The global in vitro diagnostics quality control market size was estimated at USD 1.28 billion in 2023 and is projected to reach USD 1.59 billion by 2030, growing at a CAGR of 3.2% from 2024 to 2030. This growth is primarily driven by the increasing number of certified clinical laboratories providing reliable IVD-based diagnostic services, which in turn enhances patient confidence and fuels demand for high-quality diagnostic testing.

A wide range of key pathogens are routinely diagnosed using multiplex PCR, including HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachomatis (genital infections), G. lamblia, C. parvum (diarrheal diseases), and Leishmania spp. (Leishmaniasis). The ability to detect multiple pathogens efficiently underscores the critical role of IVD QC products in ensuring accurate and reliable laboratory results.

Regulatory frameworks are periodically updated to enhance quality standards and safeguard the accuracy and reliability of diagnostic services provided to patients. The high prevalence of diseases such as diabetes, cardiovascular conditions, and infectious diseases has led to increased demand for diagnostic testing, prompting many private and public laboratories to undergo accreditation processes. These procedures help laboratories meet industry standards, expand test volumes, and attract more patients, further driving the need for high-quality IVD QC products globally.

Key Market Trends & Insights:

• In 2023, the North America in vitro diagnostics (IVD) quality control market emerged as the dominant regional market, accounting for a 47.1% share of the global market. This leadership can be attributed to the region’s advanced healthcare infrastructure, the presence of numerous certified clinical laboratories, and the widespread adoption of high-quality diagnostic testing practices.

• Within the region, the U.S. IVD quality control market accounted for a significant portion of the global market in 2023, reflecting the country’s strong focus on laboratory accreditation, regulatory compliance, and investment in cutting-edge diagnostic technologies.

• When analyzed by product type, the controls segment held the largest share, representing 48.3% of the market in 2023. This indicates that control products continue to be essential for ensuring the accuracy, reliability, and standardization of diagnostic testing procedures across laboratories.

• By type, the quality controls segment accounted for the largest market revenue share in 2023, highlighting the increasing emphasis on maintaining stringent quality standards in laboratory testing to guarantee reliable patient results.

• In terms of application, the immunochemistry segment held the largest revenue share in 2023. This reflects the widespread use of immunochemistry-based assays in diagnosing a variety of conditions, including infectious diseases, metabolic disorders, and hormone-related illnesses, driving the demand for specialized IVD quality control products in this segment.

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Market Size & Forecast:

• 2023 Market Size: USD 1.28 Billion

• 2030 Projected Market Size: USD 1.59 Billion

• CAGR (2024-2030): 3.2%

• North America: Largest market in 2023

• Asia Pacific: Fastest growing market

Key Companies & Market Share Insights:

Some of the key players in the global in vitro diagnostics (IVD) quality control market include Siemens Healthineers AG, Abbott, Bio-Rad Laboratories, and Danaher. These companies are recognized for their extensive product portfolios, global presence, and continuous innovation in diagnostic solutions.

Siemens Healthineers AG provides a wide range of healthcare solutions, including diagnostics (both in vitro and in vivo), imaging and therapy systems, clinical products, audiology solutions, and healthcare IT solutions. The company also offers medical accessories, OEM components, medical electronics solutions, refurbished medical imaging and therapy systems, and a variety of technical, maintenance, professional, and consulting services. Its products and solutions are utilized across numerous clinical areas, such as therapeutic drug monitoring, cardiology, organ transplant, urology, infectious diseases, diabetes, women’s health, surgery, oncology, neurology, and growth disorders, underscoring the company’s comprehensive role in supporting global healthcare needs.

Abbott operates as a leading healthcare and pharmaceutical company, with its business organized into four core segments: pharmaceuticals, medical devices, nutritional products, and diagnostics. The company maintains a presence in over 160 countries through its research, manufacturing, sales, and distribution networks. Abbott is a global leader in clinical diagnostics, offering solutions in areas such as clinical chemistry, molecular diagnostics, and hematology, among others. Its extensive diagnostic capabilities and worldwide reach make it a pivotal player in ensuring accurate and reliable laboratory testing.

Key Players

• Siemens Healthineers AG

• Abbott

• Bio-Rad Laboratories

• Danaher

• F. Hoffmann-La Roche Ltd

• Sysmex Corporation

• QuidelOrtho Corporation

• Randox Laboratories Ltd

• Helena Laboratories Corporation

• Thermo Fisher Scientific Inc

• SeraCare Life Sciences Inc

• BD

• Merck KGaA

• QIAGEN

• Hologic, Inc.

• Bio-Techne

• Fortress Diagnostics

• Microbiologics

• Trina Bio Reactive AG

• ConeBioproducts

• Biorex Diagnostics

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Conclusion:

The global in vitro diagnostics (IVD) quality control market is experiencing steady growth, driven by the increasing number of certified clinical laboratories offering reliable IVD-based diagnostic services. This expansion enhances patient confidence and subsequently boosts market demand. Key pathogens routinely diagnosed using multiplex PCR, such as HIV, HSV, and H. influenza, underscore the critical role of quality control in ensuring accurate diagnostics. Additionally, periodic amendments to regulatory frameworks aim to enhance existing standards, safeguarding the qualitative superiority of diagnostic services provided to patients.