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¼¼°èÀÇ Ã¼¿ÜÁø´Ü(IVD) ǰÁú°ü¸® ½ÃÀå ¿¹Ãø(-2030³â) : Á¦Ç° ¹× ¼­ºñ½º, ±â¼úº°, Á¦Á¶¾÷üº°, ÃÖÁ¾»ç¿ëÀÚº°

In Vitro Diagnostics (IVD) Quality Control Market by Product & Service (QC (Plasma, Serum, Blood), Solutions), Technology (Immunoassay, MDx, Microbiology, Hematology), Manufacturer (Third-party, OEM), End User (Hospitals, Labs) - Global Forecast to 2030

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¡Ø º» »óǰÀº ¿µ¹® ÀÚ·á·Î Çѱ۰ú ¿µ¹® ¸ñÂ÷¿¡ ºÒÀÏÄ¡ÇÏ´Â ³»¿ëÀÌ ÀÖÀ» °æ¿ì ¿µ¹®À» ¿ì¼±ÇÕ´Ï´Ù. Á¤È®ÇÑ °ËÅ並 À§ÇØ ¿µ¹® ¸ñÂ÷¸¦ Âü°íÇØÁֽñ⠹ٶø´Ï´Ù.

¼¼°èÀÇ IVD ǰÁú°ü¸® ½ÃÀå ±Ô¸ð´Â 2025³â¿¡ ÃßÁ¤ 16¾ï 5,000¸¸ ´Þ·¯·Î, 2030³â±îÁö 21¾ï 5,000¸¸ ´Þ·¯¿¡ ´ÞÇÒ °ÍÀ¸·Î ¿¹ÃøµÇ¸ç, ¿¹Ãø ±â°£¿¡ CAGR·Î 5.5%ÀÇ ¼ºÀåÀÌ Àü¸ÁµË´Ï´Ù.

Á¶»ç ¹üÀ§
Á¶»ç ´ë»ó ¿¬µµ 2023-2030³â
±âÁØ¿¬µµ 2024³â
¿¹Ãø ±â°£ 2025-2030³â
´ÜÀ§ ´Þ·¯
ºÎ¹® Á¦Ç°¡¤¼­ºñ½º, ±â¼ú, Á¦Á¶¾÷ü À¯Çü, ÃÖÁ¾»ç¿ëÀÚ
´ë»ó Áö¿ª ºÏ¹Ì, À¯·´, ¾Æ½Ã¾ÆÅÂÆò¾ç, ¶óƾ¾Æ¸Þ¸®Ä«, Áßµ¿ ¹× ¾ÆÇÁ¸®Ä«

IVD ǰÁú°ü¸®´Â ÀÓ»ó ½ÇÇè½Ç ¹× ÀÇ·á½Ã¼³ Àüü¿¡¼­ Áø´Ü °Ë»ç °á°úÀÇ Á¤È®¼º, ½Å·Ú¼º ¹× Àϰü¼ºÀ» º¸ÀåÇÏ´Â µ¥ Áß¿äÇÑ ¿ªÇÒÀ» ÇÕ´Ï´Ù. Ÿ»ç ǰÁú°ü¸®ÀÇ Ã¤Åà Ȯ´ë´Â IVD ǰÁú°ü¸® ½ÃÀåÀÇ ÁÖ¿ä ÃËÁø¿äÀÎ Áß ÇϳªÀÔ´Ï´Ù. ƯÁ¤ ±â±â °ü¸®¿Í ´Þ¸® Ÿ»ç ¼Ö·ç¼ÇÀº À¯¿¬¼ºÀÌ ³ô°í, ¿©·¯ Ç÷§Æû°ú ȣȯµÇ¸ç, º¸Á¸ ±â°£ÀÌ ±é´Ï´Ù.

ü¿ÜÁø´Ü(IVD) ǰÁú°ü¸® ½ÃÀå - IMG1

À̸¦ ÅëÇØ °øÁ¤ÇÑ ¼º´É Æò°¡¿Í ÀϰüµÈ ºÐ¼®¹°ÀÇ ¾ÈÁ¤¼ºÀ» Á¦°øÇϰí, ½ÇÇè½Ç¿¡¼­ ÀçÇö¼º ÀÖ°í ½Å·ÚÇÒ ¼ö ÀÖ´Â °á°ú¸¦ À¯ÁöÇÒ ¼ö ÀÖµµ·Ï µµ¿ÍÁÝ´Ï´Ù. ±ÔÁ¦ ¹× ÀÎÁõ¿¡ ´ëÇÑ ¿ä±¸»çÇ×ÀÌ Áõ°¡ÇÔ¿¡ µû¶ó °Ë»ç½ÇÀº ¿öÅ©Ç÷οì È¿À²¼ºÀ» ÃÖÀûÈ­ÇÏ°í ±ÔÁ¤ Áؼö¸¦ º¸ÀåÇϱâ À§ÇØ Å¸»ç °ü¸®¸¦ ¼±È£Çϰí ÀÖ½À´Ï´Ù. ´ÙÁß Ç׸ñ °ü¸®ÀÇ »ç¿ëÀÌ Áõ°¡ÇÔ¿¡ µû¶ó ¿©·¯ ºÐ¼®ÀÇ µ¿½Ã ¸ð´ÏÅ͸µÀÌ °¡´ÉÇÏ°í ¿î¿µ ºñ¿ëÀ» Àý°¨ÇÒ ¼ö ÀÖÀ¸¹Ç·Î ¼ö¿ä°¡ ´õ¿í Áõ°¡Çϰí ÀÖ½À´Ï´Ù. ƯÈ÷ º´¿ø°ú ÀÓ»ó°Ë»ç½ÇÀº ´ë·®ÀÇ °Ë»ç¿Í ´Ù¾çÇÑ Áø´Ü Àû¿ëÀ» Áö¿øÇϱâ À§ÇØ ÀÌ·¯ÇÑ ¼Ö·ç¼ÇÀ» äÅÃÇϰí ÀÖ½À´Ï´Ù. ÀÌ·¯ÇÑ Á¦3ÀÚ Ç°Áú°ü¸®·ÎÀÇ ÀüȯÀº ¼¼°è IVD ǰÁú°ü¸® ½ÃÀåÀÇ Çõ½Å, äÅà ¹× Áö¼ÓÀûÀÎ ¼ºÀåÀ» Áö¼ÓÀûÀ¸·Î ÃËÁøÇÒ °ÍÀÔ´Ï´Ù.

