The global Breakthrough Therapies market size is predicted to grow from US$ 17950 million in 2025 to US$ 41620 million in 2031; it is expected to grow at a CAGR of 15.0% from 2025 to 2031.
Breakthrough therapy is a new drug review channel created by the U.S. Food and Drug Administration (FDA) in July 2012 to accelerate the development and review of new drugs to treat serious or life-threatening diseases. A breakthrough therapy designation is for听a drug that treats a serious or life-threatening condition听and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
United States market for Breakthrough Therapies is estimated to increase from US$ million in 2024 to US$ million by 2031, at a CAGR of % from 2025 through 2031.
China market for Breakthrough Therapies is estimated to increase from US$ million in 2024 to US$ million by 2031, at a CAGR of % from 2025 through 2031.
Europe market for Breakthrough Therapies is estimated to increase from US$ million in 2024 to US$ million by 2031, at a CAGR of % from 2025 through 2031.
Global key Breakthrough Therapies players cover F. Hoffmann-La Roche, Merck & Co., Bristol-Myers Squibb, Novartis, AstraZeneca, etc. In terms of revenue, the global two largest companies occupied for a share nearly % in 2024.
The 鈥淏reakthrough Therapies Industry Forecast鈥 looks at past sales and reviews total world Breakthrough Therapies sales in 2024, providing a comprehensive analysis by region and market sector of projected Breakthrough Therapies sales for 2025 through 2031. With Breakthrough Therapies sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Breakthrough Therapies industry.
This Insight Report provides a comprehensive analysis of the global Breakthrough Therapies landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Breakthrough Therapies portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms鈥 unique position in an accelerating global Breakthrough Therapies market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Breakthrough Therapies and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Breakthrough Therapies.
This report presents a comprehensive overview, market shares, and growth opportunities of Breakthrough Therapies market by product type, application, key players and key regions and countries.
Segmentation by Type:
Targeted Therapy
Immunotherapy
Gene Therapy
Cell Therapy
Other
Segmentation by Application:
Cardiovascular
Central Nervous System and Neurology
Rare Diseases
Oncology
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
F. Hoffmann-La Roche
Merck & Co.
Bristol-Myers Squibb
Novartis
AstraZeneca
Johnson & Johnson
Pfizer
AbbVie
Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.
1 Scope of the Report
1.1 麻豆原创 Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 麻豆原创 Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 麻豆原创 Estimation Caveats
2 Executive Summary
2.1 World 麻豆原创 Overview
2.1.1 Global Breakthrough Therapies 麻豆原创 Size (2020-2031)
2.1.2 Breakthrough Therapies 麻豆原创 Size CAGR by Region (2020 VS 2024 VS 2031)
2.1.3 World Current & Future Analysis for Breakthrough Therapies by Country/Region (2020, 2024 & 2031)
2.2 Breakthrough Therapies Segment by Type
2.2.1 Targeted Therapy
2.2.2 Immunotherapy
2.2.3 Gene Therapy
2.2.4 Cell Therapy
2.2.5 Other
2.3 Breakthrough Therapies 麻豆原创 Size by Type
2.3.1 Breakthrough Therapies 麻豆原创 Size CAGR by Type (2020 VS 2024 VS 2031)
