Breakthrough therapy drugs are intended to treat serious and life-threatening conditions. The breakthrough therapy is the designation given by FDA for the drugs when there is a preliminary clinical evidence indicates that the drug proves a substantial improvement over available drug treatment. Two factors determine the efficiency of breakthrough therapy drug, they are the magnitude of the treatment effect and observed clinical difference over the existed drug.? The standard for breakthrough therapy drug is not same as standard drug approval because, in breakthrough therapy, morbidity and mortality considered for approval of the drug. They are meant to be administered by itself or in combinations. Breakthrough therapy drug development is cost effective due to faster approval of drugs on limited data from the FDA. Manufacturer of breakthrough therapy drugs has to develop additional post-marketing surveillance data for the other reimbursements and market access. Presently available breakthrough therapy medicinal products in the market belong to the treatment class of oncology, infectious diseases, cardiovascular conditions, etc. The designation is given when the drug is in 1st?or 2nd?stage of clinical trials.
This report aims to provide a comprehensive presentation of the global market for Breakthrough Therapy Drugs, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Breakthrough Therapy Drugs. This report contains market size and forecasts of Breakthrough Therapy Drugs in global, including the following market information:
Global Breakthrough Therapy Drugs Market Revenue, 2018-2023, 2024-2029, ($ millions)
Global top five companies in 2022 (%)
The global Breakthrough Therapy Drugs market was valued at US$ million in 2022 and is projected to reach US$ million by 2029, at a CAGR of % during the forecast period. The influence of COVID-19 and the Russia-Ukraine War were considered while estimating market sizes.
Increasing prevalence of life-threatening conditions and for the speedy development of pipeline drugs is the primary driver for the breakthrough therapy drugs market. This is because of the high unmet need of presently available treatment for severe conditions. Breakthrough designation of the drug captures the more attention of the manufacturers due to the expedited market access and greater returns on their investments. Because of Breakthrough therapy drugs market are associated with less robust clinical developments. Increasing support of FDA for small scale industries in R&D by providing additional funding and faster approval of drugs fuelling the growth of the breakthrough therapy drugs market. All these factors are boosting the growth of the breakthrough therapy drug market.
We surveyed the Breakthrough Therapy Drugs companies, and industry experts on this industry, involving the revenue, demand, product type, recent developments and plans, industry trends, drivers, challenges, obstacles, and potential risks.
Total Market by Segment:
Global Breakthrough Therapy Drugs Market, by Type, 2018-2023, 2024-2029 ($ millions)
Global Breakthrough Therapy Drugs Market Segment Percentages, by Type, 2022 (%)
Oncology
Anti-Viral
Neurology
Others
Global Breakthrough Therapy Drugs Market, by Application, 2018-2023, 2024-2029 ($ millions)
Global Breakthrough Therapy Drugs Market Segment Percentages, by Application, 2022 (%)
Hospitals
Clinics
Ambulatory Services
Global Breakthrough Therapy Drugs Market, By Region and Country, 2018-2023, 2024-2029 ($ Millions)
Global Breakthrough Therapy Drugs Market Segment Percentages, By Region and Country, 2022 (%)
North America
US
Canada
Mexico
Europe
Germany
France
U.K.
Italy
Russia
Nordic Countries
Benelux
Rest of Europe
Asia
China
Japan
South Korea
Southeast Asia
India
Rest of Asia
South America
Brazil
Argentina
Rest of South America
Middle East & Africa
Turkey
Israel
Saudi Arabia
UAE
Rest of Middle East & Africa
Competitor Analysis
The report also provides analysis of leading market participants including:
Key companies Breakthrough Therapy Drugs revenues in global market, 2018-2023 (estimated), ($ millions)
Key companies Breakthrough Therapy Drugs revenues share in global market, 2022 (%)
Further, the report presents profiles of competitors in the market, key players include:
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Outline of Major Chapters:
Chapter 1: Introduces the definition of Breakthrough Therapy Drugs, market overview.
