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市場調查報告書

疾病分析:第一型糖尿病

Disease Analysis: Type 1 Diabetes

出版商 Datamonitor Healthcare 商品編碼 927049
出版日期 內容資訊 英文 96 Pages
商品交期: 最快1-2個工作天內
價格
疾病分析:第一型糖尿病 Disease Analysis: Type 1 Diabetes
出版日期: 2020年06月10日內容資訊: 英文 96 Pages
簡介

儘管有複數確立的產品,第一型糖尿病市場,今後10年預計有限成長。第一型糖尿病市場上未來的成長機會,由於複數成熟的胰島素的飽和狀態,及生物相似藥銷售後的價格壓力,鈉/葡萄糖共同輸送體2 (SGLT-2) 抑制劑的失敗等,市場成長有受限的可能性。

本報告提供全球第一型糖尿病 市場相關調查分析,疾病的背景,治療,上市品,開發平台醫藥品,臨床實驗形勢,未來趨勢等相關的系統性資訊。

目錄

概要

疾病的背景

  • 疾病定義
  • 患者的分類
  • 疾病診斷

治療

  • 日常性的胰島素補充療法上,必須預防高血糖

流行病學

  • 成人的盛行率
  • 兒童、未成年的盛行率

上市品

開發平台醫藥品

主要的法規趨勢

  • Empagliflozin
  • EMA:PRIME
  • AstraZeneca:Farxiga
  • Sanofi:NovoRapid
  • AZ:Forxiga

成功的可能性

許可證、資產取得契約

臨床實驗形勢

  • 贊助商:各狀態
  • 贊助商:各階段
  • 最近的趨勢

醫藥品評估模式

市場動態

未來趨勢

  • 下一代產品的拿進來變得慢
  • 合理的價格的胰島素
  • Teplizumab
  • SGLT-2抑制劑

共識的預測

最近的趨勢和分析師的見解

今後的主要趨勢

KOL的考察

未滿足需求

參考文獻

附錄

目錄
Product Code: DMKC0211578

Disease definition

Diabetes mellitus is a group of chronic endocrine disorders characterized by hyperglycemia due to insufficient levels of insulin, a hormone responsible for regulating blood sugar. Symptoms include excessive excretion of urine (polyuria), thirst (polydipsia),

constant hunger, weight loss, vision changes, and fatigue. According to the World Health Organization (WHO), approximately 8.5% of adults had diabetes in 2014. Type 1 diabetes accounts for around 5-10% of the total diabetic population. The majority of cases of type 1 diabetes may be classified as type 1a, an autoimmune disease characterized by the destruction of pancreatic beta cells, with a minority of cases making up type 1b, which is described as idiopathic diabetes mellitus.

Latest key takeaways

Despite the presence of multiple well-established products, the type 1 diabetes market is expected to see limited growth over the next decade. Future growth opportunities in the type 1 diabetes market are expected to be limited by its saturation with multiple maturing insulins, pricing pressures following the launches of biosimilars, and the expected failure of sodium-glucose cotransporter-2 (SGLT-2) inhibitors to gain approval in the lucrative US market.

Datamonitor Healthcare expects patients will continue to switch from Novo Nordisk's Levemir to its successor product Tresiba due to the company's promotion of Tresiba's longer duration of blood sugar control compared to Levemir. Likewise, Sanofi is pursuing a comparable commercial strategy to Novo Nordisk by promoting its next-generation insulin glargine product Toujeo over Lantus, as Lantus continues to lose patient share to the more affordable biosimilar Basaglar. However, key opinion leaders interviewed by Datamonitor Healthcare suggest that physicians are unconvinced that Toujeo possesses tangible benefits over biosimilar insulin glargine to justify its higher price.

Payers are severely restricting the use of specific insulin brands in the US. As the list price of insulins continues to increase, cost is becoming a strong determining factor for the choice of insulin treatment. Interviewed endocrinologists emphasized the impact of pricing on prescribing trends, as price fluctuations in the US lead to regular switching among patients.

