Global Breakthrough Therapy Drugs Market Insights, Forecast to 2025

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.
The global Breakthrough Therapy Drugs market is valued at xx million US$ in 2018 and will reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025. The objectives of this study are to define, segment, and project the size of the Breakthrough Therapy Drugs market based on company, product type, end user and key regions.

This report studies the global market size of Breakthrough Therapy Drugs in key regions like North America, Europe, Asia Pacific, Central & South America and Middle East & Africa, focuses on the consumption of Breakthrough Therapy Drugs in these regions.
This research report categorizes the global Breakthrough Therapy Drugs market by top players/brands, region, type and end user. This report also studies the global Breakthrough Therapy Drugs market status, competition landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels and distributors.

The following manufacturers are covered in this report, with sales, revenue, market share for each company:
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated

Market size by Product
Oncology
Anti-Viral
Neurology
Others 
Market size by End User
Hospitals
Clinics
Ambulatory Services

Market size by Region
North America
United States
Canada
Mexico
Asia-Pacific
China
India
Japan
South Korea
Australia
Indonesia
Singapore
Malaysia
Philippines
Thailand
Vietnam
Europe
Germany
France
UK
Italy
Spain
Russia
Central & South America
Brazil
Rest of Central & South America
Middle East & Africa
GCC Countries
Turkey
Egypt
South Africa

The study objectives of this report are:
To study and analyze the global Breakthrough Therapy Drugs market size (value & volume) by company, key regions, products and end user, breakdown data from 2014 to 2018, and forecast to 2025.
To understand the structure of Breakthrough Therapy Drugs market by identifying its various subsegments.
To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
Focuses on the key global Breakthrough Therapy Drugs companies, to define, describe and analyze the sales volume, value, market share, market competition landscape and recent development.
To project the value and sales volume of Breakthrough Therapy Drugs submarkets, with respect to key 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

This report includes the estimation of market size for value (million US$) and volume (K Units). Both top-down and bottom-up approaches have been used to estimate and validate the market size of Breakthrough Therapy Drugs market, to estimate the size of various other dependent submarkets in the overall market. Key players in the market have been identified through secondary research, and their market shares have been determined through primary and secondary research. All percentage shares, splits, and breakdowns have been determined using secondary sources and verified primary sources.

For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.