"Á¦Ç° ¹× ¼­ºñ½ºº°·Î´Â ǰÁú°ü¸® Á¦Ç° ºÎ¹®ÀÌ 2024³â IVD ǰÁú°ü¸® ½ÃÀåÀ» ÁÖµµÇß½À´Ï´Ù. "

2024³â,ǰÁú°ü¸® Á¦Ç°ÀÌ °¡Àå Å« Á¡À¯À²À» Â÷ÁöÇß½À´Ï´Ù. ÀÌ´Â Áø´Ü °Ë»ç Ƚ¼ö Áõ°¡¿Í Á¤È®ÇÏ°í ½Å·ÚÇÒ ¼ö ÀÖ´Â ÀçÇö¼º ÀÖ´Â °á°ú¿¡ ´ëÇÑ ´ÏÁî¿¡ ±âÀÎÇÕ´Ï´Ù. ±ÔÁ¦ ¹× ÀÎÁõ ¿ä°ÇÀº °Ë»ç½ÇÀÌ ±ÔÁ¤ Áؼö¸¦ À¯ÁöÇϰí ȯÀÚÀÇ ¾ÈÀüÀ» º¸ÀåÇÏ´Â °ÍÀ» ¸ñÇ¥·Î ÇϹǷΠǰÁú°ü¸® Á¦Ç°ÀÇ Ã¤ÅÃÀ» ´õ¿í ÃËÁøÇϰí ÀÖ½À´Ï´Ù. ǰÁú°ü¸® Á¦Ç°Àº ¿©·¯ ºÐ¼® ¹× Ç÷§Æû¿¡¼­ ÀϰüµÈ ¼º´É ¸ð´ÏÅ͸µÀ» ÅëÇØ ¿À·ù¸¦ ÁÙÀÌ°í ¿öÅ©Ç÷οìÀÇ È¿À²¼ºÀ» ³ôÀÏ ¼ö ÀÖµµ·Ï Áö¿øÇÕ´Ï´Ù. Ÿ»ç °ü¸® ¹× ´ÙÁß Ç׸ñ °ü¸®ÀÇ »ç¿ëÀÌ Áõ°¡ÇÔ¿¡ µû¶ó ÀÌ ºÎ¹®ÀÌ ´õ¿í °­È­µÇ¾î ¿î¿µ ºñ¿ëÀ» ÃÖÀûÈ­Çϸ鼭 µ¿½Ã¿¡ ¿©·¯ ºÐ¼®¹°À» µ¿½Ã¿¡ °Ë»çÇÒ ¼ö ÀÖ°Ô µÇ¾ú½À´Ï´Ù. Àü¹ÝÀûÀ¸·Î QC Á¦Ç°Àº ¿©ÀüÈ÷ ½ÇÇè½Ç ǰÁú°ü¸®ÀÇ ÁßÃßÀ̸ç, IVD ǰÁú°ü¸® ½ÃÀåÀ» µ¶Á¡ÇÏ´Â ºÎ¹®ÀÔ´Ï´Ù.

"Á¦Á¶¾÷ü À¯Çüº°·Î´Â Ÿ»ç °ü¸® ºÎ¹®ÀÌ ¿¹Ãø ±â°£ Áß °¡Àå ³ôÀº ¼ºÀå·üÀ» ³ªÅ¸³¾ °ÍÀ¸·Î ¿¹ÃøµË´Ï´Ù. "

