Super Generics Market: Industry Trends and Global Forecasts, Till 2035: Distribution by Therapeutic Area

Super Generics Market: Industry Trends and Global Forecasts, Till 2035: Distribution by Therapeutic Area



In the pharmaceutical domain the super generic drugs represent the enhanced versions of original pharmaceuticals that have lost their patent exclusivity. These refined pharmacological interventions are often termed as complex generics or value-added generics and serve as generic alternatives to their branded counterparts. Notably, in 2022, the US FDA sanctioned over 32,000 generic drug products, with 91% of all US prescriptions being filled with generics. These improved super generics hold the potential for advancements in drug delivery, manufacturing processes, and reformulation techniques. This value-added segment operates within a framework of ongoing innovation, offering promising opportunities in the pharmaceutical market. Super generic drugs are granted a form of marketing exclusivity, typically for 3 to 7 years, allowing developers to achieve relatively high profit margins as compared to the conventional generics. Regulatory bodies such as the FDA (in the US) or the EMA (in Europe) scrutinize these drugs and grant approval for their entry in the super generics market.

Developing super generic drugs entails rigorous research and development to ensure their safety, efficacy, and quality. Industry stakeholders invest in extensive preclinical and clinical studies to establish bioequivalence or therapeutic equivalence with the reference brand-name drug. As regulatory agencies worldwide greenlight more generic drugs, competition in the industry is expected to intensify. The primary consequence of this heightened competition is a decrease in the cost of generics, leading to reduced profit margins for developers. Hence, to sustain growth in the off-patent drug market, companies are progressively adopting innovative drug alteration techniques to create value-added medicinal products with better commercial prospects. Retail and online pharmacies offer a wide array of generic options, empowering consumers to lower healthcare expenses. Moreover, in numerous European countries, pharmacists have the authority to substitute brand-name prescriptions with generic equivalents unless otherwise specified by healthcare. providers.

Key Market Segments

Therapeutic Area

Cardiovascular Disorders

Metabolic Disorders

Neurological Disorders

Oncological Disorders

Respiratory Disorders

Other Disorders

Route of Administration

Intravenous

Oral

Subcutaneous

Others

Type of Molecule

Small

Other Molecules

Type of Small Molecule

Generics

Other Small Molecule

Type of Product

Aerosols

Capsules

Prefilled Syringes

Tablets

Vials

Other Products

Geography

North America

Europe

Asia-Pacific

Rest of the World

Research Coverage:

A summary of super generics technologies, including details on various pertinent parameters such as the type of drug modification, technology type, molecules formulated/delivered, route of administration, and type of value addition. This encompasses information on technology providers offering platforms/solutions for super generic drug development, including their year of establishment, company size (in terms of the number of employees), and headquarters location.

An insightful analysis of the competitiveness of the technologies compiled in our database, considering pertinent parameters including supplier power (based on the company size of technology providers) and technology competitiveness, such as the type of molecule, impact on drug properties, and route of administration.

Detailed profiles of prominent technology developers involved in this domain are provided, offering an overview of the company, its financial information where available, technology portfolio, recent advancements, and future outlook.

A compilation of marketed generics that, in our assessment, are poised to be developed as super generics in the near future, derived from a thorough analysis considering various pertinent parameters. These parameters include the current annual cost of treatment of the parent drug, year of patent expiry, sales revenues generated in the year prior to patent expiry, target therapeutic area, and the number of competitor (generic) drugs available in the market.

Comprehensive case studies are presented for five approved supergeneric drugs, encompassing an overview of the drug along with details on the original/parent drug, the value proposition offered by the supergeneric version, pricing strategies adopted by the developer where available, annual sales revenues of the supergeneric and parent drug if available, and key learnings/takeaways from each case study.

A discourse on associated trends, key drivers, and challenges within a SWOT framework, which are anticipated to influence the evolution of the industry, accompanied by a Harvey ball analysis to illustrate the relative impact of each SWOT parameter on the overall super generics market.

