Respiratory sensitization is becoming a critical regulatory and industrial challenge, yet companies still lack practical, human-relevant tools to address it. In this video, our CEO explains why current approaches fall short and how ALIsens® changes what is possible in practice.
Regulatory Challenges and Risks
Testing forrespiratory sensitization is expected to become a regulatory requirement in thecoming years. And ALIsens®, which is based on immortalized human cell lines, iscompatible with OECD guidelines. It is designed for reproducibility and inter‑laboratorytransfer and is progressing toward OECD standardisation, while remainingaligned with REACH, ECHA, EPA, and future respiratory requirements.
Compounds may be challenged, delayed, or even blocked when respiratory sensitization data is missing, incomplete, or not sufficiently robust to meet regulatory expectations. In many cases, traditional testing approaches fail to provide clear, human-relevant evidence, leaving critical questions unanswered during regulatory review.
As a result, companies may face:
- Requests for additional studies or follow-up testing late in development
- Delays in approval timelines and market access
- Increased documentation requirements to justify safety conclusions
- Greater uncertainty during regulatory interactions and scientific advice procedures
- Or even the closure of production plants if a compound is considered a sensitiser.
These challenges often emerge at stages where development decisions are already advanced and flexibility is limited. Without early, predictive respiratory sensitization data, regulatory risk accumulates silently—until it becomes a barrier that impacts timelines, budgets, and strategic planning.
Discover how ALIsens® supports regulatory decisions →Reputation at Risk
Regulatory actions, safety concerns, or product recalls related to respiratory sensitization can have long-lasting consequences for an industrial company’s reputation. Once trust is compromised, recovery is slow and costly.
Beyond the immediate financial impact, these events can:
- Erode confidence among customers, partners, and distributors
- Trigger increased scrutiny from regulators across markets
- Weaken brand credibility in safety-critical sectors
- Slow down commercial momentum and future product launches
In highly competitive markets, reputational damage creates space for competitors to position themselves as safer or more reliable alternatives.
Despite this risk, many companies still rely on reactive safety strategies, identifying respiratory issues only after regulatory review, market feedback, or post-launch signals. Without early, human-relevant data, teams have limited ability to anticipate problems, respond quickly, or demonstrate control when it matters most.
A lack of proactive respiratory risk assessment not only exposes products to regulatory action—it leaves brands vulnerable at the exact moment when transparency, evidence, and confidence are most critical.
Discover how ALIsens® protects brand credibility →Business Impact
When hazardous respiratory properties are identified at late stages of development, the business consequences extend far beyond the laboratory.
Late-stage failures often translate into significant sunk R&D costs, as years of investment in formulation, testing, scale-up, and market preparation cannot be recovered. Companies may be forced into costly reformulation efforts, additional testing programs, or, in some cases, complete product withdrawal from the market.
These outcomes frequently lead to:
- Delayed product launches and missed market opportunities
- Disruption across supply chains and manufacturing planning
- Unplanned regulatory interactions, inspections, or penalties
- Increased internal pressure on R&D, regulatory, and commercial teams
At a strategic level, late identification of respiratory hazards undermines portfolio predictability and long-term planning. What began as a scientific gap becomes a business liability, converting manageable risks into avoidable financial loss and operational disruption.
Without early, reliable respiratory sensitization data, companies are left reacting to problems rather than managing risk proactively—turning years of development effort into setbacks that could have been anticipated and mitigated earlier.
Discover how ALIsens® reduces development risk →Attrition Risk Factors
When compounds are replaced due to safety concerns, regulators and internal decision-makers increasingly expect the alternatives to be meaningfully safer, not simply different versions of the same risk profile.
If respiratory safety issues emerge late in development, replacement strategies often fail to deliver the intended risk reduction. Instead, companies face repeated late-stage failures, additional testing cycles, and escalating development costs—driving higher attrition across the pipeline.
These late discoveries can result in:
- Selection of substitute molecules with insufficient safety improvement
- Repetition of regulatory concerns across multiple candidates
- Loss of confidence in internal prioritization and screening strategies
- Increased pressure on R&D teams to move faster with less certainty
High attrition is rarely the result of a single poor decision. More often, it reflects a lack of early, predictive data capable of distinguishing truly safer alternatives from marginal improvements.
By prioritizing robust, human-relevant respiratory safety assessment early in development, companies can make more informed portfolio decisions, reduce late-stage surprises, and focus resources on candidates with a genuinely improved safety profile—protecting both patients and long-term pipeline value.
Discover how ALIsens® supports safer portfolio decisions →
