Super Generics Revolutionizing Drug Market with Advanced Delivery Systems and Extended Exclusivity, Enhancing Efficacy and Patient Compliance
The global super generics market was estimated to be USD 84 billion in 2024 and is projected to reach USD 200 billion in 2035. The market is anticipated to grow at a CAGR of 8%, during the forecast period 2024-2035.
The new research study consists of super generics market trends, detailed super generic drugs market landscape, technology landscape, likely drug analysis, SWOT analysis, and market forecast and opportunity analysis. The super generics market growth over the next decade is likely to be the result of anticipated increase in regulatory support, patent expirations, healthcare costs, therapeutic innovation, and ongoing technological advancements.
In the pharmaceutical industry, super generic drugs represent improved versions of an original pharmaceutical drug that have lost their patent exclusivity. These modified pharmacological interventions are commonly referred to as complex generics / value added generics. These enhanced versions are readily available in the market as generic alternatives to their branded drugs. Interestingly, in 2022, the US FDA approved more than 32,000 generic drug products, 91% of all prescriptions in the United States are filled as generic drugs.
The improved super generics may enable enhancements in drug delivery, manufacturing processes and reformulation techniques. This value-added segment operates within a framework of continuous innovation, presenting lucrative opportunities in the pharmaceutical market landscape. Super generic drugs are granted a form of marketing exclusivity (for a period of 3-7 years), enabling their developers to generate relatively high profit margins, compared to conventional generics. Regulatory agencies such as the FDA in the United States or the EMA in Europe review these studies and grant approval for drugs to enter the super generics market.
The development of super generic drugs involves rigorous research and development processes to ensure their safety, efficacy, and quality. Industry players invest in extensive preclinical and clinical studies to demonstrate bioequivalence or therapeutic equivalence to the reference brand-name drug. As more generic drugs get approved by regulators across the globe, the competition in the industry is likely to increase.
The most evident impact of this competition is deflation of the 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 to develop value added medicinal products, which offer better commercial benefits. Retail pharmacies offer a diverse selection of generic options, providing consumers with opportunities to reduce healthcare expenses.
Furthermore, in numerous European countries, pharmacists have the authority to substitute brand-name prescriptions with generic equivalents unless otherwise specified by a healthcare provider. Retail pharmacies and online pharmacies serve as key resources for patients seeking information about their medications, offering guidance on the benefits and distinctions between super generics and standard generics.
Super Generics Market Share Insights
The super generics market report presents an in-depth analysis of the various companies that are involved in the super generics market, across different segments, as defined below:
- Historical Trend: 2018-2023
- Base Year: 2023
- Forecast Period: 2024-2035
- Market Size Value in 2023: USD 77 Billion
- Growth Rate: CAGR of 8% from 2024 to 2035
- 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 Molecules
- Type of Product
- Aerosols
- Capsules
- Prefilled Syringes
- Tablets
- Vials
- Other Products
- Geography
- North America
- Europe
- Asia-Pacific
- Rest of the World
- Leading Market Players
- 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
- PowerPoint Presentation (Complimentary)
- Customization Scope: 15% Free Customization
- Excel Data Packs (Complimentary)
- Overall Landscape
- Technology Landscape
- Likely Drug Analysis
- Market Size and Opportunity Analysis
Super Generics Market Key Segments
Market Share by Therapeutic Area
The global super generics market is segmented into cardiovascular disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders. The oncological disorders capture the highest share in 2023 and is expected to remain dominant during the forecast period. This can be attributed to increasing cancer prevalence, patent expiration of oncology drugs and advancements in drug delivery technologies driving the adoption of super generic drugs in cancer treatment.
Market Share by Route of Administration
Based on the route of administration, the global super generics market is categorized into intravenous, oral, subcutaneous and others. The market for super generics offering treatment by oral route of administration is likely to hold the maximum share in 2023 and this trend is expected to remain same during the forecast period. This can be primarily due to the convenience, patient preference and availability of oral formulations for a wide range of therapeutic indications.
