As the Market Prepares for New Regulations Closed System Drug Transfer Set to Grow at CAGR of 10.6 Percent to 2024

The risks to patients and caregivers posed by selected drug classes that include cytotoxic drugs routinely used in the treatment of oncology have been known for some time. Drug handling systems commonly known as closed system drug transfer (CSDT) devices, introduced to reduce potential harm from escaping particulates and gases during the dose preparation and delivery process, have been available for more than a decade but adoption has been slow and uneven. New regulations that mandate the use of closed systems have been in development by standards agencies in the U.S. These have been finalized and are set to take effect in late 2018. The regulations will drive uptake of CSDTs, pushing growth to over 10 percent annually for the period to 2024.

Interest in closed system drug transfer devices has been growing as regulatory activity and practitioner awareness surrounding hazardous drug compounding and administration continue to increase. Drugs deemed hazardous to humans have been receiving increasing amounts of scrutiny in recent years as the dangers of these substances become more clearly understood. For caregivers and their patients, the therapeutic area that is at the forefront of attempts to mitigate exposure to hazardous drugs is clinical oncology, a field that – in spite of promising new drugs based on therapeutic antibodies – continues to rely heavily on antineoplastics, a class that includes alkylating agents and antimetabolites, to treat a wide range of cancers.

Globally, annual spending on anticancer drugs is around US $100 billion and is predicted to rise to $150 billion by 2020. In the U.S., a novel anticancer drug routinely costs more than $100,000 per year of treatment. When adjusted for per capita spending power, however, drugs are most unaffordable in economically developing nations, such as India and China. Not only are launch prices high and rising, but individual drug prices are often escalated during exclusivity periods.

At the product level the CSDT supplier market consists of eight companies that supply and/or market these devices. This segment is currently led by Becton Dickinson, which has acquired its leadership position through shrewd acquisitions, first of Carmel Pharma, a Swedish company in 2011, and more recently CareFusion in 2014. Other significant players include ICU Medical, Equashield and Teva which has a marketing collaboration on its technology with Braun.

The U.S. is currently the largest market for CSDTs. The adoption of USP <800> is expected to accelerate the market in the region, with other regions lagging for reasons related to economics and the lack of a centralized medical device regulatory infrastructure.

Detailed analysis of systems for the closed transfer of hazardous drugs is included in a new and comprehensive report. The report - Closed System Drug Transfer: Products, Players and Prospects - includes detailed assessments of devices and therapeutic market segments, analysis of market factors, market data and forecasts by region and profiles of market participants.

More information is available at ​http://www.greystoneassociates.org.

About Greystone

Greystone Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

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