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Biosimilar Monoclonal Antibodies Market - Global Industry, Analysis, Size, Share, Growth, Trends, and Forecasts 2023-2030

A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies can have monovalent affinity, binding only to the same epitope (the part of an antigen that is recognized by the antibody). In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different antibody-secreting plasma cell lineages. Bispecific monoclonal antibodies can also be engineered by increasing the therapeutic targets of one monoclonal antibody to two epitopes. It is possible to produce monoclonal antibodies that specifically bind to almost any suitable substance, they can then serve to detect or purify it. This capability has become an investigative tool in biochemistry, molecular biology, and medicine. Monoclonal antibodies are used in the diagnosis of illnesses such as cancer and infections and are used therapeutically in the treatment of cancer and inflammatory diseases.

The work behind the production of monoclonal antibodies is rooted in the production of hybridomas, which involves identifying antigen-specific plasma/plasmablast cells that produce antibodies specific to an antigen of interest and fusing these cells with myeloma cells. Monoclonal antibodies have a wide range of applications such as antibodies used to purify their target compounds from mixtures, using the method of immunoprecipitation. Therapeutic monoclonal antibodies act through multiple mechanisms, such as blocking targeted molecule functions, inducing apoptosis in cells that express the target, or modulating signaling pathways. Monoclonal antibodies used for autoimmune diseases include infliximab and adalimumab which are effective in rheumatoid arthritis.

Global Biosimilar Monoclonal Antibodies Market – Competitive Landscape

On October 24, 2023, Aiolos Bio launched with USD 245 million series A investment to advance the development of a novel phase 2-ready TSLP antibody. On August 22, 2023, Project NextGen awarded over USD 1.4 billion to develop the future of COVID-19 vaccines and therapeutics. On July 20, 2023, Tillotts Pharma and TVM Capital Life Science announced the formation of Mage Biologics to develop innovative oral antibody therapy for Ulcerative Colitis. On September 14, 2022, Novartis invested USD 300 million in Next Generation Biotherapeutics development. On February 19, 2021, GSK and Vir Biotechnology added new influenza therapeutics to coronavirus collaboration.

Some of the Key Players in the Global Biosimilar Monoclonal Antibodies Market Include –

  • Novartis
  • GlaxoSmithKline
  • Genentech
  • Amgen
  • Bristol-Myers Squibb
  • EPIVAX Inc
  • AstraZeneca
  • Eli Lily
  • Johnson & Johnson
  • Regeneron Pharmaceuticals Inc.
  • Acorda Therapeutics Inc.
  • Immatics NV
  • AbbVie Inc.

Global Biosimilar Monoclonal Antibodies Market – Growth Drivers

The continuous growth of the biologics market creates opportunities for biosimilar mAbs, especially as patents for originator biologics expire. Increasing incidences of chronic diseases, such as cancer and autoimmune disorders, drive the demand for biosimilar mAbs as effective and more affordable treatment options.  According to the Centers for Disease Control and Prevention autoimmune disease affects approximately 8% of the population, 78% of whom are women. Evolving and supportive regulatory frameworks worldwide facilitate a smoother path for biosimilar mAbs development, approval, and commercialization. Growing expertise among pharmaceutical companies in biosimilar development, including advancements in manufacturing technologies, accelerates the production of high-quality biosimilar mAbs. Ongoing research and development efforts contribute to an expanding biosimilar mAbs pipeline, offering a diverse range of therapeutic options and addressing unmet medical needs. Achieving interchangeability status for certain biosimilar mAbs enhances their acceptance, providing healthcare providers and patients with confidence in their efficacy and safety. The aging global population creates an increased demand for innovative healthcare solutions, positioning biosimilars mAbs as crucial components in managing age-related diseases. Growing awareness and educational initiatives among healthcare professionals and patients contribute to a more favorable perception and increased adoption of biosimilar mAbs.

Global Biosimilar Monoclonal Antibodies Market – Restraints

The intricate manufacturing processes involved in producing biosimilar monoclonal antibodies pose challenges, including higher development costs and potential difficulties in achieving consistency. The annual price of mAb therapies is about USD 100,000 higher in oncology and hematology. Stringent regulatory scrutiny and requirements for demonstrating similarity to reference biologics create barriers, delaying the approval and market entry of biosimilar mAbs. Limited long-term clinical data for biosimilar mAbs may contribute to hesitancy among healthcare professionals and patients, impacting adoption rates. Concerns about immunogenicity, including potential immune responses to biosimilar mAbs, raise safety issues and may influence market acceptance. Legal challenges and patent disputes with originator biologic manufacturers can hinder the timely market entry of biosimilar mAbs, delaying commercialization. Intense competition among biosimilar manufacturers, coupled with pricing pressures, may affect profit margins and limit the overall biosimilar monoclonal antibodies market growth potential. Varied levels of understanding and acceptance of biosimilars among physicians and patients can impede adoption, influencing prescription patterns. Challenges associated with switching patients from originator biologics to biosimilar mAbs, including concerns about efficacy and safety, may slow biosimilar monoclonal antibody market penetration. Insufficient education and awareness programs may contribute to misconceptions about similar mAbs, hindering their acceptance in clinical practice. Limited manufacturing capacities for biosimilar mAbs may lead to supply chain challenges and impact the ability to meet the growing biosimilar monoclonal antibodies market demand.

Global Biosimilar Monoclonal Antibodies Market – Opportunities

Achieving interchangeability status for biosimilar mAbs with reference biologics provides a significant opportunity, increasing confidence among healthcare providers and patients. Expansion into emerging markets with improving healthcare infrastructure and rising healthcare spending offers substantial growth opportunities for biosimilar mAbs. Innovation in bioprocessing and manufacturing technologies contributes to increased efficiency, reduced costs, and scalability, creating favorable conditions for market growth. Implementing patient access programs and affordability initiatives enhances accessibility to biosimilar mAbs, especially in regions facing economic challenges.

Global Biosimilar Monoclonal Antibodies Market – Geographical Insight

The market for global biosimilar monoclonal antibodies 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 biosimilar monoclonal antibodies due to the increasing adoption of biosimilars in the U.S. healthcare system contributes to market expansion. Regulatory approvals and favorable reimbursement policies drive market growth. Europe has a matured biosimilar market with a well-established regulatory framework. Growing acceptance of biosimilar mAbs in the European healthcare landscape. In Asia-Pacific emerging as a lucrative market for biosimilar mAbs, with increasing healthcare investments. The rising prevalence of chronic diseases fuels the demand for cost-effective therapeutic options.

Global Biosimilar Monoclonal Antibodies Market – Key Development

  • On November 16, 2023, Lonza launched a new cell line for higher potency antibody development.
  • On September 16, 2023, 20 monoclonal antibody doses to arrive from Australia, and ICMR to start work on the Nipah Vaccine.
  • On October 16, 2023, Proteintech launched new multi-rAb recombinant secondary antibodies.
  • On September 6, 2023, MD Anderson and Panacea created Manaolana Oncology to develop a novel portfolio of monoclonal antibodies.
  • On June 26, 2023, Invivyd, the FDA agreed on steps to emergency approval for COVID monoclonal antibody.
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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.
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