Global Breakthrough Therapies Market Analysis with Forecasts to 2022 | Growth Opportunities

Princeton, NJ -- (SBWire) -- 06/06/2018 --The Global Breakthrough Therapies Market is predicted to grow from $48.8 billion in 2017 to $99.2 billion by 2022, according to a new comprehensive market analysis by Research Cosmos.

The U.S. Food and Drug Administration launched the BTD pathway in 2012 to expedite the approval process for drug candidates that treat serious or life-threatening diseases, and that outperform existing therapies. The European Medicines Agency introduced a similar fast-track program called PRIME (PRIority MEdicines) in March 2016.

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Our analysis of the breakthrough drug market shows companies have an opportunity to leapfrog the lengthy drug approval process by up to three years, generating hundreds of millions of dollars in revenue and maximizing the time their drug is on the market before their patent expires.

Opportunity and Challenges of a Breakthrough Status

Since the BTD pathway was introduced, 141 drugs gained BTD status and 49 have been approved in the U.S. Oncology therapies took the largest share (46.8 %) of the breakthrough designations and $11 billion of the global breakthrough drug market in 2016.

Lessons learned from the breakthrough therapy pioneers show the BTD process can pose a challenge. To take full competitive advantage of the time saved during the approval process, pharmaceutical manufacturers must create new strategies in clinical research, manufacturing, and sales and market campaigns.

Big pharmaceutical and biotech companies were largely the first to enter the BTD market. From their successes and failures, the BCC report found new strategies in clinical research programs, manufacturing, and sales and marketing campaigns will be key to a successful entry into the breakthrough therapy market.

As more companies adapt, our analysis predicts that pharmaceutical and bio tech companies of various sizes will gain a foothold in the breakthrough therapy market with drugs that target a wider variety of diseases.

By 2022, Research Cosmos forecasts drugs that treat rare diseases will generate $1.6 billion in the global breakthrough therapy market, while central nervous system and neurological therapies will generate $8.4 billion and cancer drugs will generate $58.6 billion designated breakthrough therapy sales.

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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

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