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| Report Code: PP10214 | Published: February 2019 | Pages: 192 | Available format: |
| Therapeutic Area(s): | Neurology | Report Type: Competitive Landscape Reports |
Chapter 1. Research Background
1.1 Research Objectives
1.2 Definition
1.3 Research Scope
1.3.1 Pipeline Drugs by Phase
1.3.2 Pipeline and Marketed Drugs by Mechanism of Action
1.3.3 Pipeline and Marketed Drugs by Route of Administration
1.4 Key Stakeholders
Chapter 2. Research Methodology
2.1 Secondary Research
2.2 Primary Research
2.2.1 Breakdown of Primary Research Respondents
2.2.1.1 By industry participant
2.2.1.2 By region
2.2.1.3 By designation
2.2.2 KOLs Validation
2.3 Coverage of Epidemiology Analysis
2.4 Forecast Methodology for Epidemiology Analysis
2.5 Assumptions for Epidemiology Analysis across 7MM
Chapter 3. Executive Summary
3.1 Voice of KOLs
Chapter 4. Introduction
4.1 Disease Overview
4.2 Causes and Risk Factors
4.3 Prognosis
4.4 Signs and Symptoms
4.5 Pathophysiology
4.6 Diagnosis
4.7 Treatment
4.7.1 Anti-Epileptic Drugs (AEDs)
4.7.2 Ketogenic Diet
4.7.3 Vagus Nerve Stimulation (VNS)
4.8 Treatment Algorithm for LGS
4.9 Key Drivers
4.9.1 Technological Advancements and Positive Clinical Results
4.9.2 Development of Small Molecule Therapeutics
4.10 Key Barriers
4.10.1 High Chances of Toxicities and Side-effects
4.10.2 Unidentified Cause and Challenges in Diagnosis
4.10.3 High Cost of Therapy
4.11 Technology Overview
4.11.1 Pharmfilm Drug Delivery Technology
4.11.2 Microtrol Delivery Technology
4.12 Drug Designations
Chapter 5. LGS Epidemiology Forecast for 7MM
5.1 U.S.
5.2 Japan
5.3 EU5
5.3.1 U.K.
5.3.2 Germany
5.3.3 France
5.3.4 Italy
5.3.5 Spain
Chapter 6. Pipeline and Marketed Drugs Outlook
6.1 LGS Pipeline and Marketed Drugs Snapshot
6.1.1 Pipeline Drugs Snapshot by Phase
6.1.2 Pipeline and Marketed Drugs Snapshot by Mechanism of Action
6.1.3 Pipeline and Marketed Drugs Snapshot by Route of Administration
6.1.4 Pipeline and Marketed Drugs Snapshot by Company
Chapter 7. LGS Marketed Drugs Analysis
7.1 Marketed Drugs Profiles
7.1.1 Lamictal
7.1.1.1 Dosage
7.1.1.2 Regulatory milestones
7.1.1.3 Clinical trials and results
7.1.2 Xxxx
7.1.2.1 Dosage
7.1.2.2 Regulatory Milestones
7.1.2.3 Clinical Trials
7.1.2.4 Clinical Trial Results
7.1.2.5 Strategic developments
7.1.2.6 Patents
7.1.3 Xxxx
7.1.3.1 Dosage
7.1.3.2 Regulatory Milestones
7.1.3.3 Clinical Trials and Results
7.1.3.4 Strategic Developments
7.1.4 Xxxx
7.1.4.1 Dosage
7.1.4.2 Regulatory Milestones
7.1.4.3 Clinical Trials and Results
7.1.4.4 Strategic Developments
7.1.5 Xxxx
7.1.5.1 Dosage
7.1.5.2 Regulatory Milestones
7.1.5.3 Clinical Trials and Results
7.1.5.4 Strategic Developments
7.1.5.5 Patents
7.1.6 Xxxx
7.1.6.1 Dosage
7.1.6.2 Regulatory Milestones
7.1.6.3 Clinical Trials and Results
7.1.6.4 Strategic Developments
7.1.7 Xxxx
7.1.7.1 Dosage
7.1.7.2 Regulatory Milestones
7.1.7.3 Clinical Trials and Results
7.1.7.4 Patents
7.1.8 Xxxx
7.1.8.1 Dosage
7.1.8.2 Regulatory Milestones
7.1.8.3 Clinical Trials and Results