Chapter 2: Global Breakthrough Therapy Drugs market size in revenue.
Chapter 3: Detailed analysis of Breakthrough Therapy Drugs company competitive landscape, revenue and market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 5: Provides the analysis of various market segments by application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6: Sales of Breakthrough Therapy Drugs in regional level and country level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space of each country in the world.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 8: The main points and conclusions of the report.
TABLE OF CONTENTS
1 Introduction to Research & Analysis Reports
1.1 Breakthrough Therapy Drugs Market Definition
1.2 Market Segments
1.2.1 Market by Type
1.2.2 Market by Application
1.3 Global Breakthrough Therapy Drugs Market Overview
1.4 Features & Benefits of This Report
1.5 Methodology & Sources of Information
1.5.1 Research Methodology
1.5.2 Research Process
1.5.3 Base Year
1.5.4 Report Assumptions & Caveats
2 Global Breakthrough Therapy Drugs Overall Market Size
2.1 Global Breakthrough Therapy Drugs Market Size: 2022 VS 2029
2.2 Global Breakthrough Therapy Drugs Market Size, Prospects & Forecasts: 2018-2029
2.3 Key Market Trends, Opportunity, Drivers and Restraints
2.3.1 Market Opportunities & Trends
2.3.2 Market Drivers
2.3.3 Market Restraints
3 Company Landscape
3.1 Top Breakthrough Therapy Drugs Players in Global Market
3.2 Top Global Breakthrough Therapy Drugs Companies Ranked by Revenue
3.3 Global Breakthrough Therapy Drugs Revenue by Companies
3.4 Top 3 and Top 5 Breakthrough Therapy Drugs Companies in Global Market, by Revenue in 2022
3.5 Global Companies Breakthrough Therapy Drugs Product Type
3.6 Tier 1, Tier 2 and Tier 3 Breakthrough Therapy Drugs Players in Global Market
3.6.1 List of Global Tier 1 Breakthrough Therapy Drugs Companies
3.6.2 List of Global Tier 2 and Tier 3 Breakthrough Therapy Drugs Companies
4 Market Sights by Product
4.1 Overview
4.1.1 By Type - Global Breakthrough Therapy Drugs Market Size Markets, 2022 & 2029
4.1.2 Oncology
4.1.3 Anti-Viral
4.1.4 Neurology
4.1.5 Others
4.2 By Type - Global Breakthrough Therapy Drugs Revenue & Forecasts
4.2.1 By Type - Global Breakthrough Therapy Drugs Revenue, 2018-2023
4.2.2 By Type - Global Breakthrough Therapy Drugs Revenue, 2024-2029
4.2.3 By Type - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
5 Sights by Application
5.1 Overview
5.1.1 By Application - Global Breakthrough Therapy Drugs Market Size, 2022 & 2029
5.1.2 Hospitals
5.1.3 Clinics
5.1.4 Ambulatory Services
5.2 By Application - Global Breakthrough Therapy Drugs Revenue & Forecasts
5.2.1 By Application - Global Breakthrough Therapy Drugs Revenue, 2018-2023
5.2.2 By Application - Global Breakthrough Therapy Drugs Revenue, 2024-2029
5.2.3 By Application - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
6 Sights by Region
6.1 By Region - Global Breakthrough Therapy Drugs Market Size, 2022 & 2029
6.2 By Region - Global Breakthrough Therapy Drugs Revenue & Forecasts
6.2.1 By Region - Global Breakthrough Therapy Drugs Revenue, 2018-2023
6.2.2 By Region - Global Breakthrough Therapy Drugs Revenue, 2024-2029
6.2.3 By Region - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
6.3 North America
6.3.1 By Country - North America Breakthrough Therapy Drugs Revenue, 2018-2029
6.3.2 US Breakthrough Therapy Drugs Market Size, 2018-2029
6.3.3 Canada Breakthrough Therapy Drugs Market Size, 2018-2029
6.3.4 Mexico Breakthrough Therapy Drugs Market Size, 2018-2029
6.4 Europe
6.4.1 By Country - Europe Breakthrough Therapy Drugs Revenue, 2018-2029
6.4.2 Germany Breakthrough Therapy Drugs Market Size, 2018-2029
6.4.3 France Breakthrough Therapy Drugs Market Size, 2018-2029
6.4.4 U.K. Breakthrough Therapy Drugs Market Size, 2018-2029
