Breakthrough Therapies: Market Dynamics and Investment Opportunities

Breakthrough Therapies: Market Dynamics and Investment Opportunities



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

Companies Mentioned

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.


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.

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