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.

Market Analysis and Insights: Global Breakthrough Therapy Drugs Market
The global Breakthrough Therapy Drugs market size is projected to reach US$ XX million by 2027, from US$ XX million in 2020, at a CAGR of XX% during 2021-2027.
With industry-standard accuracy in analysis and high data integrity, the report makes a brilliant attempt to unveil key opportunities available in the global Breakthrough Therapy Drugs market to help players in achieving a strong market position. Buyers of the report can access verified and reliable market forecasts, including those for the overall size of the global Breakthrough Therapy Drugs market in terms of revenue.
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Global Breakthrough Therapy Drugs Scope and Market Size
Breakthrough Therapy Drugs market is segmented by company, region (country), by Type, and by Application. Players, stakeholders, and other participants in the global Breakthrough Therapy Drugs market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2016-2027.

Segment by Type
Oncology
Anti-Viral
Neurology
Others

Segment by Application
Hospitals
Clinics
Ambulatory Services

By Region
North America
U.S.
Canada
Europe
Germany
France
U.K.
Italy
Russia
Nordic
Rest of Europe
Asia-Pacific
China
Japan
South Korea
Southeast Asia
India
Australia
Rest of Asia
Latin America
Mexico
Brazil
Rest of Latin America
Middle East & Africa
Turkey
Saudi Arabia
UAE
Rest of MEA

By Company
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated