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市場調查報告書

疾病分析:癲癇

Disease Analysis: Epilepsy

出版商 Datamonitor Healthcare 商品編碼 923380
出版日期 內容資訊 英文 79 Pages
商品交期: 最快1-2個工作天內
價格
疾病分析:癲癇 Disease Analysis: Epilepsy
出版日期: 2020年05月22日內容資訊: 英文 79 Pages
簡介

2018年,全世界有5400萬癲癇病例。預計到2027年,這一數字將達到5900萬。傳統的抗癲癇藥市場正在越來越普及,品牌藥也受到限制。儘管新品牌的抗癲癇藥與常規抗癲癇藥有所區別,但仍存在未解決的需求,例如頑固性癲癇。

本報告提供癲癇的相關調查,彙整疾病的背景和患者趨勢,治療指南,藥物趨勢,臨床實驗趨勢,未來趨勢等相關資訊。

概要

疾病的背景

  • 定義
  • 患者市場區隔
  • 風險因素
  • 診斷

治療

  • 治療指南
  • 藥物方法
  • 非藥物方法

流行病學

  • 罹患方法

上市完畢藥物

開發平台藥物

主要的法規活動

成功概率

授權與資產收購交易

臨床實驗趨勢

藥物評估模式

市場趨勢

未來趨勢

共識預測

近幾年的活動和分析師的見解

今後的活動

關鍵意見領袖的意見

  • 未滿足需求

參考文獻

附錄

目錄
Product Code: DMKC0210873

Latest key takeaways

Datamonitor Healthcare estimates that in 2019, there were 54.6 million prevalent cases of active epilepsy worldwide, and forecasts that number to increase to 59.0 million prevalent cases by

2027. The traditional anti-epileptic drug (AED) market is highly genericized and there are limited branded AEDs left without generic equivalents. Additionally, though these newer branded AEDs differentiate themselves from older ones, there are still unmet needs in this market that need to be addressed, including refractory epilepsy and rare specific epilepsy.

The partial-onset seizure (POS) market represents the largest market in the epilepsy disease space, however, it is highly saturated with an extensive repertoire of anticonvulsants available for prescription. Leading drugs in this patient segment are the broad-label leaders, Keppra/Keppra XR and Lamictal/Lamictal XR. Although GlaxoSmithKline has managed to slow the ensuing generic erosion of Lamictal/Lamictal XR, UCB has not been so successful with Keppra/Keppra XR and sees significant sales only remaining in Japan.

Keppra/Keppra XR and Lamictal/Lamictal XR sales will continue to plummet as increasing numbers of generic levetiracetam and lamotrigine drugs threaten their respective market shares. Brand and company reputation will help to offset the decrease in sales, particularly with Lamictal/Lamictal XR, but ultimately opportunities for follow-on successors such as Vimpat and Fycompa will open for these drugs to become brands of choice for prescribers. UCB will continue to encourage physicians to opt for its newer branded products, Briviact or Vimpat, in order to maintain its market-leading position in the epilepsy space.

The breadth of each epilepsy drug's product label is highly pertinent to its competitive edge and provides impetus for the ongoing uptake of branded anti-epileptics. Even in the saturated POS market, numerous label expansions broadening POS drug usage to monotherapy use and the treatment of pediatric patients are likely to bolster uptake. Further expansion to generalized and secondary generalized seizures, specific subpopulations such as refractory epilepsy patients, and rare pediatric epilepsy patients may also help to maximize commercial potential.

Despite rare niche epilepsy syndromes containing much smaller patient populations, companies which successfully achieve approval and marketing for drugs in these indications should see a high return on investment. Few drugs have been specifically approved for these niche indications, justifying higher drug prices for what are such devastating diseases. Epidiolex, for instance, has minimal competition and is indicated for several of these niche indications, and consequently is bringing in large profits for GW Pharmaceuticals.

The most pressing unmet needs in the epilepsy area appear to have remained consistent over the past several years. Primary unmet needs include additional treatment options for refractory epilepsy patients, effective medicines for specific epilepsy syndromes such as PCDH19 epilepsy and CDKL5 syndrome, and better ways to manage common comorbidities afflicting epilepsy patients.

In the past year UCB released positive topline Phase III results for Vimpat in patients with primary generalized tonic-clonic seizures, thus working towards the goal of extending Vimpat's label. This is part of UCB's strategy so that the drug may succeed Keppra/Keppra XR as a broad-label epilepsy market leader and help maintain the company's large market share in the wider epilepsy space.

