The Medical Textiles Market In India Economics Essay

Medical Textiles come under the category of technical textile. Medical textiles are the products and constructions used for medical and biological applications and are used primarily for first aid, clinical and hygienic purposes. It consists of all those textile materials used in health and hygienic applications in both consumer and medical markets [1].

Textile has always been a part of healthcare. But it is only recently that its application has started going beyond the usual wound care and incontinence products, plasters, clothing, bedding, etc. With latest innovations in textile technology, a wide variety of woven, non-woven and knitted forms of textile are increasingly finding their way into a variety of surgical procedures [2].

Medical Textile

Surgical

Implantable

Non-implantable

Extra corporeal

Health care &

Hygiene

Soft tissue

Hard tissue

Cardiovascular

Bandage, wound dressing, plasters

Artificial kidney, lever, lung

Surgical gowns and drapes, sanitary napkins, Diapers

The Indian market for medical textiles, currently worth around US$500 million, is witnessing robust growth of about 10-12% a year. However, compared with a global market of US$8238 million, Indian market size is still very small [3].

According to experts, one of the main reasons for India not producing enough technical textiles is a very high duty on the import of its machinery coupled with the need for a high investment. This has automatically resulted in a high demand for imports [2].

Table1: Medical textile market in India

Medical Textile

Market size

Annual Growth rate

surgical dressings

US$ 154.43 million

5-10%

healthcare textiles

US$26.72 million

13-16%

sutures

US$98 million

15-20%

Sanitary napkins

——

8-10%

Diapers

US$17.4m

5-10%

Medical implants and devices

US$4.2 million

10-15%

HEALTH CARE TEXTILES

Healthcare textiles comprise surgical clothing (gowns, caps, masks, uniforms etc.), surgical covers (drapes, covers etc.) and beddings (sheets, blankets, pillow cases etc.). Healthcare textiles can be disposable or non-disposable [4].

Concerns over infection in the operating room have stimulated research into improved surgical gowns and drapes. Several studies have confirmed the superiority of single-use surgical products in terms of resistance to bacterial and liquid penetration. Further improvements can be expected for single-use surgical textiles with new nonwovens and films that improve barrier performance and comfort properties for gowns.

In the reusable segment, development has been concerned with the production of laminates, particularly spunbond-meltblown-spunbond (SMS) nonwoven structures [5].

In India health care textile continues to be dominated by non-disposable however in the world disposable textiles are fast replacing non-disposables.

Market for Health care textiles

In line with the growth of the Healthcare sector, healthcare textiles overall are growing at a rate of 13-16% a year. Healthcare textiles are valued at US$26.72 million [3].

SURGICAL DRESSINGS

Surgical dressings include wound care products and bandages. Wound care products include wound contact layer / absorbent pad / base material / non-adherent dressings / perforated films, while bandages include inelastic bandages /elastic bandages / light support bandages / orthopedic cushion bandages / plasters /waddings / guazes / lint [4].

Bandages are one of the most important medical textiles and have a range of uses, including retention of dressings, providing support to joints, preventing the development of oedema, exerting pressure on a limb, treating skin diseases and providing protection against physical damage.

The fibers and fabrics used for bandage applications are dependent upon their intended functions. Warp-knitted spacer fabrics, elasticated woven fabrics, tubular knitted hose with elastane fiber, and nonwovens, for example, are widely used [5].

Different types of bandages are gauze bandage (simple woven strip of material), compression bandage, triangular bandage (cloth cut into a right-angled triangle), tube bandage (woven in a continuous circle) [6].

Fibrin bandages have been manufactured by saturating a biodegradable cloth with blood-clotting chemicals and an enzyme purified from human blood, which prevents excessive blood loss in severe injuries [5].

Orthopedic cushions are made of cotton and synthetics. These bandages retain their cushioning effect in the moist atmosphere between skin and plaster. The plaster of Paris bandages are made of cotton gauze material of leno weave cloth. The interlocking thread is impregnated in the plaster of Paris solution and dried to get the bandages [4].

