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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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.
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.
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% |
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.
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.
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.
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.
| 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.
| 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.
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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
As per manufacturing, the sector has been categorized into preclinical manufacturing, clinical manufacturing, and commercial manufacturing.
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.
Different drug types include monoclonal antibodies (mAbs), cytokines, insulin, peptide hormones, vaccines, immunoglobulins, blood factors, peptide antibiotics, and others.
Organization size segments include small, mid-sized, large, and very large.
Based on end-users, the sterile injectable CDMO sector is segmented into pharmaceutical companies, biopharmaceutical companies, research institutes, and others.
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.
The sector is set to witness a CAGR of 11.7% by 2034.
The sector witnessed a CAGR of 10.6% from 2019 to 2023.
In 2034, the sector is anticipated to reach USD 33.7 billion.
Abbvie, Famar, Polfa Tarchomin, and Pfizer.
The sector is set to reach USD 11.1 billion by 2024.
The stand-alone segment is estimated to hold a significant share in 2024.
| Market Value for 2024 | USD 49.44 billion |
|---|---|
| Projected Market Value for 2034 | USD 113.87 billion |
| Value-based CAGR (2024 to 2034) | 8.70% |
| Market Value for 2024 | USD 5,97,980.6 million |
|---|---|
| Projected Market Value for 2034 | USD 9,91,631.3 million |
| Value-based CAGR of Market for 2024 to 2034 | 5.8% |
| Estimated Market Value (2024) | USD 74,998.1 million |
|---|---|
| Projected Market Size (2034) | USD 124,532.4 million |
| Market Value CAGR (2024 to 2034) | 5.2% |
| Market Value (2023) | USD 22.5 billion |
|---|---|
| Market Expected Value (2033) | USD 39.4 billion |
| Market Projected CAGR (2023 to 2033) | 5.7% |
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Sterile Injectable CDMO Market
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