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.Ê 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 1stÊor 2ndÊstage of clinical trials.
Scope of the Report:This report focuses on the Breakthrough Therapy Drugs in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.
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 worldwide market for Breakthrough Therapy Drugs is expected to grow at a CAGR of roughly xx% over the next five years, will reach xx million US$ in 2026, from xx million US$ in 2020, according to a new study.
Market Segment by Manufacturers, this report covers Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Market Segment by Regions, regional analysis covers North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia and Italy)
Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
South America (Brazil, Argentina, Colombia etc.)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
Market Segment by Type, covers Oncology
Anti-Viral
Neurology
OthersÊ
Market Segment by Applications, can be divided into Hospitals
Clinics
Ambulatory Services
There are 15 Chapters to deeply display the global Breakthrough Therapy Drugs market.
Chapter 1, to describe Breakthrough Therapy Drugs Introduction, product scope, market overview, market opportunities, market risk, market driving force;
Chapter 2, to analyze the top manufacturers of Breakthrough Therapy Drugs, with sales, revenue, and price of Breakthrough Therapy Drugs, in 2018 and 2019;
Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2018 and 2019;
Chapter 4, to show the global market by regions, with sales, revenue and market share of Breakthrough Therapy Drugs, for each region, from 2015 to 2020;
Chapter 5, 6, 7, 8 and 9, to analyze the market by countries, by type, by application and by manufacturers, with sales, revenue and market share by key countries in these regions;
Chapter 10 and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2015 to 2020;
Chapter 12, Breakthrough Therapy Drugs market forecast, by regions, type and application, with sales and revenue, from 2020 to 2026;
Chapter 13, 14 and 15, to describe Breakthrough Therapy Drugs sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source
Frequently Asked Questions
The base year for the study has been considered 2019, historic year 2014 and 2018, the forecast period considered is from 2020 to 2027. The regions analyzed for the market include North America, Europe, South America, Asia Pacific, and Middle East and Africa. These regions are further analyzed at the country-level. The study also includes attractiveness analysis of type, application and regions which are benchmarked based on their market size, growth rate and attractiveness in terms of present and future opportunity for understanding the future growth of the market.
Market is segmented on the basis:
- By Type
- By Application
- By Region
- By Country
- By Manufacturer
The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The report emphasizes on all the key trends that play a vital role in the enlargement of the market from 2019 to 2026.
The report provides company profile of the key players operating in the market and a comparative analysis based on their business overviews industry offering, segment market share, regional presence, business strategies, innovations, mergers & acquisitions, recent developments, joint venture, collaborations, partnerships, SWOT analysis, and key financial information.