Tresiba is forecasted to see the greatest uptake of all the long-acting insulin therapies in type 1 diabetes. Its long-acting duration of 42+ hours and its flexible dosing window (it can be administered at different times each day) offer improved convenience for patients, along with strong glycated hemoglobin (HbA1c) reductions. In addition, favorable pricing compared to Lantus and Toujeo within the US market is expected to drive growth of Novo Nordisk's market share.

The maturation of multiple short-acting insulin products has resulted in companies promoting switching to successor products with extended patent protection to maintain their diabetes revenues. Novo Nordisk's NovoLog will be facing biosimilar competition from Sanofi's SAR341402, therefore Novo Nordisk is actively encouraging patients to switch to NovoLog's successor ultra-rapid product Fiasp, which is positioned as having a faster onset of activity than NovoLog. Similarly, Eli Lilly has developed a faster-acting version of Humalog, ultra-rapid lispro, which is currently in preregistration in the US.

Increasing out-of-pocket costs for patients and competition from Sanofi's Admelog (a biosimilar of Humalog) have resulted in developers of branded products launching authorized generics in order to increase competitiveness in US government-insured patients, who must make co-payments based on a percentage of a drug's list price. In May 2019, Eli Lilly launched an authorized generic of Humalog at 50% of the list price of branded Humalog in hopes of maintaining government-insured patient share. This was followed in January 2020 by Novo Nordisk's launch of an authorized generic version of NovoLog, also at a 50% discount to the branded product.

Pipeline product teplizumab has shown promising potential to prevent or delay the onset of type 1 diabetes, as Phase II data have demonstrated that a single course of the drug significantly delayed disease onset in at-risk patients by a median of two years. Provention Bio began a rolling Biologics License Application (BLA) submission for the prevention or delay of type 1 diabetes in April 2020, and expects to complete the BLA by the end of 2020. The review process will be fast tracked due to Breakthrough Therapy designation granted by the US Food and Drug Administration (FDA), allowing for possible approval in mid-2021. However, if approved, teplizumab is likely to face two challenges when attempting to enter the market, the first of which is appropriately pricing the product to reflect the market value of delaying or preventing diabetes while ensuring that a high upfront cost does not prevent reimbursement. Indeed, achieving widespread reimbursement will be particularly challenging given the lack of a currently approved comparator and the fact that the mean duration of any delay in the onset of diabetes may not be known at the time of approval. The second challenge is the lack of existing screening programs to detect patients that are at risk for type 1 diabetes, which could severely limit the drug's target population (at least initially). Teplizumab's commercial success will therefore require healthcare services, physicians, and industry to collaborate on creating and integrating accessible screening programs into different health services globally.

SGLT-2 inhibitors may offer benefits to type 1 diabetes patients beyond improved glycemic control (namely blood pressure reduction and weight loss), but the FDA has now rejected all three members of the class that had been filed for regulatory approval (Farxiga, Jardiance, and Zynquista). Our base case is that the class will not gain FDA approval for type 1 diabetes without additional studies to further investigate the risk of diabetic ketoacidosis (DKA), the durability of glycemic benefits, and the effectiveness of proposed risk-management strategies. Thus far, none of the companies have publicly announced any intention to conduct such studies. In fact, Eli Lilly decided to discontinue further development of Jardiance for type 1 diabetes in April 2020, and AstraZeneca has not provided any further updates on Farxiga's supplemental New Drug Application (sNDA) since its initial rejection by the FDA in July 2019, thus we expect that the company will also abandon US development. Lexicon has expressed its reluctance to conduct additional trials for Zynquista and has instead unsuccessfully appealed twice to the FDA to overturn its initial rejection. While Lexicon claimed it still has options available for Zynquista's US approval in its Q1 2020 earnings call, we believe that the FDA is highly unlikely to approve the drug in the absence of new trial data.

Datamonitor Healthcare estimates that in 2018, there were approximately 46.6 million prevalent cases of type 1 diabetes in adults aged 20 years and over worldwide, and forecasts that number to increase to 51.8 million prevalent cases by 2027.

Datamonitor Healthcare estimates that in children and adolescents aged below 20 years, there were approximately 1.08 million prevalent cases of type 1 diabetes worldwide in 2018, which are expected to increase to 1.12 million prevalent cases by 2027.

