The Biologics CDMO Secondary Packaging Market is projected to grow from USD 1,761.0 million in 2024 to an estimated USD 3,382.1 million by 2032, with a compound annual growth rate (CAGR) of 8.5% from 2024 to 2032.
The market is gaining momentum due to the rising demand for biologics, including monoclonal antibodies, cell and gene therapies, and recombinant proteins. Pharmaceutical companies are increasingly outsourcing secondary packaging processes to specialized CDMOs to maintain compliance, ensure cold-chain integrity, and streamline production timelines. As biologics require highly sensitive handling and customized labeling or tamper-evident packaging, CDMOs with advanced packaging technologies and serialization capabilities are becoming indispensable. This outsourcing trend is further fueled by the need for operational flexibility, global supply chain coordination, and reduced time-to-market for biologic therapies.
North America leads the Biologics CDMO Secondary Packaging Market, driven by its strong biologics manufacturing ecosystem, early adoption of serialization regulations, and robust cold-chain logistics infrastructure. Europe follows, benefiting from regulatory harmonization and rising investment in biosimilar development. Meanwhile, Asia Pacific is emerging rapidly as a high-growth region due to expanding biomanufacturing capacities, lower operational costs, and increasing government support for pharmaceutical outsourcing in countries like China, India, and South Korea. These regional dynamics reflect a global shift toward decentralized, specialized packaging solutions aligned with regional compliance and biologic innovation.
Market Insights:
The Biologics CDMO Secondary Packaging Market was valued at USD 1,761.0 million in 2024 and is expected to reach USD 3,382.1 million by 2032, growing at a CAGR of 8.5%.
Increasing demand for personalized biologics and injectable therapies is accelerating the need for specialized secondary packaging services.
Stringent serialization and anti-counterfeiting regulations are driving CDMOs to invest in compliant and traceable packaging solutions.
High capital requirements and regulatory complexities pose operational challenges for smaller CDMOs.
North America holds 42% of the market share, supported by advanced infrastructure and strong biopharma presence.
Asia Pacific is the fastest-growing region, fueled by rising biologics production in China, India, and South Korea.
Europe benefits from harmonized regulations and growing demand for biosimilars, making it a strong secondary packaging hub.
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Rising Outsourcing of Biologics Manufacturing and Packaging Operations
The growing complexity and cost of biologic drug development are prompting pharmaceutical companies to outsource packaging tasks to CDMOs. This shift allows companies to streamline operations and focus on core R&D. The Biologics CDMO Secondary Packaging Market is benefiting from this trend, as secondary packaging often requires specialized handling and regulatory compliance. Outsourcing offers access to advanced infrastructure without heavy capital investment. CDMOs deliver scalable solutions tailored to biologic formulations. The need for flexibility in production timelines also fuels this trend. Partnerships between biotech firms and CDMOs are becoming more strategic. It enables rapid global distribution with consistent quality assurance.
For example, Catalent’s 2023 Company Filings reveal the installation of two high-speed, fully automated secondary packaging lines in their Bloomington, IN facility, each capable of processing up to 300 vials or prefilled syringes per minute.
Growing Demand for Cold Chain-Enabled Packaging Solutions
Biologic therapies typically require strict temperature control, making cold chain-compatible secondary packaging a vital component. The increasing development of temperature-sensitive biologics is creating new demands for specialized packaging formats. CDMOs are investing in insulated materials, tamper-evident seals, and real-time tracking systems. The Biologics CDMO Secondary Packaging Market is responding with innovative, thermally stable solutions. This demand spans across monoclonal antibodies, mRNA vaccines, and cell therapies. Regulatory bodies are tightening storage and transportation standards. CDMOs must comply with evolving global guidelines. It is prompting upgrades in packaging technologies to ensure integrity across the supply chain.
Rising Regulatory Requirements and Serialization Mandates
Global serialization mandates are transforming the packaging landscape for biologics. Regulations in regions such as the US, EU, and India now require traceable and secure packaging for high-value drugs. The Biologics CDMO Secondary Packaging Market is adapting by integrating digital solutions like barcoding, QR codes, and RFID tags. These enhancements ensure product traceability and combat counterfeiting. CDMOs that offer turnkey serialization solutions are gaining competitive advantages. Regulatory compliance is now a primary selection criterion in CDMO partnerships. Integration of IT systems with packaging lines has become a standard practice. It enhances visibility and audit readiness throughout the product lifecycle.
For example, Almac Group has published case study data demonstrating a 30% reduction in batch release times after installing VisionScan barcoding systems and adopting electronic batch records (EBR), ensuring all secondary packaging lots are fully traceable and audit-ready in less than 48 hours post-packaging.
