Breakthrough Therapy Designation Market by Applications (Rare Diseases, Oncology, Autoimmune Diseases, Infectious Diseases, Neurology Diseases, Pulmonary Diseases, and Others) and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021-2028
The global breakthrough therapy designation market size is estimated to expand at a significant CAGR during the forecast period, 2021-2028. The growth of the market is attributed to increase in demand for cancer treatment and requirement for treatment drugs for rare diseases along with rise in the number of molecules achieving breakthrough therapy status. Moreover, the increase in the incidence of cancer cases is also expected to boost the growth of the market.
Breakthrough therapy is a process originated to accelerate the development and evaluation of new drugs in order to treat a significant health condition and determines whether the trials conducted prior to phase I trials are effective or not. The effectiveness of the therapy is dependent on a key factor on what duration the therapy is effective and the final outcome of the therapy. In order to achieve success by breakthrough therapy, the trials conducted in the research phase is required to show a clear advantage over the other therapies that are available and currently in use.
The US Food and Drugs Administration (FDA) has approved numerous drugs over the years but several of these drugs as breakthrough therapy have failed in the last stages of the trials as they were unable to provide desirable results. For example, a tylenol-sized capsule named SER 109 was granted as breakthrough therapy in 2015 for the treatment of Clostridium Difficile Infection (CDI) but has failed in the phase II trials for the prevention of recurring of the infection. There is a large share of the market for generic medicines in developing countries such as China and India attributed to shallow spending on healthcare and unfavorable IP laws. Whereas, South Africa and Saudi Arabia have profitable markets for breakthrough therapy drugs attributed to high spending power as compared to other countries.
The outbreak of COVID-19 had a negative impact on the market as the process of approval and launch of a product is delayed due to the reduction in the approval of non-COVID therapies by FDA. The process of research and development has been also slowed down along with trials in order to reduce the spread of infection among the participants.
Market Trends, Drivers, Restraints, and Opportunities
- Increase introduction of new and innovative drugs providing effective and show quick results is a major factor propelling the market growth.
- Rise in the drugs approval by several regulatory bodies especially FDA for the treatment of rare disease and oncology is expected to boost the growth of the market.
- Development of Intellectual Property (IP) rights and laws along with increase in expenditure for healthcare are anticipated to drive the market expansion.
- Increase in the number of healthcare initiatives taken by various governments to create awareness regarding breakthrough therapy designation is another key driving factor of the market.
- Low success rate of clinical trials for breakthrough therapy designation is expected to hamper the market growth and prove to be a major restraining factor of the market.
Scope of the Report
The report on the global breakthrough therapy designation market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes |
Details |
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Report Title |
Breakthrough Therapy Designation Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast |
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Base Year |
2020 |
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Historic Data |
2018–2019 |
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Forecast Period |
2021–2028 |
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Segmentation |
Applications (Rare Diseases, Oncology, Autoimmune Diseases, Infectious Diseases, Neurology Diseases, Pulmonary Diseases, and Others) |
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Regional Scope |
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
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Report Coverage |
Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast |
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Key Players Covered in the Report |
F. Hoffmann-La Roche Ltd.; Gilead; Novartis AG; Pfizer Inc.; AbbVie Inc.; Janssen Global Services LLC; Bristol-Myers Squibb Co.; Eli Lilly and Co.; Sanofi; Regeneron; Acadia Pharmaceuticals Inc.; Boehringer Ingelheim GmbH; Amgen Inc.; AstraZeneca; and GlaxoSmithKline plc. |
Market Segment Insights
Rare disease segment is estimated to grow at a rapid pace
On the basis of applications, the breakthrough therapy designation market is segmented into rare diseases, oncology, autoimmune diseases, infectious diseases, neurology diseases, pulmonary diseases, and others. The infectious disease segment held a major share of the market in 2019 owing to a rise in sales of breakthrough therapy drugs such as Sovaldi and Harvoni. Moreover, several anti-infective drugs are achieving the title of breakthrough therapy status. However, a great competition is taking place in the hepatitis C market and a decline has also been observed in the sales of such drugs that are expected to hinder the infectious disease segment. The oncology segment, on the other hand, is anticipated to exhibit a healthy growth rate during the forecast period owing to increase in number of anti-cancer drugs achieving the breakthrough therapy status. As per the statistics of 2016, the anti-cancer drugs were the most in number in achieving the breakthrough therapy status, which is anticipated to propel the oncology segment in the coming years.
