Membranes for Medical Devices Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2034

Membranes for medical devices are specialized barriers that are designed to selectively filter separate and purify substances in various medical applications. These membranes are critical components in devices used for dialysis, filtration, drug delivery and other medical treatments. It utilizes materials like polysulfone (PSU) & polyether sulfone (PESU), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), polypropylene (PP), modified acrylics, polyethylene and Others. It allows for the control of fluid and gas exchange, providing essential functions in life-saving and quality of life improving medical equipment.

MARKET OVERVIEW

The market valuation of Membranes for Medical Devices market was valued at approximately USD 3.6 billion in 2023 and is projected to reach USD 8.7 billion in 2034 exhibiting a CAGR of 7.5% during the forecast period of 2024-2034. Membranes for medical devices are integral components in various healthcare applications that provides essential filtration, separation and purification function. The market is aligned with healthcare sector, which makes it a sustainable and growing market.

GROWTH DRIVERS

The rising incidence of chronic disease like diabetes, cardiovascular disease and kidney disease, drives the demand for advanced medical devices including dialysis and drug delivery systems. According to the World Health Organization (WHO), chronic diseases, also known as noncommunicable diseases (NCDs), are a growing health problem that kill 41 million people annually, or 74% of all deaths globally. These diseases include cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases. In high-income countries, as many as 1 in 3 people with diabetes and 1 in 5 with hypertension have chronic kidney disease.

According to National Kidney Foundation, 37 million adults in the United States are living with CKD - and approximately 90% do not even know they have it. The advancements in membrane technology where innovations like membrane materials and fabrication technologies enhances the performance and efficiency of medical devices. The development of nanomaterials and biomimetic membranes offering improved filtration and biocompatibility, drives the adoption of the market. The global aging population leads to higher incidence of age-related diseases. This drives the need for devices that use membranes for renal care and respiratory support.

According to WHO, by 2030, 1 in 6 people in the world will be aged 60 years or over. At this time the share of the population aged 60 years and over will increase from 1 billion in 2020 to 1.4 billion. The United Nations (UN) projects that the global population of people aged 65 and older will more than double from 761 million in 2021 to 1.6 billion in 2050. This is due to the fact that the proportion of people aged 65 and older is increasing faster than those below that age. The favorable regulatory policies and government initiatives that supports the healthcare sector, boosts the development and adoption of innovative medical devices incorporating advanced membranes. The US FDA has streamlined process for approving medical devices, facilitating quicker market entry for new technologies. For instance, CDRH is committed to fostering innovation that improves public health by launching the Home as a Health Care Hub effort to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people's lives, leading to a longer, higher quality life for all.

The increase in healthcare spending leads to higher investments in advanced medical technologies. including the specialized membranes for various applications. According to Becker and WHO, the cost of global healthcare soared from 7.4% in 2022 to 10.7% in 2023, a record high. The 2024 insurer-reported cost trend is forecasted at 9.9% average worldwide, though some regions will see a steeper increase. There is a sharp increase in government spending on health at all country income levels underpinned the rise in health spending to a new high of USD 9 trillion, which is approximately 11% of global GDP. The membranes are crucial in various medical filtration and separation processes like hemodialysis, blood oxygenation, and sterile filtration, this expands their application and market demand.

MARKET SEGMENTATION:

·         By Material- Polysulfone (PSU) & Polyether Sulfone (PESU), Polyvinylidene Fluoride (PVDF)- Hydrophobic PVDF Membrane and Hydrophilic PVDF Membrane, Polytetrafluoroethylene (PTFE), Polypropylene (PP), Modified Acrylics, Polyethylene and Others

·         By Process Technology- Dialysis, Gas Filtration, Microfiltration (MF), Nanofiltration (NF), Reverse Osmosis (RO), Ultrafiltration (UF) and Others

·         By Application- Bio-Artificial Processes, Drug Delivery, Hemodialysis, IV Infusion & Sterile Filtration, Pharmaceutical Filtration and Others

·         By Distribution Channel- Direct and Indirect Sales

·         By Type- IV Filters, Respiratory and Anesthesia Filters and others

·         By Region- North America, Europe, Asia Pacific, The Middle East and Africa, South America

Membranes for Medical Devices Market Segment By Material Type Review:

The PSU and PESU are known for their high thermal stability, chemical and mechanical strength. These materials offer excellent biocompatibility, making them ideal for medical applications. They are commonly used in hemodialysis, blood filtration and other applications requiring sterile filtration. The superior of PSU & PSEU ensures minimal adverse reactions, enhancing their adoption in various devices. The PVDF is available in both hydrophobic and hydrophilic forms offering excellent chemical resistance high thermal stability and good mechanical properties.

The hydrophobic membranes are used in air and gas filtration and hydrophilic are employed in microfiltration and ultrafiltration for medical applications. The PTFE membranes offers outstanding chemical resistance, low friction, and excellent thermal stability. They are non-reactive and highly biocompatible. They are widely used in membrane distillation, filtration of aggressive solvents and as a barrier in medical implants and surgical garments. The polypropylene membranes are characterized by their good chemical resistance, low cost and ease of fabrication. They are often used on applications requiring high throughput and durability. The modified acrylic membranes offer good clarity, chemical resistance and biocompatibility. They can be tailored for specific application by modifying their chemical resistance. Polyethylene membranes are known for their flexibility, chemical resistance and low moisture absorption.  They are used in various filtration and separation applications.

