Breakthrough Therapy Comprehensive Study by Application (Oncology, Infectious Diseases, Rare Diseases, Autoimmune Diseases, Pulmonary Diseases, Neurological Disorders, Others), End-users (Hospitals, Clinics, Ambulatory Services), Drug Class (Oncology, Anti-Viral, Neurology, Others) Players and Region - Global Market Outlook to 2027

Breakthrough Therapy Market by XX Submarkets | Forecast Years 2022-2027  

  • Summary
  • Market Segments
  • Table of Content
  • List of Table & Figures
  • Players Profiled
What is Breakthrough Therapy Market Scope?
A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. The factors such as the Increased Number of Cancer Therapies and the Increasing Number of Molecules Getting BT Status are driving the global breakthrough therapy market.

Breakthrough Therapy Market Dynamics:
AttributesDetails
Growth Drivers
  • Increased Number of Cancer Therapies
  • Increasing Number of Molecules Getting BT Status
Influencing Trends
  • Rise in the Healthcare Spending
Restraints
  • High Cost of Breakthrough Therapy
Road Blocks / Challenges
  • Stringent Government Rules and Regulations
Gaps & Opportunities
  • Increasing Prevalence of Cancer Disease
  • Growth in the Healthcare Industry


The Breakthrough Therapy market study is being classified, by Application and major geographies with country level break-up.

The companies are exploring the market by adopting expansions, investments, new service launches and collaborations as their preferred strategies. The players are exploring new geographies through expansions and acquisitions across the globe to gain a competitive advantage through combined collaborations. Analysts at AMA predicts that Players from United States will contribute to the maximum growth of Global Breakthrough Therapy market throughout the predicted period.

C.H. Boehringer Sohn AG & Ko. KG (Germany), Acadia Pharmaceuticals, Inc., GlaxoSmithKline plc. (United Kingdom), AstraZeneca plc (United Kingdom), Merck & Co., Inc. (United States), Pfizer Inc. (United States), AbbVie Inc (United States), Bristol-Myers Squibb Company, Genentech Inc (United States) and Gilead Sciences, Inc. are some of the key players profiled in the study. Additionally, the Players which are also part of the research are Novartis International AG (Switzerland) and Vertex Pharmaceuticals Incorporated.

Segmentation Analysis
Analyst at AMA have segmented the market study of Global Breakthrough Therapy market by Type, Application and Region. On the basis of Type, Hospitals are dominating the market in the year 2021

On the basis of application, Infectious Diseases segment is dominating the market in the year 2021 where as Rare Disease segment stood as second largest market.

On the basis of geography, the market of Breakthrough Therapy has been segmented into South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).

Market Influencers and their Development Strategies
On 8th December 2020, Amgen announced that the FDA has granted Breakthrough Therapy designation to sotorasib, an investigational KRASG12C inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.
On 15th June 2020,Emmes announced that it has funded a Phase 3 clinical trial for a new investigational cell therapy that offers a promising treatment option for patients requiring an allogeneic bone marrow transplant. Emmes' work for Gamida Cell Ltd., an advanced cell therapy company dedicated to finding cures for blood cancers and serious blood diseases, included full-scale clinical trial support for this study, which was carried out at more than 50 sites across the United States, Latin America, Europe, and Asia.
This draught guidance is issued in accordance with the FDA's good guidance practise regulation. When finalised, the draught guidance will represent the FDA's current thinking on Considerations for Rescinding Breakthrough Therapy Designation. It creates no rights for anyone and is not binding on the FDA or the general public. If it satisfies the requirements of the applicable statutes and regulations, you may use an alternative approach.

Key Target Audience
Breakthrough Therapy Providers, Emerging Companies, Research Professionals and End-users

Breakthrough Therapy Market Study: Important Years
AttributesDetails
Study Period2017-2027
Base Year2021
Forecast Period2022-2027
Historical Period2017-2021
UnitValue (USD Million)
Customization ScopeAvail customization with purchase of this report. Add or modify country, region & or narrow down segments in the final scope subject to feasibility


Major Highlights of Market Study

Demand Determinants: Identifying top-notch application and business segments that seek high growth potentials in Breakthrough Therapy Market.

Key Strategic Developments: To target untapped regions more aggressively by focusing on product/service developments, innovation and R & D, new launches, Merger & acquisitions, JVs & partnerships.

Forces & Market Dynamics: Growth drivers, restraints & opportunities available in Breakthrough Therapy industry is examined with reference relevant market sectors and sub-sectors.

Customization available in this Study:
The Study can be customized to meet your requirements. Please connect with our representative, who will ensure you get a report that suits your needs.

