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Global Biologics Contract Manufacturing Market “By Type (Monoclonal Antibodies, Recombinant Proteins, Vaccines. Insulin, Interferons, Growth Factors and Others); By Source (Microbial, Mammalian and Others); By Therapeutic Area (Oncology, Autoimmune Disease, Metabolic Disease, Ophthalmology, Cardiovascular Disease, Neurology, Respiratory Disorder and Others)” - Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2022-2030

A prominent research firm, Cognizance Market Research added a cutting-edge industry report on the “Global Biologics Contract Manufacturing Market”. The report studies the current as well as past growth trends and opportunities for the market to gain valuable insights during the forecast period from 2023 to 2030.

Global Biologics Contract Manufacturing Market Analysis

According to cognizance market research, The Global Biologics Contract Manufacturing Market was valued at US$ 13,467.6 Million in 2022 and is anticipated to reach US$ 29,034.2 Million by the end of 2030 with a CAGR of 10.1% from 2023 to 2030.

biologics contract manufacturing market

What is Biologics Contract Manufacturing?

Biologics, which encompass proteins, antibodies, and gene therapies, represent a distinct class of pharmaceuticals derived from living cells or organisms. Unlike conventional medications produced through chemical synthesis, biologics are notably intricate due to their origin. These therapeutic agents find prominent utility in addressing complex diseases such as cancer, autoimmune disorders, and rare genetic conditions.

Biologics contract manufacturing involves the production of materials utilized in medical imaging modalities such as X-rays, computed tomography (CT), magnetic resonance imaging (MRI), and ultrasound. These contract agents, administered through injection, ingestion, or inhalation, serve to enhance the visibility of internal bodily structures during various imaging procedures.

The manufacturing process for biological contract agents commonly harnesses recombinant DNA technology, which leverages living cells to generate these agents. These agents can comprise proteins or antibodies engineered to selectively target and bind to specific areas within the body, thus augmenting the precision and accuracy of imaging outcomes.

The production of biological contract agents entails a multi-faceted process encompassing cell culture, purification, and formulation. The product must conform to stringent standards of quality and purity, devoid of impurities and contaminants, to meet stringent regulatory prerequisites prior to being considered suitable for medical applications.

Global Biologics Contract Manufacturing Market Outlook

The outlook section of the biologics contract manufacturing market report encompasses critical market dynamics, including drivers, restraints, opportunities, and challenges shaping the industry’s landscape. Opportunities and challenges are external factors, while drivers and restraints are intrinsic factors that influence the market’s trajectory.

The biopharmaceutical sector is experiencing a notable surge in sales, accompanied by an expanding pharmaceutical pipeline. This surge has fueled the demand for biologics clinical development and manufacturing services, spanning from pre-clinical stages to full-scale commercial production. Notably, this demand is evidenced by the evaluation of over 3,500 recombinant proteins and antibodies in various pre-clinical and clinical studies, including those that have secured regulatory approval.

A noteworthy trend is the increasing generation of pipeline compounds by small and emerging biotech companies. Often lacking internal manufacturing capacity and expertise, these entities are inclined towards outsourcing to expedite bringing their prospects to market. This emerging segment of biopharma firms currently constitutes around 80% of the new product pipeline.

Market leaders are actively investing in research and development endeavours to craft innovative pharmaceutical solutions. This is driven by the burgeoning demand for technologically advanced products capable of effectively treating a diverse array of medical conditions.

Recent intensive research into novel and combination therapies has underscored the efficacy of biologics in addressing a wide spectrum of chronic diseases, encompassing cancer, rheumatoid arthritis, macular degeneration, and haematological malignancies.

Biologics, a class of medications synthesized from live cells, have emerged as pivotal tools for treating both common ailments and serious diseases like cancer, diabetes, rheumatoid arthritis, and autoimmune disorders. Their potency and targeted mechanism of action have propelled their widespread application across various disease treatments.

Unlike traditional small-molecule compounds characterized by simple chemical structures, biologic medications—often referred to as large molecules—are intricate proteins manufactured within living cells. The inherent complexity of producing biologics, exemplified by monoclonal antibodies, translates into elevated production costs. As a consequence, the market’s global growth trajectory within the forecasted period may encounter limitations due to the high production costs associated with biologic medications.

Segment Analysis:

The biologics contract manufacturing market has been segmented into type, source, therapeutic area and region.

