23andMe, once one of the largest direct-to-consumer (DTC) genomics companies with a vast database of genetic, familial, and self-reported health data, has entered bankruptcy proceedings. While Regeneron was initially seen as a potential acquirer, the company was ultimately bought back by its founder Anne Wojcicki for $305 million (June 2025 report: Article Link).
23andMe accumulated extensive genomic and self-reported health data, which attracted attention as a potential asset for drug discovery, biomarker identification, and AI model training in biomedicine. However, several core challenges remain with such RWD (real-world data) businesses.
Challenges in the RWD & Genomics Business
- Sample Size Dependence: Large-scale datasets are valuable but increasingly expensive to maintain.
- Data Quality Issues: Self-reported health data may include bias, inaccuracies, or interviewer influence.
- Sampling Conditions: Variability in biological samples (blood, urine, saliva) can affect data consistency.
- Privacy & Ethical Concerns: Handling sensitive personal health data raises regulatory and societal challenges.
- Ongoing Maintenance Burden: Sustaining data accuracy and updating systems requires continuous investment.
RWD Remains a Key Asset Despite Challenges
Despite these limitations, real-world data continues to play an important role in fields such as AI drug discovery, target identification, and biomarker development. Particularly for rare diseases or diverse patient populations that are difficult to capture through traditional clinical trials, RWD offers valuable supplemental insights.
The RWD sector remains one where potential and complexity coexist.
Source: Fierce MedTech (June 2025), Article Link
【My Thoughts】
While the scale of RWD and genomic databases is attractive, their accumulation and use come with significant challenges in data quality, ethics, and long-term sustainability. Carefully balancing short-term enthusiasm with practical limitations will be crucial for responsible application. I will continue to share updated perspectives on these evolving issues in this series.
