Market Spotlight: Amyotrophic Lateral Sclerosis (ALS)
Market Spotlight: Amyotrophic Lateral Sclerosis (ALS)
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This Market Spotlight report covers the Amyotrophic Lateral Sclerosis (ALS) market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- Description
- Contents
- Samples
This Market Spotlight report covers the Amyotrophic Lateral Sclerosis (ALS) market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare estimates that in 2016, there were 46,080 incident cases of amyotrophic lateral sclerosis (ALS) in adults aged 40 years and older worldwide, and forecasts that number to increase to 54,750 incident cases by 2025.
- Oceania and Europe are estimated to have the highest disease incidence (2.33 and 2.16 cases per 100,000 people, respectively), while Asia and Africa have the lowest incidence (0.62 and 0.89 cases per 100,000 people, respectively).
- Mitsubishi Tanabe’s Radicava, Concordia’s Rilutek, and Corestem’s Neuronata-R are the only marketed drugs available for ALS.
- The majority of industry-sponsored drugs in active clinical development for ALS are in Phase II. Therapies in mid-to-late-stage development for ALS focus on a wide variety of targets. Approximately one third of the drugs in mid-to-late-stage development for ALS are administered via the oral route.
- High impact upcoming events for drugs in the ALS space comprise topline Phase II and Phase III trial results, and an expected CHMP opinion for masitinib.
- There have been 19 licensing and asset acquisition deals involving ALS drugs during 2013–18. The $1,050m exclusive strategic collaboration and option agreement signed in 2018 between AbbVie and Voyager to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer’s disease and other neurodegenerative diseases was the largest deal.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for ALS have been in the early and midphases of development, with 82% of trials in Phase I–II, and only 18% in Phase III–IV.
- The US has a substantial lead in the number of ALS clinical trials globally. The UK leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the ALS space is dominated by completed trials. Otsuka and Biogen have the highest number of completed clinical trials for ALS, with 11 and 10 trials, respectively.
- Biogen and Otsuka lead industry sponsors with the highest number of clinical trials for ALS, followed by Cytokinetics.
CONTENTS
5 OVERVIEW
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
7 Subtypes
8 TREATMENT
8 Symptomatic treatments
8 Ventilatory management
8 Nutritional management
8 Disease-modifying therapies
10 EPIDEMIOLOGY
14 MARKETED DRUGS
16 Approvals by country
18 PIPELINE DRUGS
25 KEY UPCOMING EVENTS
26 KEY REGULATORY EVENTS
26 Radicava US Approval Boost To Mitsubishi As Sales Decline
27 LICENSING AND ASSET ACQUISITION DEALS
27 Deal Watch: Pfizer Begins 2018 With Two Deals, Including ALS Tie-Up With Sangamo
28 PARENT PATENTS
29 REVENUE OPPORTUNITY
30 CLINICAL TRIAL LANDSCAPE
31 Sponsors by status
32 Sponsors by phase
33 Recent events
34 BIBLIOGRAPHY
34 Prescription information
35 APPENDIX
LIST OF FIGURES
11 Figure 1: Trends in incident cases of ALS, 2016–25
13 Figure 2: Incident cases of ALS, 2017
18 Figure 3: Pipeline drugs for ALS in the US
19 Figure 4: Pipeline drugs for ALS, by company
20 Figure 5: Pipeline drugs for ALS, by drug type
20 Figure 6: Pipeline drugs for ALS, by classifications
25 Figure 7: Key upcoming events in ALS
27 Figure 8: Licensing and asset acquisition deals in ALS, 2013–18
28 Figure 9: Parent patents in ALS
30 Figure 10: Clinical trials in ALS
30 Figure 11: Top 10 drugs for clinical trials in ALS
31 Figure 12: Top 10 companies for clinical trials in ALS
31 Figure 13: Trial locations in ALS
32 Figure 14: ALS trials status
33 Figure 15: ALS trials sponsors, by phase
LIST OF TABLES
10 Table 1: Incident cases of ALS, 2016–25
12 Table 2: Incidence rates of ALS, 2016–25
15 Table 3: Marketed drugs for ALS
17 Table 4: Approvals by country for ALS
21 Table 5: Pipeline drugs for ALS in the US
29 Table 6: Historical global sales, by drug ($m), 2012–17
29 Table 7: Forecasted global sales, by drug ($m), 2018–22
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