6.4.5 Italy Breakthrough Therapy Drugs Market Size, 2018-2029
6.4.6 Russia Breakthrough Therapy Drugs Market Size, 2018-2029
6.4.7 Nordic Countries Breakthrough Therapy Drugs Market Size, 2018-2029
6.4.8 Benelux Breakthrough Therapy Drugs Market Size, 2018-2029
6.5 Asia
6.5.1 By Region - Asia Breakthrough Therapy Drugs Revenue, 2018-2029
6.5.2 China Breakthrough Therapy Drugs Market Size, 2018-2029
6.5.3 Japan Breakthrough Therapy Drugs Market Size, 2018-2029
6.5.4 South Korea Breakthrough Therapy Drugs Market Size, 2018-2029
6.5.5 Southeast Asia Breakthrough Therapy Drugs Market Size, 2018-2029
6.5.6 India Breakthrough Therapy Drugs Market Size, 2018-2029
6.6 South America
6.6.1 By Country - South America Breakthrough Therapy Drugs Revenue, 2018-2029
6.6.2 Brazil Breakthrough Therapy Drugs Market Size, 2018-2029
6.6.3 Argentina Breakthrough Therapy Drugs Market Size, 2018-2029
6.7 Middle East & Africa
6.7.1 By Country - Middle East & Africa Breakthrough Therapy Drugs Revenue, 2018-2029
6.7.2 Turkey Breakthrough Therapy Drugs Market Size, 2018-2029
6.7.3 Israel Breakthrough Therapy Drugs Market Size, 2018-2029
6.7.4 Saudi Arabia Breakthrough Therapy Drugs Market Size, 2018-2029
6.7.5 UAE Breakthrough Therapy Drugs Market Size, 2018-2029
7 Breakthrough Therapy Drugs Companies Profiles
7.1 Merck
7.1.1 Merck Company Summary
7.1.2 Merck Business Overview
7.1.3 Merck Breakthrough Therapy Drugs Major Product Offerings
7.1.4 Merck Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.1.5 Merck Key News & Latest Developments
7.2 Pfizer
7.2.1 Pfizer Company Summary
7.2.2 Pfizer Business Overview
7.2.3 Pfizer Breakthrough Therapy Drugs Major Product Offerings
7.2.4 Pfizer Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.2.5 Pfizer Key News & Latest Developments
7.3 AbbVie
7.3.1 AbbVie Company Summary
7.3.2 AbbVie Business Overview
7.3.3 AbbVie Breakthrough Therapy Drugs Major Product Offerings
7.3.4 AbbVie Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.3.5 AbbVie Key News & Latest Developments
7.4 Bristol-Myers Squibb Company
7.4.1 Bristol-Myers Squibb Company Company Summary
7.4.2 Bristol-Myers Squibb Company Business Overview
7.4.3 Bristol-Myers Squibb Company Breakthrough Therapy Drugs Major Product Offerings
7.4.4 Bristol-Myers Squibb Company Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.4.5 Bristol-Myers Squibb Company Key News & Latest Developments
7.5 Genentech
7.5.1 Genentech Company Summary
7.5.2 Genentech Business Overview
7.5.3 Genentech Breakthrough Therapy Drugs Major Product Offerings
7.5.4 Genentech Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.5.5 Genentech Key News & Latest Developments
7.6 Gilead
7.6.1 Gilead Company Summary
7.6.2 Gilead Business Overview
7.6.3 Gilead Breakthrough Therapy Drugs Major Product Offerings
7.6.4 Gilead Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.6.5 Gilead Key News & Latest Developments
7.7 Novartis
7.7.1 Novartis Company Summary
7.7.2 Novartis Business Overview
7.7.3 Novartis Breakthrough Therapy Drugs Major Product Offerings
7.7.4 Novartis Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.7.5 Novartis Key News & Latest Developments
7.8 Vertex Pharmaceuticals Incorporated
7.8.1 Vertex Pharmaceuticals Incorporated Company Summary
7.8.2 Vertex Pharmaceuticals Incorporated Business Overview
7.8.3 Vertex Pharmaceuticals Incorporated Breakthrough Therapy Drugs Major Product Offerings
7.8.4 Vertex Pharmaceuticals Incorporated Breakthrough Therapy Drugs Revenue in Global Market (2018-2023)
7.8.5 Vertex Pharmaceuticals Incorporated Key News & Latest Developments
8 Conclusion
9 Appendix
9.1 Note
9.2 Examples of Clients
9.3 Disclaimer
LIST OF TABLES & FIGURES
List of Tables
Table 1. Breakthrough Therapy Drugs Market Opportunities & Trends in Global Market
Table 2. Breakthrough Therapy Drugs Market Drivers in Global Market
