2026 Bioanalysis Trends: AI Integration and Personalized Medicine

来源: Bioanalysis Zone
链接: https://www.bioanalysis-zone.com/what-does-2026-hold-for-bioanalysis/

# 2025 FDA New Drug Approval Review

According to the latest report from Bioanalysis Zone, the FDA’s Center for Drug Evaluation and Research (CDER) approved 46 new therapeutic drugs in 2025, slightly lower than 50 in 2024. Small molecule drugs continued to dominate with 31 approvals, followed by protein drugs with 12, and oligonucleotide drugs with 3.

# Industry Challenges and Opportunities

Despite widespread restructuring and budget cuts in the US health and research departments, with 18% of FDA’s CDER and CBER staff being cut or forced to resign in the first 9 months, new drug approvals remain strong.

# Technology Trends

## Small Molecule Drug Dominance
Small molecule drugs continue to dominate new drug approvals, reflecting the important position of traditional chemically synthesized drugs in the therapeutic field. For organic synthesis service providers like Wuhan Henrysintai, this means sustained demand for small molecule drug intermediates and high-purity raw materials.

## Protein Drug Growth
Protein drugs with 12 approvals reflect continuous innovation in the biopharmaceutical field. Although this mainly involves biotechnology rather than traditional chemical synthesis, protein drug purification processes also require high-quality chemical raw materials and chromatography materials.

## Oligonucleotide Drug Rise
Oligonucleotide drugs with 3 approvals, while small in number, represent an emerging therapeutic field. These drugs typically require complex synthesis processes and high-purity chemical raw materials.

# Impact on Organic Synthesis Services

Advances in bioanalytical technology have had a profound impact on the entire drug development process:

## Increased Analytical Method Requirements
As the complexity of new drug molecular structures increases, requirements for bioanalytical methods are also constantly improving. This requires higher purity reference standards and more precise analytical reagents.

## Quality Control Challenges
The complexity of new drugs poses higher requirements for quality control, requiring more sensitive, accurate analytical methods and higher purity chemical raw materials.

## R&D Efficiency Needs
Against the backdrop of budget cuts, pharmaceutical companies have more urgent needs for improving R&D efficiency, creating opportunities for high-quality CRO/CDMO services.

# Company Commentary

Wuhan Henrysintai is closely monitoring technological advances in the bioanalysis field, particularly the application of AI technology in drug analysis. The high-purity organic synthesis raw materials and reference standards we provide can meet the demand for high-quality reagents in bioanalytical methods.

As a supplier of small molecule drugs and oligonucleotide drug intermediates, we are committed to providing reliable chemical raw material support for the bioanalysis field through advanced synthesis technology and strict quality control. Our high-purity synthesis capability can meet the most stringent bioanalysis requirements.

At the same time, we also note the demand for high-quality chromatography materials in protein drug purification processes and are expanding related product lines to provide more comprehensive chemical raw material solutions for the biopharmaceutical field.