This strategic report provides a comprehensive analysis of the Global Breakthrough Therapy (BT) Designation Market, assessing the regulatory landscape, therapeutic pipeline value, and growth projections for the period 2026–2036.
Global Breakthrough Therapy (BT) Designation Market Report (2026–2036)
1. Market Executive Summary
The Breakthrough Therapy (BT) Designation market refers to the high-value pharmaceutical and biotechnological pipeline products that have been granted expedited status by regulatory bodies (such as the US FDA, EMA’s PRIME, and China’s NMPA). This designation is reserved for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over existing therapies.
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Estimated Market Pipeline Value (2025): Approximately USD 92.4 Billion.
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Projected Market Pipeline Value (2036): Expected to exceed USD 185 Billion.
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CAGR (2026–2036): Projected at 6.8%.
2. Key Players
The competitive landscape is dominated by large-cap pharmaceutical entities and aggressive mid-cap biotech innovators:
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Roche (Genentech)
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Novartis International AG
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Merck & Co. (MSD)
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Bristol Myers Squibb (BMS)
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Pfizer Inc.
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AbbVie Inc.
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Eli Lilly and Company
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AstraZeneca
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Johnson & Johnson (Janssen)
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Gilead Sciences
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Sanofi / Regeneron
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Amgen Inc.
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GlaxoSmithKline (GSK)
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Takeda Pharmaceutical Company
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Vertex Pharmaceuticals
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Bluebird Bio
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Alnylam Pharmaceuticals
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Moderna, Inc.
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BioNTech SE
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BeiGene
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Genmab A/S
3. Comprehensive Segment Analysis
By Therapeutic Area
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Oncology: Historically the largest segment (over 40% of designations), focused on immuno-oncology and targeted kinase inhibitors.
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Rare/Orphan Diseases: High-growth segment driven by the expansion of gene therapy and protein replacement treatments.
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Infectious Diseases: Accelerated by post-pandemic research into mRNA vaccines and novel anti-virals.
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Neurological Disorders: Focused on Alzheimer’s, Parkinson’s, and ALS, where unmet medical needs are critical.
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Hematology: Breakthroughs in sickle cell disease and hemophilia through CRISPR and cell therapy.
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Autoimmune & Pulmonary: Targeted biologics for severe asthma, COPD, and refractory RA.
By Modality
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Small Molecules: Traditional chemical entities remains significant in CNS and oncology.
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Biologics (Monoclonal Antibodies): The backbone of modern breakthrough designations.
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Cell & Gene Therapy: The fastest-growing modality segment, requiring specialized regulatory "rolling reviews."
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mRNA Technology: Emerging segment for both oncology and prophylactic vaccines.
4. Regional Analysis
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United States (Dominant Hub): The FDA’s BT designation remains the global gold standard. The US accounts for the highest volume of applications and approvals due to robust venture capital and the presence of "Big Pharma" R&D centers.
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Europe (EMA PRIME): The Priority Medicines (PRIME) scheme acts as the European equivalent, focusing heavily on rare diseases and pediatric oncology.
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China (NMPA): The fastest-growing region. Regulatory reforms in China have led to a surge in domestic breakthrough designations, particularly in oncology, to reduce the time-to-market for local patients.
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Japan (Sakigake): The Ministry of Health, Labour and Welfare (MHLW) offers the Sakigake designation, prioritizing innovative drugs developed first in Japan.
5. Porter’s Five Forces Analysis
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Bargaining Power of Suppliers (Moderate): Suppliers of specialized clinical reagents and CRO (Contract Research Organization) services have moderate leverage due to the high-stakes nature of BT trials.
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Bargaining Power of Buyers (Low to Moderate): Payers (governments/insurers) struggle to negotiate prices on BT-designated drugs because they often treat conditions with zero alternative therapies.
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Threat of New Entrants (Low): The extreme cost of R&D and the rigorous requirement for "substantial clinical evidence" act as massive barriers.
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Threat of Substitutes (Moderate): Rival "First-in-Class" drugs within the same therapeutic class can cannibalize market share if they also receive BT designation.
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Competitive Rivalry (High): Intense race between top firms to secure BT status, as it significantly impacts stock valuation and time-to-market.
6. SWOT Analysis
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Strengths: Accelerated approval timelines; frequent interaction with regulatory experts; high investor confidence; premium pricing potential.
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Weaknesses: High cost of specialized manufacturing; heavy reliance on early-phase data which may not translate to Phase III success.
