all report title image
  • Published On : Mar 2022
  • Code : CMI4971
  • Industry : Pharmaceutical
  • Pages : 176
  • Formats :

Specialty injectables can be defined as drugs therapies that are developed for the treatment of chronic diseases and require administration by injections. These specialty injectables are used for complex and rare diseases such as cancer, hemophilia, human immunodeficiency virus (H.I.V), inflammatory bowel diseases, and rheumatoid arthritis. The increasing prevalence of chronic diseases and subsequent increase in the demand for medicines are driving the specialty injectable market growth. Increasing prevalence of chronic diseases is driving the global specialty market over the forecast period. For instance, As per Centers for Disease Control and Prevention (CDC) in United States 7 of the top 10 causes of death is due to chronic diseases and also the leading causes of disability in the US and the leading drivers of the nation’s US$ 3.8 trillion annual health care costs.

Global Specialty Injectable Market - Impact of the Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic is expected to drive the global specialty injectable market growth, owing to the increasing use of monoclonal antibody therapy for treating the COVID-19. For instance, on October 19, 2021, the U.S National Institute of Healthcare (NIH) released an article covering available therapies for COVID-19 treatment. The article explained Anti SARS-CoV2 Monoclonal Antibodies therapy for treating the COVID-19, which also received emergency use authorization from the U.S Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 infection.

Market players are involved in presenting their research at conferences, which is expected to fuel the specialty injectable market growth over the forecast period. For instance, on October 7, 2021, Trevi Therapeutics, a clinical-stage pharmaceutical company focused on the development and commercialization of the Haduvio (nalbuphine ER) The company is developing Haduvio for the treatment of chronic cough in individuals with idiopathic pulmonary fibrosis, which is an investigational medicine designed for the treatment of life-threatening neurologically mediated illnesses (IPF). Also connected with prurigo nodular is chronic pruritus. This breakthrough will also benefit Haduvio in levodopa-induced dyskinesia (LID) for Parkinson's disease patients. He spoke at the Alliance Global partners' Virtual Biotech and Specialty Pharma conference on October 17, 2021, about Haduvio, a specialty injectable.

The global specialty injectable market is estimated to be valued at US$ 43.6 Bn in 2021 and is expected to exhibit a CAGR of 10.2% over the forecast period (2021-2028).

Figure 1: Global Specialty Injectable Market Share (%) Analysis, By Application, 2021

Specialty Injectable  | Coherent Market Insights

Increasing research and development activities by the market players for developing specialty injectable for the treatment for chronic diseases is expected to drive the global specialty injectable market growth over the forecast period.

Market players are involved in research and development activities such as clinical trials for developing specialty injectable indicated for the treatment of chronic diseases such as cancer, diabetes, or heart diseases. This is expected to drive the market growth over the forecast period. For instance, Merck Sharp & Dohme Corp., a research-based pharmaceutical company, released pipeline data, where it is mentioned that clinical trial for Pembrolizumab injection indicated for the treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC) is currently in its Phase 3, and it is expected to complete the primary study in 2023.

Increasing approvals from the regulatory authorities for specialty injectable indicated for chronic diseases such as cancer, diabetes, heart diseases, and others is expected to fuel the global specialty injectable market growth over the forecast period.

Increasing approvals from the regulatory authorities for specialty injectable products is indicated for chronic diseases is expected to drive the market growth over the forecast period. For instance, on January 27, 2021, ViiV Healthcare, a pharmaceutical company specialized in developing therapeutics for HIV and owned by GSK Healthcare, received approvals from the U.S. FDA for Cabenuva, which is used for HIV-affected adult patients to maintain viral suppression with 12 doses for one year.

