The demand for dialysis services in India is huge, and players need to innovate and come up with business models to cater to this opportunity.
With increasing life expectancy and lifestyle diseases, there has been an increase in chronic kidney disease (CKD) and end-stage renal disease (ESRD) in the last decade. The burden of ESRD is rising drastically in India. The age-adjusted incidence of ESRD in India is 226 per million populations. It is estimated that ∼220,000 new ESRD patients are added every year. The shortage of nephrologists, late referral of patients, inadequate health awareness about preventive measures, and a lack of more cost-effective alternatives like renal transplantation or peritoneal dialysis (PD) are important issues in the provision of care to ESRD patients. Unequal distribution of nephrologists, with their concentration in large cities and in the private sector, is a major barrier to equitable provision of dialysis to all sections of the society. Inadequate insurance coverage further aggravates the situation. Furthermore, ∼70 percent of those who start dialysis in India eventually give it up due to financial constraints or death. Only 10–20 percent of dialysis patients in India continue long-term treatment. This high need for care is particularly relevant given the way healthcare is financed in India.
Thus, the demand for dialysis services in India is huge, and players need to innovate and come up with business models to cater to this opportunity. Despite the increase in disposable income, there are large sections of patients, who are not able to afford dialysis care. Other than possible collaborations and redevelopment of business models, technology needs to be more cost-effective to combat the mortality rate, or at least make the quality of life better for patients with renal failure, if not prolong it. The cost of cutting-edge dialysis equipment is a major impediment in pushing the dialysis equipment industry toward an upward curve. However, with the government laying emphasis on implementing National Dialysis Program across India, an attempt is being made to bridge the gap so that each district hospital compulsorily has a few dialysis machines obtained by PPP. In 2018, 647 operational dialysis units/centers and 3953 dialysis machines have been made operational and nearly 35 lakh dialysis sessions have been conducted.
Overall, these are interesting times for this industry, and a focused player can clearly create a double bottom-line impact by serving the society and at the same time rewarding its shareholders.
Global marketThe global dialysis equipment market has been estimated at USD 14,783.7 million in 2018, and is expected to expand at a CAGR of 4.8 percent from 2018 to 2028, estimates Future Market Insights. 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. Focus on patient-caregiver connectivity, though the global dialysis equipment market is expected to witness impressive growth over the years. However, healthcare laws and regulations are factors expected to hamper market growth.
In terms of value, the hemodialysis devices segment has been estimated to account for 60.4 percent share of the global dialysis equipment market in 2018, and is projected to register a healthy CAGR of 4.6 percent in terms of value. The CRRT segment is expected to witness a growth rate of 6.8 percent, attributing to the relatively less time for the suturing process as compared to the conventional approach.
North America is projected to dominate the global market in terms of revenue share. The foray of leading North American companies into the hemodialysis devices market over the last few years is a factor expected to boost overall sales of these devices in the region. APEJ and Japan are expected to witness significant growth owing to significant investments in healthcare infrastructure, and increasing geriatric population in these regions.
The key players in the market focus on various strategies such as expansions; product launches and product enhancements; mergers and acquisitions; and partnerships, agreements, and collaborations in order to strengthen their global position. 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 strategy 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.
In March 2019, Baxter International Inc. and bioMérieux signed an agreement to develop future biomarkers with the goal to rapidly identify and inform treatment of acute kidney injury (AKI).
In January 2019, Fresenius Medical Care launched the 4008A dialysis machine, which was especially designed to meet the needs of emerging markets. With the launch of the 4008A, the company is aiming to improve accessibility to life-sustaining dialysis treatment for patients in these countries who are living with end-stage renal disease (ESRD).
In April 2018, bioMérieux acquired Astute Medical, which developed the Nephrocheck test, an FDA-approved test for early risk assessment of AKI, based on two biomarker levels.
Technology trendsAlthough the incidence of ESRD is relatively stable, the prevalence of maintenance dialysis is increasing, and it is expected to reach a staggering 5439 million patients worldwide by 2030. Despite the great technological evolution that has taken place in recent years, most patients are still treated with in-center hemodialysis, and their prognosis remains far from desirable. Since 1980, there has been an increasing interest in the development of a portable device for renal-replacement therapy (RRT), which ultimately led to the creation of the wearable artificial kidney (WAK) and the wearable ultrafiltration (WUF) system. Portable RRT devices may be acceptable alternatives that deal with several unmet clinical needs of ESRD patients. In the future, all RRT techniques are anticipated to evolve to cohere with the clinical and personal needs of each patient, allowing for an improved health-related quality of life.
