Continuous product rollouts, automation, and innovations are common in the industry and is a critical strategy for retaining consumer interest and loyalty in the highly competitive environment.

Highly populated countries are advancing their healthcare coverage. As large numbers of people gain access to more advanced medical treatment, additional demand for blood components, plasma-derived drugs, and surgical procedures is directly increasing. At the same time, tighter donor eligibility requirements to improve blood safety have decreased the number of donors willing to donate blood. This worldwide market is growing modestly in the low single digits.

Blood banking devices include all instrumentations, which are involved in collecting, processing, and storing blood and blood components. Furthermore, typing the blood group, separating into several components for specific usage, and preparing for transfusions are also important processes within the blood banking activity chain. Blood collection equipment and devices form the basic and most critical portion of the entire blood transfusion medicine space. For safe and efficient blood collection procedure, a variety of specialized blood collection equipment and devices are available in the market, which include blood collection monitors, blood donor couches, blood bags, and blood bag tube sealers.

The majority of manual collection devices consist of blood bags, needles, donor tubings, anticoagulants, donor blood sampling arms, and inline leukoreduction filters. Blood bags are available in different sizes; most of them sold across India are triple or quadruple bags, which allow separation of blood components into different compartments. They are single-use disposables that collect blood manually based on the principle of gravity.

Disposable pouches and bags owing to their ease of use and relative cost advantage form an essential component in the specialty medical supplies market. Despite government initiatives stressing on re-use of medical specialty bags, repeated risk of infection and costs related to washing and sterilizing the bags prove to be major detriments for consumers. The scenario posts bright outlook for development of new products and technologies in the market.

Disposable medical pouches and bags are preferred containers for standard devices and supplies, owing to their cost-effectiveness and intrinsic advantages. These plastic blood bags are ideal substitutes for glass bottles that are traditionally used to collect, store, and transport blood and blood components. Environmental organizations and governments in several parts of the world are urging consumers to use reusables due to heightened concerns over the amount of landfill waste generated. Despite reusables being cheaper in the long run, large number of people prefer disposables due to issues related to embarrassing leakages, inconvenience in usage, and high cost of washing and sterilizing the products.

It is estimated that 66 percent of blood collection bags are supplied by NACO to all government and most of the voluntary blood banks. The rest of the demand is taken care of by non-government blood banks, which are mostly associated with hospitals. RITES Ltd. is acting as a procurement agent to NACO under this project and intends to apply a part of proceeds for provisions of consultancy services for the project by hiring an inspection agency. The agency will be responsible for carrying out all the activities related to inspection, viz., preliminary inspection, collection of samples, delivering samples to labs, testing of samples, and other prescribed measures for quality assurance, for almost two years. RITES Ltd. has bought a tender for Rs. 18 crore on behalf of NACO.

Global Market

The global medical specialty bags market is poised to grow at a healthy rate in the near future backed by technological advancements, ageing population, and introduction of a number of sophisticated products. Extensive reimbursement options and increased availability of a number of economically priced products are some of the major growth drivers. Hospitals and healthcare institutions constituting over 60 percent of total demand remain the strongest end-user segments, with an urgent need to deal with the rise in chronic and age-related diseases keeping up the market momentum. Non-hospital settings such as surgi-centers and home healthcare are specific niche areas growing in importance, and largely focused on the medical disposables segment.

Europe is the largest market for ostomy care products, while Asia and Latin America are some of the emerging markets sporting rapid growth rates.

Market Dynamics

In India, the blood collection equipment and devices market in 2011 is estimated at Rs. 89.3 crore. It may be segmented as blood collection monitors, blood donor couches, tube sealers, and blood bags.

In 2011, the market of blood collection monitors was 450 systems, valued at Rs. 4.5 crore. This compact instrument provides smooth and gentle rocking for homogeneous mixing with anticoagulants without clot formation during collection of blood from a donor. Aggressive players in the blood collection monitors segment include Terumo Penpol, REMI, Fenwal, Fresenius, and Skylab Instruments.

Blood donor couches had sales of 400 units at Rs. 4.4 crore in 2011. Manufactured in accordance with the current market trends, their qualitative array of DC motorized equipment is valued for precise functioning, durability, energy-efficiency, and low maintenance cost. Sturdy construction of this equipment ensures consistent performance year after year. Couches are available with single, dual, and triple motors. The leading players include Terumo Penpol, Fenwal, Polymed, HLL Lifecare, Skylab Instruments, Fresenius, Insignia, Ultimate Hospicare, Grabner, and Authentic Instruments.

