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Breakthrough Therapy (BT) Designation Market Analysis Report By Application (Oncology, Infectious Diseases, Rare Diseases, Autoimmune Diseases, Pulmonary Diseases, Neurological Disorders), And Segment Forecasts, 2015 - 2025

Breakthrough Therapy (BT) Designation Market Analysis Report By Application (Oncology, Infectious Diseases, Rare Diseases, Autoimmune Diseases, Pulmonary Diseases, Neurological Disorders), And Segment Forecasts, 2015 - 2025

The global breakthrough therapy designation market is anticipated to reach USD 144.6 billion by 2025, according to a new report by Grand View Research, Inc. Breakthrough Therapy (BT) designation is granted to drugs that display substantial results in the treatment of life-threatening diseases in initial stages of the drug development process. Expedited regulatory process in North America and EU regions is driving growth. Increase in the number of innovative molecules receiving the BT status, coupled with rise in the demand for orphan drugs as well as those for the treatment of cancer, is anticipated to boost the market over the forecast period.

The development time of BT therapy is 30.0% to 50.0% lesser than those without the designation. This significantly increases the net present value of investigational molecule. Reduction in the development time of these drugs is expected to accelerate their approval process as compared to standard drugs as well as boost growth opportunities. The BT tag also increases the value of the drug due to its high scientific value.

There has been a consistent rise in the number of drugs receiving BT status in the U.S., and this trend is also expected to drive the number of applications submitted for the same, thereby contributing to the market growth.

Further Key Findings From the Study Suggest:

  • The infectious diseases segment dominated the market in 2016. However, it is expected to exhibit moderate growth in the forecast period owing to decline in sales of blockbuster drugs such as Harvoni and Sovaldi
  • Oncology is expected to be the dominating segment over the forecast period owing to rise in the demand for cancer medicines and increase in the number of oncology molecules gaining BT status. As of 2017, the number of molecules gaining BT status is the highest in this segment
  • The rare diseases segment is estimated to exhibit fastest growth owing to rise in demand and increase in the R&D pipeline of orphan drugs
  • North America is expected to dominate the market over the forecast period owing to well-established intellectual property laws and preference of patients and healthcare professionals for innovative medicines
  • Some of the key players are F. Hoffmann-La Roche Ltd; Gilead; Novartis AG; Pfizer, Inc.; AbbVie, Inc.; Janssen Global Services, LLC; Bristol-Myers Squibb Company; Eli Lilly and Company; Sanofi; Regeneron; AcadiaPharmaceuticals, Inc.; Boehringer Ingelheim GmbH; Amgen, Inc.; AstraZeneca; and GlaxoSmithKline plc.


