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Sterile Injectable CDMO Market Outlook from 2024 to 2034

The global sterile injectable CDMO market is projected to surge at a CAGR of 11.7% by 2034. The market value is set to increase from USD 11.1 billion in 2024 to USD 33.7 billion by 2034.

The demand for sterile injectables is surging, outsourcing agreements between contract manufacturers and drug sponsors, bolstering the sterile injectable contract manufacturing industry.

Pharmaceutical companies in injectable manufacturing are gaining traction for large molecule injectable drugs, monoclonal antibody therapies, and infectious disease treatments, boosting global growth.

The industry is propelled by the growing pipeline and approvals of injectable drugs, which offer advantages such as fast onset of action, precise dosing, and improved patient compliance. This has led to a wide range of therapeutic areas, including oncology, diabetes, and autoimmune diseases, contributing to rapid growth.

Developments in biotechnology and novel drug delivery technologies have further fueled the growth of sterile injectable CDMO. Leading manufacturing organizations with unique facilities and biologics expertise are vital in meeting the increasing demand, fueling the sterile injectable CDMO market.

Increasing demand for cell and gene therapies is another fueling force behind the growth of the sterile injectable contract manufacturing industry. These therapies provide personalized, curative treatments for genetic and chronic diseases, requiring specialized manufacturing to produce sterile injectable products that meet strict regulatory requirements.

Contract manufacturing organizations with sterile injectable CDMO expertise and specialized facilities are well-positioned to meet the unique manufacturing needs of cell and gene therapies.

Rapid developments in biotechnology and gene editing techniques have significantly accelerated the development of novel cell and gene therapies. The pharmaceutical industry is investing in innovative therapies, leading to a surging demand for manufacturing services for commercial-scale production.

Commercial and clinical manufacturing companies with specialized capabilities are set to play a key role in meeting sterile injectable product manufacturing needs, thereby augmenting demand.

Attributes Description
Estimated Global Sterile Injectable CDMO Market Size (2024E) USD 11.1 billion
Projected Global Sterile Injectable CDMO Market Value (2034F) USD 33.7 billion
Value-based CAGR (2024 to 2034) 11.7%

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Key Industry Highlights

Rise of Specialized Injectable Therapies

Chronic conditions worldwide are increasing, leading to a need for innovative therapies. These need complex molecules, often requiring injection delivery due to the fragile nature. Injectable delivery is essential for therapeutic efficacy, especially in oncology, autoimmune diseases, and rare genetic disorders.

The sterile injectable CDMO market is growing rapidly, providing opportunities for pharmaceutical companies and CDMOs to meet the needs of patients and healthcare providers.

Role of CDMOs in the Pharmaceutical Industry

CDMOs are well-positioned to meet the increasing demand for sterile injectable products by offering specialized manufacturing capabilities, expertise, and quality control measures. By partnering with CDMOs, pharmaceutical companies can access state-of-the-art facilities and technologies without the need for substantial upfront investments.

Strategic Adoption of CDMO Business Models

The strategic adoption of CDMO business models offers pharmaceutical companies opportunities to optimize operations and fuel growth. By outsourcing research and development and commercialization activities to CDMOs, companies would reduce time-to-market and low operational costs. CDMOs are partnering with companies in clinical development stages to improve efficiency and offer specialized service providers' expertise.

Stringent Government Regulations to Restrain Growth

The market faced significant challenges in the past decade, particularly in the United States and Europe due to stringent regulations like Current Good Manufacturing Practices (cGMP).

These regulations slowed down product approvals and market entry, hindering revenue generation for CDMOs. The intricate nature of sterile injectable manufacturing processes, including aseptic filling, lyophilization, and terminal sterilization, also presented significant challenges.

2019 to 2023 Global Sterile Injectable CDMO Sales Analysis Compared to Demand Forecast for 2024 to 2034

Global sterile injectable CDMO sales increased at a CAGR of 10.6% from 2019 to 2023. The sector emerged between 2019 and 2023 as pharmaceutical companies streamlined operations and focused on core competencies.

Innovations in aseptic processing, lyophilization, high-containment manufacturing, single-use systems, and digitalization further improved operational efficiency, product quality, and regulatory compliance. These developments enabled CDMOs to meet increasing demand for sterile injectable products more effectively.

The sterile injectable CDMO industry has evolved significantly due to the rise of biologics and complex molecules. CDMOs have invested in specialized infrastructure to support the manufacturing of these products, which is set to boost sales.

