
Already a member? Login to access this report free.
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.
Report Synopsis
Report Metrics | Details | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Base year considered | 2023 | ||||||||||
Forecast period considered | 2024-2029 | ||||||||||
Base year market size | $133.3 Billion | ||||||||||
Market size forecast | $287.5 Billion | ||||||||||
Growth rate | CAGR of 13.8% from 2024 to 2029 | ||||||||||
Units considered | $ Millions | ||||||||||
Segments covered | Therapy and Region | ||||||||||
Regions covered | North America, Europe, Asia-Pacific and Rest of the World (RoW) | ||||||||||
Key Market Drivers |
|
||||||||||
Companies studied |
|
Frequently Asked Questions (FAQs)
- Increasing number of drugs gaining breakthrough status.
- Expedited approval process adopted in the Europe.
- Increasing prevalence of life-threatening conditions.
Analyst Credentials
BCC Research Team possesses expertise and experience in life and physical science domains. They specialize in offering valuable business insights, including industry analysis, competitor intelligence, strategic and financial analysis, and opportunity assessment. The team has in-depth knowledge of various sectors, including healthcare, biotechnology, pharmaceuticals, IT, automation, advanced materials, and energy. They are proficient in qualitative and quantitative market intelligence providing clients with actionable insights. With a vast understanding of the competitive landscape, the team can support clients in making data-driven decisions to help them achieve a competitive edge in their respective markets.
Related Reports
Biologic Therapeutic Drugs: Technologies and Global Markets
The global market for biologic therapeutic drugs is estimated to increase from $499.2 billion in 2024 to reach $794.5 billion by 2029, at a compound annual growth rate (CAGR) of 9.7% from 2024 through 2029.
Neurology Market: A BCC Research Overview
The global market for neurology is estimated to increase from $67.3 billion in 2024 to reach $94.8 billion by 2029, at a compound annual growth rate (CAGR) of 7.1% from 2024 through 2029.
Alzheimer's Disease Therapeutics and Diagnostics: Global Markets
The global market for Alzheimer’s disease therapeutics and diagnostics was valued at $9 billion in 2023. This market is expected to grow from $9.7 billion in 2024 to $19.6 billion by 2029, at a compound annual growth rate (CAGR) of 15.1% from 2024 to 2029.
Drug Discovery Technologies
The global market for drug discovery technologies is expected to grow from $111.9 billion in 2024 and is projected to reach $197.0 billion by the end of 2029, at a compound annual growth rate (CAGR) of 12.0% during the forecast period of 2024 to 2029.
Track the Latest Global Tariff Developments
In today's fast-paced global economy, tariffs are no longer static—they are dynamic levers shaped by geopolitical realignments, supply chain vulnerabilities, inflationary pressures, and sustainability-driven trade reforms. As governments worldwide recalibrate their trade strategies, businesses are left to navigate a maze of shifting rules, rising costs, and regulatory uncertainty.
Our analysis empowers you with real-time updates and in-depth expert analysis on all facets of global tariff activity. From new trade agreements and sanctions to abrupt tariff hikes and retaliatory duties, we monitor developments across borders, sectors, and industries—so you don't have to.
Whether it's the ongoing U.S.–China trade dynamics, the evolving EU Carbon Border Adjustment Mechanism (CBAM), or the emerging policies in India, ASEAN, and Latin America, we provide full-spectrum coverage. We also track multilateral trade negotiations, World Trade Organization (WTO) rulings, and sector-specific duty structures—ensuring you are always ahead of global trade shifts.
With our analysis, you can stay informed, identify risks, and confidently respond to tariff changes—no matter where you operate.
Ready to see what tariff means for your business?
Consult with our experts or request your custom Tariff Impact Brife today
Stay Informed, Stay Competitive
In today's interconnected and unpredictable global economy, staying ahead of tariff shifts is not just important—it's essential. BCC Research provides decision-makers with trusted, research-driven insights that turn uncertainty into opportunity.
Our in-depth market analysis and trade intelligence help you decode how tariff changes impact your specific sector—manufacturing, healthcare, technology, agriculture, or energy. We break down complex data into actionable knowledge through comprehensive reports, expert commentaries, and sector-focused forecasts.
Our analysis includes:
- Thorough breakdowns of current and proposed tariff policies and how they affect regional and global trade flows.
- Sector-specific implications, helping you understand the strategic impact on sourcing, pricing, and competitiveness.
- Forward-looking insights to support risk management, planning, and response strategies for evolving trade conditions.
With BCC Research, you gain more than just information—you gain clarity and confidence to make well-informed decisions in a volatile trade environment.
Don't let tariffs catch you off guard—let our insights guide your strategy.
Recent Reports
Over-the-Counter (OTC) Drugs, and Vitamins & Dietary Supplements: Global Markets
The global market for over-the- counter (OTC) drugs, vitamins and dietary supplements is expected to grow from $276.9 billion in 2025 and is projected to reach $371.7 billion by the end of 2030, at a compound annual growth rate (CAGR) of 6.1% during the forecast period of 2025 to 2030.
Global Pharmaceutical Drugs Industry: Competitive Landscape 2023
This report discusses the global pharmaceutical drugs industry and its competitive landscape in terms of significant player market ranking and top pharmaceutical drugs. Company profiles of the top 50 pharmaceutical companies, innovative products and technologies, trends and market dynamics, competitive intelligence, and regional trends are well-researched and analyzed in this report.
The Global Influenza Market
The global influenza market is expected to grow from $9.0 billion in 2024 and is projected to reach $12.8 billion by the end of 2029, at a compound annual growth rate (CAGR) of 7.2% during the forecast period of 2024 to 2029.
Liver Disease Treatments: The Global Market
The global market for liver disease treatments is estimated to increase from $46.0 billion in 2024 to reach $69.1 billion by 2030, at a compound annual growth rate (CAGR) of 7.1% from 2025 through 2030.
Cancer Immunotherapy: Technologies and Global Markets
The global cancer immunotherapy market is expected to grow from $144.2 billion in 2024 and is projected to reach $247.2 billion by the end of 2029, at a compound annual growth rate (CAGR) of 11.4% during the forecast period of 2024 to 2029.
Top Trending Reports
Next-Generation Advanced Batteries: Global Markets
The global market for next-generation advanced batteries is estimated to grow from $1.5 billion in 2024 to reach $5.3 billion by the end of 2029, at a compound annual growth rate (CAGR) of 28.5% from 2024 through 2029.
Global Pharmaceutical Drugs Industry: Competitive Landscape 2023
This report discusses the global pharmaceutical drugs industry and its competitive landscape in terms of significant player market ranking and top pharmaceutical drugs. Company profiles of the top 50 pharmaceutical companies, innovative products and technologies, trends and market dynamics, competitive intelligence, and regional trends are well-researched and analyzed in this report.
Global Markets and Manufacturing Technologies for Protein Drugs
The global protein drugs market is expected to grow from $441.7 billion in 2024 and is projected to reach $655.7 billion by the end of 2029, at a compound annual growth rate (CAGR) of 8.2% during the forecast period of 2024 to 2029.
Biologic Therapeutic Drugs: Technologies and Global Markets
The global market for biologic therapeutic drugs is estimated to increase from $499.2 billion in 2024 to reach $794.5 billion by 2029, at a compound annual growth rate (CAGR) of 9.7% from 2024 through 2029.
Global Markets for Emerging Medical Device Technologies
The global market for emerging medical devices is estimated to increase from $136.6 billion in 2024 to reach $223.9 billion by 2029, at a compound annual growth rate (CAGR) of 10.4% from 2024 through 2029.
Report Highlights
The global market for breakthrough therapy designation drugs should reach $99.2 billion by 2022 from $48.8 billion in 2017 at a compound annual growth rate (CAGR) of 15.2%, from 2017 to 2022.
Report Includes
- An overview of the global markets for breakthrough therapies, their dynamics, and investment opportunities
- Analyses of global market trends, with data from 2015, 2016, and projections of compound annual growth rates (CAGRs) through 2022
- The challenges and opportunities of developing breakthrough therapies
- A compare and contrast of different fast track drug development approaches (logistics, criteria and implications) and the potential risk and rewards of gaining break through designation
- Analysis of the regulatory environment
- Coverage of the market's dynamics, specifically growth drivers, restraints, and opportunities
- Profiles of major players in the industry
Become A Member
BCC Research offers a comprehensive library of reports, granting members unlimited access to data, insights, and market intelligence for informed business decisions, while actively supporting members in their evolving journeys and prioritizing high-quality, relevant topics based on continuous engagement with the research community.
Find Out MoreCustom Consulting
BCC Research emphasizes the importance of organizations leveraging highly customized market insights aligned with specific strategic business objectives through direct engagement with primary sources and proprietary forecasting models for profitable decision-making in maximizing growth opportunities and minimizing risks.
Customize NowScorecard
The Venture Scorecard provides commercialization offices and decision makers with expert analysis, offering strategic insights crucial for aligning objectives with market realities at various stages of commercializing new products or evaluating investment opportunities, from opportunity assessment to growth planning.
Find Out MoreInnovation Spotlight
Our industry experts offer strategic guidance to maximize the market potential of commercialized products, patents, and IP by providing insights into market trends, competitive dynamics, and effective positioning, using the Innovation Spotlight service for enhanced exposure to thought leaders and the wider community.
Find Out More