

List of Tables

• Table 1: Global: Medical Device Outsourcing Market: Key Industry Highlights, 2023 and 2032
• Table 2: Global: Medical Device Outsourcing Market Forecast: Breakup by Service (in Million US$), 2024-2032
• Table 3: Global: Medical Device Outsourcing Market Forecast: Breakup by Therapeutics (in Million US$), 2024-2032
• Table 4: Global: Medical Device Outsourcing Market Forecast: Breakup by Application (in Million US$), 2024-2032
• Table 5: Global: Medical Device Outsourcing Market Forecast: Breakup by Region (in Million US$), 2024-2032
• Table 6: Global: Medical Device Outsourcing Market: Competitive Structure
• Table 7: Global: Medical Device Outsourcing Market: Key Players

The global medical device outsourcing market size reached US$ 126.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 258.2 Billion by 2032, exhibiting a growth rate (CAGR) of 8.1% during 2024-2032. The rising need to reduce overall medical costs, the implementation of stringent regulatory requirements and quality standards, the expanding adoption of wearable medical devices, and the surging demand for personalized medicine are among the key factors driving the market growth.

Medical device outsourcing refers to the practice of contracting or partnering with external companies or service providers to handle various aspects of the medical device product lifecycle. These external partners are typically specialized contract manufacturers, design and development firms, regulatory consultants, logistics providers, or other service providers with expertise in the medical device industry. These services offer several benefits to companies, including cost savings, access to specialized expertise, increased operational efficiency, and the ability to adapt to market demands more effectively. It also allows medical device manufacturers to concentrate on core competencies, such as research and development, marketing, and strategic planning, while leveraging the capabilities of external partners to handle other essential aspects of the product lifecycle.

The market is experiencing significant growth due to the increasing prevalence of medical ailments and the surging need for quality healthcare services. In addition, outsourcing offers medical device companies the flexibility to scale production volumes based on market demand. This adaptability is essential for managing fluctuations in product demand, especially for devices with seasonal variations or in response to unexpected market shifts. Moreover, the surging demand for personalized medicine, the expanding adoption of wearable medical devices, the growing popularity of minimally invasive surgical procedures, and the rising trend of home healthcare, telemedicine, and medical tourism are some of the other factors propelling the market. Besides, contract manufacturers with international operations can provide access to diverse markets and navigate import/export regulations, facilitating a smoother expansion into new regions and influencing the market growth.

Medical Device Outsourcing Market Trends/Drivers:

The rising need to reduce overall medical costs

Medical device outsourcing offers cost savings to healthcare providers and medical device companies. Contracting with specialized manufacturers or service providers is more cost-efficient than maintaining in-house operations. External partners have established production facilities, economies of scale, and streamlined processes, enabling them to produce medical devices at lower costs. Moreover, outsourcing non-core activities, such as manufacturing and logistics, allows medical device companies to optimize resource allocation. By delegating routine tasks to external partners, companies can focus their internal resources on core competencies like research, development, and innovation, which can lead to more cost-effective and competitive products.

The implementation of stringent regulatory requirements and quality standards

The implementation of stringent regulations places a higher compliance burden on both medical device companies and their outsourcing partners. Contract manufacturers must adhere to the same regulatory standards as the OEMs to ensure that the medical devices they produce meet the required safety and quality benchmarks. This requires rigorous documentation, quality management systems, and adherence to good manufacturing practices (GMP). Moreover, with higher regulatory scrutiny, quality assurance becomes paramount in the medical device outsourcing process. Contract manufacturers are now under pressure to implement robust quality control measures and risk management strategies to identify and mitigate potential issues in the production process.

The expanding adoption of wearable medical devices

Wearable medical devices often incorporate advanced sensors, wireless connectivity, and sophisticated data analytics capabilities. The development and manufacturing of such technology-intensive devices require specialized expertise and resources, leading to an increased demand for outsourcing partners with expertise in advanced electronics and software development. Moreover, medical devices need to be lightweight, comfortable, and ergonomically designed to ensure user compliance and long-term wearability. Contract manufacturers with expertise in miniaturization techniques and materials selection play a crucial role in achieving these design requirements.

Medical Device Outsourcing Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global medical device outsourcing market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on service, therapeutics and application.