Regulatory agencies such as the FDA and EMA also introduced stringent requirements for sterile injectable manufacturing, requiring CDMOs to enhance quality systems and implement robust quality control measures. Technological developments, such as barrier isolators and automation, have transformed the production of injectables, improving efficiency and reducing costs.

Globalization and development have boosted growth, emphasizing quality and compliance, with clients prioritizing partners with a strong regulatory compliance record. CDMOs are investing in state-of-the-art facilities and continuous improvement initiatives to fuel further growth. The global sterile injectable CDMO market is projected to surge at a CAGR of 11.7% by 2034.

Sabyasachi Ghosh
Sabyasachi Ghosh

Principal Consultant

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Comparative Market Overview

The section below offers a comprehensive evaluation of two interrelated markets: the global small molecule CMO/CDMO and the global injectable drug sector. The focus is on dissecting the distinctive characteristics of each market, encompassing respective CAGRs by 2034. The section also delves into the pivotal factors that exert influence on key growth trajectories.

Small Molecule CMO/CDMO Industry Assessment:

Leading companies in the biotechnology and biopharmaceutical industries adopt CDMO for development and production services. This allows firms to significantly reduce costs, save time, and streamline several processes. Pharmaceutical, biopharma, and biotechnology companies are collaborating with CDMOs to outsource drug research and manufacturing.

Attributes Description
Related Market Small Molecule CMO/CDMO Market
CAGR (2024 to 2034) 5.2%
Growth Factor Rising demand for pharmaceuticals is set to boost growth of the small molecule CMO/CDMO sector.
Opportunity Pharmaceutical companies are outsourcing drug development and manufacturing to CMOs and CDMOs to reduce costs, mitigate risks, and access specialized expertise, allowing focus on core competencies.
Key Trends The pharmaceutical industry is focusing on cost-effective manufacturing solutions, with CMOs and CDMOs offering competitive pricing, flexible capacity, and operational efficiency to clients.

Injectable Drug Industry Assessment:

The injectable drug industry encompasses pharmaceutical products administered through injections, either intravenously, intramuscularly, or subcutaneously.

The sector is experiencing significant growth propelled by various factors contributing to increasing preference among patients and healthcare professionals. Injectable drugs are increasingly preferred for efficient and reliable healthcare solutions due to quick recovery times and treatment for various ailments.

Attributes Description
Related Market Injectable Drug Market
CAGR (2024 to 2034) 5.8%
Growth Factor Increasing prevalence of eye disorders such as dry eye syndrome, conjunctivitis, and allergies is projected to spur growth.
Opportunity The rise of personalized medicine is transforming injectable drugs into personalized therapies, utilizing biomarkers, genetic information, and other factors to optimize treatment outcomes.
Key Trends Developments in drug delivery technologies are enhancing the development of injectable formulations with enhanced efficacy, safety, and patient convenience.

Country-wise Insights

The following table shows the estimated growth rates of the leading countries. China and South Korea are set to exhibit high sterile injectable CDMO consumption, recording CAGRs of 10.1% and 11.1%, respectively, through 2034. In North America, the United States is set to rise at 7.4% CAGR by 2034.

Countries CAGR 2024 to 2034
United States 7.4%
South Korea 11.1%
United Kingdom 8.2%
Russia 6.5%
China 10.1%

Proliferation of Emerging Biotechnology to Influence Growth in the United States

The United States dominated the global market with a 33.3% share in 2023. The country has experienced slight growth in recent years, spurred by factors such as increasing drug development and cost-containment efforts by pharmaceutical companies.

In the United States, several pharmaceutical companies, both large and small, have turned to CDMOs to handle various aspects of drug development and manufacturing in injectables. Small and emerging biotechnology companies often rely heavily on CDMOs to bring drug candidates from discovery to industry.

Furthermore, rising demand for personalized medicine is also influencing the demand for customized sterile injectable products in the United States.

Adoption of Robotics and Automation by Manufacturers to Benefit South Korea

South Korea is booming in the sterile injectable CDMO sector, with a global share of 13.8%. The pharmaceutical industry has experienced rapid growth, with increasing investments in research and development and manufacturing capabilities.

South Korea has been a leading hub for active pharmaceutical ingredient (API) manufacturing. Renowned companies in the country are utilizing technology progressions like single-use systems, robotics, and automation to enhance efficiency and reduce costs.

These firms are further forming strategic partnerships with pharmaceutical companies, academic institutions, and technology providers to access new markets and fuel innovation.

