Global Sterile Injectable Market - 2024-2031

Report Overview

The Global Sterile Injectable Market reached US$ 577.32 billion in 2023 and is expected to reach US$ 1008.11 billion by 2031 growing with a CAGR of 7.8% during the forecast period 2024-2031.

The global sterile injectable market refers to the sector involving injectable pharmaceutical formulations administered directly into the bloodstream or human tissues. These formulations are critical for treating various medical conditions, especially chronic diseases, due to their rapid absorption and effectiveness compared to other forms of medication, such as oral tablets or sprays.

Sterile injectable medications are formulations that must be completely devoid of living microorganisms and are commonly administered through injections. This category encompasses various products, including vaccines, monoclonal antibodies, and other biological drugs.

These medications can be delivered via various routes, such as intravenous (IV) infusions, intramuscular (IM) shots, or subcutaneous (SC) injections. These administration methods enable rapid therapeutic action and targeted delivery of the active pharmaceutical ingredients directly into the bloodstream or specific tissues, bypassing potential barriers or degradation that may occur with other routes of administration.

Market Dynamics: Drivers

Rising prevalence of chronic diseases and technological advancements

The demand for the global sterile injectable market is driven by multiple factors. One of the primary factors is the rising prevalence of chronic diseases and technological advancements. The growing incidence of chronic illnesses worldwide, such as cancer, diabetes, and heart disease, is a significant driver propelling the sterile injectables market growth. Several injectable medications are utilized in the treatment of these chronic conditions, thereby stimulating the demand for sterile injectable formulations.

According to the World Health Organization (WHO) data in September 2023, indicating that chronic diseases are responsible for approximately 71% of global deaths highlights a significant public health challenge. Sterile injectable drugs have emerged as a crucial treatment modality for managing various chronic diseases. Moreover, ongoing advancements in prefilled syringes and autoinjectors are making injectable drug therapies increasingly convenient and user-friendly. These innovations are fueling greater adoption of injectable treatments by patients and healthcare providers.

In addition, major players in the industry investments such as the expansion of the market, and key development strategies are driving the market growth. For instance, in April 2023, Bridgewest Group launched a new Contract Development and Manufacturing Organization (CDMO) focused on sterile injectable drug products. This follows Bridgewest's recent acquisition of Pfizer's sterile injectable manufacturing plant in Perth, Australia.

Similarly, in July 2023, WuXi STA launched a state-of-the-art sterile injectable manufacturing line at its drug product facility in Wuxi City, China. The line has an annual capacity of 12 million units, allowing WuXi STA to meet the growing demand for sterile injectable drugs. The manufacturing process utilizes fully enclosed isolation systems and automated filling machines. This minimizes human intervention and exposure, enhancing product quality and worker safety.

Also, in August 2023, Pfizer implemented an emergency ordering process for certain sterile injectable products due to a significant increase in demand following a tornado that impacted its manufacturing plant in North Carolina. This emergency measure allows Pfizer to ship specific sterile injectables directly to customers, ensuring continued access to these critical medications during the disruption.

Restraints

Factors such as high development costs, stringent regulatory requirements, complex manufacturing processes, patent expiration & reimbursement challenges, are expected to hamper the market.

Market Segment Analysis

The global sterile injectable market is segmented based on molecule type, drug class, application, route of administration, distribution channels, and region.

The monoclonal antibodies (mAbs) segment accounted for approximately 40.6% of the global sterile injectable market share

The monoclonal antibodies (mAbs) segment is expected to hold the largest market share over the forecast period. The increasing use of monoclonal antibody (mAb) therapies to treat chronic conditions such as cancer, autoimmune disorders, and cardiovascular diseases is a significant factor driving demand for mAb injectables in the global sterile injectables market.

Moreover, key players in the industry's innovative product launches and approvals are helping to drive this segment growth in the market. For instance, in May 2024, Roche Pharma India officially entered the ophthalmology market with the launch of Vabysmo (faricimab), a groundbreaking treatment for neovascular or "wet" age-related macular degeneration (nAMD) and diabetic macular edema (DME). Both nAMD and DME are significant contributors to vision loss globally, affecting millions of individuals.

