市場調查報告書

帕金森氏病:預測和市場分析(∼2035)

Parkinson's disease forecast and market analysis to 2035

出版商 Datamonitor Healthcare 商品編碼 951556
出版日期 內容資訊 英文 91 Pages
商品交期: 最快1-2個工作天內
價格
帕金森氏病:預測和市場分析(∼2035) Parkinson's disease forecast and market analysis to 2035
出版日期: 2020年07月17日內容資訊: 英文 91 Pages
簡介

全球40歲以上成年人的帕金森氏病(PD)患病率預計將從2019年的970萬增加到2027年的1240萬。在過去的一年半中,PD領域取得了許多重大進展。在II期對照試驗中,與安慰劑相比,Cerevel's Tavapadon在改善運動症狀方面顯示出統計學意義。此外,Kyowa Kirin於2019年8月獲得了人們期待已久的Nourianz批准,該藥物於2008年被美國FDA拒絕。

本報告調查了帕金森氏病的上市銷售和管道療法,包括疾病的背景,療法,法規發展,公司之間的主要許可和資產交易協議以及主要藥物和發展。總結了公司的詳細分析。

概述

疾病背景

  • 定義
  • 患者分類
  • 症狀
  • 風險因素
  • 診斷

治療

  • 非藥物治療方法
  • 藥物治療
  • 對主要藥物治療指南的建議

流行病學

  • 患病率調查方法

新藥

管道藥物

主要法律法規的發展

成功的可能性

許可/資產收購交易

臨床試驗環境

藥物評估模型

市場動態

未來發展

  • 傳統的通用核心療法保持壟斷市場佔有率
  • 針對需求未滿足的細分PD部門,獲取薪酬

共識預測

最新動態/分析師意見

  • THN102
  • Foliglurax
  • Tavapadon
  • Nourianz
  • AP-CD/LD
  • Ongentys
  • VY-AADC
  • DynaCirc
  • AXO-Lenti-PD
  • Vectorized Alpha-Synuclein Antibody Program (AbbVie/Voyager)
  • AP-CD/LD
  • Kynmobi
  • VY-AADC
  • Protein Degradation Program (Biogen/C4)

主要未來趨勢

未滿足的需求

參考

附錄

目錄
Product Code: DMKC0218479

Disease Overview

Parkinson's disease is a chronic and progressive neurodegenerative disorder characterized by tremors, rigidity, bradykinesia (slowness of movement), and postural instability. Patients also experience significant non-motor symptoms including changes in cognition and mood, sleep disturbances, and autonomic dysfunction. The condition is caused by the degeneration of dopamine-producing cells of the substantia nigra. Parkinson's disease is incurable, but non-fatal, resulting in poor quality of life and increasing disability as the disease progresses.

Latest key takeaways

Datamonitor Healthcare estimates that in 2019, there were 9.7 million prevalent cases of Parkinson's disease (PD) in adults aged 40 years and older worldwide, and forecasts that number to increase to 12.4 million prevalent cases by 2027.

In the last 18 months there has been an array of impactful events that have occurred in the PD space. In a Phase II controlled study, Cerevel's tavapadon exhibited statistical significance in the improvement of motor symptoms compared to placebo. Tavapadon is directed at D1 and D5 receptors, the latter of which no currently approved PD therapies target. Kyowa Kirin achieved a long-awaited US approval for Nourianz in August 2019, after initially being rejected by the US FDA in 2008. 2019 also saw updated results from Ongentys's pivotal trials, confirming the drug's superiority in increasing "on" time over placebo and a robust safety profile, thus paving the way for the drug's successful US approval in April 2020.

Duopa is among the most lucrative drugs currently available in the PD market. A contributing factor to the drug's successful market penetration is the clinical efficacy data achieved in trials. Duopa treatment significantly reduced "off" periods in PD patients compared to the standard of care, Sinemet (carbidopa/levodopa). While Duopa is also a carbidopa/levodopa combination, Duopa is delivered directly and continuously into the intestines by a pump for up to 16 hours per day, thus reducing or even eliminating fluctuations and "off" periods. The procedure is one of the most invasive in this market and comes with the usual risks of surgical complications. Duopa also has one of the highest price tags in the PD market, but since payers view the cost-effectiveness ratio positively, AbbVie looks set to maintain fruitful returns on Duopa.

