Kickstart your research into New Approach Methodologies (NAMs) with key insights from a selection of transcripts available within our Third Bridge Library below.
Certara – FDA Animal Testing Shifts & Customer Adoption Timeline Impacts
Transcript key insights:
- FDA's 3-5-year roadmap to phase out animal studies creates a significant tailwind, shifting model-informed drug development from a niche capability to a mandatory industry evolution.
- It's projected that the regulatory shift could drive a significant 10-15% revenue uplift for the Simcyp biosimulation platform as sponsors are now compelled to adopt the modelling capabilities.
- Certara's historical slowness in integrating its siloed product portfolio presents a key strategic risk, potentially hindering its ability to fully capitalise on the market opportunity.
- Technology lag makes Certara vulnerable to new AI-native entrants who can leverage modern tools and massive data repositories to develop competing solutions much more rapidly.
- Growth hinges on aggressively modernising legacy platforms such as Phoenix and targeting emerging pharma to offset softness from large clients who may favour homegrown solutions.
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Charles River Laboratories – FDA Animal Testing Phase-out Announcement & Potential In Vitro Research Implications
Transcript key insights:
- Charles River’s estimated 60% toxicology market share is vulnerable, as the FDA’s de-emphasis on animal testing requires significant diversification away from its legacy in vivo models.
- Specialist believes the FDA’s five-year timeline to phase out animal models for monoclonal antibodies is reasonable, while complex gene therapies will require a longer 5-10-year transition period.
- Smaller biotechs' critical reliance on outsourcing validates Charles River's recent revenue growth from this segment, as these clients lack the required internal infrastructure and personnel.
- Data comparability with live animal models presents the single-biggest hurdle for adopting new methodologies, which must be validated before replacing traditional safety and efficacy studies.
- Recent activist involvement could accelerate a necessary strategic pivot towards new approach methodologies, which is crucial for the company’s long-term competitive positioning and growth trajectory.
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3D Cell Culture Model Market – Scaffold-based vs Scaffold-free Methods & Drug Discovery Revolutionising Capabilities
Transcript key insights:
- 3D cell culture models, particularly spheroids, offer superior sensitivity and functionality to 2D cultures, maintaining basic liver functions and metabolism capabilities for extended periods. 3D cell system miniaturisation and automation are opportunities for increasing flexibility, reducing resource consumption and accelerating time-to-market for drug development.
- Drug development is moving from cell lines to isolated hepatocytes to 3D spheroids or organoids. Goal is creating body-on-a-chip systems for clinical studies.
- Personalised medicine approaches using 3D cultures can investigate idiosyncratic drug reactions by testing tissues from diseased patients or inducing disease conditions in vitro.
- Specialist believes in vitro 3D models cannot replace animal testing due to the complexity of organ interactions, but are valuable for understanding mechanisms and identifying risks.
- Specialist does not foresee bottlenecks in scaling up 3D cell culture production, as companies are adapting and finding solutions for cell supply and system improvements.
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Organoid Technology’s Application Outlook & Major Players – Part 2 (Conducted in Mandarin)
Transcript key insights:
- Organoid technology prescription for precision medicine is available in a few hospitals in Beijing and Shanghai, but patients must cover testing costs. It remains a supplementary approach to traditional treatment with uncertain outcomes and medical anti-corruption efforts have dampened doctors’ enthusiasm for its adoption.
- Specialist sees long-term potential in organoid technology for precision medicine, but companies developing organoids-on-chips may not benefit significantly due to low technical barriers - hospitals could eventually conduct their own experiments.
- Over 60% of domestic pharmaceutical companies, either in-house or outsourced, use organoid technology for preclinical innovative drug efficacy evaluation and early screening. Due to difficulties in obtaining samples, most prefer outsourcing to organoids-on-chips firms.
- The market, including reagents, chips and services, is valued at RMB 100m-200m. Industry players vary in positioning, with specialist recommending close attention to Avatarget, whose chips offer biomimicry comparable to international standards.
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Accurate International Biotechnology – Organoid Technology’s Application Outlook & Company’s Competencies (Conducted in Mandarin)
Transcript key insights:
- China’s organoid technology market for personalised treatment is currently at RMB 100m-200m. Specialist expects it to reach RMB 1bn by 2027, with a potential total market size of around RMB 5bn. Organoid-based treatment is considered a rigid demand, and market growth will likely accelerate as clinical evidence accumulates.
- However, organoids cannot replace traditional animal testing, as they fail to reflect systemic biological responses. Specialist believes organoids will serve as a complementary tool in safety evaluation and related scenarios.
- Specialist thinks organoid technology growth on the pharma side is expected to lag behind the clinical side. This is mainly due to the limited diversity of organoid biobanks currently available, which are insufficient to meet pharmaceutical companies’ demand.
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