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Specialty Injectable Market Report Coverage

Report Coverage Details
Base Year: 2020 Market Size in 2021:

US$ 43.6 Bn

Historical Data for: 2018 to 2020 Forecast Period: 2021 to 2028
Forecast Period 2021 to 2028 CAGR: 10.2% 2028 Value Projection:

US$ 85.9 Bn

Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Drug Type: Small Molecule Drugs, Biologics
  • By Application: Oncology, Cardiovascular Diseases, Central Nervous System Diseases, Infectious Diseases, Auto-immune Disorders, Others
  • By Distribution Channel: Hospital Pharmacies, Specialty Pharmacies, Online Pharmacies
Companies covered:

Pfizer Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Novartis AG, Baxter International Inc., Mylan N.V., Merck & Co. Inc., Fresenius SE & Co. KGaA, Endo International Plc., AstraZeneca, Hikma Pharmaceuticals PLC, Lupin Ltd., Genentech USA Inc., Sagent Pharmaceuticals Inc., Cipla Limited, Sun Pharmaceutical Industries Limited, Genzyme Corporation, Dr. Reddy's Laboratories, Biogen, Alnylam Pharmaceuticals Inc., and Amgen Inc.

Growth Drivers:
  • Increasing research and development activities
  • Increasing product approvals from regulatory authorities
Restraints & Challenges:
  • Product recall
  • Side effects of specialty injectable

Global Specialty Injectable Market – Restraints

Product recalls due to packaging error, transport error, or production issues can hamper the global specialty injectable market over the forecast period. For instance, on December 1, 2021, Sandoz, Inc., a global manufacturer of generic and biosimilar medicines, released a notification for recall for one lot of its product called Enoxaparin Sodium Injection for packaging error. This product is used for the prevention of blood clots and in combination with aspirin for the prevention of chest pain or heart attacks.

Side effects of specialty injectable during treatment may also hamper the global specialty injectable market over the forecast period. For instance, on October 20, 2021, Sanofi, a leading pharmaceutical company developer and manufacturer of vaccines, announced important safety information for Dupixent (Dupilumab) Injection, stating some side effects caused by Dupixent, such as eye problems, asthma, atopic dermatitis, and anaphylaxis, inflammation of blood vessels, or chronic rhino sinusitis.

Global Specialty Injectable Market – Regional Analysis

On the basis of region, the global specialty injectable market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America is expected to hold a dominant position during the forecast period, owing to the increasing products launches in the region. For instance, on October 21, 2021, Biocon Biologics, a pharmaceutical company that develops biosimilars and novel biologics, launched Semglee in the U.S. It is a branded product of interchangeable biosimilars insulin glargine injection with Viatris, a manufacturer and provider of various therapeutics. This insulin injection will help patients with high blood sugar and pediatric patients with Type 1 or Type 2 diabetes.

Furthermore, Europe is estimated to witness significant growth in the global specialty injectable market, owing to increasing product availability in the region. For instance, on July 19, 2021, Xeris Biopharma, a developer of ready-to-use liquid stable injectables, entered into supply agreement and exclusive license with Tetris Pharma Limited, a company that develops and markets healthcare products in Europe, to commercialize Ogluo, which is indicated for the treatment of hypoglycemia or very low sugar level in blood.

Figure 2: Global Specialty Injectable Market Value (US$ Bn), by Region, 2021

Specialty Injectable  | Coherent Market Insights

Global Specialty Injectable Market – Competitive Landscape

Major players operating in the global specialty injectable market include Pfizer Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Novartis AG, Baxter International Inc., Mylan N.V., Merck & Co. Inc., Fresenius SE & Co. KGaA, Endo International Plc., AstraZeneca, Hikma Pharmaceuticals PLC, Lupin Ltd., Genentech USA Inc., Sagent Pharmaceuticals Inc., Cipla Limited, Sun Pharmaceutical Industries Limited, Genzyme Corporation, Dr. Reddy's Laboratories, Biogen, Alnylam Pharmaceuticals Inc., and Amgen Inc.

Specialty injectable is a high cost drug therapy that requires administration by injection. This medication is indicated for the treatment of chronic or life threatening diseases such as human immunodeficiency virus (HIV), rheumatoid arthritis, hemophilia, cancer, cardiovascular diseases, infectious diseases, auto immune disorders, and other diseases. Surveillance, counselling, or monitoring are all required when using specialty injectables. Specialty injectable are high cost drugs that require precise temperature control, special handling, and clinical management to ensure the drug performance.

