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米国の医療機器アウトソーシング市場規模、シェア、動向分析レポート：サービス別、用途別、クラス別、国別、セグメント別予測、2025年～2030年

U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Service, By Application, By Class, By Country, And Segment Forecasts, 2025 - 2030

出版日
ページ情報
英文 190 Pages
納期
2～10営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=145.28円
米国の医療機器アウトソーシング市場規模、シェア、動向分析レポート：サービス別、用途別、クラス別、国別、セグメント別予測、2025年～2030年
出版日: 2025年04月01日
発行: Grand View Research
ページ情報: 英文 190 Pages
納期: 2～10営業日
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概要

米国の医療機器アウトソーシング市場の成長と動向

Grand View Research, Inc.の最新レポートによると、米国の医療機器アウトソーシング市場規模は2030年に634億米ドルに達し、予測期間のCAGRは13.0%で成長すると予測されています。

この市場は、オフショア動向の増加、ハイテク医療機器に対する需要の高まり、米国における医療機器に対する厳しい規制の結果として成長しています。

医療機器産業は常に競合が激しく、冠動脈ステント、整形外科機器、創傷治療などのカテゴリーが成熟に向かっています。上記のカテゴリーでは、インパクトの大きい科学的イノベーションを達成するのは難しく、時間のかかるプロセスであるため、中小企業は低価格を提供し、革新的なビジネスモデルを導入することで市場シェアを獲得しています。課題が山積し、市場力学が変化しているため、医療機器メーカーは、コスト削減、ビジネスリスクの管理、サービス提供の改善を目的に、アウトソーシングビジネスモデルを選択する可能性が高いです。この要因は、予測期間中の市場成長を促進すると予想されます。

政府当局は必要不可欠な機器の研究開発のための資金を増額しており、これが市場を牽引しています。Clinical Trials .govによると、世界的に機器の臨床研究の大半は米国だけで行われています。医療機器の場合も、重要な研究は米国で行われています。

例えば、2023年2月現在、2万5,033件以上の医療機器の調査がClinical Trials .govに登録されています。医療機器企業は、熟練した労働力と先進的インフラを利用できることに加え、質の高いサービスを提供するCROが数多く存在することから、米国で調査を実施しています。これらすべての要因が、パンデミック後の市場を下支えすると予想されます。

米国の医療機器アウトソーシング市場レポートハイライト

  • 米国の医療機器アウトソーシング産業は、FDA規制の厳格化により開発途上にあり、メーカーは専門的なコンプライアンスサポートを求める必要があります。
  • 規制要件の進化、コスト圧力、市場投入までの時間短縮の必要性により、市場は急速に変化しています。
  • 米国の医療機器アウトソーシング産業は、コスト抑制の圧力、厳格な規制遵守、機器開発の複雑化によって牽引されています。
  • 2024年には、受託製造部門が46.74%の最大シェアを占めています。このセグメントの成長は、コスト圧力の高まり、FDA規制要件の厳格化、医療機器の複雑化に起因しています。
  • 用途別では、循環器セグメントが2024年の市場を独占しました。心血管疾患（CVDs）の高い有病率による心血管機器の需要増加が、これらの機器のアウトソーシングの成長に起因しています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 市場の変数、動向、範囲

  • 市場系統の展望
    • 親市場の展望
    • 関連/補助市場展望
  • 市場力学
    • 市場の促進要因分析
    • 市場抑制要因分析
    • 産業の課題
  • 技術の進歩
  • 規制の枠組み
  • 価格モデル分析
  • 市場分析ツール
    • ポーターのファイブフォース分析
    • SWOT分析によるPESTEL
    • COVID-19の影響分析

