医療機器試験サービスの世界市場 - 市場規模、シェア、成長分析：サービス別（生体適合性検査、化学検査）、フェーズ別（前臨床、臨床） - 業界予測（2023年～2030年）

世界の医療機器試験サービスの市場規模には、安全性と有効性を確保するための医療機器の評価と検証が含まれます。この分野は、厳しい規制と高品質のヘルスケア製品に対する需要の高まりにより成長を遂げてきました。提供されるサービスには、機能性、生体適合性、無菌性などのテストが含まれます。市場の拡大は、技術の進歩、患者の安全に対する意識の高まり、国際規格への準拠の必要性によって推進されています。このダイナミックな業界は、医療機器の完全性を維持し、最終的には世界中の患者ケアを向上させる上で重要な役割を果たしています。

医療機器の規制基準と前提条件がますます厳しくなっているため、徹底した試験サービスのニーズが高まっています。メーカーは、自社の製品が規制当局の承認を取得し、市場で受け入れられるために不可欠な安全性と有効性の基準を満たしていることを保証するための対策を積極的に追求しています。

ウェアラブルデバイス、遠隔医療ツール、低侵襲手術機器の開発に代表される、医療機器技術の途切れることのない革新は、厳格なテストの不可欠性を強調しています。パフォーマンス、精度、安全性の検証が重要となり、業界動向のダイナミックな変化に合わせて専門的なテストサービスの需要が高まっています。

医療機器の評価は複雑であり、多くの場合、複雑な手順や特殊な装置が必要となるため、多額のコストがかかる可能性があります。これは、小規模生産者、新興ベンチャー企業、および資金が限られている企業にとって、広範な評価サービスを調達する際に困難を引き起こす可能性があります。その結果、製品の進歩のペースが妨げられ、迅速な市場浸透が妨げられる可能性があります。

FDAや欧州医薬品庁などの規制機関からの監視の強化に対応して、医療機器メーカーは品質と安全基準の厳格な順守を確保することに重点を置いています。この重要性の高まりにより、医療機器の性能、安全性、有効性を検証することを目的とした包括的な試験サービスに対する需要が高まっています。この分野のサービスプロバイダーは、メーカーが複雑な規制状況に対処できるよう支援するために、市場前と市場後の両方のテストをカバーする幅広い規制要件を網羅する能力を拡張しています。

当レポートは、世界の医療機器検査サービス市場について調査し、市場の概要とともに、サービス別、フェーズ別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

エグゼクティブサマリー

親市場分析

市場規模

• 市場力学
• 促進要因
• 機会
• 抑制要因
• 課題

主要な市場の洞察

• 技術分析
• 価格分析
• サプライチェーン分析
• バリューチェーン分析
• 市場のエコシステム
• IP分析
• 動向分析
• スタートアップ分析
• 原材料分析
• イノベーションマトリックス
• パイプライン製品分析
• マクロ経済指標
• トップ投資分析
• 主な成功要因
• 競合の程度

市場力学と見通し

• 市場力学
• 促進要因
• 機会
• 抑制要因
• 課題
• 規制状況
• ポーター分析

世界の医療機器検査サービス市場、サービス別

• 市場概要
• 生体適合性試験
• 化学試験
• 微生物学・無菌試験
• バイオバーデンの決定
• 発熱物質とエンドトキシンの検査
• 無菌試験と検証
• 抗菌活性試験
• その他

世界の医療機器検査サービス市場、フェーズ別

• 市場概要
• 前臨床
• 臨床

世界の医療機器検査サービス市場、地域別

• 市場概要
• 北米
• 欧州
• アジア太平洋
• ラテンアメリカ
• 中東・アフリカ

競合情勢

• 主要企業プロファイル
  • SGS SA
  • Toxikon, Inc
  • American Preclinical Services
  • Sterigenics International LLC
  • River Laboratories International Inc
  • Medical Device Testing Services
  • North America Science Associates Inc
  • Eurofins Scientific
  • Pace Analytical Services LLC
  • Intertek Group Plc

Global Medical Device Testing Services Market Size, Share, Growth Analysis, By Services (Biocompatibility Tests, Chemistry Test), By Phase (Preclinical, and Clinical) - Industry Forecast 2023-2030

The Global Medical Device Testing Services Market encompasses the assessment and validation of medical devices to ensure safety and efficacy. This sector has experienced growth due to stringent regulations and the rising demand for quality healthcare products. Services offered include testing for functionality, biocompatibility, sterility, and more. The market's expansion is driven by technological advancements, increasing awareness of patient safety, and the need for compliance with international standards. This dynamic industry plays a crucial role in maintaining the integrity of medical devices and ultimately enhancing patient care worldwide.

