Global Specialty Injectable Generics Market Size (2024 - 2029)

The specialty injectable generics market is expected to experience growth despite challenges posed by the COVID-19 pandemic, which disrupted supply chains and research activities. The market size is anticipated to expand due to factors such as the rising prevalence of chronic diseases and the increasing number of patent expirations, which drive demand for cost-effective treatment options. The affordability of specialty injectable generics makes them particularly appealing in low- and middle-income countries, where non-communicable diseases are prevalent. Regulatory changes in various regions also support the market's expansion by facilitating quicker approval processes for generic drugs. However, the complex development process of specialty generics may pose a challenge to market growth.

Market Size of Global Specialty Injectable Generics Industry

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Market Snapshot
Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 10.20 %
Fastest Growing Market Asia-Pacific
Largest Market North America
Market Concentration Medium

Major Players

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*Disclaimer: Major Players sorted in no particular order

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Specialty Injectable Generics Market Analysis

The specialty injectable generic market is projected to register a CAGR of 10.2% during the forecast period (2022-2027).

The COVID-19 pandemic disrupted the research and development of other therapies and drugs for medical conditions other than COVID-19. This also impacted the studied market of the specialty injectable generic market around the world. For instance, as per the research study published in April 2020, titled, 'The Consequence of COVID-19 on the Global Supply of Medical Products: Why Indian Generics Matter for the World?', India is the largest manufacturer of generic drugs and Indian firms import almost 70% of their bulk drugs from China, where the production of active pharmaceutical ingredients (APIs) and supply chain logistics have taken a big hit due to the COVID-19 pandemic. Potential shortages as a result of export bans in India and China, which are major suppliers of generics, have prompted governments in many countries to consider supply chain self-sufficiency and to issue regulations to prevent shortages in such a crisis. Hence, the COVID-19 pandemic is likely to have a negative impact on the market. However, the market will grow in the upcoming period.

Factors such as the rising prevalence of diseases and the increasing number of patent expirations are expected to increase the market share. In recent times, the burden of chronic diseases, such as cancer, cardiovascular diseases, and arthritis, among others, has increased significantly, which has led to a serious burden on the healthcare expenditure of people.

Specialty injectable generic drugs are not only effective but also cheaper as compared to conventional medicines, and that's why they are gaining popularity among people suffering from chronic diseases, thus, driving growth in the market. According to the article titled' The Patterns of Non-Communicable Disease Multimorbidity in Iran: A Multilevela Analysis' published in February 2020 Non-Communicable Disease multimorbidity affects more young people in low-middle income countries. the mean prevalence was 7.8% in 28 developing countries. Thus, the demand for specialty injectable generic drugs is expected to increase over the period in low- and middle-income countries as NCDs are more prevalent in these countries, and they cannot afford costly drugs, but specialty injectable generic drugs are cheap, and that's why its consumption is expected to increase over the forecast period, and the market is expected to grow.

According to the Patented Medicine Prices Review Board report 2020, the average price of generic medicines in Canada has dropped substantially by 60% relative to price levels. The decrease in prices is one of the key factors for the growth of the market, as low-price medicines are most accessible to the end-users. Due to lower costs, specialty injectable generic medicines are likely to be preferred, which would increase the growth of the market. Additionally, In August 2020, the regulatory agency in Mexico (COFEPRIS) put forward new operating rules for the approval of generic drugs in Mexico, based on the following guidelines: COFEPRIS will have a special procedures window for the generic pharmaceutical products. These applications for approvals of generics could be filed the day after the granting of the patent related to the innovative medicine. The respective applications would be decided at any time prior to the expiration of the patent. If the registration or approval is given, COFEPRIS will provide a provisional official communication, which would be exchanged for the definitive sanitary registration or approval, the day after the expiration of the validity of the patent.

Furthermore, the launch of injectable generic drugs is anticipated to drive the segment growth over the forecast period. For instance, in October 2021, Adalvo completed a mandatory requirement for marketing authorization in the European Union for its generic version of Firazyr (icatibant injection), which is approved for acute attacks in adults with hereditary angioedema (HAE). This is anticipated to increase the demand for generic injectables in the upcoming future. Hence, the abovementioned factors are likely to increase market growth in the upcoming future.