¿¹Ãø ±â°£ Áß Å¸»ç °ü¸® ºÎ¹®ÀÌ °¡Àå ºü¸£°Ô ¼ºÀåÇÒ °ÍÀ¸·Î ¿¹ÃøµË´Ï´Ù. À̵éÀº ¿©·¯ Ç÷§Æû¿¡ ȣȯµÇ°í, º¸Á¸ ±â°£ÀÌ ±æ°í, ¼º´É Æò°¡¿¡ ´ëÇÑ Æí°ßÀÌ ¾ø±â ¶§¹®¿¡ °Ë»ç½Ç¿¡¼­ Á¡Á¡ ´õ ¼±È£µÇ°í ÀÖ½À´Ï´Ù. Ÿ»ç °ü¸®´Â ¶ÇÇÑ ´ÙÇ׸ñ °Ë»ç ¹× Ç¥ÁØÈ­µÈ QC ÀýÂ÷¸¦ Áö¿øÇÏ¿© ½ÇÇè½ÇÀÌ ¿öÅ©Ç÷οì È¿À²¼ºÀ» °³¼±ÇÏ°í ¹Ýº¹ °¡´ÉÇÑ °á°ú¸¦ º¸ÀåÇÒ ¼ö ÀÖµµ·Ï µµ¿ÍÁÝ´Ï´Ù. ƯÁ¤ ±â±â ¿ëµµ¿¡¼­ OEM °ü¸®ÀÇ Á߿伺Àº º¯ÇÔ¾øÁö¸¸, ´Ù¿ëµµÇÏ°í ºñ¿ë È¿À²ÀûÀÌ¸ç ½Å·ÚÇÒ ¼ö ÀÖ´Â ¼Ö·ç¼Ç¿¡ ´ëÇÑ ¼ö¿ä°¡ Áõ°¡ÇÔ¿¡ µû¶ó Àü ¼¼°è¿¡¼­ Ÿ»ç °ü¸®ÀÇ ±Þ¼ÓÇÑ Ã¤ÅÃÀÌ °è¼Ó Áõ°¡Çϰí ÀÖ½À´Ï´Ù.

"¾Æ½Ã¾ÆÅÂÆò¾çÀÌ ¿¹Ãø ±â°£ Áß °¡Àå ºü¸£°Ô ¼ºÀåÇÏ´Â ½ÃÀåÀÌ µÉ °ÍÀ¸·Î ¿¹ÃøµË´Ï´Ù. "

ÀÇ·á ÀÎÇÁ¶óÀÇ ±Þ¼ÓÇÑ ¹ßÀü°ú ÷´Ü Áø´Ü ±â¼ú¿¡ ´ëÇÑ ÅõÀÚ Áõ°¡·Î ¾Æ½Ã¾ÆÅÂÆò¾çÀº ¿¹Ãø ±â°£ Áß IVD ǰÁú°ü¸® ½ÃÀå¿¡¼­ °¡Àå ºü¸£°Ô ¼ºÀåÇÏ´Â Áö¿ªÀÌ µÉ °ÍÀ¸·Î ¿¹ÃøµË´Ï´Ù. ÀÌ Áö¿ª¿¡´Â ÀÓ»ó½ÇÇè½Ç, º´¿ø, Áø´Ü¼¾ÅÍÀÇ ¼ö°¡ Áõ°¡Çϰí ÀÖÀ¸¸ç, ½Å·ÚÇÒ ¼ö ÀÖ°í Á¤È®ÇÑ Ç°Áú°ü¸® Á¦Ç°¿¡ ´ëÇÑ ¼ö¿ä°¡ Áõ°¡Çϰí ÀÖ½À´Ï´Ù. Áúº´ Á¶±â ¹ß°ßÀÇ Á߿伺¿¡ ´ëÇÑ ÀνÄÀÌ ³ô¾ÆÁö¸é¼­ ±ÔÁ¦ ´ç±¹ÀÇ °Ë»ç½Ç Ç¥ÁØÀ» °³¼±ÇÏ·Á´Â ³ë·Â°ú ÇÔ²² ½ÃÀå ¼ºÀåÀ» ´õ¿í ÃËÁøÇϰí ÀÖ½À´Ï´Ù. ¶ÇÇÑ È¯ÀÚ ¼ö Áõ°¡¿Í ¸¸¼ºÁúȯ ¹× °¨¿°¼º ÁúȯÀÇ È®»êÀ¸·Î ÀÎÇØ Á¤È®¼º°ú ÀçÇö¼ºÀ» º¸ÀåÇϴ ǰÁú°ü¸® ¼Ö·ç¼Ç¿¡ ´ëÇÑ ¼ö¿ä°¡ Áõ°¡Çϰí ÀÖ½À´Ï´Ù.

¼¼°èÀÇ Ã¼¿ÜÁø´Ü(IVD) ǰÁú°ü¸® ½ÃÀå¿¡ ´ëÇØ Á¶»çºÐ¼®ÇßÀ¸¸ç, ÁÖ¿ä ÃËÁø¿äÀΰú ¾ïÁ¦¿äÀÎ, °æÀï ±¸µµ, ÇâÈÄ µ¿Çâ µîÀÇ Á¤º¸¸¦ Á¦°øÇϰí ÀÖ½À´Ï´Ù.

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Á¦10Àå IVD ǰÁú°ü¸® ½ÃÀå : Áö¿ªº°

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Á¦12Àå ±â¾÷ °³¿ä

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    • BIO-RAD LABORATORIES, INC.
    • THERMO FISHER SCIENTIFIC, INC.
    • ABBOTT
    • LGC LIMITED
    • F. HOFFMANN-LA ROCHE LTD.
    • RANDOX LABORATORIES LTD.
    • SIEMENS HEALTHINEERS AG
    • QUIDELORTHO CORPORATION
    • DANAHER CORPORATION
    • SYSMEX CORPORATION
    • BIO-TECHNE CORPORATION
    • MICROBIX BIOSYSTEMS INC.
    • GRIFOLS, S.A.
    • MICROBIOLOGICS, INC.
    • ZEPTOMETRIX
    • FORTRESS DIAGNOSTICS
  • ±âŸ ±â¾÷
    • HELENA LABORATORIES CORPORATION
    • STRECK, INC.
    • MAINE MOLECULAR QUALITY CONTROLS, INC.
    • SUN DIAGNOSTICS, LLC
    • SERO AS
    • CONEBIOPRODUCTS
    • ALPHA-TEC
    • EUROTROL B.V.
    • BIOREX DIAGNOSTICS

Á¦13Àå ºÎ·Ï

KSA 25.10.02

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.

