Breakthrough Therapy (BT) Designation Market – By Application (Oncology, Rare Diseases, Infectious Diseases, Neurological Disorders, Autoimmune Diseases, Pulmonary Diseases, Others) By Geography (North America, Europe, Asia-Pacific, Latin America, Middle East & Africa) - Industry Analysis, Opportunity and Forecast 2020 To 2027
Published Date: Aug 2020
No. of Pages: 180
Status: Published
Report Code: ARI100848
Summary
Global Breakthrough Therapy (BT) Designation market, which accumulated revenue worth 46.1 (USD Billion) in 2018 and projected to gather earnings about 70.11 (USD Billion) by 2025, is set to grow at a CAGR of nearly 14.3% during the period from 2019 to 2025.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.
Rising number of molecules gaining BT status, coupled with a hike in the demand for cancer treatments and drugs for rare diseases, is anticipated to boost the market throughout the forecast period. Rising prevalence of cancer and the rise in healthcare expenditure is also projected to back to market growth.
There has been a consistent rise in the number of drugs gaining BT status in the U.S. This is also expected to drive the number of applications submitted for the same, thereby contributing to market growth. An increase in the number of patients preferring innovative medicines in developed countries is also a major factor in boosting the market. The U.S, EU5 regions and Japan are three main markets for BT drugs. The recently expedited agreement process in Europe, which is comparable to that of the U.S., is also projected to boost the number of approvals for BT drugs in the region.
Booming healthcare costs in developing nations and the progress of Intellectual Property (IP) laws are also among factors expected to drive the demand for innovative medicines for the treatment of life-threatening diseases. At present, developing countries such as India and China hold a larger share of the generic medicines market owing to unfavourable IP laws and relatively low healthcare spending. Countries such as Saudi Arabia and South Africa have relatively high spending power, owing to which they are lucrative markets for BT drugs.
Some of the key players in the BT designation market are F. Hoffmann-La Roche Ltd; Novartis AG; Pfizer, Inc.; AbbVie, Inc.; Bristol-Myers Squibb Company; Gilead;Eli Lilly and Company; Sanofi; Regeneron; Janssen Global Services, LLC; Acadia Pharmaceuticals, Inc.; Boehringer Ingelheim GmbH; Amgen, Inc.; AstraZeneca; and GlaxoSmithKline plc.Roche is one of the companies that produce the largest number of BT drugs in the market, and this is expected to significantly boost its revenue over the forecast period.
Analyst Commentary
Risingusage of orphan medicines and large-scale acceptance of BT status in drugs will embellish the market growth over the years ahead. Need for supplying effective drug treatment to patients suffering from life-threatening diseases and need of bringing improvement in disease condition through determining of effective drug therapies will boost the market trends. In addition to this, surge in the healthcare spending in both emerging economies and developed countries will prompt the market size over the forecast timeline. Citing an instance, there has been a prominent surge in the number of medicines getting BT status in the countries such as the U.S.
Furthermore, growth in the infectious diseases and rise in the epidemics like Swine Flu, COVID-19, Ebola, and Bird Flu will generate new growth ways for breakthrough therapy (BT) designation industry in the upcoming years. However, huge costs of the BT designated medicines will restrict the business growth. Likewise, easy availability and low costs of generic medicines will put more brakes on the industry expansion in the years ahead.
Segmentation
The global breakthrough Therapy market can be segmented into two segments, namely, by application and by region. Based on application, the global breakthrough therapy market can be segmented into Oncology, Rare Diseases, Infectious Diseases, Neurological Disorders, Autoimmune Diseases, Pulmonary Diseases and Others. Based on region, the global breakthrough therapy market can be segmented into North America, Europe. Asia-Pacific, Latin America and Middle East & Africa.
Regional Analysis
The expansion of the industry in North American sub-continent over the assessment period is attributed to favourable intellectual property legislations rewarding breakthroughs through data protection and copyright security. In addition to this, easy access to innovative healthcare facilities and surge in the chronic disorders will propagate the market penetration over the forthcoming years.North America is expected to dominate the market over the forecast period owing to well-established intellectual property laws and preference of patients and healthcare professionals for innovative medicines.
The European market is the second major market after North America for BT drugs due to better infrastructure and reimbursement policies. Consumers in this region mostly prefer usingadvanced medicines. According to the European Federation of Pharmaceutical Industries and Associations, diseases linked to the cardiovascular system, cancer, respiratory system, digestive system, and nervous system are among major causes of death in Europe.
