表紙
市場調查報告書

糖尿病腎病變:市場預測與分析 (到2037年)

Diabetic Nephropathy Market and Forecast Analysis to 2037

出版商 Datamonitor Healthcare 商品編碼 955903
出版日期 內容資訊 英文 90 Pages
商品交期: 最快1-2個工作天內
價格
糖尿病腎病變:市場預測與分析 (到2037年) Diabetic Nephropathy Market and Forecast Analysis to 2037
出版日期: 2020年07月29日內容資訊: 英文 90 Pages
簡介

20歲以上的成人的糖尿病腎病變 (DN) 患者,估計2018年時刻全球整體達到了1億2260萬人,其數至2027年預計增加到1億3820萬人。現在降壓性ACE抑制劑(血管收縮素轉換酵素抑制劑)和ARB成為第一型、2型DN的主要治療藥,不過,SGLT-2抑制劑的利用也開始了,其他各種開發中產品臨床實驗現在也有所發展。

本報告提供糖尿病腎病變的治療藥臨床實驗、認證、上市的趨勢相關分析,疾病概要和目前治療方法,未來潛力治療藥物的一覽,目前臨床實驗的發展情形,近來的認證、上市的案例,主要企業的產品開發、上市及資本交易的動向,市場主要促進、阻礙因素,今後的技術、市場趨勢的方向性等資訊彙整,為您概述為以下內容。

目錄

目錄

概要

疾病的背景

  • 定義與診斷
  • 風險因素
  • 病因
  • 分期和預後
  • 患者的明細
  • 心血管疾病 (CV)的並存症

治療

  • 主要的治療指南
  • 處方趨勢 - 篩檢與降壓藥
  • 處方趨勢 - 抗糖尿病藥物
  • 治療設定

流行病學

  • 盛行率的調查手法

成藥

開發平台藥物

成功的概率

臨床試驗情勢

  • 資金提供者:各階段
  • 資金提供者:各相 (各phase)
  • 最近趨勢

藥物評估模式

  • 一般可取得的ACE抑制劑(血管收縮素轉換酵素抑制劑)和ARB
  • SGLT-2抑制劑
  • 其他等級

市場動態

未來趨勢

共識預測

最新案例和分析師的見解

  • 糖尿病腎病變用Finerenone (2020年7月9日)
  • 糖尿病腎病變用TMX-049 (2020年6月13日)
  • 糖尿病腎病變用Farxiga (2020年3月30日)
  • 糖尿病腎病變用RDEA3170 (2019年11月9日)
  • 糖尿病腎病變用Esaxerenone (2019年11月7日)
  • 糖尿病腎病變用藥物療法 (2019年10月30日)
  • 糖尿病腎病變用Invokana (2019年6月11日)
  • 糖尿病腎病變用Invokana (2019年4月14日)

今後的主要趨勢預測

產業的有學識者 (KOL)的見解

未滿足需求

參考文件

  • 藥方資訊

附錄

目錄
Product Code: DMKC0218913

DISEASE OVERVIEW

Diabetic nephropathy, also known as diabetic kidney disease, is caused by damage to small blood vessels which can cause the kidneys to be less efficient in their blood filtration role or to fail altogether. The disease is a clinical syndrome characterized by albuminuria, decline in glomerular filtration rate, and elevated arterial blood pressure. Up to 50% of diabetics with a disease duration of over 20 years have diabetic nephropathy.

LATEST KEY TAKEAWAYS

Datamonitor Healthcare estimates that in 2018, there were approximately 122.6 million prevalent cases of diabetic nephropathy (DN) in adults aged 20 years and older worldwide, and forecasts that number to increase to 138.2 million prevalent cases by 2027, driven by population demographics. Approximately 30% of diagnosed diabetics are also diagnosed with DN. However, screening practices differ among countries and local health systems, which can impact patients identified for treatment.

The DN market is complex, because in addition to specific mechanisms that directly impact the disease, blood pressure and glycemic control are additional general targets that affect the condition. Moreover, there is high cardiovascular (CV) risk in DN patients, and many physicians may be more concerned about that than the risk for end-stage renal disease, especially in less advanced patients. Hence, drugs that directly impact DN and also benefit these other targets or have a CV benefit can have a competitive advantage.

The antihypertensive ACE inhibitors or ARBs are the mainstay of treatment currently for type 1 and type 2 DN, as they have renal benefits beyond blood pressure lowering. Usage increases at higher renal stages (indicating greater renal impairment), though it may decline in stage 4 due to concerns about complications of hyperkalemia or deterioration of renal function in more advanced patients. Patients may also be receiving these medications for hypertension, which is present in most with DN, or other CV indications, without a specific intention of treating DN.

