Table of Content

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.



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

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