Breakthrough Therapies: Transforming Market Dynamics and Expanding Investment Opportunities

“Accelerating Innovation: The FDA's Breakthrough Therapy Designation, established by the FDA Safety and Innovation Act’s Section 902, Expedites Development and Access to Life-Saving Drugs for Patients with Severe Illnesses”

February 20, 2025

According to the latest study from BCC Research, “Breakthrough Therapies: Market Dynamics and Investment Opportunities” is expected to grow from $150.6 billion in 2024 to $287.5 billion by the end of 2029, at a compound annual growth rate (CAGR) of 13.8% from 2024 to 2029.

This report compares the potential risks and benefits of Breakthrough Therapy Designation (BTD) with other fast-track drug development methods. It covers areas such as cardiovascular, neurology, rare diseases, and oncology. The report also profiles leading companies, reviews approved and pending products and analyzes revenues. It discusses BTD's successes and challenges and how companies can use BTD to their advantage. The market analysis includes North America, Europe, Asia-Pacific, and the Rest of the World, with data from 2023 and forecasts from 2024 to 2029.

Regulators and the pharmaceutical industry are looking for ways to get new, innovative medicines to patients faster, especially for serious health needs. The BTD pathway in the U.S. and the PRIME pathway in Europe are two methods to do this. The report explains the challenges and opportunities of using these fast-track routes and the success criteria.

The factors driving the market include:

More Drugs Attaining Breakthrough Status: More drugs are designated breakthrough therapies due to advances in biotechnology and a better understanding of diseases. This status helps speed up their development and approval.

Faster Approvals in Europe: The European Medicines Agency (EMA) has expedited pathways such as the PRIME scheme and accelerated assessment, reducing the time it takes to approve new, promising medicines.

Rising Prevalence of Serious Conditions: The increasing prevalence of serious conditions, including cancer and heart disease, drives the demand for new treatments, boosting the market for breakthrough therapies.

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Report Synopsis

Interesting facts:

• In 2023, AbbVie’s drug epcoritamab, used for treating relapsed or refractory follicular lymphoma (FL), received Breakthrough Therapy Designation from the FDA. This means it can be used for adults with FL who have already tried two or more therapies. The EMA also validated a similar application for epcoritamab.
• In 2024, the FDA approved Merck's drug sotatercept-csrk (U.S. brand name: WINREVAIR, for injection, 45mg, 60mg) for treating adults with pulmonary arterial hypertension. This drug helps improve exercise capacity and reduces the risk of worsening symptoms.

The report addresses the following questions:

1. How big is the global breakthrough therapies market, and how fast is it growing?

• The market was worth $133.3 billion in 2023 and is expected to grow to $287.5 billion by the end of 2029, with an annual growth rate of 13.8%.

2. What market segments are covered in the report?

• The global breakthrough therapies market is segmented by therapy and region.

3. Which therapy segment will dominate the market in 2029?

• The oncology segment will dominate the market in 2029.

4. Which region has the largest market share?

• North America holds the largest share of the market.

Market leaders include:

• ABBVIE INC.
• ASTRAZENECA
• BRISTOL-MYERS SQUIBB CO.
• F. HOFFMANN-LA ROCHE LTD.
• JOHNSON & JOHNSON SERVICES INC.
• MERCK & CO. INC.
• NOVARTIS AG
• PFIZER INC.
• REGENERON PHARMACEUTICALS INC.
• VERTEX PHARMACEUTICALS INC.

Related reports include:

Drug Discovery Technologies: This report covers trends from 2023, estimates for 2024, and projections through 2029. It examines drug discovery technologies and their applications, market potential, competitive landscape, and regional analysis for North America, Europe, and Asia-Pacific. The report provides forecasts, assess market size, and identifies key drivers and constraints.

Global Markets and Technologies for Advanced Drug Delivery Systems: This report offers quantitative and qualitative data to help businesses develop strategies, assess the market, and make informed decisions. The analysis includes historical data and projections on sales by technology, administration route, drug carrier, and application. It covers advanced drug delivery system (ADDS) technologies like immediate-release and targeted-release drug delivery, as well as market revenues. The report also examines applications in oncology, cardiovascular, and respiratory diseases. The geographic scope includes the U.S. and global companies, identifying key industry trends.

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Breakthrough Therapies: Market Dynamics and Investment Opportunities( PHM176B )
Publish Date: Dec 2024    

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