第4章 米国の医療機器アウトソーシング市場：サービス別、推定・動向分析

  • 米国の医療機器アウトソーシング市場（サービス別）：セグメントダッシュボード
  • 米国の医療機器アウトソーシング市場（サービス別）：変動分析
  • サービス別、2018～2030年
  • 品質保証サービス
    • 品質保証サービス市場の推定とセグメント予測、2018～2030年
  • 規制関連サービス
    • 規制関連業務サービス市場の推定とセグメント予測、2018～2030年
    • 臨床検査申請と製品登録
    • 規制文書の執筆と出版
    • 法的代理
    • その他
  • 製品設計・開発サービス
    • 製品設計・開発サービス市場の推定とセグメント予測、2018～2030年
    • 設計とエンジニアリング
    • 機械加工
    • 成形
    • 包装
  • データ管理と生物統計学
    • データ管理と生物統計市場の推定とセグメント予測、2018～2030年
  • 製品検査と滅菌サービス
    • 製品検査と滅菌サービス市場の推定とセグメント予測、2018～2030年
  • 製品実装サービス
    • 製品実装サービス市場の推定とセグメント予測、2018～2030年
  • 製品アップグレードサービス
    • 製品アップグレードサービス市場の推定とセグメント予測、2018～2030年
  • 製品保守サービス
    • 製品保守サービス市場の推定とセグメント予測、2018～2030年
  • 契約製造
    • 契約製造市場の推定とセグメント予測、2018～2030年
    • 付属品製造
    • 組立製造
    • 部品製造
    • 機器製造
  • その他
    • その他市場予測とセグメント予測、2018～2030年

第5章 米国の医療機器アウトソーシング市場：用途別、推定・動向分析

  • 米国の医療機器アウトソーシング市場（用途別）：セグメントダッシュボード
  • 米国の医療機器アウトソーシング市場（用途別）：変動分析
  • 用途別、2018～2030年
  • 心臓病学
    • 心臓病学市場の推定とセグメント予測、2018～2030年
  • 診断画像
    • 診断画像市場の推定とセグメント予測、2018～2030年
  • 整形外科
    • 整形外科市場の推定とセグメント予測、2018～2030年
  • 体外診断医療機器
    • 体外診断用医療機器市場の推定とセグメント予測、2018～2030年
  • 眼科
    • 眼科市場予測とセグメント別予測（2018～2030年）
  • 一般外科と形成外科
    • 一般外科と形成外科市場の推定とセグメント予測、2018～2030年
  • ドラッグデリバリー
    • ドラッグデリバリー市場の推定とセグメント予測、2018～2030年
    • プレフィルドシリンジ
    • オートインジェクタ
    • 輸液ポンプ
    • その他
  • 歯科
    • 歯科市場の推定とセグメント予測、2018～2030年
  • 内視鏡検査
    • 内視鏡市場の推定とセグメント予測、2018～2030年
  • 糖尿病ケア
    • 糖尿病ケア市場の推定とセグメント予測、2018～2030年
  • その他
    • その他市場予測とセグメント予測、2018～2030年

第6章 米国の医療機器アウトソーシング市場：クラス別、推定・動向分析

  • 米国の医療機器アウトソーシング市場（クラス別）：セグメントダッシュボード
  • 米国の医療機器アウトソーシング市場（クラス別）：変動分析
  • クラス別、2018～2030年
  • クラスI
    • クラスI医療機器アウトソーシング市場の推定とセグメント予測、2018～2030年
  • クラスII
    • クラスII医療機器アウトソーシング市場の推定とセグメント予測、2018～2030年
  • クラスIII
    • クラスIII医療機器アウトソーシング市場の推定とセグメント予測、2018～2030年

第7章 米国の医療機器アウトソーシング市場：最終用途別、推定・動向分析

  • 米国の医療機器アウトソーシング市場（最終用途別）：セグメントダッシュボード
  • 米国の医療機器アウトソーシング市場（最終用途別）：変動分析
  • 用途別、2018～2030年
  • 心臓病学
    • クラスI
    • クラスII
    • クラスIII
  • 診断画像
    • クラスI
    • クラスII
    • クラスIII
  • 整形外科
    • クラスI
    • クラスII
    • クラスIII
  • 体外診断用医薬品
    • クラスI
    • クラスII
    • クラスIII
  • 眼科
    • クラスI
    • クラスII
    • クラスIII
  • 一般外科と形成外科
    • クラスI
    • クラスII
    • クラスIII
  • ドラッグデリバリー
    • クラスI
    • クラスII
    • クラスIII
  • 歯科
    • クラスI
    • クラスII
    • クラスIII
  • 内視鏡検査
    • クラスI
    • クラスII
    • クラスIII
  • 糖尿病ケア
    • クラスI
    • クラスII
    • クラスIII
  • その他
    • クラスI
    • クラスII
    • クラスIII