7.1.9 Xxxx
7.1.9.1 Dosage
7.1.9.2 Regulatory Milestones
7.1.9.3 Clinical Trials and Results
7.2 Global LGS Therapeutics Market Size and Share
7.2.1 Market Size
7.2.2 Market Share
7.3 Challenges faced by Marketed Drug Manufacturers
Chapter 8. Pipeline Products
8.1 Phase III
8.1.1 ZX008
8.1.1.1 Clinical trials
8.1.1.2 Clinical results
8.1.1.3 Designation
8.1.2 Xxxx
8.1.2.1 Clinical trials
8.2 Phase II
8.2.1 TAK 935
8.2.1.1 Clinical trials
8.2.1.2 Strategic developments
8.2.1.3 Designation
8.2.2 Xxxx
8.2.2.1 Clinical trials
8.2.2.2 Strategic developments
8.2.2.3 Financing
8.2.2.4 Patent
8.3 Phase I
8.3.1 Carisbamate
8.3.1.1 Clinical trials
8.3.2 Xxxx
8.4 Pre-Clinical
8.4.1 Research Program for LGS: Epygenix Therapeutics Inc.
8.4.2 Lorazepam
8.4.2.1 Strategic developments
8.4.2.2 Designation
8.5 Inactive
8.5.1 Cannabidiol Oral Solution
8.5.1.1 Clinical trials
8.5.1.2 Designation
8.6 Discontinued
8.6.1 Retigabine
8.6.1.1 Clinical trials
8.6.1.2 Clinical results
8.6.1.3 Strategic developments
Chapter 9. Clinical Trials Review
9.1 Clinical Trials by Geography
9.2 Clinical Trials by Trial Status
Chapter 10. Regulatory Framework for Drug Approval
10.1 U.S.
10.2 Europe
10.2.1 Centralized Procedure
10.2.2 Mutual Recognition Procedure
10.2.3 Decentralized Procedure
10.2.4 Nationalized Procedure
10.3 Japan
Chapter 11. Competitive Landscape
11.1 Summary of Strategic Developments
11.2 Attribute Analysis
11.3 Expected Launch Time of Clinical Stage Products
11.4 Key Winning Strategies
11.4.1 Technological Advancements
11.4.2 Collaborations and Partnerships
11.4.3 Distinctive Drug Candidates
11.5 Pharma Proff’s View
Chapter 12. Company Profiles
12.1 GlaxoSmithKline plc
12.1.1 Business Overview
12.1.2 Product and Service Offerings
12.1.2.1 Marketed products
12.1.2.2 Pipeline products
12.2 Xxxx
12.2.1 Business Overview
12.2.2 Product and Service Offerings
12.2.2.1 Marketed products
12.2.2.2 Pipeline products
12.3 Xxxx
12.3.1 Business Overview
12.3.2 Product and Service Offerings
12.3.2.1 Marketed products
12.3.2.2 Pipeline products
12.4 Xxxx
12.4.1 Business Overview
12.4.2 Product and Service Offerings
12.4.2.1 Pipeline products
12.5 Xxxx
12.5.1 Business Overview
12.5.2 Product and Service Offerings
12.5.2.1 Pipeline products
12.6 Xxxx
12.6.1 Business Overview
12.6.2 Product and Service Offerings
12.6.2.1 Marketed products
12.6.2.2 Pipeline products
12.7 Xxxx.
12.7.1 Business Overview
12.7.2 Product and Service Offerings
12.7.2.1 Marketed products
12.7.2.2 Pipeline products
12.8 Xxxx
12.8.1 Business Overview
12.8.2 Product and Service Offerings
12.8.2.1 Marketed products
12.8.2.2 Pipeline products
12.9 Xxxx
12.9.1 Business Overview
12.9.2 Product and Service Offerings
12.9.2.1 Marketed products
12.10 Takeda Pharmaceutical Company Limited
12.10.1 Business Overview
12.10.2 Product and Service Offerings
12.10.2.1 Marketed products
12.10.2.2 Pipeline products
12.11 Xxxx
12.11.1 Business Overview
12.11.2 Product and Service Offerings
12.11.2.1 Marketed products
12.11.2.2 Pipeline products
12.12 Xxxx
12.12.1 Business Overview
