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.

Market Concentration & Characteristics

The sterile injectables CDMO market growth stage is medium, and pace of market growth is accelerating. The market is characterized by a degree of innovation, Level of M&A activities, impact of regulations, service expansions, and regional expansions.

The sterile injectables CDMO market fortifies a high degree of innovation. Increasing focus on the adoption of advanced aseptic processing techniques that ensure the sterility of injectable products throughout the manufacturing process. This includes the use of isolators and restricted access barrier systems (RABS) to maintain aseptic conditions during filling and finishing operations. Additionally, advancements in lyophilization technology have improved the stability and shelf-life of injectable products, especially for biologics and complex molecules. High-containment manufacturing facilities have also emerged to address the growing demand for potent drug products, ensuring safe handling and production of hazardous substances.

Regulations have a high impact on the market, influencing compliance requirements, quality standards, and market entry barriers. Regulatory agencies impose rigorous guidelines to enhance safety, efficacy, and manufacturing processes, impacting the time and cost associated with novel biologics development and commercialization. Moreover, Continuous updates and amendments in regulatory guidelines require companies to stay informed and adaptable. Biopharmaceutical companies find it critical to track updated regulatory guidelines, so they outsource regulatory affairs services to comply with updated regulatory standards.

The level of M&A (mergers and acquisitions) activities in the market is high. Several companies are undertaking mergers and acquisitions strategies to expand biologics regulatory affairs portfolios, gain access to advanced technologies, and enhance their market presence. For instance, In April 2023, the Bridgewest Group, an investment firm, completed the acquisition of a sterile injectables manufacturing facility in Bentley, a suburb of Perth, Australia, from Pfizer. Following this acquisition, Bridgewest Group launched a new Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectable drug products called NovaCina.

Service expansion in the market is medium owing to increasing demand for specialized regulatory expertise and comprehensive support services in the biologics sector. Moreover, service providers are expanding their regulatory consulting, compliance services, and end-to-end support for biologics development to cater to customer demand and broaden revenue growth opportunities. For instance, in February 2024, Pharmascience announced a USD 120 million expansion of its sterile injectable manufacturing facility last fall at its Candiac site. This expansion marked a crucial milestone for the company, demonstrating its commitment to enhancing its manufacturing capabilities in the pharmaceutical sector.

The market is experiencing significant regional expansion, with service providers strategically expanding their presence to new geographic areas. Biologics companies are expanding into emerging markets in Asia-Pacific, Latin America, and MEA owing to growing healthcare needs and favorable regulatory environments. Thus, growing contract development and manufacturing organizations trend for regulatory affairs due to the rising need to navigate country-specific regulatory requirementsand skilled expertise.

Molecule Insights

The large molecule segment dominated the market and accounted for 65.73% of global revenue in 2023. The high segment growth is primarily attributable to the rising investments by contract manufacturers for large molecule-based therapeutics development, the increasing product pipeline of injectables, and market approvals for biosimilars. Moreover, the segment is estimated to witness lucrative growth during the forecast period owing to an increasing number of biologics being in the pipeline, which is estimated to be launched in the near future.

For instance, according to the U.S. FDA, biologics witnessed approximately 44% to 45% of the development pipeline from 2023 to 2024. Thus, substantial growth across the pipeline of large molecule categories is anticipated to augment the growth of the sterile injectable CDMO market. Additionally, the rapid surge in the development pipeline of cell & gene therapies is likely to drive the demand for large molecule-based injectables across the globe.

In 2023, the small molecule segment is projected to witness considerable CAGR over the forecast period. The high segment growth is due to the increasing demand for generic injectables among small molecules. The increasing pipeline of small molecules is a major factor supporting the segment's stable growth during the forecast period. However, the growing adoption of advanced technologies has led to the growth of small molecule-based injectables in past few years, thereby accelerating the segment’s growth.

Product Insights

The pre-filled syringes segment accounted for the largest market share in 2023 and is anticipated to grow at the fastest CAGR over the forecast period. The growth is attributed to its enhanced safety and convenience offering for healthcare providers and patients by reducing the risk of medication errors and contamination. The user-friendly design of pre-filled syringes also improves dosing accuracy and reduces the need for manual handling of drugs, making them particularly suitable for self-administration by patients.

Additionally, the growing prevalence of chronic diseases requiring long-term treatment, such as diabetes and autoimmune disorders, boosts the demand for pre-filled syringes as they provide a convenient and efficient delivery method for these therapies. For instance, in June 2023, The Lancet published its study involving 22 million individuals, revealing that approximately 1 in 10 people are affected by autoimmune disorders. This high prevalence emphasizes the significant impact on the adoption of pre-filled syringes for disease treatment.

