By AMG NewTech News | February 05, 2019 at 04:45 PM EST | No Comments
The global market for bioresorbable polymers (BPs) is estimated at $896 million in 2018. Bioresorbable polymers are gaining increasing attention in the medical industry for their ability to completely and naturally dissolve in the human body, while contributing to the formation of new tissue.
BPs consist of two categories of materials: biopolyesters and agro-polymers. Biopolyesters currently represent the largest segment at 82% of the total market and include materials such as polylactic acid (PLA, or polylactide), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), and their copolymers (e.g., PLA/PGA and PLA/PCL) and derivatives (e.g., PLLA and PDLA). Polylactic acid is the most popular in this category. PLA decomposes into lactic acid, a compound that already forms in muscle tissue during exercise and that is naturally eliminated by the body.
Although less popular, agro-polymers, which comprise polysaccharides and proteins, also find various uses as biodegradable implants, drug delivery products, and surgical threads.
To date, BPs have been primarily applied in the fabrication of medical products for orthopedics, drug delivery, surgery, and dentistry, as summarized in the next table.
However, there are several technological trends that are reshaping this market. The most relevant relates to the introduction of bioresorbable polymers in the manufacturing of stents. Stents are implantable devices whose function is to restore adequate flow of biological fluids in cardiovascular, urethral, esophageal, biliary, and pancreatic vessels. Cardiovascular bioresorbable stents, in particular, have become the subject of numerous research and development activities in recent years.
Originally, stents were made from metals such as platinum, chromium and stainless steel. They were not biodegradable and over time they caused new tissue overgrowth resulting in restenosis (narrowing of the artery) and aggregation of platelets leading to thrombosis. In the early 2000s, drug-eluting stents based on metal alloys (e.g., nitinol) were introduced comprising immunosuppressants and antiproliferative agents , the most common of which are sirolimus and everolimus. These drugs prevent excessive proliferation of vascular smooth muscle cells but also delay growth of endothelial cells.
In 2016, the FDA approved a bioresorbable vascular scaffold (BVS) based on PLLA that re-establishes normal blood flow while supporting the artery for three to six months. The BVS slowly degrades within 3 years, leaving behind a completely healed artery with restored vasomotion. This absorbable coronary DES, which contains everolimus, is called Absorb GT1 BVS and was introduced by Abbott Vascular ( Santa Clara, CA).
However, in 2017, the FDA issued a safety alert for this product due to the occurrence of adverse cardiac events, leading Abbott to halt sales. Since then, the company has continued to work on the development of a new generation of bioresorbable devices.
Current issues with biodegradable stents are incomplete endothelialization, fragmentation of the stent, and severe inflammation, but there are some products on the market that have shown good performance to date. Elixir Medical (Milpitas, CA) manufactures DESolve, a fully bioresorbable PLLA novolimus-eluting scaffold that degrades in 1 year. The device is CE-mark approved, but not yet available in the U.S. Arterial Remodeling Technologies (Paris, France), a division of Terumo (Tokyo, Japan), produces ART PBS, a PDLLA-based bioresorbable stent that received its CE-mark approval in 2015. The device is completely absorbed in 2 years.
Development of bioresorbable DES is continuing at full speed worldwide, as these devices are considered a very promising alternative to conventional metal stents. Improvements are being achieved by the addition of nitric oxide-releasing nanoparticles to prevent platelet adhesion and through BP patterning by ultrashort pulsed laser technology to promote adhesion and proliferation of endothelial cells.
In addition to anti-inflammatory drugs, bioactive agents are being incorporated into these devices including platelet-derived growth factors with the function of stimulating growth of endothelial, muscle and fibroplastic cells. Bioresorbable polymers encapsulate these therapeutic agents and also ensure that they are gradually released.
Other emerging cardiovascular applications for BPs include prosthetic heart valves and coatings for metal stents. Also, composite bioresorbable membranes are being introduced as barriers to prevent post-cardiac surgical sternal and epicardial adhesions. During resorption, these membranes act as scaffolds for new cell growth, forming a natural barrier once they are completely degraded.