12.12.2 Product and Service Offerings
12.12.2.1 Pipeline products
12.13 Xxxx
12.13.1 Business Overview
12.13.2 Product and Service Offerings
12.13.2.1 Pipeline products
12.14 INSYS Therapeutics Inc.
12.14.1 Business Overview
12.14.2 Product and Service Offerings
12.14.2.1 Marketed products
12.14.2.2 Pipeline products
12.15 SK Life Science Inc.
12.15.1 Business Overview
12.15.2 Product and Service Offerings
12.15.2.1 Pipeline products
12.16 Zogenix Inc.
12.16.1 Business Overview
12.16.2 Product and Service Offerings
12.16.2.1 Pipeline products
12.17 Epygenix Therapeutics Inc.
12.17.1 Business Overview
12.17.2 Product and Service Offerings
12.17.2.1 Pipeline products
Chapter 13. Appendix
13.1 Recently Organized/Held Seminars and Conferences
13.2 Upcoming Conferences
13.3 Sources & References
13.4 Abbreviations
13.5 Related Reports
LIST OF TABLES
TABLE 1 TYPE OF SEIZURES AND THEIR SIGN AND SYMPTOMS
TABLE 2 LGS EPIDEMIOLOGY FOR 7MM (2016-2021)
TABLE 3 LGS EPIDEMIOLOGY FOR 7MM (2022-2028)
TABLE 4 LGS EPIDEMIOLOGY FOR THE U.S. (2016-2021)
TABLE 5 LGS EPIDEMIOLOGY FOR THE U.S. (2022-2028)
TABLE 6 LGS EPIDEMIOLOGY FOR JAPAN (2016-2021)
TABLE 7 LGS EPIDEMIOLOGY FOR JAPAN (2022-2028)
TABLE 8 LGS EPIDEMIOLOGY FOR EU5 (2016-2021)
TABLE 9 LGS EPIDEMIOLOGY FOR EU5 (2022-2028)
TABLE 10 LGS EPIDEMIOLOGY FOR THE U.K. (2016-2021)
TABLE 11 LGS EPIDEMIOLOGY FOR THE U.K. (2022-2028)
TABLE 12 LGS EPIDEMIOLOGY FOR GERMANY (2016-2021)
TABLE 13 LGS EPIDEMIOLOGY FOR GERMANY (2022-2028)
TABLE 14 LGS EPIDEMIOLOGY FOR FRANCE (2016-2021)
TABLE 15 LGS EPIDEMIOLOGY FOR FRANCE (2022-2028)
TABLE 16 LGS EPIDEMIOLOGY FOR ITALY (2016-2021)
TABLE 17 LGS EPIDEMIOLOGY FOR ITALY (2022-2028)
TABLE 18 LGS EPIDEMIOLOGY FOR SPAIN (2016-2021)
TABLE 19 LGS EPIDEMIOLOGY FOR SPAIN (2022-2028)
TABLE 20 COMPANY BENCHMARKING BASED ON DRUG CANDIDATES
TABLE 21 DESCRIPTION OF LAMICTAL
TABLE 22 DOSING SCHEDULE OF LAMICTAL
TABLE 23 DESCRIPTION OF XXXX
TABLE 24 XXXX PATENTS
TABLE 25 DESCRIPTION OF XXXX
TABLE 26 DESCRIPTION OF XXXX
TABLE 27 DESCRIPTION OF XXXX
TABLE 28 DESCRIPTION OF XXXX
TABLE 29 ADVERSE REACTIONS IN POOLED PLACEBO-CONTROLLED, ADD-ON EPILEPSY TRIALS IN PEDIATRIC PATIENTS 2 TO 15 YEARS OF AGE
TABLE 30 DESCRIPTION OF XXXX
TABLE 31 XXXX XR PATENTS
TABLE 32 DESCRIPTION OF XXXX
TABLE 33 DESCRIPTION OF XXXX
TABLE 34 DESCRIPTION OF ZX008
TABLE 35 CLINICAL TRIALS OF ZX008
TABLE 36 DESCRIPTION OF PERAMPANEL (FYCOMPA)
TABLE 37 CLINICAL TRIALS OF PERAMPANEL (FYCOMPA)
TABLE 38 DESCRIPTION OF TAK-935
TABLE 39 CLINICAL TRIALS OF TAK-935
TABLE 40 DESCRIPTION OF XXXX
TABLE 41 CLINICAL TRIALS OF XXXX
TABLE 42 DESCRIPTION OF CARISBAMATE
TABLE 43 CLINICAL TRIALS OF CARISBAMATE
TABLE 44 DESCRIPTION OF LORAZEPAM (TUVETA)
TABLE 45 DESCRIPTION OF CANNABIDIOL ORAL SOLUTION
TABLE 46 CLINICAL TRIALS OF CANNABIDIOL
TABLE 47 DESCRIPTION OF RETIGABINE
TABLE 48 CLINICAL TRIALS OF RETIGABINE
TABLE 49 COLLABORATIONS AND LICENSING
TABLE 50 ACQUISITIONS
TABLE 51 ATTRIBUTE ANALYSIS - XXXX AND XXXX
TABLE 52 EXPECTED LAUNCH TIME OF CLINICAL STAGE PRODUCTS