A thorough assessment of the current market size, existing opportunity, and the future growth potential of the super generics market over the next decade is conducted. Drawing from various parameters, including likely adoption trends, we have formulated an informed estimate on the market evolution during the forecast period from 2024 to 2035. The report also includes an analysis of the likely distribution of current and forecasted opportunities within the super generics market. Additionally, to accommodate future uncertainties and enhance the robustness of our model, three forecast scenarios—conservative, base, and optimistic—are provided, representing different trajectories of growth in the super generics market.

Key Benefits of Buying this Report

The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.

Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.

The report provides stakeholders with a pulse on the Super Generics Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Leading Market Companies

Accord Healthcare

Alcon Laboratories

Ascendia Pharmaceuticals

Azurity Pharmaceuticals

Baxter

CritiTech

Crossject

DelSiTech

Dr. Reddy’s Laboratories

Exela Pharma Sciences

Harrow Health

Heron Therapeutics

Hikma Pharmaceuticals

Intellipharmaceutics International

Kashiv BioSciences

Latitude Pharmaceuticals

Mayne Pharma

meda pharmaceuticals

Neurelis

Rubicon Research

Sun Pharmaceutical industries

Taiwan Liposome Company

Tesa Labtec

Teva Pharmaceutical


1. Preface
1.1 Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
1.5. Key Questions Answered
1.6. Chapter Outlines
2. Research Methodology
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations
2.7. Key Considerations
2.7.1. Demographics
2.7.2. Economic Factors
2.7.3. Government Regulations
2.7.4. Supply Chain
2.7.5. Covid Impact / Related Factors
2.7.6. Market Access
2.7.7. Healthcare Policies
2.7.8. Industry Consolidation
3. Economic And Other Project Specific Considerations
3.1. Chapter Overview
3.2. Market Dynamics
3.2.1. Time Period
3.2.1.1. Historical Trends
3.2.1.2. Current And Forecasted Estimates
3.2.2. Currency Coverage
3.2.2.1. Overview Of Major Currencies Affecting The Market
3.2.2.2. Impact Of Currency Fluctuations On The Industry
3.2.3. Foreign Exchange Impact
3.2.3.1. Evaluation Of Foreign Exchange Rates And Their Impact On Market
3.2.3.2. Strategies For Mitigating Foreign Exchange Risk
3.2.4. Recession
3.2.4.1. Historical Analysis Of Past Recessions And Lessons Learnt
3.2.4.2. Assessment Of Current Economic Conditions And Potential Impact On The Market
3.2.5. Inflation
3.2.5.1. Measurement And Analysis Of Inflationary Pressures In The Economy
3.2.5.2. Potential Impact Of Inflation On The Market Evolution
4. Executive Summary
5. Introduction
5.1. Chapter Overview
5.2. Overview Of Generic Drugs
5.2.1. Key Challenges Within The Generics Industry
5.2.1.1. Policy Changes
5.2.1.2. Increasing Competition
5.2.1.3. Price Erosion
5.3. Super Generics
5.3.1. Techniques Used For The Development Of Super Generics
5.3.2. Regulatory Pathways For Approval Of Super Generics
5.4. Advantages Of Super Generics
5.4.1. Improved Efficacy
5.4.2. Increased Ip Protection
5.4.3. Cost And Time Efficient Development Process
5.5. Challenges Related To Super Generics
5.6. Future Perspectives
6. Super Generic Drugs: Market Landscape
6.1. Chapter Overview
6.2. Super Generic Drugs: Overall Market Landscape
6.2.1. Analysis By Route Of Administration
6.2.2. Analysis By Target Indication
