Closed System Drug Transfer Device (CSTD) is a device that mechanically restricts the inflow of environmental contaminants and outflow of hazardous drug or vapor concentrations outside the system during drug reconstitution and administration. CSTD enables to transfer drugs without exposing it to be healthcare personnel handling the harmful drugs. CSTDs are useful in transferring cytotoxic chemotherapeutic agents and drugs such as antineoplastic a cancer treating drug. For instance, for preparing and administering chemotherapy drugs that contains hazardous antineoplastic agents, the drugs needs to be transferred from vial to syringe and then from syringe to IV infusion bag. During each transfer there is a possibility for exposure to the hazardous drugs. CSTDs are used to prevent such exposures, as these may lead to serious health complications from skin irritation to birth defects and even cancers. According to World Health Organization (WHO), nurses working with cytotoxic drugs on regular basis have found a statistically 7.2% higher rate of spontaneous abortion.
According to American Society of Health-System Pharmacists (ASHP), traces of cytotoxic drugs are found on unlikely places like doorknobs, keyboards, and other surfaces putting not only oncology professionals at risk, but also other hospital staff, and even patients and their families.
The global closed system drug transfer device market will exhibit a CAGR of 10.2% during forecast period of 2019-2026.
The major drivers fueling the growth of market are rising prevalence of cancer, increasing number of oncology drug approvals, improving regulatory guidelines regarding the safe handling and use of hazardous drugs and technological advancements.
According to World Cancer Research Fund, in the year 2017, around 50 million people globally are suffering from some type of cancer. Cumulative five-year prevalence population of all cancers was estimated to be 32.6 million people in 2012 worldwide. Various government bodies such as ASHP, The Oncology Nursing Society and The Occupational Safety and Health Administration among many others have set up a list of guidelines for safer handling of hazardous drugs leading to the increased use of the closed drug transfer systems.
Players in the market are continuously introducing innovative devices or line-extensions of existing products with advanced features and technologies, for instance, most of the recently launched CSTDs features advanced locking mechanisms which minimizes the risk of contact with hazardous drugs like ChemoClave and ChemoLock.
Market Restraints:
Lack of comprehensive guidelines in emerging nations and inadequate product efficiency are going to restrain the market in the forecast period. According to National Medical Products Administration, around 10 million healthcare personnel in China are exposed to hazardous drugs annually due to lack of government policies and proper guidelines regarding closed system drug delivery.
Market Segmentation:
The market is segmented by closing mechanism as Luer-Lock, color-to-color, click-to-lock and push-to-turn, by type as membrane-to-membrane and needleless, by technology as diaphragm, compartmentalize and air filtration, by component as vial access devices, syringe safety devices, line access devices and accessories and on the basis of end user as hospitals and clinics.
Large hospitals typically have a hospital bed capacity of more than 500, according to Pharmacy Purchasing & Products (PPP) magazine, a monthly published magazine pertaining to practical and actionable information on the pharmacy products and services in US, about 85% of the hospitals of size 400+ bed capacity are utilizing CSTDs for drug preparation. By end user hospital segment is expected to grow at a CAGR of 10.48% over the period of forecast.
Geographical Analysis:
Geographically, the global closed system drug transfer device market is divided into North America, Europe, South America, Asia-Pacific and Middle East and Africa.
North America occupied a dominant share of more than 50% of global CSDT market due to well-established healthcare infrastructure, better access to healthcare services, and adequate reimbursement for varied healthcare treatments. Many government and non-government health organizations such as National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) are working on creating awareness of adverse effects due to hazardous drugs. According to a survey performed by Pharmacy Purchasing and Products magazine, approximately 49% of the hospitals and around 42% of nursing departments that responded, stated that their pharmacy departments were using CSTDs.
The European Market is expected to grow at a CAGRof 9.52% over the period of forecast. European Parliament (EP), in November 2015, formed a Commission to take action on chemical risk factors, including exposure to hazardous drugs. And in April 2016, the EP launched new policy recommendations on preventing occupational exposure to cytotoxic drugs as an initiative designed to protect healthcare professionals working across Europe.
Competitive Analysis:
Some of the major key players in the market are BD Medical, Inc., ICU Medical, Inc., Equashield, LLC, Corvida Medical and Teva Medical Ltd.
The top four competitors in the global CSTD market are – BD, B.Braun, ICU Medical and EquaShield, and they account for more than 75% of the global CSTD market. In recent years, the global CSTD market has witnessed many strategic initiatives by key vendors and other prominent vendors, which intensify the market competitiveness. The major strategic collaboration, which had occured in recent years is the acquisition of Pfizer’s Hospira Infusion Systems (HIS) business by ICU Medical. Others include –
· In October 2018, Equashield LLC. entered into a partnership with Max Care Medical to distribute its CSTDs in Saudi Arabia as well as the wider Middle East and Africa region.
· In April 2018, Equashield and Transmedic Pte Ltd. Partner to Increase Safe Handling of Hazardous Drugs in Hong Kong
· In January 2018, Equashield announced opening of new $30 million manufacturing facility to accommodate future growth in product portfolio and increase production capabilities.
· In April 2017, BD entered into a definitive agreement to acquire C. R. Bard, Inc. (Bard), for approximately $24 billion. The combined company is uniquely positioned to improve both the treatment of disease for patients and the process of care for health care providers.
· In November 2017, ICU Medical acquired Medical Australia for approximately $9.0 million. Medical Australia delivers consumable Infusion products to Australia and surrounding regions.
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