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糖尿病性腎症:市場の予測と分析 (2037年まで)

Diabetic Nephropathy Market and Forecast Analysis to 2037

出版日: | 発行: Datamonitor Healthcare | ページ情報: 英文 90 Pages | 納期: 即日から翌営業日

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糖尿病性腎症:市場の予測と分析 (2037年まで)
出版日: 2020年07月29日
発行: Datamonitor Healthcare
ページ情報: 英文 90 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

20歳以上の成人の糖尿病性腎症 (DN) 患者は、2018年時点で世界全体で1億2260万人に達したと推計されており、その数は2027年までに1億3820万人にまで増加する見通しです。現在は降圧性ACE阻害剤やARBが1型・2型DNの主な治療薬となっていますが、SGLT-2阻害剤の利用も始まっており、他にも様々なパイプライン製品の治験が現在進められています。

当レポートでは、糖尿病性腎症の治療薬の治験・認証・上市の動向について分析し、疾患の概要や現在の治療法、将来有望な治療薬の一覧、現在の治験の進展状況、昨今の認証・上市の事例、主要企業の製品開発・上市および資本取引の動き、市場の主な促進・抑制要因、今後の技術・市場動向の方向性、といった情報を取りまとめてお届けいたします。

目次

目次

概要

病気の背景

  • 定義と診断
  • リスク因子
  • 病因
  • 病期と予後
  • 患者の内訳
  • 心血管疾患 (CV) の併存症

治療

  • 主な治療ガイドライン
  • 処方動向 - スクリーニングと降圧薬
  • 処方動向 - 抗糖尿病薬
  • 治療設定

疫学

  • 有病率の調査手法

市販薬

パイプライン薬

成功の確率

臨床試験の情勢

  • 資金提供者:段階別
  • 資金提供者:相別 (フェーズ別)
  • 最近動向

薬物評価モデル

  • 一般的に入手可能なACE阻害剤とARB
  • SGLT-2阻害剤
  • 他のクラス

市場力学

将来の動向

コンセンサス予測

最新事例とアナリストの見解

  • 糖尿病性腎症向けファインレノン (2020年7月9日)
  • 糖尿病性腎症向けTMX-049 (2020年6月13日)
  • 糖尿病性腎症向けFarxiga (2020年3月30日)
  • 糖尿病性腎症向けRDEA3170 (2019年11月9日)
  • 糖尿病性腎症向けエサセレノン (2019年11月7日)
  • 糖尿病性腎症向け薬物療法 (2019年10月30日)
  • 糖尿病性腎症向けインボカナ (2019年6月11日)
  • 糖尿病性腎症向けインボカナ (2019年4月14日)

今後の主な動向見通し

業界の有識者 (KOL) の見解

アンメットニーズ

参考文献

  • 処方せん情報

付録

目次
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)
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