Global Breakthrough Therapy (BT) Designation Market – Industry Trends - Forecast to 2026

  • Medical Devices
  • Upcoming Report
  • Apr 2019
  • Global
  • 350 Pages
  • No of Tables: 60
  • No of Figures: 220

Global Breakthrough Therapy (BT) Designation Market By Application (Oncology, Infectious Diseases, Rare Diseases, Autoimmune Diseases, Pulmonary Diseases, Neurological Disorders, Others), End- User (Hospital, Clinic, Research Institute, Laboratories), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa)– Industry Trends & Forecast to 2026

Market Analysis: Global Breakthrough Therapy (BT) Designation Market

Global Breakthrough Therapy (BT) Designation Market is expected to rise from its initial estimated value of USD 57.56 billion to an estimated value of USD 167.10 billion by 2026, registering a CAGR of 14.25% in the forecast period of 2019-2026. Increasing demand for cancer therapies is driving the growth of this market.

Market Definition: Global Breakthrough Therapy (BT) Designation Market

Breakthrough therapy is the designation given by the US Food and Drug Administration to a drug if it is able to treat any serious and life- threatening disease. Its main motive is that to make sure that drug is of high- quality and can treat a particular disease. Rising health awareness among consumer is major factor fueling the growth of this market.

Market Drivers

  • Increasing demand for orphan drugs among consumer is driving the growth of this market.
  • Increasing adoption of BT status in molecules is driving the market.

Market Restraints

  • Expensive cost of the BT drug is restraining the growth of this market.
  • Availability of generics is restraining the market growth.

Segmentation: Global Breakthrough Therapy (BT) Designation Market

  • By Application

    •  Oncology
    •  Infectious Diseases
    •  Rare Diseases
    •  Autoimmune Diseases
    •  Pulmonary Diseases
    •  Neurological Disorders
    •  Others

  • By End- User

    •  Hospital
    •  Clinic
    •  Research Institute
    •  Laboratories

  • By Geography

    • North America

      • uS.
      • Canada
      • Mexico

    • South America

      • Brazil
      • Argentina
      • Rest of South America

    • Europe

      • Germany
      • France
      • United Kingdom
      • Italy
      • Spain
      • Russia
      • Turkey
      • Belgium
      • Netherlands
      • Switzerland
      • Rest of Europe

    • Asia-Pacific

      • Japan
      • China
      • South Korea
      • India
      • Australia
      • Singapore
      • Thailand
      • Malaysia
      • Indonesia
      • Philippines
      • Rest of Asia Pacific

    • Middle East & Africa

      • South Africa
      • Egypt
      • Saudi Arabia
      • United Arab Emirates
      • Israel
      • Rest of Middle East & Africa

Key Developments in the Market:

  • In January 2015, Lucentis has got dsignation from US Food and Drug Administration for their Breakthrough Therapy (BT) designation which is specially designed for the diabetic patients. FDA gave them approval on the basis of result of RISE and RIDE phase 3 trials.
  • In April 2015, DBV Technologies announced that there Viaskin Peanut patch has received the Breakthrough Therapy” (BT) designation from the US Food and Drug Administration (FDA). This Viaksin targets the antigen-presenting cells so that they can directly apply superficial layers of the skin.

Competitive Analysis: Global Breakthrough Therapy (BT) Designation Market 

Global breakthrough therapy (BT) designation market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of breakthrough therapy (BT) designation market for global, Europe, North America, Asia Pacific, South America and Middle East & Africa.

Key Market Competitors: Global Breakthrough Therapy (BT) Designation Market 

Few of the major competitors currently working in the breakthrough therapy (BT) designation market are F. Hoffmann-La Roche Ltd, AbbVie Inc., Novartis AG, Janssen Global Services, LLC, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi, ACADIA Pharmaceuticals Inc., Boehringer Ingelheim International GmbH, Amgen Inc, AstraZeneca, GlaxoSmithKline plc., Vertex Pharmaceuticals Incorporated, Alexion, Merck KGaA, Jazz Pharmaceuticals, Inc., Exelixis, Inc., Takeda Pharmaceutical Company Limited.

Research Methodology: Global Breakthrough Therapy (BT) Designation Market

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analysed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more please Request an Analyst Call or can drop down your inquiry.

The key research methodology used by DBMR Research team is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Apart from this, other data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, Top to Bottom Analysis and Vendor Share Analysis. To know more about the research methodology, drop in an inquiry to speak to our industry experts.

Primary Respondents

Demand Side: Doctors, Surgeons, Medical Consultants, Nurses, Hospital Buyers, Group Purchasing Organizations, Associations, Insurers, Medical Payers, Healthcare Authorities, Universities, Technological Writers, Scientists, Promoters, and Investors among others.

Supply Side: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, and Regulatory Affairs Managers among others.

Reasons to Purchase this Report

  • Current and future of global breakthrough therapy (BT) designation market outlook in the developed and emerging markets
  • The segment that is expected to dominate the market as well as the segment which holds highest CAGR in the forecast period
  • Regions/Countries that are expected to witness the fastest growth rates during the forecast period
  • The latest developments, market shares, and strategies that are employed by the major market players

Customization of the Report:

  • All segmentation provided above in this report is represented at country level
  • All products covered in the market, product volume and average selling prices will be included as customizable options which may incur no or minimal additional cost (depends on customization)


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