Monoclonal antibody drugs have become a core growth engine for the global pharmaceutical industry. According to BCG's "New Drug Modalities 2025" report, antibody-   based drugs (including monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies) account for over 35% of the market value of new drug modalities (see Table 1), and both the number and value of their clinical pipelines have experienced sustained and steady growth ^[1]. Adalimumab, the world's first fully human anti-TNF-α monoclonal antibody, has been approved to treat multiple autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and psoriasis^[2]. However, some patients develop anti-drug antibodies during adalimumab therapy. These antibodies can neutralize the drug's activity, resulting in reduced plasma concentrations, diminished clinical efficacy, and adverse events, such as infusion reactions ^[2]. Therefore, the timely and accurate detection of anti-adalimumab antibodies is essential for therapeutic drug monitoring and guiding clinical decisions, such as dose adjustment, combination with immunosuppressants, or switching to other biologics.

Table 1: Value Statistics for mAb, ACD, and BsAb New Drug Modality Pipelines

This kit employs advanced chemiluminescent immunoassay technology, whose core principle utilizes a double-antigen sandwich method.Target substances are quantified by measuring the intensity of light signals released by luminescent reagents, such as luminol and azide, in chemical reactions. Compared to traditional enzyme-linked immunosorbent assays (ELISAs), this method has significant advantages. A 2024 study published in Antibodies directly compared the performance of chemiluminescent immunoassays and ELISA methods for monitoring adalimumab and its antibodies ^[2]. The study confirmed that chemiluminescence methods have greater practical advantages. Furthermore, this technology can be integrated with fully automated immunoassay systems, enabling the automation of the entire process, from sample loading to result analysis and reporting. This aligns with the current trend in healthcare institutions toward high-throughput, standardized testing requirements.

Table 2: Performance Comparison Between Chemiluminescent Immunoassay and ELISA Methods

● 3.1 Detection Principle and Process

This product uses a sandwich immunoassay design to detect anti-adalimumab antibodies specifically in patient serum or plasma. The basic procedure is as follows: First, biotin-labeled adalimumab is incubated with the sample. The resulting antibody-drug immune complexes are captured by streptavidin-coated plate wells. Then, enzyme-labeled adalimumab is added for detection, and ultimately, antibody levels are quantified via chemiluminescent signal ^[3].

● 3.2 Key Performance Parameters

‖ High Sensitivity: The detection limit is as low as 0.1 ng/mL, enabling the early identification of low-concentration drug-resistant antibodies.

‖ Exceptional Specificity: A meticulously designed antigen-antibody reaction system effectively avoids cross-reactions with interferents, resulting in a false positive rate of 2.8% (393 cases) and 3.17% (315 cases) in two rounds of random sample testing.

‖ Excellent Precision and Recovery Rate: Rigorous process control and quality assurance systems ensure stable and accurate results within and between batches.

‖ Rapid Testing Cycle: Leveraging an automated platform, results are delivered within hours to support timely clinical decision-making.

● 3.3 Sample Requirements

Serum or EDTA samples are recommended. The timing of blood collection is critical to avoid drug interference and false negatives. Samples should be obtained either before the next adalimumab injection (when the concentration is at its peak) or at least two weeks after the previous injection. Samples may be stored short-term at 2–8°C. For long-term storage, maintain samples at −20°C or below, and avoid repeated freeze-thaw cycles.

This product's development aligns closely with two major trends in the diagnostics and pharmaceutical industries:

Widespread adoption of therapeutic drug monitoring (TDM): As precision medicine gains traction, TDM for macromolecular drugs, such as monoclonal antibodies, is transitioning from research to routine clinical practice. It is becoming a vital tool for optimizing treatment and managing healthcare costs ^[2].

Diagnostic Reagent Technology Advancement: In the field of in vitro diagnostics, chemiluminescence methods are replacing traditional approaches, such as ELISA, due to their advantages. These methods are becoming the mainstream technique for immunoassays. The global market for diagnostic antibody proteins is projected to grow at a compound annual growth rate (CAGR) of 8.0% ^[5]. Additionally, China is rapidly emerging as a major force in biologics innovation and development, becoming a significant player in global antibody drug R&D ^[1]. The market potential for high-quality therapeutic monitoring tools that support this growth is substantial.

The detection of drug resistance antibodies is not an isolated laboratory indicator. Its core value lies in its ability to guide personalized clinical treatment.

Explaining Treatment Failure: For patients with primary or secondary non-response, testing for drug resistance antibodies helps distinguish between pharmacokinetic causes, such as accelerated drug clearance due to antibody production, and pharmacodynamic causes, such as altered target pathways.

Optimizing Treatment Strategies: Upon confirming antibody positivity, clinicians may consider increasing the dosage of adalimumab, shortening the dosing interval, adding immunosuppressants such as methotrexate, or switching to biologics with different mechanisms of action ^[2].

Prediction and Prevention: Dynamic monitoring of antibody levels helps predict the risk of efficacy decline and enables early intervention.

Economic Benefits: Avoiding the continued use of ineffective and costly biologics in patients with high-titer antibodies conserves healthcare resources.

In summary, the anti-adalimumab antibody detection kit, which is based on a chemiluminescent immunoassay, is an advanced diagnostic tool. It is characterized by its high sensitivity, strong specificity, and high degree of automation. Not only does it address the critical technical need for monitoring anti-drug antibodies during adalimumab therapy, it also aligns with the industry-wide trend toward precision medicine and the advancement of in vitro diagnostic technologies. Widespread adoption of this product will provide clinicians in rheumatology, gastroenterology, dermatology, and related departments with robust decision support, ultimately achieving the goal of improving patient outcomes and enhancing pharmacoeconomic benefits.

Reference:

[1] BCG.(2025).New Drug Modalities 2025. 

https://on.bcg.com/4h1Yeup. 

[2] Vroemen WHM, Agata SS, van Beers JJBC, Damoiseaux JGMC. Therapeutic Drug Monitoring of Infliximab and Adalimumab through Concentration and Anti-Drug Antibodies Assessment; Comparison of Sanquin Diagnostics and Theradiag Assays. Antibodies (Basel). 2024 Sep 5;13(3):73. doi: 10.3390/antib13030073. PMID: 39311378; PMCID: PMC11417797.

[3] 抗阿达木单抗抗体测定试剂盒（化学发光免疫分析法） 说明书,北京丹大生物技术有限公司.

[4] Tourdot S, Vazquez-Abad MD, Cox DS, Cai CH, Wang K, Zhang W, Lepsy C.Antidrug antibodies to adalimumab do not associate with immunologically related adverse events. Front Immunol. 2025 Feb 27;15:1457993. doi: 10.3389/fimmu.2024.1457993. PMID: 40084239; PMCID: PMC11904412.

[5] QYResearch. (2025). 2025-2031Global China Angtigen and Antibody for Diagnostic Industry Research and 15th Five Year Plan Analysis Report.