ALLN-346

The expected launch of therapies by several pharma companies such as ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, AstraZeneca, and others will lead to change in the chronic kidney disease market dynamic during the forecast period (2023-2032) LAS VEGAS, April 27, 2023 /PRNewswire/ -- DelveInsight's Chronic Kidney Disease Market Insights report includes a comprehensive understanding of current treatment practices, chronic kidney disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Chronic Kidney Disease Market Report As per DelveInsight analysis, the chronic kidney disease market size in the 7MM was approximately USD 5 billion in 2022. According to the assessment done by DelveInsight, the estimated total diagnosed prevalent chronic kidney disease cases in the 7MM were approximately 16 million in 2022. Leading chronic kidney disease companies such as ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc, Lexicon Pharmaceuticals, Sanofi, and others are developing novel chronic kidney disease drugs that can be available in the chronic kidney disease market in the coming years. The promising chronic kidney disease therapies in the pipeline include Renal Autologous Cell Therapy (REACT), Bardoxolone methyl, Ziltivekimab, Semaglutide, JARDIANCE (empagliflozin), KBP-5074, KT-301, CIN-107 (Baxdrostat), Zibotentan, ALLN-346, DM199, Sotagliflozin , and others. Discover which therapies are expected to grab the major chronic kidney disease market share @ Chronic Kidney Disease Market Report Chronic Kidney Disease Overview Chronic kidney disease occurs when the kidneys get damaged and cannot filter blood as efficiently as they should. Chronic kidney disease is defined as abnormalities in kidney structure or function that have been present for more than three months and have a negative impact on health. Chronic kidney disease is categorized into five phases based on the extent of kidney damage and function. In stage 1, there is modest kidney disease, and in stage 5, the kidneys have stopped working. The severity of chronic kidney disease varies. In the early stages of kidney disease, there are usually no chronic kidney disease symptoms. It can only be diagnosed if a blood or urine test is performed for another reason and the results show a kidney issue. Tiredness, swollen ankles, feet, or hands, shortness of breath, unwellness, and blood in the urine indicate a more advanced stage. Chronic kidney disease can be detected using blood and urine tests. The eGFR blood test measures the efficiency with which the kidneys function. Ultrasound, CT scan, X-ray, and MRI imaging examinations are also used for chronic kidney disease diagnosis. Chronic Kidney Disease Epidemiology Segmentation DelveInsight estimates that there were approximately 16 million diagnosed prevalent cases of chronic kidney disease in the 7MM in 2022. As per our analysis, chronic kidney disease has been identified as a female-dominant disease, with more females suffering than males. In 2022, 52% of cases of CKD were of females, while 48% of cases were of males in the 7MM. The chronic kidney disease market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Chronic Kidney Disease Prevalent Cases Chronic Kidney Disease Diagnosed Prevalent Cases Chronic Kidney Disease Gender-specific Diagnosed Prevalent Cases Chronic Kidney Disease Age-specific Diagnosed Prevalent cases Chronic Kidney Disease Complication-specific Diagnosed Prevalent cases Chronic Kidney Disease Stage-specific Diagnosed Prevalent Cases Chronic Kidney Disease Etiology-specific Diagnosed Prevalent Cases Download the report to understand which factors are driving chronic kidney disease epidemiology trends @ Chronic Kidney Disease Epidemiological Insights Chronic Kidney Disease Treatment Market There are various types of drugs in the chronic kidney disease market. Although available medications cannot cure CKD, they can treat problems and halt future kidney damage. DelveInsight's chronic kidney disease market projection focuses on pharmacological therapy (including all presently utilized off-label medications) recommended for chronic kidney disease management and excludes revenue produced by devices and surgical procedures, including dialysis. The chronic kidney disease drugs market is classified for the study based on drug class, such as erythropoietin stimulating agents (ESA), angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers (ACE-I and ARBs), antidiabetics, secondary hyperparathyroidism treatment (SHPT), and urate-lowering therapies. There are also approved therapies for chronic kidney disease treatment, such as KERENDIA, INVOKANA, JYNARQUE, and FARXIGA. According to DelveInsight's analysis, antidiabetics and antihypertensives are the most widely utilized among the top prescribed pharmaceuticals. Given the health risks associated with renal dysfunction, DelveInsight analysts developed a comprehensive understanding of chronic kidney disease and its etiologies, defining the breadth of the therapeutic paradigm. The chronic kidney disease treatment market is classified into three segments: diabetic kidney disease (DKD), polycystic kidney disease (PKD), and hypertension induced kidney disease. To know more about chronic kidney disease treatment guidelines, visit @ Chronic Kidney Disease Management Chronic Kidney Disease