SK Biopharmaceuticals' Xcopri was approved by the FDA for the treatment of POS epilepsy in adults in November

2019. The drug exhibited cases of drug reaction with eosinophilia and systemic symptoms (DRESS) in Phase II clinical trials. However, results from a large Phase III open-label extension study of Xcopri as an adjunctive treatment in POS epilepsy patients have shown that a slower titration rate than that utilized in earlier studies mitigates the risk of DRESS syndrome occurring. These results permitted the omission of a black box warning for DRESS syndrome on Xcopri's prescribing information. Xcopri's Phase II efficacy data are extremely encouraging in refractory epilepsy patients and in achieving seizure freedom.

In the near future, there are several key events expected in the epilepsy space. Fintepla is set to receive a CHMP opinion for its use in the EU to treat Dravet syndrome patients, and a PDUFA decision has been extended until the end of June

2020. Further notable future events include topline Phase III data for padsevonil, and for ganaxolone in rare pediatric epilepsy patients in 2021.

TABLE OF CONTENTS

CONTENTS

7 OVERVIEW

7 Latest key takeaways

9 DISEASE BACKGROUND

9 Definition

9 Patient segmentation

10 Risk factors

10 Diagnosis

12 TREATMENT

12 Treatment guidelines

14 Drug approaches

15 Non-drug approaches

16 EPIDEMIOLOGY

16 Prevalence methodology

19 MARKETED DRUGS

26 PIPELINE DRUGS

33 KEY REGULATORY EVENTS

33 Interview: Arvelle Aims To Be Major Player In CNS

33 GW's Cannabidiol Drug To Be Funded In England For Epilepsy

33 Major Milestone For SK Biopharm As Anti-Epileptic Gets US Approval

33 Pent-Up Demand As GW Pharma's Epidyolex Approved In Europe

33 Seizure Drugs: Adult Efficacy Data May Be Extrapolated To Pediatric Patients

35 PROBABILITY OF SUCCESS

36 LICENSING AND ASSET ACQUISITION DEALS

36 Bloom Licenses Bacterial IP From Duke For Therapeutic Investigation

36 Deals Shaping The Medical Industry, December 2019

36 Neurocrine Adds Epilepsy Assets From Xenon

37 CLINICAL TRIAL LANDSCAPE

38 Sponsors by status

39 Sponsors by phase

40 Recent events

42 DRUG ASSESSMENT MODEL

44 MARKET DYNAMICS

45 FUTURE TRENDS

45 Drugs approved for rare pediatric epilepsies will deliver large revenues for respective companies

45 Large POS market is highly saturated and will be difficult to penetrate

46 Key epilepsy player UCB will follow new strategies and lifecycle management to maintain market share

47 CONSENSUS FORECASTS

52 RECENT EVENTS AND ANALYST OPINION

52 OV935 for Seizure Disorders (Epilepsy) (March 30, 2020)

53 Padsevonil for Partial Seizures (Epilepsy) (March 13, 2020)

54 Staccato Alprazolam for Partial Seizures (Epilepsy) (March 12, 2020)

56 Fintepla for Lennox-Gastaut Syndrome (LGS; Epilepsy) (February 6, 2020)

57 Ganaxolone for Seizure Disorders (Epilepsy) (September 26, 2019)

59 OV935 for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 23, 2019)

61 Zygel for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 18, 2019)

63 E2082 for Partial Seizures (Epilepsy) (July 30, 2019)

65 Vimpat for Partial Seizures (Epilepsy) (June 30, 2019)

66 Lamictal for Epilepsies (June 25, 2019)

67 Fintepla for Dravet Syndrome (Epilepsy) (May 30, 2019)

68 Lyrica for Partial Seizures (Epilepsy) (May 24, 2019)

69 STK-001 for Dravet Syndrome (Epilepsy) (May 23, 2019)

70 Valtoco for Seizure Disorders (Epilepsy) (May 5, 2019)

72 KEY UPCOMING EVENTS

73 KEY OPINION LEADER INSIGHTS

73 Refractory epilepsy patients

73 Rare pediatric epilepsies

73 Pipeline epilepsy prospects

75 UNMET NEEDS

76 BIBLIOGRAPHY

