Breakthrough Therapies: Market Dynamics and Investment Opportunities

  • ID: 4040652
  • Report
  • Region: Global
  • 250 Pages
  • BCC Research
1 of 5
The Global Market for Breakthrough Therapy Designation Drugs Should Reach $99.2 Billion by 2022 from $48.8 Billion in 2017 at a CAGR of 15.2%

FEATURED COMPANIES

  • Abbvie Inc.
  • Astrazeneca Plc
  • DBV Technologies
  • Gilead Sciences Inc.
  • Johnson & Johnson
  • Novartis AG
  • MORE

Report Includes

  • An overview of the global markets for breakthrough therapies, their dynamics, and investment opportunities
  • Analyses of global market trends, with data from 2015, 2016, and projections of compound annual growth rates (CAGRs) through 2022
  • The challenges and opportunities of developing breakthrough therapies
  • A compare and contrast of different fast track drug development approaches (logistics, criteria and implications) and the potential risk and rewards of gaining break through designation
  • Analysis of the regulatory environment
  • Coverage of the market's dynamics, specifically growth drivers, restraints, and opportunities
  • Profiles of major players in the industry

This report highlights the challenges and opportunities of developing breakthrough therapies, it compares and contrasts difference fast track drug development approaches (logistics, criteria, and implications) and the potential risk and rewards of gaining BTD. It analyzes BTD in different therapy areas (cardiovascular, central nervous systems and neurology, rare diseases, oncology and other diseases), leading companies, approved and pipeline products, pricing market access and product revenues. It reviews BTD successes and failures and discusses the different business strategies that companies have adopted in order to maximize the competitive advantage of BTD. It summarizes the current regulatory framework and the potential application of BTD in other regions of the world, and the potential to combine BTD with early access to medicine schemes to improve patient access to medicine to treat rare diseases and address areas of high unmet clinical need.

Note: Product cover images may vary from those shown
2 of 5

FEATURED COMPANIES

  • Abbvie Inc.
  • Astrazeneca Plc
  • DBV Technologies
  • Gilead Sciences Inc.
  • Johnson & Johnson
  • Novartis AG
  • MORE

1: Introduction

  • Study Goals And Objectives
  • Reasons For Doing The Report
  • Scope Of Report
  • Intended Audience
  • Methodology And Information Sources

2: Summary
Table Summary : Global Market For Breakthrough Therapy Designation Drugs, By Therapy, Through 2022
Figure Summary : Global Market For Breakthrough Therapy Designation Drugs, By Therapy, 2015-2022

3: Overview

  • Defining Breakthrough Therapy Designation

4: Commercial Application Of Breakthrough Therapy Designation

  • Introduction
  • Cardiovascular
  • Central Nervous System And Neurological Disorders
  • Infectious Diseases
  • Oncology
  • Rare Diseases
  • Other Diseases

5: Implications Of Breakthrough Therapy Designation On Business Strategy

  • Introduction

6: Regulatory Implications And Breakthrough Therapy Designation

  • Expedited Programs
  • Significance Of Btd For The Pharmaceutical And Biotechnology Industries

7: Company Profiles

  • Abbvie Inc.
  • Acadia Pharmaceuticals Inc.
  • Adaptimmune Therapeutics Plc
  • Aduro Biotech Inc.
  • Aimmune Therapeutics Inc.
  • Alexion Pharmaceuticals Inc.
  • Allergan Plc
  • Amgen Inc.
  • Anatara Lifesciences Limited
  • Ariad Pharmaceuticals Inc.
  • Astrazeneca Plc
  • Avexis Inc.
  • Boehringer Ingelheim Gmbh
  • Celldex Therapeutics Inc.
  • Clovis Oncology Inc.
  • Daiichi Sankyo Company, Limited
  • DBV Technologies
  • Eisai Co. Ltd.
  • Eli Lilly And Company
  • Exelixis Inc.
  • F. Hoffmann-La Roche Ltd.
  • Gilead Sciences Inc.
  • Glaxosmithkline Plc
  • Immunomedics Inc.
  • Individor Plc
  • Jazz Pharmaceuticals
  • Johnson & Johnson
  • Juno Therapeutics Inc.
  • Kite Pharma Inc.
  • Merck & Co. Inc.
  • Merck Kgaa
  • Novartis AG
  • Pfizer Inc.
  • Pharmacyclics Inc.
  • Progenics Pharmaceuticals Inc.
  • Regeneron Pharmaceuticals Inc.
  • Rhythm Pharmaceuticals Inc.
  • Syndax Pharmaceuticals Inc.
  • Syneurx International Corporation
  • Teva Pharmaceuticals Inc.
  • Trevena Inc.
  • Vertex Pharmaceuticals Inc.
  • Vtesse Inc.
  • Wellstat Therapeutics Corporation

