Breakthrough Therapy Designation Market To Reach $242.7 Billion By 2030

Breakthrough Therapy Designation Market Growth & Trends

The global breakthrough therapy designation market size is anticipated to reach USD 242.7 billion in 2030 and is projected to grow at a CAGR of 14.2% from 2024 to 2030. Breakthrough Therapy (BT) designation is granted to drugs that display substantial results in the treatment of life-threatening diseases in the initial stages of the drug development process. Expedited regulatory process in North America and EU regions is driving growth. An increase in the number of innovative molecules receiving the BT status, coupled with a rise in the demand for orphan drugs as well as those for the treatment of cancer, is anticipated to boost the market over the forecast period.

The development time of BT therapy is 30.0% to 50.0% lesser than those without the designation. This significantly increases the net present value of the investigational molecule. Reduction in the development time of these drugs is expected to accelerate their approval process as compared to standard drugs as well as boost growth opportunities. The BT tag also increases the value of the drug due to its high scientific value.

There has been a consistent rise in the number of drugs receiving BT status in the U.S., and this trend is also expected to drive the number of applications submitted for the same, thereby contributing to the market growth.

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Breakthrough Therapy Designation Market Report Highlights

• Infectious diseases dominated the application segment with a share of 33.5% in 2023 owing to an increase in the sales of popular drugs such as Harvoni and Sovaldi;

• Hospitals led the market and accounted for the largest revenue share of 32.0% in 2023, owing to the large patient volume at the hospitals, which creates a significant demand for advanced treatments

• Clinics witnessed significant growth and are expected to grow at a CAGR of 14.5% over the forecast period

• The North America breakthrough therapy designation market had the largest market share of 41.8% in 2023

• The increasing prevalence of life-threatening conditions and the necessity for the rapid development of pipeline drugs are also some factors that propel the breakthrough therapy drug market

Breakthrough Therapy Designation Market Segmentation

Grand View Research has segmented the global breakthrough therapy designation market report based on application, end use, and region:

Breakthrough Therapy Designation Application Outlook (Revenue, USD Billion, 2018 - 2030)

• Oncology

• Infectious Diseases

• Rare Diseases

• Autoimmune Diseases

• Pulmonary Diseases

• Neurological Disorders

• Others

Breakthrough Therapy Designation End Use Outlook (Revenue, USD Billion, 2018 - 2030)

• Hospitals

• Clinics

• Research Institutes

• Laboratories

• Others

Breakthrough Therapy Designation Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Breakthrough Therapy Designation Market

• F. Hoffmann-La Roche Ltd

• Novartis AG

• Pfizer, Inc.

• AbbVie, Inc.

• Bristol-Myers Squibb Company

• Gilead Sciences, Inc.

• Sanofi

• Regeneron Pharmaceuticals Inc.

• AstraZeneca

• Boehringer Ingelheim GmbH