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Generics Market: Focus on Value-Added Medicines / Supergenerics, 2019-2030

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    Report

  • 231 Pages
  • October 2019
  • Region: Global
  • Roots Analysis
  • ID: 4850776
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In 2018, it was estimated that the availability of low-cost, generic versions of pharmaceutical interventions saved nearly USD 1.6 trillion in healthcare costs in the US over the last decade.  Given the cost benefits offered, generic medicines usually have high adoption rates. Moreover, upcoming patent expiries of several blockbuster drugs, such as LYRICA®, Cialis®, Advair® and Sensipar®, have intensified the interest of several drug manufacturers in the development of generics. As more generic drugs get approved by regulators across the globe, the competition in the industry has steadily increased. Interestingly, in 2018, the US FDA approved more than 780 generic products, which represented more than 90% increase in the number of such drug approvals since 2014.  The most evident impact of the growth in competition in this domain is deflation of cost of generics, resulting in diminished profit margins for the developers of such products. Therefore, to ensure sustainable growth within the off-patent drug products market, companies are gradually adopting innovative drug alteration techniques in order to develop value-added medicinal products, which offer better commercial benefits.

The availability of several advanced drug development and technology platforms have enabled the fabrication and formulation of improved versions of existing drug products. Such modified pharmacological interventions are commonly referred to as supergenerics / complex generics / value-added generics. Although supergenerics are based on the same mechanism of action as that of the original drug, these versions usually have certain additional attributes, such as a new active ingredient, improved manufacturing process, alternative dosage regimen, modified release properties or different formulation. Typically, such drugs are granted a form of marketing exclusivity (for a period of 3-7 years ), enabling their developers to generate relatively higher profit margins, compared to conventional generics. Moreover, the development of value-added generics is generally directed at certain unmet clinical needs, which may have been unaddressed by previous versions of the drug. In addition, the approval process for such products is not as complicated; in the US, value-added medicines are evaluated under the FDA’s 505(b)(2) pathway. This evolving segment of the pharmaceutical industry has also witnessed a surge in the availability of technology providers, offering a diverse range of platforms / solutions to support the development of supergeneric drugs. After a detailed analysis of prevalent trends, we are led to believe that value-added generic products market is poised to witness significant growth over the coming years.

The ‘Generics Market: Focus on Value-added Medicines / Supergenerics, 2019-2030’ report features an extensive study of supergenerics, as well as the current landscape and future potential of technology providers that are offering innovative platforms / solutions to supergeneric drug developers. Amongst other elements, the report features:


  • An overview of recently approved supergenerics (over the period 2016-2018), featuring information on route of administration, target disease indication(s), target therapeutic area(s), approval timeline, submission classification code and most active drug developers (in terms of number of product approvals). Additionally, it provides a detailed assessment of technology providers, offering platforms / solutions for supergeneric drug development, including information on year of establishment, company size and geographical location.
  • An informed competitiveness analysis of the technologies captured in our database, taking into consideration relevant parameters, such as supplier power (based on company size of technology provider) and other important technology-related specifications, such as the type of molecule, impact on drug properties and route of administration.
  • Elaborate profiles of prominent technology developers engaged in this domain, featuring an overview of the company, its financial information (if available), a detailed description of its technology platform(s), recent developments and a comprehensive future outlook.
  • A list of marketed generics that, we believe, are likely to be developed as supergenerics in the near future, based on an in-depth analysis taking into consideration multiple relevant parameters, such as the current annual cost of treatment of the parent drug, year of patent expiry, revenues generated in the year before patent expiry, target therapeutic area and number of competitor (generic) drugs available in the market.
  • Detailed case studies on five approved supergeneric drugs, including an overview of the product along with information on the original / parent drug, value proposition offered by the supergeneric version, pricing strategies adopted by the developer (if available), annual revenues of the supergeneric and parent drug (if available) and the key learnings / takeaways from individual case studies.
  • A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall supergenerics industry.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity within the market. Based on several parameters, such as size of the generic drugs market, share of supergenerics within the generic drugs market and expected annual growth rate across various geographies, we have provided an informed estimate of the likely evolution of the market, in the mid to long term, for the period 2019-2030. The chapter also presents a detailed market segmentation across [A] different therapeutic areas (autoimmune disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, pain disorders, respiratory disorders and others), [B] routes of administration (parenteral, intravitreal, oral, topical and others) and [C] key geographical regions (North America, Asia-Pacific, Europe, South America, and Africa and Middle East).

In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.