New Launches and Developments in Pharmaceutical Sector Push the United Kingdom

The United Kingdom is making significant strides in the sterile injectable CDMO industry, with a global share of 6.6%, showcasing positive growth trends. The country has been at the forefront of developing and manufacturing innovative therapies, including cell and gene therapies. CDMOs are broadening global presence to support innovative therapies and meet the rising demand for sterile injectables in emerging markets.

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Category-wise Insights

The section below analyzes the leading segments of the industry. In terms of manufacturing, the commercial manufacturing segment is estimated to account for a share of 57.2% in 2024. Based on services, the stand-alone segment is anticipated to follow by holding a share of 61.1% in 2024.

Commercial Manufacturing Leads with High Production Capacity

Segment Commercial Manufacturing (Manufacturing)
Value Share (2024) 57.2%

Commercial manufacturing is set to dominate the global sector with a 57.2% share in 2024. The segment is projected to continue experiencing high growth throughout the forecast period. Commercial manufacturers operate at large scale, with significant production capacity and capabilities for commercial-scale manufacturing.

CDMOs source raw materials like active pharmaceutical ingredients (APIs) from approved suppliers, which undergo rigorous testing for identity, purity, and quality. CDMOs in the sterile injectable market adhere to FDA and EMA regulations, maintaining comprehensive documentation of the entire manufacturing process.

Demand for Stand-alone Services to Remain High through 2034

Segment Stand-alone (Services)
Value Share (2024) 61.1%

Stand-alone services are projected to lead the global industry with a 61.1% share in 2024 and are set to continue experiencing high growth throughout the forecast period. Stand-alone service providers offer quick turnaround times and more rapid project initiation compared to integrated providers.

CDMOs help clients develop and optimize manufacturing processes for sterile injectable drugs, focusing on process scale-up and unit operation optimization for improved efficiency and product quality.

Competition Outlook

The sterile injectable contract development and manufacturing organization (CDMO) market is witnessing significant growth and competition. Key companies offer a wide range of services encompassing formulation development, aseptic processing, fill-finish, lyophilization, and packaging for sterile injectable drugs.

Despite intense competition, leading companies differentiate from competitors based on capabilities, quality, reliability, and customer service, aiming to capture a significant share of the growing sector. Development and product launch is a priority for leading sterile injectable CDMO manufacturers as the focus is on working to create new product lines and broaden the global consumer base.

Key sterile injectable contract manufacturing companies are implementing strategic initiatives like mergers and partnerships while escalating production capacity to enhance industry positioning. Abbvie, Famar, Polfa Tarchomin, Pfizer, Quotient Sciences, Temad Co., Tianjin Hankang Pharmaceutical Biotechnology, and Fareva are the leading manufacturers in the sector.

Industry Updates

  • On May 22, 2023, Aurigene Pharmaceutical Services, an India-based company, announced to enhance capacity in biologics CDMO services through the establishment of a new biomanufacturing facility. With an initial investment of USD 40 million, Aurigene targets to establish a research and development and pilot scale facility, marking the first phase of a series of strategic investments.
  • On October 24, 2023, Quotient Sciences, headquartered in the United Kingdom, announced a significant investment in broadening sterile fill/finish capabilities at the Alnwick, United Kingdom facility. This investment is geared towards augmenting the existing capacity of the Annex 1 compliant facility to address the growing demand for fully integrated drug development programs.
  • In 2023, PCI Pharma Services, headquartered in Philadelphia, invested USD 50 million in a new 200,000ft manufacturing facility in Illinois, United States, to boost contract development capacity in injectable biologics and small molecules.

Leading Sterile Injectable CDMO Brands

  • Abbvie
  • Famar
  • Polfa Tarchomin
  • Pfizer
  • Quotient Sciences
  • Temad Co.
  • Tianjin Hankang Pharmaceutical Biotechnology
  • Fareva
  • Sharp
  • Astral SteriTech
  • Evonik
  • Aurigene Pharmaceutical Services
  • Prague Scientific
  • Ethypharm
  • TriRx Pharmaceutical Services
  • Biophrama Group
  • Gensenta Pharmaceuticals
  • BioTechnique
  • Mithra CDMO
  • S.C. Rompharm Company SRL
  • Flagship Biotech International Pvt. Ltd
  • Curida AS
  • BirgiMefar Group
  • Brooks Laboratories Limited

Key Segments of Market Report

By Manufacturing:

As per manufacturing, the sector has been categorized into preclinical manufacturing, clinical manufacturing, and commercial manufacturing.