Scope of the Report
Years Considered for the Study2023-2030
Base Year2024
Forecast Period2025-2030
Units ConsideredValue (USD)
SegmentsProduct & Service, Technology, Manufacturer Type, End User
Regions coveredNorth America, Europe, Asia Pacific, Latin America, and the Middle East & Africa

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.

In Vitro Diagnostics (IVD) Quality Control Market - IMG1

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.

"By product & service, the quality control products segment dominated the IVD quality controls market in 2024."

By product & service, the IVD quality controls market is segmented into quality control products, data management solutions, and quality assurance services. In 2024, quality control products held the largest share, driven by the increasing number of diagnostic tests and the need for accurate, reliable, and reproducible results. Regulatory and accreditation requirements further support their adoption, as laboratories aim to maintain compliance and ensure patient safety. Quality control products enable consistent performance monitoring across multiple assays and platforms, helping reduce errors and improve workflow efficiency. The rising use of third-party and multianalyte controls has further strengthened this segment, allowing simultaneous testing of multiple analytes while optimizing operational costs. Overall, QC products remain the backbone of laboratory quality management, making them the dominant segment within the IVD quality controls market.

"By manufacturer type, the third-party controls segment is projected to achieve the highest growth during the forecast period."

By manufacturer type, the IVD quality controls market is segmented into third-party controls and original equipment manufacturer (OEM) controls. Third-party controls are projected to be the fastest-growing segment during the forecast period. Their compatibility across multiple platforms, longer shelf life, and unbiased performance assessment make them increasingly preferred by laboratories. Third-party controls also support multianalyte testing and standardized QC procedures, helping laboratories improve workflow efficiency and ensure reproducible results. While OEM controls remain important for instrument-specific applications, the growing demand for versatile, cost-effective, and reliable solutions continues to drive the rapid adoption of third-party controls globally.

"The Asia Pacific is projected to be the fastest-growing regional market during the forecast period."

The market for IVD quality controls is categorized into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific is anticipated to be the fastest-growing region in the IVD quality controls market during the forecast period, driven by the rapid development of healthcare infrastructure and increasing investment in advanced diagnostic technologies. The region is witnessing a growing number of clinical laboratories, hospitals, and diagnostic centers, which is boosting the demand for reliable and accurate quality control products. Rising awareness about the importance of early disease detection, coupled with regulatory initiatives to improve laboratory standards, is further supporting market growth. Additionally, the expanding patient population and the rising prevalence of chronic and infectious diseases are creating strong demand for quality control solutions to ensure accuracy and reproducibility.

Breakdown of the profiles of primary participants in the IVD quality controls market:

  • By Company Type: Tier 1 (40%), Tier 2 (30%), and Tier 3 (30%)
  • By Designation: C-level Executives (27%), Director-level Executives (18%), and Others (55%)
  • By Region: North America (51%), Europe (21%), Asia Pacific (18%), Latin America (6%), and the Middle East & Africa (4%)

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)

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 STUDY OBJECTIVES
  • 1.2 MARKET DEFINITION
  • 1.3 STUDY SCOPE
    • 1.3.1 MARKETS COVERED & REGIONAL SCOPE
  • 1.4 INCLUSIONS & EXCLUSIONS
    • 1.4.1 YEARS CONSIDERED
  • 1.5 CURRENCY CONSIDERED
  • 1.6 KEY STAKEHOLDERS
  • 1.7 SUMMARY OF CHANGES

2 RESEARCH METHODOLOGY

  • 2.1 RESEARCH DATA
  • 2.2 RESEARCH APPROACH
    • 2.2.1 SECONDARY DATA
      • 2.2.1.1 Key secondary sources
      • 2.2.1.2 Key data from secondary sources
    • 2.2.2 PRIMARY DATA
      • 2.2.2.1 Primary sources
      • 2.2.2.2 Key data from primary sources
      • 2.2.2.3 Key industry insights
      • 2.2.2.4 Breakdown of primary interviews
  • 2.3 MARKET SIZE ESTIMATION
    • 2.3.1 BOTTOM-UP APPROACH
      • 2.3.1.1 Approach 1: Company revenue estimation approach
      • 2.3.1.2 Approach 2: Presentations of companies and primary interviews
      • 2.3.1.3 Growth forecast
      • 2.3.1.4 CAGR projections
    • 2.3.2 TOP-DOWN APPROACH
  • 2.4 MARKET BREAKDOWN & DATA TRIANGULATION
  • 2.5 MARKET SHARE ASSESSMENT
  • 2.6 RESEARCH ASSUMPTIONS
    • 2.6.1 PARAMETRIC ASSUMPTIONS
  • 2.7 RESEARCH LIMITATIONS
  • 2.8 RISK ASSESSMENT

