Report Highlights

The global market for breakthrough therapy drugs was valued at $133.3 billion in 2023. This market is expected to grow from $150.6 billion in 2024 to $287.5 billion by 2029, at a compound annual growth rate (CAGR) of 13.8% from 2024 to 2029.

Report Includes

26 data tables and 49 additional tables

An overview of the global market dynamics and investment opportunities for breakthrough therapy designation (BTD) drugs

Analyses of the global market trends, with sales data for 2021-2023, estimates for 2024, and projections of compound annual growth rates (CAGRs) through 2029

Evaluation and forecast the market size for breakthrough therapies based on type, and geographical region

Discussion of emerging technologies and developments and various macroeconomic factors affecting the breakthrough therapies market

Review of patent data and new developments regarding various categories and sub-categories of breakthrough therapies

A discussion on ESG challenges and practices of the industry

Assessment of the vendor landscape, including the market shares of leading companies, their product portfolios and financial overviews

Information on recent mergers, acquisitions, expansions, collaborations, investments, divestments, product launches, and other strategic developments

Profiles of the leading market vendors, including F. Hoffmann-La Roche Ltd., Merck & Co. Inc., Bristol-Myers Squibb Co., Novartis AG and AstraZeneca

Report Scope

This report examines the potential risks and benefits of receiving breakthrough therapy designation (BTD), compares and contrasts fast-track drug development approaches (logistics, criteria and implications), and highlights the opportunities and challenges of creating breakthrough therapies. Cardiovascular, central nervous systems and neurology, rare diseases, oncology and other diseases are among the therapy areas in which this report analyzes BTD. It also examines leading companies, approved and pending products, and product revenues. It examines BTD’s achievements and shortcomings and discusses the tactics organizations use to optimize BTD’s competitive edge.

To provide an in-depth understanding of the market, this report also includes profiles of market participants, the competitive landscape, key competitors and respective market share.

The market in this report is divided into four regions: North America, Europe, Asia-Pacific and Rest of the World (RoW). For market estimates, data has been provided for 2023 as the base year, with forecasts for 2024 through 2029.