No single dressing is useful for all types of wounds. Often a number of different types will be used during the healing process of a single wound. An ideal dressing performs the following functions: maintenance of a moist environment at the wound/ dressing interface, absorption of excess exudates without leakage to the surface of wound dressing, pliable, thermal insulation & mechanical protection, bacterial protection, gaseous and fluid exchange, absorption of wound odor, non-adherent to the wound and easy removal without trauma, debridment action ( removal of dead tissue / or foreign particles), non-toxic, non-allergic and non-sensitising (to both patient & medical staff), and sterile.

Table2: Classification of wound dressing types

Type

Properties

Passive

products

Traditional dressings that provide cover over the wound, e.g. gauze and tulle dressings

Interactive

products

Polymeric films and forms which are mostly transparent, permeable to water vapor and oxygen, non-permeable to bacteria, e.g. hyaluronic acid, hydrogels, foam dressings

Bioactive

products

Dressings which deliver substances active in wound healing, e.g. hydrocolloids, alginates, collagens, chitosan

These can also be classified as gauze, tulle, semi permeable film (Sterile sheet of polyurethane coated with acrylic adhesive), Hydrocolloids (Composed of carboxymethylcellulose, gelatin, pectin, elastomers and adhesives that turn into a gel when exudate is absorbed), hydrogels, alginates (Composed of calcium alginate , a seaweed component), Polyurethane or silicone foams, hydrofibre (Soft non-woven pad or ribbon dressing made from sodium carboxymethylcellulose fibers), and collagen containing dressings [7].

Traditionally cotton guazes were used for dressing because of their good absorption property and softness. Even today hospitals use the gauzes for dressing purposes mostly in layers to form swabs for better and higher absorption [4].

Waddings are single use cotton pieces in great demand abroad. In India, for clinical practices as well as domestic purpose cotton rolls are preferred, pieces of cotton are removed as and when required. In the foreign countries, sterile single use cotton waddings are highly popular [4].

Lint is used as wipes or swabs for primary cleaning of wounds before applying the dressings [4].

Market for surgical dressings

India’s market for surgical dressings, currently valued at US$ 154.43 million, is growing at a rate of around 5-10% a year. Some of the multinationals, including Johnson & Johnson, are leading manufacturers of surgical dressings in the country. However, a large segment of the production is also done in the decentralized small-scale sector, which does not follow any quality and production standards.

The unorganized state of production is further evident from the fact that there are no standard testing facilities for surgical dressings in the country. Multinationals use their own in house testing facilities for their products.

Hospitals and institutions buy 60% of the total sales of surgical dressings, the remainder being sold to individuals and general practitioners [3].

SANITARY NAPKINS

Sanitary napkin or menstrual pad is a disposable absorbent worn by females to receive and absorb menstrual flow. These are similar to incontinence pads but with lower absorbency. Kotex lists the materials used in their Maxi and Regular disposable pads as being made “mostly of wood cellulose fibers”, the “outer cover and the moisture-proof shields are made with a moisture-proof plastic such as polypropylene or polyethylene” [8].

Market for sanitary napkin

The Indian market for sanitary napkins is dominated by a few multinational companies – such as Johnson & Johnson, Kimberly Clark, Procter & Gamble” – who between them account for 80-85% of the total market. The remainder is taken by smaller units (those with an annual turnover of US$667 000 or less) in the decentralized sector. Earlier the government reserved the production to be limited by SSI, now government realizing the potential of this segment, has dereserved the production in order to attract investment.

The technical textiles or nonwovens component in sanitary napkins stands at a little less than 1.5 kt a year, most of which is met through imports at present” [3].

The feminine hygiene market is still a young market—only 20-25% women are estimated to use branded sanitary napkins in the urban sectors; the figure is much lower in rural India [9].

The industry for sanitary napkin is closely related with the mode of life. While the urban market has been growing at 7%, the total market is estimated to be growing at 8% to 10% annually [10].

SUTURES

Sutures are bio-medical devices used for wound closure to close cuts and incisions and thus prevent infection [4].

Criteria of good sutures

They must be strong i. e. high tensile strength and good knot security (so they do not break easily) [12],

non-toxic and hypoallergenic (to avoid adverse reactions in the body),

and flexible (so they can be tied and knotted easily).