To compete effectively, companies also require quantitative estimates of the future growth and qualitative nature of the market. AMA Research features not just specific market sizing estimates, but also includes significant value-added commentary on Technological Trends and Innovations, Regulatory Policies, Market Maturity Indicators, Market Share Movements, New Entrants into the Market & Entry/Exit Barriers, Consumer Demographics, Supporting Company Financial and Cash Flow Planning, Open Up New Markets, To Seize Powerful Market Opportunities, Key Decision in Planning and to Further Expand Market Share, Identify Key Business Segments, Market Proposition & Gap Analysis.

Report Objectives / Segmentation Covered

By Application
  • Oncology
  • Infectious Diseases
  • Rare Diseases
  • Autoimmune Diseases
  • Pulmonary Diseases
  • Neurological Disorders
  • Others
By End-users
  • Hospitals
  • Clinics
  • Ambulatory Services

By Drug Class
  • Oncology
  • Anti-Viral
  • Neurology
  • Others

By Regions
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Taiwan
    • Australia
    • Rest of Asia-Pacific
  • Europe
    • Germany
    • France
    • Italy
    • United Kingdom
    • Netherlands
    • Rest of Europe
  • MEA
    • Middle East
    • Africa
  • North America
    • United States
    • Canada
    • Mexico
  • 1. Market Overview
    • 1.1. Introduction
    • 1.2. Scope/Objective of the Study
      • 1.2.1. Research Objective
  • 2. Executive Summary
    • 2.1. Introduction
  • 3. Market Dynamics
    • 3.1. Introduction
    • 3.2. Market Drivers
      • 3.2.1. Increased Number of Cancer Therapies
      • 3.2.2. Increasing Number of Molecules Getting BT Status
    • 3.3. Market Challenges
      • 3.3.1. Stringent Government Rules and Regulations
    • 3.4. Market Trends
      • 3.4.1. Rise in the Healthcare Spending
  • 4. Market Factor Analysis
    • 4.1. Porters Five Forces
    • 4.2. Supply/Value Chain
    • 4.3. PESTEL analysis
  • 5. Global Breakthrough Therapy, by Application, End-users, Drug Class and Region (value) (2016-2021)
    • 5.1. Introduction
  • 6. Breakthrough Therapy: Manufacturers/Players Analysis
    • 6.1. Company Profile
      • 6.1.1. C.H. Boehringer Sohn AG & Ko. KG (Germany)
        • 6.1.1.1. Business Overview
        • 6.1.1.2. Products/Services Offerings
        • 6.1.1.3. Financial Analysis
        • 6.1.1.4. SWOT Analysis
      • 6.1.2. Acadia Pharmaceuticals, Inc.
        • 6.1.2.1. Business Overview
        • 6.1.2.2. Products/Services Offerings
        • 6.1.2.3. Financial Analysis
        • 6.1.2.4. SWOT Analysis
      • 6.1.3. GlaxoSmithKline plc. (United Kingdom)
        • 6.1.3.1. Business Overview
        • 6.1.3.2. Products/Services Offerings
        • 6.1.3.3. Financial Analysis
        • 6.1.3.4. SWOT Analysis
      • 6.1.4. AstraZeneca plc (United Kingdom)
        • 6.1.4.1. Business Overview
        • 6.1.4.2. Products/Services Offerings
        • 6.1.4.3. Financial Analysis
        • 6.1.4.4. SWOT Analysis
      • 6.1.5. Merck & Co., Inc. (United States)
        • 6.1.5.1. Business Overview
        • 6.1.5.2. Products/Services Offerings
        • 6.1.5.3. Financial Analysis
        • 6.1.5.4. SWOT Analysis
      • 6.1.6. Pfizer Inc. (United States)
        • 6.1.6.1. Business Overview
        • 6.1.6.2. Products/Services Offerings
        • 6.1.6.3. Financial Analysis
        • 6.1.6.4. SWOT Analysis
      • 6.1.7. AbbVie Inc (United States)
        • 6.1.7.1. Business Overview
        • 6.1.7.2. Products/Services Offerings
        • 6.1.7.3. Financial Analysis
        • 6.1.7.4. SWOT Analysis
      • 6.1.8. Bristol-Myers Squibb Company
        • 6.1.8.1. Business Overview
        • 6.1.8.2. Products/Services Offerings
        • 6.1.8.3. Financial Analysis
        • 6.1.8.4. SWOT Analysis
      • 6.1.9. Genentech Inc (United States)
        • 6.1.9.1. Business Overview
        • 6.1.9.2. Products/Services Offerings
        • 6.1.9.3. Financial Analysis
        • 6.1.9.4. SWOT Analysis
      • 6.1.10. Gilead Sciences, Inc.
        • 6.1.10.1. Business Overview
        • 6.1.10.2. Products/Services Offerings
        • 6.1.10.3. Financial Analysis
        • 6.1.10.4. SWOT Analysis
  • 7. Global Breakthrough Therapy Sale, by Application, End-users, Drug Class and Region (value) (2022-2027)
    • 7.1. Introduction
  • 8. Appendix
    • 8.1. Acronyms
  • 9. Methodology and Data Source
