Dialysis industry has a long way to go

With a mere 4950 dialysis centers, largely in the private sector in India, the demand is met less than half with the existing infrastructure.

India’s chronic kidney disease problems have reached epidemic proportions, and disease rates will likely continue to go up in the future. Failing both the kidneys is akin to getting a death sentence, and lifelong dialysis is the only available solution as of today. Only 10 percent of patients all over India can get dialysis done. The kidney failure at a young age of working professionals is a big socio-economic issue. With rising income levels and affordability by the middle class, the demand for home dialysis is increasing. The high capital cost of machines and the operational cost of consumables cause major concern. There are technical challenges in terms of dialysis machines and some players are working on innovative, cost-effective, and portable machine designs.

Along with these challenges, there are big opportunities available in the healthcare sector. Some players have already developed business models to address these issues and grab opportunities. In short, nephrology is one of the single specialty themes and an attractive sub-segment in the healthcare chain from a business and private investment point of view.

Innovation and competition in this sector will ultimately drive quality, operational excellence, comfort, and help avoid the death of dialysis patients.

Global market
The global dialysis equipment market is estimated at USD 15,492.7 million in 2019 and is expected to expand at a CAGR of 4.8 percent from 2019 to 2028, predicts Future Market Insights. The growth of the market is mainly driven by the high prevalence of CKD worldwide. The use of dialysis over kidney replacement, aging epidemiology, product innovation, and wide product portfolio drive market growth.

Over recent years, business players are investing vigorously in R&D activities to develop novel dialysis devices that support specific dialysis treatment. Thus, the availability of advanced quality dialysis equipment and dialyzers will also surge dialysis industry growth in the coming years.

Hemodialysis segment is estimated to exceed USD 95 billion by 2025, with rising prevalence of kidney diseases among the geriatric and adult population. More than 89 percent of the global population that suffers from CKDs prefers hemodialysis treatment. Thus, with rising incidence of end-stage renal diseases (ESRD) leading to kidney failure, the adoption of hemodialysis should upsurge during 2020–2025.

The key players in the market focus on various strategies to strengthen their global position. The expansion was the key growth strategy adopted by a majority of the industry players to increase their share in the dialysis market. Companies as Fresenius Medical Care, Baxter International, DaVita Healthcare Partners, Diaverum Deutschland, B. Braun Melsungen, Nipro Corporation, NxStage Medical, Asahi Kasei Medical, Nikkiso, and Mar Cor Purification majorly adopted this strategy. Apart from geographic expansion, a number of leading players adopted the strategies of product launches and enhancements to develop new and technologically advanced dialysis products and treatment, strengthen their product portfolios, upgrade existing products, and address the unmet needs of end-users.

Indian scenario
India has a substantial patient base suffering from various stages of CKD and ESRD. The market is severely underpenetrated in terms of the number of ESRD patients on dialysis, with an even smaller number of patients on peritoneal dialysis. Factors as these and the establishment of government initiatives such as PD First is expected to drive the Indian dialysis market growth in the coming years.

According to The Ministry of Health and Family Welfare, under the Pradhan Mantri National Dialysis Program, every year, 0.22 million new patients of ESRD get added in India, resulting in the additional demand for 34 million dialysis annually. These trends and the advantages associated with dialysis modality is expected to drive the market.

Another critical factor driving Indian dialysis equipment market is the government initiatives for the greater adoption of peritoneal dialysis. This includes the establishment of guidelines for peritoneal dialysis by the Indian health ministry. The aim of the establishment is better accessibility of peritoneal dialysis, which can be undertaken in home settings. This is especially beneficial for patients in rural areas who incur additional costs traveling to dialysis centers in far places. Peritoneal dialysis also allows for greater flexibility and freedom in the treatment schedule. The inclusion of peritoneal dialysis in the Pradhan Mantri National Dialysis Program is further anticipated to reduce the out-of-pocket expenditure of the patients undergoing dialysis. The other reasons for the Indian government’s increasing push include the lesser requirement of technical power, better productivity, and quality of life at a lower cost.

Advances in membrane technology
Despite remarkable advances, high rates of hospitalization and mortality still characterize hemodialysis (HD) therapy. Although survival and quality of life have improved compared with the past, results are still unsatisfactory. New strategies and solutions are required to respond to unmet clinical needs. Poor clinical outcomes, however, are not only due to the increased age and comorbidity of the population but also due to intrinsic limitations of current techniques. These are due to the inability of current dialysis membranes to remove the full spectrum of uremic toxins accumulated in the body.

The current trend in dialysis technology is the development of membranes with increased permeability to facilitate enhanced removal of uremic toxins. Advances in membrane design, composition, and sterilization methods give rise to enhanced performance and versatility. These have the potential to result in improved patient outcomes.