6.2.3. Analysis By Target Therapeutic Area
6.2.4. Analysis By Submission Classification Code
6.2.5. Most Active Players: Analysis By Number Of Super Generic Drugs
7. Super Generic Technologies: Market Landscape
7.1 Chapter Overview
7.2. Super Generic Technologies: Overall Market Landscape
7.2.1 Analysis By Type Of Drug Modification
7.2.2 Analysis By Type Of Technology
7.2.3 Analysis By Type Of Molecules Formulated / Delivered
7.2.4 Analysis By Route Of Administration
7.2.5 Analysis By Type Of Value Addition
7.3. Super Generics Technology Developers
7.3.1 Analysis By Year Of Establishment
7.3.2 Analysis By Company Size
7.3.3 Analysis By Location Of Headquarters (Region)
7.3.4. Most Active Players: Analysis By Number Of Super Generics Technologies
8. Technology Competitivenss Analysis
8.1. Chapter Overview
8.2. Methodology And Key Parameters
8.3. Technologies Offered By Companies Based In North America
8.3.1 Technologies Offered By Companies Based In North America (Peer Group I)
8.3.2 Technologies Offered By Companies Based In North America (Peer Group Ii)
8.4 Technologies Offered By Companies Based In Europe
8.5. Technologies Offered By Companies Based In Asia-pacific
9. Company Profiles
9.1. Chapter Overview
9.2. Ascendia Pharmaceuticals
9.2.1. Company Overview
9.2.2. Technology Portfolio
9.2.2.1. Nanosol
9.2.2.2. Amorsol
9.2.2.3. Emulsol
9.2.3. Recent Developments And Future Outlook
9.3. Crititech
9.3.1. Company Overview
9.3.2. Technology Portfolio
9.3.2.1. Spray Drying Technology
9.3.2.2. Supercritical Precipitation Technology
9.3.3. Recent Developments And Future Outlook
9.4. Crossject
9.4.1. Company Overview
9.4.2. Technology Portfolio
9.4.2.1. Zeneo®
9.4.3. Recent Developments And Future Outlook
9.5. Delsitech
9.5.1. Company Overview
9.5.2. Technology Portfolio
9.5.2.1. Delsitech™ Silica
9.5.3. Recent Developments And Future Outlook
9.6. Heron Therapeutics
9.6.1. Company Overview
9.6.2. Technology Portfolio
9.6.2.1. Biochronomer®
9.6.3. Recent Developments And Future Outlook
9.7. Latitude Pharmaceuticals
9.7.1. Company Overview
9.7.2. Technology Portfolio
9.7.2.1. Nano-e™
9.7.2.2. Pg-depot™
9.7.2.3. Artss™
9.7.2.4. Rfap™ Matrix
9.7.2.5. Rtts
9.7.2.6. 24h™
9.7.2.7. Minispheres
9.7.2.8. Gelpatch
9.7.3. Recent Developments And Future Outlook
9.8. Mayne Pharma
9.8.1. Company Overview
9.8.2. Financial Information
9.8.3. Technology Portfolio
9.8.3.1. Suba™
9.8.3.2. Cleantaste™
9.8.3.3. Pellet Technology
9.8.4. Recent Developments And Future Outlooks
9.9. Neurelis
9.9.1. Company Overview
9.9.2. Technology Portfolio
9.9.2.1. Intravail®
9.9.2.2. Protek®
9.9.2.3. Hydrogel™
9.9.3. Recent Developments And Future Outlook
9.10. Rubicon Research
9.10.1. Company Overview
9.10.2. Technology Portfolio
9.10.2.1. Rubiert®
9.10.2.2. Rubidt®
9.10.2.3. Rubireten®
9.10.2.4. Rubisrl®
9.11. Taiwan Liposome Company
9.11.1. Company Overview
9.11.2. Financial Information
9.11.3. Technology Portfolio
9.11.3.1. Bioseizer®
9.11.3.2. Nanox™
9.11.3.3. Polymeric Micelle
9.11.4. Recent Developments And Future Outlook
9.12. Tesa Labtec
9.12.1. Company Overview
9.12.2. Technology Portfolio
9.12.2.1. Transfilm®
9.12.2.2. Mucofilm®
9.12.2.3. Rapidfilm®
9.12.3. Recent Developments And Future Outlook
10 Case Study: Approved Super Generic Drugs
10.1. Chapter Overview
10.2. Austedo®
10.2.1. Overview
10.2.2. Originator Drug Overview
10.2.3. Value Proposition
10.2.4. Financial Information
10.2.5. Key Learnings
10.3. Abraxane®
10.3.1. Overview
10.3.2. Originator Drug Overview
10.3.3. Value Proposition