Asia Pacific and Latin America are expected to exhibit lucrative growth over the forecast period owing to the development of favourable IP laws and a rise in per capita healthcare expenditure in these regions. Developing countries like as India and China hold a major share of the generic medicines market owing to unfavourable IP laws and relatively low healthcare spending. Arab countries and South Africa have relatively high spending power, owing to which they are lucrative markets for BT drugs.
TABLE OF CONTENTS
Chapter 1. Executive Summary
Chapter 2. Research Methodology
2.1. Research approach
2.2. Scope, definition, and assumptions
2.3. Data sources
2.3.1. Secondary Sources
2.3.1.1. Preliminary data mining
2.3.2. Primary Sources
2.3.2.1. Statistical Model
2.3.2.2. Data Triangulation
2.3.2.3. Research Objective
Chapter 3. Market Outlook
3.1. Introduction
3.2. Key trends
3.2.1. xx
3.3. Market drivers
3.3.1. Impact analysis of Market Drivers
3.4. Market restraints
3.4.1. Impact analysis of Market Restraints
3.5. Market opportunities
3.5.1. Impact analysis of Market Opportunities
3.6. Market Challenges
3.6.1. Impact analysis of Market Trends
3.7. Porter’s Five Forces’ analysis
3.7.1. Bargaining Power of Suppliers
3.7.2. Bargaining Power of Buyers
3.7.3. Threat of New Entrant
3.7.4. Threat of Substitutes
3.7.5. High Competitive Rivalry
3.8. Value chain analysis
Chapter 4. COVID-19 Impact On Breakthrough Therapy (BT) Designation Market
Chapter 5. Global Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
5.1. Global Breakthrough Therapy (BT) Designation Market Share, By Applications, 2015 - 2027(USD Million)
5.1.1. Oncology
5.1.1.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.1.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
5.1.2. Rare Diseases
5.1.2.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.2.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
5.1.3. Infectious Diseases
5.1.3.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.3.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
5.1.3.3.
5.1.4. Neurological Disorders
5.1.4.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.4.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
5.1.5. Autoimmune Diseases
5.1.5.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.5.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
5.1.6. Pulmonary Diseases
5.1.6.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.6.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
5.1.7. Others
5.1.7.1. Market Size and Projections,2015 - 2027 (USD Million)
5.1.7.2. Market Size and Projections, by Region, 2015 - 2027 (USD Million)
Chapter 6. Global Breakthrough Therapy (BT) Designation Market Overview, By Geography, 2015 - 2027(USD Million)
6.1. Global Breakthrough Therapy (BT) Designation Market Share, By Geography, 2015 - 2027(USD Million)
6.1.1. Market Size and projections, by Countries, 2015 - 2027(USD Million)
6.1.2. Market Share and CAGR Comparison, by Countries, 2020 - 2027 (%)
Chapter 7. North America Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
7.1. North America Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
7.1.1. Market Size and projections, 2015 - 2027(USD Million)
7.1.2. North America Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
7.1.3. North America Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
7.1.3.1. U.S. Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
7.1.3.1.1. Market Size and projections, 2015 - 2027(USD Million)
7.1.3.1.2. U.S. Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
7.1.3.2. Canada Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
7.1.3.2.1. Market Size and projections, 2015 - 2027(USD Million)
7.1.3.2.2. Canada Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
7.1.3.3. Mexico Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
7.1.3.3.1. Market Size and projections, 2015 - 2027(USD Million)
7.1.3.3.2. Mexico Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
Chapter 8. Europe Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
8.1. Europe Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
8.1.1. Market Size and projections, 2015 - 2027(USD Million)
8.1.2. Europe Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
8.1.3. Europe Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
8.1.3.1. Germany
8.1.3.1.1. Market Size and projections, 2015 - 2027(USD Million)
8.1.3.1.2. Germany Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
8.1.3.2. France
8.1.3.2.1. Market Size and projections, 2015 - 2027(USD Million)
8.1.3.2.2. France Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
8.1.3.3. UK
8.1.3.3.1. Market Size and projections, 2015 - 2027(USD Million)
8.1.3.3.2. UK Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
8.1.3.4. Italy
8.1.3.4.1. Market Size and projections, 2015 - 2027(USD Million)
8.1.3.4.2. Italy Breakthrough Therapy (BT) Designation Market Overview, By Applications2015 - 2027(USD Million)
8.1.3.5. Spain
8.1.3.5.1. Market Size and projections, 2015 - 2027(USD Million)
8.1.3.5.2. Spain Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