While current dialysis techniques have improved the care of patients with ESRD, these advancements have not always been met with improved patient outcomes, especially in terms of medium- and long-term outcomes, and survival. Complications have been attributed to blood accumulation and retention of large middle molecules, which are insufficiently cleared by traditional renal replacement therapies.

Membrane technology has been key to the advancement of dialysis treatment for patients with ESRD.
Medium cut-off (MCO) membranes are novel dialyzer membranes with large pores and, at the same time, increased selectivity to optimize the removal of large middle molecules. Aside from their narrow-pore size distribution, effective elimination of large middle molecules is achieved by MCO membranes through the application of new membrane-formation technologies, namely, tighter control of the molecular characteristics of the polymers, and improvements in post-treatment processes. MCO high-flux membranes are used with HDx to optimize permeability, allowing filtration that more closely mimics that of the natural kidney. The membranes facilitate the removal of large middle molecules effectively without significant albumin loss, thereby overcoming the protein-leaking effects of super-flux or high cut-off (HCO) membranes.

In particular, HDx with MCO membranes represents an important innovation that provides an efficient way to deliver hemodialysis without sacrificing performance. These membranes enable HDx by combining principles of permeability, selectivity, retention, and internal filtration into a single dialyzer design. HDx with MCO membranes is also designed to work with most standard hemodialysis machines. This reduces the economic drawbacks and more complex set-up associated with carrying out HDF, such as the need for special equipment and ultrapure fluids. The set-up also does not require specific hardware and reduces specialist training for nurses. By providing HDF performance with a standard hemodialysis set-up, thereby reducing costs and complexity associated with high-volume HDF, HDx with MCO membranes can raise the standard of care for hemodialysis patients.

Research update
The US Kidney Research Corporation (formerly Curion Research Corp) has created a new technology for cleansing the blood of patients with ESRD. The research has led to the development of a ground-breaking prototype device. In-house lab testing of the prototype has shown positive results.

Currently, dialysis is the only therapy available to purify a patient’s blood, but its water dependency makes the methodology unusable for creating an implantable artificial kidney. The new technology addresses that problem. The technology has the potential to completely replace current dialysis procedures in an industry that has not changed its methodology in over 75 years.

Unlike dialysis, the technology does not require water, dialysate concentrate solutions, or a dialyzer; the technology can be miniaturized and used to make an implantable artificial kidney and a wearable artificial kidney (also a standalone machine) that provides data in real time.

The innovative approach combines new multiple mesh electro-deionization technology with pressure-driven ultrafiltration, nanofiltration, reverse osmosis modules, sensors, and a computer chip to regulate all processes. Each of the components performs unique functions that simulate key aspects of the native kidney’s filtration and transport functions. A user-friendly touchscreen is incorporated into the design for setup and monitoring.

Way forward
India’s chronic kidney disease problems have reached epidemic proportions, and it is likely that disease rates will continue to go up in the future. This will impose great social, technological, and managerial challenges. But it will also create business opportunities for those who will take up these challenges in this prominent healthcare segment.

Companies that can bring down the average price of dialysis equipment will be at a greater advantage when they sell their products to public dialysis centers and homecare patients. There is a need to experiment with new approaches that could address a large incremental market. There is a great scope for private investment in professionally run dialysis chains and dialysis equipment and consumables manufacturers. Looking at the growing rate of people who prefer and can afford home hemodialysis, there is scope for developing profitable business models to cater to such patients. It is also an opportunity for banks and other financial institutions who are providing healthcare and medical finance.

There is scope for increasing dialysis centers in Tier-II and Tier-III cities, where access to quality healthcare is a challenge. Lack of quality kidney-care facilities in small cities and towns provide an opportunity for specialists to establish their presence in collaboration with either established private hospitals or with the government under public-private partnership (PPP) mode. This will enable in addressing the market constituted by the ESRD patients who can afford to pay for the services but cannot travel long distances to avail the services.

There is also an opportunity for insurance companies to be the first mover in designing their products, which will suit the requirements of such patients. Currently, there are no insurance products for home-hemodialysis and peritoneal dialysis. Nevertheless, with increasing interest and affordability, they need to design insurance products in the future. The dialysis industry has great potential to create skilled healthcare jobs. Conducting courses to train required skilled labor can be an added opportunity for generating revenue for private players.

The entry of more dialysis service providers will foster competition in markets across the country and may benefit end-user in terms of reduction in cost. The success of innovative products like low cost, small size, and transportable dialysis machines is essential for reducing the cost of machines, and will be a great step toward increasing the affordability of dialysis and improving the quality of life of patients.