report cover1

Biologics Outsourcing Market - Global Industry, Analysis, Size, Share, Growth, Trends, and Forecasts 2023-2030

Biologics outsourcing is a strategic practice within the pharmaceutical and biotechnology industries that involves contracting specialized external organizations to perform various aspects of the development, manufacturing, and testing of biologic drugs. Biologics, which are complex therapeutic products derived from living organisms, present unique challenges in terms of production and expertise. Outsourcing allows companies to leverage the capabilities and resources of contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs) to streamline the biologics development process. One key aspect of biologics outsourcing is the manufacturing of these intricate products. CMOs equipped with state-of-the-art facilities and specialized expertise can efficiently produce large-scale batches of biologics, ensuring quality, consistency, and compliance with regulatory standards. These approaches allow pharmaceutical companies to focus on their core competencies, such as research, innovation, and commercialization while relying on outsourcing partners for the intricate manufacturing processes.

Biologics outsourcing extends beyond manufacturing to encompass various stages of the drug development lifecycle. This includes early-phase development, process optimization, analytical testing, and even post-marketing activities. By outsourcing these functions, companies can accelerate the overall development timeline, reduce costs, and mitigate risks associated with in-house resource constraints or lack of specialized knowledge. Additionally, biologics outsourcing facilitates access to a global network of scientific and technical expertise. Collaborating with CMOs or CDMOs enables companies to tap into a pool of skilled professionals, often with diverse backgrounds and experiences contributing to enhanced problem-solving and innovation. Biologics outsourcing plays a pivotal role in the pharmaceutical and biotechnology industries by enabling companies to harness external expertise, optimize manufacturing processes, accelerate development timelines, and navigate complex regulatory landscapes.

Global Biologics Outsourcing Market – Competitive Landscape

On November 2, 2023, Aragen launched a USD 30 million biologics manufacturing facility. On June 1, 2023, WuXi Biologics expanded its manufacturing capacity in Germany. On April 14, 2023, Samsung Biologics invested in a Swiss ADC firm.  On March 17, 2023, Samsung Biologics is set to begin construction of a new USD 1.5 billion plant, the start of Biologics Campus II. On January 11, 2023, Lotte Biologics to invest USD 3 billion for 3 plants in Korea by 2030.  On March 25, 2021, Chime Biologics announced the completion of USD 190 million in series A financing to accelerate capacity expansion.

Some of the Key Players in the Global Biologics Outsourcing Market Include –

  • AbbVie Inc.
  • Thermo Fisher Scientific
  • Boehringer Ingelheim
  • International GmbH
  • Merck & Co
  • Lonza Group AG
  • Catalent Inc.
  • Abzena Ltd
  • Novartis AG

Global Biologics Outsourcing Market – Growth Drivers

The rising demand for biologics drugs, driven by advancements in personalized medicine and targeted therapies, fuels the growth of biologics outsourcing as companies seek external expertise to expedite development processes. According to the National Center for Biotechnology Information (NCBI), the number of patients using biologics increased from 5.1% to 16.2%. the intricate nature of biologics production, involving living organisms and complex processes, leads pharmaceutical companies to outsource manufacturing to specialized contract organizations with advanced facilities and expertise. Outsourcing biologics development and manufacturing allows companies to reduce capital expenditures and operational costs, leveraging the cost efficiencies of specialized contract partners. The globalization of clinical trials necessitates a network of diverse capabilities. Biologics outsourcing provides access to a global talent pool, helping companies navigate regional regulatory requirements and diverse patient populations. Stringent regulatory requirements for biologics necessitate specialized knowledge. Outsourcing partners often have a deep understanding of regulatory frameworks, ensuring compliance and accelerating the approval process. Biologics outsourcing offers flexibility in adapting to changing project needs and scalability to accommodate varying production volumes, allowing companies to respond effectively to market dynamics. Outsourcing mitigates risks associated with in-house resource constraints, reducing the financial and operational risks related to biologics development and manufacturing.

