GlobalData’s AI tool predicts pharmaceutical drug approvals with 85% success rate

GlobalData’s enhanced AI-powered Likelihood of Approval (LoA) model boosts its predictive power, providing probability of a drug receiving market authorization.

LONDON, 25 September 2025 – GlobalData Plc, the trusted intelligence partner to the world’s most successful organizations, today announced the significant accuracy of its upgraded predictive analytics tool “Likelihood of Approval (LoA)” model, powered by artificial intelligence (AI). 

The upgraded model delivers greater accuracy in assessing the probability of a drug with specific characteristics progressing to the next stage of clinical development, as well as its ultimate probability of the drug receiving market authorization.

This enables stakeholders such as pharma companies, investment firms, and consulting firms to leverage LoA for portfolio prioritization, risk assessment, deal, evaluation, and improve strategic decision-making across the pharmaceutical development lifecycle.

Powerful predictive analytics

LoA estimates the probability of a drug receiving regulatory approval in the US. The tool employs 108 specialized machine (ML) learning models using Random Forest algorithms across 18 therapy areas, trained on a comprehensive 24-year historical dataset including extensive data on approved drugs, failed developments, and current pipeline drugs.

The model predicts the Phase Transition Success Rate (PTSR) for each clinical development stage from Phase I to Pre-Registration. The LoA is calculated by compounding the PTSR at the current and following stages the drug is yet to progress through.

The LoA database provides a detailed and comprehensive analysis and Phase transition success probabilities for drugs in development. It features two distinct datasets:

• Drug-Specific LoA – Drug success rate prediction by using ML models with close to 20 data attributes analysed ranging from drug, clinical trial, regulatory and company.
• Benchmark LoA – Historical success rate across therapy areas, indications, molecule types (modalities), and targets/mechanism of actions.

AI-powered upgrade delivers increased accuracy

The updated Drug-Specific LoA model now leverages advanced ML to make predictions, marking a full shift to pure ML for improved accuracy. As a result of these upgrades, the model’s prediction accuracy has improved significantly, to 85.4%. 

Broad applications across the biopharma ecosystem

The enhanced LoA model delivers value across multiple stakeholders:

• Pharmaceutical & Biotech Companies: Prioritize pipeline assets and optimize clinical trial designs to improve chances of success
• Investors & Financial Analysts: Strengthen due diligence and integrate LoA predictions into valuation and revenue forecast models
• Business Development & Licensing Teams: Quantify regulatory risk of in-licensing or acquisition targets and choose partnership opportunities with a high probability of success
• Regulatory Affairs Professionals: Inform submission strategies for IND, NDA, or BLA based on factors influencing regulatory outcomes
• Consulting & Advisory Firms: Advise clients on drug development strategy with predictive insights grounded in historical data

A game-changer for pharmaceutical companies

The LoA platform enables

• Pharmaceutical companies to make evidence-based decisions by providing AI-driven predictions, reducing the need for time-consuming manual research and potential human biases.
• Helps stakeholders make informed strategic choices by quantifying the risk of regulatory failure or success.
• Assists companies in prioritizing drug candidates with higher approval probabilities, improving R&D efficiency and ROI.
• Enables early identification of high-risk programs, allowing proactive mitigation strategies.

Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData, says: “With the regulatory approval in the US being the most critical milestone in drug development, GlobalData’s enhanced LoA model empowers pharmaceutical companies to assess LoA of competing assets, determine market share and make informed strategic decisions.”

Further information on LoA can be viewed and searched in more detail on the GlobalData Pharma Intelligence Center.