Table of Contents

1 PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2 EXECUTIVE SUMMARY
3 INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Generic Drugs
3.2.1. Key Challenges within the Generics Industry
3.2.1.1. Policy Changes
3.2.1.2. Increasing Competition
3.2.1.3. Price Erosion
3.3. Supergenerics
3.3.1. Techniques Used for the Development of Supergenerics
3.3.2. Regulatory Pathways for Approval of Supergenerics
3.4. Advantages of Supergenerics
3.4.1. Improved Efficacy
3.4.2. Increased IP Protection
3.4.3. Cost and Time Efficient Development Process
3.5. Challenges Related to Supergenerics
3.6. Future Perspectives
4 SUPERGENERIC DRUGS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Supergenerics: Overall Market Overview
4.2.1. Analysis by Route of Administration
4.2.2. Analysis by Target Indication
4.2.3. Analysis by Target Therapeutic Area
4.2.4. Analysis by Approval Timeline
4.2.5. Analysis by Submission Classification Code
4.2.6. Analysis by Route of Administration, Target Therapeutic Area and Submission Classification Code
4.2.7. Analysis by Most Active Players
5 TECHNOLOGY PROVIDERS FOR SUPERGENERIC DEVELOPMENT: MARKET LANDSCAPE
5.1. Chapter Overview
5.2. Supergenerics Technology Providers: Overall Market Overview
5.3. Analysis by Type of Drug Modification
5.4. Analysis by Type of Technology
5.5. Analysis by Type of Molecules Formulated / Delivered
5.6. Analysis by Route of Administration
5.7. Analysis by Type of Value Addition
5.8. Analysis by Type of Molecule, Route of Administration and Type of Value Addition
5.9. Analysis by Year of Establishment
5.10. Analysis by Company Size
5.11. Analysis by Geography
5.12 Platform Competitiveness Analysis
5.12.1 Competitiveness Analysis: Technologies of Companies Based in North America
5.12.2 Competitiveness Analysis: Technologies of Companies Based in Europe
5.12.3 Competitiveness Analysis: Technologies of Companies Based in Asia-Pacific
6 COMPANY PROFILES: SUPERGENERIC TECHNOLOGY PROVIDERS
6.1. Chapter Overview
6.2. Ascendia Pharmaceuticals
6.2.1. Company Overview
6.2.2. Technology Overview
6.2.2.1. NanoSol
6.2.2.2. AmorSol
6.2.2.3. EmulSol
6.2.3. Recent Developments and Future Outlook
6.3. CritiTech
6.3.1. Company Overview
6.3.2. Technology Overview
6.3.2.1. Spray Drying Technology
6.3.2.2. Supercritical Precipitation Technology
6.3.3. Recent Developments and Future Outlook
6.4. Crossject
6.4.1. Company Overview
6.4.2. Technology Overview
6.4.2.1. ZENEO®
6.4.3. Recent Developments and Future Outlook
6.5. DelSiTech
6.5.1. Company Overview
6.5.2. Technology Overview
6.5.2.1. DelSiTech™ Silica
6.5.3. Recent Developments and Future Outlook
6.6. Heron Therapeutics
6.6.1. Company Overview
6.6.2. Technology Overview
6.6.2.1. Biochronomer®
6.6.3. Recent Developments and Future Outlook
6.7. Intellipharmaceutics International
6.7.1. Company Overview
6.7.2. Financial Information
6.7.3. Technology Overview
6.7.3.1. Hypermatrix™
6.7.3.2. nPODDDS™
6.7.3.3. PODRAS™
6.7.3.4. IntelliFOAM™
6.7.3.5. IntelliGITransporter™
6.7.3.6. IntelliMatrix™
6.7.3.7. IntelliOsmotics™
6.7.3.8. IntelliPaste™
6.7.3.9. IntelliPellets™
6.7.3.10. IntelliShuttle™
6.7.4. Recent Developments and Future Outlook
6.8. Kashiv BioSciences
6.8.1. Company Overview
6.8.2. Technology Overview
6.8.2.1. GRANDE™
6.8.2.2. KRONOTEC™
6.8.2.3. BIOMAXX®
6.8.2.4. LOAD®
6.8.3. Recent Developments and Future Outlook
6.9. Latitude Pharmaceuticals
6.9.1. Company Overview
6.9.2. Technology Overview
6.9.2.1. Nano-E™
6.9.2.2. PG-Depot™
6.9.2.3. ARTSS™
6.9.2.4. RFAP™ Matrix
6.9.2.5. RTTS
6.9.2.6. 24H™
6.9.2.7. MiniSpheres
6.9.2.8. GelPatch
6.9.3. Recent Developments and Future Outlook
6.10. Mayne Pharma
6.10.1. Company Overview
6.10.2. Financial Information
6.10.3. Technology Overview
6.10.3.1. SUBA™
6.10.3.2. Cleantaste™
6.10.3.3. Pellet Technology
6.10.4. Recent Developments and Future Outlooks
6.11. Neurelis
6.11.1. Company Overview
6.11.2. Technology Overview
6.11.2.1. Intravail®
6.11.2.2. ProTek®
6.11.2.3. Hydrogel™
6.11.3. Recent Developments and Future Outlook
6.12. Rubicon Research
6.12.1. Company Overview
6.12.2. Technology Overview
6.12.2.1. RubiERT®
6.12.2.2. RubiDT®
6.12.2.3. RubiReten®
6.12.2.4. RubiSRL®
6.12.3. Recent Developments and Future Outlook
6.13. Taiwan Liposome Company
6.13.1. Company Overview
6.13.2. Financial Information
6.13.3. Technology Overview
6.13.3.1. BioSeizer®
6.13.3.2. NanoX™
6.13.3.3. Polymeric Micelle
6.13.4. Recent Developments and Future Outlook
6.14. tesa Labtec
6.14.1. Company Overview
6.14.2. Technology Overview
6.14.2.1. Transfilm®
6.14.2.2. Mucofilm®
6.14.2.3. Rapidfilm®
6.14.3. Recent Developments and Future Outlook
7 CASE STUDY OF APPROVED SUPERGENERIC DRUGS
7.1. Chapter Overview
7.2. Austedo®
7.2.1. Overview
7.2.2. Originator Drug Overview
7.2.3. Value Proposition
7.2.4. Financial Information
7.2.5. Key Learnings
7.3. Abraxane®
7.3.1. Overview
7.3.2. Originator Drug Overview
7.3.3. Value Proposition
7.3.4. Financial Information
7.3.5. Key Learnings
7.4. Avycaz®
7.4.1. Overview
7.4.2. Originator Drug Overview
7.4.3. Value Proposition
7.4.4. Financial Information