76 Prescription information

78 APPENDIX

LIST OF FIGURES

  • 9 Figure 1: ILAE 2017 Classification of Seizure Types: Basic Version
  • 12 Figure 2: Levels of efficacy and effectiveness evidence supporting use of AEDs in epilepsy subpopulations
  • 14 Figure 3: Recommendations for monotherapy in adults with new-onset epilepsy with focal epilepsy or unclassified tonicclonic seizures
  • 15 Figure 4: Drug approaches for treating the various types of epilepsy
  • 18 Figure 5: Trends in prevalent cases of active epilepsy, 2018-27
  • 26 Figure 6: Overview of pipeline drugs for epilepsy in the US
  • 26 Figure 7: Pipeline drugs for epilepsy, by company
  • 27 Figure 8: Pipeline drugs for epilepsy, by drug type
  • 27 Figure 9: Pipeline drugs for epilepsy, by classification
  • 35 Figure 10: Probability of success in the epilepsy pipeline
  • 37 Figure 11: Clinical trials in epilepsy
  • 37 Figure 12: Top 10 drugs for clinical trials in epilepsy
  • 38 Figure 13: Top 10 companies for clinical trials in epilepsy
  • 38 Figure 14: Trial locations in epilepsy
  • 39 Figure 15: Epilepsy trials status
  • 40 Figure 16: Epilepsy trials sponsors, by phase
  • 42 Figure 17: Datamonitor Healthcare's drug assessment summary for epilepsy
  • 44 Figure 18: Market dynamics in epilepsy
  • 45 Figure 19: Future trends in epilepsy
  • 54 Figure 20: Padsevonil for Partial Seizures (Epilepsy) (March 13, 2020): Phase IIb - ARISE
  • 56 Figure 21: Staccato Alprazolam for Partial Seizures (Epilepsy) (March 12, 2020): Phase IIb - StATES
  • 57 Figure 22: Fintepla for Lennox-Gastaut Syndrome (LGS; Epilepsy) (February 6, 2020): Phase III - Adjunctive Therapy
  • 59 Figure 23: Ganaxolone for Seizure Disorders (Epilepsy) (September 26, 2019): Phase II - Status Epilepticus
  • 61 Figure 24: OV935 for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 23, 2019): Phase II - ENDYMION(OLE)
  • 63 Figure 25: Zygel for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 18, 2019): Phase II - BELIEVE 1 (DEE)
  • 66 Figure 26: Vimpat for Partial Seizures (Epilepsy) (June 30, 2019): Phase III - VALOR (PGTC Seizures)
  • 69 Figure 27: Lyrica for Partial Seizures (Epilepsy) (May 24, 2019): Phase III - PGTC (Grand Mal) Seizures
  • 72 Figure 28: Key upcoming events in epilepsy

LIST OF TABLES

  • 17 Table 1: Prevalent cases of active epilepsy, 2018-27
  • 20 Table 2: Marketed drugs for epilepsy
  • 28 Table 3: Pipeline drugs for epilepsy
  • 48 Table 4: Historical global sales, by drug ($m), 2014-18
  • 50 Table 5: Forecasted global sales, by drug ($m), 2020-24
  • 52 Table 6: OV935 for Seizure Disorders (Epilepsy) (March 30, 2020)
  • 53 Table 7: Padsevonil for Partial Seizures (Epilepsy) (March 13, 2020)
  • 55 Table 8: Staccato Alprazolam for Partial Seizures (Epilepsy) (March 12, 2020)
  • 56 Table 9: Fintepla for Lennox-Gastaut Syndrome (LGS; Epilepsy) (February 6, 2020)
  • 58 Table 10: Ganaxolone for Seizure Disorders (Epilepsy) (September 26, 2019)
  • 60 Table 11: OV935 for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 23, 2019)
  • 61 Table 12: Zygel for LGS, Dravet Syndrome and Seizure Disorders (Epilepsy) (September 18, 2019)
  • 64 Table 13: E2082 for Partial Seizures (Epilepsy) (July 30, 2019)
  • 65 Table 14: Vimpat for Partial Seizures (Epilepsy) (June 30, 2019)
  • 66 Table 15: Lamictal for Epilepsies (June 25, 2019)
  • 67 Table 16: Fintepla for Dravet Syndrome (Epilepsy) (May 30, 2019)
  • 68 Table 17: Lyrica for Partial Seizures (Epilepsy) (May 24, 2019)
  • 69 Table 18: STK-001 for Dravet Syndrome (Epilepsy) (May 23, 2019)
  • 70 Table 19: Valtoco for Seizure Disorders (Epilepsy) (May 5, 2019)