2.3.2 Global Breakthrough Therapies 麻豆原创 Size 麻豆原创 Share by Type (2020-2025)
2.4 Breakthrough Therapies Segment by Application
2.4.1 Cardiovascular
2.4.2 Central Nervous System and Neurology
2.4.3 Rare Diseases
2.4.4 Oncology
2.4.5 Others
2.5 Breakthrough Therapies 麻豆原创 Size by Application
2.5.1 Breakthrough Therapies 麻豆原创 Size CAGR by Application (2020 VS 2024 VS 2031)
2.5.2 Global Breakthrough Therapies 麻豆原创 Size 麻豆原创 Share by Application (2020-2025)
3 Breakthrough Therapies 麻豆原创 Size by Player
3.1 Breakthrough Therapies 麻豆原创 Size 麻豆原创 Share by Player
3.1.1 Global Breakthrough Therapies Revenue by Player (2020-2025)
3.1.2 Global Breakthrough Therapies Revenue 麻豆原创 Share by Player (2020-2025)
3.2 Global Breakthrough Therapies Key Players Head office and Products Offered
3.3 麻豆原创 Concentration Rate Analysis
3.3.1 Competition Landscape Analysis
3.3.2 Concentration Ratio (CR3, CR5 and CR10) & (2023-2025)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 Breakthrough Therapies by Region
4.1 Breakthrough Therapies 麻豆原创 Size by Region (2020-2025)
4.2 Global Breakthrough Therapies Annual Revenue by Country/Region (2020-2025)
4.3 Americas Breakthrough Therapies 麻豆原创 Size Growth (2020-2025)
4.4 APAC Breakthrough Therapies 麻豆原创 Size Growth (2020-2025)
4.5 Europe Breakthrough Therapies 麻豆原创 Size Growth (2020-2025)
4.6 Middle East & Africa Breakthrough Therapies 麻豆原创 Size Growth (2020-2025)
5 Americas
5.1 Americas Breakthrough Therapies 麻豆原创 Size by Country (2020-2025)
5.2 Americas Breakthrough Therapies 麻豆原创 Size by Type (2020-2025)
5.3 Americas Breakthrough Therapies 麻豆原创 Size by Application (2020-2025)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Breakthrough Therapies 麻豆原创 Size by Region (2020-2025)
6.2 APAC Breakthrough Therapies 麻豆原创 Size by Type (2020-2025)
6.3 APAC Breakthrough Therapies 麻豆原创 Size by Application (2020-2025)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
7 Europe
7.1 Europe Breakthrough Therapies 麻豆原创 Size by Country (2020-2025)
7.2 Europe Breakthrough Therapies 麻豆原创 Size by Type (2020-2025)
7.3 Europe Breakthrough Therapies 麻豆原创 Size by Application (2020-2025)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa Breakthrough Therapies by Region (2020-2025)
8.2 Middle East & Africa Breakthrough Therapies 麻豆原创 Size by Type (2020-2025)
8.3 Middle East & Africa Breakthrough Therapies 麻豆原创 Size by Application (2020-2025)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 麻豆原创 Drivers, Challenges and Trends
9.1 麻豆原创 Drivers & Growth Opportunities
9.2 麻豆原创 Challenges & Risks
9.3 Industry Trends
10 Global Breakthrough Therapies 麻豆原创 Forecast
10.1 Global Breakthrough Therapies Forecast by Region (2026-2031)
10.1.1 Global Breakthrough Therapies Forecast by Region (2026-2031)
10.1.2 Americas Breakthrough Therapies Forecast
10.1.3 APAC Breakthrough Therapies Forecast
10.1.4 Europe Breakthrough Therapies Forecast
10.1.5 Middle East & Africa Breakthrough Therapies Forecast
10.2 Americas Breakthrough Therapies Forecast by Country (2026-2031)
10.2.1 United States 麻豆原创 Breakthrough Therapies Forecast
10.2.2 Canada 麻豆原创 Breakthrough Therapies Forecast
10.2.3 Mexico 麻豆原创 Breakthrough Therapies Forecast
10.2.4 Brazil 麻豆原创 Breakthrough Therapies Forecast
10.3 APAC Breakthrough Therapies Forecast by Region (2026-2031)
10.3.1 China Breakthrough Therapies 麻豆原创 Forecast
