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
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, 2022-202
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