3 EXECUTIVE SUMMARY

4 PREMIUM INSIGHTS

  • 4.1 IVD QUALITY CONTROLS MARKET OVERVIEW
  • 4.2 IVD QUALITY CONTROLS MARKET, BY PRODUCT & SERVICE, 2025 VS. 2030
  • 4.3 IVD QUALITY CONTROLS MARKET, BY TECHNOLOGY, 2025 VS. 2030
  • 4.4 IVD QUALITY CONTROLS MARKET, BY MANUFACTURER TYPE, 2025 VS. 2030
  • 4.5 IVD QUALITY CONTROLS MARKET, BY END USER, 2025 VS. 2030
  • 4.6 IVD QUALITY CONTROLS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES

5 MARKET OVERVIEW

  • 5.1 INTRODUCTION
  • 5.2 MARKET DYNAMICS
    • 5.2.1 DRIVERS
      • 5.2.1.1 Increasing number of accredited clinical laboratories
      • 5.2.1.2 Growing adoption of third-party quality controls
      • 5.2.1.3 Rising demand for external quality assessment support
      • 5.2.1.4 Rising geriatric population and subsequent growth in prevalence of chronic and infectious diseases
      • 5.2.1.5 Increasing adoption of POC instruments in developed regions
    • 5.2.2 RESTRAINTS
      • 5.2.2.1 Additional costs and budget constraints in hospitals and laboratories
      • 5.2.2.2 Unfavorable reimbursement scenario for IVD tests
    • 5.2.3 OPPORTUNITIES
      • 5.2.3.1 Rising demand for multianalyte controls
      • 5.2.3.2 Increasing growth opportunities in emerging economies
    • 5.2.4 CHALLENGES
      • 5.2.4.1 Stringent product approval process
      • 5.2.4.2 Lack of regulations for clinical laboratory accreditation in several emerging countries
  • 5.3 PRICING ANALYSIS
    • 5.3.1 AVERAGE SELLING PRICE TREND OF IVD QUALITY CONTROL PRODUCTS, 2023-2025
    • 5.3.2 AVERAGE SELLING PRICE TREND OF IVD QUALITY CONTROLS, BY KEY PLAYER, 2023-2025
    • 5.3.3 AVERAGE SELLING PRICE TREND OF IVD QUALITY CONTROL PRODUCTS, BY REGION, 2023-2025
  • 5.4 PATENT ANALYSIS
    • 5.4.1 LIST OF MAJOR PATENTS
  • 5.5 VALUE CHAIN ANALYSIS
  • 5.6 SUPPLY CHAIN ANALYSIS
  • 5.7 TRADE ANALYSIS
    • 5.7.1 IMPORT DATA (HS CODE 3822)
    • 5.7.2 EXPORT DATA (HS CODE 3822)
  • 5.8 ECOSYSTEM ANALYSIS
    • 5.8.1 IVD QUALITY CONTROLS MARKET: ROLE OF COMPANIES IN ECOSYSTEM
  • 5.9 PORTER'S FIVE FORCES ANALYSIS
    • 5.9.1 THREAT OF NEW ENTRANTS
    • 5.9.2 THREAT OF SUBSTITUTES
    • 5.9.3 BARGAINING POWER OF BUYERS
    • 5.9.4 BARGAINING POWER OF SUPPLIERS
    • 5.9.5 INTENSITY OF COMPETITIVE RIVALRY
  • 5.10 REGULATORY ANALYSIS
    • 5.10.1 REGULATORY FRAMEWORK
      • 5.10.1.1 North America
        • 5.10.1.1.1 US
        • 5.10.1.1.2 Canada
      • 5.10.1.2 Europe
        • 5.10.1.2.1 Germany
        • 5.10.1.2.2 UK
        • 5.10.1.2.3 France
        • 5.10.1.2.4 Italy
      • 5.10.1.3 Asia Pacific
        • 5.10.1.3.1 China
        • 5.10.1.3.2 Japan
        • 5.10.1.3.3 India
      • 5.10.1.4 Latin America
        • 5.10.1.4.1 Brazil
        • 5.10.1.4.2 Mexico
      • 5.10.1.5 Middle East
      • 5.10.1.6 Africa
    • 5.10.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
  • 5.11 TECHNOLOGY ANALYSIS
    • 5.11.1 KEY TECHNOLOGIES
      • 5.11.1.1 Immunoassays
    • 5.11.2 COMPLEMENTARY TECHNOLOGIES
      • 5.11.2.1 Molecular diagnostics
    • 5.11.3 ADJACENT TECHNOLOGIES
      • 5.11.3.1 Clinical chemistry
  • 5.12 KEY CONFERENCES & EVENTS, 2025-2026
  • 5.13 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS' BUSINESSES
  • 5.14 KEY STAKEHOLDERS & BUYING CRITERIA
    • 5.14.1 KEY STAKEHOLDERS IN BUYING PROCESS
    • 5.14.2 BUYING CRITERIA
  • 5.15 INVESTMENT & FUNDING SCENARIO
  • 5.16 CASE STUDY ANALYSIS
    • 5.16.1 CASE STUDY 1: QUALITY CONTROL DATA MANAGEMENT WITH UNITY REAL-TIME IN MOLECULAR VIROLOGY
    • 5.16.2 CASE STUDY 2: ENHANCING RELIABILITY OF INFLUENZA DIAGNOSTICS WITH EXTERNAL QUALITY CONTROLS
  • 5.17 IMPACT OF AI/GENERATIVE AI ON IVD QUALITY CONTROLS MARKET
    • 5.17.1 INTRODUCTION
    • 5.17.2 MARKET POTENTIAL OF AI
    • 5.17.3 AI USE CASES
    • 5.17.4 IMPLEMENTATION OF AI, BY KEY COMPANY AND USE CASE
    • 5.17.5 FUTURE OF AI IN IVD QUALITY CONTROLS MARKET
  • 5.18 IMPACT OF 2025 US TARIFFS ON IVD QUALITY CONTROLS MARKET
    • 5.18.1 INTRODUCTION
    • 5.18.2 KEY TARIFF RATES
    • 5.18.3 PRICE IMPACT ANALYSIS
    • 5.18.4 IMPACT ON COUNTRY/REGION
      • 5.18.4.1 North America
      • 5.18.4.2 Europe
      • 5.18.4.3 Asia Pacific
    • 5.18.5 IMPACT ON END-USE INDUSTRIES
      • 5.18.5.1 Hospitals
      • 5.18.5.2 Clinical laboratories
      • 5.18.5.3 Academic & research institutes

