How brokers can help life sciences clients navigate risk
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Australia’s life sciences sector continues to evolve at an impressive pace
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FROM BIOTECHNOLOGY and medical devices to digital health platforms, clinical research and advanced therapeutics, innovation is driving growth across the industry. At the same time, the risks facing these businesses are becoming more complex and interconnected.
While investment conditions remain selective, Australia’s strong research capabilities, favourable clinical trial environment and globally recognised healthcare infrastructure continue to attract significant activity. For brokers, this creates an opportunity to move beyond traditional insurance conversations and help clients address emerging exposures before they become significant problems.
Keystone Underwriting is an Australian specialist underwriting agency, providing tailored insurance solutions to brokers and their clients. Underwriting exclusively on behalf of certain underwriters at Lloyd’s, Keystone combines strong security with responsive local decision-making.
The business is known for its practical, no-nonsense approach, giving brokers direct access to experienced underwriters who understand complex risks and act decisively. Its product suite spans financial lines, liability, property, accident and sickness, medical malpractice, life sciences and specie. With a focus on service, quality products and long-term partnerships, Keystone continues to build a strong reputation in the Australian market.
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Clinical trials in Australia, 2014–2024
“As life sciences organisations become more dependent on connected technologies and digital platforms, cyber resilience is becoming a key differentiator from both risk management and insurance perspectives”
Kelly Ross-Howard, Keystone Underwriting
Many organisations are embracing emerging technologies such as artificial intelligence to accelerate drug discovery, improve diagnostics and enhance healthcare delivery. Others are expanding globally through clinical trials, technology licensing agreements and strategic partnerships.
While these developments create exciting opportunities, they also introduce new areas of exposure. Intellectual property disputes, cyber incidents, regulatory scrutiny and professional liability concerns are becoming increasingly important considerations for life sciences organisations.
“Many businesses focus heavily on innovation and commercialisation, which is understandable,” Ross-Howard explains. “However, growth initiatives can also create new risks that require careful management and appropriate insurance protection.”
Cyber remains a dominant concern Cyber risk continues to be one of the most significant exposures facing the life sciences sector.
Unlike many industries, a cyber incident within a life sciences business can involve highly sensitive information, including clinical trial data, research findings, patient information and proprietary intellectual property. A breach can disrupt operations, damage reputation and potentially compromise years of research investment.
Insurers are increasingly focused on cyber maturity when assessing risks. Multi-factor authentication, endpoint detection, employee training and incident response planning have become standard underwriting expectations. This comes as the average cost to businesses of cybercrime jumped a stunning 50% from 2024 to 2025, according to the Australian Signals Directorate (ASD) Annual Cyber Threat Report.
“As life sciences organisations become more dependent on connected technologies and digital platforms, cyber resilience is becoming a key differentiator from both risk management and insurance perspectives,” Ross-Howard says.
Clinical trials continue to attract scrutiny Australia’s reputation as a clinical trial destination remains strong, particularly across oncology, rare diseases, gene therapies and medical devices. World Health Organization data shows that more than 2,500 clinical trials take place in Australia each year, an increase of around 60% in the last decade.
However, insurers continue to apply heightened scrutiny to clinical trial exposures, particularly where novel therapies or first-in-human trial activity are involved. Participant injury risks, regulatory obligations, data privacy requirements and cross-border exposures all contribute to a more complex underwriting environment.
Businesses involved in advanced therapies and gene-based treatments may face increased underwriting requirements and higher premiums due to the potential severity of claims.
For brokers, early engagement with specialist underwriters can be critical in ensuring appropriate protection is in place before trial commencement.
Intellectual property is often the most valuable asset For many life sciences organisations, intellectual property represents the foundation of enterprise value.
Patent disputes, licensing disagreements, research collaboration conflicts and questions surrounding AI-generated intellectual property are becoming increasingly common. Investors and stakeholders are also paying closer attention to how organisations protect and manage their intellectual property assets.
“Many life sciences companies are built around a single technology platform or innovation,” Ross-Howard says. “Protecting that intellectual property can be just as important as protecting physical assets or revenue streams.”
As a result, interest in intellectual property insurance and specialist liability solutions continues to grow across the sector.
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Published 7 Sep 2026
“The [life sciences] sector continues to present significant opportunities, but it also demands a deeper understanding of evolving risks”
Kelly Ross-Howard, Keystone Underwriting
Source: WHO clinical trial database
Source: ASD Annual Cyber Threat Report 2024–25
Cost to businesses per cybercrime jumps
“Life sciences businesses operate in a highly innovative environment where growth and risk often evolve together,” says Kelly Ross-Howard, head of life science and allied health at Keystone Underwriting. “As technologies advance and organisations expand, insurance needs to keep pace with the changing risk profile.”
Innovation brings opportunity and new exposures Australia remains a preferred destination for clinical research and healthcare innovation, supported by R&D incentives, strong academic partnerships and efficient regulatory pathways.
Management liability remains critical Management liability insurance and directors & officers (D&O) insurance remain essential protections for both private and publicly listed life sciences businesses. Capital raising activity, shareholder expectations, regulatory investigations and employment-related disputes continue to generate significant exposure for directors and senior executives.
Additional scrutiny is emerging around clinical trial disclosures, cyber incident management, AI governance and environmental, social and governance reporting obligations. Employment practices claims also continue to rank among the
most common sources of management liability losses across the sector.
A favourable market with specialist challenges The broader insurance market remains relatively competitive, with strong capacity available across many liability classes, including public and products liability, professional indemnity, clinical trials and cyber insurance.
However, underwriters continue to exercise caution around advanced therapies, medical device manufacturers, AI-driven healthcare platforms and organisations with significant United States exposure. Businesses that demonstrate strong governance, robust cyber controls, quality risk management and clear commercialisation strategies are generally achieving more favourable insurance outcomes.
Supporting brokers in a specialised sector For brokers, life sciences clients often require a different level of expertise than many traditional industries. Understanding clinical development pathways, regulatory obligations, intellectual property considerations and emerging technologies can be critical when designing an insurance program.
Keystone Underwriting specialises in supporting brokers and their life sciences clients through access to tailored insurance solutions and specialist underwriting expertise.
“The sector continues to present significant opportunities, but it also demands a deeper understanding of evolving risks,” Ross-Howard says. “By working closely with brokers, we help clients navigate these challenges and build insurance programs that support innovation, growth and long-term resilience.”
As Australia’s life sciences industry continues to expand, brokers who can identify emerging exposures and provide specialist guidance will be best positioned to deliver value to clients operating at the forefront of healthcare innovation.
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Overall average
$56,000
$97,200
$202,700
$80,850
+14%
+55%
+219%
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