医療機器アウトソーシングの世界市場-2022-2029

市場概要

医療機器アウトソーシングの世界市場規模は、2022年に1,125億7,891万米ドル、2029年には2,897億6,864万米ドルに達すると予測され、予測期間（2022-2029年）のCAGR13.26%で成長する見込みです。

アウトソーシングとは、通常、企業がコスト削減のために、社外の第三者にサービスの遂行や商品の作成を依頼することです。医療機器業界では、医療機器の製造と関連サービスの両方をアウトソーシングしています。アウトソーシングにより、機器メーカーは新製品の市場投入までの時間を短縮し、投資回収を早めることができます。

市場力学

世界の医療機器アウトソーシング市場を牽引する主な要因は、心血管などの慢性疾患の発生率の上昇、製造施設の増加、運用コストの削減、アウトソーシング需要の増加です。

製造施設の拡大や運用コストの削減は、市場の成長を牽引するものと考えられます。

医療機器のアウトソーシング市場は、高度な製品に対する需要の高まりとオフショアリングの動向によって牽引されます。この成長は主に、医療機器のコスト上昇、ひいては医療費の増加を抑制する必要性によってもたらされるでしょう。医療機器メーカーは、医療サービスの質を維持しながら間接費や運営費を削減する必要に迫られており、これが医療機器アウトソーシング市場の推進力となっています。製品のアウトソーシングは、生産コストを10～15%削減するのに役立ちます。

さらに、質の高いヘルスケアに対する需要の高まりも、世界の医療機器アウトソーシング市場の成長を促す重要な要因の1つとなっています。提供されるヘルスケアの質は、診断機器の品質に依存します。このため、医療機器メーカーは競争の激しいヘルスケア業界で優位に立つため、製品開発のアウトソーシングを余儀なくされています。

医療機器アウトソーシング市場のもう一つの促進要因は、さまざまな新製品の発売と施設の拡張です。例えば、2022年8月、研究開発・製造受託機関（CRDMO）のWuXi STAが、米国デラウェア州に医薬品製造キャンパスを開設することを発表しました。顧客の需要に対応するため、米国に2つ目の施設を設置します。

機密情報紛失の脅威が市場成長の妨げになると予想。

しかし、製造、製品設計、プロトタイプ作成などを第三者と契約する際に、機密情報を失う恐れがあることが、世界の医療機器アウトソーシング市場の妨げになっています。

COVID-19の影響分析

パンデミックは、世界の財政的な期待、オペレーション、危機対応戦略にプラスの影響を与えています。COVID-19の発生はヘルスケア産業に深刻な影響を与えました。医療機器アウトソーシング市場は、斬新で効果的なワクチンや薬剤の需要増と臨床試験数の増加により、莫大な利益を経験しました。さまざまなバイオ製薬会社が、需要と成長する研究開発活動を満たすために、委託研究機関と提携または協力しました。様々なイニシアチブ、コラボレーション、合併が世界中で起こっており、市場の成長を後押ししています。例えば、2022年7月、メディデータは、異なる治療分野での臨床研究を継続するために、Novotechとのパートナーシップの拡大と更新を発表しました。メディデータのRave EDC、Ecoa、Rave RTSMなど様々な技術を活用し、ノボテックは現在、設定可能で柔軟性が高く、大規模な臨床研究ニーズに対応するツールを備えています。

目次

第1章 調査手法と調査範囲

• 調査手法
• 調査目的および調査範囲

第2章 市場の定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 市場影響要因
  • 促進要因
    • 生産コスト削減
    • 製造拠点の拡大
  • 抑制要因
    • 機密情報漏洩の脅威
  • ビジネスチャンス
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• プライシング分析
• 規制分析

第6章 COVID-19の分析

• COVID-19の市場分析
  • COVID-19以前の市場シナリオ
  • COVID-19の現在の市場シナリオ
  • COVID-19の後、または将来のシナリオ
• COVID-19の中での価格ダイナミクス
• 需要-供給スペクトラム
• パンデミック時の市場に関連する政府の取り組み
• メーカーの戦略的取り組み
• まとめ

第7章 製品別

• 原材料
• エレクトロニクス
• 完成品

第8章 デバイスタイプ別

• クラスI
• クラスII
• クラスIII

第9章 サービス別

• 機器製造受託
• プロトタイプ開発
• 臨床研究・薬事支援サービス
• 製品設計・開発
• 製品テスト
• 組立・梱包
• 品質保証
• その他

第10章 アプリケーション別

• 循環器
• 整形外科・脊椎
• ラジオロジー
• ドラッグデリバリー
• 眼科
• 一般医療機器
• その他

第11章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ地域

第12章 競合情勢

• 主な展開と戦略
• 企業シェア分析
• 製品ベンチマーク
• 注目の主要企業リスト

第13章 企業プロファイル

• Integer Holdings Corporation
  • 企業概要
  • 製品ポートフォリオと説明
  • 主なハイライト
  • 財務概要
• Thermo Fisher Scientific
• Nortech Systems, Inc.
• Plexus Corp.
• West Pharmaceutical Services, Inc
• Celestica, Inc
• Intertek Group
• Wuxi Apptec
• IQVIA Holdings
• Benchmark Electronic Inc.