Furthermore, the shift towards biologics and biosimilars in pharmaceutical development has increased the need for specialized drug delivery systems like pre-filled syringes to ensure the stability and efficacy of these complex molecules. These factors are contributing to the rising adoption of pre-filled syringes in the sterile injectables CDMO market.

In 2023, sterile liquid injectables segment is anticipated to grow at a significant CAGR over the forecast period. The increasing aging population in several countries is driving the demand for injectable drugs as elderly individuals often require medications that are easy to administer and have precise dosing. Moreover, ongoing advancements in biotechnology and pharmaceutical research have resulted in the development of complex biologics that are best delivered through injection, further fueling the demand for sterile liquid injectables. Furthermore, the rise in outpatient procedures and home healthcare services has increased the need for convenient and ready-to-administer injectable medications, contributing to the growth of this segment in the CDMO market.

Service Insights

The contract manufacturing segment accounted for the largest market share in 2023. Pharmaceutical companies are increasingly outsourcing their manufacturing operations to CDMOs to reduce costs associated with establishing and maintaining sterile injectable production facilities, driving segment growth. Additionally, the growing complexity of sterile injectable products, including biologics and complex formulations, requires advanced technologies and specialized equipment that may not be economically feasible for individual companies to invest in. Contract manufacturing allows pharmaceutical firms to access state-of-the-art facilities and expertise without significant capital expenditure. Furthermore, regulatory requirements for sterile injectables are stringent, necessitating compliance with Good Manufacturing Practices (GMP) and other quality standards. CDMOs often have established quality systems and regulatory expertise that can expedite the approval process for new drug products

In 2023, the lyophilization services segment is anticipated to grow at the fastest CAGR over the forecast period. This can be attributed to increasing demand for sterile injectable drugs, particularly biologics and complex formulations, which leads to a growing need for lyophilization services. Additionally, the rise in outsourcing of pharmaceutical manufacturing activities by drug companies to CDMOs has further fueled the demand for lyophilization services. Moreover, advancements in lyophilization technology, such as improved cycle times, energy efficiency, and automation capabilities, have made it an attractive option for CDMOs seeking to enhance their service offerings and stay competitive in the market.

Therapeutic Area Insights

The oncology segment dominated the sterile injectables CDMO market in 2023. The increasing incidence of cancer globally is leading to a growing need for effective oncology treatments. The rise in cancer cases has fueled the demand for sterile injectables manufacturing services from CDMOs to meet the needs of pharmaceutical companies developing oncology drugs. Moreover, the complexity of oncology drug formulations often necessitates specialized manufacturing capabilities that CDMOs can provide. Additionally, regulatory requirements encompassing sterile injectables production are stringent due to the critical nature of these drugs in treating patients. The expertise of CDMOs in navigating these regulatory hurdles while maintaining high-quality standards makes them valuable partners for pharmaceutical companies developing oncology drugs. Furthermore, the trend toward personalized medicine led to an increased demand for customized sterile injectable formulations tailored to individual patient needs.

In 2023, the central nervous system diseases segment is anticipated to grow at the fastest CAGR over the forecast period. This can be attributed to increasing prevalence of CNS disorders across the globe, attributed to factors such as aging populations, lifestyle changes, and environmental influences led to a growing need for effective treatments delivered via sterile injectables. Moreover, the rise in R&D activities focused on discovering novel therapies for CNS diseases spurred the demand for specialized manufacturing services provided by CDMOs. Stringent regulatory requirements governing the production of sterile injectables for CNS indications necessitate expertise and infrastructure that CDMOs can offer. The complexity of formulating injectable drugs targeting the CNS, which often require precise dosing and delivery mechanisms to cross the blood-brain barrier effectively, further underlines the importance of CDMOs with advanced capabilities in this therapeutic area.

Route of Administration Insights

The intravenous (IV) segment accounted for the largest market share in 2023. This is attributable to the large number of sterile injectables approval which required intravenous route administration. Further, a robust pipeline of IV sterile injectables is expected to be launched in the near future. The U.S. FDA stated that in 2021, the total volume of injectables launched majorly constituted IV infusion dosages accounted for approximately 30-35% of the total injectable volume. Hence, the aforementioned factors are driving the segmental growth.

The Subcutaneous segment is projected to grow at the fastest CAGR over the forecast period. This can be attributed to its high demand, due to its ability to administer various types of medications for several medical conditions owing to a sustained absorption rate. Thus, it is highly effective in vaccines, insulin, and growth hormone administration, requiring continuous delivery at a low dose rate. Hence, the aforementioned advantages of the subcutaneous route of administration are some of the major factors driving the segmental revenue growth.