Global Biologics Outsourcing Market – Restraints

Ensuring consistent and high-quality production of biologics challenges, and outsourcing may encounter difficulties in maintaining stringent quality control standards across diverse facilities and processes. Companies may face concerns related to the protection of intellectual property when outsourcing critical aspects of biologics development, raising issues of confidentiality and proprietary information. Despite expertise in regulatory affairs, navigating complex global regulatory landscapes can lead to prolonged approval timelines, impacting the overall time-to-market for biologics drugs. Overreliance on external partners for key stages of biologics development and manufacturing introduces risks related to supply chain disruptions, changing contractual terms, and potential conflicts of interest. The transport and logistics involved in the shipment of biologics, especially those with specific temperature and storage requirements, may pose challenges that affect the integrity of the product. Collaborating with outsourcing partners across different geographical locations may lead to communication challenges, potentially impacting project coordination, timelines, and overall efficiency. While outsourcing cost efficiencies, unexpected expenses related to changes in project scope, quality control measures, or regulatory compliances can lead to unforeseen financial burdens. According to the National Center for Biotechnology Information (NCBI), biologics outsourcing is expensive on average costing USD 10,000 to 30,000 per year. The fast-paced evolution of bioprocessing technologies may result in outsourcing partners needing continual investment to stay current, potentially impacting cost-effectiveness for both parties.

Global Biologics Outsourcing Market – Opportunities

Growing demand for biosimilars presents a significant opportunity for biologics outsourcing, as companies seek cost-effective strategies for developing and manufacturing these complex molecules. The expanding field of cell and gene therapies opens new avenues for biologics outsourcing, as companies explore external collaborations to address the unique manufacturing and development challenges associated with these innovative therapies. The adoption of digital technologies in bioprocessing, including process automation and data analytics, creates opportunities for outsourcing partners to optimize production processes, improve efficiency, and reduce costs.

Global Biologics Outsourcing Market – Geographical Insight

The market for global biologics outsourcing is segmented into regions such as North America, Latin America, Europe, Asia-Pacific, the Middle East & and Africa. North America is the largest market for biologics outsourcing due to advanced technologies, fostering innovation, and attracting outsourcing partnerships for cutting-edge development in the region. European countries focus on forming strategic collaborations to enhance research capabilities and accelerate product development. High-quality standards, make the region attractive for outsourcing partners committed to regulatory compliance. Asia-Pacific is increasingly recognized as a hub for clinical trials, Asia-Pacific attracts outsourcing for various stages of biologics development, including early-phase trials.

Global Biologics Outsourcing Market – Key Development

  • On October 16, 2023, Tanvex CDMO launched empowers advancements in novel biologics and Biosimilars.
  • On September 12, 2023, Waters launched new walk-up solutions that further simplify the analysis of biologics drug products and cell culture media.
  • On August 25, 2023, CVS launched a new subsidiary for biosimilars.
  • On March 9, 2020, BrevisRefero launched the CDMO proposal platform.
Complete the form below and we'll get back to you shortly
Table of Content
Complete the form below and we'll get back to you shortly

Research Methodology: Aspects

Market research is a crucial tool for organizations aiming to navigate the dynamic landscape of customer preferences, business trends, and competitive landscapes. At Cognizance Market Research, acknowledging the importance of robust research methodologies is vital to delivering actionable insights to our clientele. The significance of such methodologies lies in their capability to offer clarity in complexity, guiding strategic management with realistic evidence rather than speculation. Our clientele seek insights that excel superficial observations, reaching deep into the details of consumer behaviours, market dynamics, and evolving opportunities. These insights serve as the basis upon which businesses craft tailored approaches, optimize product offerings, and gain a competitive edge in an ever-growing marketplace.

The frequency of information updates is a cornerstone of our commitment to providing timely, relevant, and accurate insights. Cognizance Market Research adheres to a rigorous schedule of data collection, analysis, and distribution to ensure that our reports reflect the most current market realities. This proactive approach enables our clients to stay ahead of the curve, capitalize on emerging trends, and mitigate risks associated with outdated information.