第14章 医療機器アウトソーシングの世界市場-DataM

Market Overview

The global medical device outsourcing market size was valued at US$ 112,578.91 million in 2022 and is estimated to reach US$ 289,768.64 million by 2029, growing at a CAGR of 13.26% during the forecast period (2022-2029).

Outsourcing is a practice usually undertaken by companies as a cost-cutting measure by hiring a party outside a company to perform services and create goods. The medical device industry is outsourcing both the manufacturing of medical devices and associated services; outsourcing can help equipment manufacturers to accelerate their time to market for a new product and speed up return on investment.

Market Dynamics

The major factors driving the global medical device outsourcing market are the rising incidence of chronic diseases such as cardiovascular, the increasing number of manufacturing facilities, reducing operational costs and the rising demand for outsourcing.

Expanding manufacturing facilities and reducing operational costs are expected to drive the market's growth.

The medical device outsourcing market is driven by rising demand for advanced products and the trend of offshoring. This growth would be mainly led by the need to curb the rising cost of medical equipment and, thereby, healthcare expenses. An increase in pressure on the manufacturers to reduce the overhead expenses and operational costs while maintaining the quality of healthcare services is propelling the medical device outsourcing market. Product outsourcing helps in reducing production costs by 10-15%.

Additionally, the growing demand for quality healthcare is one of the key factors driving the global medical devices outsourcing market growth. The quality of healthcare delivered depends on the quality of diagnostic devices. This forces device manufacturers to outsource product development to stay ahead in the competitive healthcare industry.

Another driving factor for the medical device outsourcing market is various novel product launches and facility expansion. For instance, in Aug 2022, WuXi STA, a contract research development and manufacturing organization (CRDMO), announced its pharmaceutical manufacturing campus in Delaware, United States. A second facility in the United States to meet the demand of customers.

The threat of losing confidential information is expected to hamper the market growth.

However, the threat of losing confidential information in contracting with a third party for manufacturing, product designing, prototyping, and others is hampering the global medical device outsourcing market.

COVID-19 Impact Analysis

The pandemic has positively impacted global financial expectations, operations and crisis response strategy. The COVID-19 outbreak has severely impacted the healthcare industry. The medical device outsourcing market has experienced huge profits due to the increase in demand for novel and effective vaccines and drugs and the rise in the number of clinical trials. Various biopharmaceutical companies partnered or collaborated with contract research organizations to meet the demands and growing R&D activities. Various initiatives, collaborations and mergers are happening worldwide, boosting the market's growth. For instance, in Jul 2022, Medidata announced their partnership expansion and renewal with Novotech to continue clinical studies in different therapeutic areas. Leveraging various technologies such as Rave EDC, Ecoa, Rave RTSM etc., from Medidata, Novotech now has equipped tools that are configurable and flexible and address clinical research needs at a large scale.

Segment Analysis

The services segment is expected to grow at the fastest CAGR during the forecast period (2022-2029)

The services segment is the highest market holder in the global medical device outsourcing market. Based on the services segment, the contract device manufacturing sub-segment holds the largest market share. The need for contract manufacturing is increasing with the need for reducing operational costs and overhead expenses with good quality services.

Manufacturers require high-quality safety gadgets, and the rising manufacturing complexity makes contract manufacturing a better choice. Furthermore, during medical device development, inspection level is getting high, resulting in multiple standards and regulations, leading to increased demand for contract device manufacturing.

The service segment dominates the market due to the rising demand for contract manufacturing and rising global incidences of chronic diseases such as cardiovascular and neurological disorders. The growing number of regulatory approvals, technological advancements, expansion, and research/clinical trial studies drive the market's growth. For instance, in Aug 2022, Plexus Corp., a product design, manufacturing and marketing services provider, announced its novel manufacturing facility opening in Bangkok, Thailand. Around $60 million is invested in constructing a 400,000 sq. ft. site. This facility will strengthen energy-efficient operational and monitoring systems supporting Plexus's environmental, social and governance mission (ESG) for the betterment of the world.

Geographical Analysis

North America holds the largest market share in the global medical device outsourcing market.

North America dominates the global medical device outsourcing market, primarily attributed to the rising number of chronic disorders, such as cardiac and neurological. According to WHO, it was estimated that coronary artery disease (CAD) was responsible for a total of 11.1 million deaths globally in 2020.

Increasing expenditure on healthcare and raising awareness among people are also contributing to the market's growth in this region. The presence of a large number of medical device manufacturers and the availability of advanced healthcare systems and manufacturing hubs for high-end, consistent, and complex medical devices in this region are contributing to the growth of the medical device outsourcing market.

Moreover, the growing number of product launches is responsible for the market's growth. Many key developments, technological advancements, collaborations, and agreements are taking place in this region. For instance, in Apr 2022, Integer Holdings Corporation acquired Connemara Biomedical Holdings Teoranta along with its subsidiaries (Aran Biomedical & Proxy Biomedical). Aran is a high-precision biomaterial coating and advanced metal and polymer manufacturer for and provides solutions for implantable medical devices developing and manufacturing.

