A Fast Growing Segment

Indian dialysis industry is witnessing an era of unprecedented growth with the increasing number of end-stage renal disease patients, rise in aging population, and rising adoption of dialysis procedures over renal transplants. With an unstoppable rise in the number of patients on dialysis in India, the demand for dialysis is growing at a rate of  31 percent, compared to 6 percent in the US and 8 percent in the rest of the world. Smaller cities are given the access to the dialysis centers, which were till recently limited to only Tier-I and Tier-II cities.

Several hospitals are setting up dialysis centers in the country.

Fortis is planning to open around 50 dialysis centers by investing over 30 crore over the next couple of years.

Apollo Health and Lifestyle (AHLL) is planning to invest 500 crore in the next 5 years to expand its core businesses across the country. It is looking for collaboration with government to expand dialysis centers through public-private participation model.

Nephroplus has plans to establish 100 centers in the coming years.

Alliance Medicorp India, a JV between Apollo Hospitals and Trivitron, which operates both dental and dialysis centers is looking to raise 60 crore in PE funding.

Nipro, the Japanese device manufacturer, is projected to invest 187 crore in India to build a plant in Maharashtra by 2018 so as to double its dialysis equipment production in the Indian market, an effort to capitalize on a growing market in the subcontinent.

NephroLife Care (India) Pvt. Ltd., a renal disease management chain, has raised 160 crore from New Enterprise Associates (NEA) and DaVita, Inc., one of the largest kidney care companies in the USA.

With dialysis patients spread disproportionately across metropolitan and Tier-II and Tier-III cities, the need for new dialysis centers is on the rise. Of the total dialysis centers operational in India, 29 percent are concentrated in the metropolitan cities. There exists a stark contrast in the services offered and the mode of operation of dialysis centers in non-metro towns as compared to metropolitan cities. These centers are typically characterized by major cost-cutting measures, and operational streamlining efforts to offer cost-effective dialysis. Corporate chain dialysis centers position themselves as facilities with high-end infrastructure and value-added services for their dialysis patients. Such corporate groups are looking for expansion to non-metro cities by acquiring in-hospital dialysis centers that may be typically running to moderate to low profits.

The initiatives taken by the Indian government to promote dialysis centers in hospitals and free dialysis services to poor under the National Dialysis Program will help in controlling mortality due to unaffordable and unavailable dialysis services. With all these breakthrough advancements, new product launches, and initiatives, the dialysis equipment industry is envisaged to flourish in the next few years.

Government Initiatives
Pursuant to announcement in the Union Budget 2016-17 regarding starting of National Dialysis Program under NHM, the Pradhan Mantri National Dialysis Program was rolled out in 2016. A sum of 152.80 crore has been approved by the government on the proposals received from the states/UTs in 2016-17 (up to December, 2016) for provision of free dialysis services to the poor. This program has the potential of increasing the growth of public dialysis equipment to approximately 17 percent as opposed to the current 5 percent growth.

Technology Trends
Emergence of new-generation sensors, single-chip solutions, and new-generation components has impacted the design architectures of dialysis machines. Patient and operator safety is of prime importance and has been regulated by the certifying authorities, which has imposed huge challenges for the medical device manufacturers. Better understanding of physiology, anatomy, and disease patterns is also triggering a new wave of innovation in dialysis.

Improvements in adsorption. Portable and wearable hemodialysis devices require sorbent technology to recycle dialysate. Improvements in adsorption, particularly the development of carbons capable of adsorbing urea would potentially allow a new generation of adsorbent dialysis devices.

In-home and portable dialysis machines. The new hemodialysis systems provide flexibility to be used in a range of clinical settings ranging from dialysis clinics to hospitals and skilled nursing facilities. The upcoming technologies include advanced features such as sensor-based automation, wireless data transmission, and an easy touchscreen interface, helping to deliver dialysis effectively with reduced costs in settings such as hospitals and extended care facilities.

Wearable artificial kidneys. Wearable artificial kidneys, under various stages of development, hold a promising future for the dialysis industry. The device includes a miniature, battery-powered pump to power the flow of both the blood and the dialysate, and additional micro pumps to control ultrafiltration (fluid removal), the infusion of anticoagulants, and the delivery of other substances to the dialysate.

Single-use dialyzers. Dialysis service delivery continues to rapidly evolve toward single-use dialyzers. The manufactures are leading to the development of synthetic polysulfone membranes owing to the medical disadvantages of cellulose-based membranes, combined with the cost and complexity. High-flux membranes with consistently larger pore sizes are being manufactured. The larger pore size enables more rapid diffusion of small molecules, compared to the older cellulose or mixed-cellulose membranes.

Indigenous dialyzers. An innovated technology using simple disposable syringe assemblies has been developed in India to spin dialysis-grade fibers having an internal diameter of 220 microns and thickness of 35 microns. The estimated manufacturing cost of such an indigenous dialyzer is expected to be around 200–300. This was a project of national importance funded by the Department of Science and Technology, Government of India, and industrial partners of technology Forus Health Pvt. Ltd. and Renalyx, Bangalore, in order to promote technology development.

With an increasing number of dialysis membrane manufacturers becoming available, as well as improvements in membrane manufacture technology driving down production costs, the economic impetus has decreased. It has become difficult to ignore the advantages of single-use both from a medical and healthcare delivery perspective. Mid-size dialysis providers have moved toward implementing single use across the company. It is likely that this trend will continue amongst large- and mid-size providers.

Challenges
With India being the diabetes capital of the world, it should hardly come as a surprise that a large number of Indians are falling prey to the epidemic of kidney disease. Almost 2.2 lakh new patients of end-stage renal diseases get added in India every year, resulting in an additional demand for 3.4 crore dialysis sessions. It is clear that the healthcare infrastructure in the country is not equipped to cater to a need of this magnitude. Of all the instruments and consumables involved in dialysis, the cumulative expense is the highest for a hemodialyzer. It accounts for 58 percent of the dialysis costs incurred per session of dialysis. These are not manufactured in India and all hemodialyzers are imported from Germany, Korea, or Japan. The challenge in manufacturing hemodialyzers is in spinning the clinical-grade hollow fiber membranes. India does not possess the technology to spin hollow fiber membranes of inner diameter 180–220 microns and thickness 15–40 microns. Only 4–5 companies worldwide enjoy the monopoly in this business and all have their own patented technology. Due to this, each dialyzer costs 1000–1500, and ideally three such dialyzers are needed per week for each patient.

Dialysis for Hepatitis B positive patients has always been of great concern in India for most dialysis providers. Due to fever number of patients, providers find it difficult to provide dialysis for them. Such sessions need to be done in isolated rooms due to high risk of cross infections to other patients. Most guidelines recommend single use of dialyzer and bloodline, which has affordability issue. Also, single-use dialysis dramatically increases the amount of medical waste generated as part of ongoing treatment. Medical waste management itself is associated with significant direct costs as well as critical environmental impacts, and continues to emerge as an important area of research and development.

Road to the Future
The demand for dialysis is likely to surge in the near future, and the industry urgently needs to explore cost-effective and scalable solutions over a relatively short time frame. One option is promoting peritoneal dialysis, which is affordable, does not have infrastructure and manpower requirements, and has been adopted as the preferred modality by many countries – Thailand being the latest example.

Industry also needs to come to the forewith indigenous manufacturing of dialysis machines and disposables, which would reduce the cost.

Increasing demand for hemodialysis is emerging as a key driver Patients are willing to pay a premium for quality dialysis and this segment this therapy is poised to increase manifold.