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.
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.
Breakthrough therapy designation requires additional planning for the pricing, market access and reimbursements acts as restraints in the growth of the market. Uncertainty around the breakthrough therapy drugs acts as a primary challenge for the manufacturers.
In 2019, the market size of Breakthrough Therapy Drugs is xx million US$ and it will reach xx million US$ in 2025, growing at a CAGR of xx% from 2019; while in China, the market size is valued at xx million US$ and will increase to xx million US$ in 2025, with a CAGR of xx% during forecast period.
In this report, 2018 has been considered as the base year and 2019 to 2025 as the forecast period to estimate the market size for Breakthrough Therapy Drugs.
This report studies the global market size of Breakthrough Therapy Drugs, especially focuses on the key regions like United States, European Union, China, and other regions (Japan, Korea, India and Southeast Asia).
This study presents the Breakthrough Therapy Drugs sales volume, revenue, market share and growth rate for each key company, and also covers the breakdown data (sales, revenue and market share) by regions, type and applications. history breakdown data from 2014 to 2019, and forecast to 2025.
For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2014 to 2019.
In global market, the following companies are covered:
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Market Segment by Product Type
Oncology
Anti-Viral
Neurology
Others
Market Segment by Application
Hospitals
Clinics
Ambulatory Services
Key Regions split in this report: breakdown data for each region.
United States
China
European Union
Rest of World (Japan, Korea, India and Southeast Asia)
The study objectives are:
To analyze and research the Breakthrough Therapy Drugs status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.
To present the key Breakthrough Therapy Drugs manufacturers, presenting the sales, revenue, market share, and recent development for key players.
To split the breakdown data by regions, type, companies and applications
To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
To identify significant trends, drivers, influence factors in global and regions
To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
In this study, the years considered to estimate the market size of Breakthrough Therapy Drugs are as follows:
History Year: 2014-2018
Base Year: 2018
Estimated Year: 2019
Forecast Year 2019 to 2025
Summary:
Get latest Market Research Reports on Breakthrough Therapy Drugs. Industry analysis & Market Report on Breakthrough Therapy Drugs is a syndicated market report, published as Global (United States, European Union and China) Breakthrough Therapy Drugs Market Research Report 2019-2025. It is complete Research Study and Industry Analysis of Breakthrough Therapy Drugs market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.