| 出版社 | MarketsandMarkets |
| 出版年月 | 2025年9月 |
In Vitro Diagnostics (IVD) Quality Control Market – Global Forecast to 2030
体外診断（IVD）品質管理市場 – 製品とサービス [QC（血漿、血清、血液）、ソリューション]、技術（免疫測定、MDx、微生物学、血液学）、メーカー（サードパーティ、OEM）、エンドユーザー（病院、研究所） – 2030年までの世界予測
この調査レポートでは、体外診断（IVD）品質管理市場を、製品とサービス（品質管理製品、データ管理ソリューション、品質保証サービス）、技術（免疫測定法、臨床化学、分子診断、微生物学、血液学、凝固および止血、その他の技術）、メーカータイプ（サードパーティ管理（独立管理、機器固有の管理、OEM管理）、エンドユーザー（病院、臨床検査室、学術研究機関、その他のエンドユーザー）、地域（北米、ヨーロッパ、アジア太平洋、ラテンアメリカ、中東およびアフリカ）別に分類しています。
本レポートは、体外診断（IVD）品質管理市場の成長に影響を与える主要な要因（促進要因、制約要因、機会、課題など）に関する詳細な情報を網羅しています。主要業界プレーヤーの詳細な分析により、各社の事業概要、ソリューション、主要戦略、買収、契約に関する洞察を提供しています。また、IVD品質管理市場エコシステムにおける新興企業の競合分析も含まれています。
本レポートは、体外診断（IVD）品質管理市場全体および各サブセグメントの収益数値の近似値に関する情報を提供し、市場リーダーおよび新規参入企業にとって役立ちます。また、関係者が競争環境を理解し、事業のポジショニングを改善し、適切な市場開拓戦略を策定するための洞察を深めるのに役立ちます。さらに、本レポートは、関係者が市場の動向を把握し、主要な市場牽引要因、制約要因、機会、課題に関する情報を提供するのに役立ちます。
体外診断（IVD）品質管理市場は、2025年に16億5,000万米ドルに達すると推定され、予測期間中に5.5％のCAGRで成長し、2030年までに21億5,000万米ドルに達すると予測されています。
体外診断（IVD）品質管理は、臨床検査室や医療施設における診断検査結果の正確性、信頼性、一貫性を確保する上で重要な役割を果たしています。サードパーティ製品質管理の導入拡大は、IVD品質管理市場の主要な推進力の一つです。機器固有の管理とは異なり、サードパーティ製ソリューションは、より高い柔軟性、複数のプラットフォーム間の互換性、そしてより長い保存期間を提供します。これらは、偏りのない性能評価と一貫した分析対象物の安定性を提供し、検査室が再現性と信頼性の高い結果を維持するのに役立ちます。規制および認定要件の強化に伴い、検査室はコンプライアンスを確保しながらワークフローの効率を最適化するために、サードパーティ製管理を採用しています。多検体管理の利用拡大は、複数のアッセイの同時モニタリングを可能にし、運用コストを削減することで、需要をさらに高めています。特に病院や臨床検査室は、大量検査と多様な診断アプリケーションをサポートするために、これらのソリューションを導入しています。サードパーティ製品質管理へのこうした移行は、世界の体外診断（IVD）品質管理市場におけるイノベーション、導入、そして持続的な成長を促進し続けています。
The IVD quality controls market is valued at an estimated USD 1.65 billion in 2025 and is projected to reach USD 2.15 billion by 2030, at a CAGR of 5.5% during the forecast period.
IVD quality controls play a critical role in ensuring the accuracy, reliability, and consistency of diagnostic test results across clinical laboratories and healthcare facilities. The growing adoption of third-party quality controls is one of the major drivers of the IVD quality controls market. Unlike instrument-specific controls, third-party solutions offer greater flexibility, compatibility across multiple platforms, and longer shelf life. They provide unbiased performance assessment and consistent analyte stability, helping laboratories maintain reproducible and reliable results. With increasing regulatory and accreditation requirements, laboratories are favoring third-party controls to ensure compliance while optimizing workflow efficiency. The rising use of multianalyte controls further enhances demand, allowing simultaneous monitoring of multiple assays and reducing operational costs. Hospitals and clinical laboratories, in particular, are adopting these solutions to support high-volume testing and diverse diagnostic applications. This shift toward third-party quality controls continues to drive innovation, adoption, and sustained growth in the global IVD quality controls market.
In Vitro Diagnostics (IVD) Quality Control Market – Global Forecast to 2030
The key players in the IVD quality controls market are Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott (US), LGC Limited (UK), F. Hoffmann-La Roche Ltd. (Switzerland), Randox Laboratories Ltd. (UK), Siemens Healthineers AG (Germany), QuidelOrtho Corporation (US), Danaher Corporation (US), Sysmex Corporation (Japan), Bio-Techne Corporation (US), Microbix Biosystems Inc. (Canada), Microbiologics, Inc. (US), ZeptoMetrix (US), Fortress Diagnostics (UK), Helena Laboratories Corporation (US), Streck, Inc. (US), SERO AS (Norway), Maine Molecular Quality Controls, Inc. (US), Sun Diagnostics, LLC (US), Alpha-Tec (US), Grifols, S.A. (Spain), ConeBioproducts (US), Eurotrol B.V. (Netherlands), and Biorex Diagnostics (UK).
Research Coverage:
This research report categorizes the IVD quality controls market by product & service (quality control products, data management solutions, and quality assurance services), technology (immunoassays, clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation & hemostasis, and other technologies), manufacturer type [third-party controls ([independent controls, instrument-specific controls), original equipment manufacturer controls], end user (hospitals, clinical laboratories, academic & research institutes, and other end users), and region (North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa).
The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, opportunities, and challenges influencing the growth of the IVD quality controls market. A detailed analysis of the key industry players has been done to provide insights into their business overview, solutions, key strategies, acquisitions, and agreements. A competitive analysis of upcoming startups in the IVD quality controls market ecosystem is covered in this report.
Reasons to Buy this Report:
The report will help market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall IVD quality controls market and the subsegments. It will also help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, restraints, opportunities, and challenges.
The report provides insights into the following pointers:
- Analysis of key drivers (increasing number of accredited clinical laboratories, growing adoption of third-party quality controls, rising demand for external quality assessment support, rising geriatric population and subsequent growth in prevalence of chronic and infectious diseases, and increasing adoption of PoC instruments in developed regions), opportunities (rising demand for multianalyte controls and increasing growth opportunities in emerging economies), restraints (additional costs and budget constraints in hospitals and laboratories and unfavorable reimbursement scenario for IVD tests), and challenges (stringent product approval process and lack of regulations for clinical laboratory accreditation in several emerging countries) influencing the growth of the IVD quality controls market.
- Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the IVD quality controls market
- Market Development: Comprehensive information about lucrative markets across varied regions
- Market Diversification: Exhaustive information about products, untapped geographies, recent developments, and investments in the IVD quality controls market
- Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players like Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott (US), LGC Limited (UK), and F. Hoffmann-La Roche Ltd. (Switzerland)