Expansion of Biologic Drug Pipelines and Personalized Medicines
Pharmaceutical companies are expanding their pipelines to include a broader range of biologics, including gene therapies and biosimilars. These products often require complex, personalized packaging strategies. The Biologics CDMO Secondary Packaging Market is capitalizing on this need with highly adaptable packaging formats. Custom labeling, variable data printing, and patient-specific inserts are now essential. Personalized medicine trends increase packaging volume and variability. CDMOs are integrating digital design and short-run manufacturing capabilities. It allows rapid adaptation to varying product and patient requirements. The market is shifting toward flexibility and modularity in packaging services.
Market Trends
Emergence of Smart and Connected Packaging Technologies
Smart packaging technologies are gaining traction in pharmaceutical logistics. These innovations include sensors, RFID chips, and data-embedded labels that monitor temperature and location. The Biologics CDMO Secondary Packaging Market is adopting these tools to enhance supply chain transparency. Smart packaging supports real-time data exchange between manufacturers and distributors. It helps detect disruptions and prevents cold chain breaches. The use of digital indicators improves patient safety and regulatory compliance. Integration with mobile apps and cloud platforms is advancing rapidly. It positions smart packaging as a standard for high-value biologic products.
Increased Focus on Sustainable and Eco-Friendly Packaging Materials
Sustainability is now a priority in pharmaceutical packaging due to rising environmental concerns and stricter ESG goals. CDMOs are adopting recyclable, biodegradable, and compostable materials. The Biologics CDMO Secondary Packaging Market is aligning with this shift by offering sustainable carton designs, low-impact inks, and reduced plastic use. Clients demand eco-friendly solutions without compromising product safety. Packaging innovation now focuses on reducing waste during design and transport. Regulatory pressures are accelerating adoption of green alternatives. It supports both brand value and environmental responsibility in biologics packaging strategies.
For instance, Origin’s 2025 Environmental Positioning Policy prioritizes recyclable glass, plastics, and cardboard, while EcoVadis awards and SBTi validation underscore measurable improvements in carbon footprint and waste reduction.
Customization of Packaging Formats for Home-Based Biologic Therapies
The growing trend of administering biologics outside clinical settings is reshaping packaging needs. Home-based care requires packaging that is intuitive, portable, and tamper-proof. The Biologics CDMO Secondary Packaging Market is witnessing a rise in demand for unit-dose formats, auto-injector packaging, and easy-to-read instructions. Customization improves patient adherence and safety. CDMOs are working closely with pharma clients to develop user-friendly formats. Packaging design is becoming a critical differentiator in treatment success. It also reduces healthcare costs by minimizing in-clinic visits. The homecare model is driving a paradigm shift in secondary packaging design.
Digitalization and Integration of Packaging Line Automation
Automation is reshaping secondary packaging operations for biologics. CDMOs are investing in robotics, vision systems, and digital control platforms. The Biologics CDMO Secondary Packaging Market is optimizing throughput, precision, and error reduction through automation. Integrated systems enable seamless transition between product types and packaging runs. Digital twins and predictive maintenance are reducing downtime. It enables faster validation and compliance with GMP standards. Automation also supports real-time documentation and traceability. The trend is leading to cost-efficiency and scalability across CDMO operations.
For example, Cytiva’s SA-25 aseptic robotic workcells at PCI Pharma Services are Annex 1-compliant and support flexible filling of vials, syringes, and cartridges with minimal product loss, estimated at 50 mL per batch. While the system supports automation, public sources do not confirm routine MES or digital twin integration at PCI.
Market Challenges Analysis
High Complexity and Cost Associated with Biologic Packaging Compliance
Secondary packaging for biologics must meet stringent regulatory and quality requirements. This includes cold chain integrity, anti-tampering measures, and serialization compliance. The Biologics CDMO Secondary Packaging Market must continuously adapt to global standards set by regulatory bodies. Meeting these expectations involves high capital investment and technical expertise. Many CDMOs face challenges in integrating end-to-end serialization and quality systems. Smaller players struggle to match the scale and precision demanded by biopharma clients. It limits the availability of reliable partners for niche or emerging therapies. The cost burden also affects pricing flexibility and long-term partnerships.
Operational and Supply Chain Disruptions Across Global Markets
Global supply chains have become more vulnerable to disruption from geopolitical instability, logistics constraints, and raw material shortages. The Biologics CDMO Secondary Packaging Market is exposed to these risks due to its dependence on imported materials and temperature-sensitive logistics. Lead times for packaging components such as vials, labels, and cartons have increased. CDMOs must maintain redundancy and buffer inventory to mitigate delays. Cross-border regulations on drug shipments create compliance challenges. Limited local infrastructure in emerging markets compounds the complexity. It forces CDMOs to invest heavily in supply chain diversification and risk management.
