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

DUBLIN--()--The "Generics Market: Focus on Value-Added Medicines / Supergenerics, 2019-2030" report has been added to's offering.

This 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.

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.

Report Scope

  • 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.

Key Topics Covered

1 Preface

2 Executive Summary

3 Introduction

4 Supergeneric Drugs: Market Landscape

5 Technology Providers for Supergeneric Development: Market Landscape

6 Company Profiles: Supergeneric Technology Providers

7 Case Study of Approved Supergeneric Drugs

8 Likely Drug Candidates for Supergeneric Development

9 SWOT Analysis

10 Market Forecast

11 Conclusion

12 Appendix 1: Tabulated Data

13 Appendix 2: List of Companies & Organization

  • 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
  • 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
  • and many, many more...

For more information about this report visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900