Breakthrough Therapies: Market Dynamics and Investment Opportunities

PUBLISHED: December 4, 2024

PAGES: 114 Pages

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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

Product Code: PHM176B

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.

Product Code: PHM176B

List of Tables

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
Table 11 : Selected Breakthrough Therapy Drugs for Oncology
Table 12 : Global Market for Breakthrough Therapies for Oncology, by Region, Through 2029
Table 13 : Selected Breakthrough Therapy Drugs for Rare Diseases
Table 14 : Global Market for Breakthrough Therapies for Rare Diseases, by Region, Through 2029
Table 15 : Selected Breakthrough Therapy Drugs for Other Diseases
Table 16 : Global Market for Breakthrough Therapies for Other Diseases, by Region, Through 2029
Table 17 : Global Market for Breakthrough Therapies, by Region, Through 2029
Table 18 : North American Market for Breakthrough Therapies, by Therapy, Through 2029
Table 19 : North American Market for Breakthrough Therapies, by Country, Through 2029
Table 20 : European Market for Breakthrough Therapies, by Therapy, Through 2029
Table 21 : European Market for Breakthrough Therapies, by Country, Through 2029
Table 22 : Asia-Pacific Market for Breakthrough Therapies, by Therapy, Through 2029
Table 23 : Asia-Pacific Market for Breakthrough Therapies, by Country, Through 2029
Table 24 : RoW Market for Breakthrough Therapies, by Therapy, Through 2029
Table 25 : CDER Breakthrough Therapy Approvals, 2024
Table 26 : CBER Breakthrough Therapy Approvals, 2024
Table 27 : CDER Breakthrough Therapy Approvals, 2023
Table 28 : CBER Breakthrough Therapy Approvals, 2023
Table 29 : Medicines Granted PRIME Eligibility in 2024
Table 30 : Medicines Granted PRIME Eligibility in 2023
Table 31 : Ranks of Leading Pharmaceutical Manufacturers
Table 32 : ESG Risk Ratings and Rankings for Pharmaceutical Companies, 2024*
Table 33 : Abbreviations Used in this Report
Table 34 : Information Sources in this Report
Table 35 : AbbVie Inc.: Company Snapshot
Table 36 : AbbVie Inc.: Financial Performance, FY 2022 and 2023
Table 37 : AbbVie Inc.: Product Portfolio
Table 38 : AbbVie Inc: News/Key Developments, 2021-2023
Table 39 : AstraZeneca: Company Snapshot
Table 40 : AstraZeneca: Financial Performance, FY 2022 and 2023
Table 41 : AstraZeneca: Product Portfolio
Table 42 : AstraZeneca: News/Key Developments, 2022-2024
Table 43 : Bristol-Myers Squibb Co.: Company Snapshot
Table 44 : Bristol-Myers Squibb Co.: Financial Performance, FY 2022 and 2023
Table 45 : Bristol-Myers Squibb Co.: Product Portfolio
Table 46 : Bristol-Myers Squibb Co.: News/Key Developments, 2023
Table 47 : F. Hoffmann-La Roche Ltd.: Company Snapshot
Table 48 : F. Hoffmann-La Roche Ltd.: Financial Performance, FY 2022 and 2023
Table 49 : F. Hoffmann-La Roche Ltd.: Product Portfolio
Table 50 : F. Hoffmann-La Roche Ltd.: News/Key Developments, 2022-2024
Table 51 : Johnson & Johnson Services Inc.: Company Snapshot
Table 52 : Johnson & Johnson Services Inc.: Financial Performance, FY 2022 and 2023
Table 53 : Johnson & Johnson Services Inc.: Product Portfolio
Table 54 : Johnson & Johnson Services Inc.: News/Recent Developments, 2022-2024
Table 55 : Merck & Co. Inc.: Company Snapshot
Table 56 : Merck & Co. Inc.: Financial Performance, FY 2022 and 2023
Table 57 : Merck & Co. Inc.: Product Portfolio
Table 58 : Merck & Co. Inc.: News/Key Developments, 2021-2024
Table 59 : Novartis AG: Company Snapshot
Table 60 : Novartis AG: Financial Performance, FY 2022 and 2023
Table 61 : Novartis AG: Product Portfolio
Table 62 : Novartis AG: News/Key Developments, 2023 and 2024
Table 63 : Pfizer Inc.: Company Snapshot
Table 64 : Pfizer Inc.: Financial Performance, FY 2022 and 2023
Table 65 : Pfizer Inc.: Product Portfolio
Table 66 : Pfizer Inc.: News/Key Developments, 2023 and 2024
Table 67 : Regeneron Pharmaceuticals Inc.: Company Snapshot
Table 68 : Regeneron Pharmaceuticals Inc.: Financial Performance, FY 2022 and 2023
Table 69 : Regeneron Pharmaceuticals Inc.: Product Portfolio
Table 70 : Regeneron Pharmaceuticals Inc.: News/Key Developments, 2022-2023
Table 71 : Vertex Pharmaceuticals Inc.: Company Snapshot
Table 72 : Vertex Pharmaceuticals Inc.: Financial Performance, FY 2022 and 2023
Table 73 : Vertex Pharmaceuticals Inc.: Product Portfolio
Table 74 : Vertex Pharmaceuticals Inc.: News/Key Developments, 2022-2024

