Safety First!

Summary

• Since sharps safety laws were put in place in the USA and Europe, safety-engineered drug delivery devices have become standard practice
• Even so, full compliance with sharps safety rules in hospitals is still a work in progress, and compliance rates are even lower in other settings like homecare and at-home self-injection, whether in the US, Europe, or elsewhere
• Besides regulatory requirements in primary and acute care, several other factors are boosting the use of safety devices: protecting healthcare workers in home settings; the trend toward homecare; self-injection of biological therapies; and keeping caregivers in non-medical settings safe
• At the same time, pre-filled syringes are becoming even more popular, making it easier for patients to be treated at home and to self-inject, while also streamlining workflows in healthcare organizations
• Market analysts say the worldwide safety syringe market is growing at about 8.96% a year
• The global market for pre-filled syringes is also seeing over 8% yearly growth, going from over $772 million in 2018 up to around $1.137 billion in 2023
• Safety-engineered pre-filled syringes now make up most of the pre-filled market, with about 76% market share expected in 2023, valued at over $868 million

Introduction

It’s been almost 20 years since needlestick and sharps safety laws were introduced in the US, and more than six years since similar laws took effect in the EU. Even though safety devices are now widely used, compliance still has room to grow. This is especially true outside of hospital settings (like at home), where compliance is even lower, but where the rise of self-injection means more disposable syringes are being used — especially pre-filled syringes for subcutaneous injections.

This short paper explores compliance trends since the original legislation in the US and Europe. It also looks at what’s driving the demand for safety devices, focusing on the main factors behind strong growth for these products, and presents research showing likely market growth through 2023.

Background

– Compliance trends

In the US, the Needlestick Safety and Prevention Act amended OSHA’s rules on occupational exposure to bloodborne pathogens — including HIV, hepatitis B, and hepatitis C — and it was signed into law on November 6, 2000¹ and took effect in 2001. Treatments are now available that can eliminate hepatitis C, so these infections are no longer career-ending for healthcare workers, but treatment is still expensive and disruptive, and there’s still no vaccine. The federal needlestick law was championed by the American Nurses Association (ANA) and other advocates. After the law was passed, needlestick injuries dropped by about 30%².

Still, according to the Association of Occupational Health Professionals in Healthcare (AOHP)³, healthcare workers suffer 320,000 needlestick injuries every year in both hospital and non-hospital settings. The Centers for Disease Control and Prevention estimates that about half of all sharps injuries go unreported⁴, and OSHA calculates that 5.6 million workers in healthcare and related fields are exposed to risks involving bloodborne pathogens⁵. Some experts say over half of non-hospital care settings are not following OSHA law⁶. More and more healthcare is being delivered outside hospitals, with more than 40% of registered nurses now working in non-hospital settings⁷.

In Europe, EU Directive 2010/52/EU on preventing sharps injuries — which took effect in 2014 — requires employers to take action to protect healthcare staff from sharps risks. Employers are responsible for making sure workers get the right training and equipment, and for assessing and minimizing risks when exposure is possible.

As in the US, higher compliance in Europe has greatly expanded safety device use, but it still does not meet regulatory expectations. In some countries, regulators are still sending out improvement notices to hospitals and clinics for not meeting safety standards in both acute care and other settings⁸. The latest independent European Biosafety Network survey⁹ found roughly 70% compliance with safety-engineered injection devices across the EU, dropping to about 60% in homecare.

Safety-engineered drug delivery devices

– Self-injection pushes demand

The home is a key area for evaluating safety devices today. The Coalition for Safe Community Needle Disposal estimates that more than 7.5 billion syringes are used every year at home in the US¹⁰, which is similar to trends in home healthcare worldwide and is likely to rise for several reasons.

Aging populations — a global trend thanks to longer life expectancy — will naturally develop more chronic illnesses¹¹. Alongside longer lives, rising obesity¹², diabetes, cancers, and heart disease in younger people are putting new pressure on healthcare systems, so many countries are encouraging patient self-injection wherever possible¹³. As one expert wrote, “increasingly the focus has been to provide safe, reliable and convenient self-administration for patients, with the goal of minimising the impact on their everyday lifestyle and freeing them from the burden of receiving their medication in a formal healthcare setting¹⁴.”