    • 9.1. Methodology/Research Approach
      • 9.1.1. Research Programs/Design
      • 9.1.2. Market Size Estimation
      • 9.1.3. Market Breakdown and Data Triangulation
    • 9.2. Data Source
      • 9.2.1. Secondary Sources
      • 9.2.2. Primary Sources
    • 9.3. Disclaimer
List of Tables
  • Table 1. Company Basic Information, Sales Area and Its Competitors
  • Table 2. Company Basic Information, Sales Area and Its Competitors
  • Table 3. Company Basic Information, Sales Area and Its Competitors
  • Table 4. Company Basic Information, Sales Area and Its Competitors
  • Table 5. Company Basic Information, Sales Area and Its Competitors
  • Table 6. Company Basic Information, Sales Area and Its Competitors
  • Table 7. Company Basic Information, Sales Area and Its Competitors
  • Table 8. Company Basic Information, Sales Area and Its Competitors
  • Table 9. Company Basic Information, Sales Area and Its Competitors
  • Table 10. Company Basic Information, Sales Area and Its Competitors
  • Table 11. Research Programs/Design for This Report
  • Table 12. Key Data Information from Secondary Sources
  • Table 13. Key Data Information from Primary Sources
List of Figures
  • Figure 1. Porters Five Forces
  • Figure 2. Supply/Value Chain
  • Figure 3. PESTEL analysis
  • Figure 4. C.H. Boehringer Sohn AG & Ko. KG (Germany) Revenue, Net Income and Gross profit
  • Figure 5. C.H. Boehringer Sohn AG & Ko. KG (Germany) Revenue: by Geography 2021
  • Figure 6. Acadia Pharmaceuticals, Inc. Revenue, Net Income and Gross profit
  • Figure 7. Acadia Pharmaceuticals, Inc. Revenue: by Geography 2021
  • Figure 8. GlaxoSmithKline plc. (United Kingdom) Revenue, Net Income and Gross profit
  • Figure 9. GlaxoSmithKline plc. (United Kingdom) Revenue: by Geography 2021
  • Figure 10. AstraZeneca plc (United Kingdom) Revenue, Net Income and Gross profit
  • Figure 11. AstraZeneca plc (United Kingdom) Revenue: by Geography 2021
  • Figure 12. Merck & Co., Inc. (United States) Revenue, Net Income and Gross profit
  • Figure 13. Merck & Co., Inc. (United States) Revenue: by Geography 2021
  • Figure 14. Pfizer Inc. (United States) Revenue, Net Income and Gross profit
  • Figure 15. Pfizer Inc. (United States) Revenue: by Geography 2021
  • Figure 16. AbbVie Inc (United States) Revenue, Net Income and Gross profit
  • Figure 17. AbbVie Inc (United States) Revenue: by Geography 2021
  • Figure 18. Bristol-Myers Squibb Company Revenue, Net Income and Gross profit
  • Figure 19. Bristol-Myers Squibb Company Revenue: by Geography 2021
  • Figure 20. Genentech Inc (United States) Revenue, Net Income and Gross profit
  • Figure 21. Genentech Inc (United States) Revenue: by Geography 2021
  • Figure 22. Gilead Sciences, Inc. Revenue, Net Income and Gross profit
  • Figure 23. Gilead Sciences, Inc. Revenue: by Geography 2021
List of companies from research coverage that are profiled in the study
  • C.H. Boehringer Sohn AG & Ko. KG (Germany)
  • Acadia Pharmaceuticals, Inc.
  • GlaxoSmithKline plc. (United Kingdom)
  • AstraZeneca plc (United Kingdom)
  • Merck & Co., Inc. (United States)
  • Pfizer Inc. (United States)
  • AbbVie Inc (United States)
  • Bristol-Myers Squibb Company
  • Genentech Inc (United States)
  • Gilead Sciences, Inc.
Additional players considered in the study are as follows:
Novartis International AG (Switzerland) , Vertex Pharmaceuticals Incorporated
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Aug 2022 197 Pages 94 Tables Base Year: 2021 Coverage: 15+ Companies; 18 Countries

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Frequently Asked Questions (FAQ):

The prominent players of Global Breakthrough Therapy market are C.H. Boehringer Sohn AG & Ko. KG (Germany), Acadia Pharmaceuticals, Inc., GlaxoSmithKline plc. (United Kingdom), AstraZeneca plc (United Kingdom), Merck & Co., Inc. (United States), Pfizer Inc. (United States), AbbVie Inc (United States), Bristol-Myers Squibb Company, Genentech Inc (United States) and Gilead Sciences, Inc..
In this highly competitive & fast evolving Breakthrough Therapy industry, the top strategic priorities would remain consistent like innovation, R&D, and M&A.
Oncology, Infectious Diseases, Rare Diseases, Autoimmune Diseases, Pulmonary Diseases, Neurological Disorders and Others are the potential customers of Breakthrough Therapy industry.

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