List of Figures

Summary Figure : Global Market for Breakthrough Therapies, by Therapy, 2021-2029
Figure 1 : Market Dynamics of Breakthrough Therapies
Figure 2 : CBER Breakthrough Therapy Designation Requests Received, by Fiscal Year, 2013-2024
Figure 3 : CDER Breakthrough Therapy Designation Requests Received, by Fiscal Year, 2012-2024
Figure 4 : Global Market Shares of Breakthrough Therapies, by Therapy, 2023
Figure 5 : Worldwide Deaths from Cardiovascular Diseases, by Region, 2000 and 2021
Figure 6 : Worldwide Deaths from Cardiovascular Diseases, by Type, 2021
Figure 7 : Global Market Shares of Breakthrough Therapies for CVD, by Region, 2023
Figure 8 : Global Burden of Conditions Affecting the Nervous System, 2021
Figure 9 : Global Market Shares of Breakthrough Therapies for CNS and Neurology, by Region, 2023
Figure 10 : Global Market Shares of Breakthrough Therapies for Infectious Diseases, by Region, 2023
Figure 11 : Share of Global Incidence Cases of All Cancer Types, by WHO Region, 2022
Figure 12 : Cancer Incidence in the U.S., 2000-2021
Figure 13 : Global Market Shares of Breakthrough Therapies for Oncology, by Region, 2023
Figure 14 : Global Market Shares of Breakthrough Therapies for Rare Diseases, by Region, 2023
Figure 15 : Global Market Shares of Breakthrough Therapies for Other Diseases, by Region, 2023
Figure 16 : Global Market Shares of Breakthrough Therapies, by Region, 2023
Figure 17 : North American Market for Breakthrough Therapies, by Therapy, 2021-2029
Figure 18 : North American Market Shares of Breakthrough Therapies, by Country, 2023
Figure 19 : European Market for Breakthrough Therapies, by Therapy, 2021-2029
Figure 20 : European Market Shares of Breakthrough Therapies, by Country, 2023
Figure 21 : Asia-Pacific Market for Breakthrough Therapies, by Therapy, 2021-2029
Figure 22 : Asia-Pacific Market Shares of Breakthrough Therapies, by Country, 2023
Figure 23 : RoW Market for Breakthrough Therapies, by Therapy, 2021-2029
Figure 24 : PRIME Recommendations Granted, by Therapeutic Area, Till 2024
Figure 25 : AbbVie Inc.: Revenue Share, by Business Unit, FY 2023
Figure 26 : AbbVie Inc.: Revenue Share, by Country/Region, FY 2023
Figure 27 : AstraZeneca: Revenue Share, by Business Unit, FY 2023
Figure 28 : AstraZeneca: Revenue Share, by Region/Country, FY 2023
Figure 29 : Bristol-Myers Squibb Co.: Revenue Share, by Business Unit, FY 2023
Figure 30 : Bristol-Myers Squibb Co.: Revenue Share, by Country/Region, FY 2023
Figure 31 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Business Unit, FY 2023
Figure 32 : F. Hoffmann-La Roche Ltd.: Revenue Share, by Country/Region, FY 2023
Figure 33 : Johnson & Johnson Services Inc.: Revenue Share, by Business Unit, FY 2023
Figure 34 : Johnson & Johnson Services Inc.: Revenue Share, by Region/Country, FY 2023
Figure 35 : Merck & Co. Inc.: Revenue Share, by Business Unit, FY 2023
Figure 36 : Merck & Co. Inc.: Revenue Share, by Country/Region, FY 2023
Figure 37 : Novartis AG: Revenue Share, by Business Unit, FY 2023
Figure 38 : Novartis AG: Revenue Share, by Country/Region, FY 2023
Figure 39 : Pfizer Inc.: Revenue Share, by Business Unit, FY 2023
Figure 40 : Pfizer Inc.: Revenue Share, by Country/Region, FY 2023
Figure 41 : Regeneron Pharmaceuticals Inc.: Revenue Share, by Business Unit, FY 2023
Figure 42 : Regeneron Pharmaceuticals Inc.: Revenue Share, by Country/Region, FY 2023
Figure 43 : Vertex Pharmaceuticals Inc.: Revenue Share, by Business Unit, FY 2023
Figure 44 : Vertex Pharmaceuticals Inc.: Revenue Share, by Country/Region, FY 2023