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
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.
Specialty Injectable Market Report Coverage
Report Coverage | Details | ||
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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: |
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Segments covered: |
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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. |
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Growth Drivers: |
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Restraints & Challenges: |
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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
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.
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