10.3.4. Financial Information
10.3.5. Key Learnings
10.4. Avycaz®
10.4.1. Overview
10.4.2. Originator Drug Overview
10.4.3. Value Proposition
10.4.4. Financial Information
10.4.5. Key Learnings
10.5. Procysbi®
10.5.1. Overview
10.5.2. Originator Drug Overview
10.5.3. Value Proposition
10.5.4. Financial Information
10.5.5. Key Learnings
10.6. Trokendi Xr®
10.6.1. Overview
10.6.2. Originator Drug Overview
10.6.3. Value Proposition
10.6.4. Financial Information
10.6.5. Key Learnings
11. Super Generics: Likely Drug Candidates
11.1. Chapter Overview
11.2. Marketed Drug Candidates
11.2.1. Most Likely Drug Candidates For Super Generics
11.2.2. Likely Drug Candidates For Super Generics
11.2.3. Less Likely Drug Candidates For Super Generics
11.2.4. Least Likely Drug Candidates For Super Generics
12. Swot Analysis
12.1. Chapter Overview
12.2. Strengths
12.3. Weakness
12.4. Opportunities
12.5. Threats
12.6. Concluding Remarks
13. Global Super Generics Market
13.1. Chapter Overview
13.2. Key Assumptions And Methodology
13.3. Overall Super Generics Market, Historical Trends (2018-2022) And Forecasted Estimates (2023-2035)
13.4. Super Generics Market: Distribution By Therapeutic Area, 2023-2035
13.5. Super Generics Market: Distribution By Route Of Administration, 2023-2035
13.6. Super Generics Market: Distribution By Type Of Molecule, 2023-2035
13.7. Super Generics Market: Distribution By Type Of Small Molecule, 2023-2035
13.8. Super Generics Market: Distribution By Type Of Product, 2023-2035
13.9. Super Generics Market: Distribution By Geography, 2023-2035
13.9.1. Super Generics Market In North America, 2023-2035
13.9.1.1. Super Generics Market In North America: Distribution By Therapeutic Area, 2023-2035
13.9.1.1.1. Super Generics Market For Oncological Disorders In North America, 2023-2035
13.9.1.1.2. Super Generics Market For Metabolic Disorders In North America, 2023-2035
13.9.1.1.3. Super Generics Market For Neurological Disorders In North America, 2023-2035
13.9.1.1.4. Super Generics Market For Respiratory Disorders In North America, 2023-2035
13.9.1.1.5. Super Generics Market For Cardiovascular Disorders In North America, 2023-2035
13.9.1.1.6. Super Generics Market For Other Disorders In North America, 2023-2035
13.9.1.2. Super Generics Market: Distribution By Route Of Administration In North America
13.9.1.2.1. Super Generics Market For Oral Route Of Administration In North America, 2023-2035
13.9.12.2. Super Generics Market For Subcutaneous Route Of Administration In North America, 2023-2035
13.9.1.2.3. Super Generics Market For Intravenous Route Of Administration In North America, 2023-2035
13.9.1.2.4. Super Generics Market For Other Routes Of Administration In North America, 2023-2035
13.9.1.3. Super Generics Market: Distribution By Type Of Molecule In North America
13.9.1.3.1. Super Generics Market For Small Molecule In North America, 2023-2035
13.9.1.3.2. Super Generics Market For Biologics In North America, 2023-2035
13.9.1.4. Super Generics Market: Distribution By Type Of Small Molecules In North America
13.9.1.4.1 Super Generics Market For Complex Generics In North America, 2023-2035
13.9.1.4.2. Super Generics Market For Other Small Molecules In North America, 2023-2035
13.9.1.5. Super Generics Market: Distribution By Type Of Product Offered In North America
13.9.1.5.1. Super Generics Market For Prefilled Syringe In North America, 2023-2035
13.9.1.5.2. Super Generics Market For Vials In North America, 2023-2035
