THE CHALLENGE
Late-stage clinical failure is the single largest driver of R&D waste. Clinical trials consume the majority of sunk capital, leaving companies exposed to multi-hundred-million dollar write-offs when late candidates fail. In traditional drug development, only about 1 in 10 programs successfully reaches approval. This means the cost of all failed candidates is effectively absorbed by the one that succeeds – driving the average cost per approved drug to around $2.5 billion.

Traditional drug development in numbers

$2.5 billion

Average cost to market per drug

>10 years

Average time to bring a drug to the market

>90%

of new drugs that show efficacy fail in clinical trials

Cost of failure of traditional drug development

Developing a new drug is extraordinarily costly, largely because traditional preclinical models – cell lines, animal studies, and other non-human systems—frequently fail to predict how patients will respond. These limitations allow weak or non-efficacious candidates to progress into clinical trials, where failures become exponentially more expensive. Phase II and III attrition now accounts for the majority of sunken R&D cost, contributing to an average $2.5B investment per approved drug and timelines that stretch a decade or more. The status quo is no longer sustainable: improving human relevance in early discovery is essential to reduce late-stage failure, protect capital, and accelerate delivery of effective therapies to patients.

Cumulative cost $0M
$0M
with Organoids

Disclaimer: These figures are illustrative approximations based on industry averages; actual costs and outcomes may vary

OUR SOLUTION
Organoids are the first and only technology to enable predicting human drug response at the preclinical phase. We have shown that drug testing on HUB Organoids, patient-derived in vitro cell models, directly correlates with the response of patients in oncology and other diseases.

The economic value of organoid-based screening

Organoid technology changes the R&D cost curve. By enabling more accurate human-response testing in the preclinical phase, companies can predict success or fail fast and (re)direct investment earlier. This might mean slightly higher preclinical costs, but preventing many of the expensive Phase II and III failures that consume the majority of R&D budgets. Across a portfolio, this shift delivers 30–40% greater capital efficiency, translating to savings of $400 million or more per program, shorter development timelines, and higher confidence in clinical success.

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Discover how we helped our client Merus receive FDA Breakthrough Therapy Designation for Pentosemtamab®

Merus’s clinical success with Petosemtamab—whose preclinical development relied entirely on HUB Organoids—played a major role in the company’s acquisition. From a library of more than 500 bispecific antibodies, Merus and HUB identified 24 high-performing candidates, then validated the lead—Petosemtamab—across 80 patient-derived organoids to predict clinical efficacy. Petosemtamab is now in a global Phase 3 trial (LiGeR-HN1) with pembrolizumab for first-line treatment of PD-L1-positive recurrent or metastatic HNSCC, a combination that has received FDA Breakthrough Therapy Designation. Merus is also evaluating the therapy in other cancers, including colorectal cancer.

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Conclusion

Drug development is capital intensive, with traditional models incurring ~$2.5B per approved drug and >90% failure rates in clinical trials. HUB Organoids enables a candidate prioritization paradigm – allowing you to predict success or fail fast suboptimal compunds, and empowering executive teams to reallocate capital early, optimize portfolio returns, and maximize shareholder value. With validated organoid models, companies can de-risk clinical investment, accelerate timelines, and achieve up to 40% program-level cost savings

Early adopters are turning organoid
data into competitive advantage.

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Are you ready to expedite your drug development program?

By adopting organoid technology early in development, pharma leaders are cutting late-stage attrition, strengthening portfolio capital efficiency, and increasing the odds of blockbuster approvals. Want to discuss your research program with us?

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FAQs

HUB Organoids’ predictive preclinical models allow early identification of ineffective compounds, empowering leadership to terminate non-viable projects before significant capital is committed.

By generating actionable human-relevant data preclinically, organoid platforms reduce unnecessary clinical spend, streamline portfolio management, and deliver up to 40% cost savings per program.

Organoid models support data-driven decision-making, allowing companies to prioritize assets with the highest probability of clinical success, thus optimizing overall portfolio returns.

Organoid-based screening provides a robust validation platform to assess efficacy and safety, substantially lowering the risk of late-stage clinical failure and unproductive capital deployment.

By improving R&D capital efficiency and reducing attrition, organoid adoption increases the likelihood of successful approvals and enhances long-term shareholder returns.

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