(Schizophrenia) – Forecast and Market Analysis to 2022

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BREXPIPRAZOLE (SCHIZOPHRENIA) –
FORECAST AND MARKET ANALYSIS TO 2022

BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

Table below provides a summary of the key metrics for Brexpiprazole in the seven major pharmaceutical markets during the forecast period upto 2022.



May have an effect on negative symptoms.

  • Otsuka has
  • a
  • strong presence in the

schizophrenia drug market.

Conversely, the major barriers for the growth of Brexpiprazole in the schizophrenia market include:

Brexpiprazole : Key Metrics in the Seven Major Pharmaceutical Markets, 2012–2022

  • Key Events (2012-2022)
  • Level of Impact

Higher cost of therapy compared to older medications.

Anticipated launch of Brexpiprazole in US(2015)

↑↑↑

Anticipated launch of Brexpiprazole in Japan (2016)

Requires daily oral dosing.

↑↑

2022 Market Sales

The figure below illustrates Brexpiprazole sales in the 7MM by region during the forecast period.

  • US
  • $1,648.9m

  • $28.4m
  • 5EU

  • Japan
  • $105.8m

$1,783.1m

Sales for Brexpiprazole by Region, 2022

7MM

5.9%

2022

1.6%

Source: GlobalData.

Total: $1,783.1m

7MM = US, France, Germany, Italy, Spain, UK, Japan; 5EU = France, Germany, Italy, Spain, UK

US

Sales of Brexpiprazole in Global Schizophrenia Market, 2022

5EU Japan

Brexpiprazole sales are expected to increase from $176.2 million upon launch in 2015 to $1,783.1 million in 2022.

92.5%

Source: GlobalData.

Major growth drivers for Brexpiprazole in the Schizophrenia market over the forecast period include:

Structurally similar to Otsuka’s Abilify, the current market leader in the schizophrenia drug market.

Improved tolerability and similar efficacy to Abilify demonstrated in clinical trials.

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

What Do the Physicians Think?

in terms of epidemiology. But they have increased in terms of rate of prescribing because the diagnosis has expanded to which these medications are directed to.”
“Unfortunately there is really nothing out there which would give me confidence that we will have something reasonably effective in the next several years. We are probably coming to one set of results very soon, probably sometime early next year or maybe the spring of next year, the glutamatergic compounds.”
[EU] KOL, November 2013
“[We] treat them according to the presenting syndrome. And even more specifically – in terms of the positive symptoms, depression, affective symptoms, or cognitive symptoms, negative symptoms – they will be cueing in much more on that rather than on the label of, ‘Is this schizoaffective, is it bipolar, is it a schizophrenic patient?’ I think once it gets down to medications, then it gets much simpler. These discussions do not reach into the medication decision-making process.”
[US] KOL, October 2013
“There isn’t that much coming out these days, so that’s a fact which many of us have actually agreed on is a major, major issue. We’ve had discussions with pharmaceutical companies as a group of pharmacologically oriented and research-oriented psychiatrists and say, ‘Please come back and reactivate your research and development sections and divisions. Don’t desert this group of patients, because we need better drugs.’ There’s no doubt about it.”
[EU] KOL, December 2013
“Going systematically, you have the glutamatergic compounds, you have nicotinic acid agonists, you have the me-too drugs, which are the D2/5-HT2 antagonists, and of those we have plenty, we don’t need anything more, that mechanism of action is entirely taken care of, so to speak.”
[US] KOL, September 2013
“If you look at the utilization patterns of antipsychotics you do see that once the atypicals were introduced, the usage of these medications went up significantly. And this is not at all because there are more schizophrenic patients around. In fact, schizophrenia has actually decreased slightly
[US] KOL October, 2013

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

  • 1
  • Table of Contents

1 Table of Contents..........................................................................................................................4

1.1 List of Tables.........................................................................................................................7 1.2 List of Figures .......................................................................................................................7

2 Introduction ...................................................................................................................................8

2.1 Catalyst.................................................................................................................................8 2.2 Related Reports....................................................................................................................9 2.3 Upcoming Reports ..............................................................................................................10

3 Disease Overview .......................................................................................................................11

3.1 Etiology and Pathophysiology .............................................................................................11
3.1.1 Etiology...........................................................................................................................11 3.1.2 Pathophysiology .............................................................................................................12
3.2 Symptoms...........................................................................................................................13

4 Disease Management..................................................................................................................14

4.1 Diagnosis............................................................................................................................14
4.1.1 Subjective Assessments.................................................................................................15 4.1.2 Disease Subtypes...........................................................................................................16
4.2 Treatment Overview............................................................................................................18
4.2.1 Treatment of Acute Agitation Associated with Schizophrenia..........................................21 4.2.2 Maintenance Treatment of Schizophrenia.......................................................................22

5 Competitive Assessment.............................................................................................................23

5.1 Overview.............................................................................................................................23

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

5.2 Strategic Competitor Assessment .......................................................................................24

6 Opportunity and Unmet Need......................................................................................................26

