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Generic Drugs Market By Product Type (Simple Generic Drugs, Super Generic Drugs, Others) By Application (CNS, Cardiovascular, Genitourinary/Hormonal Drugs, Others) Regional Analysis & Forecast - 2026

  • OI-80
  • |
  • Published date: Mar, 2019
  • |
  • Biopharmaceuticals
  • |
  • Pages

A generic drug is a pharmaceutical drug, which is equivalent to a brand-name product in terms of dosage, strength, quality, route of administration, performance, and its intended use. The term may also be defined as any drug marketed under its chemical name without advertisement, or as the chemical makeup of a drug rather than the brand name under which the drug is sold. These low-cost alternatives to brand-name products or generic drugs must contain the same active chemical ingredient and rate of absorption as the branded product. The chemical ingredients, along with inert substances, which aid in the body's absorption and in binding the drug, make up the composition of the drug.

Market Overview


The global average gross margin of generic drugs is in the decreasing trend, from 45.19% in 2011 to 43.56% in 2015. With the status of the global economy, gross margin will be in decreasing trend in the following five years. Further, the stability in the industry sets the stage for industry players to get back on the growth track. A large number of blockbuster drugs from big pharma companies have lost or are set to lose patent protection. This creates a significant opportunity for generic drug makers with billions of dollars in sales up for grabs. The market for generic drugs thus, has expanded, and it is expected to flourish tremendously, especially between 2012 and 2018.


Lower drug prices in the US have been a continuous drag on revenues of industry players. Further, accelerated FDA approvals to generic drugs and ongoing customer consolidation have augmented the competition by putting further pressure on drug prices. Many of the large companies in the industry are restructuring or exploring strategic alternatives as the safeguard against the macro challenges.


The low cost of generics, as an alternative to branded drugs, is the most crucial factor triggering the global generic drugs market growth. Generic drug companies do not have to suffer from high initial drug development costs, and hence they cost 85% less than the branded drugs. Additionally, generic drug applicants do not have to repeat animal and clinical (human studies) studies needed to demonstrate the safety and effectiveness of brand name medicines. As a result, generic drugs are available at a lower price than branded drugs, while comprising of identical active ingredients with similar strength, stability, purity, efficacy, and safety of the branded drug. These benefits are encouraging patients to opt for generics as alternatives to expensive branded medicines.


The use of RPA to ensure regulatory and standards compliance is one of the major branded generics market trends, which will gain traction in forthcoming years. This helps in maintaining compliance with regulations and standards, completing processes at a quicker pace, and reducing costs. The generic drugs market experts predict that the above-mentioned factors will be critical in driving growth in the generic drugs market, which is expected to grow at a CAGR of over 10% during the forecast period.


Key Developments



  • In July 2018, Pfizer announced plans to split its business into three units- Innovative Medicines, Consumer Healthcare, and its generics branch, Established Medicines.

  • In Sep 2018, in another generics shake-up, Novartis agreed to divest its US generic oral solids and dermatology businesses to Aurobindo Pharma US.

  • In 2018, USFDA set a record with highest number of generic approvals and tentative approvals of 971 generic drugs.

  • Some of the upcoming generics are Treprostinil- treats high blood pressure in the lungs anticipated launch in first quarter of 2019, Pregabalin- treats fibromyalgia, treats painful nerve diseases anticipated launch in July 2019, Doxepin Hydrochloride to treat sleep disorders anticipated launch in Jan 2020


Segmentation


Generic drugs market is segmented based on the product type, application, and region.


Product Type:



  • Simple Generic Drugs

  • Super Generic Drugs

  • Biosimilars


The small molecule generics will retain dominance in the generic drugs market share, while rapidly growing biosimilars will account for the highest growth in the market.


Application:



  • CNS

  • Cardiovascular

  • Genitourinary/Hormonal Drugs

  • Respiratory

  • Rheumatology

  • Diabetes

  • Oncology

  • Others


Region: North America, Asia-Pacific, Europe, Central & South America, and Middle East & Africa


Global generic drugs market analysis reveals that the Americas is the leader in generic drugs market share and will retain its position over the next few years. In addition, our market experts have also concluded that APAC is expected to have the highest growth rate throughout the forecast period. This is primarily driven by the growing popularity of generic medicines due to the rising drug prices and medicine shortages in the region.


The key pharmaceutical companies profiled in the report are Actavis, Mylan, Inc., Teva Pharmaceutical Industries, Ltd., Dr. Reddy’s Laboratories, Sandoz International GmbH, Apotex, Inc., Par Pharmaceutical, Inc., Hospira, Inc., and others.

Report Description: The report covers in-depth analysis on Generic Drugs Market. The report assesses the market products pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (cardiovascular illnesses, diabetes, oncologic diseases, and others). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.

The report includes in-depth company profiles of key players in Generic Drugs Market. The company profile includes key information on overview, financial highlights, product portfolio, business strategies, and key recent developments.


The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.


Scope:



  • Provides detailed analysis of the market structure along with forecast of the various segments and sub-segments of the Generic Drugs Market.

  • Provides a comparative analysis of key marketed products and pipeline market products.

  • Provides key information on players involved on the Generic Drugs Market.

  • Provides a complete overview of market segments and the regional outlook of Generic Drugs Market.

  • Provides in-depth coverage of key news related to Generic Drugs Market, including major mergers and acquisitions and product development updates such as clinical trial progression updates and regulatory updates

Our research works on a holistic 360° approach to deliver high quality, validated and reliable information in our market reports. The Market estimation and forecasting involve the following steps:




  • Data Collation (Primary & Secondary)




  • In-house Estimation (Based on proprietary databases and Models)




  • Market Triangulation




  • Forecasting




  • Market-related information is assembled from both primary and secondary sources. 






  • Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services. 






  • Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others. 






  • Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. 





 


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