Based on type, the biologics contract manufacturing market has been segmented into monoclonal antibodies, recombinant proteins, vaccines, insulin, interferons, growth factors and others. The monoclonal antibodies segment dominated the biologics contract manufacturing market. The extensive use of MABS’s products in several therapeutic fields is responsible for the segment’s rapid expansion. Cancer, chronic Hepatitis B (HBV) infection, infectious disorders, and autoimmune diseases including rheumatoid arthritis are all treated with the medications made by MABs.

Based on source, the market for biologics contract manufacturing is classified into mammalian, microbial and others. The mammalian source sector took over as the leading industry. The primary advantage of employing mammalian cells for protein production and producing mammalian proteins with appropriate post-translational modifications that provide a native structure is the reason behind this.

Based on therapeutic area, the biologics contract manufacturing market has been bifurcated into oncology, autoimmune disease, metabolic disease, ophthalmology, cardiovascular disease, neurology, respiratory disorder and others. The oncology segment is the leading one in the biologics contract manufacturing market. It is anticipated to continue dominating during the forecast period. The high costs of medication development, an increase in cancer cases, and FDA restrictions requiring biologic drugs to be developed more quickly are all factors contributing to the category growth.

Geographical Analysis:

Based on geography the global biologics contract manufacturing market has been segmented into five main regions namely, North America, Asia Pacific, Europe, Latin America, and Middle East & Africa.

North America holds a commanding position in the market, driven by a combination of strategic partnerships, acquisitions, and escalating demand for specialized testing services. The burgeoning trend of outsourcing and intensified clinical trial activities within the region has notably contributed to the growth of contract development organizations (CDOs). The prevalence of chronic diseases and the aging population further amplifies the demand for clinical trials in North America, thereby providing substantial impetus for market expansion.

Looking ahead, the Asia Pacific region is poised to witness an upsurge in the market for biologics contract development. This projection is underpinned by the multitude of regulatory organization revisions that have aligned standards for clinical trial review with global requirements. Consequently, biotechnology enterprises have initiated significant investments within the Asia-Pacific region, contributing to the region’s promising growth prospects.

geographical analysis

The report offers the revenue of the biologics contract manufacturing market for the period 2020-2030, considering 2020 & 2021 as a historical years, 2022 as the base year and 2023 to 2030 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the biologics contract manufacturing market for the forecast period. The biologics contract manufacturing market report provides insights and in-depth analysis into developments impacting enterprises and businesses on a regional and global level. The report covers the biologics contract manufacturing market performance in terms of revenue contribution from several segments and comprises a detailed analysis of key drivers, trends, restraints, and opportunities prompting revenue growth of the biologics contract manufacturing market.

The report has been prepared after wide-ranging secondary and primary research. Secondary research included internet sources, numerical data from government organizations, trade associations, and websites. Analysts have also employed an amalgamation of bottom-up and top-down approaches to study numerous phenomena in the biologics contract manufacturing market. Secondary research involved a detailed analysis of significant players’ product portfolios. Literature reviews, press releases, annual reports, white papers, and relevant documents have been also studied to understand the biologics contract manufacturing market. Primary research involved a great extent of research efforts, wherein experts carried out interviews telephonic as well as questioner-based with industry experts and opinion-makers.

The report includes an executive summary, along with a growth pattern of different segments included in the scope of the study. The Y-o-Y analysis with elaborate market insights has been provided in the report to comprehend the Y-o-Y trends in the biologics contract manufacturing market. Additionally, the report focuses on altering competitive dynamics in the global market. These indices serve as valued tools for present market players as well as for companies interested in participating in the biologics contract manufacturing market. The subsequent section of the biologics contract manufacturing report highlights the USPs, which include key industry events (Type launch, research partnership, acquisition, etc.), technology advancements, pipeline analysis, prevalence data, and regulatory scenario.

Global Biologics Contract Manufacturing Market Competitive Landscape

The “Global Biologics Contract Manufacturing Market” study report will provide valuable insight with an emphasis on the global market including some of the major players such as –

  • AbbVie, Inc.
  • Abzena Ltd, AGC Biologics
  • Ajinomoto Bio-Pharma
  • Avid Bioservices, Inc
  • Biogen
  • Bionova Scientific Inc,
  • BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH)
  • Cambrex Corporation
  • Catalent, Inc.
  • Curia Global, Inc.
  • Fujiifilm Diosynth Biotechnologies
  • Genscript
  • KBI Biopharma
  • LakePharma
  • Lonza Group
  • Recipharm Pharmaceuticals
  • Roche
  • Samsung Biologics Co Ltd.
  • Sanofi
  • STC Biologics
  • Thermo Fisher Scientific Inc.
  • WuXi Biologics.