Similarly, in December 2023, KBI Biopharma, Inc., a subsidiary of JSR Life Sciences, launched SUREmAb, a new offering built on its SUREtechnology Platform. This innovative platform is designed to optimize the development and manufacturing processes of monoclonal antibodies (mAbs), making them more efficient, safe, and cost-effective.

Also, in June 2023, UCB announced that the U.S. Food and Drug Administration (FDA) has approved RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are positive for either anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. This approval marks a significant advancement in the treatment options available for gMG, a chronic autoimmune neuromuscular disorder characterized by weakness and rapid fatigue of voluntary muscles.

Market Geographical Analysis

North America accounted for approximately 43.6% of the global sterile injectable market share

North America region is expected to hold the largest market share over the forecast period owing to the rising prevalence of chronic diseases, aging population, and well-advanced healthcare infrastructure, which are driving this market growth in this region.

Moreover, in this region, a major number of key players' presence, financial investments, government initiatives & support, and product launches are helping to propel this market growth. For instance, in July 2024, in New Jersey, Amneal Pharmaceuticals launched FOCINVEZ (fosaprepitant), a novel ready-to-use sterile injectable that offers several advantages over existing fosaprepitant products. FOCINVEZ was developed by SPES Pharmaceuticals, a specialized R&D firm focused on innovative formulations, and is manufactured by Steriscience, a global sterile injectables CDMO. The launch of this innovative fosaprepitant product represents an important new treatment option for patients undergoing chemotherapy, with its unique formulation and ease-of-use features designed to improve efficiency and safety in administration.

Similarly, in April 2024, Baxter International Inc., a global leader in injectables, anesthesia, and drug compounding, announced the launch of five new injectable products in the U.S., expanding its Pharmaceuticals portfolio. These launches demonstrate Baxter's focus on developing differentiated products that address unmet patient needs in critical therapeutic areas, including anti-infective and anti-hypotensive medications.

Also, in February 2024, Pharmascience, the largest Canadian-owned pharmaceutical company, announced a significant expansion of its sterile injectable manufacturing facility located in Candiac, Quebec, with a substantial investment of $120 million. This expansion is a pivotal milestone for the company as it aims to enhance its capabilities in producing sterile injectables and strengthen its position in the pharmaceutical market.

Market Segmentation

By Molecule Type

Small Molecule

Large Molecule

By Drug Class

Monoclonal Antibodies (mAbs)

Cytokines

Insulin

Peptide Hormones

Vaccines

Immunoglobulins

Blood Factors

Peptide Antibiotics

Others

By Application

Oncology

Cardiovascular Diseases

Neurology

Autoimmune Diseases

Infectious Diseases

Diabetes

Others

By Route of Administration

Subcutaneous (SC)

Intravenous (IV)

Intramuscular (IM)

Others

By Distribution Channel

Hospital Pharmacies

Online Pharmacies

Retail Pharmacies

By Region

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

The rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the sterile injectable market include Pfizer Inc., Merck & Co., Inc., Novartis AG, Sanofi, GSK plc, AbbVie Inc., F. Hoffmann-La Roche Ltd, Gilead Sciences, Inc., Amgen Inc., and Teva Pharmaceuticals USA, Inc. among others.

Key Developments

In June 2024, Sharp Services announced a significant expansion of its facility in Macungie, Pennsylvania, aimed at enhancing its production capacity for sterile injectable secondary packaging. This strategic move is designed to meet the increasing demand for sterile injectables in the pharmaceutical and biotech sectors.

In June 2024, Bora Pharmaceuticals Co., Ltd. announced a significant step in its commercial expansion strategy by agreeing to acquire Emergent BioSolutions' sterile manufacturing facility located in Baltimore-Camden, Maryland. This acquisition marks Bora's first sterile manufacturing facility and is a strategic move to enhance its capabilities in sterile injectable drug product manufacturing.

In March 2023, Hikma Pharmaceuticals PLC announced the launch of four new sterile injectable medicines in Canada, marking a significant expansion of its product offerings in the region. This development is crucial for both patients and healthcare providers, as it introduces important new treatment options and reinforces Hikma's growing presence in the Canadian market.

Why Purchase the Report?

To visualize the global sterile injectable market segmentation based on molecule type, drug class, application, route of administration, distribution channels, and region and understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points of the sterile injectable market with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in excel consisting of key products of all the major players.

The global sterile injectable market report would provide approximately 78 tables, 82 figures, and 184 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies