Super Generic Drugs Market

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

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Generic Drugs Market Overview

The super generic drugs market is estimated to be worth $38 billion in 2019 and is expected to grow at CAGR of 12% during the forecast period.
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. 

This image highlights the context of Generics Market report. Given lucrative cost benefits and marketing exclusivity, supergeneric medicines represent an attractive product segment within the modern pharma industry; upcoming patent expiries of blockbuster drugs have intensified the interest in this field This image provides list of	Approved Value-Added Medicines / Supergenerics. Over time, there has been a significant increase in interest in value added generic drugs; in fact, in the last three years alone, more than 130 such products have been approved for the treatment of various diseases This image provides list of Available Technologies for Value Added Drug Development. Currently, there are several technology platforms, capable of significantly enhancing the properties of existing therapeutic products and / or improving therapy adherence, available for use by supergeneric drug developers

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 market growth during the forecast period.

Key Companies in Generic Drugs Market 

Examples of key generic pharmaceutical companies engaged in generic drugs industry (which have also been profiled in this market report; the complete list of generic pharmaceutical companies is available in the full report) include Ascendia Pharmaceuticals, CritiTech, Crossject, DelSiTech, Heron Therapeutics, Intellipharmaceutics International, Kashiv BioSciences, Latitude Pharmaceuticals, Mayne Pharma, Neurelis, Rubicon Research, Taiwan Liposome Company and tesa Labtec. This market report includes an easily searchable excel database of all the generic drug companies providing generic drugs, worldwide.

Recent Developments in Super Generic Drugs Market:

Several recent developments have taken place in the field of generic drugs industry. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In September 2023, Takeda Pharmaceuticals announced the FDA approval of multiple first generics of lisdexamfetamine dimesylate chewable tablets and capsules for patients of 6 years suffering from attention-deficit/hyperactivity disorder. 
  • In January 2023, Amneal Pharmaceuticals entered into a licensing agreement with Orion Corporation with an aim to commercialize a number of Amneal’s complex generic products.

Scope of the Reports

The ‘Super Generic Drugs Market: Focus on Value-added Medicines / Supergenerics, 2019-2030’ market report features an extensive study of current market landscape, generic drugs market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the super generic drugs market.

This image presents current market landscape of Supergeneric Development Technologies. The primary focus in this domain is on improving small-molecule drugs and conferring controlled-release properties to oral formulations of such products This image highlights the geographical distribution of Supergeneric Development Technologies. Upcoming technologies are increasingly exploiting parenteral routes of drug delivery; the US is currently considered to be the base of operations for majority of such companies This image highlights competitive analysis of Supergeneric Development Technologies. In order to achieve an edge over competing players, technology developers in this market are increasingly focusing on the integration of advanced features in their respective platforms and affiliated offerings

Amongst other elements, the super generic drugs market research 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 super generic drugs market, 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.

The key objective of super generic drugs market report is to provide a detailed market analysis in order to estimate the existing generic drugs market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for generic drugs market during the forecast period. Based on several parameters, such as size of the super 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 forecast 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 market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are generic drugs?

Answer: Generic drugs are pharmaceutical compositions created to mimic an already marketed drug in formulation, safety, efficacy and intended use.

Question 2: How big is the generic drugs market?

Answer: The generic drugs market size is estimated to be worth $38 billion in 2019.

Question 3: What is the projected market growth of the generic drugs market?

Answer: The generic drugs market is expected to grow at compounded annual growth rate (CAGR) of 12% during the forecast period 2019 – 2030.

Question 4: Who are the leading companies in the generic drugs market?

Answer: Examples of key companies engaged in generic drugs market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Ascendia Pharmaceuticals, CritiTech, Crossject, DelSiTech, Heron Therapeutics, Intellipharmaceutics International, Kashiv BioSciences, Latitude Pharmaceuticals, Mayne Pharma, Neurelis, Rubicon Research, Taiwan Liposome Company and tesa Labtec.

Question 5: How many generic drugs have been approved by the FDA over last few years?

Answer: In 2018 alone, more than 780 generic drugs have been approved by the FDA.

Question 6: How many drugs have been launched by companies engaged in the generic drugs market over the last few years?

Answer: Between 2016 to 2018, over 130 drugs have been launched by players engaged in the generic drugs market.

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