Our research process is characterized by meticulous attention to detail and methodological rigor. It begins with a comprehensive understanding of client objectives, industry dynamics, and research scope. Leveraging a combination of primary and secondary research methodologies, we gather data from diverse sources including surveys, interviews, industry reports, and proprietary databases. Rigorous data analysis techniques are then employed to derive meaningful insights, identify patterns, and uncover actionable recommendations. Throughout the process, we remain vigilant in upholding the highest standards of data integrity, ensuring that our findings are robust, reliable, and actionable.

Key phases involved in in our research process are mentioned below:


Understanding Clients’ Objectives:

Extensive Discussions and Consultations:

  • We initiate in-depth discussions and consultations with our clients to gain a comprehensive understanding of their objectives. This involves actively listening to their needs, concerns, and aspirations regarding the research project.
  • Through these interactions, we aim to uncover the underlying motivations driving their research requirements and the specific outcomes they hope to achieve.

Industry and Market Segment Analysis:

  • We invest time and effort in comprehensively understanding our clients’ industry and market segment. This involves conducting thorough research into market trends, competitive dynamics, regulatory frameworks, and emerging opportunities or threats.
  • By acquiring a deep understanding of the broader industry landscape, we can provide context-rich insights that resonate with our clients’ strategic objectives.

Target Audience Understanding:

  • We analyze our clients’ target audience demographics, behaviors, preferences, and needs to align our research efforts with their consumer-centric objectives. This entails segmenting the audience based on various criteria such as age, gender, income level, geographic location, and psychographic factors.
  • By understanding the nuances of the target audience, we can tailor our research methodologies to gather relevant data that illuminates consumer perceptions, attitudes, and purchase intent.


Identifying Challenges and Opportunities:

  • We proactively identify the challenges and opportunities facing our clients within their respective industries. This involves conducting SWOT (Strengths, Weaknesses, Opportunities, Threats) analyses and competitive benchmarking exercises.
  • By identifying potential obstacles and growth drivers, we can provide strategic recommendations that help our clients navigate complexities and capitalize on emerging opportunities effectively.

Grasping Specific Goals:

  • We delve into the intricacies of our clients’ objectives to gain clarity on the specific goals they aim to accomplish through the research. This entails understanding their desired outcomes, such as market expansion, product development, or competitive analysis.
  • By gaining a nuanced understanding of our clients’ goals, we can tailor our research approach to address their unique challenges and opportunities effectively.

Data Collection:


Primary Research Process:

  • Surveys: We design and administer surveys tailored to capture specific information relevant to our clients’ objectives. This may involve employing various survey methodologies, such as online, telephone, or face-to-face interviews, to reach target audiences effectively.
  • Interviews: We conduct structured or semi-structured interviews with key stakeholders, industry experts, or target consumers to gather in-depth insights and perspectives on relevant topics. These interviews allow us to probe deeper into specific issues and uncover valuable qualitative data.
  • Focus Groups: We organize focus group discussions with carefully selected participants to facilitate interactive discussions and gather collective opinions, attitudes, and preferences. This qualitative research method provides rich contextual insights into consumer behaviors and perceptions.
  • Observations: We conduct observational research by directly observing consumer behaviors, interactions, and experiences in real-world settings. This method enables us to gather objective data on consumer actions and reactions without relying on self-reported information.

Secondary Research Process:

  • Literature Review: We conduct comprehensive literature reviews to identify existing studies, academic articles, and industry reports relevant to the research topic. This helps us gain insights into previous research findings, theoretical frameworks, and best practices.
  • Industry Reports: We analyze industry reports published by reputable trade associations (whitepapers, research studies, etc.), and government agencies (U.S. Census Bureau, Bureau of Labor Statistics, and Securities and Exchange Commission etc.) to obtain macro-level insights into market trends, competitive landscapes, and industry dynamics.
  • Government Publications: We review government publications, such as economic reports, regulatory documents, and statistical databases, to gather relevant data on demographics, market size, consumer spending patterns, and regulatory frameworks.
  • Online Databases: We leverage online databases, such as industry portals, and academic repositories (PubMed Central (PMC), ScienceDirect, SSRN (Social Science Research Network), Directory of Open Access Journals (DOAJ), NCBI, etc.), to access a wide range of secondary data sources, including market statistics, financial data, and industry analyses.



