What does 2026 hold for bioanalysis?

16 Jan 2026

Written by Ellen Williams, Taylor & Francis

Antibodies | ADCs Article Biopharmaceuticals Biosensors Collaborations and mergers

As we move into 2026, we review key bioanalytical trends and activities to look out for this year.

In 2025, the FDA’s Center for Drug Evaluation and Research (CDER; MD, USA) approved 46 new therapeutic agents, marginally down from 50 in 2024 [1]. Small molecules continued to dominate approvals, accounting for 31 approvals, followed by proteins at 12 and oligonucleotides with three [1]. These approvals came despite widespread restructuring and budget cuts within the US health and research department, with 18% of the FDA’s CDER and CBER workforce being cut or pushed to quit in the first 9 months of the year [1].

Looking ahead, the pharmaceutical industry faces a critical period of patent expirations, with PwC (London, UK) reporting that approximately US $47 billion in global pharmaceutical revenue is at risk over the next 4 years [2]. These imminent patent deadlines are expected to drive mergers and acquisitions (M&A) activity as companies are looking to replenish their pipelines and maintain competitiveness [2]. PwC’s US Pharma & Life Sciences Deals Leader, Roel van den Akker, remarked:

“M&A will pick up in 2026, and the winners will be those who deploy capital with precision, speed and foresight.”

Antibody–drug conjugates (ADCs) in 2025 and beyond

The ADCs market continues its rapid growth with two new ADCs approved in 2025: datopotamab deruxtecan for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer, and telisotuzumab vedotin for EGFR-mutant non-small-cell lung cancer [3]. These approvals bring the total number of approved ADCs to 15, reflecting the increasing importance of this modality. These approvals, paired with an increase in the number of ADCs in clinical trials, indicate significant market growth in 2026 and the global ADC market size, which was valued at US $13.63 billion in 2025, is anticipated to grow to US $15.41 billion by 2026 [4].

Join our ‘Antibodies to watch in 2026’ webinar with BioTechniques

Presented in association with the journal mAbs, Drs. Crescioli and Reichert discuss recent trends in antibody therapeutics development and forecast key events that may occur in 2026.

ADCs are increasingly being combined with conventional chemotherapy to maximize therapeutic efficacy, and as a result, there are an increasing number of clinical trials investigating ADC-chemotherapy combinations across cancer types [3]. Pharmaceutical companies are heavily investing in ADC research, with partnerships and acquisitions expected to expand ADC portfolios in 2026. For example, AbbVie (IL, USA) is diversifying its oncology pipeline by entering into a US $650 million exclusive licensing agreement with RemeGen (Yantai, China) for the development, manufacturing and commercialization of RC148 — a novel bispecific antibody being explored for use in combination with ADCs [5].

Jianmin Fang, Chief Executive Officer of RemeGen, highlighted the importance of this partnership:

“This collaboration is a significant milestone for RemeGen, highlighting the innovative potential of RC148 in addressing critical unmet medical needs in cancer treatment. The deal further underscores RemeGen’s commitment to bringing cutting-edge therapies to patients worldwide…”

Mergers and acquisitions

M&A activity surged in 2025 with investment more than doubling compared with 2024. Johnson & Johnson’s US $14.6 billion acquisition of Intra-Cellular Therapies Inc was the largest deal, followed by considerable acquisitions by Novartis AG (Basel, Switzerland), Merck & Co (NJ, USA), Sanofi (Paris, France) and Pfizer Inc (NY, USA) [6]. This trend is likely to continue, as evidenced by Eli Lilly’s (IN, USA) swift acquisition of Ventyx Biosciences (CA, USA) early in the year.

Find our coverage of the mergers and acquisitions from the first half of 2025 here.

Bioanalysis journal trends

Publication trends from our partner journal Bioanalysis are helpful for predicting future research avenues. A Perspective published in Bioanalysis in January 2025 explored the transformative potential of artificial intelligence (AI) and blockchain technology in clinical trials. Cited 13 times since its release, the article summarizes how these technologies can address data integrity issues, privacy and process inefficiencies. It also outlines strategies for blockchain and AI integration, particularly in resource-limited settings. In our recent Expert Opinion, Seema Rajaram reports on tamper-evident record keeping and the growing regulatory support for digital innovation in pharmaceutical research.

Another highly cited Bioanalysis Review Article offers insight into the latest advancements in green sample preparation techniques tailored for complex biological matrices and trace analyte levels. These techniques not only offer environmental benefits, but also often streamline workflows, reduce reagent volumes and enhance compatibility with miniaturized analytical platforms. Both articles exemplify the continued drive for efficiency and sustainability in bioanalytical processes, trends that are likely to gain further momentum in 2026.

Remote, decentralized and personalized bioanalytical testing

In 2025, we saw many new and improved wearable and point-of-care technologies, as demonstrated by our continued coverage on Bioanalysis Zone. These technologies are becoming more sophisticated, compact, user-friendly and cost-effective, and many pharmaceutical companies and contract research organizations are investing heavily in these sampling and testing capabilities [7]. As global healthcare systems face growing population pressure alongside limited clinical resources, these portable and wearable devices are in high demand [7], offering greater opportunities for decentralized clinical trials, which will likely improve patient recruitment and retention by reducing travel times and improving accessibility. As these technologies continue to evolve, they are expected to play a pivotal role in shaping the future of bioanalytical monitoring.

Together, these trends underscore a dynamic and rapidly evolving bioanalytical space, and I, like you, am excited to see what 2026 brings.