Bioresorbable polymers are also being adopted in the fabrication of probes for evaluating neural activities. Existing probes are made from metals and are rigid. Since the brain is made of a soft tissue, metallic probes cause irreversible tissue damage if inserted for long periods, leading to electrode failures. Probes made from bioresorbable polymers become softer as they degrade and eventually are completely resorbed, thus improving the long-term performance of depth probes.
Another application of BPs in neurology is for producing nerve guidance channels (or conduits) to connect the ends of damaged nerves located in the peripheral nervous system. Nerve conduits provide axons with space where they can grow while being protected from new traumatic events. Nerve channels made from BPs can be engineered so that the time of their degradation matches the time needed for functional recovery of the injured nerve.
BPs are finding additional uses as embolic coils and particles to control bleeding during surgery, restrict blood supply to tumors, and stop hemorrhages. Typically, these coils are made from metals and work by promoting clot formation around the coil. Although metal coils have desirable properties such as radiopacity and shape memory, they also show drawbacks including chronic tissue damage, tissue overgrowth, and permanent incorporation into the tissue. BPs are attractive materials for embolotherapy since they are inherently radiopaque, degradable, and applicable in repeated treatments.
In drug delivery, bioresorbable polymers are becoming popular as drug carriers for cancer therapy. They are being engineered to respond more effectively to physical and chemical stimuli such as temperature, light, ultrasound, electric current, pH changes, and enzymatic activities, so that targeting of cancerous cells can be optimized.
Electrospun nonwoven fabrics based on BPs are being manufactured for wound treatment and repair of soft and hard tissues. These products incorporate growth factors and proteins that can be delivered to the wound area with good spatial and temporal control.
3D printing is being investigated for fabrication of scaffolds with complex and customized shapes. Currently, one of the main issues with 3D printing is that common bioresorbable polymers can only be formed at relatively high temperatures. For example, PLA requires processing temperatures greater than 200°C, which negatively impact the biological properties of this material.
Biocomposites are gaining traction in bone tissue regeneration applications. Bioresorbable polymers are combined with calcium phosphate-based materials, such as hydroxyapatite (HA), to create products with improved load-bearing properties and biocompatibility. Polymers with different properties can be mixed together before addition to calcium phosphate compounds. For example, PLA, which is characterized by fast degradation behavior, can be blended with PCL, which exhibits a ductile behavior, to optimize biological and mechanical properties of the composite product. Composites based on PLA/PCL are generating strong interest because PCL reduces the brittleness of PLA, providing a material with characteristics similar to cancellous bone and easier to form by 3D printing. Nanomaterials, such nanohydroxyapatite, are also being added to BPs to fabricate composite membranes, fixation devices, and other advanced biomedical products with enhanced performance.
All these trends are projected to contribute to healthy market growth during the next five years, with BP revenues estimated to rise at a CAGR of 13.8% through 2023. BPs for cardiovascular products are expected to account for approximately 10% of the market by the end of the forecast period.
By AMG NewTech News | January 10, 2017 at 01:33 PM EST | No Comments
The market for graphene used in medical applications is projected to grow at a CAGR of 39.1% through 2026.
Graphene was first isolated from graphite in 2004 by Prof. Andre Geim and Prof. Kostya Novoselov at the University of Manchester in the U.K. Since then, this one-atom-thick carbon allotrope with a hexagonal honeycomb structure has been rapidly gaining attention worldwide for its unique structure and properties.
Various methods are available for producing graphene. They are summarized in the table below, based on popularity. Popularity has been calculated based on the share of global patents and patent applications published during the past 20 years for that particular production method.
Most of the existing fabrication methods are unable to produce graphene in large quantities without compromising its intrinsic characteristics, thus contributing to the high unit price of this material. In recent years, roll-to-roll and plasma-enhanced CVD processes, and liquid-phase exfoliation have been developed to manufacture graphene on a mass scale.
Graphene is presently sold primarily as mono-, bi-, and few-layer coatings (e.g., on copper foil, silica substrate, or polymer film); nanostructures (e.g., nanoplatelets, quantum dots, and nanoribbons); and graphene oxide powder.
At the present time, graphene is chiefly used for applications within the electronics (including optoelectronics), composites, and energy sectors, for fabrication of devices such as supercapacitors, batteries, organic photovoltaic cells, high-strength composites, touch screens, liquid crystal displays, and organic light-emitting diodes. A number of applications are also emerging within the medical field.