Data Analysis:

The data analysis phase serves as a critical juncture where raw data is transformed into actionable insights that inform strategic decision-making. Through the utilization of analytical methods such as statistical analysis and qualitative techniques like thematic coding, we uncover patterns, correlations, and trends within the data. By ensuring the integrity and validity of our findings, we strive to provide clients with accurate and reliable insights that accurately reflect the realities of the market landscape.


Transformation of Raw Data:

  • Upon collecting the necessary data, we transition into the data analysis phase, where raw data is processed and transformed into actionable insights. This involves organizing, cleaning, and structuring the data to prepare it for analysis.

Utilization of Analytical Methods:

  • Depending on the research objectives, we employ a diverse range of analytical methods to extract meaningful insights from the data. These methods include statistical analysis, trend analysis, regression analysis, and qualitative coding.

Statistical Analysis:

  • Statistical tools are instrumental in uncovering patterns, correlations, and trends within the data. By applying statistical techniques such as descriptive statistics, hypothesis testing, and multivariate analysis, we can discern relationships and derive valuable insights.

Qualitative Analysis Techniques:

  • In addition to quantitative analysis, we leverage qualitative analysis techniques to gain deeper insights from qualitative data sources such as interviews or open-ended survey responses. One such technique is thematic coding, which involves systematically categorizing and interpreting themes or patterns within qualitative data.

Integrity and Validity Maintenance:

  • Throughout the analysis process, we maintain a steadfast commitment to upholding the integrity and validity of our findings. This entails rigorous adherence to established methodologies, transparency in data handling, and thorough validation of analytical outcomes.

Data Validation:

The final phase of our research methodology is data validation, which is essential for ensuring the reliability and credibility of our findings. Validation involves scrutinizing the collected data to identify any inconsistencies, errors, or biases that may have crept in during the research process. We employ various validation techniques, including cross-referencing data from multiple sources, conducting validity checks on survey instruments, and seeking feedback from independent experts or peer reviewers. Additionally, we leverage internal quality assurance protocols to verify the accuracy and integrity of our analysis. By subjecting our findings to rigorous validation procedures, we instill confidence in our clients that the insights they receive are robust, reliable, and trustworthy.


Importance of Data Validation:

  • Data validation is the final phase of the research methodology, crucial for ensuring the reliability and credibility of the findings. It involves a systematic process of reviewing and verifying the collected data to detect any inconsistencies, errors, or biases.

Scrutiny of Collected Data:

  • The validation process begins with a thorough scrutiny of the collected data to identify any discrepancies or anomalies. This entails comparing data points, checking for outliers, and verifying the accuracy of data entries against the original sources.

Validation Techniques:

  • Various validation techniques are employed to ensure the accuracy and integrity of the data. These include cross-referencing data from multiple sources to corroborate findings, conducting validity checks on survey instruments to assess the reliability of responses, and seeking feedback from independent experts or peer reviewers to validate the interpretation of results.

Internal Quality Assurance Protocols:

  • In addition to external validation measures, internal quality assurance protocols are implemented to further validate the accuracy of the analysis. This may involve conducting internal audits, peer reviews, or data validation checks to ensure that the research process adheres to established standards and guidelines.
- Get Started -

Get insights that lead to new growth opportunities

Need a Custom Report?

We can customize every report – free of charge – including purchasing stand-alone sections or country-level reports

Want to Buy a Report but have a Limited Budget?

We help clients to procure the report or sections of the report at their budgeted price. Kindly click on the below to avail

Business Development

small c popup.png
Buy Now
small c popup.png
Complete the form below and we'll get back to you shortly
small c popup.png
Complete the form below and we'll get back to you shortly
small c popup.png
Complete the form below and we'll get back to you shortly
Ask an Expert