8.1.3.6. Rest of Europe
8.1.3.6.1. Market Size and projections, 2015 – 2027
8.1.3.6.2. Rest of Europe Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
Chapter 9. Asia Pacific Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
9.1. Asia Pacific Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
9.1.1. Market Size and projections, 2015 - 2027(USD Million)
9.1.2. Asia Pacific Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
9.1.3. Asia Pacific Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
9.1.3.1. India
9.1.3.1.1. Market Size and projections, 2015 - 2027(USD Million)
9.1.3.1.2. India Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
9.1.3.1.3. Other Segments
9.1.3.2. China
9.1.3.2.1. Market Size and projections, 2015 - 2027(USD Million)
9.1.3.2.2. China Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
9.1.3.3. Japan
9.1.3.3.1. Market Size and projections, 2015 - 2027(USD Million)
9.1.3.3.2. Japan Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
9.1.3.4. South Korea
9.1.3.4.1. Market Size and projections, 2015 - 2027(USD Million)
9.1.3.4.2. South Korea Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
9.1.3.5. Rest of Asia Pacific
9.1.3.5.1. Market Size and projections, 2015 - 2027(USD Million)
9.1.3.5.2. Rest of Asia Pacific Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
Chapter 10. Middle East & Africa Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
10.1. Middle East & Africa Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
10.1.1. Market Size and projections, 2015 - 2027(USD Million)
10.1.2. Middle East & Africa Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
10.1.3. Middle East & Africa Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
10.1.3.1. GCC
10.1.3.1.1. Market Size and projections, 2015 - 2027(USD Million)
10.1.3.1.2. GCC Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
10.1.3.2. South Africa
10.1.3.2.1. Market Size and projections, 2015 - 2027 (USD Million)
10.1.3.2.2. South Africa Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
10.1.3.3. Rest of Middle East & Africa
10.1.3.3.1. Market Size and projections, 2015 - 2027(USD Million)
10.1.3.3.2. Rest of Middle East & Africa Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
Chapter 11. South America Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015 - 2027(USD Million)
11.1. South America Breakthrough Therapy (BT) Designation Market Overview, 2015 - 2027(USD Million)
11.1.1. Market Size and projections, 2015 - 2027(USD Million)
11.1.2. South America Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027 (USD Million)
11.1.3. South America Breakthrough Therapy (BT) Designation Market Overview, By Countries, 2015- 2026 (USD Million)
11.1.4. Brazil
11.1.4.1. Market Size and projections, 2015 - 2027(USD Million)
11.1.4.2. Brazil Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
11.1.5. Argentina
11.1.5.1. Market Size and projections, 2015 - 2027(USD Million)
11.1.5.2. Argentina Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
11.1.6. Rest of South America
11.1.6.1. Market Size and projections, 2015 – 2027
11.1.6.2. Rest of South America Breakthrough Therapy (BT) Designation Market Overview, By Applications, 2015 - 2027(USD Million)
Chapter 12. Competitive Landscape
12.1. Competitive environment, 2020
12.2. Strategic framework
12.2.1. Partnership/agreement
12.2.2. Expansion
12.2.3. Mergers & Acquisitions
12.2.4. New Offering development
Chapter 13. Key Vendor Analysis
13.1. F. Hoffmann-La Roche Ltd
13.1.1. Company overview
13.1.2. Financial performance
13.1.3. Mice Benchmarking
13.1.4. Recent initiatives
13.1.5. SWOT analysis
13.2. Novartis AG
13.2.1. Company overview
13.2.2. Financial performance
13.2.3. Mice Benchmarking
13.2.4. Recent initiatives
13.2.5. SWOT analysis
13.3. PFIZER, INC
13.3.1. Company overview
13.3.2. Financial performance
13.3.3. Mice Benchmarking
13.3.4. Recent initiatives
13.4. AbbVie, Inc
13.5. Bristol-Myers Squibb Company
13.6. Gilead
13.7. Eli Lilly
13.8. Others
Chapter 14. Breakthrough Therapy (BT) Designation Market Cost Analysis
14.1. Breakthrough Therapy (BT) Designation Market Cost Analysis
14.1.1. Key Offering
14.1.2. Price Trend of Key Raw Material
14.1.3. Key Suppliers
14.1.4. Labor Cost
Chapter 15. Industrial Chain, Sourcing Strategy and Downstream Buyers
15.1. Breakthrough Therapy (BT) Designation Market Industrial Chain Analysis
15.2. Upstream Offering
15.3. Raw Material Sources of Breakthrough Therapy (BT) Designation Market Major Manufacturers in 2021
15.4. Downstream Buyers
Chapter 16. Marketing Strategy Analysis, Distributors/Oncology
16.1. Marketing Channel
16.1.1. Direct Marketing
16.1.2. Indirect Marketing
16.1.3. Marketing Channel Development Trend
16.2. Market Positioning
16.2.1. Pricing Strategy
16.2.2. Brand Strategy
16.2.3. Target Client
16.3. Distributors/Oncology List
Chapter 17. Market Effect Factors Analysis
17.1. Technology Progress/Risk
17.1.1. Substitutes Threat
17.1.2. Technology Progress in Related Size
17.2. Consumer Needs/Customer Preference Change
