The biotechnology industry is rapidly changing the world, from developing new medicines and agricultural solutions to creating innovative biofuels and materials. Projections show the global market growing to over a trillion dollars by 2030, driven by groundbreaking research, gene therapies, and precision medicine. While this growth presents exciting opportunities for biotech companies, it also comes with a unique set of risks, from clinical trial liabilities and intellectual property infringement to product contamination and cyberattacks. Founder Shield offers specialized insurance for biotech companies, providing the comprehensive protection you need to innovate and scale with confidence.
Biotechnology, or biotech, is the innovative union between technology and biological systems, leveraging living organisms or their components to develop new products and technologies. From small startups working on a single gene therapy to large pharmaceutical companies developing a new class of drugs, biotech companies benefit many individuals and industries.
Although biotech companies have been on the rise for several decades, recent breakthroughs in gene editing, RNA-based therapies, and personalized medicine have catapulted them to the front lines. Without these innovations, many of the medical advancements we take for granted today would not be possible.
Because of this distinct shift, the biotech industry has an exceptionally positive forecast. Even in such high demand, though, it doesn’t mean all risks have disappeared. Biotech companies still face many of the same challenges that other companies do. The slow rise to fame has helped them to tackle vulnerabilities in stride, making this market even more secure than expected.
Why is Insurance for Biotech Companies Important?
Biotech companies can use insurance to protect themselves from various risks, streamline their operations, and build credibility within the industry.
Research & Development
This stage can present various risks because of the fragile elements required and damaged materials can leave you at ground zero. Human error also contributes to R&D risk. Misplaced items, ill-followed procedures, or even everyday accidents can cause damage.
Clinical Trials
The journey from a lab-based discovery to a marketable drug is long and fraught with potential issues. If a clinical trial fails, or a product doesn’t perform as expected, it could disrupt the entire development process, leading to massive financial losses and reputational damage. Keep in mind that one of the main reasons why biotech startups fail—despite the global value of biotech being over $1.5 trillion—is that many are unable to keep up with the fast-paced scientific and regulatory shifts in the industry.
Funding
Funding is necessary for biotech to thrive. However, securing the massive capital required for R&D, clinical trials, and manufacturing can be tricky. Navigating this climate and settling for less than a product is worth isn’t an option for biotech companies. Naturally, securing funding in this situation requires financial savvy.
Property Protection
Aside from protecting proprietary technology via patents, also consider physical property. Lab equipment, lab facilities, manufacturing tools, and many more items are worth a lot of money to a biotech operation. Property risks increase as your company experiences growth; the bigger you are, the harder you fall.
Biotech Insurance Coverage & Policies
These coverages form the foundation of any risk management program for biotech companies:
This policy protects a company from claims of bodily injury or property damage to a third party. For a biotech company, this could cover a visitor slipping and falling in a lab, or accidental damage to a partner’s property during a business meeting. While seemingly basic, this coverage is essential for day-to-day operations and is often required to secure a lease for lab or office space. It provides a financial safety net for a variety of common, non-specialized risks.
Workers’ Compensation is a state-mandated policy that covers medical expenses and lost wages for employees who are injured or become ill on the job. In the biotech industry, employees often work with complex machinery, hazardous chemicals, and biological materials, making the risk of a workplace injury higher than in a typical office environment. This insurance not only protects the company from costly lawsuits but also provides crucial support for its most valuable asset: its people.
Biotech companies rely on expensive, highly specialized equipment like centrifuges, microscopes, and cold storage units. Commercial Property Insurance protects the company’s physical assets—including its building, lab equipment, inventory, and research samples—from a range of perils, such as fire, theft, or natural disasters. Given the high cost of this equipment and the irreplaceable nature of research materials, this policy is vital for business continuity and recovery after a physical loss.
Once a biotech company begins testing its products on human subjects, this policy becomes an absolute necessity. Clinical Trials Liability Insurance provides coverage for bodily injury to human participants in a clinical trial, whether a claim is based on negligence or a “no-fault” basis. Many regulatory bodies and research institutions require this insurance, and it is crucial for protecting the company from the significant financial and legal exposure associated with a failed trial or an adverse event.
Directors and Officers insurance is essential for protecting the personal assets of a company’s leaders. In the highly regulated and capital-intensive biotech industry, directors and officers are exposed to a wide range of legal threats, from shareholder lawsuits over a failed clinical trial to claims of mismanagement by investors. D&O insurance covers the legal defense costs and settlements arising from “wrongful acts” in a leadership capacity, allowing executives and board members to make difficult decisions without the constant fear of personal financial ruin. This policy is often a requirement for attracting high-quality talent and securing venture capital funding.
