De-Risk and Streamline Antibody Pair-Based Immunoassay Development
How to: Save Time, Reduce Variability, and Optimize Assay Performance
R&D investment in biopharma topped a $300 billion1 global spend in 2023. Even so, bringing a new drug to market remains difficult, with only 10% to 15%2 of new candidates reaching the public. With nearly 75% of R&D costs attributed to drug development failures3, it’s critical to ensure accurate and reliable data is used to guide decisions at every stage of the drug development process. Prioritizing the development of robust and reproducible assays that leverage sensitive, specific antibodies can control costs and enable data quality. This ensures fast, accurate results that facilitate data-driven decision-making and minimize potential risks as projects continue to future stages.
$300 Billion
Biopharma R&D investment in 2023
10%–15% of Drugs
Go to market
75% of R&D Costs
Attributed to drug development failures
$28 Billion
Annual spend on irreproducible pre-clinical research in the US
$350 Million
Annual spend on poor-performing antibodies in the US (of the $28B spend)
36% of Research Expenses Wasted
Attributed to biological reagents in the US
$10 Billion
Estimated annual spend on wasted research expenses attributed to biological reagents in the US
Key Factors & Challenges in Antibody Pair-Based Immunoassay Development
ELISA and ELISA-like immunoassays are staples in the drug discovery workflow, and are used during biomarker discovery, compound screening, and PK/PD studies. Utilizing antibody pairs to detect your protein of interest offers increased specificity, sensitivity, and accuracy compared to single antibody assays.
Developing a robust pair-based assay to detect and quantify your target can be time-consuming, costly, and fraught with challenges that result in extended project timelines and wasted resources, due to the complexities around:
Finding and identifying sensitive and specific immunoassays or antibodies.
A significant amount of time can be wasted searching for and validating commercially available, off-the-shelf ELISA or ELISA-like assay kits, matched antibody pairs, or individual antibodies to create a custom assay. An off-the-shelf immunoassay kit must be evaluated to confirm that there is no compound binding site interference, that it meets specificity and sensitivity requirements, and/or whether further optimization is necessary. If a custom assay is being developed, all suitable combinations of commercial pairs or individual antibodies must be tested to find the ideal pair.
However, many antibodies currently on the market lack the sensitivity, specificity, and consistency required, which can result in a time-intensive internal validation process.
Verifying assay reproducibility and robustness.
In the United States, an estimated $28 billion is spent annually on preclinical research that is not reproducible, with approximately $350 million attributed to subpar antibodies.4 Antibodies not properly validated across lots can lead to specificity or performance variations, resulting in assays that can become less reliable and reproducible over time. Additional variability may be introduced during antibody conjugation if the purity of the conjugate cannot be verified.
Ensuring platform compatibility and supply.
Many assay technology and instrumentation companies offer off-the-shelf assay kits, but may have a limited portfolio of targets. Even when a kit is available, it may lack the required sensitivity, may not be offered in the optimal format, or may not be available in sufficient quantities to support a project’s entire duration. Antibody vendors that do not own their manufacturing rely on third-party providers to source products and have limited control over supply and final formulation. They may have trouble accepting and filling bulk orders or offering custom formulations, causing unexpected delays and increased assay variability.
Meeting accelerated development timelines.
Preclinical timelines are typically fast-paced and require assay design, optimization, and validation efficiencies. However, every variable added at each stage can increase risk and delay project timelines.
Managing cost constraints.
Assay development is expensive, requiring organizations to balance cost-effectiveness with antibody quality and performance. 36% of research expenses wasted in the US are assigned to biological reagents, an estimated cost of $10 billion annually.5
Download the complete how-to guide, which offers solutions for these challenges associated with developing pair-based immunoassays and helps de-risk drug development.
References
1. Total global spending on pharmaceutical research and development from 2014 to 2030. Statista. June 20, 2025. July 7, 2025. https://www.statista.com/statistics/309466/global-r-and-d-expenditure-for-pharmaceuticals/
2. Sun D, Gao W, Hu H, Zhou S. Why 90% of clinical drug development fails and how to improve it?. Acta Pharm Sin B. 2022;12(7):3049-3062. doi:10.1016/j.apsb.2022.02.002
3. P. Corr, D. Williams. Conflict of Interest in Medical Research, Education, and Practice. E, The Pathway from Idea to Regulatory Approval: Examples for Drug Development. NIH National Library of Medicine. 2009. July 7, 2025. https://www.ncbi.nlm.nih.gov/books/NBK22930/
4. M. Biddle, P. Stylianou, M. Rekas, A. Wright, J. Sousa, D. Ruddy, et al. Improving the integrity and reproducibility of research that uses antibodies: a technical, data sharing, behavioral and policy challenge. MAbs. 2024;16(1):2323706. doi:10.1080/19420862.2024.2323706
5. Weller MG. Quality Issues of Research Antibodies. Analytical
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