Global Breakthrough Therapies Market 2025 by Company, Regions, Type and Application, Forecast to 2031

According to our (Global Info Research) latest study, the global Breakthrough Therapies market size was valued at US$ 17050 million in 2024 and is forecast to a readjusted size of USD 41800 million by 2031 with a CAGR of 14.2% during review period.

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 a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.



This report is a detailed and comprehensive analysis for global Breakthrough Therapies market. Both quantitative and qualitative analyses are presented by company, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.

Key Features:

Global Breakthrough Therapies market size and forecasts, in consumption value ($ Million), 2020-2031

Global Breakthrough Therapies market size and forecasts by region and country, in consumption value ($ Million), 2020-2031

Global Breakthrough Therapies market size and forecasts, by Type and by Application, in consumption value ($ Million), 2020-2031

Global Breakthrough Therapies market shares of main players, in revenue ($ Million), 2020-2025

The Primary Objectives in This Report Are:

To determine the size of the total market opportunity of global and key countries

To assess the growth potential for Breakthrough Therapies

To forecast future growth in each product and end-use market

To assess competitive factors affecting the marketplace

This report profiles key players in the global Breakthrough Therapies market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include F. Hoffmann-La Roche, Merck & Co., Bristol-Myers Squibb, Novartis, AstraZeneca, Johnson & Johnson, Pfizer, AbbVie, etc.

This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.

Market segmentation

Breakthrough Therapies market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.

Market segment by Type

Targeted Therapy

Immunotherapy

Gene Therapy

Cell Therapy

Other

Market segment by Application

Cardiovascular

Central Nervous System and Neurology

Rare Diseases

Oncology

Others

Market segment by players, this report covers

F. Hoffmann-La Roche

Merck & Co.

Bristol-Myers Squibb

Novartis

AstraZeneca

Johnson & Johnson

Pfizer

AbbVie

Market segment by regions, regional analysis covers

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia, Italy and Rest of Europe)

Asia-Pacific (China, Japan, South Korea, India, Southeast Asia and Rest of Asia-Pacific)

South America (Brazil, Rest of South America)

Middle East & Africa (Turkey, Saudi Arabia, UAE, Rest of Middle East & Africa)

The content of the study subjects, includes a total of 13 chapters:

Chapter 1, to describe Breakthrough Therapies product scope, market overview, market estimation caveats and base year.

Chapter 2, to profile the top players of Breakthrough Therapies, with revenue, gross margin, and global market share of Breakthrough Therapies from 2020 to 2025.

Chapter 3, the Breakthrough Therapies competitive situation, revenue, and global market share of top players are analyzed emphatically by landscape contrast.

Chapter 4 and 5, to segment the market size by Type and by Application, with consumption value and growth rate by Type, by Application, from 2020 to 2031

Chapter 6, 7, 8, 9, and 10, to break the market size data at the country level, with revenue and market share for key countries in the world, from 2020 to 2025.and Breakthrough Therapies market forecast, by regions, by Type and by Application, with consumption value, from 2026 to 2031.

Chapter 11, market dynamics, drivers, restraints, trends, Porters Five Forces analysis.

Chapter 12, the key raw materials and key suppliers, and industry chain of Breakthrough Therapies.

Chapter 13, to describe Breakthrough Therapies research findings and conclusion.