As shown in the next figure, graphene exhibits various relevant properties, such as high conductivity (electrons move faster than in other materials), flexibility and elasticity, biocompatibility, and antimicrobial properties. All these properties make graphene (and its oxide) suitable for different types of applications within the healthcare sector. They can be grouped according to five main categories: sensors, implants and scaffolds, imaging and testing, therapies, and others.
The global graphene market is estimated to be valued at $31.3 million in 2016 and forecast to grow at a 45.7% CAGR during the next 10 years, exceeding global revenues of $1.3 billion by 2026. Graphene for medical applications is estimated to account for just 2.2% of the global market in 2016. Growing at a CAGR of 39.1%, graphene for the healthcare sector is projected to generate global revenues of $18.7 million in 2026. Sensors and therapies will account for nearly 70% of the market.
The next table provides a list of key producers of graphene, with special focus on medical applications.
By AMG NewTech News | November 01, 2016 at 01:28 AM EDT | No Comments
The market for microfluidic devices for neurology is forecast to grow at a CAGR of 20.1% through 2021.
The human nervous system consists of the central nervous system (CNS), which includes the brain and spinal cord, and the peripheral nervous system (PNS), which includes nerves and ganglia. The basic cell unit for the tissues forming the human nervous system is the neuron. There is growing interest in the development of technologies for the regeneration and repair of nervous tissue.
One of the most advanced technologies in this field is microfluidics. In neurology, microfluidics is applied eitherin vitroorin vivoto grow and isolate cells, probe functional properties of neurons, deliver treatments to diseased tissues, and regenerate the affected tissue.
A detailed summary of current and emerging applications of microfluidics in neurology is provided in the table below.
The market for microfluidic devices for neurological applications is estimated to be valued at approximately $30 million in 2015 but it is forecast to expand at a very healthy CAGR of 20.1% through 2020.
The next table provides a list of key producers of microfluidic devices for the medical sector with special focus on neurological applications.
By AMG NewTech News | November 01, 2016 at 01:09 AM EDT | No Comments
The market for nanotextiles is forecast to grow at a CAGR of 22.3% through 2020.
The term nanotextiles is used to define fabrics that are manufactured based on nanotechnology. There are several processes that are employed to produce nanotextiles, the most common of which are the following:
Incorporating nanostructures within the fibers that form the fabric. Examples of suitable nanostructures are nanoparticles, nanochips, nanotubes, nanorods, nanofibers and nanocapsules.
Coating the fibers or the fabric with colloidal solutions containing nanostructures (this process is also known as nanocoating).
Directly utilizing nanofibers to manufacture fabrics.
Introducing nanoporosity in the manufacture of fabrics.
Nanotextiles are made primarily from natural and synthetic fibers and include woven and nonwoven textiles. Products based on inorganic fibers (e.g., ceramic and metallic fibers) are typically not included in the definition of nanotextiles. As indicated in the table below, nanotextiles find application in various industry sectors ranging from apparel/home furnishing to space exploration.
The next table provides a representative list of key players in the nanotextile industry.
The global market for nanotextiles is estimated to have reached global revenues of $2.5 billion in 2015 and is forecast to grow at a compound annual growth rate (CAGR) of 22.3% through 2020. The largest segment of the market is represented by nanocoated fabrics.
By AMG NewTech News | November 01, 2016 at 12:32 AM EDT | No Comments
The market for superalloys and shape memory alloys for medical applications is forecast to grow at a CAGR of 10.6% through 2020.
Superalloys are a group of high-performance alloys that are resistant to creep, corrosion and high temperatures (above 540ºC). There are three main classes of super alloys: nickel-, nickel/iron-, and cobalt-based. Other elements forming superalloys include chromium, tungsten, molybdenum, tantalum, niobium, titanium, and aluminum. Their unique properties are related to the presence of an austenitic face-centered cubic structure reinforced by a secondary phase (called gamma prime).
Currently, the main application of superalloys is for the fabrication of aircraft engines and power generation turbines. Superalloys are also used in the healthcare sector, where they are valued for their anticorrosion properties, mechanical strength, low weight, and good biocompatibility and inertness. As displayed in the table below, common uses are for the fabrication of medical devices and implants (e.g. stents, catheters, and prostheses), surgical instruments, drugs and drug delivery devices, biosensors and microfluidic devices, diagnostic equipment, and dental restorations.
