Parkinson's disease forecast and market analysis to 2035
|出版日期||內容資訊||英文 91 Pages
|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|
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。
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.
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.