Meanwhile, the rare disease segment is estimated to grow at a rapid pace during the forecast period owing to an increase in the number of molecules authorized for rare diseases. Those drugs developed for the rare diseases treatment, if able to analyze, treat or prevent the disease, are given the title of Orphan Drug and are also given 50% of tax credit in the U.S. The most selling medicine for rare disease was Asfotase Alfa in 2016. The rare disease segment does not consist of rare cancer diseases as they are already covered in the oncology segment. A report by FDA entitled, “Insights into Rare Disease Drug Approval: Trends and Recent Developments” states that 23% of the total breakthrough therapy is accounted for rare diseases that do not include rare cancer diseases.
Asia Pacific is anticipated to exhibit a high CAGR
In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America held a dominant share of the market in 2019 due to the existing favorable legislative frameworks and Intellectual Property (IP) laws. Other major driving factors for the regional market growth are the increasing incidence of chronic diseases, improving healthcare access, and rising demand for innovative drugs by consumers in the region. Europe is the second-largest market for breakthrough therapy and is projected to hold a considerable market share in the coming years owing to favorable reimbursement policies and better infrastructure in the region.
However, the market Asia Pacific is anticipated to exhibit a high CAGR during the forecast period owing to the build-up of profitable Intellectual Property (IP) laws and increase in expenditure for healthcare. One of the challenges in India and China in the growth of innovative medicines is the inclination of consumers towards generic medicines.