第8章 競合情勢

  • 企業分類
    • マーケットリーダー
    • 新興参入企業
  • 市況分析、2024年（ヒートマップ分析）
  • 企業プロファイル
    • SGS SA
    • Laboratory Corporation Of America Holdings
    • Eurofins Scientific
    • Pace Analytical Services, Inc.
    • TUV SUD
    • Charles River Laboratories
    • Freyr
    • Global Regulatory Partners
    • Parexel International Corporation
    • Genpact
    • Criterium, Inc.
    • Promedica International
    • Medpace
    • ICON Plc.
    • IQVIA Inc.
    • Integer Holdings Corporation
    • Jabil Inc.
    • Flex Ltd.
    • Plexus Corp.
    • West Pharmaceutical Services, Inc.
図表

List of Tables

  • Table. 1 List of Secondary Sources
  • Table. 2 List of Abbreviations
  • Table. 3 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Service, 2018 - 2030 (USD Million)
  • Table. 4 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Regulatory Affairs Services, 2018 - 2030 (USD Million)
  • Table. 5 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Product Design and Development Services, 2018 - 2030 (USD Million)
  • Table. 6 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Contract Manufacturing, 2018 - 2030 (USD Million)
  • Table. 7 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Application, 2018 - 2030 (USD Million)
  • Table. 8 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Drug Delivery, 2018 - 2030 (USD Million)
  • Table. 9 U.S. Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 10 U.S. Cardiology Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 11 U.S. Diagnostic imaging Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 12 U.S. Orthopedic Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 13 U.S. IVD Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 14 U.S. Ophthalmic Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 15 U.S. General & Plastic Surgery Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 16 U.S. Drug Delivery Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 17 U.S. Dental Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 18 U.S. Endoscopy Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 19 U.S. Diabetes Care Medical Device Outsourcing Market Estimates and Forecasts, by Class, 2018 - 2030 (USD Million)
  • Table. 20 U.S. Others Medical Device Outsourcing Market Estimates and Forecasts, by class, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market Segmentation
  • Fig. 2 Information Procurement
  • Fig. 3 Primary Research Pattern
  • Fig. 4 Market Research Approaches
  • Fig. 5 Value Chain-Based Sizing & Forecasting
  • Fig. 6 Market Formulation & Validation
  • Fig. 7 Market Driver Relevance Analysis
  • Fig. 8 Market Restraint Relevance Analysis
  • Fig. 9 Porter's Five Forces Analysis
  • Fig. 10 PESTEL by SWOT Analysis
  • Fig. 11 U.S. Quality Assurance Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 12 U.S. Regulatory Affairs Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 13 U.S. Clinical Trial Applications & Product Registration Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 14 U.S. Regulatory Writing & Publishing Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 15 U.S. Legal Representation Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 16 U.S. Others Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 17 U.S. Product Design and Development Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 18 U.S. Designing & Engineering Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 19 U.S. Machining Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 20 U.S. Molding Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 21 U.S. Packaging Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 22 U.S. Data Management and Biostatistics Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 23 U.S. Product Testing & Sterilization Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 24 U.S. Product Implementation Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 25 U.S. Product Upgrade Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 26 U.S. Product Maintenance Services Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 27 U.S. Contract Manufacturing Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 28 U.S. Accessories Manufacturing Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 29 U.S. Assembly Manufacturing Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 30 U.S. Component Manufacturing Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 31 U.S. Device Manufacturing Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 32 U.S. Others Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 33 U.S. Cardiology Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 34 U.S. Diagnostic Imaging Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 35 U.S. Orthopedic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 36 U.S. IVD Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 37 U.S. Ophthalmic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 38 U.S. General & Plastic Surgery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 39 U.S. Drug Delivery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 40 U.S. Prefilled Syringe Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 41 U.S. Autoinjectors Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 42 U.S. Infusion Pump Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 43 U.S. Other Drug Delivery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 44 U.S. Dental Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 45 U.S. Endoscopy Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 46 U.S. Diabetes Care Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 47 U.S. Others Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 48 U.S. Class I Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 49 U.S. Class II Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 50 U.S. Class III Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 51 U.S. Class I Cardiology Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 52 U.S. Class II Cardiology Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 53 U.S. Class III Cardiology Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 54 U.S. Class I Diagnostic Imaging Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 55 U.S. Class II Diagnostic Imaging Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 56 U.S. Class III Diagnostic Imaging Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 57 U.S. Class I Orthopedic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 58 U.S. Class II Orthopedic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 59 U.S. Class III Orthopedic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 60 U.S. Class I IVD Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 61 U.S. Class II IVD Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 62 U.S. Class III IVD Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 63 U.S. Class I Ophthalmic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 64 U.S. Class II Ophthalmic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 65 U.S. Class III Ophthalmic Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 66 U.S. Class I General & Plastic Surgery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 67 U.S. Class II General & Plastic Surgery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 68 U.S. Class III General & Plastic Surgery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 69 U.S. Class I Drug Delivery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 70 U.S. Class II Drug Delivery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 71 U.S. Class III Drug Delivery Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 72 U.S. Class I Dental Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 73 U.S. Class II Dental Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 74 U.S. Class III Dental Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 75 U.S. Class I Endoscopy Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 76 U.S. Class II Endoscopy Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 77 U.S. Class III Endoscopy Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 78 U.S. Class I Diabetes Care Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 79 U.S. Class II Diabetes Care Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 80 U.S. Class III Diabetes Care Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 81 U.S. Class I Others Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 82 U.S. Class II Others Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • Fig. 83 U.S. Class III Others Medical Device Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
目次
Product Code: 978-1-68038-600-4