Therapies and Key Companies Renal Autologous Cell Therapy (REACT): ProKidney Bardoxolone methyl: Reata Pharmaceuticals, Inc. Ziltivekimab: Novo Nordisk A/S Semaglutide: Novo Nordisk A/S JARDIANCE (empagliflozin): Boehringer Ingelheim/Eli Lilly and Company KBP-5074: KBP Biosciences KT-301: Kibow Pharma CIN-107 (Baxdrostat): Cincor Pharma Zibotentan: AstraZeneca ALLN-346: Allena Pharmaceuticals DM199: DiaMedica Therapeutics Inc Sotagliflozin: Lexicon Pharmaceuticals/Sanofi Learn more about the FDA-approved drugs for chronic kidney disease @ Drugs for Chronic Kidney Disease Treatment Chronic Kidney Disease Market Dynamics The dynamics of the chronic kidney disease market are expected to change in the coming years. The emerging treatment pipeline is robustly humongous, attributing to novel MoAs. Moreover, the rising data on chronic kidney disease and its risk factors is expected to add significantly to the patient pool. Furthermore, the current therapy paradigm includes FARXIGA (SGLT2 inhibitor), which is utilized for diabetic and non-diabetic chronic kidney disease patients. In the US, FARXIGA had a market size of USD 111 million in 2021 and is anticipated to reach USD 559 million as its peak revenue. Top SGLT2 players have been competing for lucrative approvals in recent years. The chronic kidney disease market may see another approval with Empagliflozin from Boehringer Ingelheim Pharmaceuticals, Inc by 2023. Empagliflozin has achieved landmark results in chronic kidney disease studies and would be a contender to FARXIGA because the findings could pave the road for a catch-up approval. Farxiga's sales have increased considerably as the label has expanded, but Jardiance is not far behind. According to the model, the therapy will produce a chronic kidney disease market size of USD 9 million by its launch year (2023), and this chronic kidney disease market size is predicted to grow to USD 772 million by 2032. However, several factors may impede the growth of the chronic kidney disease market, such as the undiagnosed, unreported cases, and unawareness about the disease may also impact future chronic kidney disease market growth. On the contrary, there are significant factors that may contribute to the growth in the market, as chronic kidney disease is associated with major complications, including anemia, hyperparathyroidism, and metabolic acidosis. Moreover, there is a scope for branded pharmacologic treatment with good safety and efficacy data and broader range coverage like impulse control. Scope of the Chronic Kidney Disease Market Report Therapeutic Assessment: Chronic Kidney Disease current marketed and emerging therapies Chronic Kidney Disease Market Dynamics: Attribute Analysis of Emerging Chronic Kidney Disease Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Chronic Kidney Disease Market Access and Reimbursement Discover more about chronic kidney disease drugs in development @ Chronic Kidney Disease Clinical Trials Table of Contents Related Reports Chronic Kidney Disease Epidemiology Forecast Chronic Kidney Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted chronic kidney disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic kidney disease companies, including KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, among others. Moderate and Severe Chronic Kidney Disease Market Moderate and Severe Chronic Kidney Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key moderate and severe chronic kidney disease companies, including Kibow Pharma, Bayer, Roche, Caladrius Biosciences, UnicoCell Biomed, Pharmicell, Scohia Pharma, Unicycive Therapeutics, among others. Moderate and Severe Chronic Kidney Disease Pipeline Moderate and Severe Chronic Kidney Disease Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key moderate and severe chronic kidney disease companies, including Kibow Pharma, Bayer, Roche, Caladrius Biosciences, UnicoCell Biomed, Pharmicell, Scohia Pharma, Unicycive Therapeutics, among others. Anemia In Chronic Kidney Disease Market Anemia In Chronic Kidney Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key anemia in chronic kidney disease companies, including Biocad, Xenetic Biosciences, Chiasma, Liminal BioSciences, among others. Anemia In Chronic Kidney Disease Pipeline Anemia In Chronic Kidney Disease Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key anemia in chronic kidney disease companies, including Biocad, Xenetic Biosciences, Chiasma, Liminal BioSciences, among others. 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Courtesy ThamKC/Getty Images Incidence of gout has increased globally during the past quarter-century, spurring the development of new, more effective therapies aimed at chronic gout. "Gout is the most common inflammatory arthritis in the world, and existing treatments rarely achieve target serum urate levels,” said Shunqi Yan, Ph.D., founder and chief operating officer of Arthrosi Therapeutics in an interview with BioSpace. “As patients continue to be undertreated with current therapies, monosodium urate crystals (called tophi) continue to accumulate in the joints and tendons, worsening flares, joint erosions and disability.” An aging, more sedentary population is one of the reasons for the uptick, along with purine-rich diets (such as red and organ meats, anchovies, sardines, mussels, scallops, trout