Medium cut-off (MCO) membranes. The latest technological advances in chemical composition and new production techniques have resulted in improved biocompatibility and permeability of dialysis membranes. Medium cut-offs (MCOs) intend to improve the clinical outcomes as they have been developed to improve the clearance of medium- to high-molecular-weight (MW) solutes. MCO membranes have peculiar retention onset and cut-off characteristics. The application of MCO membranes in a classic dialysis modality characterizes a new technique called expanded hemodialysis. This therapy does not need any specific software or dedicated hardware, making its application possible in every setting where the quality of dialysis fluid meets current standards as it would enable the nephrology treatment providers to be patient-centric by reducing high rates of hospitalization and mortality, and enhance the quality of life of the patient. Enhanced dialysis devices or interventions could be a self-contained PD device that weighs less than 10 pounds or a suitcase hemodialyzer that weighs less than 20 pounds, or a sleek dialyzer designed for simplicity of use, either in center or in the home, promoting patient self-care.
Wearable artificial kidneys. Based on results from a first-in-human safety trial of the AWAK peritoneal dialysis device completed in October 2018, the device is all set to be launched in the market. The trial showed that the device efficiently removed the accumulation of toxins from the body, and patients in the trial did not experience any serious adverse events during dialysis procedure. The WAK’s unique design helps eliminate fluid on a regular basis to reduce strain on the kidneys, lungs, and heart while also reducing blood pressure. Instead of having to be plugged into an electrical outlet, the WAK is battery operated. The device also requires only 370 cc of water as opposed to 40 gallon. The early iteration of the WAK weighed 4.98 kg but the latest generation of the device weighs only 0.90 kg; however, the efforts to reduce the size even more are being made. The device is connected to the patient via one catheter that is surgically inserted within a 20-minute procedure under local anesthesia.
Implantable artificial kidneys. The IAK is a biohybrid, combining artificial channels and biological cells. Waiting to be introduced to the dialysis equipment industry, it is currently in preclinical testing. These compact gadgets decrease the requirement for huge amounts of water and consistent electrical supply. This could bring down certain impediments to home dialysis, making self-care renal substitution treatment progressively open. On the off chance that is generally fruitful, these devices could diminish the need to assemble and staff dialysis offices, along these lines bringing down expenses related with dialysis. The objective is to go past expanding life and at last make an implantable kidney, concocted from living tissue or manufactured materials that would not be dismissed by the body or require broad support. The prime target is to enable patients to carry on with their typical life expectancy while not constraining their mobility.
Two-dimensional filtering material. A different group of engineers is tackling a portable dialysis material with its design of a blood-filtration material just a few atoms thick. The new material called MXene has demonstrated to be a compelling absorbent for urea from blood plasma. Atomically slender two-dimensional (2D) materials are a thriving class of structures that presently include various sciences past graphene. They offer profoundly adaptable properties and promising capacities that rise above the dialysis abilities of customary materials. While certain applications promptly come to mind for these materials – gadgets, memory chips, and vitality stockpiling, these are not restricted to these devices only.
Novel biomaterials likewise remain to profit by 2D nanostructures. Specifically, wearable artificial kidneys, which direct nonstop dialysis for patients with end-stage renal failure, require new sorbents so as to turn out to be adequately lightweight, convenient, and effective to give this lifesaving treatment.
New stem-cell shunts. A company in California is in the late stages of testing a lifelong shunt in patients with renal failure. It is made of human stem cells, unlike the man-made material of current dialysis shunts. The idea behind it? The body would not reject organic material and will be able to fight its own shunt infections. The shunt becomes a piece of the patient’s body, like any other. Humacyte’s new shunt development is in stage two and three of FDA clinical trials. More research needs to be done on the long-term health of
the patients before it is released to the public.
Since dialysis drastically affects the patients’ lifestyle, there are great expectations for the development of wearable artificial kidneys, although their use is currently impeded by major concerns about safety.
On the other hand, dialysis patients with hemodynamic instability do not usually tolerate intermittent dialysis therapy because of their inability to adapt to a changing scenario of unforeseen events. Thus, the development of novel wearable dialysis devices and the improvement of clinical tolerance will need contributions from new branches of engineering, such as artificial intelligence (AI) and machine learning (ML) for the real-time analysis of equipment alarms, dialysis parameters, and patient-related data with a real-time feedback response.
Emerging technologies derived from AI, ML, electronics, and robotics will offer great opportunities for dialysis therapy.
However, much innovation in AI and ML is still needed before the ultimate goal of the design of an operative smart dialysis machine, able to analyze and understand changes in patient homeostasis and respond appropriately in real time, is achieved.
Great efforts are being made in the fields of tissue engineering and regenerative medicine to provide alternative cell-based approaches for the treatment of renal failure, including bioartificial renal systems and the implantation of bioengineered kidney constructs.