7.4.5. Key Learnings
7.5. Procysbi®
7.5.1. Overview
7.5.2. Originator Drug Overview
7.5.3. Value Proposition
7.5.4. Financial Information
7.5.5. Key Learnings
7.6. Trokendi XR®
7.6.1. Overview
7.6.2. Originator Drug Overview
7.6.3. Value Proposition
7.6.4. Financial Information
7.6.5. Key Learnings
8 LIKELY DRUG CANDIDATES FOR SUPERGENERIC DEVELOPMENT
8.1. Chapter Overview
8.2. Marketed Generic Drugs, 2016-2018
8.2.1. Most Likely Candidates for supergeneric development
8.2.2. Likely Candidates for supergeneric development
8.2.3. Less Likely Candidates for supergeneric development
8.2.4. Least Likely Candidates for supergeneric development
9 SWOT ANALYSIS
9.1. Chapter Overview
9.2. Strengths
9.3. Weakness
9.4. Opportunities
9.5. Threats
9.6. Concluding Remarks
10 MARKET FORECAST
10.1. Chapter Overview
10.2. Overall Supergeneric Drugs Market, 2019-2030
10.3. Supergeneric Drugs Market: Distribution by Therapeutic Area, 2019-2030
10.4. Supergeneric Drugs Market: Distribution by Route of Administration, 2019- 2030
10.5. Supergeneric Drugs Market: Distribution by Geography, 2019-2030
10.5.1. Supergeneric Drugs Market in North America, 2019-2030
10.5.1.1. Supergeneric Drugs Market in North America: Distribution by Therapeutic Area,2019-2030
10.5.1.1.1. Supergeneric Drugs Market for CNS Disorders in North America, 2019-2030
10.5.1.1.2. Supergeneric Drugs Market for Cardiovascular Disorders in North America, 2019 and 2030
10.5.1.1.3. Supergeneric Drugs Market for Respiratory Disorders in North America, 2019 and 2030
10.5.1.1.4. Supergeneric Drugs Market for Autoimmune Disorders in North America, 2019 and 2030
10.5.1.1.5. Supergeneric Drugs Market for Metabolic Disorders in North America, 2019 and 2030
10.5.1.1.6. Supergeneric Drugs Market for Oncological Disorders in North America, 2019 and 2030
10.5.1.1.7. Supergeneric Drugs Market for Pain Disorders in North America, 2019 and 2030
10.5.1.1.8. Supergeneric Drugs Market for Other Disorders in North America, 2019 and 2030
10.5.1.2. Supergeneric Drugs Market Distribution by Route of Administration in North
10.5.1.2.1. Supergeneric Drugs Market for Oral Route of Administration in North America, 2019-2050
10.5.1.2.2. Supergeneric Drugs Market for Parenteral Route of Administration in North America, 2019 and 2030
10.5.1.2.3. Supergeneric Drugs Market for Topical Route of Administration in North America, 2019 and 2030
10.5.1.2.4. Supergeneric Drugs Market for Intravitreal Route of Administration in North America, 2019 and 2030
10.5.1.2.5. Supergeneric Drugs Market for Other Routes of Administration in North America, 2019 and 2030
10.5.2. Supergeneric Drugs Market in Europe, 2019-2030
10.5.2.1. Supergeneric Drugs Market: Distribution by Therapeutic Area in Europe
10.5.2.1.1. Supergeneric Drugs Market for CNS Disorders in Europe, 2019 and 2030
10.5.2.1.2. Supergeneric Drugs Market for Cardiovascular Disorders in Europe, 2019 and 2030
10.5.2.1.3. Supergeneric Drugs Market for Respiratory Disorders in Europe, 2019 and 2030
10.5.2.1.4. Supergeneric Drugs Market for Autoimmune Disorders in Europe, 2019 and 2030
10.5.2.1.5. Supergeneric Drugs Market for Metabolic Disorders in Europe, 2019 and 2030
10.5.2.1.6. Supergeneric Drugs Market for Oncological Disorders in Europe, 2019 and 2030
10.5.2.1.7. Supergeneric Drugs Market for Pain Disorders in Europe, 2019 and 2030
10.5.2.1.8. Supergeneric Drugs Market for Other Disorders in Europe, 2019 and 2030
10.5.2.2. Supergeneric Drugs Market Distribution by Route of Administration in Europe
10.5.2.2.1. Supergeneric Drugs Market for Oral Route of Administration in Europe, 2019 and 2030
10.5.2.2.2. Supergeneric Drugs Market for Parenteral Route of Administration in Europe, 2019 and 2030
10.5.2.2.3. Supergeneric Drugs Market for Topical Route of Administration in Europe, 2019 and 2030
10.5.2.2.4. Supergeneric Drugs Market for Intravitreal Route of Administration in Europe, 2019 and 2030
10.5.2.2.5. Supergeneric Drugs Market for Other Routes of Administration in Europe, 2019 and 2030
10.5.3. Supergeneric Drugs Market in Asia-Pacific, 2019-2030
10.5.3.1. Supergeneric Drugs Market: Distribution by Therapeutic Area in Asia-Pacific
10.5.3.1.1. Supergeneric Drugs Market for CNS Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.2. Supergeneric Drugs Market for Cardiovascular Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.3. Supergeneric Drugs Market for Respiratory Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.4. Supergeneric Drugs Market for Autoimmune Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.5. Supergeneric Drugs Market for Metabolic Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.6. Supergeneric Drugs Market for Oncological Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.7. Supergeneric Drugs Market for Pain Disorders in Asia-Pacific, 2019 and 2030
10.5.3.1.8. Supergeneric Drugs Market for Other Disorders in Asia-Pacific, 2019 and 2030
10.5.3.2. Supergeneric Drugs Market Distribution by Route of Administration in Asia-Pacific
10.5.3.2.1. Supergeneric Drugs Market for Oral Route of Administration in Asia-Pacific,2019 and 2030