6.1 Unmet Needs Overview ......................................................................................................26
6.1.1 Public Awareness...........................................................................................................27 6.1.2 Early Diagnosis and Treatment.......................................................................................29 6.1.3 Long-Acting and Advanced Drug Delivery Systems........................................................30 6.1.4 Effective Management of Negative and Cognitive Symptom Domains............................31
6.2 Gap Analysis.......................................................................................................................32
6.2.1 Long-Acting Drug Delivery..............................................................................................33 6.2.2 Treatment of Negative and Cognitive Symptoms ............................................................33

7 Pipeline Assessment...................................................................................................................34

7.1 Overview.............................................................................................................................34 7.2 Early-Stage Pipeline Assessment .......................................................................................34 7.3 Novel Therapeutic Approaches...........................................................................................35
7.3.1 Negative Symptoms........................................................................................................36 7.3.2 Cognitive Symptoms.......................................................................................................36
7.4 Long-Acting Drug Delivery ..................................................................................................36 7.5 Technology Trends Analysis ...............................................................................................37 7.6 Key Drugs in Clinical Development .....................................................................................38

8 Brexpiprazole ..............................................................................................................................40

8.1 Overview.............................................................................................................................40 8.2 Efficacy ...............................................................................................................................40 8.3 Safety..................................................................................................................................41

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

8.3.1 Dosing and Formulation..................................................................................................41 8.3.2 Potential Clinical Positioning...........................................................................................41 8.3.3 Potential Commercial Positioning ...................................................................................41 8.3.4 Pricing and Reimbursement............................................................................................42
8.4 SWOT Analysis...................................................................................................................42 8.5 Forecast..............................................................................................................................42

9 Appendix.....................................................................................................................................43

9.1 Bibliography........................................................................................................................43 9.2 Abbreviations......................................................................................................................48 9.3 Methodology .......................................................................................................................51 9.4 Forecasting Methodology....................................................................................................51
9.4.1 Diagnosis and Treatment Rates......................................................................................51 9.4.2 Adherence Rates............................................................................................................52 9.4.3 General Pricing Assumptions..........................................................................................52 9.4.4 Generic Erosion..............................................................................................................53 9.4.5 Pricing of Pipeline Agents...............................................................................................53
9.5 Key Opinion Leaders...........................................................................................................54 9.6 About the Authors ...............................................................................................................55
9.6.1 Author.............................................................................................................................55 9.6.2 Reviewers.......................................................................................................................55 9.6.3 Global Head of Healthcare..............................................................................................56
9.7 About GlobalData................................................................................................................57 9.8 Disclaimer...........................................................................................................................57

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

1.1 List of Tables

Table 1: Symptom Clusters of Schizophrenia.................................................................................................13 Table 2: Common Subjective Rating Scales Employed in Schizophrenia Diagnosis .......................................16 Table 3: Development-Based Classification of Antipsychotic Drugs................................................................19 Table 4: Receptor Binding Profiles of Atypical Antipsychotics.........................................................................20 Table 5: Guidelines for the Treatment of Schizophrenia.................................................................................21 Table 6: Leading Branded Treatments for Schizophrenia, 2013 .....................................................................25 Table 7: Strategic Competitor Assessment of the Marketed Products in Schizophrenia, 2014.........................25 Table 8: Unmet Needs – Current Level of Attainment.....................................................................................27 Table 9: Clinical Unmet Needs – Gap Analysis, 2013.....................................................................................32 Table 10: Technological Trends Analytic Framework in the Schizophrenia Pipeline, 2014..............................37 Table 11: Pipeline Candidates in Development for Schizophrenia, 2014 ........................................................38 Table 12: Comparison of Novel Therapeutic Classes in Development for Schizophrenia, 2013 ......................39 Table 13: Product Profile – Brexpiprazole ......................................................................................................40 Table 14: Brexpiprazole SWOT Analysis, 2014..............................................................................................42 Table 15: Global Sales Forecasts ($m) for Brexpiprazole, 2012–2022............................................................42

1.2 List of Figures

Figure 1: Schizophrenia – Pipeline Drugs by Target, 2014 .............................................................................35 Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012–2022....................38

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Introduction

  • 2
  • Introduction

2.1 Catalyst

Schizophrenia is a chronic, severe, and disabling group of psychotic disorders characterized by fundamental disturbances of thinking such as hallucinations, delusions, disorganized communication and reduced motivation (NIMH, 2013; WHO, 2013). Globally, the condition is prevalent in approximately 7 persons per 1,000 of the adult population ages 15–35 years (WHO, 2013).



This report provides an overview of the risk factors, comorbidities, and the global and historical trends for schizophrenia in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). In addition, the report also includes a 10-year forecast of diagnosed prevalent cases of schizophrenia segmented by age and sex.

To forecast the diagnosed prevalent cases of schizophrenia in the 7MM, GlobalData epidemiologists selected nationally representative studies that provided diagnosed prevalence of schizophrenia using uniform diagnostic criteria and classification defined by the World Health Organization’s International Classification of Diseases 9th revision (ICD-9).