A similar sales figure of 400 units was seen for tube sealers, estimated at Rs. 3.6 crore. Also available as dual net tube sealers, they seal the tube of blood bag without causing haemolysis, leakage of blood, and separate the blood through a ratio frequency sealing system. Major players in the tube sealer segment include J Mitra, Terumo Penpol, and Fenwal. Regional players as Bioline, and Labtop Instruments have loyal clientele.

Blood bags had estimated sales of Rs. 76.8 crore, with 9 million bags sold in 2011. Blood bags and their integrated accessories are high- volume, low-profit products and companies compete on price points. The major players in the blood bag segment include Eastern Medikit, J Mitra, Terumo Penpol, HLL Lifecare, Fenwal, Maco Pharma, Span Healthcare, and Fresenius.

Penta blood bags, the latest, prevent wastage as one unit of blood is given to five different recipients. The primary whole blood bag containing anticoagulant solution followed by four small satellite bags make the penta system.

Challenges and Opportunities

Market leaders in the medical specialty bags segment compete with domestic as well as international firms, leading to intense price wars, hectic corporate activity, and thrust toward product differentiation and innovation. Large players primarily compete on safety, technological advancement, performance, and pricing grounds. Obtaining on-time regulatory clearances is also crucial for the success of products. Medical devices companies across the world are facing increasing pricing pressure owing to government mechanisms to restrain healthcare expenditure and provide cost relief to the consumer. Escalating raw material and shipping costs, leading to erosion in profit margins, also pose a major challenge for manufacturers.

While price competition is globally seen as an obstacle for all suppliers within the manual blood banking devices segment, European manufacturers and distributors suffer further from the high end-user purchasing power. Over 95 percent of blood bags are sold to national blood banks, with less than 5 percent going to hospitals for use in the transfusion process. Both end-users buy in bulk, mostly through annual or biannual tenders. Purchasing in vast volume restricts the flexibility in price negotiation. Furthermore, national blood banks are publicly funded organizations and as such strongly subjected to cost containment. Consolidation of end-users is another trend, which further increases their existing high purchasing power. National blood banks as well as hospitals are merging and forming groups together in order to increase their operational efficiency.

The main challenge for all affected companies in this market is not only to maintain their competitiveness within the manual blood banking devices market but also to secure and expand their position within one or several automated segments.

UCB Collection

Umbilical cord blood (UCB) is an increasingly important and rich source of stem cells. These cells can be used for the treatment of many deadly diseases, including cancers, immune, and genetic disorders. It also provides a readily available source of stem cells for transplantation purposes.

In view of the increasing importance and usage of the UCB, many devices have been invented for extraction and/or collection of UCB to yield useful volumes from a delivered placenta and/or umbilical cord. In the early stage, the methods for UCB collection can be broadly classified into two main categories - in utero and ex utero. The former method involves extracting the blood from the umbilical cord while the placenta is still in the maternal womb. An example of such methods is the syringe-assisted collection method. In the latter method, the UCB is collected from the placenta which is outside the maternal womb. Usually, the collection of UCB is performed with the aid of a housing structure. Gravity-assisted methods are examples of such collection methods. It is stated that the amount of blood that can be collected is limited using advanced ways, which include syringe-assisted and gravity-assisted methods. These methods are manually carried out.

Apart from being a tedious and difficult process, blood also inherits a high risk of unnecessary contamination using these methods. To minimize the hazard of exposure to contaminated blood, a device was invented, which includes an upper receiving portion and a lower fluid discharge portion. The umbilical cord is placed at the upper portion of the container, allowing the blood to drain from the cord into the container due to gravity. This blood is then transferred to the second container. This transfer operation is achieved by a needle hood. During the collection, it is not necessary for the operator to touch the needle or the valve mechanism. When collecting the blood using the designed apparatus, it is also quite important to consider the availability of UCB.

According to the analysis, UCB collection typically yields 50-80 ml. Apart from obstetric factors, such as infant weight and time of collection, the procedure involved and the equipment used to perform the collection affect the final yield. There is a need for a UCB collection apparatus which can effectively yield an increased volume of blood from a delivered placenta when compared with some of the prior art known.

The trend in the industry is such that the UCB collection system incorporates advanced computer technology and intelligent sensors in UCB collection methods in order to enable an efficient and automated process. In addition to prevent contamination from the external environment, an enclosed housing is present to minimize contamination of the UCB from the external environment. Work is undertaken to design the mechanical part.

Another future development of UCB systems is to incorporate the automated UCB collection system into the whole process, beginning from placenta harvesting to cell isolation and storage. In this aspect, hierarchical control architecture and advanced system diagnostic tools may provide good solutions to realize an integrated and comprehensive solution.