10.5.3.2.2. Supergeneric Drugs Market for Parenteral Route of Administration in Asia-Pacific, 2019 and 2030
10.5.3.2.3. Supergeneric Drugs Market for Topical Route of Administration in Asia-Pacific, 2019 and 2030
10.5.3.2.4. Supergeneric Drugs Market for Intravitreal Route of Administration in Asia-Pacific, 2019 and 2030
10.5.3.2.5. Supergeneric Drugs Market for Other Routes of Administration in Asia-Pacific, 2019 and 2030
10.5.4. Supergeneric Drugs Market in Latin America, 2019-2030
10.5.4.1. Supergeneric Drugs Market: Distribution by Therapeutic Area in Latin America
10.5.4.1.1. Supergeneric Drugs Market for CNS Disorders in Latin America, 2019 and 2030
10.5.4.1.2. Supergeneric Drugs Market for Cardiovascular Disorders in Latin America, 2019 and 2030
10.5.4.1.3. Supergeneric Drugs Market for Respiratory Disorders in Latin America, 2019 and 2030
10.5.4.1.4. Supergeneric Drugs Market for Autoimmune Disorders in Latin America, 2019 and 2030
10.5.4.1.5. Supergeneric Drugs Market for Metabolic Disorders in Latin America, 2019 and 2030
10.5.4.1.6. Supergeneric Drugs Market for Oncological Disorders in Latin America, 2019 and 2030
10.5.4.1.7. Supergeneric Drugs Market for Pain Disorders in Latin America, 2019 and 2030
10.5.4.1.8. Supergeneric Drugs Market for Other Disorders in Latin America, 2019 and 2030
10.5.4.2. Supergeneric Drugs Market Distribution by Route of Administration in Latin America
10.5.4.2.1. Supergeneric Drugs Market for Oral Route of Administration in Latin America, 2019 and 2030
10.5.4.2.2. Supergeneric Drugs Market for Parenteral Route of Administration in Latin America, 2019 and 2030
10.5.4.2.3. Supergeneric Drugs Market for Topical Route of Administration in Latin America, 2019 and 2030
10.5.4.2.4. Supergeneric Drugs Market for Intravitreal Route of Administration in Latin America, 2019 and 2030
10.5.4.2.5. Supergeneric Drugs Market for Other Routes of Administration in Latin America, 2019 and 2030
10.5.5. Supergeneric Drugs Market in Africa and Middle-East, 2019-2030
10.5.5.1. Supergeneric Drugs Market: Distribution by Therapeutic Area in Africa and Middle East
10.5.5.1.1. Supergeneric Drugs Market for CNS Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.2. Supergeneric Drugs Market for Cardiovascular Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.3. Supergeneric Drugs Market for Respiratory Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.4. Supergeneric Drugs Market for Autoimmune Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.5. Supergeneric Drugs Market for Metabolic Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.6. Supergeneric Drugs Market for Oncological Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.7. Supergeneric Drugs Market for Pain Disorders in Africa and Middle-East, 2019 and 2030
10.5.5.1.8. Supergeneric Drugs Market for Other Disorders in Africa and Middle East, 2019 and 2030
10.5.5.2. Supergeneric Drugs Market: Distribution by Route of Administration in Africa and Middle-East
10.5.5.2.1. Supergeneric Drugs Market for Oral Route of Administration in Africa and Middle-East, 2019 and 2030
10.5.5.2.2. Supergeneric Drugs Market for Parenteral Route of Administration in Africa and Middle-East, 2019 and 2030
10.5.5.2.3. Supergeneric Drugs Market for Topical Route of Administration in Africa and Middle-East, 2019 and 2030
10.5.5.2.4. Supergeneric Drugs Market for Intravitreal Route of Administration in Africa and Middle-East, 2019 and 2030
10.5.5.2.5. Supergeneric Drugs Market for Other Routes of Administration in Africa and Middle-East, 2019 and 2030
11 CONCLUSION12 APPENDIX 1: TABULATED DATA13 APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION
List of Tables
Table 3.1 Different Nomenclatures Used for Value-added Generics
Table 3.2 Comparison of FDA Drug Approval Pathways
Table 3.3 Market Exclusivity Period for Different Submission Classifications
Table 3.4 Comparison of Drug Development Timeline
Table 4.1 Supergenerics: List of FDA Approved Drugs, 2016-2018
Table 4.2 Supergenerics: Additional Details, 2016-2018
Table 5.1 Supergeneric Technology Platforms: List of Technology Providers
Table 5.2 Supergeneric Technology Platforms: Information on Type of Drug Modification, Type of Technology and Type of Molecule Delivered / Formulated
Table 5.3. Supergeneric Technology Platforms: Information on Route of Administration and Type of Value Addition Offered
Table 6.1 List of Profiled Supergeneric Technology Providers
Table 6.2 CritiTech (NanOlogy): Pipeline Overview
Table 6.3 CritiTech (NanOlogy): Recent Developments and Future Outlook
Table 6.4 Crossject: Pipeline Overview
Table 6.5 Crossject: Recent Developments and Future Outlook
Table 6.6 DelSiTech: Pipeline Overview
Table 6.7 DelSiTech: Recent Developments and Future Outlook
Table 6.8 Heron Therapeutics: Recent Developments and Future Outlook
Table 6.9 Intellipharmaceutics International: Recent Developments and Future Outlook
Table 6.10 Kashiv BioSciences: Pipeline Overview
Table 6.11 Mayne Pharma: Recent Developments and Future Outlook
Table 6.12 Neurelis: Pipeline Overview
Table 6.13 Taiwan Liposome Company: Pipeline Overview