U.S. Medical Device Outsourcing Market Growth & Trends:

The U.S. medical device outsourcing market size is expected to reach USD 63.40 billion in 2030 and is expected to grow at a CAGR of 13.0% over 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.

U.S. Medical Device Outsourcing Market Report Highlights:

  • The U.S. medical device outsourcing industry is developing due to stricter FDA regulations, which require manufacturers to seek specialized compliance support
  • The market is rapidly transforming due to evolving regulatory requirements, cost pressures, and the need for faster time to market
  • The U.S. medical device outsourcing industry is driven by cost containment pressures, stringent regulatory compliance, and increasing complexity in device development.
  • The contract manufacturing segment accounted for the largest share of 46.74% in 2024. The segment growth is owing to increasing cost pressures, stringent FDA regulatory requirements, and the growing complexity of medical devices
  • Based on application, the cardiology segment dominated the market in 2024. The growing demand for cardiovascular devices due to the high prevalence rate of cardiovascular diseases (CVDs) is attributed to the growth of outsourcing these devices

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
    • 1.1.1. Estimates and Forecast Timeline
  • 1.2. Market Definitions
  • 1.3. Research Methodology
    • 1.3.1. Information Procurement
    • 1.3.2. Purchased Database
    • 1.3.3. GVR's Internal Database
    • 1.3.4. Secondary Sources
    • 1.3.5. Primary Research
  • 1.4. Information or Data Analysis
    • 1.4.1. Information Analysis
    • 1.4.2. Market Formulation & Data Visualization
    • 1.4.3. Data Validation & Publishing
  • 1.5. Model Details
    • 1.5.1. Commodity Flow Analysis (Model 1)
    • 1.5.2. Top Down Market Estimation (Model 2)
    • 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
    • 1.5.4. Multivariate Analysis (Model 4)
    • 1.5.5. Bottom-Up Approach (Model 5)
  • 1.6. List of Secondary Sources
  • 1.7. List of Abbreviations
  • 1.8. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. Changing Regulatory Landscape
      • 3.2.1.2. Increase in the Offshoring of Medical Device Manufacturing
      • 3.2.1.3. Rising Demand for Advanced Products
      • 3.2.1.4. Implementation of International Standards by Contract Manufacturers
      • 3.2.1.5. Rising Price Competition and the Need to Reduce Costs
      • 3.2.1.6. Increasing Complexity in Product Design and Engineering
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Compliance Issues While Outsourcing
      • 3.2.2.2. Regulatory and Legal Compliance
      • 3.2.2.3. Contractual Obligations
    • 3.2.3. Industry Challenges
      • 3.2.3.1. Managing Relationships
  • 3.3. Technological Advancements
  • 3.4. Regulatory Framework
  • 3.5. Pricing Model Analysis
  • 3.6. Market Analysis Tools
    • 3.6.1. Porter's Five Forces Analysis
    • 3.6.2. PESTEL by SWOT Analysis
    • 3.6.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Outsourcing Market: Service Estimates & Trend Analysis