Breakup by Service:

Regulatory Consulting

Product Design and Development

Product Testing and Sterilization

Product Implementation

Product Upgrade

Product Maintenance

Product design and development represent the leading segment

The report has provided a detailed breakup and analysis of the market based on the service. This includes regulatory consulting, product design and development, product testing and sterilization, product implementation, product upgrade, and product maintenance. According to the report, product design and development represented the largest segment.

Medical device design and development requires a high level of technical expertise, including knowledge of regulatory requirements, engineering principles, and medical standards. Many medical device companies lack in-house capabilities or resources to handle the complex design process efficiently. Outsourcing product design and development allows them to tap into the specialized expertise of experienced design firms and engineering companies with a proven track record in the medical device industry. Moreover, outsourcing product design and development enables medical device companies to access fresh ideas, creative solutions, and cutting-edge technologies from external design partners.

Breakup by Therapeutics:

Cardiology

Diagnostic Imaging

Orthopedic

IVD

Ophthalmic

General and Plastic Surgery

Drug Delivery

Dental

Endoscopy

Diabetes Care

Cardiology exhibits a clear dominance in the market

A detailed breakup and analysis of the market based on therapeutics have also been provided in the report. This includes cardiology, diagnostic imaging, orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, and diabetes care. According to the report, cardiology accounted for the largest market share.

Cardiovascular diseases (CVDs) remain one of the leading causes of death worldwide. The increasing prevalence of conditions such as coronary artery disease, heart failure, and arrhythmias has led to a rising demand for innovative medical devices and technologies to diagnose, treat, and manage these conditions. This high demand has driven medical device companies to focus extensively on cardiology-related products and services, leading to a dominant presence in the outsourcing market. Besides, the field of cardiology has witnessed rapid technological advancements and continuous innovation. These innovations include implantable devices such as pacemakers, defibrillators, stents, and heart valves, as well as diagnostic devices like electrocardiograms (ECGs) and cardiac imaging equipment. To keep up with the pace of innovation and meet market demands, medical device companies often seek specialized outsourcing partners with expertise in cardiology product development.

Breakup by Application:

Class I

Class II

Class III

Class II accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the application. This includes class I, II, and III. According to the report, class II represented the largest segment.

Class II medical devices encompass a wide range of products, including moderate to high-risk devices that do not fall into the highest-risk Class III category. This broad product range includes items such as infusion pumps, diagnostic imaging equipment, electrocardiographs, surgical instruments, and certain implantable devices. The diversity of Class II devices contributes to a larger market share in the outsourcing industry. Moreover, these medical devices are subject to intermediate levels of regulatory scrutiny compared to Class III devices. While Class II devices must still meet strict regulatory requirements for safety and efficacy, the regulatory process is generally less burdensome and time-consuming than that for Class III devices, which is escalating their demand.

Breakup by Region:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

Asia Pacific exhibits a clear dominance, accounting for the largest medical device outsourcing market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Latin America (Mexico, Brazil, Others); Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others); and Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others). According to the report, Asia Pacific was the largest market for medical device outsourcing.

Asia Pacific countries, such as China, India, and Southeast Asian nations, offer a significant cost advantage in terms of labor and manufacturing. The lower labor costs, combined with well-developed manufacturing infrastructure and supply chain networks, make the region an attractive option for medical device companies seeking cost-effective outsourcing solutions. Moreover, the region boasts a large pool of skilled and trained professionals in engineering, science, and technology fields. This skilled workforce includes engineers, scientists, and technicians with expertise in medical device design, development, and manufacturing. The availability of such talent accelerates the outsourcing process and ensures high-quality products.

Competitive Landscape:

The competitive landscape of the medical device outsourcing market is highly dynamic with numerous companies offering a wide range of outsourcing services to medical device manufacturers. Nowadays, key players are expanding their service portfolios to provide a comprehensive range of outsourcing solutions. They are diversifying their offerings to include contract manufacturing, product design and development, regulatory support, post-market services, packaging, and logistics. Companies are also engaging in mergers, acquisitions, and strategic partnerships to expand their geographical presence and technical capabilities. They are also investing heavily in advanced manufacturing technologies such as automation, robotics, 3D printing, and data analytics to improve production efficiency, reduce costs, and offer faster turnaround times to medical device manufacturers.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Celestica Inc. (Onex Corporation)

Charles River Laboratories International Inc.

Flex Ltd.

