Report overview
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.
This report aims to provide a comprehensive presentation of the global market for Breakthrough Therapy Drugs, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Breakthrough Therapy Drugs. This report contains market size and forecasts of Breakthrough Therapy Drugs in global, including the following market information:
Global Breakthrough Therapy Drugs Market Revenue, 2018-2023, 2024-2029, ($ millions)
Global top five companies in 2022 (%)
The global Breakthrough Therapy Drugs market was valued at US$ million in 2022 and is projected to reach US$ million by 2029, at a CAGR of % during the forecast period. The influence of COVID-19 and the Russia-Ukraine War were considered while estimating market sizes.
Increasing prevalence of life-threatening conditions and for the speedy development of pipeline drugs is the primary driver for the breakthrough therapy drugs market. This is because of the high unmet need of presently available treatment for severe conditions. Breakthrough designation of the drug captures the more attention of the manufacturers due to the expedited market access and greater returns on their investments. Because of Breakthrough therapy drugs market are associated with less robust clinical developments. Increasing support of FDA for small scale industries in R&D by providing additional funding and faster approval of drugs fuelling the growth of the breakthrough therapy drugs market. All these factors are boosting the growth of the breakthrough therapy drug market.
We surveyed the Breakthrough Therapy Drugs companies, and industry experts on this industry, involving the revenue, demand, product type, recent developments and plans, industry trends, drivers, challenges, obstacles, and potential risks.
Total Market by Segment:
Global Breakthrough Therapy Drugs Market, by Type, 2018-2023, 2024-2029 ($ millions)
Global Breakthrough Therapy Drugs Market Segment Percentages, by Type, 2022 (%)
Oncology
Anti-Viral
Neurology
Others
Global Breakthrough Therapy Drugs Market, by Application, 2018-2023, 2024-2029 ($ millions)
Global Breakthrough Therapy Drugs Market Segment Percentages, by Application, 2022 (%)
Hospitals
Clinics
Ambulatory Services
Global Breakthrough Therapy Drugs Market, By Region and Country, 2018-2023, 2024-2029 ($ Millions)
Global Breakthrough Therapy Drugs Market Segment Percentages, By Region and Country, 2022 (%)
North America
US
Canada
Mexico
Europe
Germany
France
U.K.
Italy
Russia
Nordic Countries
Benelux
Rest of Europe
Asia
China
Japan
South Korea
Southeast Asia
India
Rest of Asia
South America
Brazil
Argentina
Rest of South America
Middle East & Africa
Turkey
Israel
Saudi Arabia
UAE
Rest of Middle East & Africa
Competitor Analysis
The report also provides analysis of leading market participants including:
Key companies Breakthrough Therapy Drugs revenues in global market, 2018-2023 (estimated), ($ millions)
Key companies Breakthrough Therapy Drugs revenues share in global market, 2022 (%)
Further, the report presents profiles of competitors in the market, key players include:
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Outline of Major Chapters:
Chapter 1: Introduces the definition of Breakthrough Therapy Drugs, market overview.
Chapter 2: Global Breakthrough Therapy Drugs market size in revenue.
Chapter 3: Detailed analysis of Breakthrough Therapy Drugs company competitive landscape, revenue and market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 5: Provides the analysis of various market segments by application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6: Sales of Breakthrough Therapy Drugs in regional level and country level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space of each country in the world.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 8: The main points and conclusions of the report.