The overall likelihood of approval of a Phase I type 1 diabetes asset is 14.8%, and the average probability a drug advances from Phase III is 75%. Type 1 diabetes drugs, on average, take 9.1 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

  • Disease definition
  • Patient segmentation
  • Disease diagnosis

TREATMENT

  • Daily insulin replacement therapy is required to prevent hyperglycemia

EPIDEMIOLOGY

  • Prevalence Methodology in Adults (20-85+ Years)
  • Prevalence Methodology in Children and Adolescents (0-19 Years)

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Keeping Track: US FDA Okays BMS' Zeposia In MS, Nixes Lilly/BI's Empagliflozin For Type 1 Diabetes
  • Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel
  • EMA Accepts First Diabetes Drug Onto PRIME
  • Sanofi Files First Biosimilar Insulin Aspart In Challenge To NovoRapid
  • AstraZeneca's Farxiga Fails To Get FDA OK As Insulin Supplement In Type 1 Diabetes

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Genprex Licenses Diabetes Gene Therapy From Pitt
  • With $260m Settlement From Sanofi, Lexicon Looks For New Zynquista Partner

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Long-acting insulins
  • Rapid-acting insulins
  • Non-insulin treatments

MARKET DYNAMICS

  • Current dynamics
  • Market opportunity
  • Threat of substitution
  • Payer pressure / buyer power

FUTURE TRENDS

  • Questionable clinical benefit and pricing pressure from biosimilars will slow uptake of next-generation products
  • Pricing pressure in the US diabetes market will shift prescribing trends towards affordable insulins
  • Teplizumab uptake will be dependent on overcoming pricing and reimbursement issues, along with the introduction of screening programs to identify at-risk patients
  • SGLT-2 inhibitors are expected to have slow uptake in the EU and Japan due to narrow target populations, DKA risk, and minor glycemic benefits

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Jardiance for Diabetes Mellitus, Type I (March 20, 2020)
  • TTP399 for Diabetes Mellitus, Type I (February 10, 2020)
  • Zynquista for Diabetes Mellitus, Type I (December 2, 2019)
  • Jardiance for Diabetes Mellitus, Type I (November 13, 2019)
  • Jardiance for Diabetes Mellitus, Type I (November 11, 2019)
  • Toujeo for Diabetes Mellitus, Type I (October 31, 2019)
  • Farxiga for Diabetes Mellitus, Type I (July 15, 2019)
  • Artificial Pancreas System - Tandem for Diabetes Mellitus, Type I (June 9, 2019)
  • LY900014 for Diabetes Mellitus, Type I (June 9, 2019)
  • SAR341402 for Diabetes Mellitus, Type I (June 9, 2019)
  • Teplizumab for Diabetes Mellitus, Type I (June 9, 2019)
  • HDV-L for Diabetes Mellitus, Type I (June 8, 2019)
  • Multiple Drugs for Diabetes Mellitus, Type I (June 8, 2019)
  • Eversense for Diabetes Mellitus, Type I (June 6, 2019)
  • TTP399 for Diabetes Mellitus, Type I (June 6, 2019)
  • NN9828 for Diabetes Mellitus, Type I (May 31, 2019)
  • sugarBEAT for Diabetes Mellitus, Type I (May 29, 2019)
  • MiniMed 640G for Diabetes Mellitus, Type I (April 29, 2019)
  • sugarBEAT for Diabetes Mellitus, Type I (April 16, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

  • Better options for glucose administration
  • Innovative therapies with new mechanisms of action
  • Prevention of type 1 diabetes
  • Faster-acting short-acting analogs