6 IVD QUALITY CONTROLS MARKET, BY PRODUCT & SERVICE

  • 6.1 INTRODUCTION
  • 6.2 QUALITY CONTROL PRODUCTS
    • 6.2.1 SERUM/PLASMA-BASED CONTROLS
      • 6.2.1.1 Greater stability and accuracy of diagnostic test results to increase demand for serum/plasma-based controls
    • 6.2.2 WHOLE BLOOD-BASED CONTROLS
      • 6.2.2.1 Rising need to ensure high-quality clinical test results to drive market
    • 6.2.3 URINE-BASED CONTROLS
      • 6.2.3.1 Growing incidence of kidney diseases to drive demand for urine-based controls
    • 6.2.4 OTHER CONTROLS
  • 6.3 DATA MANAGEMENT SOLUTIONS
    • 6.3.1 RISING FOCUS ON IMPROVING ANALYTICAL PERFORMANCE OF CLINICAL LABORATORIES TO SUPPORT MARKET GROWTH
  • 6.4 QUALITY ASSURANCE SERVICES
    • 6.4.1 GROWING NEED FOR PERFORMANCE ASSESSMENT OF CLINICAL LABORATORIES TO INCREASE DEMAND FOR QUALITY ASSURANCE SERVICES

7 IVD QUALITY CONTROLS MARKET, BY TECHNOLOGY

  • 7.1 INTRODUCTION
  • 7.2 IMMUNOASSAYS
    • 7.2.1 FOCUS ON MONITORING PRECISION OF IMMUNOASSAY TESTS TO DRIVE ADOPTION OF IMMUNOASSAY CONTROLS
  • 7.3 CLINICAL CHEMISTRY
    • 7.3.1 RISING INCIDENCE OF LIFESTYLE DISEASES TO PROVIDE OPPORTUNITIES FOR MARKET GROWTH
  • 7.4 MOLECULAR DIAGNOSTICS
    • 7.4.1 GROWING INCIDENCE OF INFECTIOUS DISEASES TO DRIVE DEMAND FOR MOLECULAR DIAGNOSTIC CONTROLS
  • 7.5 MICROBIOLOGY
    • 7.5.1 INCREASING ADOPTION OF AUTOMATED CLINICAL MICROBIOLOGY TESTING INSTRUMENTS TO SUPPORT MARKET GROWTH
  • 7.6 HEMATOLOGY
    • 7.6.1 NEED FOR ACCURACY IN HEMATOLOGICAL TEST RESULTS TO DRIVE RELIANCE ON HEMATOLOGY QUALITY CONTROLS
  • 7.7 COAGULATION & HEMOSTASIS
    • 7.7.1 GROWING NUMBER OF CARDIOVASCULAR SURGERIES TO DRIVE DEMAND FOR COAGULATION & HEMOSTASIS TESTING
  • 7.8 OTHER TECHNOLOGIES

8 IVD QUALITY CONTROLS MARKET, BY MANUFACTURER TYPE

  • 8.1 INTRODUCTION
  • 8.2 THIRD-PARTY CONTROLS
    • 8.2.1 INDEPENDENT CONTROLS
      • 8.2.1.1 Unbiased and independent performance assessment for analytical processes to drive adoption
    • 8.2.2 INSTRUMENT-SPECIFIC CONTROLS
      • 8.2.2.1 Dependence on instrument-specific compatibility to restrict demand
  • 8.3 ORIGINAL EQUIPMENT MANUFACTURER CONTROLS
    • 8.3.1 OEM CONTROLS TO WITNESS LOWER ADOPTION AS THEY ARE LESS SENSITIVE TO QC-RELATED ISSUES

9 IVD QUALITY CONTROLS MARKET, BY END USER

  • 9.1 INTRODUCTION
  • 9.2 HOSPITALS
    • 9.2.1 LARGE VOLUME OF IVD PROCEDURES PERFORMED TO DRIVE MARKET
  • 9.3 CLINICAL LABORATORIES
    • 9.3.1 GROWING NUMBER OF ACCREDITED LABORATORIES TO DRIVE MARKET
  • 9.4 ACADEMIC & RESEARCH INSTITUTES
    • 9.4.1 RISING FOCUS ON ACCURATE RESEARCH RESULTS TO SUPPORT MARKET GROWTH
  • 9.5 OTHER END USERS