Chapter 1 Research Methodology & Scope
1.1 Information Procurement
1.2 Data Analysis
1.3 Region Wise Market Calculation
1.3.1 Region wise market: Base estimates
1.3.2 Global market: CAGR calculation
1.4 List of Secondary Sources
Chapter 2 Executive Summary
2.1 Market Snapshot
Chapter 3 Market Variables, Trends & Scope
3.1 Market Segmentation
3.2 Market Size and Growth Prospects
3.3 Breakthrough Therapy Designation Market - Key Market Driver Analysis
3.3.1 Increasing number of drugs gaining BT status
3.3.2 Expedited approval process adopted in EU
3.3.3 Shorter approval time and better product image
3.4 Breakthrough Therapy Designation - Key Market Restraint Analysis
3.4.1 Shifting preference for generics
3.4.2 High price of BT drugs
3.5 Key Opportunities Prioritized
3.6 Industry Analysis Porter’s
3.7 Breakthrough Therapy Designation PESTEL Analysis
Chapter 4 Breakthrough Therapy Designation Market: Application Segment Estimates & Trend Analysis
4.1 Breakthrough Therapy Designation Market: Type Movement Analysis
4.1.1 Oncology
4.1.1.1 Top 5 oncology drugs in terms of sales in 2016
4.1.2 Oncology market, 2015 - 2025 (USD Billion)
4.1.3 Infectious diseases
4.1.3.1 List of anti-infective drugs with BT status
4.1.4 Infectious disease market, 2015 - 2025 (USD Billion)
4.1.5 Rare diseases
4.1.5.1 List of drugs with BT status and under development phase
4.1.6 Rare diseases market, 2015 - 2025 (USD Billion)
4.1.7 Autoimmune diseases
4.1.8 Autoimmune diseases market, 2015 - 2025 (USD Billion)
4.1.9 Pulmonary disease
4.1.9.1 List of drugs with BT status and are approved by FDA
4.1.10 Pulmonary disease market, 2015 - 2025 (USD Billion)
4.1.11 Neurological disorders
4.1.11.1 List of drugs with BT status and under clinical phase
4.1.12 Neurological disorders market, 2015 - 2025 (USD Billion)
4.1.13 Other diseases
4.1.13.1 Top drugs in other disease segment
4.1.14 Other diseases market, 2015 - 2025 (USD Billion)
Chapter 5 Market Categorization 4: Regional Estimates & Trend Analysis
5.1 Breakthrough Therapy Designation Market Share by Region, 2015 & 2025
5.2 North America
5.2.1 North America breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.2.2 U.S.
5.2.3 Canada
5.2.3.1 Canada breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.3 Europe
5.3.1 Europe breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.3.2 UK
5.3.2.1 UK breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.3.3 Germany
5.3.3.1 Germany breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.4 Asia Pacific
5.4.1 Asia Pacific breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.4.2 Japan
5.4.2.1 Japan breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.4.3 China
5.4.3.1 China breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.5 Latin America
5.5.1 Latin America breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.5.2 Brazil
5.5.2.1 Brazil breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.5.3 Mexico
5.5.3.1 Mexico breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.6 MEA
5.6.1 MEA breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.6.2 South Africa
5.6.2.1 South Africa breakthrough therapy designation market estimates and forecasts, 2015 - 2025
5.6.3 Saudi Arabia
5.6.3.1 Saudi Arabia breakthrough therapy designation market estimates and forecasts, 2015 - 2025
Chapter 6 Competitive Landscape
6.1 Strategy framework
6.2 Company Profiles
6.2.1 Roche
6.2.1.1 Company overview
6.2.1.2 Financial performance
6.2.1.3 Product Pipeline
6.2.1.4 Strategic initiatives
6.2.2 Abbvie
6.2.2.1 Company overview
6.2.2.2 Financial performance
6.2.2.3 Product Pipeline
6.2.2.4 Strategic initiatives
6.2.3 Novartis International AG
6.2.3.1 Company overview
6.2.3.2 Financial performance
6.2.3.3 Product Pipeline
6.2.3.4 Strategic initiatives
6.2.4 Janssen
6.2.4.1 Company overview
6.2.4.2 Financial performance
6.2.4.3 Product Pipeline
6.2.4.4 Strategic initiatives
6.2.5 BMS
6.2.5.1 Company overview
6.2.5.2 Financial performance
6.2.5.3 Product benchmarking
6.2.5.4 Strategic initiatives
6.2.6 Eli Lilly
6.2.6.1 Company overview
6.2.6.2 Financial performance
6.2.6.3 Product Pipeline
6.2.6.4 Strategic initiatives
6.2.7 Gilead
6.2.7.1 Company overview
6.2.7.2 Financial performance
6.2.7.3 Product benchmarking
6.2.7.4 Strategic initiatives
6.2.8 Sanofi
6.2.8.1 Company overview
6.2.8.2 Financial performance
6.2.8.3 Product benchmarking
6.2.8.4 Strategic initiatives
6.2.9 Regeneron
6.2.9.1 Company overview
6.2.9.2 Financial performance
6.2.9.3 Product benchmarking
6.2.9.4 Strategic initiatives
6.2.10 Acadia.
6.2.10.1 Company overview
6.2.10.2 Financial performance
6.2.10.3 Product benchmarking
6.2.10.4 Strategic initiatives
6.2.11 Boehringer Ingelheim
6.2.11.1 Company overview
6.2.11.2 Financial performance
6.2.11.3 Product benchmarking
6.2.11.4 Strategic initiatives
6.2.12 Amgen
6.2.12.1 Company overview
6.2.12.2 Financial performance
6.2.12.3 Product benchmarking
6.2.12.4 Strategic initiatives
