Sterile Injectables CDMO Market Size, Share & Trends Analysis Report By Molecule (Small Molecule, Large Molecule), By Product, By Service, By Therapeutic Area, By Route of Administration, By End Use, By Region, And Segment Forecasts, 2024 - 2030
Sterile Injectables CDMO Market Trends
The global sterile injectables CDMO market size was estimated at USD 3.94 billion in 2023 and is projected to grow at a CAGR of 9.92% from 2024 to 2030. The market growth is primarily driven by increasing pipeline and approvals of injectable drugs. Pharmaceutical companies are proactively focusing on developing injectable medications due to their numerous benefits, such as quicker onset of action, precise dosing, and enhanced patient adherence. For instance, as per the U.S. Food and Drug Administration (FDA) report published in January 2024, the Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023. These medications included injectables, indicating a robust pipeline that is anticipated to drive an increase in the demand for contract manufacturing services for both commercial and research purposes, hence contributing to overall market growth.
The increasing demand for cellular and genetic therapies is driving the market’s growth. With the expansion of therapy pipelines, there is a rising requirement for specialized manufacturing capabilities provided by contract manufacturing organizations (CMOs). For instance, according to ClinicalTrials.gov, as of March 2024, over 581 clinical trials were focused on cell therapies and related approaches for treating various diseases in North America is anticipated to drive an increase in contract manufacturing throughout the projected period.
Furthermore, strategic initiatives undertaken by market participants, such as expanding sterile manufacturing facilities and engaging in collaborations and partnerships, are anticipated to bolster market growth throughout the projected period. For instance, in November 2023, NorthEdge invested in Torbay Pharmaceuticals to support its upcoming phase of international expansion. In March 2023, PCI Pharma Services has announced a USD 50 million expansion project at its Rockford, Illinois facility, which will involve the construction of a new 200,000-square-foot building to increase the site’s capacity for manufacturing injectable drug-device combination products.
The high demand for sterile injectables propels growth in outsourced agreements amongst contract manufacturers and biopharmaceutical companies, thereby boosting the growth of the sterile injectable CDMO industry. The growing need for faster drug action, rapid absorption, and less drug concentration are a few major aspects contributing to the adoption of sterile injectables CDMO industry. Further, pharmaceutical firms actively involved in sterile injectable development and manufacturing are gaining traction to support monoclonal antibody therapies, large-molecule injectable drugs, and infectious disease-treating drugs. Several factors, including reduced time and cost-affordable research and development cycles of generic injectables and the growing advancements in rare disease treatments, are accelerating the growth of sterile injectable CDMO’s in the global market.
Moreover, advanced manufacturing techniques are crucial for ensuring the stability and efficacy of cancer therapies. Contract manufacturers specializing in sterile injectables, particularly those experienced in handling complex formulations and biologics, are well-equipped to address the specific requirements of oncology drugs. Sterile injectables are essential for delivering complex biologics and innovative treatment methods in cancer treatment, driving the growth of the sterile injectable contract manufacturing sector. The growth in outsourcing practices is expected to drive the expansion of the segment over the forecast period. Pharmaceutical companies, particularly those specializing in oncology, are increasingly turning to outsourcing manufacturing operations to streamline processes, cut costs, and capitalize on the specialized expertise offered by contract manufacturers. This shift has notably boosted the cancer sector's sterile injectable contract development and manufacturing market.
Global Sterile Injectables CDMO Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global Sterile Injectables CDMO market report based on molecule type, product, service, therapeutic area, route of administration, end use, and region:
- Molecule Outlook (Revenue, USD Million, 2018 - 2030)
- Small Molecule
- Large Molecule
- Product Outlook (Revenue, USD Million, 2018 - 2030)
- Sterile Liquid Injectables
- Pre-filled Syringes
- Vials and Ampoules
- Service Outlook (Revenue, USD Million, 2018 - 2030)
- Contract Development
- Contract Manufacturing
- Packaging
- Quality Control and Assurance
- Lyophilization Services
- Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)
- Oncology
- Cardiovascular Diseases
- Central Nervous System Diseases
- Infectious Disorders
- Musculoskeletal Diseases
- Hormonal Diseases
- Others
- Route of Administration Outlook (Revenue, USD Million, 2018 - 2030)
- Subcutaneous (SC)
- Intravenous (IV)
- Intramuscular (IM)
- Others
- End Use Outlook (Revenue, USD Million, 2018 - 2030)
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Others
- Regional Outlook (Revenue, USD Million, 2018 - 2030)
- North America
- U.S.