In addition, they must lack the so called “wick effect”, which means that sutures must not allow fluids to penetrate the body through them from outside, which could easily cause infections [11].

There are two kinds of suture- absorbable suture and non-absorbable suture.

Absorbable sutures are made of materials which break down inside the body after a given time period depending on the type of material, which can range from ten days to eight weeks. These are ideal for use inside the body as they disappear completely and no need for the patient to have the sutures removed [11].

Absorbable sutures are of two types: synthetic absorbable sutures made up of poly glycolic acid (PGA) which are absorbed into the body within 20 days — 90 days, polylactic acid or caprolactone [11].Natural absorbable sutures made up of mucosa of sheep intestine (catgut fiber).

Occasionally, absorbable sutures can cause inflammation and be rejected by the body rather than absorbed [11].

Non absorbable sutures are made of materials which are not metabolized by the body and therefore maintain [12].

These are usually used for skin wound closure, and sometimes inside the body where absorbable sutures are not adequate, for example organs like bladder contain fluids which make absorbable sutures disappear in only a few days, and in the heart and in the blood vessels, whose rhythmic movement requires sutures which stays longer than three weeks, to give enough time for wound closure [11].

Non-absorbable sutures are made of silk, polyester, polypropylene, nylon, stainless steel etc. Polypropylene sutures have been widely used because they pass easily through tissues, resist breakdown and do not promote infection, provide good knot security have minimal reaction with tissues, have high tensile strength and they maintain their in vivo strength for extended period of time. Now attempts are being made to increase their compliance, limpness or flexibility while retaining their strength [12].

VICRYL Plus is the World’s first and only antibacterial suture introduced in India by Ethicon in 2004. VICRYL Plus has the same attributes as VICRYL (Polyglactin 910) Suture but the addition of the antibacterial agent Triclosan provides an extra benefit by creating an “active zone” around the suture, which works the moment it comes in contact with the patient’s wound [13].

Suture market

The Indian market for sutures has a value of US$98 million and is growing at a rate of 15-20% a year [3] and its share in the medical textile market is around 20% [14]. Johnson&Johnson, a pioneer in the field, holds nearly 85% of the market share in India and the rest of the market is catered to through small-scale industries like Futura Surgicare Pvt. Limited. This company not only has a major share of the Indian market, but also caters to 65 % of the world market. It exports 40% of its products to countries like the US, UK and a host of African countries like Zambia [15].

DIAPERS

Diapers are highly absorbent, hygienic disposable single use product designed to receive, absorb and contain body fluids keeping the skin dry and maximizing user comfort3. These are worn by individuals who are incapable of controlling their bladder or bowel movement, or unable or unwilling to use a toilet [16].The end user segment for diapers is senior citizens and hospitals, mostly the people above 75 years of age suffering from incontinence [4].

Modern disposable baby diapers and incontinence products have a layered construction, which allows the transfer and distribution of urine to an absorbent core structure where it is locked in. Basic layers are an outer shell of breathable polyethylene film or a non-woven and film composite which prevents wetness and soil transfer, an inner absorbent layer of a mixture of cellulose pulp and super-absorbent polymers for wetness, and a layer nearest the skin of nonwoven material with a distribution layer directly beneath which transfers wetness to the absorbent layer. Other common features of disposable diapers include one or more pairs of either adhesive or velcro tapes to keep the diaper securely fastened. A disposable diaper may also include an inner fabric designed to hold moisture against the skin for a brief period before absorption to alert a toilet training or bedwetting user that they have urinated.

Some disposable diapers include fragrances, lotions or essential oils in order to help mask the scent of a soiled diaper or to protect the skin [16].

The key performance parameters for incontinence diapers are similar to the other categories of absorbent hygiene products, viz., high absorption capacity and skin dryness; reduced odor; protection from leakage; maximizing user comfort, particularly when saturated with liquid and; simple to use [4].

Kimberly Clark Lever Pvt Ltd (KCL) is today offering its Dri-Fit diapers with 50 per cent more absorbent material using super absorbent material .SAM quickly absorbs fluid and converts it into dry gel-like material, locking fluid in the core of the diaper, keeping the baby’s skin absolutely dry. SAM can absorb fluid up to 100 times its weight. This means that one gram of SAM can absorb up to 100 grams of fluid [17].