By Services:

The segment is categorized into stand-alone services and integrated services. The stand-alone services segment is further segregated into drug formulation and development, aseptic fillings, analytical development, regulatory support, packaging and assembly services, technology transfer, supply chain management, and quality control and assurance.

By Drug Type:

Different drug types include monoclonal antibodies (mAbs), cytokines, insulin, peptide hormones, vaccines, immunoglobulins, blood factors, peptide antibiotics, and others.

By Organization Size:

Organization size segments include small, mid-sized, large, and very large.

By End-user:

Based on end-users, the sterile injectable CDMO sector is segmented into pharmaceutical companies, biopharmaceutical companies, research institutes, and others.

By Region:

Industry analysis has been carried out in key countries of North America, Latin America, East Asia, South Asia and Pacific, Western Europe, Eastern Europe, and the Middle East and Africa.

Frequently Asked Questions

What is the future of sterile injectable CDMO?

The sector is set to witness a CAGR of 11.7% by 2034.

What was the worth of the sector from 2019 to 2023?

The sector witnessed a CAGR of 10.6% from 2019 to 2023.

How big is the sterile injectable CDMO industry?

In 2034, the sector is anticipated to reach USD 33.7 billion.

Who are the leading manufacturers?

Abbvie, Famar, Polfa Tarchomin, and Pfizer.

Is there a sector for sterile injectable CDMO?

The sector is set to reach USD 11.1 billion by 2024.

Which service would lead the industry?

The stand-alone segment is estimated to hold a significant share in 2024.

Table of Content

1. Executive Summary

2. Industry Introduction, including Taxonomy and Market Definition

3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments

4. Global Market Demand Analysis 2019 to 2023 and Forecast 2024 to 2034, including Historical Analysis and Future Projections

5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034

    5.1. By Manufacturing

    5.2. By Services

    5.3. By Drug Type

    5.4. By Organization Size

    5.5. By End User

    5.6. By Region

6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Manufacturing

    6.1. Preclinical Manufacturing

    6.2. Clinical Manufacturing

    6.3. Commercial Manufacturing

7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Services

    7.1. Stand-alone Services

        7.1.1. Drug Formulation and Development

        7.1.2. Aseptic Fillings

        7.1.3. Analytical Development

        7.1.4. Regulatory Support

        7.1.5. Packaging and Assembly Services

        7.1.6. Technology Transfer

        7.1.7. Supply Chain Management

        7.1.8. Quality Control and Assurance

    7.2. Integrated Services

8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Drug Type

    8.1. Monoclonal Antibodies (mAbs)

    8.2. Cytokines

    8.3. Insulin

    8.4. Peptide Hormones

    8.5. Vaccines

    8.6. Immunoglobulins

    8.7. Blood Factors

    8.8. Peptide Antibiotics

    8.9. Others

9. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Organization Type

    9.1. Small

    9.2. Mid-sized

    9.3. Large

    9.4. Very large

10. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by End User

    10.1. Pharmaceutical Companies

    10.2. Biopharmaceutical Companies

    10.3. Research Institutes

    10.4. Others

11. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Region

    11.1. North America

    11.2. Latin America

    11.3. Western Europe

    11.4. Eastern Europe

    11.5. East Asia

    11.6. South Asia and Pacific

    11.7. Middle East and Africa

12. North America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

13. Latin America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

14. Western Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

15. Eastern Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

16. East Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

17. South Asia and Pacific Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

18. Middle East and Africa Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries

19. Sales Forecast 2024 to 2034 by Molecule, Indication, and Sales Channel for 30 Countries

20. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard

21. Company Profile

    21.1. Abbvie

    21.2. Famar

    21.3. Polfa Tarchomin

    21.4. Pfizer

    21.5. Quotient Sciences

    21.6. Temad Co.

    21.7. Tianjin Hankang Pharmaeutical Biotechnology

    21.8. Fareva

    21.9. Sharp

    21.10. Astral SteriTech

    21.11. Evonik

    21.12. Aurigene Pharmaceutical Services

    21.13. Prague Scientific

    21.14. Ethypharm

    21.15. TriRx Pharmaceutical Services

    21.16. Biophrama Group

    21.17. Gensenta Pharmaceuticals

    21.18. BioTechnique

    21.19. Mithra CDMO

    21.20. S.C. Rompharm Company SRL

    21.21. Flagship Biotech International Pvt.Ltd

    21.22. Curida AS

    21.23. BirgiMefar Group

    21.24. Brooks Laboratories Limited

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