Table 6.14 Taiwan Liposome Company: Recent Developments and Future Outlook
Table 7.1 Adverse Events Comparison: Austedo® versus Xenazine®
Table 7.2 Adverse Events Comparison: Abraxane® versus Taxol®
Table 7.3 Adverse Events Comparison: Procysbi® versus Cystagon®
Table 7.4 Adverse Events Comparison: Trokendi XR® versus Topiramate IR®
Table 8.2 Most Likely Candidates for Supergeneric Development
Table 8.3 Likely Candidates for Supergeneric Development
Table 8.4 Less Likely Candidates for Supergeneric Development
Table 8.5 Least Likely Candidates for Supergeneric Development
Table 12.1 Impact of Number of Drug Manufacturers on Price of Generic Drugs
Table 12.2 Year-wise Trend of NDA 505(b)(2) Approvals, 2008-2017
Table 12.3 Distribution of NDA 505(b)(2) Approvals by Submission Classification Code, 2018
Table 12.4 Historical Drug Development Costs
Table 12.5 Supergenerics: Distribution by Route of Administration
Table 12.6 Supergenerics: Distribution by Target Indication
Table 12.7 Supergenerics: Distribution by Target Therapeutic Area
Table 12.8 Supergenerics: Distribution by Approval Timeline
Table 12.9 Supergenerics: Distribution by NDA Submission Classification
Table 12.10 Supergenerics: Most Active players by Number of Approvals
Table 12.11 Supergeneric Technology Providers: Distribution by Type of Drug Modification
Table 12.12 Supergeneric Technology Providers: Distribution by Type of Technology
Table 12.13 Supergeneric Technology Providers: Distribution by Type of Molecules
Table 12.14 Supergeneric Technology Providers: Distribution by Route of Administration
Table 12.15 Supergeneric Technology Providers: Distribution by Type of Value Addition
Table 12.16 Supergeneric Technology Providers: Distribution by Year of Establishment
Table 12.17 Supergeneric Technology Providers: Distribution by Company Size
Table 12.18 Supergeneric Technology Providers: Distribution by Geography
Table 12.19 Intellipharmaceutics International: Annual Revenues, 2013-2018 (USD million)
Table 12.20 Mayne Pharma: Annual Revenues, 2013-2019 (USD Million)
Table 12.21 Taiwan Liposome Company: Annual Revenues, 2014-H1 2019 (NT$ Million)
Table 12.22 Revenue Comparison: Xenazine® versus Austedo® (USD Million)
Table 12.23 Revenue Comparison: Taxol® versus Abraxane® (USD Million)
Table 12.24 Annual Revenues: Abraxane® 2012-2018 (USD Million)
Table 12.25 Annual Revenues: Avycaz® 2015-2018 (USD Million)
Table 12.26 Annual Revenues: Procysbi® 2016-2018 (USD Million)
Table 12.27 Annual Revenues: Trokendi XR® 2014-2018 (USD Million)
Table 12.28 Supergeneric Drugs: Overall Market Opportunity, 2019-2030 (USD Billion)
Table 12.29 Supergeneric Drugs Market: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 12.30 Supergeneric Drugs Market: Distribution by Route of Administration, 2019-2030 (USD Billion)
Table 12.31 Supergeneric Drugs Market: Distribution by Geography, 2019-2030 (USD Billion)
Table 12.32 Supergenerics Drugs Market in North America, 2019-2030 (USD Billion)
Table 12.33 Supergenerics Drugs Market for CNS Disorders in North America, 2019-2030 (USD Billion)
Table 12.34 Supergenerics Drugs Market for Cardiovascular Disorders in North America, 2019-2030 (USD Billion)
Table 12.35 Supergenerics Drugs Market for Respiratory Disorders in North America, 2019-2030 (USD Billion)
Table 12.36 Supergenerics Drugs Market for Autoimmune Disorders in North America, 2019-2030 (USD Billion)
Table 12.37 Supergenerics Drugs Market for Metabolic Disorders in North America, 2019-2030 (USD Billion)
Table 12.38 Supergenerics Drugs Market for Oncological Disorders in North America, 2019-2030 (USD Billion)
Table 12.39 Supergenerics Drugs Market for Pain Disorders in North America, 2019-2030 (USD Billion)
Table 12.40 Supergenerics Drugs Market for Other Disorders in North America, 2019-2030 (USD Billion)
Table 12.41 Supergenerics Drugs Market for Oral Route of Administration in North America, 2019-2030 (USD Billion)
Table 12.42 Supergenerics Drugs Market for Parenteral Route of Administration in North America, 2019-2030 (USD Billion)
Table 12.43 Supergenerics Drugs Market for Topical Route of Administration in North America, 2019-2030 (USD Billion)
Table 12.44 Supergenerics Drugs Market for Intravitreal Route of Administration in North America, 2019-2030 (USD Billion)
Table 12.45 Supergenerics Drugs Market for Other Routes of Administration in North America, 2019-2030 (USD Billion)
Table 12.46 Supergenerics Drugs Market in Europe, 2019-2030 (USD Billion)
Table 12.47 Supergenerics Drugs Market for CNS Disorders in Europe, 2019-2030 (USD Billion)
Table 12.48 Supergenerics Drugs Market for Cardiovascular Disorders in Europe, 2019-2030 (USD Billion)
Table 12.49 Supergenerics Drugs Market for Respiratory Disorders in Europe, 2019-2030 (USD Billion)
Table 12.50 Supergenerics Drugs Market for Autoimmune Disorders in Europe, 2019-2030 (USD Billion)
Table 12.51 Supergenerics Drugs Market for Metabolic Disorders in Europe, 2019-2030 (USD Billion)
Table 12.52 Supergenerics Drugs Market for Oncological Disorders in Europe, 2019-2030 (USD Billion)