Market Share by Type of Molecule
Based on the type of molecule, the global super generics market is segmented into small and other molecules. The market for small molecules is anticipated to occupy the largest market share in the overall super generics market. This can be attributed to the favourable characteristics of small molecules, versatility in targeting various diseases and established regulatory pathways for approval, facilitating their widespread adoption across therapeutic areas.
Market Share by Type of Small Molecule
Based on the type of small molecule, the super generics market is segmented into complex generics and other small molecules. Presently, the market is dominated by sales revenues generated from complex generics. This can be attributed to their advanced formulations or delivery systems, which often offer improved efficacy or safety compared to traditional generics. Additionally, complex generics may have longer periods of market exclusivity due to the complexity associated with their development, providing manufacturers with greater sales revenue opportunities. Overall, the dominance of complex generics in the super generics market underscores their importance in addressing unmet medical needs and driving super generic drugs market growth. This trend is unlikely to change in the near future.
Market Share by Type of Product
Based on the type of product, the super generics market is segmented into aerosols, capsules, prefilled syringes, tablets, vials and others. Presently, the super generics market is dominated by sales revenues generated from tablets, followed by capsules. This can be attributed to the widespread acceptance, convenience, and versatility of tablets and capsules as dosage forms, offering ease of administration, precise dosing, and longer shelf lives compared to other dosage forms.
Super Generic Market Share by Key Geographical Regions
This segment highlights the distribution of global super generics market across various geographies, namely North America, Europe, Asia-Pacific, and Rest of the World. According to the projections, the super generics market in North America is likely to capture the majority (55%) of the share. It is worth highlighting that the market in Rest of the World is expected to grow at a relatively higher CAGR (14%), during the period 2024-2035.
Super Generic Market Key Market Insights
The report features an extensive study of the current market landscape, market size and future opportunities associated with super generic drugs market size, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the super generics market report are briefly discussed below.
Advantages of Super Generics / Value Added Drugs Over Generics
Super generics / value added drugs offer numerous advantages over traditional generic drugs. By incorporating advanced drug delivery systems, novel formulations, and therapeutic modifications they enhance efficacy, safety, and patient compliance. These advanced formulations also improve the bioavailability of active pharmaceutical ingredients, ensuring better absorption and distribution in the body, thereby potentially enhancing treatment outcomes. Moreover, super generics have longer periods of market exclusivity due to their enhanced formulations or delivery systems, providing manufacturers with a competitive advantage and the potential for higher sales revenues. Additionally, super generics offers unique features such as extended-release formulations, combination therapies, or alternative routes of administration. This allows them to cater to specific patient needs and preferences more effectively.
Super Generics Market Trends
The market landscape of super generic drugs is dynamic and diverse, with close to 270 super generic drugs developed by various industry players across different regions. These drugs are designed to provide therapeutic alternatives to branded drugs that have lost patent protection. Super generic drugs can be administered through various routes of administration, such as oral (tablets, capsules), intravenous (IV infusions), intranasal (nasal sprays), ophthalmic (eye drops), subcutaneous (injections), topical (creams, gels).
This diversity allows healthcare providers to tailor treatment regimens to individual patient needs, enhancing patient adherence and treatment outcomes. Overall, the market landscape of super generic drugs is characterized by innovation, competition, and affordability, providing patients with access to high-quality and cost-effective treatment options for a wide range of disease indications.
In addition to the aforementioned super generic drugs, close to 70 super generic technologies have also been developed. These technologies play a crucial role in the development and manufacturing of super generic drugs, contributing to their efficacy, safety, and affordability. Super generic technologies encompass a range of innovations and advancements in drug delivery systems, formulation techniques, manufacturing processes, and quality control methods, ultimately enhancing the overall quality and accessibility of generic pharmaceutical products.