Key developments in the biologics contract manufacturing market-

  • WuXi Biologics completed the purchase of the Hangzhou-based biologics drug substance and product facilities (MFG20/DP9/DP10) from Pfizer China in March 2021. These facilities have two 2,000-liter single-use bioreactors that can be expanded to four 2,000-liter ones. Additionally, the business purchased CMAB, a Suzhou, China-based biologics contract development and manufacturing organisation (CDMO).
  • Samsung Biologics announced an investment of US$ 1.7 billion in August 2020 for a second bio complex and the company’s fourth biomanufacturing facility, which will be located in Incheon, South Korea.

The report explores the competitive scenario of the biologics contract manufacturing market. Major players operating in the biologics contract manufacturing market have been identified and profiled for unique commercial attributes. Company overview (company description, Type portfolio, geographic presence, employee strength, Key management, etc.), financials, SWOT analysis, recent developments, and key strategies are some of the features of companies profiled in the biologics contract manufacturing market report.

Segmentation:

Global Biologics Contract Manufacturing Market, by Type

  • Monoclonal Antibodies
  • Recombinant Proteins
  • Vaccines
  • Insulin
  • Interferons
  • Growth Factors
  • Others

Global Biologics Contract Manufacturing Market, by Source

  • Microbial
  • Mammalian
  • Others

Global Biologics Contract Manufacturing Market, by Therapeutic Area

  • Oncology
  • Autoimmune Disease
  • Metabolic Disease
  • Ophthalmology
  • Cardiovascular Disease
  • Neurology
  • Respiratory Disorder
  • Others

Global Biologics contract manufacturing Market, by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Spain
    • Italy
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia & New Zealand
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
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Table of Content

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:

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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.

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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:

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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.

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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.

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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.

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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.

Report Scope:

Attribute

Description

Market Size

US$ 29,034.2 Million (2030)

Compound Annual Growth Rate (CAGR)

10.10%

Base Year

2022

Forecast Period

2023-2030

Forecast Units

Value (US$ Million)

Report Coverage

Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

Geographies Covered

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Countries Covered

U.S., Canada, Germany, U.K., France, Spain, Italy, Rest of Europe, Japan, China, India, Australia & New Zealand, South Korea, Rest of Asia Pacific, Brazil, Mexico, Rest of Latin America, GCC, South Africa, Rest of Middle East & Africa

Key Companies Profiled

AbbVie, Inc., Abzena Ltd, AGC Biologics, Ajinomoto Bio-Pharma, Avid Bioservices, Inc, Biogen, Bionova Scientific Inc,, BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH), Cambrex Corporation, Catalent, Inc., Curia Global, Inc., Fujiifilm Diosynth Biotechnologies, Genscript, KBI Biopharma, LakePharma, Lonza Group, Recipharm Pharmaceuticals, Roche, Samsung Biologics Co Ltd., Sanofi, STC Biologics, Thermo Fisher Scientific Inc., WuXi Biologics

Key Questions Answered in Biologics Contract Manufacturing Market Report

Drugs known as biologics, including proteins, antibodies, and gene treatments, are created from living cells or other species. As opposed to conventional medications, which are chemically synthesised, they are often more complex. Treatments for complicated diseases like cancer, autoimmune conditions, and unusual genetic disorders frequently involve the use of biologics.

The major players operating in the biologics contract manufacturing market include Abzena Ltd, AGC Biologics, Ajinomoto Bio-Pharma, Avid Bioservices, Inc; Bionova Scientific Inc, BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH), Curia Global, Inc., Fujiifilm Diosynth Biotechnologies, Genscript, KBI Biopharma, LakePharma, Lonza, STC Biologics, Samsung Biologics, Thermo Fisher Scientific Inc., and WuXi Biologics.

An increase in biopharmaceutical sales and pipeline drugs, and demand for the development of newer and technologically enhanced products are some of the factors driving the biologics contract manufacturing market.

The oncology segment is expected to dominate the biologics contract manufacturing market. It is anticipated to continue dominating during the forecast period. The high costs of medication development, an increase in cancer cases, and FDA restrictions requiring biologic drugs to be developed more quickly are all factors contributing to the category growth.

The monoclonal antibodies segment is anticipated to dominate the biologics contract manufacturing market. The extensive use of MABS’s products in several therapeutic fields is responsible for the segment’s rapid expansion. Cancer, chronic Hepatitis B (HBV) infection, infectious disorders, and autoimmune diseases including rheumatoid arthritis are all treated with the medications made by MABs.

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