  • 4.1. U.S. Medical Device Outsourcing Market, By Service: Segment Dashboard
  • 4.2. U.S. Medical Device Outsourcing Market, By Service: Movement Analysis
  • 4.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By Service, 2018 - 2030
  • 4.4. Quality Assurance Services
    • 4.4.1. Quality Assurance Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.5. Regulatory Affairs Services
    • 4.5.1. Regulatory Affairs Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.5.2. Clinical Trial Applications & Product Registration
      • 4.5.2.1. Clinical Trial Applications & Product Registration Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.5.3. Regulatory Writing & Publishing
      • 4.5.3.1. Regulatory Writing & Publishing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.5.4. Legal Representation
      • 4.5.4.1. Legal Representation Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.5.5. Others
      • 4.5.5.1. Others Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.6. Product Design and Development Services
    • 4.6.1. Product Design and Development Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.6.2. Designing & Engineering
      • 4.6.2.1. Designing & Engineering Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.6.3. Machining
      • 4.6.3.1. Machining Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.6.4. Molding
      • 4.6.4.1. Molding Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.6.5. Packaging
      • 4.6.5.1. Packaging Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.7. Data Management and Biostatistics
    • 4.7.1. Data Management and Biostatistics Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.8. Product Testing & Sterilization Services
    • 4.8.1. Product Testing & Sterilization Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.9. Product Implementation Services
    • 4.9.1. Product Implementation Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.10. Product Upgrade Services
    • 4.10.1. Product Upgrade Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.11. Product Maintenance Services
    • 4.11.1. Product Maintenance Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.12. Contract Manufacturing
    • 4.12.1. Contract Manufacturing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.12.2. Accessories Manufacturing
      • 4.12.2.1. Accessories Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.12.3. Assembly Manufacturing
      • 4.12.3.1. Assembly Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.12.4. Component Manufacturing
      • 4.12.4.1. Component Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 4.12.5. Device Manufacturing
      • 4.12.5.1. Device Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.13. Others
    • 4.13.1. Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 5. U.S. Medical Device Outsourcing Market: Application Estimates & Trend Analysis

  • 5.1. U.S. Medical Device Outsourcing Market, By Application: Segment Dashboard
  • 5.2. U.S. Medical Device Outsourcing Market, By Application: Movement Analysis
  • 5.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By Application, 2018 - 2030
  • 5.4. Cardiology
    • 5.4.1. Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.5. Diagnostic Imaging
    • 5.5.1. Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.6. Orthopedic
    • 5.6.1. Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.7. IVD
    • 5.7.1. IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.8. Ophthalmic
    • 5.8.1. Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.9. General & Plastic Surgery
    • 5.9.1. General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.10. Drug Delivery
    • 5.10.1. Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 5.10.2. Prefilled Syringe
      • 5.10.2.1. Prefilled Syringe Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 5.10.3. Autoinjectors
      • 5.10.3.1. Autoinjectors Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 5.10.4. Infusion Pump
      • 5.10.4.1. Infusion Pump Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 5.10.5. Others
      • 5.10.5.1. Others Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.11. Dental
    • 5.11.1. Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.12. Endoscopy
    • 5.12.1. Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.13. Diabetes Care
    • 5.13.1. Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.14. Others
    • 5.14.1. Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 6. U.S. Medical Device Outsourcing Market: Class Estimates & Trend Analysis

