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 Scope:

This report highlights the challenges and opportunities of developing breakthrough therapies, it compares and contrasts difference fast track drug development approaches (logistics, criteria, and implications) and the potential risk and rewards of gaining BTD. 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.

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
- 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
- Coverage of the market's dynamics, specifically growth drivers, restraints, and opportunities
- Profiles of major players in the industry

REASONS FOR DOING THE REPORT

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 EMA’s 
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.

SCOPE OF REPORT

This report highlights the challenges and opportunities of developing breakthrough therapies, it compares and contrasts difference fast track drug development approaches (logistics, criteria, and implications) and the potential risk and rewards of gaining BTD. 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.