End Use Insights

The biopharmaceutical companies segment held the largest market share in 2023 and is anticipated to grow at the fastest CAGR over the forecast period. This high segment growth is owing to the increasing trend of end-to-end outsourcing services, especially among small- and mid-size biopharmaceutical companies. Furthermore, the increasing number of biologics pipelines, coupled with the growing outsourcing trend among biopharmaceutical companies, is anticipated to drive growth of this segment over the forecast period.

In 2023, the pharmaceutical company’s segment is anticipated to grow at a significant CAGR over the forecast period. The robust segment growth is due to the growing number of pharmaceutical companies penetrating the advanced therapy medicinal products industry. Moreover, rising R&D investments by major biopharmaceutical firms to develop innovative rare disease therapeutics is another factor propelling the segment’s growth.

Regional Insights

North America held the largest market share of 40.91% in 2023. This can be attributed to the establishment of contract manufacturing facilities, the increase in chronic diseases, and the advancement of biology. The growth of the contract manufacturing market is significantly driven by the growing focus on biologics and biosimilars, which often necessitate sterile injectable formulations. For instance, as per the report published by FDA in March  2023, a total of 15 biologics were approved by regulatory authorities for various indications in 2022. Among these approvals, 6 biologics were specifically indicated for the treatment of different types of cancers. This signifies a significant advancement in the field of oncology and highlights the growing focus on developing targeted therapies for cancer patients. Additionally, Strategic initiatives undertaken by market participants, such as expanding manufacturing facilities, forming collaborations, establishing partnerships, and engaging in acquisitions, are anticipated to drive the market’s growth throughout the projected period. For instance, in October 2023, Sharp Corporation acquired Berkshire Sterile Manufacturing (BSM). This acquisition expands Sharp’s capabilities in providing clinical and commercial sterile injectable products to its clients, hence, contributing to the overall market growth.

U.S. Sterile Injectables CDMO Market Trends

The sterile injectables CDMO market in the U.S. held the largest share in North America in 2023. Several biopharmaceutical companies outsource their complex development and manufacturing services to CDMOs. Moreover, stringent regulatory policies are anticipated to promote domestic CDMO services. Moreover, growing R&D investments by biopharmaceutical companies are anticipated to spur the demand for sterile injectable CDMOs in the region.

Europe Sterile Injectables CDMO Market Trends

The sterile injectables CDMO market in Europe is expected to grow significantly due to growing development and manufacturing facilities for sterile injectable drugs in the region Moreover, strong presence of biopharmaceutical companies in the region and high adoption of advanced therapeutics to treat several chronic ailments in the region are few factors propelling regional market revenue growth.

The sterile injectables CDMO market in Germany held the largest share in 2023 in Europe.In January 2023, Vetter invested USD 249.1 million in its new production building at its global corporate headquarters site in Ravensburg, Germany. The investment aimed to broaden its aseptic manufacturing capacity. This increased investment is aimed at enhancing aseptic manufacturing capacity, which is crucial for sterile injectable products. By expanding their production capabilities, Vetter will be better equipped to cater to the increasing demand for sterile injectables from their global customer base.The strategic location of this new facility in Germany is anticipated to further strengthen the country’s position in the CDMO market for sterile injectables.

The UK sterile injectables CDMO market is anticipated to grow significantly over the forecast period. The grant received by Kindeva to expand its sterile injectables capabilities in Germany is expected to have a significant impact on the market in the country. In August 2023, Kindeva Drug Delivery, a global leader in pharmaceutical contract development and manufacturing organization (CDMO), received a grant from the German Federal Ministry for Economic Affairs and Energy. This grant is aimed at supporting Kindeva’s investment in expanding its sterile injectables capabilities at its site in Horselberg-Hainich, Germany. The investment will focus on enhancing Kindeva’s manufacturing capacity for sterile injectable products, including vials and pre-filled syringes.

Asia Pacific Sterile Injectables CDMO Market Trends

The Asia Pacific market is anticipated to grow at the fastest CAGR of 11.21% during the estimated timeframe. This is due to cost affordable services in Asian countries and supportive regulatory reforms, especially in India and China. FDA and EMA-approved R&D and manufacturing facilities in the region are also anticipated to surge foreign investments. For instance, around 92 healthcare contract service organizations are headquartered in Jiangsu, China, with over 72% of the facilities having FDA and EMA approval. Thus, the high number of FDA and EMA-approved facilities boosts the overall market growth.

The sterile injectables CDMO market in China held the largest share in 2023. In July 2023, WuXi STA, a leading CDMO in China, recently launched a new injectable manufacturing line. This development marks a significant advancement in the company’s capabilities to produce sterile injectable drugs. The launch of this injectable manufacturing line by WuXi STA is crucial for several reasons. Firstly, it enhances the company’s ability to cater to the growing demand for sterile injectables in the pharmaceutical industry. Sterile injectables are a vital component of modern healthcare, used for delivering critical medications directly into the bloodstream.