Acadia's Nuplazid, the first and only US-approved drug for Parkinson's disease psychosis (PDP), should see exponential uptake over the coming years. In pivotal trials, Nuplazid demonstrated significant efficacy in reducing the hallucinations and delusions associated with PDP, and through its non-dopaminergic mechanism it has shown no negative impacts on motor function. Furthermore, most other atypical antipsychotics are contraindicated for PDP, with none approved by the FDA for this specific condition. Acadia reported $339.1m sales for Nuplazid in 2019, and this is expected to increase substantially over the coming decade given the lack of competition in this segment and the drug's ongoing clinical development in other indications.

Neupro has performed considerably well commercially since its US approval in 2007, but a looming patent cliff jeopardizes the brand's revenues in the PD market. Several factors have contributed to the drug's performance, including a transdermal, continuous delivery system, its targeting of both early- and late-stage PD patients, monotherapy use, and its availability across the US, EU, and Japan. In trials the drug showed slightly lower efficacy compared to Mirapex (pramipexole), though despite this has established itself firmly in the PD treatment algorithm. UCB has fended off generic rivals thus far, but market exclusivity could expire in 2021. Currently, there are ongoing patent litigation battles, and if UCB fails to uphold relevant patents then genericization will diminish Neupro sales over the coming years.

Despite levodopa's status as the drug of choice in PD, long-term use frequently results in diminished efficacy and the development of motor fluctuations and dyskinesia. Advanced PD, therefore, has the greatest opportunities for drug developers. Competition in the rescue therapy space has begun to heat up, with Inbrija and Kynmobi both approved over the past couple of years, and this segment will continue to grow as developers look to target the rapid treatment of "off" periods. Continuous infusions have also emerged to tackle this issue, mimicking the continuous release of dopamine in non-pathological conditions. These therapies have been the most efficacious in reducing "off" time and increasing quality "on" time. Developers have also incorporated complex devices/formulations to extend market exclusivity and combat generic imitations.

As has been the case for many years, and despite new drug entrants, one of the greatest unmet pharmacological needs in the treatment of PD is for neuroprotective therapies to prevent disease progression. In addition to this, more tolerable drugs and regimens are needed, as well as more effective drugs for non-motor symptoms, and improved control of motor fluctuations/"off" periods.

The majority of high-impact upcoming catalysts in the PD space comprise later-stage trial readouts for pipeline PD drugs. Roche plans a Phase II trial readout of its novel alpha-synuclein monoclonal antibody, prasinezumab, by the end of 2020. In later-stage trials, results from Amneal's IPX203 Phase III trial in advanced PD patients experiencing motor fluctuations are expected by late 2020 or early 2021. Likewise, AbbVie foresees Phase III trial data in 2021 for its subcutaneous carbidopa/levodopa formulation, ABBV-951.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis

TREATMENT

  • Non-pharmacological treatment approaches
  • Pharmacological therapy
  • Key pharmacological treatment guideline recommendations

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Keeping Track: CDER Ties Monthly Novel Approval Record With Nourianz Green Light

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Bayer Eyes Indications Beyond BlueRock's Initial Focus With $240m-Plus Buyout

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Older, genericized core therapies will continue to dominate market share
  • Targeting niche PD segments with the greatest unmet needs will be highly rewarded

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • THN102 for Parkinson's Disease (March 31, 2020)
  • Foliglurax for Parkinson's Disease (March 27, 2020)
  • Tavapadon for Parkinson's Disease (September 23, 2019)
  • Nourianz for Parkinson's Disease (August 27, 2019)
  • AP-CD/LD for Parkinson's Disease (July 22, 2019)
  • Ongentys for Parkinson's Disease (May 5, 2019)
  • VY-AADC for Parkinson's Disease (May 5, 2019)
  • DynaCirc for Parkinson's Disease (May 2, 2019)
  • AXO-Lenti-PD for Parkinson's Disease (March 11, 2019)
  • Vectorized Alpha-Synuclein Antibody Program (AbbVie/Voyager) for Parkinson's Disease (February 22, 2019)
  • AP-CD/LD for Parkinson's Disease (February 19, 2019)
  • Kynmobi for Parkinson's Disease (January 29, 2019)
  • VY-AADC for Parkinson's Disease (January 29, 2019)
  • Protein Degradation Program (Biogen/C4) for Parkinson's Disease (January 4, 2019)