The antidiabetic SGLT-2 inhibitors are already used in some DN patients to treat their diabetes, albeit they are hampered by some side effects, but are poised to expand further, with additional approvals specifically for type 2 DN. They have a number of benefits in addition to renoprotective and antidiabetic effects, including blood pressure lowering, reducing co-morbid CV risk - especially heart failure (HF), but also, in some situations, CV death or MACE - weight loss, and a low risk of hypoglycemia. Their antidiabetic effects start to wane in stage 3 renal impairment, however, even though renal and CV benefits may persist further, raising the dilemma for physicians whether to instead then use other antidiabetics with stronger antiglycemic effects, such as the GLP-1 agonists, which also have CV and possibly renal benefits. Invokana was the first SGLT-2 inhibitor with a type 2 DN indication, but is unlikely to be able to capitalize much on it due to concerns about a possible increased risk of amputations. Farxiga and Jardiance have pivotal trials that include non-diabetic CKD patients as well, and Farxiga's was stopped early due to a positive interim analysis. Farxiga also already has approvals related to HF, including a general HFrEF indication that includes non-diabetics, which could help, but Jardiance should have broad HF data in 2020 and also showed a large reduction in CV death in its CVOT, which has propelled it to be the class leader in diabetes generally. Both Farxiga and Jardiance have ongoing trials in HFpEF, for which there currently are no approved treatments, but expectations are muted given how difficult the condition has been to treat. Loss of exclusivity for the class starts in 2025, however.

Finerenone is a mineralocorticoid receptor antagonist (MRA) that has shown renal and CV benefits in its initial Phase III study in type 2 DN, though details on efficacy and safety have not been released. While there are approved generic MRAs in other CV indications which have shown some renal benefits, they have not had a definitive trial in DN due to concerns about hyperkalemia. Finerenone was designed to have an improved risk/benefit profile, but that remains to be proven, and physician concern about potential hyperkalemia may still relegate it to a specialty drug.

Ozempic is a weekly injectable GLP-1 agonist, and Rybelsus is its daily oral formulation. Both drugs are highly effective in treating type 2 diabetes and have shown signals of a CV benefit, though only Ozempic currently has a CV indication in the US. Ozempic is the first GLP-1 agonist with a dedicated type 2 DN outcomes trial, FLOW, though primary completion is only slated for 2024. If positive, Novo Nordisk plans to bridge results to Rybelsus using renal outcomes data from the latter's CVOT. There is some uncertainty, as the evidence for a renal benefit is not as strong as for SGLT-2 inhibitors, and there are still questions about the mechanism by which GLP-1 agonists could have renoprotective effects. Nevertheless, another weekly GLP-1 agonist, Trulicity, showed benefits on a renal composite in DN patients, bolstering confidence, though Trulicity itself is not being further developed in DN. If the results for FLOW are positive, both Ozempic and Rybelsus would have the advantage of better glycemic control than SGLT-2 inhibitors, even at more advanced stages of renal impairment, though they do have more GI side effects.

Bardoxolone has had a tortured history in DN, with early termination of the BEACON trial in 2012 due to an excess of HF hospitalizations or death from HF. Subsequent analyses suggested this was due to fluid retention in at-risk patients, and the drug did indeed have an impact on a renal composite. Following this, development resumed in orphan conditions and type 1 DN. It is not clear if Reata will develop it further in the latter, as other indications would allow orphan pricing, but in Japan, Kyowa Kirin is conducting a Phase III study in patients with either type 1 or type 2 DN, stage 3-4, with results expected in 2022. There are some concerns about the drug, though, because it also increases UACR, which typically is a negative sign, though there are possible explanations. Physicians will also have to be concerned about avoiding it in patients who may be at risk for HF.

While bardoxolone is the only drug including type 1 DN in its development, which would give it an advantage in that indication, that is a smaller group of patients, and other drugs could be used off-label by specialists, especially as there are not mechanistic reasons to think they may not also work in type 1.