Competitive Landscape

The medical device outsourcing market is moderately competitive with local and global companies' presence. Integer Holdings Corporation, Thermo Fisher Scientific, Nortech Systems, Inc., Plexus Corp., West Pharmaceutical Services, Inc, Celestica, Inc, Intertek Group, Wuxi Apptec, IQVIA Holdings, Benchmark Electronic Inc. and more. The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations, contributing to the market's growth. For instance, in Apr 2021, IQVIA Holdings Inc., technology solutions, analytical and clinical research service provider, announced that it completely acquired Q2 Solutions, a clinical laboratory services organization, from Quest Diagnostics, a diagnostic information service provider. It already acquired 60% of the shares and now has acquired the remaining 40% of the minority shares resulting in 100% IQVIA's ownership.

Integer Holdings Corporation.

Overview: Integer Holdings is a medical device outsourcing company that serves various markets, such as cardiac, vascular, neuromodulation and portable medical markets. It provides a novel, innovative technologies with high quality to the medical device industry. It was established in 1940 and is headquartered in Texas, United States.

Product Portfolio:

QHR high-rate primary cells: These are commonly used for treating tachycardia in cardiac rhythm devices and for giving effective therapy in other implantable applications that need pulse currents of ampere-level. This QHR hybrid cathode technology is specially designed to provide high device performance and longevity in a small size.

Key Development: In Dec 2021, Integer Holdings Corporation, a manufacturer of medical device outsourcing, announced that it had completely acquired Oscor, Inc., a private company designing, developing and producing a portfolio of highly specific implantable devices, medical devices, and diagnostic catheters.

The global medical device outsourcing market report would provide access to approx. 45+ market data table, 40+ figures and 200 (approximate) pages.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

4. Market Dynamics

• 4.1. Market Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Reducing production cost
    • 4.1.1.2. Expansion of manufacturing facilities
  • 4.1.2. Restraints:
    • 4.1.2.1. Threat of loss of confidential information
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1 Porter's Five Forces Analysis
• 5.2 Supply Chain Analysis
• 5.3 Pricing Analysis
• 5.4 Regulatory Analysis

6. COVID-19 Analysis

• 6.1. Analysis of Covid-19 on the Market
  • 6.1.1. Before COVID-19 Market Scenario
  • 6.1.2. Present COVID-19 Market Scenario
  • 6.1.3. After COVID-19 or Future Scenario
• 6.2. Pricing Dynamics Amid Covid-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During the Pandemic
• 6.5. Manufacturer's Strategic Initiatives
• 6.6. Conclusion

7. By Product

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 7.1.2. Market Attractiveness Index, By Product
• 7.2. Raw Material *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 7.3. Electronics
• 7.4. Finished Goods

8. By Device Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 8.1.2. Market Attractiveness Index, By Device Type
• 8.2. Class I *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 8.3. Class II
• 8.4. Class III

9. By Services

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Services
  • 9.1.2. Market Attractiveness Index, By Services
• 9.2. Contract Device Manufacturing *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 9.3. Prototype Development
• 9.4. Clinic Research & Regulatory Support Services
• 9.5. Product Design and Development
• 9.6. Product Testing
• 9.7. Assembly & Packaging
• 9.8. Quality Assurance
• 9.9. Others

10. By Application

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.1.2. Market Attractiveness Index, By Application
• 10.2. Cardiovascular *
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 10.3. Orthopedic & Spine
• 10.4. Radiology
• 10.5. Drug Delivery
• 10.6. Ophthalmic
• 10.7. General Medical Devices
• 10.8. Others

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Services
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.7.1. U.S.
    • 11.2.7.2. Canada
    • 11.2.7.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Services
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.7.1. Germany
    • 11.3.7.2. U.K.
    • 11.3.7.3. France
    • 11.3.7.4. Italy
    • 11.3.7.5. Spain
    • 11.3.7.6. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Services
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.7.1. Brazil
    • 11.4.7.2. Argentina
    • 11.4.7.3. Rest of South America
• 11.5. Asia Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Services
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.7.1. China
    • 11.5.7.2. India
    • 11.5.7.3. Japan
    • 11.5.7.4. Australia
    • 11.5.7.5. Rest of Asia Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Services
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application

12. Competitive Landscape

• 12.1. Key Developments and Strategies
• 12.2. Company Share Analysis
• 12.3. Products Benchmarking
• 12.4. List of Key Companies to Watch

13. Company Profiles

• 13.1. Integer Holdings Corporation
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Key Highlights
  • 13.1.4. Financial Overview
• 13.2. Thermo Fisher Scientific
• 13.3. Nortech Systems, Inc.
• 13.4. Plexus Corp.
• 13.5. West Pharmaceutical Services, Inc
• 13.6. Celestica, Inc
• 13.7. Intertek Group
• 13.8. Wuxi Apptec
• 13.9. IQVIA Holdings
• 13.10. Benchmark Electronic Inc.

LIST NOT EXHAUSTIVE

14. Global Medical Device Outsourcing Market - DataM

• 14.1. Appendix
• 14.2. About Us and Services
• 14.3. Contact Us