The Japan sterile injectables CDMO market is expected to grow over the forecast period due to rising demand for new and cost-effective medicines, which may attract investments from biopharmaceutical companies in this region. For instance, in January 2022, Adragos, a pharmaceutical company, made a significant investment in the Japanese Kawagoe plant. This move aims to expand its operations and capabilities in producing sterile injectables. The investment signifies Adragos’ commitment to enhancing its presence in the pharmaceutical market, particularly in the field of Contract Development and Manufacturing Organization (CDMO) services for sterile injectables.

Latin America Sterile Injectables CDMO Market Trends

The sterile injectables CDMO market in Latin America is anticipated to grow at a substantial rate over the forecast period. The increasing M&A activity in the pharmaceutical industry and favorable environment for sterile injectables CDMOs to secure new contracts and expand their market presence in Latin America are driving market growth in the country. Additionally, rising initiatives by regulatory bodies in countries including Brazil and Argentina have been implementing stringent regulations to ensure the quality and safety of pharmaceutical products.

The sterile injectables CDMO market in Brazil is anticipated to grow at a significant CAGR over the forecast period due to the increasing demand for healthcare services. According to the Brazilian Institute of Geography and Statistics (IBGE), public health expenditure in Brazil totaled USD 82.82 billion in 2020, representing an increase of 10.6% compared to 2019. This increased spending has led to a greater demand for pharmaceutical products, including sterile injectables, which are used to treat a wide range of conditions, from cancer to autoimmune disorders.

MEA Sterile Injectables CDMO Market Trends

The sterile injectables CDMO market in MEA is expected to grow substantially over the forecast period. The regulatory environment in the MEA is evolving, with stricter regulations being implemented to ensure the quality and safety of pharmaceutical products. This has pushed pharmaceutical companies to outsource their manufacturing processes to specialized CDMOs that adhere to these stringent regulations. Additionally, the cost-effectiveness of outsourcing production to CDMOs rather than investing in building their own manufacturing facilities is another driving factor for pharmaceutical companies in the region. Moreover, advancements in technology and expertise offered by CDMOs play a crucial role in driving the market growth, as companies seek access to state-of-the-art facilities and specialized knowledge for efficient production processes.

The sterile injectables CDMO market in South Africa is anticipated to grow at the fastest CAGR over the forecast period owing to increasing partnerships between international pharmaceutical companies and local CDMOs in South Africa. These partnerships are fostering innovation, technology transfer, and knowledge exchange, further boosting the market growth in the country.

Key Sterile Injectables CDMO Company Insights

The key market participants operating across the market focus on adopting several in-organic strategic initiatives such as mergers, partnerships, collaborations, acquisitions, etc. The key companies are implementing several strategies such as mergers & acquisitions/joint ventures, service launches, partnership & agreements, mergers, expansions, and others to increase market presence & revenue and gain a competitive edge driving market growth. Hence, increasing adoption of in-organic strategic initiatives is highly anticipated to boost the market share of prominent players. For instance, in January 2024, Bora Pharmaceuticals acquired Emergent BioSolutions’ sterile manufacturing facility in Baltimore-Camden, Maryland. The acquisition, priced at approximately USD 30 million, includes the transfer of assets, equipment, and around 350 Emergent employees. This move is part of Emergent’s strategy to optimize its manufacturing network and focus on facilities in Lansing, Michigan, and Winnipeg, Canada.

Recent Developments

• In April 2024, Delpharm acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. This acquisition marks a significant strategic move for Delpharm as it expands its manufacturing capabilities and strengthens its presence in the pharmaceutical industry.

• In April 2023, Bridgewest Group launched a new CDMO named NovaCina, majorly focused on sterile injectable drug products. This initiative follows Pfizer's acquisition of the Perth sterile injectable manufacturing plant to enhance manufacturing services for sterile injectables across all clinical phases.

• In February 2024, Novo Holdings, under the Novo Nordisk Foundation, acquired Catalent for USD 16.5 billion. This acquisition is part of Novo Holdings’ strategy to utilize its Wegovy cash and expand its manufacturing capabilities. The deal includes Novo Nordisk acquiring three of Catalent’s fill-finish sites from Novo Holdings for USD 11 billion upfront. These sites specialize in sterile drug filling and are expected to enhance Novo Nordisk’s manufacturing network for current and future treatments for diabetes and obesity. The acquisition is set to increase Novo Nordisk’s filling capacity starting in 2026 gradually.

Sterile Injectables CDMO Market Report Scope

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