Table 12.53 Supergenerics Drugs Market for Pain Disorders in Europe, 2019-2030 (USD Billion)
Table 12.54 Supergenerics Drugs Market for Others in Europe, 2019-2030 (USD Billion)
Table 12.55 Supergenerics Drugs Market for Oral Route of Administration in Europe, 2019-2030 (USD Billion)
Table 12.56 Supergenerics Drugs Market for Parenteral Route of Administration in Europe, 2019-2030 (USD Billion)
Table 12.57 Supergenerics Drugs Market for Topical Route of Administration in Europe, 2019-2030 (USD Billion)
Table 12.58 Supergenerics Drugs Market for Intravitreal Route of Administration in Europe, 2019-2030 (USD Billion)
Table 12.59 Supergenerics Drugs Market for Other Routes of Administration in Europe, 2019-2030 (USD Billion)
Table 12.60 Supergenerics Drugs Market in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.61 Supergenerics Drugs Market for CNS Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.62 Supergenerics Drugs Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.63 Supergenerics Drugs Market for Respiratory Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.64 Supergenerics Drugs Market for Autoimmune Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.65 Supergenerics Drugs Market for Metabolic Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.66 Supergenerics Drugs Market for Oncological Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.67 Supergenerics Drugs Market for Pain Disorders in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.68 Supergenerics Drugs Market for Others in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.69 Supergenerics Drugs Market for Oral Route of Administration in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.70 Supergenerics Drugs Market for Parenteral Route of Administration in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.71 Supergenerics Drugs Market for Topical Route of Administration in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.72 Supergenerics Drugs Market for Intravitreal Route of Administration in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.73 Supergenerics Drugs Market for Other Routes of Administration in Asia-Pacific, 2019-2030 (USD Billion)
Table 12.74 Supergenerics Drugs Market in Latin America, 2019-2030 (USD Billion)
Table 12.75 Supergenerics Drugs Market for CNS Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.76 Supergenerics Drugs Market for Cardiovascular Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.77 Supergenerics Drugs Market for Respiratory Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.78 Supergenerics Drugs Market for Autoimmune Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.79 Supergenerics Drugs Market for Metabolic Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.80 Supergenerics Drugs Market for Oncological Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.81 Supergenerics Drugs Market for Pain Disorders in Latin America, 2019-2030 (USD Billion)
Table 12.82 Supergenerics Drugs Market for Others in Latin America, 2019-2030 (USD Billion)
Table 12.83 Supergenerics Drugs Market for Oral Route of Administration in Latin America, 2019-2030 (USD Billion)
Table 12.84 Supergenerics Drugs Market for Parenteral Route of Administration in Latin America, 2019-2030 (USD Billion)
Table 12.85 Supergenerics Drugs Market for Topical Route of Administration in Latin America, 2019-2030 (USD Billion)
Table 12.86 Supergenerics Drugs Market for Intravitreal Route of Administration in Latin America, 2019-2030 (USD Billion)
Table 12.87 Supergenerics Drugs Market for Other Routes of Administration in Latin America, 2019-2030 (USD Billion)
Table 12.88 Supergenerics Drugs Market in Africa and Middle-East, 2019-2030 (USD Billion)
Table 12.89 Supergenerics Drugs Market for CNS Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.90 Supergenerics Drugs Market for Cardiovascular Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.91 Supergenerics Drugs Market for Respiratory Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.92 Supergenerics Drugs Market for Autoimmune Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.93 Supergenerics Drugs Market for Metabolic Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.94 Supergenerics Drugs Market for Oncological Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.95 Supergenerics Drugs Market for Pain Disorders in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.96 Supergenerics Drugs Market for Others in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.97 Supergenerics Drugs Market for Oral Route of Administration in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.98 Supergenerics Drugs Market for Parenteral Route of Administration in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.99 Supergenerics Drugs Market for Topical Route of Administration in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.100 Supergenerics Drugs Market for Intravitreal Route of Administration in Africa and Middle East, 2019-2030 (USD Billion)
Table 12.101 Supergenerics Drugs Market for Other Routes of Administration in Africa and Middle East, 2019-2030 (USD Billion)

