Is Certara profitable in 2026?

Certara remains adjusted-EBITDA positive but under pressure: Q1 2026 adjusted EBITDA fell 9% YoY to $31.7 million on revenue of $106.9 million, and FY2026 guidance implies only 0 to 4% revenue growth versus 9% in FY2025, per its May 11, 2026 earnings release.

Could AI replace Certara's biosimulation software?

Unlikely soon. Certara's Simcyp is the first EMA-qualified PBPK platform and its tools are embedded in FDA, EMA and PMDA workflows, a regulatory-acceptance moat AI-native entrants cannot quickly replicate, though its lower-margin services revenue, down 4% YoY in Q1 2026, is more exposed to automation.

Who is Certara's biggest competitor?

Simulations Plus is Certara's closest direct competitor in biosimulation software, but as of July 2026 Simulations Plus itself is being acquired via a pending $18.50 per share cash merger, reshaping the competitive field. IQVIA, a much larger CRO, is an adjacent incumbent whose former exec now leads Certara.

Certara trades publicly on Nasdaq as CERT. EQT VII Fund took majority control in 2017 at an $850 million enterprise value and led the December 2020 IPO, which raised about $768.5 million at $23 per share; EQT retained a majority stake, with Deerfield Management also a top shareholder as of mid-2026.

Why did Certara's stock crash in 2026?

Certara shares fell about 18.7% on May 11, 2026 after the company guided FY2026 revenue to just $395 million to $405 million, implying 0 to 4% growth versus 9% in FY2025, and dropped a further 8% by mid-June 2026 as investors questioned the growth slowdown and services decline.

What is Certara doing with AI and NVIDIA?

On July 7, 2026 Certara announced a partnership with NVIDIA to build an AI platform using NVIDIA's BioNeMo Agent toolkit combined with Certara's proprietary datasets and regulatory expertise, following its October 30, 2025 launch of Certara IQ, an AI-powered QSP modeling platform.

Medical technology and health companies · United States

Certara

certara.com ↗

Certara makes biosimulation software drug companies use to model how drugs behave before trials.

Defensible for now

Assessed 22 July 2026 · Evidence as of 22 July 2026

Real protection, with named pressure against it.

On the recordSince 22 July 2026 · Checkable from August 2026 · Every call on the record Checkpoint: Q2 2026 earnings, first full quarter after divesting regulatory writing unit and after CEO reorg

The call

Certara's regulatory foothold keeps clients locked in, but slowing growth, falling services revenue, and a fresh reorganization are testing that grip in real time.

Certara builds computer programs that help pharmaceutical companies predict how drugs will behave in the human body before human testing. Government regulators like the FDA and European regulators have approved Certara's methods as official, which is hard for competitors to replicate because it took years to earn that trust and Certara has built up proprietary data along the way. The real threat is artificial intelligence: AI tools and free open-source programs could eventually automate much of the model-building work that Certara charges a premium for, even if they cannot match Certara's regulatory standing. The one thing to watch is whether Certara's software revenue stops growing or turns negative in the coming quarters; if that happens alongside weak uptake from its new partnership with NVIDIA, it would signal that the pricing power is eroding faster than the regulatory trust can protect it.

Why

AI pressure: Open-source PBPK tools (Open Systems Pharmacology) and AI-native modeling entrants. AI can speed up model-building, but regulators still want Certara's qualified platform, not a random AI output, for filings. Could AI do the core job? Unlikely.

Bigger players: IQVIA. New Certara CEO came from IQVIA, a much bigger clinical data and CRO giant that could push into biosimulation but hasn't shipped a rival platform yet. Could a giant copy it? No, they are blocked.

What protects it. FDA, EMA, and PMDA workflows are built around Certara's qualified PBPK models and proprietary PK/PD data, which is hard to swap out.

What would change this call

Certara's software revenue growth rate in Q2/Q3 2026 earnings. If it turns flat-to-negative from +7%, AI or rivals are eroding the pricing moat.
IQVIA launching or acquiring a modeling/simulation or PBPK platform. Would show the incumbent adjacent giant moving directly into Certara's turf.
Certara's services revenue YoY trend in Q3/Q4 2026. Continued declines beyond 5% would confirm the moat is under real contest.

