Specialty Injectable Generics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

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 report offers the value (in USD million) for the above-mentioned segments.

Market Snapshot

Market Snapshot
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 10.2 %

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Market Overview

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. For instance, as per the April 2021 report of the World Health Organization (WHO), non-communicable diseases (NCDs) are responsible for about 41 million deaths every year around the world, which is about 71% of all deaths globally. As per the same source, cardiovascular diseases are the major form of NCDs, followed by cancer, respiratory diseases, and diabetes, and 77% of all NCD deaths are in low- and middle-income 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 2019, the average price of generic medicines in Canada has dropped substantially by 60% relative to price levels in 2007. 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.

Scope of the Report

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
By Application
Infectious Diseases
Central Nervous Systems
Autoimmune Disorders
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle East & Africa
South America
Rest of South America

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Key Market Trends

Oncology is Expected to Hold a Significant Market Share Over the Forecast Period

The factors proliferating the growth of the oncology segment are the growing burden of cancer worldwide, the increasing need for effective therapeutic drugs to treat cancer as well as increasing focus of pharmaceutical companies on developing effective drugs. As per the GLOBOCAN 2020, in 2020, there were 19.3 million estimated new cancer cases worldwide, and the number is estimated to reach 30.2 million by the year 2040. Thus, the anticipated increase in the burden of cancer is a major factor contributing to the rising demand for generic drugs, thereby boosting the market growth.

Also, as per a November 2021 study titled, “Generic Anticancer Drugs of the Jan Aushadhi Scheme in India and Their Branded Counterparts: The First Cost Comparison Study,” replacing generic anticancer drugs can result in substantial cost savings and benefit the patient requiring curative chemotherapy for breast cancer. Thus, there is a high demand for generic anticancer drugs and will continue to remain high in the coming period as well.

Product launches are another factor in the growth of the market. For instance, in August 2020, Xiromed LLC launched Irinotecan Injection USP, 20mg/mL is a generic equivalent to Camptosar and is available in a 2mL and 5mL single-dose vial. Camptosar is a medication used to treat colon cancer and small cell lung cancer.

Thus, the aforementioned factors are likely to drive the growth of the segment during the forecast period.


North America is Expected to Dominate the Market Over the Forecast Period

The North American specialty injectable generics market is expected to grow over the forecast period owing to the high burden of chronic diseases in the country coupled with the rising geriatric population and new product launches by the key market players in the country. For instance, as per the National Center for Chronic Disease Prevention and Health Promotion (January 2021), 6 in 10 adults in the United States have a chronic disease, and 4 in 10 adults have two or more chronic diseases, and these conditions are posing around USD 3.8 trillion of healthcare costs on the country's healthcare system every year and as generic drugs are a lot cheaper than other prescribed drugs. Hence, the healthcare expenditure can be significantly reduced by the wide adoption of generic drugs in the country, and that is expected to have a significant impact on the growth of the studied market.

According to the research published in August 2020 by the Pharmaceuticals Export Promotion Council of India titled "Mexico Pharma Market & Regulatory Report," stated that as one of the largest consumers of generic medicines in the world, Mexico maintains a significant presence of generic drug manufacturers, including Israel-based Teva, United States-based Mylan, Ireland-based Perrigo and Genomma Lab, a domestic company. In upcoming years, the growing consumer demand for more affordable medicines will contribute to the country's increasing rates of specialty injectable generics consumption.

Product launches are another factor in the growth of the market. For instance, in January 2021, Sandoz, a global leader in generic and biosimilar medicines, launched a generic Icatibant injection pre-filled syringe to treat acute attacks of rare disease hereditary angioedema (HAE) in adults 18 years and older in the United States.

Hence, the abovementioned factors are likely to increase market growth in the coming future.


Competitive Landscape

Most of the players are based in developing counties due to more technological advancements. But due to the ease of connectivity in modern times, these players have also penetrated developing countries and are trying to establish a market in these countries as well. The market is partially fragmented and consists of several major players. Some of the companies which are currently dominating the market are Pfizer Inc., Fresenius Kabi, Teva Pharmaceuticals, Hikma Pharmaceuticals PLC, and Novartis AG, among others.

Recent Developments

  • In March 2022, Nevakar Injectables Inc., a biopharmaceutical company developing multiple sterile injectable products for use in critical and ambulatory care settings, launched its ready-to-use Ephedrine Sulfate Injection, a formulation of pre-diluted to a 5mg/mL concentration and supplied in a 10mL vial.
  • In February 2022, Dr. Reddy’s Laboratories Ltd. launched the generic version of Par Pharmaceutical’s VASOSTRICT (vasopressin injectable, USP) Vials, has been approved by the United States Food and Drug Administration (USFDA) for sale in the United States market.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Burden of Diseases

      2. 4.2.2 Increasing Number of Patent Expirations

    3. 4.3 Market Restraints

      1. 4.3.1 Complex Development Process of Specialty Generics

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Type

      1. 5.1.1 Drugs

      2. 5.1.2 Biologics

    2. 5.2 By Application

      1. 5.2.1 Oncology

      2. 5.2.2 Cardiovascular

      3. 5.2.3 Infectious Diseases

      4. 5.2.4 Central Nervous Systems

      5. 5.2.5 Autoimmune Disorders

      6. 5.2.6 Others

    3. 5.3 Geography

      1. 5.3.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.3.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.3.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East & Africa

      5. 5.3.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Baxter

      2. 6.1.2 Cipla Inc.

      3. 6.1.3 Dr. Reddy's Laboratories Ltd

      4. 6.1.4 Fresenius Kabi

      5. 6.1.5 Hikma Pharmaceuticals PLC

      6. 6.1.6 Novartis AG

      7. 6.1.7 Par Pharmaceutical

      8. 6.1.8 Pfizer Inc.

      9. 6.1.9 Pharmascience Inc.

      10. 6.1.10 SAGENT Pharmaceuticals

      11. 6.1.11 Sun Pharmaceutical Industries Ltd

      12. 6.1.12 Teva Pharmaceuticals

    2. *List Not Exhaustive

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Specialty Injectable Generics Market market is studied from 2019 - 2027.

The Global Specialty Injectable Generics Market is growing at a CAGR of 10.2% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

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

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