Executive Summary

Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the supergeneric drugs market in the mid to long term.

Chapter 3 provides an overview of generic drugs and the contemporary challenges related to such products, such as price erosion, growing competition and unfavorable policy changes by regulatory authorities. It further highlights the rise of supergenerics / value added generics and the various techniques used for the development of these products. The chapter also provides a brief outline of the regulatory pathways involved in the approval process of supergeneric drugs. Further, it includes a discussion on the various advantages and limitations / constraints within this evolving segment of the pharmaceutical industry.

Chapter 4 provides an overview of recently approved supergenerics (over the period 2016-2018). The chapter presents detailed analyses of these drugs based on several relevant parameters, such as route of administration, target disease indication(s), target therapeutic area(s), approval timeline, submission classification code and most active drug developers (in terms of number of product approvals).

Chapter 5 provides an overview of industry players that are actively engaged in offering technology platforms for the development of supergenerics. The chapter presents an analysis of these players on the basis of their year of establishment, geographical location and company size. It also provides a list of the various technologies offered by the aforementioned companies, along with a detailed competitiveness analysis based on parameters, such as compatibility with different types of molecules, routes of administration, and impact on drug properties.

Chapter 6 includes detailed profiles of prominent technology developers engaged in this domain, featuring an overview of the company, its financial information (if available), a detailed description of its technology platform(s), recent developments and a comprehensive future outlook.

Chapter 7 presents detailed case studies on five approved supergeneric drugs, including an overview of the product along with information on the original / parent drug, value proposition offered by the supergeneric version, pricing strategies adopted by the developer (if available), annual revenues of the supergeneric and parent drug (if available) and the key learnings / takeaways from individual case studies.

Chapter 8  provides a list of marketed generics that are likely to be developed as supergenerics in the near future, based on a detailed analysis of potential candidates, taking into consideration various parameters, including the current annual cost of treatment of parent drug, its year of patent expiry, revenues generated by the parent drug in the year before patent expiry, target therapeutic area and number of competitor generic drugs available in the market.

Chapter 9 provides a discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall supergeneric drugs industry.

Chapter 10 presents a detailed market forecast, highlighting the future potential of the supergenerics market till the year 2030. The chapter features the likely distribution of the opportunity across different [A] type of therapeutic areas (autoimmune disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, pain disorders, respiratory disorders and others), [B] routes of administration (parenteral, intravitreal, oral, topical and others) and [C] geographical regions (North America, Asia-Pacific, Europe, South America, and Africa and Middle East).

Chapter 11 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it summarizes the various evolutionary trends that are likely to influence the future of this market.

Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 13 is an appendix, which contains the list of companies and organizations mentioned in the report.


Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • 3M
  • 3SBio
  • Abon Pharmaceuticals
  • Abraxis BioScience (a subsidiary of Celgene)
  • Accord Healthcare
  • AcelRx Pharmaceuticals
  • Aclaris Therapeutics
  • Acorda Therapeutics
  • Acrotech Biopharma
  • ACS Dobfar
  • Actavis (a subsidiary of Teva Pharmaceutical)
  • Adamis Pharmaceuticals
  • ADDMEDICA
  • ADIENNE
  • Aegis Therapeutics
  • Ailex Pharmaceuticals
  • Akorn
  • Alcon
  • Alembic Pharmaceuticals
  • Allergan
  • ALRISE Biosystems
  • Altaire Pharmaceuticals
  • Altus Formulation
  • Alyvant
  • American Regent
  • Amerigen Pharmaceuticals
  • Amneal Pharmaceuticals
  • ANI Pharmaceuticals
  • Antares Pharma
  • Apotex
  • Aprecia Pharmaceuticals
  • Armstrong Pharmaceuticals
  • Ascendia Pharmaceuticals
  • Ascendis Pharma
  • Assertio Therapeutics
  • AstraZeneca
  • Aurobindo Pharma
  • Avadel Pharmaceuticals
  • Avanir Pharmaceuticals
  • Avedro
  • Avion Pharmaceuticals
  • B. Braun
  • Bausch & Lomb
  • Baxter
  • Bayer
  • BDD
  • Belcher Pharmaceuticals
  • Bharat Serums and Vaccines
  • BioDelivery Sciences International
  • Birdie Pharmaceuticals
  • Bracco
  • Braeburn
  • Bristol-Myers Squibb
  • BWX Technologies
  • Celator Pharmaceuticals (a subsidiary of Jazz Pharmaceuticals)
  • Celgene
  • Cellix Bio
  • Celltrion Healthcare
  • Chiesi Farmaceutici
  • Cintex
  • Cipla
  • CMP Pharma
  • Cocoon Biotech
  • Coeptis Pharmaceuticals
  • Covis Pharma
  • Cristal Therapeutics
  • CritiTech
  • Crossject
  • C-Tri
  • Cycle Pharmaceuticals
  • Dauntless Pharmaceuticals
  • DelNova Healthcare
  • DelSiTech
  • Desitin Pharma
  • Dexcel Pharma
  • DFB Pharmaceuticals
  • DisperSol Technologies
  • Dr. Reddy's Laboratories
  • Druggability Technologies
  • EASYWELL BIOMEDICALS
  • ECI Pharmaceuticals
  • Edenbridge Pharmaceuticals
  • ELPEN
  • Emmaus Life Sciences
  • Encore Dermatology
  • EPI Health
  • epinamics
  • Eurohealth International
  • Exela Pharma Sciences
  • EyePoint Pharmaceuticals
  • Eyevance Pharmaceuticals
  • Ferring Pharmaceuticals
  • Flexion Therapeutics
  • Foresee Pharmaceuticals
  • Fresenius Kabi
  • Galderma
  • General Atlantic
  • Genus Lifesciences
  • Gland Pharma
  • GlaxoSmithKline
  • Glenmark Pharmaceuticals
  • GP Pharm
  • Handa Pharmaceuticals
  • Hanmi Pharmaceutical
  • HANSAmed
  • HealthCare Royalty Partners
  • Heron Therapeutics
  • Hetero
  • Horizon Therapeutics
  • Hospira
  • HQ Speciality Pharma
  • Hyundai Bioscience
  • IBSA Institut Biochimique
  • iCeutica
  • Impax Laboratories
  • Impel NeuroPharma
  • Indivior
  • InfoRLife
  • Ingenus Pharmaceuticals
  • Insmed
  • INSYS Therapeutics
  • Intec Pharma
  • Integral BioSystems
  • IntelGenx
  • Intellipharmaceutics International
  • Intersect ENT
  • Inventia Healthcare
  • Ironshore Pharmaceuticals
  • Italfarmaco
  • Jiangsu Hengrui Medicine
  • Jixi Biotechnology
  • Johnson & Johnson
  • Jubilant DraxImage
  • Kala Pharmaceuticals
  • Kaleo
  • Kashiv BioSciences
  • KC Pharmaceuticals
  • KemPharm
  • Keystone Nano
  • KVK Tech
  • Larken Laboratories
  • LATITUDE Pharmaceuticals
  • leon-nanodrugs
  • LipoSeuticals
  • Liquidia Technologies
  • Lundbeck
  • Lupin
  • Macleods Pharmaceuticals
  • Mallinckrodt Pharmaceuticals
  • Mayne Pharma
  • Medesis Pharma
  • MedinCell
  • Medline Industries
  • Merck
  • Meridian Medical Technologies
  • Micelle BioPharma
  • Mikart
  • Mipharm
  • Mithra Pharmaceuticals
  • MSN Laboratories
  • Mylan
  • Nanocopoeia
  • NanoVelos
  • Natco Pharma
  • NAVINTA
  • Neos Therapeutics
  • Nesher Pharmaceuticals
  • Neurelis
  • Nexus Pharmaceuticals
  • Northstar Medical Radioisotopes
  • Norton (Waterford)
  • Nostrum Laboratories
  • NOVADAQ Technologies (a subsidiary of Stryker)
  • Novatech
  • Novel Laboratories
  • Novocol Healthcare
  • NX Development
  • Ocular Therapeutix
  • Opiant Pharmaceuticals
  • Optinose
  • Osmotica Pharmaceuticals
  • Paddock Laboratories
  • Par Pharmaceutical
  • Par Sterile Products (a subsidiary of Par Pharmaceutical)
  • Pearl Therapeutics
  • Perrigo
  • Pfizer
  • Pharmadax
  • PLx Pharma
  • Praxair
  • ProSolus
  • Provepharm Life Solutions
  • Raptor Pharmaceuticals
  • Recordati
  • Rempex Pharmaceuticals
  • Rising Pharmaceuticals
  • Rosemont Pharmaceuticals
  • Roxane Laboratories (a subsidiary of Hikma Pharmaceuticals)
  • Rubicon Research
  • RxMP Therapeutics
  • Sagent Pharmaceuticals
  • Salvat
  • Sandoz
  • SCILEX Pharmaceuticals
  • SGN Nanopharma
  • Shanghai Hengrui Pharmaceutical
  • Silvergate Pharmaceuticals
  • Solani Therapeutics
  • Sol-Gel Technologies
  • Spear Pharmaceuticals
  • St. Renatus
  • Sun Pharmaceutical
  • Sunny Pharmtech
  • Sunovion Pharmaceuticals
  • Supernus Pharmaceuticals
  • Taiwan Liposome Company
  • Taro Pharmaceuticals
  • Teligent
  • TerSera Therapeutics
  • tesa Labtec
  • Teva Pharmaceutical
  • TherapeuticsMD
  • Tiger Pharmaceuticals
  • Titan Pharmaceuticals
  • Tolmar
  • Torrent Pharmaceuticals
  • Tris Pharma
  • Upsher-Smith Laboratories
  • US Biotest
  • Valeant Pharmaceuticals
  • West-Ward Pharmaceuticals
  • Xellia
  • X-GEN Pharmaceuticals
  • Zydus Cadila

Methodology

 

 

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