2. Assumptions and Acronyms Used
3. Research Methodology
4. Breakthrough Therapy Designation Market Overview
4.1. Introduction
4.1.1. Market Taxonomy
4.1.2. Market Definition
4.2. Macro-Economic Factors
4.2.1. Industry Outlook
4.3. Breakthrough Therapy Designation Market Dynamics
4.3.1. Market Drivers
4.3.2. Market Restraints
4.3.3. Opportunity
4.3.4. Market Trends
4.4. Breakthrough Therapy Designation Market - Supply Chain
4.5. Global Breakthrough Therapy Designation Market Forecast
4.5.1. Breakthrough Therapy Designation Market Size (US$ Mn) and Y-o-Y Growth
4.5.2. Breakthrough Therapy Designation Market Size (000’ Units) and Y-o-Y Growth
4.5.3. Breakthrough Therapy Designation Market Absolute $ Opportunity
5. Global Breakthrough Therapy Designation Market Analysis and Forecast by Applications
5.1. Market Trends
5.2. Introduction
5.2.1. Basis Point Share (BPS) Analysis by Applications
5.2.2. Y-o-Y Growth Projections by Applications
5.3. Breakthrough Therapy Designation Market Size and Volume Forecast by Applications
5.3.1. Rare Diseases
5.3.2. Oncology
5.3.3. Autoimmune Diseases
5.3.4. Infectious Diseases
5.3.5. Neurology Diseases
5.3.6. Pulmonary Diseases
5.3.7. Others
5.4. Absolute $ Opportunity Assessment by Applications
5.5. Market Attractiveness/Growth Potential Analysis by Applications
6. Global Breakthrough Therapy Designation Market Analysis and Forecast by Region
6.1. Market Trends
6.2. Introduction
6.2.1. Basis Point Share (BPS) Analysis by Region
6.2.2. Y-o-Y Growth Projections by Region
6.3. Breakthrough Therapy Designation Market Size and Volume Forecast by Region
6.3.1. North America
6.3.2. Latin America
6.3.3. Europe
6.3.4. Asia Pacific
6.3.5. Middle East and Africa (MEA)
6.4. Absolute $ Opportunity Assessment by Region
6.5. Market Attractiveness/Growth Potential Analysis by Region
6.6. Global Breakthrough Therapy Designation Demand Share Forecast, 2019-2026
7. North America Breakthrough Therapy Designation Market Analysis and Forecast
7.1. Introduction
7.1.1. Basis Point Share (BPS) Analysis by Country
7.1.2. Y-o-Y Growth Projections by Country
7.2. North America Breakthrough Therapy Designation Market Size and Volume Forecast by Country
7.2.1. U.S.
7.2.2. Canada
7.3. Absolute $ Opportunity Assessment by Country
7.4. North America Breakthrough Therapy Designation Market Size and Volume Forecast by Applications
7.4.1. Rare Diseases
7.4.2. Oncology
7.4.3. Autoimmune Diseases
7.4.4. Infectious Diseases
7.4.5. Neurology Diseases
7.4.6. Pulmonary Diseases
7.4.7. Others
7.5. Basis Point Share (BPS) Analysis by Applications
7.6. Y-o-Y Growth Projections by Applications
7.7. Market Attractiveness/Growth Potential Analysis
7.7.1. By Country
7.7.2. By Product Type
7.7.3. By Application
7.8. North America Breakthrough Therapy Designation Demand Share Forecast, 2019-2026
8. Latin America Breakthrough Therapy Designation Market Analysis and Forecast
8.1. Introduction
8.1.1. Basis Point Share (BPS) Analysis by Country
8.1.2. Y-o-Y Growth Projections by Country
8.1.3. Latin America Average Pricing Analysis
8.2. Latin America Breakthrough Therapy Designation Market Size and Volume Forecast by Country
8.2.1. Brazil
8.2.2. Mexico
8.2.3. Rest of Latin America
8.3. Absolute $ Opportunity Assessment by Country
8.4. Latin America Breakthrough Therapy Designation Market Size and Volume Forecast by Applications
8.4.1. Rare Diseases
8.4.2. Oncology
8.4.3. Autoimmune Diseases
8.4.4. Infectious Diseases
8.4.5. Neurology Diseases
8.4.6. Pulmonary Diseases
8.4.7. Others
8.5. Basis Point Share (BPS) Analysis by Applications
8.6. Y-o-Y Growth Projections by Applications
8.7. Market Attractiveness/Growth Potential Analysis
8.7.1. By Country
8.7.2. By Product Type
8.7.3. By Application
8.8. Latin America Breakthrough Therapy Designation Demand Share Forecast, 2019-2026
9. Europe Breakthrough Therapy Designation Market Analysis and Forecast
9.1. Introduction
9.1.1. Basis Point Share (BPS) Analysis by Country
9.1.2. Y-o-Y Growth Projections by Country
9.1.3. Europe Average Pricing Analysis
9.2. Europe Breakthrough Therapy Designation Market Size and Volume Forecast by Country
9.2.1. Germany
9.2.2. France
9.2.3. Italy
9.2.4. U.K.
9.2.5. Spain
9.2.6. Russia
9.2.7. Rest of Europe
9.3. Absolute $ Opportunity Assessment by Country
9.4. Europe Breakthrough Therapy Designation Market Size and Volume Forecast by Applications
9.4.1. Rare Diseases
