Certara (CERT) — Stock, Pipeline & Market Cap

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CERT · Stock Price

USD 6.26-5.61 (-47.26%)

Market Cap: $978.2M

Historical price data

Market Cap: $978.2MPipeline: 3 drugsFounded: 2008Employees: 1,550+HQ: Princeton, United States

Sector Ranking#55 in Digital Health & Biotech SaaS #18 in AI / Machine Learning

Overview

Certara's mission is to transform drug development for good by integrating biosimulation, regulatory science, and AI across the entire drug development lifecycle. The company has achieved a dominant market position, with its solutions underpinning over 90% of novel FDA drug approvals from 2014-2024 and deep penetration among top-tier biopharma clients. Its strategy revolves around expanding its integrated software-as-a-service (SaaS) platform, scaling its AI-driven Certara.AI offerings, and leveraging its vast proprietary data to become an indispensable partner in model-informed drug development (MIDD).

OncologyRare DiseasesPediatricsNeurologyComplex BiologicsCell and Gene TherapyVaccines

Technology Platform

An integrated biosimulation ecosystem combining industry-standard software for PK/PD, PBPK, and regulatory compliance with a proprietary AI platform (Certara.AI) and global scientific services to accelerate model-informed drug development.

Pipeline

3

3 drugs in pipeline

Drug	Indication	Stage
Oral administration of 100 mg KH176 twice daily	Mitochondrial Diseases	Phase 2
Sonlicromanol + Placebo	Mitochondrial Diseases	Phase 2
OMTX705 + Pembrolizumab + OMTX705 + OMTX705 + OMTX705 + Tisl...	Advanced Solid Tumor	Phase 1

Funding History

2

Total raised:$348M

IPO$348MUndisclosedDec 11, 2020

Series AUndisclosedUndisclosedJun 15, 2008

Opportunities

Certara is poised to capitalize on the mandatory adoption of model-informed drug development (MIDD) by regulators, the explosive growth of AI in biopharma R&D, and the proliferation of biotech firms that lack internal simulation expertise.

Its unique integrated platform and proprietary data create a significant competitive moat.

Risk Factors

Key risks include execution challenges in integrating acquired businesses, competition from large CROs and AI-native startups, sensitivity to biotech funding cycles, and dependency on continued regulatory acceptance of biosimulation methodologies.

Competitive Landscape

Certara faces fragmented competition from specialized software vendors and large CROs offering consulting services. Its primary advantage is the regulatory embeddedness and breadth of its integrated software-service-AI platform, which is used by both drug developers and regulators, creating a high barrier to entry.