Global Breakthrough Therapy Drugs Market Growth (Status and Outlook) 2025-2031
Description
According to this study, the global Breakthrough Therapy Drugs market size will reach US$ million by 2031.
Breakthrough therapy drugs are intended to treat serious and life-threatening conditions. The breakthrough therapy is the designation given by FDA for the drugs when there is a preliminary clinical evidence indicates that the drug proves a substantial improvement over available drug treatment. Two factors determine the efficiency of breakthrough therapy drug, they are the magnitude of the treatment effect and observed clinical difference over the existed drug. The standard for breakthrough therapy drug is not same as standard drug approval because, in breakthrough therapy, morbidity and mortality considered for approval of the drug. They are meant to be administered by itself or in combinations. Breakthrough therapy drug development is cost effective due to faster approval of drugs on limited data from the FDA. Manufacturer of breakthrough therapy drugs has to develop additional post-marketing surveillance data for the other reimbursements and market access. Presently available breakthrough therapy medicinal products in the market belong to the treatment class of oncology, infectious diseases, cardiovascular conditions, etc. The designation is given when the drug is in 1st or 2nd stage of clinical trials.
The global pharmaceutical market is 1475 billion USD in 2022, growing at a CAGR of 5% during the next six years. The pharmaceutical market includes chemical drugs and biological drugs. For biologics is expected to 381 billion USD in 2022. In comparison, the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U.S. dollars in 2022. The pharmaceutical market factors such as increasing demand for healthcare, technological advancements, and the rising prevalence of chronic diseases, increase in funding from private & government organizations for development of pharmaceutical manufacturing segments and rise in R&D activities for drugs. However, the industry also faces challenges such as stringent regulations, high costs of research and development, and patent expirations. Companies need to continuously innovate and adapt to these challenges to stay competitive in the market and ensure their products reach patients in need. Additionally, the COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management, further emphasizing the need for pharmaceutical companies to be agile and responsive to emerging public health needs.
LPI (LP Information)' newest research report, the “Breakthrough Therapy Drugs Industry Forecast” looks at past sales and reviews total world Breakthrough Therapy Drugs sales in 2024, providing a comprehensive analysis by region and market sector of projected Breakthrough Therapy Drugs sales for 2025 through 2031. With Breakthrough Therapy Drugs sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Breakthrough Therapy Drugs industry.
This Insight Report provides a comprehensive analysis of the global Breakthrough Therapy Drugs landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Breakthrough Therapy Drugs portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Breakthrough Therapy Drugs market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Breakthrough Therapy Drugs and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Breakthrough Therapy Drugs.
This report presents a comprehensive overview, market shares, and growth opportunities of Breakthrough Therapy Drugs market by product type, application, key players and key regions and countries.
Segmentation by Type:
Oncology
Anti-Viral
Neurology
Others
Segmentation by Application:
Hospitals
Clinics
Ambulatory Services
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Please note: The report will take approximately 2 business days to prepare and deliver.
Breakthrough therapy drugs are intended to treat serious and life-threatening conditions. The breakthrough therapy is the designation given by FDA for the drugs when there is a preliminary clinical evidence indicates that the drug proves a substantial improvement over available drug treatment. Two factors determine the efficiency of breakthrough therapy drug, they are the magnitude of the treatment effect and observed clinical difference over the existed drug. The standard for breakthrough therapy drug is not same as standard drug approval because, in breakthrough therapy, morbidity and mortality considered for approval of the drug. They are meant to be administered by itself or in combinations. Breakthrough therapy drug development is cost effective due to faster approval of drugs on limited data from the FDA. Manufacturer of breakthrough therapy drugs has to develop additional post-marketing surveillance data for the other reimbursements and market access. Presently available breakthrough therapy medicinal products in the market belong to the treatment class of oncology, infectious diseases, cardiovascular conditions, etc. The designation is given when the drug is in 1st or 2nd stage of clinical trials.
The global pharmaceutical market is 1475 billion USD in 2022, growing at a CAGR of 5% during the next six years. The pharmaceutical market includes chemical drugs and biological drugs. For biologics is expected to 381 billion USD in 2022. In comparison, the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U.S. dollars in 2022. The pharmaceutical market factors such as increasing demand for healthcare, technological advancements, and the rising prevalence of chronic diseases, increase in funding from private & government organizations for development of pharmaceutical manufacturing segments and rise in R&D activities for drugs. However, the industry also faces challenges such as stringent regulations, high costs of research and development, and patent expirations. Companies need to continuously innovate and adapt to these challenges to stay competitive in the market and ensure their products reach patients in need. Additionally, the COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management, further emphasizing the need for pharmaceutical companies to be agile and responsive to emerging public health needs.
LPI (LP Information)' newest research report, the “Breakthrough Therapy Drugs Industry Forecast” looks at past sales and reviews total world Breakthrough Therapy Drugs sales in 2024, providing a comprehensive analysis by region and market sector of projected Breakthrough Therapy Drugs sales for 2025 through 2031. With Breakthrough Therapy Drugs sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Breakthrough Therapy Drugs industry.
This Insight Report provides a comprehensive analysis of the global Breakthrough Therapy Drugs landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Breakthrough Therapy Drugs portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Breakthrough Therapy Drugs market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Breakthrough Therapy Drugs and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Breakthrough Therapy Drugs.
This report presents a comprehensive overview, market shares, and growth opportunities of Breakthrough Therapy Drugs market by product type, application, key players and key regions and countries.
Segmentation by Type:
Oncology
Anti-Viral
Neurology
Others
Segmentation by Application:
Hospitals
Clinics
Ambulatory Services
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Please note: The report will take approximately 2 business days to prepare and deliver.
Table of Contents
90 Pages
- *This is a tentative TOC and the final deliverable is subject to change.*
- 1 Scope of the Report
- 2 Executive Summary
- 3 Breakthrough Therapy Drugs Market Size by Player
- 4 Breakthrough Therapy Drugs by Region
- 5 Americas
- 6 APAC
- 7 Europe
- 8 Middle East & Africa
- 9 Market Drivers, Challenges and Trends
- 10 Global Breakthrough Therapy Drugs Market Forecast
- 11 Key Players Analysis
- 12 Research Findings and Conclusion
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