April 17, 2024

The Surge of Elastomeric Infusion Pumps in the United States: Exploring Market Dynamics, Applications, and Regulatory Landscape of Portable Drug Delivery Devices Transforming Outpatient Care

The Rise of Elastomeric Infusion Pumps in the United States

 

Elastomeric infusion pumps have witnessed massive growth in popularity and usage across the United States in the last decade. These portable, wearable pumps provide a convenient method for continuous subcutaneous infusion of various drugs outside of a clinical setting. Let’s take a deeper look at the elastomeric pump market in America.

 

What are Elastomeric Infusion Pumps?

 

Elastomeric infusion pumps, also known as ambulatory infusion pumps, work using the principle of regulated fluid flow via a pressurized reservoir. They consist of a flexible bag made of medical-grade silicone or other elastic polymer that is filled with the drug. As the bag gradually deforms due to the elastic properties of the material, it creates continuous fluid pressure to steadily deliver very small, precise amounts of medication through a catheter or infusion set at a pre-set rate.

Unlike electronic infusion pumps that use battery power, elastomeric pumps are mechanical devices that do not require external power. Once primed and activated, they can typically infuse drugs for up to 3 days. This makes them highly portable for flexible outpatient use at home, work or during travel.

 

Market Growth

 

In the last decade, the elastomeric infusion pump market in the U.S. has grown over 15% annually to reach $2.5 billion in revenues by 2022 according to industry analysts. Rising rates of chronic diseases like cancer and diabetes that often rely on long-term subcutaneous drug delivery have been a major driver.

Other factors fueling market expansion include the preference of many adults and elderly patients for the non-electronic, low-maintenance convenience of elastomeric pumps over electronic pumps. Their extreme portability makes continuous drug administration possible even during physical activities, travels or natural disasters without external power requirements.

 

Popular Drugs Delivered

 

Some of the major drugs frequently delivered via elastomeric pumps in the U.S. include:

– Insulin: For patients with type 1 and type 2 diabetes, continuous insulin infusion helps maintain tight blood sugar control even when oral medications are not sufficient.

– Chemotherapy drugs: Patients undergoing chemotherapy for various cancers rely on elastomeric pumps to receive low-dose, steady delivery of drugs like morphine for pain management or 5-fluorouracil over days.

– Antibiotics: For conditions like spinal infections that require weeks of intravenous or subcutaneous antibiotic therapy, portable elastomeric pumps are highly convenient.

– Immunosuppressants: Organ transplant recipients utilize these pumps to receive cyclosporine or other anti-rejection medications continuously without daily injections or infusions.

 

Leading Manufacturers

 

A few companies dominate the U.S. elastomeric pump landscape with a combined market share of over 75%.

– Insulet Corporation: Best known for its Omnipod insulin pump system, Insulet has recently expanded into drug-delivery with tube-based elastomeric pumps.

– Baxter International: For decades, Baxter has been a leader in infusion therapy devices. Its Banana Bag elastomeric pumps are widely used in chemotherapy.

– West Pharmaceutical Services: As a major supplier to drug makers, West offers custom elastomeric pump development and manufacturing services to pharmaceutical firms.

– Amgen: The biotech giant works with Baxter to market elastomeric pumps pre-filled with its Neulasta for chemotherapy patients.

– Asept Inmed: This small firm specializes in elastomeric pumps for antibiotics and has a growing hospital customer base.

 

Regulatory Considerations

 

Being considered class II medical devices by the FDA, elastomeric pumps undergo a rigorous approval process involving testing, inspections and compliance with good manufacturing standards. Periodic revisions to existing regulations have focused on product safety, reliability and usability.

For example, the FDA now requires redundant features to prevent free-flow of drugs and more robust validation of dose accuracy. These steps are meant to reduce medication errors from faulty pumps while still allowing innovation. Overall, the regulatory environment remains supportive for continued expansion of this drug delivery mode.

Elastomeric infusion pumps have succeeded in transforming care for chronic disease patients by empowering convenient outpatient therapy. As more drugs are identified for ambulatory use, their market opportunities will keep widening in America and globally. With enhanced regulatory compliance and new applications on the horizon, elastomeric pumps are well-positioned for ongoing growth in the medtech industry.

Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it