GlobalData epidemiologists forecast an increase in the diagnosed prevalent cases of schizophrenia in the 7MM from 2,495,903 diagnosed prevalent cases in 2012 to 2,643,660 diagnosed prevalent cases in 2022, with an annual growth rate (AGR) of 0.59% in the forecast period.

In 2022, the US will have the highest number of diagnosed prevalent cases of schizophrenia with 1,777,333 diagnosed prevalent cases, followed by Japan with 454,961 diagnosed prevalent cases, and Italy with 154,331 diagnosed prevalent cases.

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Introduction

2.2 Related Reports



GlobalData (2014). PharmaPoint: Schizophrenia - Global Drug Forecast and Market Analysis to 2022, February 2014, GDHC81PIDR

GlobalData (2014). Schizophrenia – US Drug Forecast and Market Analysis to 2022, February 2014, GDHC224CFR

GlobalData (2014). Schizophrenia – 5EU Drug Forecast and Market Analysis to 2022, February 2014, GDHC225CFR

GlobalData (2014). Schizophrenia – Japan Drug Forecast and Market Analysis to 2022, February 2014, GDHC226CFR

GlobalData (2014). Abilify (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC355DFR

GlobalData (2014). Saphris (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC356DFR

GlobalData (2014). Clozaril (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC357DFR

GlobalData (2014). Fanapt (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC358DFR

GlobalData (2014). Latuda (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC359DFR

GlobalData (2014). Zyprexa (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC360DFR

GlobalData (2014). Invega (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC361DFR

GlobalData (2014). Seroquel (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC362DFR

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

9

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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022

Introduction



GlobalData (2014). Risperdal (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC363DFR

GlobalData (2014). Geodon (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC364DFR

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    This is a repository copy of Antipsychotics for treatment of delirium in hospitalised non-ICU patients. White Rose Research Online URL for this paper: https://eprints.whiterose.ac.uk/132847/ Version: Published Version Article: Burry, Lisa, Mehta, S.R., Perreault, M.M et al. (6 more authors) (2018) Antipsychotics for treatment of delirium in hospitalised non-ICU patients. Cochrane Database of Systematic Reviews. CD005594. ISSN 1469-493X https://doi.org/10.1002/14651858.CD005594.pub3 Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Cochrane Database of Systematic Reviews Antipsychotics for treatment of delirium in hospitalised non- ICU patients (Review) Burry L, Mehta S, Perreault MM, Luxenberg JS, Siddiqi N, Hutton B, Fergusson DA, Bell C, Rose L Burry L, Mehta S, Perreault MM, Luxenberg JS, Siddiqi N, Hutton B, Fergusson DA, Bell C, Rose L. Antipsychotics for treatment of delirium in hospitalised non-ICU patients. Cochrane Database of Systematic Reviews 2018, Issue 6.
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    Global Drug Forecast and Market Analysis to 2022

    REFERENCE CODE GDHC81PIDR | PUBLICATION DATE FEBRUARY 2014 SCHIZOPHRENIA – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary Schizophrenia: Key Metrics in the Seven Major The table above provides a summary of the key Pharmaceutical Markets, 2012–2022 metrics for schizophrenia in the seven major 2012 Epidemiology pharmaceutical markets during the forecast period Prevalent population 2.5 million from 2012–2022. Treated population 2.0 million 2012 Market Sales Schizophrenia Drug Sales by Region, 2012– US $5.2bn 2022 5EU $0.4bn Japan $0.7bn The combined sales of medications carrying an Total $6.3bn indication in schizophrenia were estimated at $6.3 Pipeline Assessment billion in 2012. By 2022, GlobalData projects these Number of drugs in Phase II–III 11 sales to grow to $7.9 billion, with a compound Number of first-in-class drugs 2 annual growth rate (CAGR) of 2.40% over the Peak-Year Promising Pipeline Candidates Sales course of the decade. These estimates cover the Brexpiprazole (Otsuka/Lundbeck) $1.8bn sales in the seven major markets (7MM) included Cariprazine (Forest/Gedeon Richter) $0.9bn in this report: the US, France, Germany, Italy, EVP-6124 (EnVivo/Mitsubishi Tanabe) $0.8bn Aripiprazole lauroxil (Alkermes) $0.7bn Spain, the UK, and Japan. We believe that the Invega Sustenna (Three-Month) $0.6bn following parameters will drive expansion in these Level of Key Events (2012–2022) markets: Impact Zyprexa (olanzapine) patent expiry in the ↓↓ Growing awareness of mental health 5EU in 2012 Seroquel (quetiapine) patent expiry in the US ↓↓ Enhanced community-level mental health care and 5EU in 2012 Geodon (ziprasidone) patent expiry in the US ↓ New product launches in 2012 Launch of Abilify Maintena (aripiprazole) in ↑↑↑ Increasing utilization of long-acting injectable the US in 2013 Abilify (aripiprazole) patent expiry in the US (LAI) antipsychotics ↓↓↓ and 5EU in 2015 2022 Market Sales US $6.1bn 5EU $0.4bn Japan $1.4bn 7MM $7.9bn Source: GlobalData.
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    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
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