Major Depressive Disorder) - Forecast and Market Analysis to 2023
Total Page:16
File Type:pdf, Size:1020Kb
REFERENCE CODE GDHC430DFR | PUBLICATION DATE MAY 2014 TEDATIOXETINE (MAJOR DEPRESSIVE DISORDER) - FORECAST AND MARKET ANALYSIS TO 2023 TEDATIOXETINE (MAJOR DEPRESSIVE DISORDER) - FORECAST AND MARKET ANALYSIS TO 2023 Executive Summary Table below presents the key metrics for Major growth drivers of tedatioxetine in the MDD tedatioxetine in the Major Depressive Disorder market during the forecast period include: (MDD) market in the seven major pharmaceutical Novel MOA. markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) and Australia in 2023. Oral administration. Tedatioxetine: Key Metrics in 7MM and Australia in Could potentially offer improved efficacy and Major Depressive Disorder Market, 2023 tolerability when compared with other Level of Key events (2013–2023) antidepressant treatments. Impact Tedatioxetine launch in 2018 (US) ↑↑ Conversely, major barriers to the growth of ↑↑ Tedatioxetine launch in 2019 (5EU) tedatioxetine in the MDD market include: Tedatioxetine launch in 2019 (Australia) ↑↑ Tedatioxetine launch in 2020 (Japan) ↑↑ No established efficacy and safety, but it is 2023 Market Sales expected to be comparable to SSRIs. US $335.0m 5EU $50.1m Slow onset of therapeutic effect. Japan $19.3m Below mentioned figure illustrates the global sales Australia $2.1m Total $406.4m for tedatioxetine by region: Source: GlobalData Sales for Tedatioxetine by Region, 2023 5EU = France, Germany, Italy, Spain, UK; 7MM = US, 5EU, and Japan 4.7% 0.5% 2023 12.3% Total: $406.4m Sales for Tedatioxetine in the MDD market US GlobalData estimates that the earliest Lundbeck/Takeda Pharmaceutical could launch 5EU tedatioxetine in the US market is in 2018. In its first Japan year, sales of tedatioxetine in the MDD market are Australia projected to reach $95.3m. By 2023, we project its sales to increase to $406.4m in the MDD market. 82.4% Source: GlobalData 5EU = France, Germany, Italy, Spain, UK Tedatioxetine (Major Depressive Disorder) - Forecast and Market Analysis to 2023 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. TEDATIOXETINE (MAJOR DEPRESSIVE DISORDER) - FORECAST AND MARKET ANALYSIS TO 2023 Executive Summary What Do the Physicians Think? “I think Brintellix has more than an SSRI. The question is how big the advantage over SSRIs in Selective serotonin reuptake inhibitors (SSRIs) are terms of tolerability and efficacy is. There are some the fist-line treatment choice in the MDD market. studies showing promising results, but we have to “My general opinion for SSRIs is that they are the see how it works in clinical practice.” standard of first-line care, so you cannot hope for something in a more exulted position than that. [OUS] Key Opinion Leader, February 2014 They have limitations however, that is why we “Brintellix may have some advantages, but it is not have unmet needs. I think they are slightly less a first-line drug in my mind, it is not the first thing I effective as a class than the SNRIs [serotonin- would prescribe. It is [a] brand new product and norepinephrine reuptake inhibitors], but they are unproven in the real world. Although the somewhat better tolerated as a class, so, the registration trials demonstrated safety, tolerability, overall advantage goes to the SSRIs.” and efficacy, it is not the same thing as the drugs that are being around for years.” [US] Key Opinion Leader, February 2014 “SSRIs are available generically now, they are [US] Key Opinion Leader, March 2014 inexpensive, they are the safest antidepressants, The most pressing unmet need in the depression work reasonably well, are easy to prescribe, and market is for the development of drugs with relevantly easy to take. So, low cost, good improved efficacy, according to the physicians tolerability, decent-great safety, and adequate interviewed by GlobalData. efficacy make these products first-line treatments.” “The major unmet need still is efficacy. It is the [US] Key Opinion Leader, February 2014 most pressing one.” Physicians need to gain experience with [OUS] Key Opinion Leader, March 2014 Lundbeck/Takeda’s Brintellix in clinical practice in “The biggest unmet need is that we do not have order to become convinced about the added good treatments. The remission and response benefits of this product in treating patients with rates are low, and we have not found new, more depression. effective agents.” [US] Key Opinion Leader, February 2014 Tedatioxetine (Major Depressive Disorder) - Forecast and Market Analysis to 2023 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. TEDATIOXETINE (MAJOR DEPRESSIVE DISORDER) - FORECAST AND MARKET ANALYSIS TO 2023 Executive Summary Physicians acknowledge that Alkermes’s ALKS- Products that demonstrate better efficacy, 5461 is one of the most promising products in the improved safety, and rapid antidepressant effects pipeline for MDD. will move to the forefront of the treatment line. “It [ALKS-5461] is [a] very intriguing product. It has “Something has to be tangibly better, not tangibly a different mechanism of action, so if it really does different, [but] tangibly better to become a first-line work, then, I think it has really good potential for antidepressant.” adoption. I would see ALKS-5461 as being [US] Key Opinion Leader, February 2014 preferred as an augmenter over second generation “If a new compound has better efficacy, [can] show antipsychotics.” rapid action and low metabolic impact, for me, it [US] Key Opinion Leader, March 2014 will be a first-line treatment.” “We have lots of things that are just the same, but [OUS] Key Opinion Leader, February 2014 this [ALKS-5461] looks a bit different and is exciting. There is a story about buprenorphine and depression anyway, and if this is a mu [opioid receptor]-blocker it might take some of the problematic aspects, such as dependence.” [OUS] Key Opinion Leader, February 2014 Tedatioxetine (Major Depressive Disorder) - Forecast and Market Analysis to 2023 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. TEDATIOXETINE (MAJOR DEPRESSIVE DISORDER) - FORECAST AND MARKET ANALYSIS TO 2023 Table of Contents 1 Table of Contents 1 Table of Contents ....................................................................................................................... 5 1.1 List of Tables ...................................................................................................................... 8 1.2 List of Figures ..................................................................................................................... 8 2 Introduction ................................................................................................................................. 9 2.1 Catalyst ............................................................................................................................... 9 2.2 Related Reports .................................................................................................................. 9 2.3 Upcoming Related Reports ............................................................................................... 11 3 Disease Overview ..................................................................................................................... 12 3.1 Etiology and Pathophysiology ........................................................................................... 12 3.1.1 Etiology ......................................................................................................................... 12 3.1.2 Pathophysiology ............................................................................................................ 12 3.2 Classification ..................................................................................................................... 14 3.3 Symptoms and Subtypes of Major Depressive Disorder .................................................... 16 3.4 Prognosis .......................................................................................................................... 17 3.5 Quality of Life .................................................................................................................... 17 4 Disease Management ............................................................................................................... 18 4.1 Diagnosis and Treatment Overview .................................................................................. 18 4.1.1 Diagnosis ...................................................................................................................... 18 4.1.2 Treatment Guidelines and Leading Prescribed Drugs ................................................... 19 4.1.3 Clinical Practice ............................................................................................................. 22 5 Competitive Assessment .......................................................................................................... 27 Tedatioxetine (Major Depressive Disorder) - Forecast and Market Analysis to 2023 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. TEDATIOXETINE (MAJOR DEPRESSIVE DISORDER) - FORECAST AND MARKET ANALYSIS TO 2023 Table of Contents 5.1 Overview ........................................................................................................................... 27 6 Unmet Needs and Opportunities