13.9.1.5.3. Super Generics Market For Aerosols In North America, 2023-2035
13.9.1.5.4. Super Generics Market For Tablets In North America, 2023-2035
13.9.1.5.5. Super Generics Market For Capsules In North America, 2023-2035
13.9.1.5.6. Super Generics Market For Other Types Of Products In North America, 2023-2035
13.9.2. Super Generics Market In Europe, 2023-2035
13.9.2.1. Super Generics Market In Europe: Distribution By Therapeutic Area, 2023-2035
13.9.2.1.1. Super Generics Market For Oncological Disorders In Europe, 2023-2035
13.9.2.1.2. Super Generics Market For Metabolic Disorders In Europe, 2023-2035
13.9.2.1.3. Super Generics Market For Neurological Disorders In Europe, 2023-2035
13.9.2.1.4. Super Generics Market For Respiratory Disorders In Europe, 2023-2035
13.9.2.1.5. Super Generics Market For Cardiovascular Disorders In Europe, 2023-2035
13.9.2.1.6. Super Generics Market For Other Disorders In Europe, 2023-2035
13.9.2.2. Super Generics Market Distribution By Route Of Administration In Europe
13.9.2.2.1. Super Generics Market For Oral Route Of Administration In Europe, 2023-2035
13.9.2.2.2. Super Generics Market For Subcutaneous Route Of Administration In Europe, 2023-2035
13.9.2.2.3. Super Generics Market For Intravenous Route Of Administration In Europe, 2023-2035
13.9.2.2.4. Super Generics Market For Other Routes Of Administration In Europe, 2023-2035
13.9.2.3. Super Generic Drugs Market: Distribution By Type Of Molecule In Europe
13.9.2.3.1. Super Generic Drugs Market For Small Molecule In Europe, 2023-2035
13.9.2.3.2. Super Generic Drugs Market For Biologics In Europe, 2023-2035
13.9.2.4. Super Generic Drugs Market: Distribution By Type Of Small Molecules In Europe
13.9.2.4.1 Super Generic Drugs Market For Complex Generics In Europe, 2023-2035
13.9.2.4.2. Super Generics Market For Other Small Molecules In Europe, 2023-2035
13.9.2.5. Super Generic Market: Distribution By Type Of Product Offered In Europe
13.9.2.5.1. Super Generic Market For Prefilled Syringe In Europe, 2023-2035
13.9.2.5.2. Super Generic Market For Vials In Europe, 2023-2035
13.9.2.5.3. Super Generic Market For Aerosols In Europe, 2023-2035
13.9.2.5.4. Super Generic Market For Tablets In Europe, 2023-2035
13.9.2.5.5. Super Generic Market For Capsules In Europe, 2023-2035
13.9.2.5.6. Super Generics Market For Other Types Of Products In Europe, 2023-2035
13.9.3. Super Generics Market In Asia-pacific, 2023-2035
13.9.3.1. Super Generics Market In Asia-pacific: Distribution By Therapeutic Area, 2023-2035
13.9.3.1.1. Super Generics Market For Oncological Disorders In Asia-pacific, 2023-2035
13.9.3.1.2. Super Generics Market For Metabolic Disorders In Asia-pacific, 2023-2035
13.9.3.1.3. Super Generics Market For Neurological Disorders In Asia-pacific, 2023-2035
13.9.3.1.4. Super Generics Market For Respiratory Disorders In Asia-pacific, 2023-2035
13.9.3.1.5. Super Generics Market For Cardiovascular Disorders In Asia-pacific, 2023-2035
13.9.3.1.6. Super Generics Market For Other Disorders In Asia-pacific, 2023-2035
13.9.3.2. Super Generics Market Distribution By Route Of Administration In Asia-pacific
13.9.3.2.1. Super Generics Market For Oral Route Of Administration In Asia-pacific, 2023-2035
13.9.3.2.2. Super Generics Market For Subcutaneous Route Of Administration In Asia-pacific, 2023-2035
13.9.3.2.3. Super Generics Market For Intravenous Route Of Administration In Asia-pacific, 2023-2035
13.9.4.2.4. Super Generics Market For Other Routes Of Administration In Asia-pacific, 2023-2035