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Opportunities: Expansion into "undruggable" targets using AI-driven discovery; convergence of diagnostics and therapeutics (theranostics).
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Threats: Regulatory pushback if safety signals emerge late; political pressure regarding high drug pricing for breakthrough therapies.
7. Trend Analysis
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AI-Enabled Discovery: Utilizing machine learning to identify molecules with a higher probability of meeting BT criteria early in the pipeline.
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Decentralized Clinical Trials (DCTs): Leveraging digital health tools to accelerate data collection for BT-designated products.
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Combination Breakthroughs: A shift toward designating "combination regimens" (e.g., PD-1 + novel agent) as a single breakthrough therapy.
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Precision Patient Selection: Using biomarkers to identify "super-responders," thereby ensuring "substantial clinical improvement" is met in smaller, faster trials.
8. Drivers & Challenges
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Driver: The rising prevalence of chronic and terminal illnesses with no current cure.
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Driver: Supportive regulatory policies and financial incentives for orphan and breakthrough medications.
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Challenge: The "Pioneer’s Risk"—Developing novel therapies often means creating new endpoints that regulators may not have pre-validated.
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Challenge: Post-market monitoring requirements are exceptionally stringent for drugs approved via accelerated pathways.
9. Value Chain Analysis
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Target Discovery: Identification of the genetic or biological driver of a serious disease.
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Clinical Evidence Generation: Conduct of high-quality Phase I/II trials to secure the BT designation.
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Regulatory Engagement: "Rolling reviews" and intensive guidance meetings with the FDA/EMA.
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Specialized Manufacturing: Scaling up often complex biologics or cell therapies in parallel with clinical trials.
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Commercial Launch & Access: Navigating the "value-based" reimbursement landscape for high-cost therapies.
10. Quick Recommendations for Stakeholders
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For Pharma Companies: Seek BT designation as early as Phase I/II. The "frequent guidance" benefit is often more valuable than the actual speed of review for complex modalities.
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For Investors: Look for "Breakthrough-Heavy" pipelines. BT status is a de-risking signal that significantly improves the probability of technical and regulatory success (PTRS).
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For Healthcare Providers: Prepare for the rapid influx of high-complexity therapies (cell/gene) by investing in specialized clinical infrastructure and patient monitoring systems.
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For Regulatory Affairs Teams: Prioritize high-quality "Preliminary Clinical Evidence" over volume of data. Regulators are looking for "Substantial Improvement," not just incremental gains.
Table of Contents
Global Breakthrough Therapy (BT) Designation global market
1 Industry Overview of Breakthrough Therapy (BT) Designation
1.1 Breakthrough Therapy (BT) Designation Market Overview
1.1.1 Breakthrough Therapy (BT) Designation Product Scope
1.1.2 Market Status and Outlook
1.2 Global Breakthrough Therapy (BT) Designation Market Size and Analysis by Regions ()
1.2.1 United States
1.2.2 Europe
1.2.3 China
1.2.4 Japan
1.2.5 Southeast Asia
1.2.6 India
1.3 Breakthrough Therapy (BT) Designation Market by Type
1.3.1 Oncology
1.3.2 Infectious Diseases
1.3.3 Rare Diseases
1.3.4 Autoimmune Diseases
1.3.5 Pulmonary Diseases
1.3.6 Neurological Disorders
1.3.7 Others
1.4 Breakthrough Therapy (BT) Designation Market by End Users/Application
1.4.1 Hospital
1.4.2 Clinic
1.4.3 Research Institute
1.4.4 Laboratories
2 Global Breakthrough Therapy (BT) Designation Competition Analysis by Players
2.1 Breakthrough Therapy (BT) Designation Market Size (Value) by Players ()
2.2 Competitive Status and Trend
2.2.1 Market Concentration Rate
2.2.2 Product/Service Differences
2.2.3 New Entrants
2.2.4 The Technology Trends in Future
3 Company (Top Players) Profiles
3.1 Roche
3.1.1 Company Profile
3.1.2 Main Business/Business Overview
3.1.3 Products, Services and Solutions
3.1.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.2 Abbvie
3.2.1 Company Profile
3.2.2 Main Business/Business Overview
3.2.3 Products, Services and Solutions
3.2.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.3 Novartis International AG
3.3.1 Company Profile
3.3.2 Main Business/Business Overview
3.3.3 Products, Services and Solutions
3.3.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.4 Janssen
3.4.1 Company Profile