6.2.13 AstraZeneca
6.2.13.1 Company overview
6.2.13.2 Financial performance
6.2.13.3 Product pipeline
6.2.13.4 Strategic initiatives
6.2.14 GlaxoSmithKline
6.2.14.1 Company overview
6.2.14.2 Financial performance
6.2.14.3 Product pipeline
6.2.14.4 Strategic initiatives
6.2.15 Vertex
6.2.15.1 Company overview
6.2.15.2 Financial performance
6.2.15.3 Product pipeline
6.2.15.4 Strategic initiatives
6.2.16 Alexion
6.2.16.1 Company overview
6.2.16.2 Financial performance
6.2.16.3 Product pipeline
6.2.16.4 Strategic initiatives
6.2.17 Merck
6.2.17.1 Company overview
6.2.17.2 Financial performance
6.2.17.3 Product pipeline
6.2.17.4 Strategic initiatives
6.2.18 Jazz Pharmaceuticals
6.2.18.1 Company overview
6.2.18.2 Financial performance
6.2.18.3 Product pipeline
6.2.18.4 Strategic initiatives
6.2.19 Exelixis
6.2.19.1 Company overview
6.2.19.2 Financial performance
6.2.19.3 Product pipeline
6.2.19.4 Strategic initiatives
6.2.20 Eisai
6.2.20.1 Company overview
6.2.20.2 Financial performance
6.2.20.3 Product pipeline
6.2.20.4 Strategic initiatives
6.2.21 Takeda
6.2.21.1 Company overview
6.2.21.2 Financial performance
6.2.21.3 Product pipeline
6.2.21.4 Strategic initiatives
6.2.22 Pfizer
6.2.22.1 Company overview
6.2.22.2 Financial performance
6.2.22.3 Product pipeline
6.2.22.4 Strategic initiatives
List of Tables
Table 1. Country share estimation
Table 2. List of market players
Table 3. North America Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 4. U.S. Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 5. Canada Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 6. Europe Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 7. UK Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 8. Germany Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 9. Asia Pacific Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 10. Japan Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 11. China Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 12. Latin America Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 13. Brazil Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 14. Mexico Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 15. MEA Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 16. South Africa Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
Table 17. Saudi Arabia Breakthrough therapy market, by application, 2015 - 2025 (USD Million)
List of Figures
FIG. 1 Market research process
FIG. 2 Information procurement
FIG. 3 Primary research pattern
FIG. 4 Market research approaches
FIG. 5 Value chain based sizing & forecasting
FIG. 6 QFD modeling for market share assessment
FIG. 7 Market summary (Figures in USD Million, 2016)
FIG. 8 Market trends & outlook
FIG. 9 Breakthrough therapy designation market: Market Segmentation
FIG. 10 Breakthrough therapy designation market revenue, (USD Million), 2014-2025
FIG. 11 Market driver relevance analysis (Current & future impact)
FIG. 12 Market restraint relevance analysis (Current & future impact)
FIG. 13 Key opportunities Prioritized
FIG. 14 Breakthrough therapy designation Porter’s analysis
FIG. 15 Breakthrough therapy designation PESTEL analysis
FIG. 16 Breakthrough therapy designation market product outlook key takeaways
FIG. 17 Breakthrough therapy designation market: Type movement analysis
FIG. 18 Oncology market, 2015 - 2025 (USD Billion)
FIG. 19 Infectious disease market, 2015 - 2025 (USD Billion)
FIG. 20 Rare disease market, 2015 - 2025 (USD Billion)
FIG. 21 Auto immune disease market, 2015 - 2025 (USD Billion)
FIG. 22 Pulmonary disease market, 2015 - 2025 (USD Billion)
FIG. 23 Neurological disorder market, 2015 - 2025 (USD Billion)
FIG. 24 Other disease market, 2015 - 2025 (USD Billion)
FIG. 25 Regional market place: Key takeaways
FIG. 26 Regional outlook, 2015 & 2025
FIG. 27 North America breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 28 U.S. breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 29 Canada Breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 30 Europe breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 31 UK breakthrough therapy designation, 2015 - 2025 (USD Billion)
FIG. 32 Germany breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 33 Asia Pacific breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 34 Japan breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 35 China breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 36 Latin America breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 37 Brazil breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 38 Mexico breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 39 MEA breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 40 South Africa breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 41 Saudi Arabia breakthrough therapy designation market, 2015 - 2025 (USD Billion)
FIG. 42 Strategy framework

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