Market Dynamics

Market players are indulged in receiving approvals for their products indicated for chronic or rare diseases from regulatory authorities. This is expected to drive the global specialty injectable market growth over the forecast period. For instance, on August 6, 2021, Sanofi, a pharmaceutical company that develops product for therapeutics treatments, received approval from the U.S. Food and Drug Administration (FDA) for Nexviazyme which is uses for pompe diseases, an inherited disordered disease where glycogen complex sugar is increased by using Nexviazyme, has received approval on the basis of positive results obtained from Phase 3 Clinical trial where Nexviazyme targets the M6P receptor which is clears the glycogen build up in muscle cells.

Market players are indulged in receiving approvals for their products by regulatory authorities is expected to drive the market growth over the forecast period. For instance, on December 23, 2020, Roche, a diagnostic and pharmaceutical company, announced the approval from European Commission for its Phesgo which is a combined dose of Perjeta and Herceptin used for the treatment of HER2 positive breast cancer. The approval was granted on the basis of results from pivotal phase 3 FeDeriCa trial which showed that Phesgo had delivered non inferior level of Perjeta and Herceptin in blood in comparison with IV formulation it showed safety and efficacy of Phesgo.

Key features of the study:

  • This report provides an in-depth analysis of global specialty injectable market, market size (US$ Billion), and compound annual growth rate (CAGR %) for the forecast period (2021-2028), considering 2020 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategies adopted by the leading players
  • It profiles leading players in the global specialty injectable market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies, and future plans
  • Key companies covered as a part of this study include Pfizer Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Novartis AG, Baxter International Inc., Mylan N.V., Merck & Co. Inc., Fresenius SE & Co. KGaA, Endo International Plc., AstraZeneca, Hikma Pharmaceuticals PLC, Lupin Ltd., Genentech USA Inc., Sagent Pharmaceuticals Inc., Cipla Limited, Sun Pharmaceutical Industries Limited, Genzyme Corporation, Dr. Reddy's Laboratories, Biogen, Alnylam Pharmaceuticals Inc., and Amgen Inc.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launch, technology up-gradation, market expansion, and marketing tactics
  • The global specialty injectable market report caters to various stakeholders in this industry including investors, suppliers, manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the specialty Injectable market

Detailed Segmentation:

  • Global Specialty Injectable Market, By Drug Type:
    • Small Molecule Drugs
    • Biologics
  • Global Specialty Injectable Market, By Application:
    • Oncology
    • Cardiovascular Diseases
    • Central Nervous System Diseases
    • Infectious Diseases
    • Auto-immune Disorders
    • Others
  • Global Specialty Injectable Market, By Distribution Channel:
    • Hospital Pharmacies
    • Specialty Pharmacies
    • Online Pharmacies
  • Global Specialty Injectable Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Pfizer Inc., *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Eli Lilly and Company
    • Teva Pharmaceutical Industries Ltd.
    • Novartis AG,
    • Baxter International Inc.
    • Mylan N.V.,
    • Merck & Co. Inc.
    • Fresenius SE & Co. KGaA
    • Endo International Plc.
    • AstraZeneca
    • Hikma Pharmaceuticals Plc
    • Lupin Ltd.
    • Genentech USA Inc.
    • Sagent Pharmaceuticals Inc.
    • Cipla Limited
    • Sun Pharmaceutical Industries Limited
    • Genzyme Corporation
    • Reddy's Laboratories
    • Biogen
    • Alnylam Pharmaceuticals Inc.
    • Amgen Inc.

 “*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global specialty injectable market is expected to exhibit a CAGR of 10.2% during the forecast period (2021-2028).
The market is estimated to be valued at US$ 43.6 Bn in 2021.
Pfizer Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Novartis AG, Baxter International Inc., Mylan N.V., Merck & Co. Inc., Fresenius SE & Co. KGaA, Endo International Plc., AstraZeneca, Hikma Pharmaceuticals PLC, Lupin Ltd., Genentech USA Inc., Sagent Pharmaceuticals Inc., Cipla Limited, Sun Pharmaceutical Industries Limited, Genzyme Corporation, Dr. Reddy's Laboratories, Biogen, Alnylam Pharmaceuticals Inc., and Amgen Inc. are some of the prominent players operating in the market.
The market is expected to be valued at US$ 85.9 Bn in 2028.
North America is the prominent region in the market.
Oncology, which belongs to the application segment, is the prominent segment in the market.

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