3.4.2 Main Business/Business Overview
3.4.3 Products, Services and Solutions
3.4.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.5 BMS
3.5.1 Company Profile
3.5.2 Main Business/Business Overview
3.5.3 Products, Services and Solutions
3.5.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.6 Eli Lilly
3.6.1 Company Profile
3.6.2 Main Business/Business Overview
3.6.3 Products, Services and Solutions
3.6.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.7 Gilead
3.7.1 Company Profile
3.7.2 Main Business/Business Overview
3.7.3 Products, Services and Solutions
3.7.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.8 Sanofi
3.8.1 Company Profile
3.8.2 Main Business/Business Overview
3.8.3 Products, Services and Solutions
3.8.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.9 Regeneron
3.9.1 Company Profile
3.9.2 Main Business/Business Overview
3.9.3 Products, Services and Solutions
3.9.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.10 Acadia
3.10.1 Company Profile
3.10.2 Main Business/Business Overview
3.10.3 Products, Services and Solutions
3.10.4 Breakthrough Therapy (BT) Designation Revenue (Million USD) ()
3.11 Boehringer Ingelheim
3.12 Amgen
3.13 AstraZeneca
3.14 GlaxoSmithKline
3.15 Vertex
3.16 Alexion
3.17 Merck
3.18 Jazz Pharmaceuticals
3.19 Exelixis
3.20 Eisai
3.21 Takeda
3.22 Pfizer
4 Global Breakthrough Therapy (BT) Designation Market Size by Type and Application ()
4.1 Global Breakthrough Therapy (BT) Designation Market Size by Type ()
4.2 Global Breakthrough Therapy (BT) Designation Market Size by Application ()
4.3 Potential Application of Breakthrough Therapy (BT) Designation in Future
4.4 Top Consumer/End Users of Breakthrough Therapy (BT) Designation
5 United States Breakthrough Therapy (BT) Designation Development Status and Outlook
5.1 United States Breakthrough Therapy (BT) Designation Market Size ()
5.2 United States Breakthrough Therapy (BT) Designation Market Size and Market Share by Players ()
5.3 United States Breakthrough Therapy (BT) Designation Market Size by Application ()
6 Europe Breakthrough Therapy (BT) Designation Development Status and Outlook
6.1 Europe Breakthrough Therapy (BT) Designation Market Size ()
6.2 Europe Breakthrough Therapy (BT) Designation Market Size and Market Share by Players ()
6.3 Europe Breakthrough Therapy (BT) Designation Market Size by Application ()
7 China Breakthrough Therapy (BT) Designation Development Status and Outlook
7.1 China Breakthrough Therapy (BT) Designation Market Size ()
7.2 China Breakthrough Therapy (BT) Designation Market Size and Market Share by Players ()
7.3 China Breakthrough Therapy (BT) Designation Market Size by Application ()
8 Japan Breakthrough Therapy (BT) Designation Development Status and Outlook
8.1 Japan Breakthrough Therapy (BT) Designation Market Size ()
8.2 Japan Breakthrough Therapy (BT) Designation Market Size and Market Share by Players ()
8.3 Japan Breakthrough Therapy (BT) Designation Market Size by Application ()
9 Southeast Asia Breakthrough Therapy (BT) Designation Development Status and Outlook
9.1 Southeast Asia Breakthrough Therapy (BT) Designation Market Size ()
9.2 Southeast Asia Breakthrough Therapy (BT) Designation Market Size and Market Share by Players ()
9.3 Southeast Asia Breakthrough Therapy (BT) Designation Market Size by Application ()
10 India Breakthrough Therapy (BT) Designation Development Status and Outlook
10.1 India Breakthrough Therapy (BT) Designation Market Size ()
10.2 India Breakthrough Therapy (BT) Designation Market Size and Market Share by Players ()
10.3 India Breakthrough Therapy (BT) Designation Market Size by Application ()
11 Market Forecast by Regions, Type and Application ()
11.1 Global Breakthrough Therapy (BT) Designation Market Size (Value) by Regions ()
11.1.1 United States Breakthrough Therapy (BT) Designation Revenue and Growth Rate ()
11.1.2 Europe Breakthrough Therapy (BT) Designation Revenue and Growth Rate ()
11.1.3 China Breakthrough Therapy (BT) Designation Revenue and Growth Rate ()
11.1.4 Japan Breakthrough Therapy (BT) Designation Revenue and Growth Rate ()
11.1.5 Southeast Asia Breakthrough Therapy (BT) Designation Revenue and Growth Rate ()
11.1.6 India Breakthrough Therapy (BT) Designation Revenue and Growth Rate ()
11.2 Global Breakthrough Therapy (BT) Designation Market Size (Value) by Type ()
11.3 Global Breakthrough Therapy (BT) Designation Market Size by Application ()
12 Breakthrough Therapy (BT) Designation Market Dynamics
12.1 Breakthrough Therapy (BT) Designation Market Opportunities
12.2 Breakthrough Therapy (BT) Designation Challenge and Risk
12.2.1 Competition from Opponents
12.2.2 Downside Risks of Economy
12.3 Breakthrough Therapy (BT) Designation Market Constraints and Threat
12.3.1 Threat from Substitute
12.3.2 Government Policy
12.3.3 Technology Risks
12.4 Breakthrough Therapy (BT) Designation Market Driving Force
12.4.1 Growing Demand from Emerging Markets
12.4.2 Potential Application
13 Market Effect Factors Analysis
13.1 Technology Progress/Risk
13.1.1 Substitutes
13.1.2 Technology Progress in Related Industry
13.2 Consumer Needs Trend/Customer Preference
13.3 External Environmental Change
13.3.1 Economic Fluctuations
13.3.2 Other Risk Factors
14 Research Finding/Conclusion
15 Appendix
Methodology
Analyst Introduction
Data Source
List of Tables and Figures