Key numbers

Q1 2026 revenue $106.9M, up just 1% YoY (2026-05-11)
Software revenue +7% YoY but services down 4% (2026-05-11)
Stock down from $45.48 high to $6.78 (2026-07-22)

Named risks

Revenue growth decelerated from 9% in FY2025 to guided 0-4% in FY2026. Severity: high
Services revenue declining, down 4% YoY in Q1 2026, amid AI-driven commoditization pressure. Severity: medium
New CEO Jon Resnick mid-reorganization since January 2026 with execution risk. Severity: medium
Divestiture of Regulatory/Medical Writing unit shrinks near-term revenue base by roughly $50 million. Severity: medium
Stock down over 85% from all-time high, reflecting sustained investor concern. Severity: high

Rivals, as read in July 2026

Rival	Direction	Evidence
Simulations Plus	contesting	Closest direct rival being acquired via pending $18.50/share cash merger as of July 2026
IQVIA	contesting	Adjacent CRO giant; Certara's new CEO Jon Resnick joined from IQVIA effective Jan 1, 2026
Schrödinger	contesting	Physics-based molecular modeling competitor in early-discovery workflows per 2026-03-20 landscape review
Open Systems Pharmacology (open-source PBPK)	gaining on	Cited as rising open-source competition to Certara's Simcyp PBPK platform, 2026-03-20

Questions people ask

Is Certara profitable in 2026?: Certara remains adjusted-EBITDA positive but under pressure: Q1 2026 adjusted EBITDA fell 9% YoY to $31.7 million on revenue of $106.9 million, and FY2026 guidance implies only 0 to 4% revenue growth versus 9% in FY2025, per its May 11, 2026 earnings release.
Could AI replace Certara's biosimulation software?: Unlikely soon. Certara's Simcyp is the first EMA-qualified PBPK platform and its tools are embedded in FDA, EMA and PMDA workflows, a regulatory-acceptance moat AI-native entrants cannot quickly replicate, though its lower-margin services revenue, down 4% YoY in Q1 2026, is more exposed to automation.
Who is Certara's biggest competitor?: Simulations Plus is Certara's closest direct competitor in biosimulation software, but as of July 2026 Simulations Plus itself is being acquired via a pending $18.50 per share cash merger, reshaping the competitive field. IQVIA, a much larger CRO, is an adjacent incumbent whose former exec now leads Certara.
Who owns Certara?: Certara trades publicly on Nasdaq as CERT. EQT VII Fund took majority control in 2017 at an $850 million enterprise value and led the December 2020 IPO, which raised about $768.5 million at $23 per share; EQT retained a majority stake, with Deerfield Management also a top shareholder as of mid-2026.
Why did Certara's stock crash in 2026?: Certara shares fell about 18.7% on May 11, 2026 after the company guided FY2026 revenue to just $395 million to $405 million, implying 0 to 4% growth versus 9% in FY2025, and dropped a further 8% by mid-June 2026 as investors questioned the growth slowdown and services decline.
What is Certara doing with AI and NVIDIA?: On July 7, 2026 Certara announced a partnership with NVIDIA to build an AI platform using NVIDIA's BioNeMo Agent toolkit combined with Certara's proprietary datasets and regulatory expertise, following its October 30, 2025 launch of Certara IQ, an AI-powered QSP modeling platform.

Timeline

2026-07-10Certara closes sale of Regulatory and Medical Writing unit to Veristat for up to $135 million
2026-07-07Certara announces AI platform partnership with NVIDIA using BioNeMo Agent toolkit
2026-05-11Q1 2026 earnings show 1% revenue growth, services down 4%, stock falls 18.7%
2026-05-07Certara announces strategic partnership with Altasciences for early-phase drug development
2026-04-21Certara signs definitive agreement to sell Regulatory and Medical Writing business to Veristat
2026-02-26Certara reports FY2025 revenue of $418.8 million, up 9%, issues weak FY2026 guidance
2026-01-01Jon Resnick, formerly of IQVIA, becomes Certara CEO
2025-12-11Certara announces William Feehery's departure and Jon Resnick's appointment as CEO
2025-10-30Certara launches Certara IQ, an AI-powered QSP biosimulation platform
2020-12Certara IPOs on Nasdaq at $23 per share, raising about $768.5 million

Revision history

22 July 2026

First assessed. Defensible for now. The text above is fixed as of this date and is not edited afterwards.

In the same band

Abridge Seegene Olympus Corporation

More in Medical technology and health companies →

Sources

GuruFocus (2026-07-22)
What is Brief History of Certara Company? (2026-03-15)
Certara Number of Employees 2026 (2026-06-29)
Arsenal announces sale of Certara
Certara Completes $768.5 Million IPO
Certara Reports Fourth Quarter 2025 Financial Results (2026-02-26)
Certara Reports First Quarter 2026 Financial Results (2026-05-11)
Certara Reports First Quarter 2026 Financial Results (2026-05-11)
AI Agents for Drug Development (2026-07-07)
How Certara turned the FDA's animal-testing shift into innovation (2025-11-06)
Certara divests its regulatory and medical writing business to Veristat (2026-07-10)
Certara (CERT) Number of Employees