and tuna, as well as alcoholic beverages and drinks high in fructose). Genetic associations may also be involved. These conditions each can cause uric acid levels to increase. Inhibiting and Degrading Uric Acid Scientists are exploring three broad ways to address this. The first tries to inhibit the production of uric acid, degrade it or enhance its ability to leave the body. “One category of treatments uses xanthine oxidase inhibitors, notably allopurinol, to reduce the production of uric acid in your body,” said Roy Wu, SVP of global business development for Atom Bioscience. Allopurinol is the standard of care, yet “Its efficacy is only about 40 to 45 percent,” Wu said. Its safety pro improvement, too. “It’s not very well tolerated, causing a skin reaction (Stevens-Johnson Syndrome) and GI problems. It also requires titration over a long period of time, which means doses can’t be adjusted rapidly," he noted. While a few companies are investigating iterations of xanthine oxidase inhibitors, a scan of ClinicalTrials.gov shows more activity focused on other approaches. Metabolizing Uric Acid Synlogic, for one, is working to metabolize uric acid in the GI tract with an engineered strain of a probiotic bacteria, said Dave Hava, Ph.D., chief scientific officer. “We hypothesize there is a significant gut component to uric acid metabolism – that uric acid can come from the diet through purine metabolism, but that it also could recirculate in the systemic circulation into the GI tract and be secreted back out, in a kind of loop. “We hypothesized that if we could design a bacteria that encounters uric acid in the GI tract, breaks it down into something non-toxic and prevents its reabsorption into systemic circulation, it could ultimately lower uric acid levels in the plasma,” Hava explained. Preclinical data from the prototype strain support that hypothesis. Non-human primate studies show the engineered strain Synlogic designed is active and can reduce systemic levels of uric acid. “We anticipate releasing more preclinical data on SYNB2081 later this year,” Hava said. Synlogic worked with Ginkgo Bioworks to design the prototype probiotic strain, essentially programming it to be effective under the conditions prevalent in gout. “Biology is fundamentally programmable,” said Patrick Boyle, Ph.D., head of Codebase, at Ginkgo Bioworks. “If you think about the substrate of biology that we’re engineering, we’re rewriting genetic code. Many of the same principles apply between digital code and software code. While biology is infinitely more complex than computer code, changing an A to a T affects how the cell reads that DNA code and changes its behavior.” Ginkgo used that approach with Synlogic to design organisms for a particular purpose. Another company, Allena Pharmaceuticals, has Fast Track designation for its orally-absorbed enzyme to treat gout and chronic kidney disease. When kidneys are impaired, uric acid is eliminated through the GI tract, so ALLN-346 degrades urate there in a way that prevents it from being absorbed systemically. Allena completed enrollment of a Phase IIa outpatient study 202 in July. Results have not been released. Urate Transporter 1 Inhibitors A third approach is to cause the system to excrete uric acid more efficiently. “About 85% of gout patients have a problem eliminating enough uric acid,” Yan said. A urate transporter 1 (URAT1) inhibitor, therefore, could fill a large unmet need. “There is an increasing body of evidence that URAT1 inhibitors may slow the progression of chronic kidney disease and also may have cardiovascular benefits,” he noted. To that end, Arthrosi is developing AR882 to normalize uric acid excretion through the kidney. This would reduce circulating levels of uric acid throughout the body as well as the formation of monosodium urate crystals. The goal is to reduce serum urate levels below the 6mg/dL needed for disease control and, ideally, below 5mg/dL. AR882 “has been shown to be well-tolerated in clinical trials…and is the only oral therapy evaluating the tophi reduction potential in a Phase II study,” Yan said. Arthrosi completed enrollment of more than 120 patients with chronic gout in a global Phase IIb study being conducted at 24 sites in the United States, Australia and Taiwan. The three-month study will evaluate dosage. In the earlier Phase IIa study, a 50 mg dose of AR882 reduced serum levels to below 5mg/dL in 93 percent of patients, whereas a 75 mg dose reduced levels below 4mg/dl in 88 percent of patients, suggesting it may also succeed in reducing flares. Atom Bioscience is also concentrating on uric acid excretion. “ABP-671 is a URAT1 inhibitor, which helps block the reabsorption of uric acid back into the body through the kidney and thus to excrete uric acid,” Wu said. “This is a more direct approach to reducing uric acid from the body than reducing its production.” Early studies showed a nearly 30 percent reduction in uric acid during the first day of treatment, which Wu called significant. Atom is finalizing the protocols for a Phase IIb/III study for chronic gout that likely will begin in 2023. It’s a six-month treatment and is expected to take six to nine months to enroll, so a readout in mid-2024 seems likely. Atom is thinking of ABP-671 as a possible first-line monotherapy, Wu said.