Also known as professional liability insurance, E&O is designed to protect a company against claims of financial loss or harm resulting from a failure in its professional services. In biotech, this could cover a claim that a research design was flawed, a diagnostic tool provided inaccurate results, or a professional consultation led to a costly error for a client. E&O is distinct from product liability and is essential for firms that provide services or intellectual work to other companies in the industry.
A biotech company’s value is often tied directly to its intellectual property, such as patents, trade secrets, and research data. IP insurance provides a critical layer of protection against the exorbitant legal costs of both defending against and prosecuting IP infringement claims. It can cover legal fees for patent defense, trademark disputes, and even trade secret litigation, allowing the company to protect its most valuable assets without crippling its R&D budget.
The cost of insurance for biotech companies is highly variable and depends on several key factors. A company’s size, its revenue, and the overall value of its assets all play a significant role. The specific risks being insured, or “exposures,” are also a major consideration. An insurer will evaluate a company’s safety, compliance, and risk management practices, such as data security protocols, intellectual property protection, and clinical trial oversight, to determine a premium.
The program’s structure, including the deductible amount and the company’s willingness to assume more risk, also influences the final cost. Finally, a company’s claims history—specifically the number and type of past claims—will be a major factor in calculating the insurance premium.
Biotech Claims & Examples
Navigating a commercial insurance claim is often challenging, often fraught with confusion and multiple unknown factors. The following four-part series outlines the ins and outs of commercial insurance claims:
For a biotech startup, a few key policies are non-negotiable. General liability insurance is foundational, protecting against common risks like a visitor getting injured in your lab. However, the most critical policies are those that address the unique exposures of the industry. This includes errors and omissions (E&O) insurance, which covers claims related to professional services, such as a faulty clinical trial design or a consulting error. Since so much of a biotech company’s value is in its research and data, cyber liability is also essential, protecting against the financial fallout of a data breach. Lastly, as soon as a company starts a clinical trial, clinical trial insurance is a must-have to cover potential bodily injury claims from human participants, and it’s often a legal requirement.
Biotech companies are prime targets for cyberattacks because their core assets are highly valuable intellectual property (IP) and sensitive data. A hack could lead to the theft of proprietary research, drug formulas, or patient data, which is devastating and can be even more costly than a physical loss. Beyond the immediate financial impact of data recovery and system repair, a cyber breach can result in massive regulatory fines, significant reputational damage, and a complete loss of investor trust. Cyber liability insurance provides a safety net to cover these costs, from legal fees and forensic investigations to public relations and regulatory fines, helping a company survive a crisis and continue its mission.
While they may seem similar, professional liability and product liability cover distinct risks. Professional liability, or Errors & Omissions (E&O) insurance, protects a company against claims of financial loss or harm resulting from a failure in its professional services or advice. For a biotech firm, this might cover a lawsuit claiming that a clinical trial protocol was flawed, leading to a negative outcome. Product liability insurance, on the other hand, is for when a physical product—like a drug, medical device, or diagnostic tool—causes bodily injury or property damage to a third party. For example, if a drug is released to market and a patient suffers a severe allergic reaction, product liability would respond to the resulting lawsuit.
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Risk Calibration
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Why Choose Founder Shield?
Founder Shield is a leading insurance provider that specializes in offering comprehensive coverage for biotech companies, offering numerous benefits and advantages over traditional insurance providers. Here’s a breakdown of some of the key features and benefits that you’ll enjoy with us:
Benefits of Choosing Founder Shield
Industry Expertise
Founder Shield is focused on protecting rapidly evolving biotech startups. We ensure that our products are tailored to meet the unique needs of biotech companies.
Customized Solutions
Founder Shield offers bespoke insurance policies that are designed specifically for each client’s needs, ensuring comprehensive coverage that addresses the unique risks associated with biotech operations.
Fast Quotes
With Founder Shield’s streamlined quoting process, you can receive a personalized quote for your biotech insurance quickly, allowing you to make informed decisions fast.
Ease of Use
Founder Shield’s user-friendly digital platform makes it easy to manage your insurance policies, submit claims, and access important documents whenever you need them.
Dedicated Support
Founder Shield provides exceptional customer service, with dedicated account managers who are always available to assist you with any questions or concerns you may have about your insurance coverage.
Scalable Coverage
As your business grows, Founder Shield’s insurance policies can grow with you, ensuring you always have the right level of coverage for your changing needs.
Founder Shield is a preferred choice for biotech businesses because of our specialization in the industry. We offer flexible and customized insurance policies, a speedy quoting process, and exceptional customer service with dedicated account managers.
Great service – proactive, responsive, go beyond what I have expected from previous providers. The team do a wonderful job