Figure Global Breakthrough Therapy (BT) Designation Market Size (Million USD) Status and Outlook ()
Table Global Breakthrough Therapy (BT) Designation Revenue (Million USD) Comparison by Regions ()
Figure Global Breakthrough Therapy (BT) Designation Market Share by Regions ()
Figure United States Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate by Regions ()
Figure Europe Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate by Regions ()
Figure China Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate by Regions ()
Figure Japan Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate by Regions ()
Figure Southeast Asia Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate by Regions ()
Figure India Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate by Regions ()
Table Global Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate (%) Comparison by Product ()
Figure Global Breakthrough Therapy (BT) Designation Revenue Market Share by Type in 2017
Figure Oncology Market Size (Million USD) and Growth Rate ()
Figure Infectious Diseases Market Size (Million USD) and Growth Rate ()
Figure Rare Diseases Market Size (Million USD) and Growth Rate ()
Figure Autoimmune Diseases Market Size (Million USD) and Growth Rate ()
Figure Pulmonary Diseases Market Size (Million USD) and Growth Rate ()
Figure Neurological Disorders Market Size (Million USD) and Growth Rate ()
Figure Others Market Size (Million USD) and Growth Rate ()
Figure Global Breakthrough Therapy (BT) Designation Market Share by Application in 2017
Figure Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate in Hospital ()
Figure Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate in Clinic ()
Figure Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate in Research Institute ()
Figure Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate in Laboratories ()
Table Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table Roche Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Roche ()
Figure Roche Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Abbvie Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Abbvie ()
Figure Abbvie Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Novartis International AG Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Novartis International AG ()
Figure Novartis International AG Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Janssen Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Janssen ()
Figure Janssen Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table BMS Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of BMS ()
Figure BMS Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Eli Lilly Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Eli Lilly ()
Figure Eli Lilly Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Gilead Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Gilead ()
Figure Gilead Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Sanofi Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Sanofi ()
Figure Sanofi Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Regeneron Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Regeneron ()
Figure Regeneron Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Acadia Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Acadia ()
Figure Acadia Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Boehringer Ingelheim Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Boehringer Ingelheim ()
Figure Boehringer Ingelheim Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table Amgen Basic Information List
Table Breakthrough Therapy (BT) Designation Business Revenue (Million USD) of Amgen ()
Figure Amgen Breakthrough Therapy (BT) Designation Business Revenue Market Share ()
Table AstraZeneca Basic Information List
Table GlaxoSmithKline Basic Information List
Table Vertex Basic Information List
Table Alexion Basic Information List
Table Merck Basic Information List
Table Jazz Pharmaceuticals Basic Information List
Table Exelixis Basic Information List
Table Eisai Basic Information List
Table Takeda Basic Information List
Table Pfizer Basic Information List
Table Global Breakthrough Therapy (BT) Designation Market Size (Million USD) by Product ()
Figure Global Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Product ()
Figure Global Breakthrough Therapy (BT) Designation Market Share by Product in 2017
Table Global Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure Global Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application in 2017
Table Top Consumer/End Users of Breakthrough Therapy (BT) Designation
Figure United States Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate ()
Table United States Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure United States Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure United States Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table United States Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure United States Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application ()
Figure United States Breakthrough Therapy (BT) Designation Market Size Share by Application in 2017
Figure Europe Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate ()