- Canada
- Mexico
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Thailand
- Latin America
- Brazil
- Argentina
- Middle East and Africa (MEA)
- South Africa
- Saudi Arabia
- UAE
- Kuwait
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.2. Market Definitions
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased Database
- 1.4.2. GVR’s Internal Database
- 1.5. Details of primary research
- 1.6. Market Formulation & Validation
- 1.7. Research Scope and Assumptions
- 1.7.1. List of Secondary Sources
- 1.7.2. List of Primary Sources
- 1.7.3. Objectives
- Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.2.1. Application Outlook
- 2.2.2. End Use Outlook
- 2.3. Competitive Insights
- Chapter 3. Annuloplasty System Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Related/Ancillary Market Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Drivers Analysis
- 3.2.1.1. The increasing prevalence of cardiovascular diseases (CVD)
- 3.2.1.2. Growing geriatric population base
- 3.2.1.3. Increasing preference for minimally invasive procedures
- 3.2.1.4. Development of advanced annuloplasty systems and products
- 3.2.2. Market Restraints Analysis
- 3.2.3. Complications and risks associated with annuloplasty procedures
- 3.3. Annuloplasty System Market Analysis Tools
- 3.3.1. Porter’s Analysis
- 3.3.1.1. Bargaining power of the suppliers
- 3.3.1.2. Bargaining power of the buyers
- 3.3.1.3. Threats of substitution
- 3.3.1.4. Threats from new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Economic and Social landscape
- 3.3.2.3. Technological landscape
- 3.3.2.4. Environmental landscape
- Chapter 4. Annuloplasty System Market: Application Estimates & Trend Analysis
- 4.1. Application Market Share Analysis, 2023 & 2030
- 4.2. Segment Dashboard
- 4.3. Annuloplasty System Market: By Application, 2018 to 2030
- 4.4. Mitral Valve Repair
- 4.4.1. Mitral Valve Repair Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5. Tricuspid Valve Repair
- 4.5.1. Tricuspid Valve Repair Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.6. Aortic Valve Repair
- 4.6.1. Aortic Valve Repair Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- Chapter 5. Annuloplasty System Market: End Use Estimates& Trend Analysis
- 5.1. End Use Market Share Analysis, 2023 & 2030
- 5.2. Segment Dashboard
- 5.3. Annuloplasty System Market: By End Use, 2018 to 2030
- 5.4. Hospitals
- 5.4.1. Hospitals Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.5. Ambulatory Surgical Centers
- 5.5.1. Ambulatory Surgical Centers Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.6. Other End
- 5.6.1. Other End Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- Chapter 6. Annuloplasty System Market: Regional Estimates & Trend Analysis by Country, Application and End Use
- 6.1. Regional Market Share Analysis, 2023 & 2030
- 6.2. Regional Market Snapshot
- 6.3. Annuloplasty System Market Share, By Region, 2023 & 2030, USD Million
- 6.4. North America
- 6.4.1. North America Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.2. U.S.
- 6.4.2.1. Key Country Dynamics
- 6.4.2.2. Regulatory Landscape/Reimbursement Scenario
- 6.4.2.3. Competitive Insights
- 6.4.2.4. U.S. Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.3. Canada
- 6.4.3.1. Key Country Dynamics
- 6.4.3.2. Regulatory Landscape/Reimbursement Scenario
- 6.4.3.3. Competitive Insights
- 6.4.3.4. Canada Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.4. Mexico
- 6.4.4.1. Key Country Dynamics
- 6.4.4.2. Regulatory Landscape/Reimbursement Scenario
- 6.4.4.3. Competitive Insights
- 6.4.4.4. Mexico Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5. Europe
- 6.5.1. Europe Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.2. UK
- 6.5.2.1. Key Country Dynamics
- 6.5.2.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.2.3. Competitive Insights
- 6.5.2.4. UK Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.3. Germany
- 6.5.3.1. Key Country Dynamics
- 6.5.3.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.3.3. Competitive Insights
- 6.5.3.4. Germany Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.4. France
- 6.5.4.1. Key Country Dynamics
- 6.5.4.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.4.3. Competitive Insights
- 6.5.4.4. France Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.5. Italy
- 6.5.5.1. Key Country Dynamics
- 6.5.5.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.5.3. Competitive Insights
- 6.5.5.4. Italy Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.6. Spain
- 6.5.6.1. Key Country Dynamics
- 6.5.6.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.6.3. Competitive Insights
- 6.5.6.4. Spain Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.7. Denmark
- 6.5.7.1. Key Country Dynamics
- 6.5.7.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.7.3. Competitive Insights
- 6.5.7.4. Denmark Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.8. Sweden
- 6.5.8.1. Key Country Dynamics