Freyr Inc.

Heraeus Holding GmbH

ICON plc

Integer Holdings Corporation

IQVIA Inc.

Plexus Corp.

Sanmina Corporation

TE Connectivity

West Pharmaceutical Services Inc.

Recent Developments:

Flex Ltd. launched "Healthcare Solutions," a comprehensive suite of medical device design, engineering, and manufacturing services. The offering includes rapid prototyping, miniaturization expertise, and end-to-end solutions to support medical device companies throughout the product lifecycle.

Celestica acquired PCI Limited, a provider of design and manufacturing services for medical and other industries. This acquisition strengthened Celestica's presence in the medical device outsourcing market and expanded its offerings in the Asia Pacific region.

Celestica Inc. acquired Atrenne Integrated Solutions, a provider of electronic manufacturing and design services for the aerospace, defense, and other industries. This acquisition enhanced Celestica's capabilities in serving the medical device market.

Key Questions Answered in This Report

• 1. What was the size of the global medical device outsourcing market in 2023?
• 2. What is the expected growth rate of the global medical device outsourcing market during 2024-2032?
• 3. What has been the impact of COVID-19 on the global medical device outsourcing market?
• 4. What are the key factors driving the global medical device outsourcing market?
• 5. What is the breakup of the global medical device outsourcing market based on the service?
• 6. What is the breakup of the global medical device outsourcing market based on the therapeutics?
• 7. What is the breakup of the global medical device outsourcing market based on the application?
• 8. What are the key regions in the global medical device outsourcing market?
• 9. Who are the key players/companies in the global medical device outsourcing market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Medical Device Outsourcing Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Service

• 6.1 Regulatory Consulting
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Product Design and Development
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Product Testing and Sterilization
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast
• 6.4 Product Implementation
  • 6.4.1 Market Trends
  • 6.4.2 Market Forecast
• 6.5 Product Upgrade
  • 6.5.1 Market Trends
  • 6.5.2 Market Forecast
• 6.6 Product Maintenance
  • 6.6.1 Market Trends
  • 6.6.2 Market Forecast

7 Market Breakup by Therapeutics

• 7.1 Cardiology
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Diagnostic Imaging
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 Orthopedic
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast
• 7.4 IVD
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast
• 7.5 Ophthalmic
  • 7.5.1 Market Trends
  • 7.5.2 Market Forecast
• 7.6 General and Plastic Surgery
  • 7.6.1 Market Trends
  • 7.6.2 Market Forecast
• 7.7 Drug Delivery
  • 7.7.1 Market Trends
  • 7.7.2 Market Forecast
• 7.8 Dental
  • 7.8.1 Market Trends
  • 7.8.2 Market Forecast
• 7.9 Endoscopy
  • 7.9.1 Market Trends
  • 7.9.2 Market Forecast
• 7.10 Diabetes Care
  • 7.10.1 Market Trends
  • 7.10.2 Market Forecast

8 Market Breakup by Application

• 8.1 Class I
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Class II
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Class III
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast

9 Market Breakup by Region

• 9.1 North America
  • 9.1.1 United States
    • 9.1.1.1 Market Trends
    • 9.1.1.2 Market Forecast
  • 9.1.2 Canada
    • 9.1.2.1 Market Trends
    • 9.1.2.2 Market Forecast
• 9.2 Asia-Pacific
  • 9.2.1 China
    • 9.2.1.1 Market Trends
    • 9.2.1.2 Market Forecast
  • 9.2.2 Japan
    • 9.2.2.1 Market Trends
    • 9.2.2.2 Market Forecast
  • 9.2.3 India
    • 9.2.3.1 Market Trends
    • 9.2.3.2 Market Forecast
  • 9.2.4 South Korea
    • 9.2.4.1 Market Trends
    • 9.2.4.2 Market Forecast
  • 9.2.5 Australia
    • 9.2.5.1 Market Trends
    • 9.2.5.2 Market Forecast
  • 9.2.6 Indonesia
    • 9.2.6.1 Market Trends
    • 9.2.6.2 Market Forecast
  • 9.2.7 Others
    • 9.2.7.1 Market Trends
    • 9.2.7.2 Market Forecast
• 9.3 Europe
  • 9.3.1 Germany
    • 9.3.1.1 Market Trends
    • 9.3.1.2 Market Forecast
  • 9.3.2 France
    • 9.3.2.1 Market Trends
    • 9.3.2.2 Market Forecast
  • 9.3.3 United Kingdom
    • 9.3.3.1 Market Trends
    • 9.3.3.2 Market Forecast
  • 9.3.4 Italy
    • 9.3.4.1 Market Trends
    • 9.3.4.2 Market Forecast
  • 9.3.5 Spain
    • 9.3.5.1 Market Trends
    • 9.3.5.2 Market Forecast
  • 9.3.6 Russia
    • 9.3.6.1 Market Trends
    • 9.3.6.2 Market Forecast
  • 9.3.7 Others
    • 9.3.7.1 Market Trends
    • 9.3.7.2 Market Forecast
• 9.4 Latin America
  • 9.4.1 Brazil
    • 9.4.1.1 Market Trends
    • 9.4.1.2 Market Forecast
  • 9.4.2 Mexico
    • 9.4.2.1 Market Trends
    • 9.4.2.2 Market Forecast
  • 9.4.3 Others
    • 9.4.3.1 Market Trends
    • 9.4.3.2 Market Forecast
• 9.5 Middle East and Africa
  • 9.5.1 Market Trends
  • 9.5.2 Market Breakup by Country
  • 9.5.3 Market Forecast

