Specialty Generics Market to Expand at a CAGR of 8.7%, Driven by Increase in Chronic Illness | Market.us Report


The latest insights show that North America led the specialty generics market in 2022, accounting for 37% of the total revenue. The region benefits from regulatory policies that support the approval of new products, and leading manufacturers are actively developing specialized generic medications for commercial use.

New York, April 28, 2023 (GLOBE NEWSWIRE) — The global Specialty Generics market size is anticipated to be worth around USD 167.6 billion by 2032 from USD 74.3 Billion in 2022, growing at a CAGR of 8.7% during the forecast period 2023 to 2032. Two key market-driving factors are the rising incidence of complex chronic diseases like hepatitis C and the increased use of specialty generic drugs for their treatment.

Due to high comorbid conditions and weakened immunity, aging is a significant risk factor for the increasing prevalence of complex chronic diseases like arthritis, cancer, and cardiovascular diseases. The rapidly increasing geriatric population is expected to present profitable growth prospects for the company. Major pharmaceutical companies have made acquisitions and mergers to increase their market dominance.


Specialty Generics Market

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Key Takeaway:

  • By Type, in 2022, the Specialty Generics market was dominated by the injectables segment due to the highest revenue share.
  • By application, the inflammatory condition segment dominated the largest market share in 2022.
  • By Distribution Channel, the specialty pharmacy segment dominated the largest market share.
  • In 2022, North America dominated the market with the highest revenue share of 37%.

Factors Affecting the Growth of the Specialty Generics Market

There are several factors that can have an impact on the growth of the Specialty Generics Market. Some of these factors include:

  • Increasing prevalence of chronic diseases: The growing incidence of chronic diseases, such as cancer, diabetes, and cardiovascular diseases, has led to rising demand for specialty generics. These products are often used to treat complex conditions that require specialized formulations, and they offer an affordable alternative to branded drugs.
  • Increasing healthcare costs: The rising healthcare costs are driving the demand for affordable alternatives, including specialty generics. These products offer remarkable cost savings compared to branded drugs, making them an attractive option for patients and healthcare providers.
  • Technological Advancement: The advancements in technology are enabling the expansion of more complex and specialized formulations, which are helping to drive the growth of the specialty generics market. The availability of new drug delivery systems and new adaptive formulations is expanding the range of treatment options available for patients.
  • Price pressure: Specialty generics face price pressure due to the competition in the market and efforts by governments to control healthcare costs. Manufacturers are often required to lower their prices to remain competitive, which affects the profitability of the specialty generics market.

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Market Growth

The specialty generics market has been growing at a rapid pace in recent years, and this trend is expected to continue in the upcoming year. With the alarming rise in chronic illnesses like cancer, diabetes, and cardiovascular diseases, the demand for specialized generic drugs has increased significantly. This trend is primarily due to the high cost of branded medicines, which many patients find unaffordable. The increasing number of approvals is also driving the growth of the specialty generics market. The increasing healthcare spending in emerging markets is creating new growth opportunities for specialty generics production.

Regional Analysis

In 2022 North America led the specialty generics market and accounted for 37% of the total revenue. because there are regulatory policies in place that support the approval of new products. The main producers are constantly working to get specialized generic medications for commercial use on the market. During the projection period, it is expected that the specialty generics market in the Asia Pacific will grow rapidly. The region’s development is primarily fueled by high unmet low-cost medicine needs and the entry of new generic medications into the market.

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Scope of the Report

Report Attribute Details
Market Value (2022) USD 74.3 billion
Market Size (2032) USD 167.6 billion
CAGR (from 2023 to 2032) 8.7%
North America Revenue Share 37%
Historic Period 2016 to 2022
Base Year 2022
Forecast Year 2023 to 2032

Market Drivers

  • Increase in Chronic Illness: Market growth is being driven by the increase in chronic diseases. Chronic diseases are long-lasting illnesses that frequently have no therapy. It is, however, occasionally treatable and manageable. The major reason for chronic illnesses is changes in poor eating habits and lifestyle choices to keep a healthy weight; a few more long-term chronic infections increase the risk of expanding cancer. The requirement for specialty generics to address complex chronic diseases is increasing as a result of the increasing incidence of these conditions.

Market Restraints

  • High Development Cost: It can be expensive to conduct extensive research and development for specialty generics. Research is more expensive due to the regulatory process for specialized generics is frequently more stringent than for traditional generics. These high costs may make it difficult for smaller businesses to enter the industry.
  • Limited Market Exclusivity: Specialty generics frequently have a limited period of market exclusivity, which means that after a certain amount of time, other companies can produce and sell similar products. Price reductions and increased competition may follow, which would reduce profit margins for market players.
  • Complex manufacturing processes: Complex manufacturing procedures are frequently required for specialty generics, and they can be challenging to scale up to fulfill demand. In addition to potential quality control problems, this may cause production delays and higher expenses.