17.3. Economic/Political Environmental Change
Chapter 18. Future Outlook of the Market
Disclaimer
List of Figures
1. Market segmentation
2. Value chain analysis
3. Porter’s Five Forces’ analysis
4. Power of Suppliers
5. Power of Buyers
6. Threat of New Entrants
7. Threat of Substitute
8. Competitive Rivalry
9. Global Breakthrough Therapy (BT) Designation Market share, by Applications, 2020 & 2027 (%)
10. Global Breakthrough Therapy (BT) Designation Market share, by Oncology, by Applications, 2015 - 2027 (USD Million)
11. Global Breakthrough Therapy (BT) Designation Market share, by Rare Diseases, by Applications, 2015 - 2027 (USD Million)
12. Global Breakthrough Therapy (BT) Designation Market share, by Infectious Diseases, by Applications, 2015 - 2027 (USD Million)
13. Global Breakthrough Therapy (BT) Designation Market share, by Neurological Disorders, by Applications, 2015 - 2027 (USD Million)
14. Global Breakthrough Therapy (BT) Designation Market share, by Autoimmune Diseases, by Applications, 2015 - 2027 (USD Million)
15. Global Breakthrough Therapy (BT) Designation Market share, by Pulmonary Diseases, by Applications, 2015 - 2027 (USD Million)
16. Global Breakthrough Therapy (BT) Designation Market share, by Others, by Applications, 2015 - 2027 (USD Million)
17. Global Breakthrough Therapy (BT) Designation Market share, by region, 2020 & 2027 (%)
18. Global Breakthrough Therapy (BT) Designation Market share, by region, 2015 - 2027(USD Million)
19. North America Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
20. North America Breakthrough Therapy (BT) Designation Market share, by Countries, 2020 & 2027 (%)
21. U.S. Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
22. Canada Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
23. Europe Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
24. Europe Breakthrough Therapy (BT) Designation Market share, by Countries, 2020 & 2027 (%)
25. Spain Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
26. UK Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
27. Italy Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
28. Germany Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
29. France Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
30. Rest of Europe Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
31. Asia-Pacific Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
32. Asia-Pacific Breakthrough Therapy (BT) Designation Market share, by Countries, 2020 & 2027 (%)
33. China Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
34. India Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
35. Australia Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
36. Japan Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
37. Rest of Asia-Pacific Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
38. Middle East & Africa Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
39. Middle East & Africa Breakthrough Therapy (BT) Designation Market share, by Countries, 2020 & 2027 (%)
40. GCC Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
41. South Africa Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
42. Rest of Middle East & Africa Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
43. South America Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
44. Brazil Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
45. Mexico Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
46. Argentina Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
47. Rest of South America Breakthrough Therapy (BT) Designation Market, 2015 - 2027(USD Million)
List of Tables
1. Impact of Market drivers
2. Impact of Market restraints
3. Global Breakthrough Therapy (BT) Designation Market, 2015-2027(USD Million)
4. Weigh-in-motion system requirement, by country, 2015-2027, (USD Million)
5. North America Breakthrough Therapy (BT) Designation Market, by Application, 2015-2027 (USD Million)
6. Europe Breakthrough Therapy (BT) Designation Market, by Application, 2015-2027(USD Million)
7. Asia Pacific Breakthrough Therapy (BT) Designation Market, by Application, 2015-2027(Revenue, USD Million)
8. Middle East & Africa Breakthrough Therapy (BT) Designation Market, by Application, 2015-2027(USD Million)
9. South America Breakthrough Therapy (BT) Designation Market, by Application, 2015-2027(USD Million)
10. Global Breakthrough Therapy (BT) Designation Market, Company Market Share, 2020 - 2027 (%)
11. Kapsch TrafficCom : Product Benchmarking
12. Kapsch TrafficCom : Financial Performance
13. Novartis AG : Product Benchmarking
14. Novartis AG : Financial Performance
15. PFIZER, INC : Product Benchmarking
16. PFIZER, INC : Financial Performance
17. AbbVie, Inc :Product Benchmarking
18. AbbVie, Inc :Financial Performance
19. Bristol-Myers Squibb Company : Product Benchmarking
20. Bristol-Myers Squibb Company : Financial Performance
21. Gilead : Product Benchmarking
22. Gilead : Financial Performance
23. Eli Lilly : Product Benchmarking
24. Eli Lilly : Financial Performance
The Leading Key Players in Breakthrough Therapy Bt Designation Market