Table 3. Breakthrough Therapy Drugs Market Restraints in Global Market
Table 4. Key Players of Breakthrough Therapy Drugs in Global Market
Table 5. Top Breakthrough Therapy Drugs Players in Global Market, Ranking by Revenue (2022)
Table 6. Global Breakthrough Therapy Drugs Revenue by Companies, (US$, Mn), 2018-2023
Table 7. Global Breakthrough Therapy Drugs Revenue Share by Companies, 2018-2023
Table 8. Global Companies Breakthrough Therapy Drugs Product Type
Table 9. List of Global Tier 1 Breakthrough Therapy Drugs Companies, Revenue (US$, Mn) in 2022 and Market Share
Table 10. List of Global Tier 2 and Tier 3 Breakthrough Therapy Drugs Companies, Revenue (US$, Mn) in 2022 and Market Share
Table 11. By Type ? Global Breakthrough Therapy Drugs Revenue, (US$, Mn), 2022 & 2029
Table 12. By Type - Breakthrough Therapy Drugs Revenue in Global (US$, Mn), 2018-2023
Table 13. By Type - Breakthrough Therapy Drugs Revenue in Global (US$, Mn), 2024-2029
Table 14. By Application ? Global Breakthrough Therapy Drugs Revenue, (US$, Mn), 2022 & 2029
Table 15. By Application - Breakthrough Therapy Drugs Revenue in Global (US$, Mn), 2018-2023
Table 16. By Application - Breakthrough Therapy Drugs Revenue in Global (US$, Mn), 2024-2029
Table 17. By Region ? Global Breakthrough Therapy Drugs Revenue, (US$, Mn), 2022 & 2029
Table 18. By Region - Global Breakthrough Therapy Drugs Revenue (US$, Mn), 2018-2023
Table 19. By Region - Global Breakthrough Therapy Drugs Revenue (US$, Mn), 2024-2029
Table 20. By Country - North America Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2023
Table 21. By Country - North America Breakthrough Therapy Drugs Revenue, (US$, Mn), 2024-2029
Table 22. By Country - Europe Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2023
Table 23. By Country - Europe Breakthrough Therapy Drugs Revenue, (US$, Mn), 2024-2029
Table 24. By Region - Asia Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2023
Table 25. By Region - Asia Breakthrough Therapy Drugs Revenue, (US$, Mn), 2024-2029
Table 26. By Country - South America Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2023
Table 27. By Country - South America Breakthrough Therapy Drugs Revenue, (US$, Mn), 2024-2029
Table 28. By Country - Middle East & Africa Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2023
Table 29. By Country - Middle East & Africa Breakthrough Therapy Drugs Revenue, (US$, Mn), 2024-2029
Table 30. Merck Company Summary
Table 31. Merck Breakthrough Therapy Drugs Product Offerings
Table 32. Merck Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 33. Merck Key News & Latest Developments
Table 34. Pfizer Company Summary
Table 35. Pfizer Breakthrough Therapy Drugs Product Offerings
Table 36. Pfizer Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 37. Pfizer Key News & Latest Developments
Table 38. AbbVie Company Summary
Table 39. AbbVie Breakthrough Therapy Drugs Product Offerings
Table 40. AbbVie Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 41. AbbVie Key News & Latest Developments
Table 42. Bristol-Myers Squibb Company Company Summary
Table 43. Bristol-Myers Squibb Company Breakthrough Therapy Drugs Product Offerings
Table 44. Bristol-Myers Squibb Company Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 45. Bristol-Myers Squibb Company Key News & Latest Developments
Table 46. Genentech Company Summary
Table 47. Genentech Breakthrough Therapy Drugs Product Offerings
Table 48. Genentech Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 49. Genentech Key News & Latest Developments
Table 50. Gilead Company Summary
Table 51. Gilead Breakthrough Therapy Drugs Product Offerings
Table 52. Gilead Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 53. Gilead Key News & Latest Developments
Table 54. Novartis Company Summary
Table 55. Novartis Breakthrough Therapy Drugs Product Offerings