  • 6.1. U.S. Medical Device Outsourcing Market, By Class: Segment Dashboard
  • 6.2. U.S. Medical Device Outsourcing Market, By Class: Movement Analysis
  • 6.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By Class, 2018 - 2030
  • 6.4. Class I
    • 6.4.1. Class I Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 6.5. Class II
    • 6.5.1. Class II Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 6.6. Class III
    • 6.6.1. Class III Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 7. U.S. Medical Device Outsourcing Market: End Use Estimates & Trend Analysis

  • 7.1. U.S. Medical Device Outsourcing Market, By End Use: Segment Dashboard
  • 7.2. U.S. Medical Device Outsourcing Market, By End Use: Movement Analysis
  • 7.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By End Use, 2018 - 2030
  • 7.4. Cardiology
    • 7.4.1. Class I
      • 7.4.1.1. Class I Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.4.2. Class II
      • 7.4.2.1. Class II Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.4.3. Class III
      • 7.4.3.1. Class III Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.5. Diagnostic Imaging
    • 7.5.1. Class I
      • 7.5.1.1. Class I Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.5.2. Class II
      • 7.5.2.1. Class II Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.5.3. Class III
      • 7.5.3.1. Class III Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.6. Orthopedic
    • 7.6.1. Class I
      • 7.6.1.1. Class I Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.6.2. Class II
      • 7.6.2.1. Class II Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.6.3. Class III
      • 7.6.3.1. Class III Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.7. IVD
    • 7.7.1. Class I
      • 7.7.1.1. Class I IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.7.2. Class II
      • 7.7.2.1. Class II IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.7.3. Class III
      • 7.7.3.1. Class III IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.8. Ophthalmic
    • 7.8.1. Class I
      • 7.8.1.1. Class I Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.8.2. Class II
      • 7.8.2.1. Class II Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.8.3. Class III
      • 7.8.3.1. Class III Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.9. General & Plastic Surgery
    • 7.9.1. Class I
      • 7.9.1.1. Class I General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.9.2. Class II
      • 7.9.2.1. Class II General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.9.3. Class III
      • 7.9.3.1. Class III General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.10. Drug Delivery
    • 7.10.1. Class I
      • 7.10.1.1. Class I Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.10.2. Class II
      • 7.10.2.1. Class II Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.10.3. Class III
      • 7.10.3.1. Class III Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.11. Dental
    • 7.11.1. Class I
      • 7.11.1.1. Class I Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.11.2. Class II
      • 7.11.2.1. Class II Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.11.3. Class III
      • 7.11.3.1. Class III Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.12. Endoscopy
    • 7.12.1. Class I
      • 7.12.1.1. Class I Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.12.2. Class II
      • 7.12.2.1. Class II Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.12.3. Class III
      • 7.12.3.1. Class III Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.13. Diabetes Care
    • 7.13.1. Class I
      • 7.13.1.1. Class I Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.13.2. Class II
      • 7.13.2.1. Class II Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.13.3. Class III
      • 7.13.3.1. Class III Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.14. Others
    • 7.14.1. Class I
      • 7.14.1.1. Class I Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.14.2. Class II