13.9.3.3. Super Generics Market: Distribution By Type Of Molecule In Asia-pacific
13.9.3.3.1. Super Generics Market For Small Molecule In Asia-pacific, 2023-2035
13.9.3.3.2. Super Generics Market For Biologics In Asia-pacific, 2023-2035
13.9.3.4. Super Generics Market: Distribution By Type Of Small Molecules In Asia-pacific
13.9.3.4.1 Super Generics Market For Complex Generics In Asia-pacific, 2023-2035
13.9.3.4.2. Super Generics Market For Other Small Molecules In Asia-pacific, 2023-2035
13.9.3.5. Super Generics Market: Distribution By Type Of Product Offered In Asia-pacific
13.9.3.5.1. Super Generics Market For Prefilled Syringe In Asia-pacific, 2023-2035
13.9.3.5.2. Super Generics Market For Vials In Asia-pacific, 2023-2035
13.9.3.5.3. Super Generics Market For Aerosols In Asia-pacific, 2023-2035
13.9.3.5.4. Super Generics Market For Tablets In Asia-pacific, 2023-2035
13.9.3.5.5. Super Generics Market For Capsules In Asia-pacific, 2023-2035
13.9.3.5.6. Super Generics Market For Other Types Of Products In Asia-pacific, 2023-2035
13.9.4. Super Generics Market In Rest Of The World, 2023-2035
13.9.4.1. Super Generics Market In Rest Of The World: Distribution By Therapeutic Area, 2023-2035
13.9.4.1.1. Super Generics Market For Oncological Disorders In Rest Of The World, 2023-2035
13.9.4.1.2. Super Generics Market For Metabolic Disorders In Rest Of The World, 2023-2035
13.9.4.1.3. Super Generics Market For Neurological Disorders In Rest Of The World, 2023-2035
13.9.4.1.4. Super Generics Market For Respiratory Disorders In Rest Of The World, 2023-2035
13.9.4.1.5. Super Generics Market For Cardiovascular Disorders In Rest Of The World, 2023-2035
13.9.4.1.6. Super Generics Market For Other Disorders In Rest Of The World, 2023-2035
13.9.4.2. Super Generics Market Distribution By Route Of Administration In Rest Of The World
13.9.4.2.1. Super Generics Market For Oral Route Of Administration In Rest Of The World, 2023-2035
13.9.4.2.2. Super Generics Market For Subcutaneous Route Of Administration In Rest Of The World, 2023-2035
13.9.4.2.3. Super Generics Market For Intravenous Route Of Administration In Rest Of The World, 2023-2035
13.9.4.2.4. Super Generics Market For Other Routes Of Administration In Rest Of The World, 2023-2035
13.9.4.3. Super Generics Market: Distribution By Type Of Molecule In Rest Of The World
13.9.4.3.1. Super Generics Market For Small Molecule In Rest Of The World, 2023-2035
13.9.4.3.2. Super Generics Market For Biologics In Rest Of The World, 2023-2035
13.9.4.4. Super Generics Market: Distribution By Type Of Small Molecules In Rest Of The World
13.9.4.4.1 Super Generics Market For Complex Generics In Rest Of The World, 2023-2035
13.9.4.4.2. Super Generics Market For Other Small Molecules In Rest Of The World, 2023-2035
13.9.4.5. Super Generics Market: Distribution By Type Of Product Offered In Rest Of The World
13.9.4.5.1. Super Generics Market For Prefilled Syringe In Rest Of The World, 2023-2035
13.9.4.5.2. Super Generics Market For Vials In Rest Of The World, 2023-2035
13.9.4.5.3. Super Generics Market For Aerosols In Rest Of The World, 2023-2035
13.9.4.5.4. Super Generics Market For Tablets In Rest Of The World, 2023-2035
13.9.4.5.5. Super Generics Market For Capsules In Rest Of The World, 2023-2035
13.9.4.5.6. Super Generics Market For Other Types Of Products In Rest Of The World, 2023-2035
14. Conclusion
15. Appendix 1: Tabulated Data
16. Appendix Ii: List Of Companies And Organizations

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