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Report Overview

The global sterile injectable contract manufacturing market was valued at USD 28.40 Billion in 2024 driven by the rising demand for biopharmaceuticals across the globe. It is expected to grow at a CAGR of 10.50% during the forecast period of 2025-2034 and attain a market value of USD 77.08 Billion by 2034.

2024

Base Year

2018-2024

Historical Year

2025-2034

Forecast Year

  • The growing complexity of biopharmaceuticals is driving the demand for specialized sterile injectable contract manufacturers. Enhancements in automated manufacturing processes and freeze-drying techniques are improving efficiency, further fueling market expansion.
  • In July 2023, WuXi STA, a contract research, development, and manufacturing organization (CRDMO) launched a high-potency sterile injectable production line in China, expanding its capacity to meet the increasing demand for complex medications. This development aligns with the rising need for customized manufacturing solutions, which is expected to accelerate market growth in the forecast period.
  • North America is expected to dominate the market due to its robust pharmaceutical infrastructure, significant biopharmaceutical activity and favorable environment for clinical trials solidifies the market presence of the region.

Sterile Injectable Contract Manufacturing Market Overview

Sterile injectable contract manufacturing involves outsourcing the production of injectable medications that require stringent sterilization and quality controls. The market growth is driven by factors such as surging demand for biopharmaceuticals, particularly vaccines and monoclonal antibodies as they offer several therapeutic benefits. Additionally, advancements in automation and freeze-drying technologies are enhancing efficiency and safety in production. Rising global investments in pharmaceutical infrastructure are expected to fuel market growth in the forecast period.

Sterile Injectable Contract Manufacturing Market Growth Drivers

Rising Demand for Biopharmaceuticals Boost Market Growth

The growing demand for biopharmaceuticals, such as monoclonal antibodies and vaccines, is significantly driving the market. As these products become more complex, the need for specialized manufacturers adept at managing stringent sterilization and production processes is rising. Outsourcing production allows biopharmaceutical companies to scale operations efficiently, thereby supporting the broader growth of the industry.

Sterile Injectable Contract Manufacturing Market Trends

Sterile Injectable Contract Manufacturing Market Segmentation

The market report offers a detailed analysis of the market based on the following segments:

Market Breakup by Molecule Type

  • Small Molecule
  • Large Molecule

Market Breakup by Route of Administration

  • Subcutaneous
  • Intravenous
  • Intramuscular
  • Others

Market Breakup by Application

  • Cancer
  • Diabetes
  • Central Nervous System Diseases
  • Cardiovascular Diseases
  • Infectious Disorders
  • Musculoskeletal Disorders
  • Anti-Viral
  • Others

Market Breakup by End User

  • Pharmaceutical Companies
  • Biopharmaceutical Companies
  • Others

Market Breakup by Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

Sterile Injectable Contract Manufacturing Market Share

Market Segmentation Based on End User Is Likely to Witness Substantial Growth

The market breakup by end user includes pharmaceutical companies, biopharmaceutical companies, and others. Among these, the biopharmaceutical companies segment is poised to lead the market share due to the increasing demand for biologics, including vaccines and monoclonal antibodies, which require specialized sterile injectable manufacturing. The growing number of biopharmaceutical firms developing complex therapeutics, along with advancements in biologic drug production, is expected to drive this segment's growth in the forecast year.

Sterile Injectable Contract Manufacturing Market Analysis by Region

Based on region, the market report covers North America, Europe, Asia Pacific, Latin America, the Middle East and Africa. Among these, North America is expected to dominate the market share. The significant presence of large corporations in the region generates new opportunities for expansion in the sterile injectable contract manufacturing sector. The region also offers more affordable market conditions for clinical trials, creating opportunities for the sterile injectable contract manufacturing market in the forecast period.

Leading Players in the Sterile Injectable Contract Manufacturing Market

The key features of the market report include patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies are:

Lonza Group

Founded in 1897 and based in Basel, Switzerland, the company has a diverse product portfolio. It supports parenteral drug development by addressing challenges posed by the increasing complexity of biotherapeutics and an evolving regulatory landscape. Its services include cell and gene therapies, biologics, and small molecule manufacturing to facilitate drug development and production.

Thermo Fisher Scientific Inc.

Founded in 2006, Thermo Fisher Scientific is headquartered in Waltham, Massachusetts, USA. The compa...

Catalent, Inc.

Founded in 2007 and headquartered in Somerset, NJ, USA, Catalent specializes in drug delivery soluti...

WuXi Biologics

WuXi Biologics is a multinational biologics company founded in the year 2010 and is headquartered in...

*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*

Other companies include Samsung Biologics, Siegfried Holding AG, Fujifilm Diosynth Biotechnologies, Recipharm AB, and Baxter BioPharma Solutions.

Key Questions Answered in the Global Sterile Injectable Contract Manufacturing Market

  • What was the global sterile injectable contract manufacturing market value in 2024?
  • What is the global sterile injectable contract manufacturing market forecast outlook for 2025-2034?
  • What are the regional markets covered in the EMR report?
  • What is the market segmentation based on the molecule type?
  • What is the market breakup based on the route of administration?
  • What is the market segmentation based on the application?
  • What is the market breakup based on the end user?
  • What are the major factors aiding the sterile injectable contract manufacturing market demand?
  • What are the market's major drivers, opportunities, and restraints?
  • Which regional market is expected to lead the market share in the forecast period?
  • Which country is expected to experience expedited growth during the forecast period?
  • What are the major sterile injectable contract manufacturing market trends?
  • How does the rise in the geriatric population impact the market size?
  • Who are the key players involved in the sterile injectable contract manufacturing market?
  • What are the current unmet needs and challenges in the market?
  • How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

REPORT FEATURES DETAILS
Base Year 2024
Historical Period 2018-2024
Forecast Period 2025-2034
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Molecule Type
  • Route of Administration
  • Application
  • End User
  • Region
Breakup by Molecule Type 
  • Small Molecule
  • Large Molecule
Breakup by Route of Administration 
  • Subcutaneous
  • Intravenous
  • Intramuscular
  • Others
Breakup by Application
  • Cancer
  • Diabetes
  • Central Nervous System Diseases
  • Cardiovascular Diseases
  • Infectious Disorders
  • Musculoskeletal Disorders
  • Anti-Viral
  • Others
Breakup by End User
  • Pharmaceutical Companies
  • Biopharmaceutical Companies
  • Others
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • PESTEL Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Company News and Developments
    • Certifications
Companies Covered
  • Lonza Group
  • Thermo Fisher Scientific Inc.
  • Catalent, Inc.
  • WuXi Biologics
  • Samsung Biologics
  • Siegfried Holding AG
  • Fujifilm Diosynth Biotechnologies
  • Recipharm AB
  • Baxter BioPharma Solutions

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63 Fiona Drive, Tamworth, NSW

+61-448-061-727

C130 Sector 2 Noida, Uttar Pradesh 201301

+91-858-608-1494

40th Floor, PBCom Tower, 6795 Ayala Avenue Cor V.A Rufino St. Makati City, 1226.

+63-287-899-028, +63-967-048-3306

6 Gardner Place, Becketts Close, Feltham TW14 0BX, Greater London

+44-753-713-2163

193/26/4 St.no.6, Ward Binh Hung Hoa, Binh Tan District, Ho Chi Minh City

+84-865-399-124