10 IVD QUALITY CONTROLS MARKET, BY REGION

  • 10.1 INTRODUCTION
  • 10.2 NORTH AMERICA
    • 10.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA
    • 10.2.2 US
      • 10.2.2.1 High healthcare expenditure to propel market growth
    • 10.2.3 CANADA
      • 10.2.3.1 Government initiatives and research funding to support market growth
  • 10.3 EUROPE
    • 10.3.1 MACROECONOMIC OUTLOOK FOR EUROPE
    • 10.3.2 GERMANY
      • 10.3.2.1 Rising volume of high-quality tests performed to support market growth
    • 10.3.3 UK
      • 10.3.3.1 Growing number of diagnostic centers to drive market
    • 10.3.4 FRANCE
      • 10.3.4.1 Increasing prevalence of infectious diseases and growing demand for early diagnosis to drive market
    • 10.3.5 ITALY
      • 10.3.5.1 Growing disease prevalence to drive demand for better and more accurate disease diagnosis
    • 10.3.6 SPAIN
      • 10.3.6.1 Rising incidence of chronic diseases to support market growth
    • 10.3.7 RUSSIA
      • 10.3.7.1 Increasing access to quality healthcare and growing incidence of lifestyle and infectious diseases to drive market
    • 10.3.8 REST OF EUROPE
  • 10.4 ASIA PACIFIC
    • 10.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC
    • 10.4.2 CHINA
      • 10.4.2.1 Growing access to modern healthcare and government support to boost market growth
    • 10.4.3 JAPAN
      • 10.4.3.1 Well-developed healthcare system and demand for improvements in quality of IVD test results to drive market
    • 10.4.4 INDIA
      • 10.4.4.1 Rising need to secure NABL accreditations to drive demand for quality controls
    • 10.4.5 AUSTRALIA
      • 10.4.5.1 Initiatives to enhance access to healthcare and improve infrastructure to propel market growth
    • 10.4.6 SOUTH KOREA
      • 10.4.6.1 Rising healthcare expenditure and growing number of hospitals to drive market
    • 10.4.7 REST OF ASIA PACIFIC
  • 10.5 LATIN AMERICA
    • 10.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA
    • 10.5.2 BRAZIL
      • 10.5.2.1 Brazil to dominate Latin American IVD quality controls market
    • 10.5.3 MEXICO
      • 10.5.3.1 Increasing number of accredited clinical laboratories to support market growth
    • 10.5.4 REST OF LATIN AMERICA
  • 10.6 MIDDLE EAST & AFRICA
    • 10.6.1 MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA
    • 10.6.2 SAUDI ARABIA
      • 10.6.2.1 Rising government healthcare expenditure to boost market
    • 10.6.3 UAE
      • 10.6.3.1 Improvements in healthcare infrastructure to support growth
    • 10.6.4 REST OF MIDDLE EAST & AFRICA

11 COMPETITIVE LANDSCAPE

  • 11.1 INTRODUCTION
  • 11.2 KEY PLAYER STRATEGIES/RIGHT TO WIN
    • 11.2.1 OVERVIEW OF STRATEGIES DEPLOYED BY PLAYERS IN IVD QUALITY CONTROLS MARKET
  • 11.3 REVENUE ANALYSIS, 2022-2024
  • 11.4 MARKET SHARE ANALYSIS, 2024
  • 11.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024
    • 11.5.1 STARS
    • 11.5.2 EMERGING LEADERS
    • 11.5.3 PERVASIVE PLAYERS
    • 11.5.4 PARTICIPANTS
    • 11.5.5 COMPANY FOOTPRINT: KEY PLAYERS, 2024
      • 11.5.5.1 Company footprint
      • 11.5.5.2 Region footprint
      • 11.5.5.3 Product & service footprint
      • 11.5.5.4 Technology footprint
      • 11.5.5.5 Manufacturer type footprint
  • 11.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024
    • 11.6.1 PROGRESSIVE COMPANIES
    • 11.6.2 RESPONSIVE COMPANIES
    • 11.6.3 DYNAMIC COMPANIES
    • 11.6.4 STARTING BLOCKS
    • 11.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2024
      • 11.6.5.1 Detailed list of key startups/SMEs
      • 11.6.5.2 Competitive benchmarking of key emerging players/startups, by product & service and manufacturer type
      • 11.6.5.3 Competitive benchmarking of key startups/SMEs, by region
  • 11.7 COMPANY VALUATION & FINANCIAL METRICS
    • 11.7.1 FINANCIAL METRICS
    • 11.7.2 COMPANY VALUATION
  • 11.8 BRAND/PRODUCT COMPARISON
    • 11.8.1 BRAND/PRODUCT COMPARATIVE ANALYSIS
  • 11.9 COMPETITIVE SCENARIO
    • 11.9.1 PRODUCT & SERVICE LAUNCHES AND APPROVALS
    • 11.9.2 DEALS
    • 11.9.3 EXPANSIONS