10.3.2 Japan 麻豆原创 Breakthrough Therapies Forecast
10.3.3 Korea 麻豆原创 Breakthrough Therapies Forecast
10.3.4 Southeast Asia 麻豆原创 Breakthrough Therapies Forecast
10.3.5 India 麻豆原创 Breakthrough Therapies Forecast
10.3.6 Australia 麻豆原创 Breakthrough Therapies Forecast
10.4 Europe Breakthrough Therapies Forecast by Country (2026-2031)
10.4.1 Germany 麻豆原创 Breakthrough Therapies Forecast
10.4.2 France 麻豆原创 Breakthrough Therapies Forecast
10.4.3 UK 麻豆原创 Breakthrough Therapies Forecast
10.4.4 Italy 麻豆原创 Breakthrough Therapies Forecast
10.4.5 Russia 麻豆原创 Breakthrough Therapies Forecast
10.5 Middle East & Africa Breakthrough Therapies Forecast by Region (2026-2031)
10.5.1 Egypt 麻豆原创 Breakthrough Therapies Forecast
10.5.2 South Africa 麻豆原创 Breakthrough Therapies Forecast
10.5.3 Israel 麻豆原创 Breakthrough Therapies Forecast
10.5.4 Turkey 麻豆原创 Breakthrough Therapies Forecast
10.6 Global Breakthrough Therapies Forecast by Type (2026-2031)
10.7 Global Breakthrough Therapies Forecast by Application (2026-2031)
10.7.1 GCC Countries 麻豆原创 Breakthrough Therapies Forecast
11 Key Players Analysis
11.1 F. Hoffmann-La Roche
11.1.1 F. Hoffmann-La Roche Company Information
11.1.2 F. Hoffmann-La Roche Breakthrough Therapies Product Offered
11.1.3 F. Hoffmann-La Roche Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.1.4 F. Hoffmann-La Roche Main Business Overview
11.1.5 F. Hoffmann-La Roche Latest Developments
11.2 Merck & Co.
11.2.1 Merck & Co. Company Information
11.2.2 Merck & Co. Breakthrough Therapies Product Offered
11.2.3 Merck & Co. Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.2.4 Merck & Co. Main Business Overview
11.2.5 Merck & Co. Latest Developments
11.3 Bristol-Myers Squibb
11.3.1 Bristol-Myers Squibb Company Information
11.3.2 Bristol-Myers Squibb Breakthrough Therapies Product Offered
11.3.3 Bristol-Myers Squibb Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.3.4 Bristol-Myers Squibb Main Business Overview
11.3.5 Bristol-Myers Squibb Latest Developments
11.4 Novartis
11.4.1 Novartis Company Information
11.4.2 Novartis Breakthrough Therapies Product Offered
11.4.3 Novartis Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.4.4 Novartis Main Business Overview
11.4.5 Novartis Latest Developments
11.5 AstraZeneca
11.5.1 AstraZeneca Company Information
11.5.2 AstraZeneca Breakthrough Therapies Product Offered
11.5.3 AstraZeneca Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.5.4 AstraZeneca Main Business Overview
11.5.5 AstraZeneca Latest Developments
11.6 Johnson & Johnson
11.6.1 Johnson & Johnson Company Information
11.6.2 Johnson & Johnson Breakthrough Therapies Product Offered
11.6.3 Johnson & Johnson Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.6.4 Johnson & Johnson Main Business Overview
11.6.5 Johnson & Johnson Latest Developments
11.7 Pfizer
11.7.1 Pfizer Company Information
11.7.2 Pfizer Breakthrough Therapies Product Offered
11.7.3 Pfizer Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.7.4 Pfizer Main Business Overview
11.7.5 Pfizer Latest Developments
11.8 AbbVie
11.8.1 AbbVie Company Information
11.8.2 AbbVie Breakthrough Therapies Product Offered
11.8.3 AbbVie Breakthrough Therapies Revenue, Gross Margin and 麻豆原创 Share (2020-2025)
11.8.4 AbbVie Main Business Overview
11.8.5 AbbVie Latest Developments
12 Research Findings and Conclusion
听
听
*If Applicable.