Market Opportunities
Growing Demand for Packaging Services for Advanced Biologic Modalities
Emerging biologic therapies, such as cell and gene therapies, demand highly tailored and compliant packaging solutions. The Biologics CDMO Secondary Packaging Market is well-positioned to serve this demand with expertise in precision packaging and real-time tracking. These advanced modalities require individualized handling and tamper-evident packaging. CDMOs that can provide flexible and secure solutions will gain competitive advantage. It opens up opportunities for high-value service offerings with longer client partnerships. The market is shifting toward niche packaging competencies that align with clinical and commercial biologics.
Expansion of Regional CDMO Capabilities in Emerging Economies
Biopharma growth in Asia Pacific, Latin America, and the Middle East is driving demand for local packaging solutions. The Biologics CDMO Secondary Packaging Market is gaining momentum in these regions through strategic expansions and joint ventures. Localized CDMO operations reduce logistics complexity and ensure compliance with regional norms. Clients seek packaging partners closer to manufacturing hubs. It creates significant opportunities for regional players to scale operations and upgrade capabilities. The market is expected to see a rise in regionally focused packaging contracts.
Market Segmentation Analysis:
The Biologics CDMO Secondary Packaging Market is segmented by packaging type and primary package type, each addressing specific functional and regulatory requirements of biologic therapies.
By packaging type, boxes and cartons remain the most commonly used formats due to their versatility, cost-effectiveness, and compatibility with cold-chain storage. Cartons provide an ideal platform for incorporating labeling, tamper-evident features, and serialization codes, making them essential for global distribution. Ampoules and bottles also play a key role, particularly for injectable biologics, where durability and sterility are critical. Their growing use in combination therapies and vaccine distribution enhances their relevance in this market.
For example, SGD Pharma’s 2025 launch of their “IDENCY Type I” molded glass ampoules and bottlesspecifically addresses combination injectable biologics and vaccines.
By primary package type, ampoules and vials are widely adopted in parenteral biologic delivery due to their ability to preserve product integrity. Blister packs and cartridges are gaining traction in self-administration settings, offering ease of use and patient safety. Bottles remain relevant for oral or liquid biologics, while prefilled syringes continue to rise in demand due to their convenience and compliance benefits. Prefilled syringes support dosing accuracy and reduce contamination risk, aligning with the market’s focus on patient-centric drug delivery. It reflects the industry’s shift toward automation-ready, tamper-proof, and compliant packaging formats tailored to each biologic’s characteristics.
For example, Bormioli Pharma’s new 2024 eco-design PET bottles, adopted by Roche for oral biologics, incorporate ≥50% rPET (post-consumer recycled content) while exceeding US Pharmacopeia light transmission standards for biologic stability.
Segmentation:
By Packaging Type
Boxes
Cartons
Ampoules
Bottles
By Primary Package Type
Ampoules
Blister packs
Cartridges
Vials
Bottles
Prefilled Syringes
By Region
North America
U.S.
Canada
Mexico
Europe
Germany
France
U.K.
Italy
Spain
Rest of Europe
Asia Pacific
China
Japan
India
South Korea
South-east Asia
Rest of Asia Pacific
Latin America
Brazil
Argentina
Rest of Latin America
Middle East & Africa
GCC Countries
South Africa
Rest of the Middle East and Africa
Regional Analysis:
North America holds the largest share of the Biologics CDMO Secondary Packaging Market, accounting for 42% of global revenue in 2024. The region’s leadership stems from a mature biologics manufacturing ecosystem, strong regulatory frameworks, and widespread adoption of serialization technologies. The United States drives most of this demand, supported by high R&D investment and the presence of major pharmaceutical and biotech firms. CDMOs in the region offer integrated packaging and cold chain services that meet FDA and DSCSA requirements. Increasing use of advanced biologics and patient-centric therapies continues to elevate the need for specialized secondary packaging. It benefits from high infrastructure readiness and growing outsourcing of late-stage packaging activities.
Europe represents 30% of the global Biologics CDMO Secondary Packaging Market in 2024, positioning it as the second-largest regional market. The region benefits from harmonized regulatory standards under the EU Falsified Medicines Directive and consistent demand for biosimilars and specialty biologics. Germany, Switzerland, and Ireland serve as major packaging and logistics hubs due to their robust CDMO networks. Packaging providers are advancing eco-friendly and serialized formats to meet growing ESG expectations. Europe’s mature pharma sector supports ongoing innovation in packaging automation and compliance technologies. It remains attractive for multinational CDMOs expanding their European operations.