Top-down and bottom-up approaches were used to estimate and validate the size of medical device testing services and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined by using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Segmental Analysis

The global medical device testing services market is segmented on the basis of services, phase, and region. By services, the market is segmented into biocompatibility tests, microbiology & sterility testing, chemistry test, bioburden determination, pyrogen & endotoxin testing, sterility test and validation, antimicrobial activity testing, and others. By Phase, the market is segmented into Preclinical, and Clinical. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

Drivers

Adherence to Regulatory Standards and Quality Assurance

The escalating rigor in regulatory standards and prerequisites for medical devices has spurred an increased need for thorough testing services. Manufacturers are actively pursuing measures to guarantee that their products meet the safety and efficacy criteria essential for obtaining regulatory approvals and gaining acceptance in the market.

Swift Technological Progress

Uninterrupted innovation in medical device technologies, exemplified by developments in wearable devices, telemedicine tools, and minimally invasive surgical equipment, underscores the imperative for stringent testing. Validation of performance, accuracy, and safety becomes crucial, propelling the demand for specialized testing services to align with the dynamic shifts in industry trends.

Restraints

Elevated Testing Expenditures

The intricate complexity of evaluating medical devices, which frequently entails intricate procedures and specialized apparatus, can result in substantial costs. This might pose difficulties for smaller producers, emerging ventures, and those with restricted funds in procuring extensive assessment services. Consequently, it could hinder the pace of product advancement and hinder swift market penetration.

Market Trends

Increasing Focus on Regulatory Adherence and Quality Assurance

In response to heightened scrutiny from regulatory entities like the FDA and the European Medicines Agency, manufacturers of medical devices are placing greater emphasis on ensuring strict adherence to quality and safety standards. This heightened emphasis has resulted in a growing demand for comprehensive testing services aimed at validating the performance, safety, and efficacy of medical devices. Service providers in this domain are expanding their capabilities to encompass a broad spectrum of regulatory requirements, covering both pre-market and post-market testing, to assist manufacturers in navigating intricate regulatory landscapes.

Technological Progress in Testing

The market for medical device testing services is undergoing a swift transformation in testing methodologies and technologies. This transformation includes the integration of advanced techniques such as artificial intelligence (AI), machine learning, and simulation models to enhance the precision, speed, and efficiency of testing processes. Additionally, the increasing adoption of virtual and augmented reality in testing environments allows for realistic simulations of device interactions within the human body. These technological advancements facilitate more accurate and comprehensive testing, ultimately reducing development time and costs for medical device manufacturers.

Table of Contents

Executive Summary

• Market Overview
• Wheel of Fortune
• Research Methodology
• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Parent Market Analysis

• Market Overview
• Market Size
• Market Dynamics
• Drivers
• Opportunities
• Restraints
• Challenges
• Key Market Insights
• Technology Analysis
• Pricing Analysis
• Supply Chain Analysis
• Value Chain Analysis
• Ecosystem of the Market
• IP Analysis
• Trade Analysis
• Startup Analysis
• Raw Material Analysis
• Innovation Matrix
• Pipeline Product Analysis
• Macroeconomic Indicators
• Top Investment Analysis
• Key Success Factor
• Degree of Competition
• Market Dynamics & Outlook
• Market Dynamics
• Drivers
• Opportunities
• Restraints
• Challenges
• Regulatory Landscape
• Porters Analysis
• Competitive rivalry
• Threat of Substitute Products
• Bargaining Power of Buyers
• Threat of New Entrants
• Bargaining Power of Suppliers
• Skyquest Special Insights on Future Disruptions
• Political Impact
• Economic Impact
• Social Impact
• Technical Impact
• Environmental Impact
• Legal Impact
• Global Medical Device Testing Services Market by Services
• Market Overview
• Biocompatibility Tests
• Chemistry Test
• Microbiology & Sterility Testing
• Bioburden Determination
• Pyrogen & Endotoxin Testing
• Sterility Test and Validation
• Antimicrobial Activity Testing
• and Others.
• Global Medical Device Testing Services Market by Phase
• Market Overview
• Preclinical
• and Clinical
• Global Medical Device Testing Services Market Size by Region
• Market Overview
• North America
• USA
• Canada
• Europe
• Germany
• Spain
• France
• UK
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• South Korea
• Rest of Asia-Pacific
• Latin America
• Brazil
• Rest of Latin America
• Middle East & Africa (MEA)
• GCC Countries
• South Africa
• Rest of MEA
• Competitive Landscape
• Top 5 Player Comparison
• Market Positioning of Key Players, 2021
• Strategies Adopted by Key Market Players
• Top Winning Strategies
• By Development
• By Company
• By Year
• Recent Activities in the Market
• Key Companies Market Share (%), 2021
• Key Company Profiles
• SGS SA - Switzerland
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• Toxikon, Inc - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• American Preclinical Services - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• Sterigenics International LLC - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• River Laboratories International Inc - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• Medical Device Testing Services - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• North America Science Associates Inc - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• Eurofins Scientific - Luxembourg
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• Pace Analytical Services LLC - United States
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments
• Intertek Group Plc - United Kingdom
• Company Overview
• Business Segment Overview
• Financial Updates
• Key Developments