Synthetic Control Arms Market Revenue and Forecast by 2033

11 Jul 2025

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Table of Content

1. Synthetic Control Arms Market Revenue and Trends 2025 to 2033 2. Segment Outlook 3. Regional Insights 4. Synthetic Control Arms Market Coverage 5. Synthetic Control Arms Market Key Players

Synthetic Control Arms Market Revenue and Trends 2025 to 2033

The synthetic control arms market outlook to 2034, driven by rising clinical trials, AI/ML integration, and demand for real-world data in drug development. Get insights on key segments, innovations, and regional trends. The market growth is driven by the need to optimize clinical trials, along with the rising number of clinical trials.

Exploring the Growth Potential of the Synthetic Control Arms Market

Through a number of evolving changes affecting clinical trial design, there is a heightened need for efficient solutions to optimize clinical trials. As a result, synthetic control arms are gaining rapid traction. One of the major factors boosting the growth of the market for synthetic control arms is the rising demand for real-world data instead of recruiting patients. Synthetic control arms (SCAs) reduce the number of patients required in clinical trials. This further leads to cost-saving and faster timeline for drug discovery and development. Another significant factor is the rising focus on novel drug discovery due to the increasing prevalence of life-threatening diseases, especially rare diseases and cancer.

Ongoing technological advancements create immense opportunities in the market. Technologies such as artificial intelligence (AI) and machine learning (ML) enhance the accuracy and efficiency of SCAs. Moreover, electronic health records (EHRs) allow researchers to access historical data, creating accurate synthetic control groups. Regulatory agencies, such as the FDA and EMA, have also recognized the importance of synthetic control arms as an additional form of evidence for the drug approval process with appropriate supporting documentation, which adds to the credibility.

Segment Outlook

• By data source, the real-world data (RWD) segment held the largest share of the market in 2024 due to the increased need to reduce trial time and accelerate drug development. RWD is capable of generating actionable information from EHRs, claims, and patient registries.
• By application, the oncology segment led the market in 2024, given the exorbitant costs associated with cancer trials and the heightened need for faster, data-driven clinical solutions.
• By technology, the AI/ML analytics platforms segment dominated the market in 2024. This is mainly due to the increased need for predictive modeling and real-time data processing capabilities to enhance trial efficiency and accuracy.
• By end-user, the pharma & biotech companies segment dominated the synthetic control arms market in 2024. This is mainly due to the increasing participation of these companies in clinical trials for faster drug development. Thus, they are seeking real-world evidence, which synthetic control arms provide.
• By trial design type, the single-arm interventional trials with SCA segment contributed the largest revenue share in the market. This trial design provides a more ethical, pragmatic, and evidence-based approach than others, making it the preferred choice.
• By delivery mode, the service-based models segment continues to dominate the market in 2024, as sponsors are increasingly turning to experts for bespoke, scalable, and compliant synthetic control solutions.

Regional Insights

North America captured the largest share of the synthetic control arms market in 2024. This is mainly due to the increased number of clinical trials and drug development activities. Regulatory acceptance of established real-world data, combined with the expansion of data sources, further supports the growth of the market. Meanwhile, Asia Pacific is emerging as the fastest-growing area in the market, driven by increasing government investment in clinical research and drug discovery. There is a strong emphasis on novel drug discovery in countries such as China, India, and Japan, making SCA a must-have solution for clinical trial agencies.

Synthetic Control Arms Market Coverage

Recent Development

• In June 2025, Qureight announced that its digitally-twinned synthetic control arm has been used in a breakthrough clinical trial application in place of a human placebo group, marking a world-first in lung disease research.

Synthetic Control Arms Market Key Players

• Option Care Health
• InfuCare Rx
• Coram CVS (now part of Option Care)
• KabaFusion
• BioScrip (now part of Option Care)
• Amerita (a PharMerica company)
• United Infusion
• Soleo Health
• Paragon Healthcare
• PromptCare
• ContinuumRx
• CareCentrix
• Chartwell Pennsylvania
• Intramed Plus
• AlayaCare
• ClearSky Health
• Healix Infusion Therapy
• Nufactor (a FFF Enterprises company)
• PharMerica Infusion Services
• Infusion Associates

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