9.4.2. Oncology
9.4.3. Autoimmune Diseases
9.4.4. Infectious Diseases
9.4.5. Neurology Diseases
9.4.6. Pulmonary Diseases
9.4.7. Others
9.5. Basis Point Share (BPS) Analysis by Applications
9.6. Y-o-Y Growth Projections by Applications
9.7. Market Attractiveness/Growth Potential Analysis
9.7.1. By Country
9.7.2. By Product Type
9.7.3. By Application
9.8. Europe Breakthrough Therapy Designation Demand Share Forecast, 2019-2026
10. Asia Pacific Breakthrough Therapy Designation Market Analysis and Forecast
10.1. Introduction
10.1.1. Basis Point Share (BPS) Analysis by Country
10.1.2. Y-o-Y Growth Projections by Country
10.1.3. Asia Pacific Average Pricing Analysis
10.2. Asia Pacific Breakthrough Therapy Designation Market Size and Volume Forecast by Country
10.2.1. China
10.2.2. Japan
10.2.3. South Korea
10.2.4. India
10.2.5. Australia
10.2.6. Rest of Asia Pacific (APAC)
10.3. Absolute $ Opportunity Assessment by Country
10.4. Asia Pacific Breakthrough Therapy Designation Market Size and Volume Forecast by Applications
10.4.1. Rare Diseases
10.4.2. Oncology
10.4.3. Autoimmune Diseases
10.4.4. Infectious Diseases
10.4.5. Neurology Diseases
10.4.6. Pulmonary Diseases
10.4.7. Others
10.5. Basis Point Share (BPS) Analysis by Applications
10.6. Y-o-Y Growth Projections by Applications
10.7. Market Attractiveness/Growth Potential Analysis
10.7.1. By Country
10.7.2. By Product Type
10.7.3. By Application
10.8. Asia Pacific Breakthrough Therapy Designation Demand Share Forecast, 2019-2026
11. Middle East & Africa Breakthrough Therapy Designation Market Analysis and Forecast
11.1. Introduction
11.1.1. Basis Point Share (BPS) Analysis by Country
11.1.2. Y-o-Y Growth Projections by Country
11.1.3. Middle East & Africa Average Pricing Analysis
11.2. Middle East & Africa Breakthrough Therapy Designation Market Size and Volume Forecast by Country
11.2.1. Saudi Arabia
11.2.2. South Africa
11.2.3. UAE
11.2.4. Rest of Middle East & Africa (MEA)
11.3. Absolute $ Opportunity Assessment by Country
11.4. Middle East & Africa Breakthrough Therapy Designation Market Size and Volume Forecast by Applications
11.4.1. Rare Diseases
11.4.2. Oncology
11.4.3. Autoimmune Diseases
11.4.4. Infectious Diseases
11.4.5. Neurology Diseases
11.4.6. Pulmonary Diseases
11.4.7. Others
11.5. Basis Point Share (BPS) Analysis by Applications
11.6. Y-o-Y Growth Projections by Applications
11.7. Market Attractiveness/Growth Potential Analysis
11.7.1. By Country
11.7.2. By Product Type
11.7.3. By Application
11.8. Middle East & Africa Breakthrough Therapy Designation Demand Share Forecast, 2019-2026
12. Competition Landscape
12.1. Global Breakthrough Therapy Designation Market: Market Share Analysis
12.2. Breakthrough Therapy Designation Distributors and Customers
12.3. Breakthrough Therapy Designation Market: Competitive Dashboard
12.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
12.4.1. F. Hoffmann-La Roche Ltd.
12.4.2. Gilead
12.4.3. Novartis AG
12.4.4. Pfizer Inc.
12.4.5. AbbVie Inc.
12.4.6. Janssen Global Services LLC
12.4.7. Bristol-Myers Squibb Co.
12.4.8. Eli Lilly and Co.
The global breakthrough therapy designation market has been segmented on the basis of
Applications
- Rare Diseases
- Oncology
- Autoimmune Diseases
- Infectious Diseases
- Neurology Diseases
- Pulmonary Diseases
- Others
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
- F. Hoffmann-La Roche Ltd.
- Gilead
- Novartis AG
- Pfizer Inc.
- AbbVie Inc.
- Janssen Global Services LLC
- Bristol-Myers Squibb Co.
- Eli Lilly and Co.
- Sanofi
- Regeneron
- Acadia Pharmaceuticals Inc.
- Boehringer Ingelheim GmbH
- Amgen Inc.
- AstraZeneca
- GlaxoSmithKline plc
Key players competing in the global breakthrough therapy designation market are F. Hoffmann-La Roche Ltd.; Gilead; Novartis AG; Pfizer Inc.; AbbVie Inc.; Janssen Global Services LLC; Bristol-Myers Squibb Co.; Eli Lilly and Co.; Sanofi; Regeneron; Acadia Pharmaceuticals Inc.; Boehringer Ingelheim GmbH; Amgen Inc.; AstraZeneca; and GlaxoSmithKline plc. Many of these players have adopted business strategies such as the development of new drugs, introducing new technology, merger, partnership, and production capacity expansion to increase their market position and expand their consumer base globally. Most number of breakthrough therapy drugs is produced in the market by F. Hoffmann-La Roche Ltd.
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