Global Anemia in Chronic Kidney Disease Analysis and Market Report 2021 - ResearchAndMarkets.com
The "Disease Analysis: Anemia in Chronic Kidney Disease" report has been added to ResearchAndMarkets.com's offering.
The "Disease Analysis: Anemia in Chronic Kidney Disease" report has been added to ResearchAndMarkets.com's offering.
The anemia in chronic kidney disease (CKD) market has struggled as usage of high-selling, standard-of-care, injectable erythropoiesis-stimulating agents (ESAs) has declined, especially in the US, due to an increased risk of CV events when targeting higher Hb levels, which has led to lower Hb targets and more caution when deciding to initiate the drugs.
Biosimilars have also taken their toll, particularly in Europe, where biosimilar short-acting ESAs have taken a majority share of usage. The first biosimilar in the US, Retacrit, was only approved in 2018, so is still ramping. The ESAs are poised to lose further share to the oral and potentially safer HIF-PH inhibitors, with roxadustat on track for initial approval in the important US market in early 2021, having already been approved in Japan and China.
It will be important to see, though, more details from its FDA review. The HIF-PH inhibitors also reduce the dose of IV iron needed in dialysis patients and appear to have other advantages as well. However, concerns over the angiogenic effects of HIF stabilizers could impact usage, and with limited data on safety for this class of drug, physicians may be reluctant to switch from ESAs, which have been the traditional form of treatment for the past 20 years.
ESAs
Despite dose reductions, ESAs are still currently the mainstay of anemia treatment in dialysis, used in at least 80% of patients in major markets; however, ESAs are less commonly used in non-dialysis CKD anemia due to the need for injection, safety issues, a broader spectrum of anemia severity, and cost.
The first-on-the-market shorter-acting intravenous ESAs are more suited for dialysis than other settings, as they are given with three-times weekly dosing. Longer-acting products can be given intravenously or, as is more convenient for non-dialysis patients, subcutaneously. In dialysis, the decision on which ESAs to use can vary greatly by country, impacted by cost, contractual arrangements (eg with dialysis providers Fresenius and DaVita in the US, which control a majority of the market), preferences for dosing frequencies, and practical issues at dialysis centers.
IV irons
Iron is the other major anemia treatment, used for patients with iron deficiency from a potential multitude of causes associated with CKD. IV irons are particularly important in the dialysis segment, as ESAs increase iron requirements for red blood cell production and IV iron can readily be given in conjunction with dialysis. In non-dialysis patients, oral iron is more convenient, though many patients have gastrointestinal side effects that can impact compliance.
HIF-PH inhibitors
The HIF-PH inhibitors have the advantages of oral administration, potentially improved safety (as they more physiologically impact erythropoietin than ESAs), improved iron utilization, and possibly greater efficacy in certain patients who can be more difficult to treat with ESAs. However, the unknown angiogenic effects could limit use to low-risk patients, pending data from the large Phase III trials. Hence, they have the potential to take some market share from ESAs, as well as grow anemia treatment in non-dialysis CKD. They are likely to also reduce IV iron use in dialysis patients. Roxadustat appears to be at least as effective as ESAs, and the others have some evidence suggesting that as well, especially since efficacy can be a matter of dose titration.
Roxadustat is also being dosed three times a week, which may be more difficult for non-dialysis patients to remember, opening the door to competitors vadadustat and daprodustat, which have daily dosing, though there may be ways around the issue.
Global Phase III data for vadadustat were somewhat disappointing, as the drug failed to demonstrate non-inferiority in terms of MACE compared to the ESA darbepoetin alfa in non-dialysis patients. In fact, MACE HR with vadadustat was worse than with darbepoetin, which raises a significant safety concern considering that ESAs are known for a poor CV safety profile. Despite achieving non-inferiority in dialysis patients, approval in this patient population could be negatively influenced by the alarming MACE data from non-dialysis patients.
- Phase III results for GlaxoSmithKline's daprodustat are expected in 2021.
- At the least, the initial HIF-PH inhibitors should receive an extra payment for two years under Medicare's Transitional Drug Add-on Payment Adjustment (TDAPA).
Overall Likelihood of Approval
- The overall likelihood of approval for Phase I assets is 20.9% for anemia in dialysis-dependent CKD and 39.4% for anemia in dialysis-independent CKD, with the average probabilities that a drug advances from Phase III at 87.5% for both indications. It takes on average 9.6-10.6 years for drugs in these indications to move from Phase I to approval, compared to 9.2 years in the overall hematology space.
Key Topics Covered:
OVERVIEW
- Latest key takeaways
DISEASE BACKGROUND
- Definition
- Patient segmentation
TREATMENT
- Major treatment guidelines
- KDIGO guidelines
- JSDT guidelines
EPIDEMIOLOGY
- Prevalence methodology
MARKETED DRUGS
PIPELINE DRUGS
KEY REGULATORY EVENTS
- Delay for Roxadustat in the US
- Japan Nods Include Global Firsts for Duvroq, Vafseo and First Local Biosimilar Humira
- Roxadustat Among New Filings at EMA
- Court Says FibroGen's UK Roxadustat Patents are Invalid
PROBABILITY OF SUCCESS
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
DRUG ASSESSMENT MODEL
- Erythropoiesis-stimulating agents
- Iron products
- HIF-PH inhibitors
- Expected Medicare dialysis reimbursement for HIF-PH inhibitors
MARKET DYNAMICS
FUTURE TRENDS
- CONSENSUS FORECASTS
- RECENT EVENTS AND ANALYST OPINION
- Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (October 22, 2020)
- Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (September 3, 2020)
- Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (June 8, 2020)
- Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and Independent (May 5, 2020)
KEY UPCOMING EVENTS
KEY OPINION LEADER INSIGHTS
- ESAs
- HIF stabilizers
- Pricing and reimbursement
UNMET NEEDS
- Rankings of unmet needs in anemia in CKD
BIBLIOGRAPHY
- Prescription information
APPENDIX
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