The global health and life sciences sector is expanding rapidly, fuelled by digital health platforms, AI integration, biotechnology breakthroughs and rising global healthcare demand.
Research from Global Growth Insights values the market at $13.7tn in 2025, with expectations to reach $26.7tn by 2035, representing a CAGR of 6.9% over the next decade, said Corlytics.
However, as innovation accelerates, so too does regulatory complexity. Organisations now face increased engagement with regulators, navigating frameworks shaped not only by technology, but also by geopolitical shifts, patient protection rules and fast-changing data laws. The pressure to grow while remaining compliant has never been higher.
For businesses in this sector, the central question is clear: how can organisations capture market opportunity, minimise operational and ethical risks, and continue to keep patient safety at the heart of their mission? Key regulatory themes include data privacy, information security, sustainability and the governance of emerging technologies such as artificial intelligence. Companies that build systems capable of adapting to regulatory change proactively stand to gain competitive advantage, especially as compliance requirements evolve across international markets.
Data privacy remains one of the most urgent priorities in health and life sciences. Organisations manage highly sensitive information including patient health records, clinical trial results, biometric data and real-world evidence collected from devices, wearables and digital applications. This data fuels innovation in areas such as personalised medicine, AI diagnostics and drug development, but it also presents major compliance challenges. Regulations such as GDPR in Europe and HIPAA in the US set strict legal obligations on data transparency, storage, consent, disclosure and cybersecurity. Global organisations must also navigate fragmented local rules and an increasing marketing focus from cybercriminals on healthcare systems. Protecting confidentiality and building privacy into every operational stage is now a strategic imperative.
Sustainability is another fast-moving compliance priority. The sector accounts for around 4.4% of global greenhouse gas emissions, according to OECD data, making it one of the planet’s most carbon-intensive industries. Governments and regulators are embedding environmental accountability into compliance frameworks, shifting sustainability from a voluntary target to an operational requirement. The transition to net zero, reductions in chemical use, resource management and green manufacturing standards are now influencing long-term investment and procurement decisions. Digital innovation is helping organisations reduce emissions, manage supply chain impact and improve resilience, but success requires cultural transformation and cross-departmental collaboration.
Artificial intelligence adoption in health and life sciences is also accelerating. According to Healthcare IT News, organisations have deployed an average of more than 170 AI models in production, outpacing other industries. AI supports drug discovery, accelerates clinical trial analysis and enhances patient care, but executives remain cautious about governance and transparency. A Deloitte study reports that more than 80% of health system leaders believe active government oversight of generative AI is necessary. Effective policies will require clear ethical frameworks, bias monitoring, data usage rules and alignment with regulatory expectations.
The sector’s regulatory challenges are increasing in complexity, especially for global organisations working across multiple jurisdictions. As demand for innovation rises, streamlining compliance processes has become essential. Corlytics argues that compliance intelligence plays a critical role in improving integrity, ethical standards and operational risk management across the sector. Over the coming months, the company plans to publish a series of blogs exploring how organisations can balance growth with evolving regulatory requirements.
Compliance is not simply a statutory obligation; it underpins patient safety, product quality and public trust in the health and life sciences ecosystem.
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