획기적 치료제 : 시장 역학과 투자 기회

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.

The global market for breakthrough therapies for oncology is expected to grow from $82.1 billion in 2024 to $177.1 billion by 2029, at a CAGR of 16.6% from 2024 to 2029.

The global market for breakthrough therapies for CNS and neurology is expected to grow from $14.9 billion in 2024 to $30.4 billion by 2029, at a CAGR of 15.4% from 2024 to 2029.

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 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

Table of Contents

Chapter 1 Executive Summary

• Market Outlook
• Scope of Report
• Market Summary

Chapter 2 Market Overview

• Overview
• Porter's Five Forces Analysis
• Potential for New Entrants: High
• Bargaining Power of Suppliers: Medium
• Bargaining Power of Buyers: Medium
• Threat of Substitute Products: High
• Industry Competition: High
• PESTEL Analysis of the Pharmaceutical Industry
• Political Factors
• Economic Factors
• Social Factors
• Technological Factors
• Environmental Factors
• Legal Factors
• Impact of Breakthrough Therapy Drugs on Business Growth

Chapter 3 Market Dynamics

• Market Dynamics
• Market Drivers
• More Drugs Gaining Breakthrough Status
• Expedited Approval Process in the EU
• Increasing Prevalence of Life-Threatening Conditions
• Market Restraints
• Increasing Preference for Generics
• Market Opportunities
• Rising Use of Technologies in Clinical Trials

Chapter 4 Emerging Trends

• Overview
• Nanotechnology: Enhancing Drug Discovery and Delivery
• Merging Technologies in Drug Discovery
• Conclusion

Chapter 5 Regulatory Landscape

• Overview
• Policy
• Procedures
• CDER-Sponsor Meetings and Other Communications
• CDER Internal Meetings and Communications
• CDER Review of Breakthrough Therapy Drug Development Programs
• Rescinding a Breakthrough Therapy Designation

Chapter 6 Market Segmentation Analysis

• Segmentation Breakdown
• Market Breakdown by Therapy
• Cardiovascular
• CNS and Neurology
• Infectious Diseases
• Oncology
• Rare Diseases
• Other Diseases
• Geographic Breakdown
• Market Breakdown by Region
• North America
• Europe
• Asia-Pacific
• Rest of the World

Chapter 7 Competitive Intelligence

• Overview
• PRIME Designation Lists
• Global Ranks of Leading Companies

Chapter 8 Sustainability in the BDT Market: An ESG Perspective

• Role of ESG in the Pharma Industry
• Environmental
• Social
• Governance
• ESG Risk Ratings
• Conclusion

Chapter 9 Appendix

• Methodology
• Abbreviations
• Sources
• Company Profiles
• 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.