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 fora drug that treats a serious or life-threatening conditionand 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.

LPI (LP Information) newest research report, the Breakthrough Therapies Industry Forecast 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 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 companys coverage, product portfolio, its market penetration.

    F. Hoffmann-La Roche
    Merck & Co.
    Bristol-Myers Squibb
    Novartis
    AstraZeneca
    Johnson & Johnson
    Pfizer
    AbbVie