Compliance risk intelligence in the health and life sciences sector is becoming more prominent as the market grows.
The industry — spanning biotechnology, pharmaceuticals, healthcare services and medical devices — is projected to almost double from $13.7tn in 2025 to $26.7tn by 2035, according to Global Growth Insights, said Corlytics.
Factors such as rising global demand, breakthroughs in gene-based therapies, and growing digital health adoption underpin this expansion.
With expansion comes heightened regulatory scrutiny. As innovation accelerates, market participants face increasing demand from regulators to maintain safe, responsible and transparent practices. This evolving oversight is being shaped by shifting geopolitical conditions, technological change and new expectations around ethics, risk and governance. For organisations looking to seize emerging opportunities while protecting patient outcomes, balancing growth with compliance is becoming a central challenge.
Against this backdrop, firms must determine how to innovate, scale and remain compliant without losing sight of patient-centric values. This requires an approach that anticipates regulatory change before it materialises. From sustainability to data protection and the integration of AI across operations, the organisations that can adapt proactively are the ones likely to benefit most.
Data privacy and information security are among the most significant considerations. The sector manages highly sensitive information — including electronic health records, genetic profiles, biometrics, clinical trial data and real-world evidence captured through apps and devices. This data is fundamental to innovation in diagnostics, drug development and personalised healthcare, yet it comes with substantial risk. Regulators in regions including the EU and the US have created strict privacy frameworks, making cybersecurity and compliance core strategic priorities. As healthcare continues to be a prime target for cyber criminals, safeguarding this data is essential not just for regulation, but to protect patient trust.
Sustainability poses another emerging pressure point. The health sector contributes around 4.4% of global greenhouse gas emissions — more than many industrial sectors. Governments are embedding sustainability duties within compliance frameworks, meaning environmental responsibilities are no longer optional. Health and life sciences firms are increasingly being required to prove their efforts to reduce emissions, improve efficiency, and embed climate resilience across their operating models. Digital transformation and more sustainable supply chains are becoming central to meeting this expectation.
Artificial intelligence is transforming the industry too. Deployments are increasing rapidly, with hundreds of models now live across major organisations. AI is reshaping research, clinical care, manufacturing and decision-making. Yet its adoption introduces challenges around risk, oversight, accountability, ethical integrity and regulatory compliance. According to a survey by Deloitte, more than 80% of health system leaders believe government oversight of generative AI is needed. Strong governance frameworks and continuous monitoring are therefore key to ensuring AI is safe, unbiased and aligned with sector-specific compliance expectations.
This blog marks the start of a series exploring regulatory complexity and its impact on growth. In a market that is both expanding and heavily regulated, compliance is fundamental to integrity and operational resilience. Corlytics argues that digital compliance intelligence is an essential enabler, particularly in an increasingly dynamic landscape.
Over the months ahead, Corlytics will release further analyses on how health and life sciences firms can navigate their regulatory responsibilities while continuing to innovate. Compliance, the company suggests, is far more than a legal minimum — it is essential for product quality, patient safety and stakeholder confidence.
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