However, the complex development process of specialty generics is likely to hinder the market growth.

Specialty Injectable Generics Industry Segmentation

Specialty injectable generics are drug therapies used for the treatment of chronic diseases that require administration by injection, infusion, or inhalation and are sold as generics. It includes biologics used in the treatment of various drugs and has the same active ingredients as the branded versions of it. However, the inactive contents of the drugs can be varied. The Specialty Injectable Generics Market is Segmented by Type (Drugs and Biologics), Application (Oncology, Cardiovascular, Infectious Diseases, Central Nervous Systems, Autoimmune Disorders, and Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Type
Drugs
Biologics
By Application
Oncology
Cardiovascular
Infectious Diseases
Central Nervous Systems
Autoimmune Disorders
Others
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle East & Africa
South America
Brazil
Argentina
Rest of South America
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Global Specialty Injectable Generics Market Size Summary

The specialty injectable generics market is poised for significant growth, driven by factors such as the rising prevalence of chronic diseases and the increasing number of patent expirations. These generics offer a cost-effective alternative to conventional medicines, making them particularly appealing in low- and middle-income countries where non-communicable diseases are prevalent. The market's expansion is further supported by regulatory changes and product launches, which enhance the availability and accessibility of these drugs. Despite the challenges posed by the complex development processes of specialty generics, the market is expected to benefit from the growing demand for affordable healthcare solutions.

The North American market is anticipated to experience robust growth due to the high burden of chronic diseases and the aging population, coupled with new product introductions by key players. In Mexico, the significant presence of generic drug manufacturers and the increasing consumer demand for affordable medicines are expected to drive market consumption. The market is characterized by partial fragmentation, with major players like Pfizer Inc., Fresenius Kabi, Teva Pharmaceuticals, Hikma Pharmaceuticals PLC, and Novartis AG leading the charge. Recent product launches, such as those by Nevakar Injectables Inc. and Dr. Reddy's Laboratories Ltd., underscore the dynamic nature of the market, promising continued growth in the coming years.

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Global Specialty Injectable Generics Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Rising Burden of Diseases

      2. 1.2.2 Increasing Number of Patent Expirations

    3. 1.3 Market Restraints

      1. 1.3.1 Complex Development Process of Specialty Generics

    4. 1.4 Porter's Five Force Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 2.1 By Type

      1. 2.1.1 Drugs

      2. 2.1.2 Biologics

    2. 2.2 By Application

      1. 2.2.1 Oncology

      2. 2.2.2 Cardiovascular

      3. 2.2.3 Infectious Diseases

      4. 2.2.4 Central Nervous Systems

      5. 2.2.5 Autoimmune Disorders

      6. 2.2.6 Others

    3. 2.3 Geography

      1. 2.3.1 North America

        1. 2.3.1.1 United States

        2. 2.3.1.2 Canada

        3. 2.3.1.3 Mexico

      2. 2.3.2 Europe

        1. 2.3.2.1 Germany

        2. 2.3.2.2 United Kingdom

        3. 2.3.2.3 France

        4. 2.3.2.4 Italy

        5. 2.3.2.5 Spain

        6. 2.3.2.6 Rest of Europe

      3. 2.3.3 Asia-Pacific

        1. 2.3.3.1 China

        2. 2.3.3.2 Japan

        3. 2.3.3.3 India

        4. 2.3.3.4 Australia

        5. 2.3.3.5 South Korea

        6. 2.3.3.6 Rest of Asia-Pacific

      4. 2.3.4 Middle-East and Africa

        1. 2.3.4.1 GCC

        2. 2.3.4.2 South Africa

        3. 2.3.4.3 Rest of Middle East & Africa

      5. 2.3.5 South America

        1. 2.3.5.1 Brazil

        2. 2.3.5.2 Argentina

        3. 2.3.5.3 Rest of South America

Global Specialty Injectable Generics Market Size FAQs

The Global Specialty Injectable Generics Market is projected to register a CAGR of 10.20% during the forecast period (2024-2029)

Fresenius Kabi, Novartis AG, Pfizer Inc, Teva Pharmaceuticals and Hikma Pharmaceuticals PLC are the major companies operating in the Global Specialty Injectable Generics Market.

Specialty Injectable Generics Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)