      • 7.14.2.1. Class II Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
    • 7.14.3. Class III
      • 7.14.3.1. Class III Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Company Categorization
    • 8.1.1. Market Leaders
    • 8.1.2. Emerging Players
  • 8.2. Market Position Analysis, 2024 (Heat Map Analysis)
  • 8.3. Company Profiles
    • 8.3.1. SGS SA
      • 8.3.1.1. Company Overview
      • 8.3.1.2. Financial Performance
      • 8.3.1.3. Service Benchmarking
      • 8.3.1.4. Strategic Initiatives
    • 8.3.2. Laboratory Corporation Of America Holdings
      • 8.3.2.1. Company Overview
      • 8.3.2.2. Financial Performance
      • 8.3.2.3. Service Benchmarking
      • 8.3.2.4. Strategic Initiatives
    • 8.3.3. Eurofins Scientific
      • 8.3.3.1. Company Overview
      • 8.3.3.2. Financial Performance
      • 8.3.3.3. Service Benchmarking
      • 8.3.3.4. Strategic Initiatives
    • 8.3.4. Pace Analytical Services, Inc.
      • 8.3.4.1. Company Overview
      • 8.3.4.2. Financial Performance
      • 8.3.4.3. Service Benchmarking
      • 8.3.4.4. Strategic Initiatives
    • 8.3.5. TUV SUD
      • 8.3.5.1. Company Overview
      • 8.3.5.2. Financial Performance
      • 8.3.5.3. Service Benchmarking
      • 8.3.5.4. Strategic Initiatives
    • 8.3.6. Charles River Laboratories
      • 8.3.6.1. Company Overview
      • 8.3.6.2. Financial Performance
      • 8.3.6.3. Service Benchmarking
      • 8.3.6.4. Strategic Initiatives
    • 8.3.7. Freyr
      • 8.3.7.1. Company Overview
      • 8.3.7.2. Financial Performance
      • 8.3.7.3. Service Benchmarking
      • 8.3.7.4. Strategic Initiatives
    • 8.3.8. Global Regulatory Partners
      • 8.3.8.1. Company Overview
      • 8.3.8.2. Financial Performance
      • 8.3.8.3. Service Benchmarking
      • 8.3.8.4. Strategic Initiatives
    • 8.3.9. Parexel International Corporation
      • 8.3.9.1. Company Overview
      • 8.3.9.2. Financial Performance
      • 8.3.9.3. Service Benchmarking
      • 8.3.9.4. Strategic Initiatives
    • 8.3.10. Genpact
      • 8.3.10.1. Company Overview
      • 8.3.10.2. Financial Performance
      • 8.3.10.3. Service Benchmarking
      • 8.3.10.4. Strategic Initiatives
    • 8.3.11. Criterium, Inc.
      • 8.3.11.1. Company Overview
      • 8.3.11.2. Financial Performance
      • 8.3.11.3. Service Benchmarking
      • 8.3.11.4. Strategic Initiatives
    • 8.3.12. Promedica International
      • 8.3.12.1. Company Overview
      • 8.3.12.2. Financial Performance
      • 8.3.12.3. Service Benchmarking
      • 8.3.12.4. Strategic Initiatives
    • 8.3.13. Medpace
      • 8.3.13.1. Company Overview
      • 8.3.13.2. Financial Performance
      • 8.3.13.3. Service Benchmarking
      • 8.3.13.4. Strategic Initiatives
    • 8.3.14. ICON Plc.
      • 8.3.14.1. Company Overview
      • 8.3.14.2. Financial Performance
      • 8.3.14.3. Service Benchmarking
      • 8.3.14.4. Strategic Initiatives
    • 8.3.15. IQVIA Inc.
      • 8.3.15.1. Company Overview
      • 8.3.15.2. Financial Performance
      • 8.3.15.3. Service Benchmarking
      • 8.3.15.4. Strategic Initiatives
    • 8.3.16. Integer Holdings Corporation
      • 8.3.16.1. Company Overview
      • 8.3.16.2. Financial Performance
      • 8.3.16.3. Service Benchmarking
      • 8.3.16.4. Strategic Initiatives
    • 8.3.17. Jabil Inc.
      • 8.3.17.1. Company Overview
      • 8.3.17.2. Financial Performance
      • 8.3.17.3. Service Benchmarking
      • 8.3.17.4. Strategic Initiatives
    • 8.3.18. Flex Ltd.
      • 8.3.18.1. Company Overview
      • 8.3.18.2. Financial Performance
      • 8.3.18.3. Service Benchmarking
      • 8.3.18.4. Strategic Initiatives
    • 8.3.19. Plexus Corp.
      • 8.3.19.1. Company Overview
      • 8.3.19.2. Financial Performance
      • 8.3.19.3. Service Benchmarking
      • 8.3.19.4. Strategic Initiatives
    • 8.3.20. West Pharmaceutical Services, Inc.
      • 8.3.20.1. Company Overview
      • 8.3.20.2. Financial Performance
      • 8.3.20.3. Service Benchmarking
      • 8.3.20.4. Strategic Initiatives