Closed System Drug Transfer Device CSTD Market

Closed system drug transfer device (CSTD) mechanically prevents the transfer of environmental contaminants into the system and the discharge of hazardous drugs or vapor concentrations outside the system.

Exposure of healthcare personnel such as pharmacists, technicians, and ancillary pharmacy staff to hazardous antineoplastic drugs (AHD), has been a great concern for several decades. Many AHDs are carcinogens, or reproductive and developmental toxicants and their prolonged exposure could lead to skin rashes, infertility, miscarriages, congenital disabilities, and possibly leukemia or other cancers. Organizations such as the National Institute for Occupational Safety and Health (NIOSH) and the United States Pharmacopeia have recommended the use of specialized IV equipment called CSTD along with personal protective equipment (PPE) such as gloves, masks, gowns, and biological safety cabinets to minimize the exposure of patients and clinicians to hazardous drugs.

The global CSTD market is emerging due to the rising prevalence of cancer cases along with an increased risk of exposure to hazardous drugs for healthcare personnel and several safety guidelines and legislation for the use of CSTDs.

However, high cost and adverse events and statutory warning by the Food and Drug Administration (FDA) for the use of CSTDs are hampering the growth of the market.

The burden of cancer is rising globally. According to the Canadian Cancer Society, in 2017, an estimated 206,200 new cases of cancer and 80,800 deaths occurred in Canada. Moreover, the Office for National Statistics reported over 65.3% of total cancers in adults aged 65 years in the UK, in 2016.

Additionally, the National Cancer Institute of National Institutes of Health (NIH) reported that approximately 1,735,350 new cases of cancer were diagnosed in the US and 609,640 people died of cancer in 2018. This alarming rise in cancer cases among the population is driving the growth of the global CSTD market. A study from the Centers for Disease Control and Prevention reported that each year, about 650,000 cancer patients receive chemotherapy in an outpatient oncology clinic in the US. Healthcare workers are at an increased risk of developing chromosomal abnormalities due to improper handling of chemotherapeutic agents, which has risen the demand for CSTD.

CSTD is a highly specialized drug compounding and drug administration device, that is uniquely designed to prevent health care staff and patients from exposure to hazardous drugs. The NIOSH, in August 2015, published a draft performance protocol for testing CSTD on the basis of its ability to avoid leakage/spill of hazardous drugs during administration as well as through disposing process. The study concluded that the application of CSTDs reduces healthcare risks when employed in the process such as chemotherapy, etc. This led to increased adoption of CSTD among healthcare professionals and patients which is likely to create a tremendous opportunity in the coming future for the growth of the market.

Moreover, the developing nations of the Asia Pacific region (India, China, Australia, etc.) provides an opportunity for the market players to expand their presence. This can be seen in terms of low product penetration within these regional markets, i.e., in comparison to the western world. Additionally, it has been reported that the healthcare sector within this region has witnessed huge investments. For instance, according to the Indian Brand Equity Foundation in 2016, the Indian healthcare sector was projected to be one of the fastest growing industries. The healthcare sector in India is expected to register a CAGR of 22.87% from 2015 to 2020 and reach USD 280 billion by 2020. Such prevailing conditions are likely to generate opportunities for CSTD market to develop and expand within the region.

The cost of implementing CSTD is high. The use of the PhaSeal, a product of CSTD has a cost USD 92,072.28, representing an estimated annual cost of USD 368,289.14. When compared with the conventional syringe-needle approach, it is estimated to lead to additional spending of USD 35,670.64 yearly.

Additionally, it is reported that physicians, nurses, and office staffs are needed to be trained for an effective CSTD implementation, as improper handling could lead to the formation of fine aerosols that may escape into the air and expose the environment, patients, and health staff to hazardous drugs. Thus, the high cost of implementation along with a need for training make healthcare providers reluctant to adopting CSTD. This is estimated to restrain the market growth during the forecast period.