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:
Attributes | Details |
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Growth Drivers | - Increased Number of Cancer Therapies
- Increasing Number of Molecules Getting BT Status
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Influencing Trends | - Rise in the Healthcare Spending
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Restraints | - High Cost of Breakthrough Therapy
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Road Blocks / Challenges | - Stringent Government Rules and Regulations
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Gaps & Opportunities | - Increasing Prevalence of Cancer Disease
- Growth in the Healthcare Industry
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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
Attributes | Details |
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Study Period | 2017-2027 |
Base Year | 2021 |
Forecast Period | 2022-2027 |
Historical Period | 2017-2021 |
Unit | Value (USD Million) |
Customization Scope | Avail 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.