KEY UPCOMING EVENTS

UNMET NEEDS

  • Neuroprotective treatments that slow down or halt disease progression
  • Non-motor symptoms
  • Improved control of motor fluctuations/"wearing off" periods
  • New effective drug treatments with improved side-effect profiles

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Parkinson's disease symptoms and symptom domains
  • Figure 2: Trends in prevalent cases of Parkinson's disease, 2018-27
  • Figure 3: Overview of pipeline drugs for Parkinson's disease in the US
  • Figure 4: Pipeline drugs for Parkinson's disease, by company
  • Figure 5: Pipeline drugs for Parkinson's disease, by drug type
  • Figure 6: Pipeline drugs for Parkinson's disease, by classification
  • Figure 7: Probability of success in the Parkinson's disease pipeline
  • Figure 8: Clinical trials in Parkinson's disease
  • Figure 9: Top 10 drugs for clinical trials in Parkinson's disease
  • Figure 10: Top 10 companies for clinical trials in Parkinson's disease
  • Figure 11: Trial locations in Parkinson's disease
  • Figure 12: Parkinson's disease trials status
  • Figure 13: Parkinson's disease trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for Parkinson's disease
  • Figure 15: Market dynamics in Parkinson's disease
  • Figure 16: Future trends in Parkinson's disease
  • Figure 17: THN102 for Parkinson's Disease (March 31, 2020): Phase II - THN102-202
  • Figure 18: Foliglurax for Parkinson's Disease (March 27, 2020): Phase II - AMBLED (Europe)
  • Figure 19: Tavapadon for Parkinson's Disease (September 23, 2019): Phase II - Early Stage PD
  • Figure 20: Ongentys for Parkinson's Disease (May 5, 2019): Phase III - BIPARK I (301; EU), Phase III - BIPARK II (302; EU)
  • Figure 21: VY-AADC for Parkinson's Disease (May 5, 2019): Phase I - PD-1102
  • Figure 22: DynaCirc for Parkinson's Disease (May 2, 2019): Phase III - STEADY-PD III
  • Figure 23: AXO-Lenti-PD for Parkinson's Disease (March 11, 2019): Phase I/II - SUNRISE-PD (1 of 2)
  • Figure 24: AXO-Lenti-PD for Parkinson's Disease (March 11, 2019): Phase I/II - SUNRISE-PD (2 of 2)
  • Figure 25: AP-CD/LD for Parkinson's Disease (February 19, 2019): Phase II - IN18001 (vs. Sinemet)
  • Figure 26: Key upcoming events in Parkinson's disease

LIST OF TABLES

  • Table 1: Major approved treatments for Parkinson's disease
  • Table 2: Prevalent cases of Parkinson's disease, 2018-27
  • Table 3: Marketed drugs for Parkinson's disease
  • Table 4: Pipeline drugs for Parkinson's disease
  • Table 5: Historical global sales, by drug ($m), 2015-19
  • Table 6: Forecasted global sales, by drug ($m), 2020-24
  • Table 7: THN102 for Parkinson's Disease (March 31, 2020)
  • Table 8: Foliglurax for Parkinson's Disease (March 27, 2020)
  • Table 9: Tavapadon for Parkinson's Disease (September 23, 2019)
  • Table 10: Nourianz for Parkinson's Disease (August 27, 2019)
  • Table 11: AP-CD/LD for Parkinson's Disease (July 22, 2019)
  • Table 12: Ongentys for Parkinson's Disease (May 5, 2019)
  • Table 13: VY-AADC for Parkinson's Disease (May 5, 2019)
  • Table 14: DynaCirc for Parkinson's Disease (May 2, 2019)
  • Table 15: AXO-Lenti-PD for Parkinson's Disease (March 11, 2019)
  • Table 16: Vectorized Alpha-Synuclein Antibody Program (AbbVie/Voyager) for Parkinson's Disease (February 22, 2019)
  • Table 17: AP-CD/LD for Parkinson's Disease (February 19, 2019)
  • Table 18: Kynmobi for Parkinson's Disease (January 29, 2019)
  • Table 19: VY-AADC for Parkinson's Disease (January 29, 2019)
  • Table 20: Protein Degradation Program (Biogen/C4) for Parkinson's Disease (January 4, 2019)