The overall likelihood of approval of a Phase I DN asset is 2.6%, and the average probability a drug advances from Phase III is 20%, though the sample for the latter is limited. DN drugs, on average, take 12.0 years from Phase I to approval, compared to 9.4 years in the overall endocrine space.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition and diagnosis
  • Risk factors
  • Etiology/pathogenesis
  • Stages and prognosis
  • Patient segmentation
  • CV co-morbidities

TREATMENT

  • Major treatment guidelines
  • Prescribing trends - screening and antihypertensives
  • Prescribing trends - antidiabetics
  • Treatment setting

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Generically available ACE inhibitors and ARBs
  • SGLT-2 inhibitors
  • Other classes

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Finerenone for Diabetic Nephropathy (July 9, 2020)
  • TMX-049 for Diabetic Nephropathy (June 13, 2020)
  • Farxiga for Diabetic Nephropathy (March 30, 2020)
  • RDEA3170 for Diabetic Nephropathy (November 9, 2019)
  • Esaxerenone for Diabetic Nephropathy (November 7, 2019)
  • Praliciguat for Diabetic Nephropathy (October 30, 2019)
  • Invokana for Diabetic Nephropathy (June 11, 2019)
  • Invokana for Diabetic Nephropathy (April 14, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Percentage of incident end-stage renal disease patients with diabetes as the primary cause
  • Figure 2: Patient segmentation by albuminuria and glomerular filtration rate, with US prevalence and risk of kidney outcomes
  • Figure 3: Risk of cardiovascular death and end-stage renal disease according to albuminuria and eGFR (% per year)
  • Figure 4: Presence of self-reported cardiovascular conditions among diabetics in the US, according to renal stage and albuminuria
  • Figure 5: Guideline recommendations for blood pressure and glycemic control - kidney organizations
  • Figure 6: Guideline recommendations for blood pressure and glycemic control - diabetes organizations
  • Figure 7: Trends in prevalent cases of diabetic nephropathy in adults with type 2 diabetes, 2018-27
  • Figure 8: Overview of pipeline drugs for diabetic nephropathy in the US
  • Figure 9: Pipeline drugs for diabetic nephropathy, by company
  • Figure 10: Pipeline drugs for diabetic nephropathy, by drug type
  • Figure 11: Pipeline drugs for diabetic nephropathy, by classification
  • Figure 12: Probability of success in the diabetic nephropathy pipeline
  • Figure 13: Clinical trials in diabetic nephropathy
  • Figure 14: Top 10 drugs for clinical trials in diabetic nephropathy
  • Figure 15: Top 10 companies for clinical trials in diabetic nephropathy
  • Figure 16: Trial locations in diabetic nephropathy
  • Figure 17: Diabetic nephropathy trials status
  • Figure 18: Diabetic nephropathy trials sponsors, by phase
  • Figure 19: Datamonitor Healthcare's drug assessment summary for diabetic nephropathy
  • Figure 20: Market dynamics in diabetic nephropathy (1 of 2)
  • Figure 21: Market dynamics in diabetic nephropathy (2 of 2)
  • Figure 22: Future trends in diabetic nephropathy
  • Figure 23: TMX-049 for Diabetic Nephropathy (June 13, 2020)
  • Figure 24: RDEA3170 for Diabetic Nephropathy (November 9, 2019)
  • Figure 25: Esaxerenone for Diabetic Nephropathy (November 7, 2019)
  • Figure 26: Praliciguat for Diabetic Nephropathy (October 30, 2019)
  • Figure 27: Invokana for Diabetic Nephropathy (June 11, 2019)
  • Figure 28: Invokana for Diabetic Nephropathy (April 14, 2019)
  • Figure 29: Key upcoming events in diabetic nephropathy

LIST OF TABLES

  • Table 1: Proportion of US patients with diabetic nephropathy who are treated with antihypertensives/RAAS inhibitors, by renal stage
  • Table 2: Prevalent cases of diabetic nephropathy in adults with type 2 diabetes, 2018-27
  • Table 3: Marketed drugs for diabetic nephropathy
  • Table 4: Pipeline drugs for diabetic nephropathy
  • Table 5: Historical global sales, by drug ($m), 2015-19
  • Table 6: Forecasted global sales, by drug ($m), 2020-24
  • Table 7: Finerenone for Diabetic Nephropathy (July 9, 2020)
  • Table 8: TMX-049 for Diabetic Nephropathy (June 13, 2020)
  • Table 9: Farxiga for Diabetic Nephropathy (March 30, 2020)
  • Table 10: RDEA3170 for Diabetic Nephropathy (November 9, 2019)
  • Table 11: Esaxerenone for Diabetic Nephropathy (November 7, 2019)
  • Table 12: Praliciguat for Diabetic Nephropathy (October 30, 2019)
  • Table 13: Invokana for Diabetic Nephropathy (June 11, 2019)
  • Table 14: Invokana for Diabetic Nephropathy (April 14, 2019)