8: References

9: Acronyms

10: Endnotes
   
List Of Tables

Summary Table : Global Market For Breakthrough Therapy Designation Drugs, By Therapy, Through 2022
Table 1 : Cder Breakthrough Therapy Designation Requests Received By Fiscal Year Cohort: July 9, 2012 - -September 30, 2015
Table 2 : Cber Breakthrough Therapy Requests For Final Year, October 1, 2014–September 30, 2015
Table 3 : Drugs Granted Prime Designations, March 7, 2016-August 24, 2016
Table 4 : Global Market For CV Breakthrough Therapy Designation Drugs, Through 2022
Table 5 : Fda Approved CV Breakthrough Therapy Designation Drugs
Table 6 : Global Market For Promacta, Through 2022
Table 7 : Global Market For Praxbind, Through 2022
Table 8 : Under Development CV Breakthrough Therapy Designation Drugs
Table 9 : Global Market For Reasanz, Through 2022
Table 10 : Global Market For Actemra/Roactemra, Through 2022
Table 11 : Global Market For CNS Breakthrough Therapy Designation Drugs, Through 2022
Table 12 : Fda Approved Cns Breakthrough Therapy Designation Drugs
Table 13 : Global Market For Nuplazid, Through 2022
Table 14 : Under Development Cns Breakthrough Therapy Designation Drugs
Table 15 : Global Market For Deutetrabenazine Er, Through 2022
Table 16 : Global Market For Ingrezza, Through 2022
Table 17 : Global Market For Of Ofatumumab, Through 2022
Table 18 : Global Market For Oliceridine, Through 2022
Table 19 : Global Market For Rapastinel, Through 2022
Table 20 : Global Market For Sepranolone, Through 2022
Table 21 : Global Market For SND-13, Through 2022
Table 22 : Global Market For Avxs-101, Through 2022
Table 23 : Global Market For Esketamine, Through 2022
Table 24 : Global Market For Rbp-8000, Through 2022
Table 25 : Global Market For Infectious Diseases Breakthrough Therapy Designation Drugs, Through 2022
Table 26 : Fda Approved Infectious Diseases Breakthrough Therapy Designation Drugs, 2016
Table 27 : Global Market For Solvadi, Through 2022
Table 28 : Global Market For Epclusa, Through 2022
Table 29 : Global Market For Viekera/Technivie, Through 2022
Table 30 : Global Market For Zepatier, Through 2022
Table 31 : Global Market For Harvoni, Through 2022
Table 32 : Under Development Infectious Disease Breakthrough Therapy Designation Drugs, 2016
Table 33 : Global Market For Arikayce, Through 2022
Table 34 : Global Market For Fostemsavir, Through 2022
Table 35 : Global Market For Glecaprevir/Pibrentasvir, Through 2022
Table 36 : Global Market For Ibalizumab, Through 2022
Table 37 : Global Market For Tafenoquine, Through 2022
Table 38 : Global Market For V920, Through 2022
Table 39 : Global Market For Oncology Breakthrough Therapy Designation Drugs, Through 2022
Table 40 : Fda Approved Oncology Breakthrough Therapy Designation Drugs, 2013-2015
Table 41 : Global Market For Alencensa, Through 2022
Table 42 : Global Market For Arzerra, Through 2022
Table 43 : Global Market For Blincyto, Through 2022
Table 44 : Global Market For Darzalex, Through 2022
Table 45 : Global Market For Gazyva, Through 2022
Table 46 : Global Market For Ibrance, Through 2022
Table 47 : Global Market For Imbruvica, Through 2022
Table 48 : Global Market For Keytruda, Through 2022
Table 49 : Global Market For Lartruvo, Through 2022
Table 50 : Global Market For Lenvima/Kisplyx, Through 2022
Table 51 : Global Market For Lynparza, Through 2022
Table 52 : Global Market For Midostaurin, Through 2022
Table 53 : Global Market For Opdivo, Through 2022
Table 54 : Global Market For Tagrisso, Sales Forecasts, Through 2022
Table 55 : Global Market For Tafinlar/Mekinist, Through 2022
Table 56 : Global Market For Tecentriq, Through 2022
Table 57 : Global Market For Venclexta, Through 2022
Table 58 : Global Market For Xalkori, Through 2022
Table 59 : Global Market For Zydelig, Through 2022
Table 60 : Global Market For Zykadia, Through 2022
Table 61 : Under Development Oncology Breakthrough Therapy Designation Drugs
Table 62 : Global Market For Abemaciclib, Through 2022
Table 63 : Global Market For Avelumab, Through 2022