Superalloys for healthcare applications are primarily based on nickel-chromium, nickel-aluminum, and cobalt-chromium. Nickel-titanium (NiTi, or Nitinol) is also often included in the category of superalloys. Nitinol is a unique material that exhibits an austenitic face-centered cubic structure at high temperatures and a martensitic crystal structure at low temperatures. It is characterized byshape memoryandsuperelasticity, which allow this material to return to its original shape upon heating. These properties have made NiTi popular fororthodontic wiresand stents. Recently, a nickel-titanium-copper shape-memory alloyhas been developed that is capable of being bent over 10 million times without exhibiting wear.
The market for superalloys and shape memory alloys for medical applications is estimated to reach global revenues of $1.9 billion in 2015 and forecast to grow at a compound annual growth rate (CAGR) of 10.6% through 2020.
The table below provides a representative list of manufacturers of superalloy and shape memory alloy products for the healthcare industry.
By AMG NewTech News | November 01, 2016 at 12:20 AM EDT | No Comments
The market for tissue engineering scaffolds is forecast to grow at a CAGR of 17.2% through 2020.
A tissue engineering scaffold is a porous three-dimensional (3D) matrix that is seeded with cells and/or bioactive factors leading to growth of new tissue either in-vitro or in-vivo. The new tissue is used to repair, replace and regenerate tissue damaged by disease, injury or congenital defect. Tissue engineering scaffolds act as a support for cells and guide their migration, adhesion, reproduction and differentiation, and also affect new tissue vascularization and the delivery of nutrients needed for cell proliferation and differentiation.
As shown in the table below, various materials, including polymers, glass, ceramics, and metals, have been introduced to manufacture tissue engineering scaffolds for hard (e.g., bone and cartilage) and soft tissues (e.g., skin, muscle and nerve).
R&D activities are not only focusing on material formulation but also on fabrication methods that are capable of producing scaffolds with the following characteristics: high porosity and pore interconnectivity, controlled pore size, biodegradability, biocompatibility, adequate cell adhesion and surface roughness, appropriate chemical and topographical surface properties, and good mechanical strength.
Processes commonly used to manufacture tissue engineering scaffolds include polymer foam replication, gas foaming, sol-gel casting, electrospinning, thermally induced phase separation (TIPS) and freeze drying. Fabrication technologies based on additive processes (e.g., 3-D printing, stereolithography, selective laser sintering, melt-extrusion, solution/slurry extrusion, and tissue/organ printing) have been attracting greater interest based on their ability to rapidly produce complex geometries. Among these technologies, 3-D printing is particularly promising due to its versatility in permitting computer-controlled construction of pores, surface roughness, and textured surfaces, all of which facilitate the growth of specific tissues.
Tissue engineering scaffolds are emerging as a promising method to repair, augment and regenerate organ functionality. These scaffolds allow for the growth of new tissue from the patient’s own cells and therefore avoid problems related to adverse immune response, pathogen transmission and donor site morbidity. The market for tissue engineering scaffolds is estimated to be valued at $720 million in 2015 and is projected to grow at a CAGR of 17.2% during the next five years. Bone repair currently accounts for approximately 65% of the market.
A representative list of relevant industry players involved in manufacturing and/or development of tissue engineering scaffolds is provided below.
By AMG NewTech News | November 01, 2016 at 12:07 AM EDT | No Comments
The market for thermoelectric materials is forecast to grow at a CAGR of 27.3% through 2020.
Although the thermoelectric effect was discovered almost 200 years ago, thermoelectric materials have been experiencing strong renewed interest in recent years thanks to the development of advanced materials with increased thermoelectric efficiency and lower production costs.
Thermoelectric materials, which can be used for direct conversion of heat into electrical energy, or viceversa, are particularly appealing for energy harvesting applications. For example, these materials can be used to obtain power from the heat generated by combustion engines, manufacturing processes and equipment, orthe human body.