- 6.5.8.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.8.3. Competitive Insights
- 6.5.8.4. Sweden Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.9. Norway
- 6.5.9.1. Key Country Dynamics
- 6.5.9.2. Regulatory Landscape/Reimbursement Scenario
- 6.5.9.3. Competitive Insights
- 6.5.9.4. Norway Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6. Asia Pacific
- 6.6.1. Asia Pacific Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.2. China
- 6.6.2.1. Key Country Dynamics
- 6.6.2.2. Regulatory Landscape/Reimbursement Scenario
- 6.6.2.3. Competitive Insights
- 6.6.2.4. China Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.3. Japan
- 6.6.3.1. Key Country Dynamics
- 6.6.3.2. Regulatory Landscape/Reimbursement Scenario
- 6.6.3.3. Competitive Insights
- 6.6.3.4. Japan Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.4. India
- 6.6.4.1. Key Country Dynamics
- 6.6.4.2. Regulatory Landscape/Reimbursement Scenario
- 6.6.4.3. Competitive Insights
- 6.6.4.4. India Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.5. South Korea
- 6.6.5.1. Key Country Dynamics
- 6.6.5.2. Regulatory Landscape/Reimbursement Scenario
- 6.6.5.3. Competitive Insights
- 6.6.5.4. South Korea Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.6. Australia
- 6.6.6.1. Key Country Dynamics
- 6.6.6.2. Regulatory Landscape/Reimbursement Scenario
- 6.6.6.3. Competitive Insights
- 6.6.6.4. Australia Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.7. Thailand
- 6.6.7.1. Key Country Dynamics
- 6.6.7.2. Regulatory Landscape/Reimbursement Scenario
- 6.6.7.3. Competitive Insights
- 6.6.7.4. Thailand Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7. Latin America
- 6.7.1. Latin America Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7.2. Brazil
- 6.7.2.1. Key Country Dynamics
- 6.7.2.2. Regulatory Landscape/Reimbursement Scenario
- 6.7.2.3. Competitive Insights
- 6.7.2.4. Brazil Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7.3. Argentina
- 6.7.3.1. Key Country Dynamics
- 6.7.3.2. Regulatory Landscape/Reimbursement Scenario
- 6.7.3.3. Competitive Insights
- 6.7.3.4. Argentina Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8. Middle East and Africa
- 6.8.1. Middle East and Africa Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.2. Saudi Arabia
- 6.8.2.1. Key Country Dynamics
- 6.8.2.2. Regulatory Landscape/Reimbursement Scenario
- 6.8.2.3. Competitive Insights
- 6.8.2.4. Saudi Arabia Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.3. UAE
- 6.8.3.1. Key Country Dynamics
- 6.8.3.2. Regulatory Landscape/Reimbursement Scenario
- 6.8.3.3. Competitive Insights
- 6.8.3.4. UAE Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.4. South Africa
- 6.8.4.1. Key Country Dynamics
- 6.8.4.2. Regulatory Landscape/Reimbursement Scenario
- 6.8.4.3. Competitive Insights
- 6.8.4.4. South Africa Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.5. Kuwait
- 6.8.5.1. Key Country Dynamics
- 6.8.5.2. Regulatory Landscape/Reimbursement Scenario
- 6.8.5.3. Competitive Insights
- 6.8.5.4. Kuwait Annuloplasty System Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- Chapter 7. Competitive Landscape
- 7.1. Recent Developments & Impact Analysis by Key Market Participants
- 7.2. Company Categorization
- 7.3. Company Market Share Analysis
- 7.4. Company Heat Map Analysis
- 7.5. Strategy Mapping
- 7.5.1. Expansion
- 7.5.2. Mergers & Acquisition
- 7.5.3. Partnerships & Collaborations
- 7.5.4. New Product Launches
- 7.5.5. Research And Development
- 7.6. Company Profiles
- 7.6.1. Medtronic
- 7.6.1.1. Participant’s Overview
- 7.6.1.2. Financial Performance
- 7.6.1.3. Product Benchmarking
- 7.6.1.4. Recent Developments
- 7.6.2. Abbott
- 7.6.2.1. Participant’s Overview
- 7.6.2.2. Financial Performance
- 7.6.2.3. Product Benchmarking
- 7.6.2.4. Recent Developments
- 7.6.3. Edwards Lifesciences Corporation
- 7.6.3.1. Participant’s Overview
- 7.6.3.2. Financial Performance
- 7.6.3.3. Product Benchmarking
- 7.6.3.4. Recent Developments
- 7.6.4. Corcym
- 7.6.4.1. Participant’s Overview
- 7.6.4.2. Financial Performance
- 7.6.4.3. Product Benchmarking
- 7.6.4.4. Recent Developments
- 7.6.5. Labcor Laboratories Ltda
- 7.6.5.1. Participant’s Overview
- 7.6.5.2. Financial Performance
- 7.6.5.3. Product Benchmarking
- 7.6.5.4. Recent Developments
- 7.6.6. AFFLUENT MEDICAL
- 7.6.6.1. Participant’s Overview
- 7.6.6.2. Financial Performance
- 7.6.6.3. Product Benchmarking
- 7.6.6.4. Recent Developments
- 7.6.7. Valcare Medical
- 7.6.7.1. Participant’s Overview
- 7.6.7.2. Financial Performance
- 7.6.7.3. Product Benchmarking
- 7.6.7.4. Recent Developments
- 7.6.8. Braile Biomédica
- 7.6.8.1. Participant’s Overview
- 7.6.8.2. Financial Performance
- 7.6.8.3. Product Benchmarking
- 7.6.8.4. Recent Developments
- 7.6.9. Micro Interventional Devices, Incorporated
- 7.6.9.1. Participant’s Overview
- 7.6.9.2. Financial Performance
- 7.6.9.3. Product Benchmarking
- 7.6.9.4. Recent Developments
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