Breakthrough Therapies: Market Dynamics and Investment Opportunities

Report Code: PHM176B

Publish Date: Dec 2024

Publisher: BCC Publishing

Category: Pharmaceuticals

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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
  • Increasing number of drugs gaining breakthrough status.
  • Expedited approval process in Europe.
  • Increasing prevalence of life-threatening conditions.
Companies studied
VERTEX PHARMACEUTICALS INC.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.
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Frequently Asked Questions (FAQs)

The global breakthrough therapies market was valued at $133.3 billion in 2023 and is expected to reach $287.5 billion by the end of 2029. The market is expected to grow at a CAGR of 13.8% from 2024 to 2029.
Key factors that are driving the growth are:
  • Increasing number of drugs gaining breakthrough status.
  • Expedited approval process adopted in the Europe.
  • Increasing prevalence of life-threatening conditions.
The global breakthrough therapies market is segmented based on therapy, and region.
The oncology segment will dominate the market in 2029.
North America holds the highest share of the market.

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.

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Table of Contents

All reports provided in PDF format. For shared licensing options (5+ Users), please call a representative at (+1) 781-489-7301 or contact us at info@bccresearch.com
Title/Chapter NamePagesMember Price
Full Report: Breakthrough Therapies: Market Dynamics and Investment Opportunities114Free
Chapter- 1: Executive Summary4Free
Chapter- 2: Market Overview6Free
Chapter- 3: Market Dynamics7Free
Chapter- 4: Emerging Trends2Free
Chapter- 5: Regulatory Landscape4Free
Chapter- 6: Market Segmentation Analysis33Free
Chapter- 7: Competitive Intelligence11Free
Chapter- 8: Sustainability in the BDT Market: An ESG Perspective3Free
Chapter- 9: Appendix44Free

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This is an Excel-only version of the report.

Report Includes

    Total Number of Tables in this Report: 75

  • Summary Table: Global Market for Breakthrough Therapies, by Therapy, Through 2029
  • Table 1: CBER Breakthrough Therapy Designation Requests Received, by Fiscal Year, 2012–2024
  • Table 2: CDER Breakthrough Therapy Designation Requests Received, by Fiscal Year, 2012–2024
  • Table 3: IND Submissions with Regulatory-Mandated or FDA-Established Timelines
  • Table 4: Global Market for Breakthrough Therapies, by Therapy, Through 2029
  • Table 5: Breakthrough Therapy Drugs for Cardiovascular Disease
  • Table 6: Global Market for Breakthrough Therapies for CVD, by Region, Through 2029
  • Table 7: Breakthrough Therapy Drugs for CNS and Neurology
  • Table 8: Global Market for Breakthrough Therapies for CNS and Neurology, by Region, Through 2029
  • Table 9: Selected Breakthrough Therapy Drugs for Infectious Diseases
  • Table 10: Global Market for Breakthrough Therapies for Infectious Diseases, by Region, Through 2029
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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

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Breakthrough Therapies: Market Dynamics and Investment Opportunities
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