Another factor is the dominance of biological drugs among new and top-selling treatments. While the cost of these drugs limited some access, as patents expire, competition is lowering prices and expanding use. From 2018 to 2020, many original biologics lost patent protection, opening up $100 billion in revenue to biosimilar competitors¹⁵ that are entering the market and likely driving even more usage. These biologics are often the best — or only — treatment for diseases with limited options. Biologics and biosimilars are usually injected under the skin (subcutaneously) due to their size and require frequent dosing for chronic illnesses like neurological, cardiovascular, and autoimmune diseases (such as Crohn’s, rheumatoid arthritis, psoriasis, etc.). At-home self-injection is the most cost-effective approach, increasing demand for devices that make self-injection safe and user-friendly and support compliance with prescribed treatment.

As more patients inject at home, it becomes even more important to manage sharps safety outside hospitals and clinics. While groups promoting safety haven’t always focused on home use, that’s beginning to change. For example, existing legislation covers nurses who help or train patients at home. Both in the US and Europe, whoever employs or contracts the professional must keep the work environment safe and protect their workers from needlestick risks. Being “at work” also covers home visits — so paramedics entering a patient’s home are included, too.

Beyond regulation, healthcare systems worldwide, from China and India to Europe and the US, are struggling with staff shortages¹⁶. Lowering risk to staff, including at home, is an important and affordable way to support recruitment and workplace satisfaction. Adding safety devices is a cost-effective way to make every environment safer — not just for medical staff, but also for people like waste collectors who might be injured by non-safety sharps, raising legal liability issues.

Patient needs also fuel growth in self-injection and safety devices. Older patients may rely on caregivers (often spouses or family), and their safety matters too, both morally and practically — it’s in the patient’s best interest for their caregivers to be healthy and able to help.

Safety device growth – the data

Do the factors driving safety device use show up in the real world? The research says yes.

Before getting into specific numbers, it’s worth highlighting two important features of self-injection devices. First, they need to be easy for patients to use. Older patients may have less dexterity, so devices should be simple to handle, require minimal force, and work automatically where possible. Many biologics treat serious, sometimes disabling illnesses — so, for example, a person with rheumatoid arthritis needs a device that’s easy to grip and activate. This demand has fueled the market for auto-injector devices that are both simple and safe. With features like automatic needle retraction, auto-injectors meet requirements for both safety and usability. The FDA now asks for “human factors” data on ease of use and risk reduction when new drug-device combinations are submitted for approval. The auto-injector safety syringe market is estimated to be growing at over 9% per year¹⁷.

Rising demand for safety devices is matched by a trend toward more drug delivery devices — especially pre-filled syringes. Several of the growth drivers mentioned above (self-injection to help healthcare resources, easy use for the elderly, and the critical need for accurate dosing, especially for biologics) are boosting demand for pre-filled products. Also, drug error scandals¹⁸ have led to regulatory scrutiny and improved practices, and pre-filled syringes are part of the solution. Recent clinical studies¹⁹ show that care processes can go faster when pre-filled syringes are used.

All this research points to rising demand for safety devices, especially safety-engineered pre-filled products, making drug delivery easier and more accurate — not only for organizations but also for self-injecting patients at home.

Market analysis²⁰ predicts that the global safety syringes market will see an annual compound growth rate (CAGR) of 8.9% from 2018 to 2023. Looking at several major sources²¹, the pre-filled syringe market was valued at more than $772 million in 2018 and will likely hit $1.137 billion in 2023, a growth rate of 8.1%. For safety-engineered pre-filled syringes specifically, the market is expected to rise from $551 million in 2018 to more than $869 million in 2023 (9.6% CAGR). This means safety-engineered pre-filled syringes will make up roughly 76% of the total pre-filled syringe market in 2023. This market dominance suggests that pharma and biotech companies see safety features as especially valuable for users in both clinical and home settings and are prioritizing these products in their portfolios and brand strategy.

Conclusion

This paper highlights key factors driving higher demand for safety-engineered syringes, including: stronger enforcement of regulations; better protection for healthcare workers in all settings (including home care); economic pressures that push toward more patient self-injection; the growing role of new biological therapies and biosimilar competition; and higher demand for easy-to-use injectable treatments for aging populations.

Market data clearly point to robust global growth in demand for safety devices. This trend is mirrored by climbing demand for pre-filled syringes, which promote better outcomes through accurate prescription and dosing. Safety-engineered products now dominate the pre-filled market, with three in four devices now including safety features — showing that drug companies view safety as a key product differentiator. In short, the safety device market is set for strong and lasting growth in the near future.