Table 64 : Global Market For Brigatinib, Through 2022
Table 65 : Global Market For Ctl019, Through 2022
Table 66 : Global Market For CRS-207 And Gvax Pancreas, Through 2022
Table 67 : Global Market For Durvalumab, Through 2022
Table 68 : Global Market For EBV-CTL, Through 2022
Table 69 : Global Market For Entinostat, Through 2022
Table 70 : Global Market For Inotuzumab Ozogamicin, Through 2022
Table 71 : Global Market For Jcar015, Through 2022
Table 72 : Global Market For KTW-C19, Through 2022
Table 73 : Global Market For Loxo-101, Through 2022
Table 74 : Global Market For Nicord, Through 2022
Table 75 : Global Market For Olmutinib, Through 2022
Table 76 : Global Market For NY-ESO, Through 2022
Table 77 : Global Market For Pexidartinib, Through 2022
Table 78 : Global Market For Pracinostat, Through 2022
Table 79 : Global Market For Pvs-Ripo, Through 2022
Table 80 : Global Market For Ribociclib, Through 2022
Table 81 : Global Market For Rintega, Through 2022
Table 82 : Global Market For Rociletinib, Through 2022
Table 83 : Global Market For Rucaparib, Through 2022
Table 84 : Global Market For Sacituzumab Govitecan, Through 2022
Table 85 : Global Market For Volasertib, Through 2022
Table 86 : Global Market For Vyxeos, Through 2022
Table 87 : Fda Approved Rare Diseases Breakthrough Therapy Designation Drugs, 2015-2016
Table 88 : Global Market For Rare Diseases Breakthrough Therapy Designation Drugs, Through 2022
Table 89 : Global Market For Ilaris, Through 2022
Table 90 : Global Market For Kanuma, Through 2022
Table 91 : Global Market For Strensiq, Through 2022
Table 92 : Under Development Rare Diseases Breakthrough Therapy Designation Drugs, 2013-2016
Table 93 : Global Market For Alxn-1101, Through 2022
Table 94 : Global Market For Firdapse, Through 2022
Table 95 : Global Market For Olipudase Alfa, Through 2022
Table 96 : Global Market For Zorblisa, Through 2022
Table 97 : Global Market For Setmelanotide, Through 2022
Table 98 : Global Market For VTS-270, Through 2022
Table 99 : Fda Approved Other Breakthrough Therapy Designation Drugs, 2015
Table 100 : Global Market For Other Diseases Breakthrough Therapy Designation Drugs, Through 2022
Table 101 : Global Market For Rapamune Breakthrough Therapy Designation Drugs, Through 2022
Table 102 : Global Market For Lucentis Breakthrough Therapy Designation Drugs, Through 2022
Table 103 : Global Market For Eylea Breakthrough Therapy Designation Drugs, Through 2022
Table 104 : Other Diseases Breakthrough Therapy Designation Drugs Awaiting Approval, 2015-2022
Table 105 : Global Market For Dupilumab Breakthrough Therapy Designation Drugs, Through 2022
Table 106 : Global Market For Ar101 Breakthrough Therapy Designation Drugs, Through 2022
Table 107 : Global Market For Ocaliva Breakthrough Therapy Designation Drugs, Through 2022
Table 108 : Global Market For Viaskin Peanut Breakthrough Therapy Designation Drugs, Through 2022
Table 109 : An Overview Of The Key Features Of The Fda's Expedited Programs
Table 110 : An Overview Of The Fda's Expedited Development And Review Programs
Table 111 : Breakthrough Therapies Considerations: Drug Development
Table 112 : Breakthrough Therapy Considerations: Marketing Application Review
Table 113 : Cder Breakthrough Therapy Designation Requests Received By Fiscal Year Cohort: July 9, 2012 - -September 30, 2015
Table 114 : Cder Breakthrough Therapy Designation Requests Received By Fiscal Year Cohort: October 1, 2015-September 30, 2016
Table 115 : Cder Breakthrough Therapy Designation Approvals Data As Of December 31, 2015
Table 116 : Cumulative Cber Breakthrough Therapy Designation Requests Received By Fiscal Year Cohort: July 9, 2012 - -December 31, 2015
Table 117 : Cber Breakthrough Therapy Designation Requests Received By Fiscal Year Cohort: October 1, 2015-September 30, 2016
Table 118 : Cumulative Cber Breakthrough Therapy Approval Data As Of September 30, 2016
Table 119 : Most Recently Announced Breakthrough Therapy Designations Data As Of February 29, 2016