Future Outlook

The healthcare industry has been witnessing phenomenal changes that are translating into fierce competition among the medical devices, pharmaceuticals, and biotechnology players. Continuous product rollouts, automation, and innovations are common in the industry and are a critical strategy for retaining consumer interest and loyalty in the highly competitive environment. Development of automated blood collection devices, environmentally compatible IV containers, and blood bags with RFID tags are just a few recent instances of the furious pace of technological developments. The adult incontinence market holds significant potential for expansion particularly in developed countries, attributed mainly to age-related diseases and higher disposable income. In addition, enhanced reimbursement policies, general awareness among patients, and lesser societal stigma attached with the condition have also played a vital role in stimulating demand.

Prion filters are the new promising development in the blood transfusion segment which hopes to trigger a similar effect of boosting the market. However, innovative modification within the manual segment tends to temporarily drive the market as opposed to inducing a sustainable growth effect. Subsequently, trends strongly suggest a strong shift toward the usage of automation.

Automated devices such as apheresis and whole blood collection and processing devices gain market share at the expense of the manual blood collection segment. Pro-automation arguments mainly are overcoming the obstacles of cost pressure and increased regulatory strictness about blood safety. Collecting and processing blood through automated devices saves time, increases efficiency, and therefore lessens the overall operational cost from the end-users side. Quality management according to regulatory demand can also be better ensured. Another important aspect of automation is the fewer sources of donors needed - less exposure to pathogen and bacterial infection throughout the entire process.

Automation is certainly the future trend that will completely take over the manual segment and dominate the whole market, with the high price competition eventually eroding the profit margin of the manual devices segment. Since the growth is moving at a slow pace, the manual blood banking devices segment is likely to remain prominent approximately for the next ten years.

The sales of blood collection equipment and devices were average due to local competition in terms of pricing, reason being dollar touching sky level in 2011 and the same is expected to come down in the coming fiscal year. The users may get more accustomed with the quality factor in the coming year, enhancing the sales by 50 percent in 2012.

On key growth drivers

Due to growing population, along with growth in the economy and rise of multi-disorders in blood, NACO has come up with the guidelines/policies for setting up state-of-the-art blood centers in each and every part of rural/urban areas of India, giving boost to the blood collection market.

The estimated market growth will be 20 percent over the next few years coming to around US$ 4.9 billion in the next three years.

On trends

Coming up of newer blood centers in various interior parts of India will surely create more awareness among common people for accurate and standardized medical care and will enhance the level of sales and command a greater share of the wallet. Indians are becoming more aware of their health, thanks to the improved availability and accessibility of better health-related products. Current trends include continuous monitoring of quality equipment requirement at various established blood centers from time to time. The company provides a single point solution to its users within the country as per global market standards.

On challenges and opportunities

The industry is facing both challenges and opportunities simultaneously. Its growth opportunities lie in increased innovation, heightened demand for medical technology, emerging market expansion with the increase in affluent middle class. Also, the growing demand for healthcare services and the failure of meeting delivery mechanisms pose both challenges and opportunities. Emerging market risk in the shape of rising costs and other payers will not be able to sustain this expenditure. Hence, the medical device manufacturers need to prove the economic value of their offerings.

If blood is treated to prevent clotting and permitted to stand in a container, the red blood cells, weighing the most, will settle down in the bottom, the plasma will stay on top, and the white blood cells and platelets will remain suspended between the plasma and the red blood cells. Major equipment required for blood banking includes: donor couch, blood collection monitor, and tube sealer for collection; centrifuges, shaker/rotator, elisa reader, and washer for testing; and blood-bank-specific refrigerator, platelet incubator, and platelet agitator for storage.

Donor Couch

Micro-controller-based donor couch is designed to provide a comfortable position for the donor. The donor's position can be easily shifted from upright body position. It is based on hemodynamic principles and tilt adjustment can be done by using remote control.

Main features of blood collection monitor includes:

• Blood volume can be pre-selected for collection
• Blood can be measured in weight and volume units
• LCD display of time and volume of collection
• Audio visual alarms
• Volume completion
• Low/high flow rate
• Pre-set time completion
• Blood collection can be paused/stopped in the middle for donor safety
• Automatic zero-volume calibration of blood bags
• Automatic release of blood bags when lifted

Bench Top Sealer

The bench top sealer, Optiseal, has been designed to meet high standards in blood component processing: consistent high quality sealing, excellent performance after repeated use, safety features, and easy use.

Platelet Agitator

Platelet agitator is a flat bed agitator specifically designed to retain viability and adhesive properties of platelets and to maintain donor platelets in an even suspension throughout the blood plasma. The various manufacturers are Baxter, Remi, and Terumo Penpol and also Rajas enterprises, Labtop, and a few others. Today, product development continues to focus on innovative technologies that automate the process of cell separation and other processes to aid in ensuring safe and available global blood supply.