Table 56. Novartis Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 57. Novartis Key News & Latest Developments
Table 58. Vertex Pharmaceuticals Incorporated Company Summary
Table 59. Vertex Pharmaceuticals Incorporated Breakthrough Therapy Drugs Product Offerings
Table 60. Vertex Pharmaceuticals Incorporated Breakthrough Therapy Drugs Revenue (US$, Mn) & (2018-2023)
Table 61. Vertex Pharmaceuticals Incorporated Key News & Latest Developments
List of Figures
Figure 1. Breakthrough Therapy Drugs Segment by Type in 2022
Figure 2. Breakthrough Therapy Drugs Segment by Application in 2022
Figure 3. Global Breakthrough Therapy Drugs Market Overview: 2022
Figure 4. Key Caveats
Figure 5. Global Breakthrough Therapy Drugs Market Size: 2022 VS 2029 (US$, Mn)
Figure 6. Global Breakthrough Therapy Drugs Revenue, 2018-2029 (US$, Mn)
Figure 7. The Top 3 and 5 Players Market Share by Breakthrough Therapy Drugs Revenue in 2022
Figure 8. By Type - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 9. By Application - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 10. By Type - Global Breakthrough Therapy Drugs Revenue, (US$, Mn), 2022 & 2029
Figure 11. By Type - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 12. By Application - Global Breakthrough Therapy Drugs Revenue, (US$, Mn), 2022 & 2029
Figure 13. By Application - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 14. By Region - Global Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 15. By Country - North America Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 16. US Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 17. Canada Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 18. Mexico Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 19. By Country - Europe Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 20. Germany Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 21. France Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 22. U.K. Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 23. Italy Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 24. Russia Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 25. Nordic Countries Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 26. Benelux Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 27. By Region - Asia Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 28. China Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 29. Japan Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 30. South Korea Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 31. Southeast Asia Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 32. India Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 33. By Country - South America Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 34. Brazil Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 35. Argentina Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 36. By Country - Middle East & Africa Breakthrough Therapy Drugs Revenue Market Share, 2018-2029
Figure 37. Turkey Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 38. Israel Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 39. Saudi Arabia Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 40. UAE Breakthrough Therapy Drugs Revenue, (US$, Mn), 2018-2029
Figure 41. Merck Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 42. Pfizer Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 43. AbbVie Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 44. Bristol-Myers Squibb Company Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 45. Genentech Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 46. Gilead Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 47. Novartis Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
Figure 48. Vertex Pharmaceuticals Incorporated Breakthrough Therapy Drugs Revenue Year Over Year Growth (US$, Mn) & (2018-2023)