List Of Figures

Summary Figure : Global Market For Breakthrough Therapy Designation Drugs, By Therapy, 2015-2022
Figure 1 : Breakthrough Therapy Requests Granted By Division, 2015 -
Figure 2 : Prime Scheme Applications And Eligibility
Figure 3 : Prime Drug By Type Of Application And Therapeutic Area
Figure 4 : Prime Drug Applications, Therapeutic Area
Figure 5 : Fda Approvals, Breakthrough Therapy Designation And Designation Rescinded, By Status, 2012-2016
Figure 6 : Fda Approvals, Breakthrough Designation And Designation Rescinded, By Therapy Area, 2012-2016
Figure 7 : Cardiovascular Breakthrough Therapy Designation Drugs, By Stage
Figure 8 : Cns Breakthrough Therapy Designation Drugs, By Stage, 2016
Figure 9 : Infectious Disease Breakthrough Therapy Designation Drugs, By Stage, 2016
Figure 10 : Cancer Drugs With Breakthrough Therapy Designation, By Cancer Type, 2016
Figure 11 : Cancer Breakthrough Therapy Designation, By Company, 2016
Figure 12 : Treatment Algorithm For All Patients
Figure 13 : Entinostat Mechanism Of Action
Figure 14 : Rare Disease Breakthrough Therapy Designation Drugs, By Stage, 2016
Figure 15 : Other Diseases Breakthrough Therapy Designation Drugs, By Stage, 2016
Figure 16 : Comparison Of Approval Times Standard Versus Breakthrough Designation
Figure 17 : Comparison Of Standard And Breakthrough Therapy Approval Times

Note: Product cover images may vary from those shown
3 of 5

Loading
LOADING...

4 of 5
  • Abbvie Inc.
  • Acadia Pharmaceuticals Inc.
  • Adaptimmune Therapeutics Plc
  • Aduro Biotech Inc.
  • Aimmune Therapeutics Inc.
  • Alexion Pharmaceuticals Inc.
  • Allergan Plc
  • Amgen Inc.
  • Anatara Lifesciences Limited
  • Ariad Pharmaceuticals Inc.
  • Astrazeneca Plc
  • Avexis Inc.
  • Boehringer Ingelheim Gmbh
  • Celldex Therapeutics Inc.
  • Clovis Oncology Inc.
  • Daiichi Sankyo Company, Limited
  • DBV Technologies
  • Eisai Co. Ltd.
  • Eli Lilly And Company
  • Exelixis Inc.
  • F. Hoffmann-La Roche Ltd.
  • Gilead Sciences Inc.
  • Glaxosmithkline Plc
  • Immunomedics Inc.
  • Individor Plc
  • Jazz Pharmaceuticals
  • Johnson & Johnson
  • Juno Therapeutics Inc.
  • Kite Pharma Inc.
  • Merck & Co. Inc.
  • Merck Kgaa
  • Novartis AG
  • Pfizer Inc.
  • Pharmacyclics Inc.
  • Progenics Pharmaceuticals Inc.
  • Regeneron Pharmaceuticals Inc.
  • Rhythm Pharmaceuticals Inc.
  • Syndax Pharmaceuticals Inc.
  • Syneurx International Corporation
  • Teva Pharmaceuticals Inc.
  • Trevena Inc.
  • Vertex Pharmaceuticals Inc.
  • Vtesse Inc.
  • Wellstat Therapeutics Corporation
Note: Product cover images may vary from those shown
5 of 5
Note: Product cover images may vary from those shown
Adroll
adroll