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 was 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.
This report focuses on Breakthrough Therapy Drugs volume and value at global level, regional level and company level. From a global perspective, this report represents overall Breakthrough Therapy Drugs market size by analyzing historical data and future prospect.
Regionally, this report categorizes the production, apparent consumption, export and import of Breakthrough Therapy Drugs in North America, Europe, China, Japan, Southeast Asia and India.
For each manufacturer covered, this report analyzes their Breakthrough Therapy Drugs manufacturing sites, capacity, production, ex-factory price, revenue and market share in global market.
The following manufacturers are covered:
Merck
Pfizer
AbbVie
Bristol-Myers Squibb Company
Genentech
Gilead
Novartis
Vertex Pharmaceuticals Incorporated
Segment by Regions
North America
Europe
China
Japan
Southeast Asia
India
Segment by Type
Oncology
Anti-Viral
Neurology
Others
Segment by Application
Hospitals
Clinics
Ambulatory Services
Table of Contents
Executive Summary
1 Industry Overview of Breakthrough Therapy Drugs
1.1 Definition of Breakthrough Therapy Drugs
1.2 Breakthrough Therapy Drugs Segment by Type
1.2.1 Global Breakthrough Therapy Drugs Production Growth Rate Comparison by Types (2014-2025)
1.2.2 Oncology
1.2.3 Anti-Viral
1.2.4 Neurology
1.2.5 Others
1.3 Breakthrough Therapy Drugs Segment by Applications
1.3.1 Global Breakthrough Therapy Drugs Consumption Comparison by Applications (2014-2025)
1.3.2 Hospitals
1.3.3 Clinics
1.3.4 Ambulatory Services
1.4 Global Breakthrough Therapy Drugs Overall Market
1.4.1 Global Breakthrough Therapy Drugs Revenue (2014-2025)
1.4.2 Global Breakthrough Therapy Drugs Production (2014-2025)
1.4.3 North America Breakthrough Therapy Drugs Status and Prospect (2014-2025)
1.4.4 Europe Breakthrough Therapy Drugs Status and Prospect (2014-2025)
1.4.5 China Breakthrough Therapy Drugs Status and Prospect (2014-2025)
1.4.6 Japan Breakthrough Therapy Drugs Status and Prospect (2014-2025)
1.4.7 Southeast Asia Breakthrough Therapy Drugs Status and Prospect (2014-2025)
1.4.8 India Breakthrough Therapy Drugs Status and Prospect (2014-2025)
2 Manufacturing Cost Structure Analysis
2.1 Raw Material and Suppliers
2.2 Manufacturing Cost Structure Analysis of Breakthrough Therapy Drugs
2.3 Manufacturing Process Analysis of Breakthrough Therapy Drugs
2.4 Industry Chain Structure of Breakthrough Therapy Drugs
3 Development and Manufacturing Plants Analysis of Breakthrough Therapy Drugs
3.1 Capacity and Commercial Production Date
3.2 Global Breakthrough Therapy Drugs Manufacturing Plants Distribution
3.3 Major Manufacturers Technology Source and Market Position of Breakthrough Therapy Drugs
3.4 Recent Development and Expansion Plans
4 Key Figures of Major Manufacturers
4.1 Breakthrough Therapy Drugs Production and Capacity Analysis
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 Breakthrough Therapy Drugs Market Professional Survey Report 2019. It is complete Research Study and Industry Analysis of Breakthrough Therapy Drugs market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.