A material’s thermoelectric efficiency is measured by the dimensionless factor (thermoelectric figure of merit) ZT =(σS2/k)T,where σ, S, k,and T are the electrical conductivity, the Seebeck coefficient (or thermoelectric power), the thermal conductivity, and the operating temperature, respectively. As a reference, bismuth telluride,a well-known thermoelectric material,has a ZT value of 1.0 at room temperature. However, bismuth telluride (Bi2Te3) has not gained widespread popularity primarily due to its high production cost.
To exhibit high thermoelectric efficiency, a material must be characterized by both high electrical conductivity and low thermal conductivity. Typically, those materials that have good electrical conductivity are also good thermal conductors. Advances in material science during the past ten years have led to the development of various formulations with relatively high ZT values. They are summarized in the table below.
At the indicated temperature, the ZT value for that particular material reaches the reported peak value. Materials with ZT values equal to or greater than 1 are attracting particular interest; although, in an effort to make thermoelectricity more competitive with alternative technologies, the objective of current research is to obtain ZT values closer to 3.
In April 2014,Nature reported that scientists at Northwestern University (Evanston, IL) and the University of Michigan (Ann Arbor, MI) discovereda ZT value of 2.6at 923 K in SnSe single crystals along the b axis of the room-temperature orthorhombic unit cell.
Thermoelectric materials with high ZT values.
Material
Peak
ZT value
Temperature (K)
p-Type
Sb2Te3
1.0
300
Bis-dithienothiophene
1.5
300
AgPbSnSbTe
1.5
630
NaPbSbTe
1.7
650
PbTe
1.0
700
PbSe
1.0
700
Ni-doped tetrahedrite (CuSbS)
1.0
700
TeAgGeSb (TAGS)
1.2
700
Tl-doped SnTe
1.3
700
Zn4Sb3
1.4
700
Tl-doped PbTe
1.5
700
Sb2Te3–based alloys
1.7
700
Na-doped PbTe
1.4
750
K-doped PbTeSe
1.6
775
NaCo2O4(single crystals)
1.2
800
SrTe-doped PbTe
1.7
800
PbS/Na-doped PbTe
1.8
800
PbS-doped PbSe
1.3
900
SrTe/Na-doped PbTe
2.2
900
Barium-doped BiCuSeO
1.1
920
Metal sulfide-doped PbS
1.2
920
SnSe single crystals
2.6
920
Nanostructured Cu2Se
2.0
975
MnSb-based alloys
1.1
1,200
n-Type
Bi2Te3
1.0
300
Bi2Te3nanocomposites
1.5
375
CuBiTeSe
1.1
400
AgSbTe2/PbTe
1.7
700
Mg2(Si,Sn)
1.3
700
Ge/Bi-doped Mg2(Si,Sn)
1.4
800
Sr/Ba/Yb-doped skutterudites
1.9
835
Nanostructured P-doped SiGe
1.5
900
SiGe nanowires
1.6
1,200
Source: AMG NewTech
The global market for thermoelectric materials is currently very small and estimated to reach $3 million in 2015, but it is forecast to grow at a rapid CAGR of 27.3% during the next five years.
By AMG NewTech News | October 31, 2016 at 11:43 PM EDT | No Comments
The market for flat glass used for radiation shielding is forecast to grow at a CAGR of 13.6% through 2020.
The global primary flat glass market is estimated to reach $49.8 billion in 2015, and grow at a CAGR of 5.9% during the next five years. Flat glass includes three main categories based on manufacturing process: float, sheet, and rolled.
The main applications for flat glass are within the following industry segments: construction (windows, facades and doors), transportation (windshields and windows for vehicles), electronics (primarily displays for computers and portable devices), and energy (thermal panels and solar cells).
Other applications include household goods (furniture, appliances, and decorative panels, such as picture framing), vision devices (eyewear and night vision systems) and specialty glass.
There are several types of flat glass that are projected to grow at a CAGR greater than 5.9%, including security and safety glass, solar control glass, self-cleaning glass, smart glass, and glass for heads-up display windshields, which are estimated to have a CAGR between 7% and 10% during the next five years.
Another relevant type is radiation shielding glass (RSG). It is primarily used to protect from X-rays and gamma-rays in laboratories, hospitals, medical and dental offices, nuclear plants, radioactive storage stations, and airport security settings. RSG is typically characterized by a higher lead content and glass thickness compared to other types of flat glass, although, in recent years, many R&D activities have been aiming at the development oflead-free RSG.