Diaper market

The Indian disposable diaper market is currently pegged at nearly Indian Rupees (Rs) 700m ($17.4m, E12.6m) and 30,000 tonnes/year, and is estimated to grow between 5-10% annually. It comprises brands like Huggies (60% market share) and Pampers (30%) from multinationals Kimberly Clark and Procter & Gamble, respectively. Domestic consumer products major Godrej’s Snuggy is the third-largest brand of diapers in the Indian market, with a 10% share [18].

The disposable diaper market in the country is at a nascent stage, with extremely low consumption. The baby diapers are reportedly reserved for production by the SSI sector and the cost of core machinery required for production of baby diapers exceeds the SSI ceiling for investment. Thus, SSI reservation prevents setting up of large scale MES units3; however, import duties of as high as 20% results in the products being relatively expensive. Another reason for low usage of the products is a lack of awareness about their existence, and the needs for and advantages of them [3].

However, the potential is huge, given the largest infant population in the world [India has about 45% more infants than China and almost six times more babies than the US] and a large, growing middle class with expanding disposable incomes. Diaper manufacturers and petrochemical companies seem to have realized the enormity of this emerging market.

However, Richer believes that within the next 25 years, India will be the largest consumer of diapers in the world because of its growing middle class and constantly rising PPP. India will overtake China, which will have to fight with a shrinking market because of a reduced birth rate and a maturing population [18].

MEDICAL IMPLANTS AND DEVICES

Medical implants and devices cover items like

cardiovascular implants (vascular grafts, heart valves etc.)

soft tissue implants (artificial tendon, artificial skin, artificial ligament, artificial cornea, eye contact lenses, hernia repair etc.)

Hard tissue implants (orthopedic implants) – Artificial joints, Bones and dental implants etc.

and extra corporeal devices (artificial kidney, artificial liver, mechanical lung, artificial heart etc.) [3].

The biological requirements for a satisfactory artificial implant are as follows:

(1) Suitable artificial surface for the body cells to easily adhere to and grow on.

(2) Porosity, which determines the rate at which tissue will grow and encapsulate the implant.

(3) Fiber diameter, in general, smaller than the cells for their adherence. Although human tissue is capable of encapsulating objects much larger than fibers, it can better encapsulate the small circular fiber than large irregular cross section fiber.

(4) Bio-degradability or bio-stability depending on the application.

(5) Non-Toxicity, where fiber polymer or fabrication techniques must be non-toxic and fiber should be free of contaminants [19].

Vascular grafts

Vascular grafts are used to treat hindrances to blood flow caused by vascular and other diseases. A vascular graft replaces the damaged artery or creates a new artery in order to increase blood flow [4].

A graft needs to satisfy certain engineering and functional criteria like

A nonthrombogenic surface,

Elements to impart compliance and elasticity,

Design to maintain long-term tensile strength,

Biocompatibility or ability to be healed by the patient,

A variety of characteristics to make its widespread application efficacy ous, such as easy handling, suturability, capacity for uniform mass production, shelf storage, repeated sterilization, and availability in appropriate sizes.

Non-fraying properties

Bacteria resistance [19]

Vascular grafts are of two types:-biologic grafts and synthetic grafts.

Biologic grafts include the following

Heterografts: Bovine carotid artery.

Homografts: Human umbilical vein.

Auto grafts: Autogenous blood vessel, such as the saphenous vein, or mammary artery.

Synthetic grafts are made of PET (Dacron), polytetrafluoroethylene (PTFE, e PTFE),polyurethane.

Fabric design: The textile fabric are either woven, knitted, 3D braids, or. non-woven. Woven structures are the most dimensionally stable structures, have a high bursting strength, a good fatigue resistance and a low permeability to water (or blood), which reduces bleeding, but they have tendency to fray at cut ends, stiff and difficult to suture. Knitted fabrics have the advantage of flexibility, compliance and easier to suture but disadvantage of high porosity and high permeability and therefore they are per clotted with patients blood before implantation. Current research is focused on surface modification for biocompatibility of current grafts, development of biodegradable materials for use in grafts, and development of new elastomeric polymers. In some research laboratories attempts are being made to tissue engineer a vascular graft using a unique matrix-based tubular scaffold and endothelial cells that are ideally isolated from the patient. Endothelial cells, which line all blood vessels in the body, should help prevent thrombosis and clotting of the graft [19].

