突破性疗法：市场动态与投资机会

预计全球突破性治疗药物市场规模将于 2029 年达到 2,875 亿美元，预测期内复合年增长率为 13.8%，而 2023 年为 1,333 亿美元，2024 年为 1,506 亿美元。

以治疗领域来看，癌症领域预计将从 2024 年的 821 亿美元成长到 2029 年的 1,771 亿美元，复合年增长率为 16.6%。此外，中枢神经系统和神经系统领域预计将从2024年的149亿美元成长到2029年的304亿美元，复合年增长率为15.4%。

本报告调查了全球创新治疗药物市场，并提供了市场概况、市场影响因素和市场机会分析、法律制度、市场规模趋势和预测、各个细分市场和地区的详细分析以及竞争资讯。 、主要企业概况等。

目录

第一章执行摘要

• 市场展望
• 调查范围
• 市场概况

第二章 市场概况

• 概述
• 波特五力分析
• PESTEL分析
• 突破性疗法对业务成长的影响

第三章市场动态

• 市场动态
• 市场驱动因素
• 越来越多的药物被认为是突破性治疗方法
• 欧盟快速核准流程
• 危及生命的疾病增加
• 市场限制因素
• 对学名药的偏好日益增加
• 市场机会
• 在临床试验中增加技术的使用

第四章 新动向

• 概述
• 奈米技术：增强药物发现与输送
• 药物发现中的技术融合
• 结论

第五章 监管状况

• 概述
• 政策
• 程式
• CDER 赞助商会议及其他通讯
• CDER 内部会议与沟通
• CDER 突破性疗法开发计划回顾
• 撤销突破性疗法认定

第六章市场区隔分析

• 细分细分
• 市场区隔：按治疗类别
• 心血管
• 中枢神经系统/神经系统
• 感染疾病
• 瘤
• 罕见疾病
• 其他的
• 地域分布
• 市场区隔：按地区
• 北美洲
• 欧洲
• 亚太地区
• 其他领域

第七章 竞争讯息

• 概述
• PRIME规格表
• 主要企业世界排名

第八章 BDT 市场的永续性：ESG 视角

• ESG 在製药业中的作用
• 环境
• 社会
• 管治
• ESG风险评估
• 结论

第九章 附录

• 调查方法
• 简称
• 来源
• 公司简介
• 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.

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.

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