TABLE 53 GLAXOSMITHKLINE PLC – AT A GLANCE
TABLE 54 MARKETED PRODUCTS
TABLE 55 PIPELINE PRODUCTS
TABLE 56 XXXX – AT A GLANCE
TABLE 57 MARKETED PRODUCTS
TABLE 58 PIPELINE PRODUCTS
TABLE 59 XXXX – AT A GLANCE
TABLE 60 MARKETED PRODUCTS
TABLE 61 PIPELINE PRODUCTS
TABLE 62 XXXX – AT A GLANCE
TABLE 63 PIPELINE PRODUCTS
TABLE 64 XXXX – AT A GLANCE
TABLE 65 PIPELINE PRODUCTS
TABLE 66 XXXX – AT A GLANCE
TABLE 67 MARKETED PRODUCTS
TABLE 68 PIPELINE PRODUCTS
TABLE 69 XXXX – AT A GLANCE
TABLE 70 MARKETED PRODUCTS
TABLE 71 PIPELINE PRODUCTS
TABLE 72 XXXX – AT A GLANCE
TABLE 73 MARKETED PRODUCTS
TABLE 74 PIPELINE PRODUCTS
TABLE 75 XXXX – AT A GLANCE
TABLE 76 MARKETED PRODUCTS
TABLE 77 TAKEDA PHARMACEUTICAL COMPANY LIMITED – AT A GLANCE
TABLE 78 MARKETED PRODUCTS
TABLE 79 PIPELINE PRODUCTS
TABLE 80 XXXX – AT A GLANCE
TABLE 81 XXXX – AT A GLANCE
TABLE 82 PIPELINE PRODUCTS
TABLE 83 XXXX – AT A GLANCE
TABLE 84 INSYS THERAPEUTICS INC. – AT A GLANCE
TABLE 85 MARKETED PRODUCTS
TABLE 86 PIPELINE PRODUCTS
TABLE 87 SK LIFE SCIENCE INC. – AT A GLANCE
TABLE 88 PIPELINE PRODUCTS
TABLE 89 ZOGENIX INC.– AT A GLANCE
TABLE 90 PIPELINE PRODUCTS
TABLE 91 EPYGENIX THERAPEUTICS INC.– AT A GLANCE
TABLE 92 PIPELINE PRODUCTS
TABLE 93 RECENTLY ORGANIZED LGS SEMINARS AND CONFERENCES
TABLE 94 UPCOMING LGS SEMINARS AND CONFERENCES
TABLE 95 SOURCES & REFERENCES
TABLE 96 ABBREVIATION
LIST OF FIGURES
FIG 1 RESEARCH METHODOLOGY
FIG 2 BREAKDOWN OF PRIMARY RESEARCH RESPONDENTS, BY INDUSTRY PARTICIPANT
FIG 3 BREAKDOWN OF PRIMARY RESEARCH BY REGION
FIG 4 BREAKDOWN OF PRIMARY RESEARCH BY DESIGNATION
FIG 5 TREATMENT ALGORITHM FOR LGS
FIG 7 LGS PREVALENCE RATE FOR 7MM (2016-2028)
FIG 8 LGS EPIDEMIOLOGY FOR 7MM (2016-2028)
FIG 9 LGS EPIDEMIOLOGY FOR THE U.S. (2016-2028)
FIG 10 LGS EPIDEMIOLOGY FOR JAPAN (2016-2028)
FIG 11 LGS EPIDEMIOLOGY FOR EU5 (2016-2028)
FIG 12 LGS EPIDEMIOLOGY FOR THE U.K. (2016-2028)
FIG 13 LGS EPIDEMIOLOGY FOR GERMANY (2016-2028)
FIG 14 LGS EPIDEMIOLOGY FOR FRANCE (2016-2028)
FIG 15 LGS EPIDEMIOLOGY FOR ITALY (2016-2028)
FIG 16 LGS EPIDEMIOLOGY FOR SPAIN (2016-2028)
FIG 17 LGS PIPELINE DRUGS SNAPSHOT, BY PHASE (2018)
FIG 18 LGS PIPELINE AND MARKETED DRUGS SNAPSHOT, BY MECHANISM OF ACTION (2018)
FIG 19 LGS PIPELINE AND MARKETED DRUGS SNAPSHOT, BY ROUTE OF ADMINISTRATION (2018)
FIG 20 GLOBAL LGS THERAPEUTICS MARKET SIZE, $M (2018 & 2028)
FIG 21 MARKET SHARE OF LGS MARKETED PRODUCTS (2018)
FIG 22 BREAKDOWN OF CLINICAL TRIALS, BY GEOGRAPHY
FIG 23 BREAKDOWN OF CLINICAL TRIALS, BY TRIAL STATUS
FIG 24 DRUG DISCOVERY AND APPROVAL PROCESS (PRE-CLINICAL AND CLINICAL TRIALS STAGES)
FIG 25 DRUG APPROVAL PROCESS (NDA REVIEW AND POST-MARKETING STAGES)
FIG 26 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN EU
FIG 27 MARKETING AUTHORIZATION PROCEDURES IN EU
FIG 28 CENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 29 MUTUAL RECOGNITION PROCEDURE FOR DRUG APPROVAL
FIG 30 DECENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 31 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN JAPAN
FIG 32 EXPECTED LAUNCH TIME OF CLINICAL STAGE PRODUCTS