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Guideline diagnostic criteria for type 1 diabetes
  • Figure 2: Recommended steps following type 1 diabetes treatment initiation
  • Figure 3: Trends in prevalent cases of type 1 diabetes in adults (20-85+ years), 2018-27
  • Figure 4: Trends in prevalent cases of type 1 diabetes in children and adolescents (0-19 years), 2018-27
  • Figure 5: Overview of pipeline drugs for type 1 diabetes in the US
  • Figure 6: Pipeline drugs for type 1 diabetes, by company
  • Figure 7: Pipeline drugs for type 1 diabetes, by drug type
  • Figure 8: Pipeline drugs for type 1 diabetes, by classification
  • Figure 9: Probability of success in the type 1 diabetes pipeline
  • Figure 10: Clinical trials in type 1 diabetes
  • Figure 11: Top 10 drugs for clinical trials in type 1 diabetes
  • Figure 12: Top 10 companies for clinical trials in type 1 diabetes
  • Figure 13: Trial locations in type 1 diabetes
  • Figure 14: Type 1 diabetes trials status
  • Figure 15: Type 1 diabetes trials sponsors, by phase
  • Figure 16: Datamonitor Healthcare's drug assessment summary for type 1 diabetes
  • Figure 17: Future trends in type 1 diabetes
  • Figure 18: Toujeo for Diabetes Mellitus, Type I (October 31, 2019): Phase III - EDITION JUNIOR
  • Figure 19: LY900014 for Diabetes Mellitus, Type I (June 9, 2019): Phase III - PRONTO-T1D
  • Figure 20: SAR341402 for Diabetes Mellitus, Type I (June 9, 2019): Phase III - GEMELLI1
  • Figure 21: Teplizumab for Diabetes Mellitus, Type I (June 9, 2019): Phase III - At-Risk (NIDDK)
  • Figure 22: HDV-L for Diabetes Mellitus, Type I (June 8, 2019): Phase II - ISLE-1
  • Figure 23: TTP399 for Diabetes Mellitus, Type I (June 6, 2019): Phase Ib/II - Simplici-T1
  • Figure 24: NN9828 for Diabetes Mellitus, Type I (May 31, 2019): Phase II - Proof-of-Principle
  • Figure 25: Key upcoming events in type 1 diabetes

LIST OF TABLES

  • Table 1: Prevalent cases of type 1 diabetes in adults (20-85+ years), 2018-27
  • Table 2: Prevalent cases of type 1 diabetes in children and adolescents (0-19 years), 2018-27
  • Table 3: Marketed drugs for type 1 diabetes
  • Table 4: Pipeline drugs for type 1 diabetes in the US
  • Table 5: Historical global sales, by drug ($m), 2015-19
  • Table 6: Forecasted global sales, by drug ($m), 2020-24
  • Table 7: Jardiance for Diabetes Mellitus, Type I (March 20, 2020)
  • Table 8: TTP399 for Diabetes Mellitus, Type I (February 10, 2020)
  • Table 9: Zynquista for Diabetes Mellitus, Type I (December 2, 2019)
  • Table 10: Jardiance for Diabetes Mellitus, Type I (November 13, 2019)
  • Table 11: Jardiance for Diabetes Mellitus, Type I (November 11, 2019)
  • Table 12: Toujeo for Diabetes Mellitus, Type I (October 31, 2019)
  • Table 13: Farxiga for Diabetes Mellitus, Type I (July 15, 2019)
  • Table 14: Artificial Pancreas System - Tandem for Diabetes Mellitus, Type I (June 9, 2019)
  • Table 15: LY900014 for Diabetes Mellitus, Type I (June 9, 2019)
  • Table 16: SAR341402 for Diabetes Mellitus, Type I (June 9, 2019)
  • Table 17: Teplizumab for Diabetes Mellitus, Type I (June 9, 2019)
  • Table 18: HDV-L for Diabetes Mellitus, Type I (June 8, 2019)
  • Table 19: Multiple Drugs for Diabetes Mellitus, Type I (June 8, 2019)
  • Table 20: Eversense for Diabetes Mellitus, Type I (June 6, 2019)
  • Table 21: TTP399 for Diabetes Mellitus, Type I (June 6, 2019)
  • Table 22: NN9828 for Diabetes Mellitus, Type I (May 31, 2019)
  • Table 23: sugarBEAT for Diabetes Mellitus, Type I (May 29, 2019)
  • Table 24: MiniMed 640G for Diabetes Mellitus, Type I (April 29, 2019)
  • Table 25: sugarBEAT for Diabetes Mellitus, Type I (April 16, 2019)