Bharat Book

Breakthrough Therapies: Market Dynamics & Investment Opportunities

Press Release   •   Jan 31, 2017 13:56 IST

The global market for breakthrough therapy designation drugs should reach $99.2 billion by 2022 from $48.8 billion in 2017 at a compound annual growth rate (CAGR) of 15.2%, from 2017 to 2022.

Report Includes

-An overview of the global markets for breakthrough therapies, their dynamics, and investment opportunities

-Analyses of global market trends, with data from 2015, 2016, and projections of compound annual growth rates (CAGRs) through 2022

-A look at the materials used in the industry ranging from inorganic clays and concrete to iron and steel, and to commodity and specialty polymers

-The challenges and opportunities of developing breakthrough therapies

-A compare and contrast of different fast track drug development approaches (logistics, criteria and implications) and the potential risk and rewards of gaining break through designation

-Analysis of the regulatory environment

-Profiles of major players in the industry



In July 2012, the FDA introduced a new Breakthrough Therapy Designation (BTD) Food and pathway by the Drug Administration Safety and Innovation Act (FDASIA) whereby a development drug can treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. By filing for approval based on compelling Phase 2 data, a BTD product can reach the market up to three years sooner than a drug without the BTD. A similar pathway has been introduced by the EMA (European Medicines Agency) on March 7, 2016, known as the PRIME (PRIority MEdicines).

To date, the main beneficiaries have been big pharma and big biotechs; the majority of approved breakthrough therapies have been in oncology. However, companies are increasingly active in pursuing the use of this new pathway in other areas of therapy including rare diseases, infectious diseases, CNS and neurology, and cardiovascular disease. In 2015, approved breakthrough therapies generated more than $33.6 billion per annum and by 2022 approved, and new BTDs are forecasted to generate over $99.2 billion as companies become more familiar with the BTD process.


The regulators and pharmaceutical industry continue to explore new ways to improve market access to innovative medicines, particularly in areas of high unmet clinical need. The advent of the BTD pathway in the U.S. and the PRIME pathway in Europe is one route by which this can be achieved. Since the BTD pathway was introduced, 141 drugs have been granted BTD and 49 have been approved. Similarly, 18 applications have been submitted and 14 have been granted PRIME status since the EMAs introduction in March 2016. The report discusses the potential challenges and opportunities of utilizing these fast track routes to get new products to market quicker, and the criteria that need to be met in or to do so.


It analyzes BTD in different therapy areas (cardiovascular, central nervous systems and neurology, rare diseases, oncology and other diseases), leading companies, approved and pipeline products, pricing market access and product revenues. It reviews BTD successes and failures and discusses the different business strategies that companies have adopted in order to maximize the competitive advantage of BTD. It summarizes the current regulatory framework and the potential application of BTD in other regions of the world, and the potential to combine BTD with early access to medicine schemes to improve patient access to medicine to treat rare diseases and address areas of high unmet clinical need.


This report provides a detailed analysis of the recent advances in breakthrough therapy designation products and success, and the impact that this fast track route may have on future drug development in the U.S. It provides summaries of products that have received breakthrough therapy designation approval and identifies the market potential through 2022.


Both primary and secondary sources were used in preparing this study. This analysis of breakthrough therapy designation drugs breaks down the market by therapeutic field and also analyzes current and potential opportunities for development. It includes market forecasts from 2015 and forecasts market revenues through 2022.

Table of Contents
1. Introduction
2. Summary
3. Overview
4. Commercial Application Of Breakthrough Therapy Designation
5. Implications Of Breakthrough Therapy Designation On Business Strategy
6. Regulatory Implications And Breakthrough Therapy Designation
7. Company Profiles
8. References
9. Acronyms
10. Endnotes

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