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Industry Landscape
The clinical research industry is undergoing a significant transformation, driven by technological advancements and the demand for more patient-centric approaches. Decentralized and hybrid trial models are gaining traction, accelerated by global events, enhancing accessibility and diversity. Focus on real-world data and efficiency is paramount, while regulatory adaptation is ongoing.
Total Assets Under Management (AUM)
Clinical Trials Market Size in United States
~70.3 billion USD
(8.7% CAGR)
- Driven by increasing R&D spending.
- Growth in adoption of decentralized trials.
- Rising prevalence of chronic diseases globally.
Total Addressable Market
70.3 billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
AI-powered Patient Matching
Leveraging artificial intelligence to identify and match eligible patients to clinical trials more efficiently, reducing recruitment times and increasing diversity.
Wearable Sensors & Remote Monitoring
Utilizing smart devices to continuously collect real-world data from participants outside clinical sites, providing richer insights and reducing in-person visits.
Blockchain for Clinical Data Management
Implementing distributed ledger technology to ensure the security, transparency, and immutability of clinical trial data, enhancing data integrity and compliance.
Impactful Policy Frameworks
FDA Decentralized Clinical Trials Guidance for Industry (2023)
The FDA issued a final guidance in May 2023 providing recommendations to sponsors, investigators, and other stakeholders regarding the use of decentralized clinical trial (DCT) elements in drug, biological product, and device studies.
This guidance directly supports and legitimizes Lightship's core business model, promoting wider adoption of DCTs and hybrid models by providing clear regulatory pathways for sponsors.
NIH Policy for Data Management and Sharing (Effective January 25, 2023)
This NIH policy requires all NIH-funded research that generates scientific data to include a Data Management and Sharing Plan outlining how data will be managed and shared, promoting open science and reproducibility.
Lightship's services, especially those involving digital data collection and remote monitoring, must align with these enhanced data sharing and management requirements, potentially increasing demand for secure and compliant data solutions.
21st Century Cures Act (2016) - Real-World Evidence Provisions
Although enacted in 2016, the Cures Act continues to drive FDA's increasing acceptance and use of Real-World Evidence (RWE) and Real-World Data (RWD) in regulatory decision-making, particularly for post-market studies and supporting new indications.
Lightship's ability to collect real-world data through decentralized and mobile approaches positions it favorably to support sponsors in generating RWE, expanding its service offerings beyond traditional trial phases.
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