Market Opportunities

  • Increasing Demand for Affordable Healthcare Solutions: Due to increasing healthcare costs, affordable medications are becoming more and more necessary. Specialty generic drugs are chosen by patients, medical workers, and insurers because they are more affordable than branded drugs.
  • Growing Need for Personalized Medicine: Advances in genomic medicine and other areas have led to a growing demand for personalized medicine. Specialty generics can play a key role in this trend by offering tailored treatments for specific patient populations.
  • Technological Advancements in drug development and Manufacturing: Complex drugs are becoming easier and more affordable to manufacture due to developments in pharmaceutical research and production. Specialty generic manufacturers today have more opportunities to expand and sell more sophisticated medications.

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Report Segmentation of the Specialty Generics Market

Type Insight

The specialty generics market was dominated by the injectables category, which also had the highest revenue share. The reason for the segment’s supremacy is the benefits of injectables, such as their long-lasting effects and quick absorption, which boost patient compliance and acceptance. The injectables industry is also anticipated to grow at the fastest rate during the forecast period due to rising product approval and higher market penetration. The number of prescriptions increases as a result of approval making it easy for cancer patients to acquire affordable specialty generic drugs.

Application Insight

The market for specialty generics was dominated by the inflammatory conditions segment, which also had the largest revenue share. The growth in inflammatory disease prevalence has made it possible for key players to boost their market dominance in this sector. The oncology sector is expected to grow significantly during the anticipated period due to an increase in the burden of cancer disease. because of a shift to a Western way of living, excessive alcohol and tobacco use, poor eating habits, and a deficiency in physical activity. As the number of cancer cases increases, it is expected that the demand for specialty generics will rise

Distribution Channel Insight

The market for specialty generics was dominated by the specialty pharmacy sector, which also contributed to the biggest revenue share of the overall market. During the anticipated era, the market is forecasted to develop at a profitable rate. Major specialty generic manufacturers and insurance companies choose specialty pharmacies for the distribution of their products due to cheap distribution costs and easy access to medications.

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Market Segmentation

Based on Type

  • Injectables
  • Oral Drugs

Based on Application

  • Oncology
  • Inflammatory Conditions
  • Hepatitis C
  • Multiple Sclerosis
  • Other Applications

By Distribution Channel

  • Specialty Pharmacy
  • Retail Pharmacy
  • Hospital Pharmacy
  • Other Distribution Channels

By Geography

  • North America
    • The US
    • Canada
    • Mexico
  • Western Europe
    • Germany
    • France
    • The UK
    • Spain
    • Italy
    • Portugal
    • Ireland
    • Austria
    • Switzerland
    • Benelux
    • Nordic
    • Rest of Western Europe
  • Eastern Europe
    • Russia
    • Poland
    • The Czech Republic
    • Greece
    • Rest of Eastern Europe
  • APAC
    • China
    • Japan
    • South Korea
    • India
    • Australia & New Zealand
    • Indonesia
    • Malaysia
    • Philippines
    • Singapore
    • Thailand
    • Vietnam
    • Rest of APAC
  • Latin America
    • Brazil
    • Colombia
    • Chile
    • Argentina
    • Costa Rica
    • Rest of Latin America
  • Middle East & Africa
    • Algeria
    • Egypt
    • Israel
    • Kuwait
    • Nigeria
    • Saudi Arabia
    • South Africa
    • Turkey
    • United Arab Emirates
    • Rest of MEA

Competitive Landscape

The specialty generics market is highly competitive with several key players dominating the market. Some of the major players in the market include:

  • Teva Pharmaceuticals Industries Ltd.
  • Viatris Inc.
  • Novartis AG
  • Hikma Pharmaceuticals PLC
  • Mallinckrodt; Akorn, Inc.
  • Bausch Health Companies Inc.
  • Dr Reddy’s Laboratories Ltd.
  • Endo Pharmaceuticals Inc.
  • Apotex Corp.
  • Sun Pharmaceutical Industries Ltd.
  • Fresenius Kabi Brasil Ltd.
  • Stada Arzeimittel AG
  • Pfizer, Inc.
  • Other Market Players

Recent Development of the Specialty Generics Market

  • April 2022: Dr. Reddy’s Laboratories made methylprednisolone sodium succinate injectable available in the United States for the therapy of rheumatoid arthritis, blood conditions, and particular uncommon tumors.
  • June 2022: The copay solutions improvement program from Elixir was launched to decrease the cost of specialized generic drugs. Through this program, a patient who meets the requirements can receive a free generic form of a specialty drug.

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