Table Europe Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure Europe Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure Europe Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table Europe Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure Europe Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application ()
Figure Europe Breakthrough Therapy (BT) Designation Market Size Share by Application in 2017
Figure China Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate ()
Table China Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure China Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure China Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table China Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure China Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application ()
Figure China Breakthrough Therapy (BT) Designation Market Size Share by Application in 2017
Figure Japan Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate ()
Table Japan Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure Japan Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure Japan Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table Japan Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure Japan Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application ()
Figure Japan Breakthrough Therapy (BT) Designation Market Size Share by Application in 2017
Figure Southeast Asia Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate ()
Table Southeast Asia Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure Southeast Asia Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure Southeast Asia Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table Southeast Asia Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure Southeast Asia Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application ()
Figure Southeast Asia Breakthrough Therapy (BT) Designation Market Size Share by Application in 2017
Figure India Breakthrough Therapy (BT) Designation Market Size (Million USD) and Growth Rate ()
Table India Breakthrough Therapy (BT) Designation Market Size (Million USD) by Players ()
Figure India Breakthrough Therapy (BT) Designation Market Size Share by Players in 2013
Figure India Breakthrough Therapy (BT) Designation Market Size Share by Players in 2017
Table India Breakthrough Therapy (BT) Designation Market Size by Application ()
Figure India Breakthrough Therapy (BT) Designation Revenue Market Share (%) by Application ()
Figure India Breakthrough Therapy (BT) Designation Market Size Share by Application in 2017
Figure Global Breakthrough Therapy (BT) Designation Market Size and Growth Rate ()
Table Global Breakthrough Therapy (BT) Designation Market Size (Million USD) by Regions ()
Figure Global Breakthrough Therapy (BT) Designation Market Size Share ()
Figure Global Breakthrough Therapy (BT) Designation Market Size Share by Regions in 2025
Figure United States Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate ()
Figure Europe Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate ()
Figure China Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate ()
Figure Japan Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate ()
Figure Southeast Asia Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate ()
Figure India Breakthrough Therapy (BT) Designation Revenue (Million USD) and Growth Rate ()
Table Global Breakthrough Therapy (BT) Designation Market Size (Million USD) by Type ()
Figure Global Breakthrough Therapy (BT) Designation Market Size Share by Type in 2018
Figure Global Breakthrough Therapy (BT) Designation Market Size Share by Type in 2025
Table Global Breakthrough Therapy (BT) Designation Market Size (Million USD) by Application ()
Figure Global Breakthrough Therapy (BT) Designation Market Size (Million USD) by Application in 2018
Key Players
The competitive landscape is dominated by large-cap pharmaceutical entities and aggressive mid-cap biotech innovators:
-
Roche (Genentech)
-
Novartis International AG
-
Merck & Co. (MSD)
-
Bristol Myers Squibb (BMS)
-
Pfizer Inc.
-
AbbVie Inc.
-
Eli Lilly and Company
-
AstraZeneca
-
Johnson & Johnson (Janssen)
-
Gilead Sciences
-
Sanofi / Regeneron
-
Amgen Inc.
-
GlaxoSmithKline (GSK)
-
Takeda Pharmaceutical Company
-
Vertex Pharmaceuticals
-
Bluebird Bio
-
Alnylam Pharmaceuticals
-
Moderna, Inc.
-
BioNTech SE
-
BeiGene
-
Genmab A/S
3. Comprehensive Segment Analysis
By Therapeutic Area
-
Oncology: Historically the largest segment (over 40% of designations), focused on immuno-oncology and targeted kinase inhibitors.
-
Rare/Orphan Diseases: High-growth segment driven by the expansion of gene therapy and protein replacement treatments.
-
Infectious Diseases: Accelerated by post-pandemic research into mRNA vaccines and novel anti-virals.
-
Neurological Disorders: Focused on Alzheimer’s, Parkinson’s, and ALS, where unmet medical needs are critical.
-
Hematology: Breakthroughs in sickle cell disease and hemophilia through CRISPR and cell therapy.
-
Autoimmune & Pulmonary: Targeted biologics for severe asthma, COPD, and refractory RA.
By Modality
-
Small Molecules: Traditional chemical entities remains significant in CNS and oncology.
-
Biologics (Monoclonal Antibodies): The backbone of modern breakthrough designations.
-
Cell & Gene Therapy: The fastest-growing modality segment, requiring specialized regulatory "rolling reviews."
-
mRNA Technology: Emerging segment for both oncology and prophylactic vaccines.