Membranes for Medical Devices Market Segment By Process Technology Review:

The dialysis involves the separation of small molecules from larger molecules in a solution through a semi-permeable membrane. It is primarily used to remove waste products and excess substances from the blood. The gas filtration uses membranes to remove contaminants and particulates from gases, ensuring the purity and safety of medical gases. The microfiltration involves the use of membranes with pore sizes typically between 0.1 to 10 microns to remove bacteria and suspended solids.

Nanofiltration uses membranes with pore sizes in the nanometer range to remove small solutes, organic compounds, and multivalent ions. The reverse osmosis involves the movement of water through a semi-permeable membrane to remove ions, molecules and larger particles. The ultrafiltration uses membranes with pore sizes of 0.01 to 0.1 microns to remove viruses, colloids and large proteins. It is used in the applications including blood purification protein concentration and sterilization of IV fluids and drugs.

Membranes for Medical Devices Market Segment By Application Review:

The hemodialysis is a medical procedure that is used to treat kidney failure by filtering waste and excessive fluids from the blood using dialysis machine and a membrane-based dialyzers. The membranes are used in drug delivery systems to control the release rate of medications. It ensures targeted and sustained delivery of therapeutic agents.

The bio-artificial organs combine synthetic membranes with living cells, in order to replicate organ functions like bioartificial livers and pancreas.  The membranes components in diagnostic devices like biosensors and point of care testing devices for filtering and detecting biomarkers. The membranes are used as scaffolds in tissue engineering to support cell growth and tissue formation, aiding in the regeneration of damaged tissue and organs.

Membranes for Medical Devices Market Segment By Distribution Channel Review:

The direct sales involve the manufacturer selling product directly to the healthcare facilities, laboratories or end users without any intermediary involvement. The manufacturers maintain greater control over the sales process, pricing, and customer relationships. They eliminate intermediaries, so that the manufacturers can achieve higher profit margins. The indirect sale includes distributors, wholesalers and retailers who purchase from manufacturers and sell to end users. The indirect sales enables manufacturers to reach a wider market, including smaller healthcare facilities that may not be directly accessible.

Membranes for Medical Devices Market Segment By Type Review:

The IV filters are used to remove particles, air bubbles and microorganisms from the intravenous fluids before they enter the patient's bloodstream. They are made from materials like PES, PVDF and nylon, which offers high filtration efficiency and compatibility with various IV fluids. The respiratory and anesthesia filters are used in respiratory circuits and anesthesia machines to prevent the passage of bacteria, viruses, and other contaminants. They are typically made from PTFE and PVDF, ensuring effective filtration of airborne particles.

Membranes for Medical Devices Market Regional Analysis:

North America is a significant market driven by the factors like well-established and robust healthcare ecosystem, which drives the demand and adoption of the market. According to Centers for Medicare & Medicaid Services, medicare spending grew 5.9% to USD 944.3 billion in 2022. Medicaid spending grew 9.6% to USD 805.7 billion in 2022. Europe is the leading market driven by the robust healthcare sector. The stringent regulatory standards by the European Medicines Agency ensures high quality medical devices, drives the demand for advanced membrane technologies.

The region has increasing geriatric population, which drives the market demand. Asia Pacific is a valuable market driven by the expanding healthcare infrastructure in countries like India. The Middle East and Africa is a promising market driven by infrastructure development including healthcare infrastructure. South America is a growing market driven by improving healthcare systems.

Key Challenges:

The development of high-performance membranes that meets the stringent requirements of medical applications is technologically challenging. These membranes need to possess precise porosity, biocompatibility and durability. The medical devices including those incorporating membranes, must comply with rigorous regulatory standards and approvals from bodies like the FDA in the US and EMA in Europe. The R&D of advanced membrane technologies requires significant financial investment. This includes costs associated with material development, prototyping, testing and clinical trials, which may hinder the market growth.

Competitive Landscape:

In the highly competitive membranes for medical devices market, companies are investing heavily in research and development to innovate and improve the product and services. They are also collaborating, forming strategi partnerships, or acquiring other companies to gain access to new market segments, enhance distribution networks, and increase market share. Recent developments includes – Xtant Medical Holdings launched two amniotic membrane allografts, SimpliGraftTM and SimpliMaxTM, in April 2024.  Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) got approval for Cholederm by the Central Drugs Standard Control Organization (CDSCO), in June 2023. Asahi Kasei acquired Bionova Scientific LLC. Merck KGaA acquired Caraway Therapeutics for around USD 610 million, in November 2023. Saritorius AG acquired Polyplus, in July 2023.

Global Key Players:

·         Asahi Kasei Corporation

·         Hangzhou Cobetter Filtration Equipment

·         Koch Membrane Systems

·         Merck Millipore (Emd Millipore)

·         Microdyn-Nadir GmbH

·         Pall Corporation

·         Sartorius AG

·         The 3M Company

·         W. L. Gore & Associates, Inc.

·         Other Players