The global market for radiation shielding glass currently represents a very small share of the total flat glass market. It is estimated to reach $110 million in 2015 but is forecast to grow at a robust CAGR of 13.6% through 2020, representing one the fastest growing segments within the flat glass industry.
Global Market for flat glass by sector, 2015 through 2020.
By AMG NewTech News | October 31, 2016 at 10:10 PM EDT | No Comments
The market for tissue repair and engineering procedures for cancer treatment is forecast to grow at a 16.1% CAGR through 2020
Tissue repair and engineering procedures for cancer treatment (TREPCs) are based on the use of implantable and transplantable materials made from body tissues and biomaterials and are used for restoring, replacing or regenerating tissues affected by cancer. Chemotherapeutic products are not included in this definition.
Existing and emerging TREPCs focus on cancer treatment for all body organ systems, including the urinary, reproductive, gastrointestinal, respiratory, cardiac, hematic, skeletal and cranium-maxillofacial, ophthalmic, neurological, muscle, and dermal systems.
In general, materials for tissue repair and engineering are categorized as autografts (obtained from the same patient), allografts (obtained from another individual), xenografts (obtained from an animal), and synthetic materials (partially or completely man-made). TREPCs are primarily based on autologous or allogeneic stem cells and on synthetic materials. Synthetic materials are prepared in the form of microspheres, nanoparticles, nanofibers, pastes, gels, solid components, and injectable solutions and emulsions, and are made from a variety of materials including ceramics, glass, glass-ceramics, polymers, metal and alloys, or composites.
TREPC materials of recent development integrate pharmaceutical compounds (i.e., drugs), biological compounds (e.g., DNA, proteins, enzymes, and peptides) and engineered microorganisms (e.g., bacteria) with the function to improve biocompatibility, bioactivity and cell regeneration speed.
Relevant market players in the field of TREPCs are Celgene, Mesoblast, BioTime, Cellerant, Gamida Cell, GlobalStem, NeoStem, and TriStem.
As shown in the table below, the global TREPC market, which includes costs for materials and surgical procedures but excludes costs associated with hospitalization stays and medical follow-ups, is estimated to reach $800.9 million in 2015. Stem cells account for the largest share of the market at 93.9% of the total, whereas all the other procedures are currently in the clinical trial stage and represent a much smaller share of the market.
AMG NewTech forecasts that the TREPC market will rise at a CAGR of 16.1% through 2020, driven primarily by the expanded use of stem cell therapies and by increased penetration of innovative nanoparticle-based regenerative products. Examples are biodegradable polymeric nanoparticles that deliver targeted drugs and also act as scaffolds for new cell growth.
Global market for tissue repair and engineering procedures for cancer treatment by material type, 2015 through 2020.
By AMG NewTech News | October 31, 2016 at 10:54 AM EDT | No Comments
Healthy market growth in medical electronics through 2016
The medical electronics sector is forecast to expand at a healthy 8.4% compound annual growth rate (CAGR) during the period 2011 through 2016. The medical electronics sector can be divided into three key segments: medical devices and implants; patient monitoring, diagnostics, and therapy; and medical imaging and instrumentation.
While the largest segment is currently represented by medical devices and implants, the fastest growth is occurring in the patient monitoring, diagnostics, and therapy segment, due to the growing use of remote patient monitoring, wireless technologies for diagnostics and therapy, and telemedicine. As a result, the patient monitoring, diagnostics, and therapy segment is projected to grow at a robust CAGR of 15.7% during the period 2011 through 2016.
The use oflasers, within the medical imaging and instrumentation segment, is also expanding at a rapid rate. Within slower growing market segments (medical devices and implants, and medical imaging and instrumentation) there are several emerging applications, such as implantable sensors, which are expected to offer important market growth opportunities over the next five years.
Global market for medical electronics, 2011 through 2016.
Market Segment
Revenues ($ Billions)
2011
2016
CAGR%
2011-2016
Medical devices and implants
Microelectronic medical implants
15.0
23.2
9.1
Cardiovascular devices
87.0
100.0
2.8
Neurosensons, neuromodulators and neurostimulators