Market Size of the Super Generics Market
Driven by patent expirations, advancements in technology and manufacturing processes, and increasing demand for affordable healthcare, the super generics market is anticipated to grow at a CAGR of 8% during the forecast period (2024-2032). Super generics offer therapeutic alternatives to branded drugs at lower costs, making them attractive options for patients and healthcare systems. This growth trajectory highlights the rising importance of super generics in addressing global healthcare needs and providing accessible treatment options for patients which plays a crucial role in driving the growth of the super generics market.
North America Holds the Largest Share of the Super Generics Market
Presently, North America captures 55% of the overall super generics market size, with a growing preference for super generic drugs due to regulatory guidance and early FDA approvals. Additionally, the presence of major pharmaceutical companies and research institutions in North America drives innovation and facilitates the introduction of new super generic products to the market. It is worth highlighting that, in the coming years, countries based in rest of the world are expected to experience higher growth in super generics adoption. This higher growth rate can be attributed to the changing demographic trends and healthcare needs owing to the aging population and rise in chronic diseases that create a growing demand for affordable treatment options. This region is likely to grow at a higher CAGR (14%) as compared to other regions.
Key Players in the Super Generics Market
Examples of key players involved in super generics market (which have also been profiled in this market report; the complete list of companies is available in the full report) include 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 and Tesa Labtec and Teva Pharmaceutical. This market report includes an easily searchable excel database of all the companies engaged in the super generics market worldwide.
Super Generic Market Report Coverage
The super generics market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market research report includes:
- An outline of the systematic research methodology adopted to conduct the study on super generics industry, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of the findings.
- An overview of economic factors that impact the overall super generics market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
- An executive summary of the insights captured during the research. It offers a high-level view on the current state of super generics and its likely evolution in the mid-long term.
- An overview of approved super generics (over the period 2016-2024), featuring information on route of administration, target disease indication, target therapeutic area, submission classification code and most active drug developers (in terms of number of product approvals).
- An overview of the super generics technologies along with information on several relevant parameters, such as type of drug modification, type of technology, type of molecules formulated / delivered, route of administration, type of value addition This includes information on the technology providers, offering platforms / solutions for supergeneric drug development along with their year of establishment, company size (in terms of number of employees) and location of headquarters.
- An informed competitiveness analysis of the technologies captured in the database, taking into consideration relevant parameters, such as supplier power (based on company size of technology provider) and technology competitiveness, 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), technology portfolio, recent developments and future outlook.
- A list of marketed generics that, we believe, are likely to be developed as super generics 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, sales 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 drug along with information on the original / parent drug, value proposition offered by the supergeneric version, pricing strategies adopted by the developer (if available), annual sales 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 SWOT framework, which are likely to impact the industry’s evolution, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall super generics market.
- A detailed estimate of the current market size, current opportunity, and the future growth potential of the super generics market over the next decade. Based on multiple parameters, such as likely adoption trends, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the super generics market. Further, in order to account for future uncertainties and to add robustness to the model, the analyst has provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the super generics market growth.
One of the key objectives of this market report was to estimate the super generic drugs market trends, current market size, opportunity and the future growth potential for the super generics market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035.
The super generic drugs market analysis also features the likely distribution of the current and forecasted opportunity within this market across various segments, such as therapeutic area (cardiovascular disorders, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders), route of administration (intravenous, oral, subcutaneous and others), type of molecule (small and other molecules) type of small molecule (generics and other small molecules), type of product (aerosols, capsules, prefilled syringes, tablets, vials and other products) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to the model, the analyst has provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.
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.
Table of Contents
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
- Atox Bio
- 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
- C-Tri
- 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
- 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
- Sol-Gel Technologies
- Solani Therapeutics
- 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
- X-GEN Pharmaceuticals
- Xellia
- Zydus Cadila
Methodology
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Table Information
Report Attribute | Details |
---|---|
No. of Pages | 257 |
Published | May 2024 |
Forecast Period | 2024 - 2035 |
Estimated Market Value ( USD | $ 84 Billion |
Forecasted Market Value ( USD | $ 200 Billion |
Compound Annual Growth Rate | 8.0% |
Regions Covered | Global |