Asia Pacific commands a 20% share of the Biologics CDMO Secondary Packaging Market, emerging as the fastest-growing region. Countries like China, India, and South Korea are expanding biopharma production capacities, leading to higher demand for localized secondary packaging services. Regulatory upgrades and government support in these markets encourage CDMO growth and foreign investments. The region’s cost-competitive infrastructure and rapid industrialization attract international partnerships. Local CDMOs are scaling up their packaging capabilities to meet both domestic and export needs. It presents significant potential for flexible and temperature-sensitive biologics packaging, especially in oncology and vaccine segments.
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The Biologics CDMO Secondary Packaging Market is moderately fragmented, with a mix of global and regional players offering diverse service portfolios. Leading companies such as FUJI MACHINERY, Cavanna Packaging Group, and Bradman Lake compete by integrating serialization, automation, and cold-chain compatible solutions. Tier I CDMOs are expanding their capabilities through acquisitions and facility upgrades to meet rising biologics demand. Smaller CDMOs target niche therapies and short-run, customized packaging formats. The competitive landscape emphasizes regulatory compliance, scalability, and flexibility in secondary packaging lines. It encourages continuous investment in innovation and client-centric packaging solutions.
Recent Developments:
In June 2025, WuXi Biologics (Cayman) Inc. announced the launch of WuXiHigh™2.0, a next-generation high-throughput formulation development platform enabling biologics concentrations up to 230mg/mL while reducing viscosity by up to 90%. This technology addresses key manufacturing and delivery challenges for high-concentration biologics and enhances efficiency from clinical through commercial production.
In June 2025, Samsung Biologics Co. Ltd. launched Samsung Organoids, an innovative drug screening service. This new offering supports precision screening, accelerates preclinical development, and marks the company’s expansion into preclinical research. Samsung Organoids provide advanced data-driven analysis to help predict patient responses and streamline timelines for investigational new drug (IND) applications.
Market Concentration & Characteristics:
The Biologics CDMO Secondary Packaging Market features a moderate to high concentration with global CDMOs holding a significant share through strategic partnerships and multi-country operations. It is characterized by high regulatory sensitivity, advanced technology requirements, and increasing demand for cold-chain, traceable, and personalized packaging formats. Entry barriers remain high due to strict compliance protocols, quality assurance needs, and capital investment in automation and serialization infrastructure. The market favors CDMOs that offer integrated, flexible, and scalable packaging services tailored to complex biologics. It continues to evolve with innovations in smart packaging, sustainability, and patient-centric formats.
Report Coverage:
The research report offers an in-depth analysis based on packaging type and primary package type. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook:
Demand for personalized and specialty biologic therapies will drive growth in customized secondary packaging solutions.
Adoption of automation and robotics in packaging lines will enhance scalability and production efficiency.
Integration of smart packaging technologies will improve traceability, compliance, and cold-chain monitoring.
Regulatory harmonization across regions will streamline cross-border biologics packaging and distribution.
Sustainability initiatives will accelerate the shift toward recyclable and eco-friendly secondary packaging materials.
Expansion of CDMO operations in emerging markets will support localized and cost-effective packaging services.
Strategic partnerships between CDMOs and biotech firms will shape innovation in biologics packaging formats.
Growth in at-home biologic treatments will increase demand for patient-centric packaging designs.
Investment in digital platforms for packaging documentation and serialization will improve data transparency.
Increasing biopharma outsourcing trends will strengthen the market position of full-service CDMO providers.
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What is the current size of the Biologics CDMO Secondary Packaging Market?
The Biologics CDMO Secondary Packaging Market is valued at USD 1,761.0 million in 2024 and is projected to reach USD 3,382.1 million by 2032, growing at a CAGR of 8.5%.
What are the key segments within the Biologics CDMO Secondary Packaging Market?
Key segments in the Biologics CDMO Secondary Packaging Market include Packaging Type (Boxes, Cartons, Ampoules, Bottles) and Primary Package Type (Ampoules, Vials, Bottles, Blister Packs, Cartridges, Prefilled Syringes).
What are some challenges faced by the Biologics CDMO Secondary Packaging Market?
The Biologics CDMO Secondary Packaging Market faces challenges such as complex regulatory compliance, supply chain disruptions, and the high cost of automation and serialization infrastructure.
Who are the major players in the Biologics CDMO Secondary Packaging Market?
Major players in the Biologics CDMO Secondary Packaging Market include WuXi Biologics, FUJIFILM Diosynth Biotechnologies, Samsung Biologics, Thermo Fisher Scientific, Rentschler Biopharma, and Lonza Group.
About Author
Rajdeep Kumar Deb
Lead Analyst – Consumer & Finance
Rajdeep brings a decade of consumer goods and financial services insight to strategic market analysis.
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