Heart valves

The heart valves assist cardio-thoracic surgeons in treating valvular diseases. The heart valves are of two types, namely, mechanical valves and tissue valves.

Mechanical valves are used for younger patients and require periodical check-ups and after a particular period, the patients need to be operated a second time. Mechanical valves are made of titanium, around which is a knitted fabric to be stitched to the original tissue called as sewing ring. The sewing ring of the caged-disc type of prostheses uses a silicon-rubber insert under a knitted composite PTFE and polypropylene fibre cloth.

Tissue valves are used for slightly aged patients and do not require any periodic checkups. The life of these valves is 15-20 years. Mechanical and tissue valves are available in sizes ranging from 17 mm to 35 mm. Mechanical valves constitute about 90 percent of the total market while tissue valves account for about 10 percent of the total market [4].

Artificial tendon (Mesh)

A hernia is a bulging of internal organs or tissues, which protrude through an abnormal opening in the muscle wall. Hernias can occur in the abdomen, groin, and at the site of a previous surgery. Mostly, these are corrected by placing a mesh at the site of hernia.

Prosthesis used for hernia repairs can be non-absorbable, composite (combination of absorbable and non-absorbable fibers) or with an absorbable or a non-absorbable barrier.

An ideal prosthesis should be 1) strong, 2) pliable, 3) non-allergenic, 4) inert, 5) non-biodegradable, 6) non-carcinogenic and 7) should stimulate adequate fibroblastic activity for optimum incorporation into the tissues.

Materials used for hernia repair are mostly made of polypropylene (Prolene, Marlex), polyester (Mersilene), PTFE and a combination of these with other materials such as carbon fiber.

Artificial joints

The artificial joints are made of stainless steel, chromium cobalt, titanium or some other inert material. The textile material present in the joints is Ultra High Molecular Weight HDPE (UHMWHDPE). The imports of artificial joints have been from Germany, France, Switzerland, USA etc.

Artificial kidney

Artificial kidney consists of a semi-permeable membrane, on one side of which blood passes while a special dialysate solution is passed along the other. The artificial kidney is made of polyacetate and polysulphone in equal proportions [4].

Market of medical implant and devices

In India the market for medical implants is estimated to be $4.2 million, of which most is imported. The market for medical implants is one of the largest healthcare markets and is a fast growing one. Future growth is driven by technical changes (active implants, spinal implants, tissue engineering) and the social and economic changes in the developing countries, as well as due to the change in the age structure in the industrialized countries. The most promising markets are the continued growth of the market for hip and knee replacements, sports medicine (mainly arthroscopic surgery), ortho/osteobiologics (meniscal/cartilage repair/bone substitutes), spinal implants, trauma fixation and cardiovascular stents, dental and ophthalmic [20].

India’s market for medical implants and devices is growing at a rate of 10-15% a year. However, being high technology, high value, items requiring a high degree of precision in manufacture, these are very rarely made within the country. Almost all of India’s requirement for medical implants and devices is satisfied by imports from countries such as Germany, the UK and the USA.

* vascular grafts generates US$800 000;

* heart valves is worth US$ 16.22 million;

* artificial tendons has sales of US$8.22 million;

* artificial joints is about US$3.16 million; and

* artificial kidneys generates US$3.78 million [3]

Vascular grafts are imported by companies such as WL Gore and Associates (which enjoys a 60% market share in India), Edwards Life Sciences, Boston Scientific and Sri Chitra. The market for vascular grafts is growing at a rate of 2-3% a year.

Imports of artificial heart valves are currently worth about US$5.30 million, and come from countries such as Singapore, Canada, the USA and Switzerland. This market sector is growing at a rate of around 7% a year.

The market for artificial tendon (mesh) is growing at an annual rate of 11 %, while that for artificial joints is climbing 12% a year. Finally, the market for artificial kidneys is growing at an annual rate of 5-10% pa [3].