10 SWOT Analysis

• 10.1 Overview
• 10.2 Strengths
• 10.3 Weaknesses
• 10.4 Opportunities
• 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

• 12.1 Overview
• 12.2 Bargaining Power of Buyers
• 12.3 Bargaining Power of Suppliers
• 12.4 Degree of Competition
• 12.5 Threat of New Entrants
• 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

• 14.1 Market Structure
• 14.2 Key Players
• 14.3 Profiles of Key Players
  • 14.3.1 Celestica Inc. (Onex Corporation)
    • 14.3.1.1 Company Overview
    • 14.3.1.2 Product Portfolio
    • 14.3.1.3 Financials
    • 14.3.1.4 SWOT Analysis
  • 14.3.2 Charles River Laboratories International Inc.
    • 14.3.2.1 Company Overview
    • 14.3.2.2 Product Portfolio
    • 14.3.2.3 Financials
    • 14.3.2.4 SWOT Analysis
  • 14.3.3 Flex Ltd.
    • 14.3.3.1 Company Overview
    • 14.3.3.2 Product Portfolio
    • 14.3.3.3 Financials
    • 14.3.3.4 SWOT Analysis
  • 14.3.4 Freyr Inc.
    • 14.3.4.1 Company Overview
    • 14.3.4.2 Product Portfolio
  • 14.3.5 Heraeus Holding GmbH
    • 14.3.5.1 Company Overview
    • 14.3.5.2 Product Portfolio
    • 14.3.5.3 SWOT Analysis
  • 14.3.6 ICON plc
    • 14.3.6.1 Company Overview
    • 14.3.6.2 Product Portfolio
    • 14.3.6.3 Financials
    • 14.3.6.4 SWOT Analysis
  • 14.3.7 Integer Holdings Corporation
    • 14.3.7.1 Company Overview
    • 14.3.7.2 Product Portfolio
    • 14.3.7.3 Financials
  • 14.3.8 IQVIA Inc.
    • 14.3.8.1 Company Overview
    • 14.3.8.2 Product Portfolio
    • 14.3.8.3 Financials
    • 14.3.8.4 SWOT Analysis
  • 14.3.9 Plexus Corp.
    • 14.3.9.1 Company Overview
    • 14.3.9.2 Product Portfolio
    • 14.3.9.3 Financials
    • 14.3.9.4 SWOT Analysis
  • 14.3.10 Sanmina Corporation
    • 14.3.10.1 Company Overview
    • 14.3.10.2 Product Portfolio
    • 14.3.10.3 Financials
    • 14.3.10.4 SWOT Analysis
  • 14.3.11 TE Connectivity
    • 14.3.11.1 Company Overview
    • 14.3.11.2 Product Portfolio
    • 14.3.11.3 Financials
    • 14.3.11.4 SWOT Analysis
  • 14.3.12 West Pharmaceutical Services Inc.
    • 14.3.12.1 Company Overview
    • 14.3.12.2 Product Portfolio
    • 14.3.12.3 Financials
    • 14.3.12.4 SWOT Analysis