12 COMPANY PROFILES

  • 12.1 KEY PLAYERS
    • 12.1.1 BIO-RAD LABORATORIES, INC.
      • 12.1.1.1 Business overview
      • 12.1.1.2 Products & services offered
      • 12.1.1.3 Recent developments
        • 12.1.1.3.1 Product & service launches
        • 12.1.1.3.2 Deals
      • 12.1.1.4 MnM view
        • 12.1.1.4.1 Key strengths
        • 12.1.1.4.2 Strategic choices
        • 12.1.1.4.3 Weaknesses & competitive threats
    • 12.1.2 THERMO FISHER SCIENTIFIC, INC.
      • 12.1.2.1 Business overview
      • 12.1.2.2 Products & services offered
      • 12.1.2.3 Recent developments
        • 12.1.2.3.1 Deals
      • 12.1.2.4 MnM view
        • 12.1.2.4.1 Key strengths
        • 12.1.2.4.2 Strategic choices
        • 12.1.2.4.3 Weaknesses & competitive threats
    • 12.1.3 ABBOTT
      • 12.1.3.1 Business overview
      • 12.1.3.2 Products & services offered
      • 12.1.3.3 MnM view
        • 12.1.3.3.1 Key strengths
        • 12.1.3.3.2 Strategic choices
        • 12.1.3.3.3 Weaknesses & competitive threats
    • 12.1.4 LGC LIMITED
      • 12.1.4.1 Business overview
      • 12.1.4.2 Products & services offered
      • 12.1.4.3 Recent developments
        • 12.1.4.3.1 Deals
      • 12.1.4.4 MnM view
        • 12.1.4.4.1 Key strengths
        • 12.1.4.4.2 Strategic choices
        • 12.1.4.4.3 Weaknesses & competitive threats
    • 12.1.5 F. HOFFMANN-LA ROCHE LTD.
      • 12.1.5.1 Business overview
      • 12.1.5.2 Products & services offered
      • 12.1.5.3 Recent developments
        • 12.1.5.3.1 Deals
      • 12.1.5.4 MnM view
        • 12.1.5.4.1 Key strengths
        • 12.1.5.4.2 Strategic choices
        • 12.1.5.4.3 Weaknesses & competitive threats
    • 12.1.6 RANDOX LABORATORIES LTD.
      • 12.1.6.1 Business overview
      • 12.1.6.2 Products & services offered
      • 12.1.6.3 Recent developments
        • 12.1.6.3.1 Product & service launches
        • 12.1.6.3.2 Deals
    • 12.1.7 SIEMENS HEALTHINEERS AG
      • 12.1.7.1 Business overview
      • 12.1.7.2 Products & services offered
    • 12.1.8 QUIDELORTHO CORPORATION
      • 12.1.8.1 Business overview
      • 12.1.8.2 Products & services offered
      • 12.1.8.3 Recent developments
        • 12.1.8.3.1 Deals
        • 12.1.8.3.2 Expansions
    • 12.1.9 DANAHER CORPORATION
      • 12.1.9.1 Business overview
      • 12.1.9.2 Products & services offered
    • 12.1.10 SYSMEX CORPORATION
      • 12.1.10.1 Business overview
      • 12.1.10.2 Products & services offered
      • 12.1.10.3 Recent developments
        • 12.1.10.3.1 Product & service launches
        • 12.1.10.3.2 Deals
        • 12.1.10.3.3 Expansions
    • 12.1.11 BIO-TECHNE CORPORATION
      • 12.1.11.1 Business overview
      • 12.1.11.2 Products & services offered
      • 12.1.11.3 Recent developments
        • 12.1.11.3.1 Product & service launches
        • 12.1.11.3.2 Deals
        • 12.1.11.3.3 Expansions
    • 12.1.12 MICROBIX BIOSYSTEMS INC.
      • 12.1.12.1 Business overview
      • 12.1.12.2 Products & services offered
      • 12.1.12.3 Recent developments
        • 12.1.12.3.1 Product & service launches
        • 12.1.12.3.2 Deals
    • 12.1.13 GRIFOLS, S.A.
      • 12.1.13.1 Business overview
      • 12.1.13.2 Products & services offered
    • 12.1.14 MICROBIOLOGICS, INC.
      • 12.1.14.1 Business overview
      • 12.1.14.2 Products & services offered
      • 12.1.14.3 Recent developments
        • 12.1.14.3.1 Deals
    • 12.1.15 ZEPTOMETRIX
      • 12.1.15.1 Business overview
      • 12.1.15.2 Products & services offered
      • 12.1.15.3 Recent developments
        • 12.1.15.3.1 Product & service launches & approvals
    • 12.1.16 FORTRESS DIAGNOSTICS
      • 12.1.16.1 Business overview
      • 12.1.16.2 Products & services offered
  • 12.2 OTHER PLAYERS
    • 12.2.1 HELENA LABORATORIES CORPORATION
    • 12.2.2 STRECK, INC.
    • 12.2.3 MAINE MOLECULAR QUALITY CONTROLS, INC.
    • 12.2.4 SUN DIAGNOSTICS, LLC
    • 12.2.5 SERO AS
    • 12.2.6 CONEBIOPRODUCTS
    • 12.2.7 ALPHA-TEC
    • 12.2.8 EUROTROL B.V.
    • 12.2.9 BIOREX DIAGNOSTICS

13 APPENDIX

  • 13.1 DISCUSSION GUIDE
  • 13.2 KNOWLEDGESTORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL
  • 13.3 CUSTOMIZATION OPTIONS
  • 13.4 RELATED REPORTS
  • 13.5 AUTHOR DETAILS
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