Antibody Therapeutics Market worth $479.0 billion by 2028

The size of global antibody therapeutics market in terms of revenue was estimated to be worth $247.3 billion in 2023 and is poised to reach $479.0 billion by 2028, growing at a CAGR of 14.1% from 2023 to 2028. The research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.

Browse?313 market data Tables and?51 Figures spread through?306 Pages and in-depth TOC on "Antibody Therapeutics Market by Format (Monoclonal, Polyclonal, Antibody Fragment, Bispecific), Disease area (Oncology, Autoimmune & Inflammatory, Neurology, Hematology, Infectious), Source (Human, Chimeric), Route (IV, SC) - Global Forecast to 2028 "View detailed Table of Content here - https://www.marketsandmarkets.com/Market-Reports/antibody-therapeutics-market-178852478.html

Monoclonal antibodies subsegment is the fastest-growing of the antibody therapeutics market by format.

Among the format subsegments, the antibody therapeutics market is segmented into monoclonal antibodies, polyclonal antibodies, antibody fragments, bispecific antibodies, and other novel antibody therapies. the monoclonal antibodies segment accounted for the fastest-growing market of the format segment. This can be attributed to factors such as the presence of a large number of pipeline monoclonal antibodies and benefits such as target specificity offered by mAbs among others.

Oncology is the fastest-growing segment of the antibody therapeutics market by disease area.

Among the disease area subsegments, the antibody therapeutics market is segmented into autoimmune & inflammatory diseases, oncology, hematology, infectious diseases, osteology, immunology, neurology, and other disease areas. the oncology segment accounted for the fastest-growing share of the disease area segment of the antibody therapeutics market. Growth in this market segment can be attributed to one of the major factors which is the presence of a large number of oncology therapeutics products in the clinical pipeline.

Europe: The second-largest region in the antibody therapeutics market.

The European market is the second-largest antibody therapeutics market globally. One of the major factors supporting the high growth of the European antibody therapeutics market is the advancements in antibody therapy research in the region. Major countries contributing to this growth include Germany, the UK and France. Moreover, the presence of some of the key market players such as F. Hoffmann-La Roche Ltd. (Switzerland), AstraZeneca (UK), and Merck KGaA (Germany) among others in the region, is another factor supporting the growth of the European antibody therapeutics market.

Antibody Therapeutics Market Dynamics

Driver: Growing advancements in antibody engineering

Antibody engineering is a specialized field that focuses on modifying antibodies to enhance their therapeutic properties. This process involves the application of technology and techniques to design antibodies with specific characteristics tailored for therapeutic applications. Antibody engineering offers several benefits such as customization for specific therapeutic indications, targeted effects and more. Severa antibody engineering techniques are being used for the production of antibody fragments. These include hybridoma technology, Phage Display, Single B-Cell Technology, and Transgenic Animals. Wacker's ESETEC secretion technology (by Wacker Chemie AG) is an approach for the expression and secretion of antibody fragments (Fab) exceeding 4.0 g/L and scFv exceeding 3.5 g/L into the fermentation broth. Another platform for the productive creation of a sizable number of antibody fragments is the Pelican Expression Technology Platform (by Ligand Pharmaceuticals) and the pOP prokaryotic expression vector. Such advancements in technology allow the development of novel antibody therapeutics, thus, supporting market growth.

Restraint: Stringent regulatory approval process

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the major regulatory authorities that regulate the commercialization of antibody therapeutics. The stringent regulatory guidelines imposed by the FDA in the US and the EMA in Europe during clinical trials have the potential to create significant restraints for companies. There have been instances of product regulatory rejections or withdrawals due to stringent regulatory parameters for antibody therapeutics. For instance, in December 2022, Y-mAbs Therapeutics issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine 131I-omburtamab (omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma for which the FDA completed the review of the application and concluded that it is unable to approve the BLA in its then presented form. Thus, the market players are required to mandatorily follow regulations put forth by the regulatory bodies to overcome this restraint.

Opportunity: Increasing collaboration of pharmaceutical companies with CROs, CDMOs and academic institutions

Market players are increasingly focusing on a collaborative approach with an aim to enhance their market position. This collaborative approach allows players to leverage the research and manufacturing capabilities as well as professional expertise from these organizations thus creating new avenues of growth for market players. For instance, AstraZeneca in collaboration with the University Health Network, Toronto, has been engaged in a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high-risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). Such

Challenge: Complexities in manufacturing processes

Manufacturing processes for antibody therapeutics involve several complexities with some challenges that impact production capacity and efficiency. For instance, bacterial systems can synthesize inactive proteins with the proper molecular structure, which can result in the creation of inclusion bodies. Additionally, bacteria can eliminate signal peptides but not preproteins like native coagulation growth factors, which they cannot break down. The purification process is challenging because endotoxins, which are created by bacteria during expression, are notoriously difficult to eliminate. Endotoxins and inclusion bodies present a hurdle to the final product's purity. Monoclonal antibodies which are the primary class of therapeutic antibodies, are large and complex molecules. Their manufacturing involves intricate processes due to the complicated nature of these molecules, presenting challenges distinct from small molecules, oral medicines, or vaccines. Therefore, low yields, protein misfolding, aggregation, post-translational modifications, immunogenicity, regulatory compliance, cost of goods, time-to-market, and process reproducibility are critical factors that can impact the efficiency, affordability, and accessibility of these therapies. Thus, market players also outsource manufacturing from service providers. This adds to the burden of costs incurred in manufacturing which creates a further challenge of manufacturing economically.

The regional analysis for the Antibody Therapeutics Market typically focuses on understanding the market dynamics, growth factors, regulatory environment, and competitive landscape across different geographical regions. Here’s a structured approach to analyzing this market regionally:

1. North America

• Market Size and Growth: North America, particularly the United States, dominates the market due to a strong biopharmaceutical industry and favorable regulatory environment.
• Key Players: Identify major pharmaceutical and biotech companies leading in antibody therapeutics.
• Regulatory Landscape: FDA regulations and approvals significantly impact market dynamics.
• Market Trends: Increasing investments in R&D, partnerships between academia and industry, and advancements in technology.

2. Europe

• Market Size and Growth: Major countries include Germany, UK, France, and Switzerland with significant investments in biotechnology and healthcare.
• Key Players: European companies contributing to the development and commercialization of antibody therapeutics.
• Regulatory Landscape: EMA (European Medicines Agency) regulations influence market entry and product approvals.
• Market Trends: Growing demand for personalized medicine, increasing prevalence of chronic diseases.

3. Asia-Pacific

• Market Size and Growth: Rapidly growing market due to increasing healthcare expenditure, expanding biopharmaceutical industry in countries like China, Japan, and India.
• Key Players: Local biotech companies and partnerships with global players.
• Regulatory Landscape: Diverse regulatory frameworks; harmonization efforts impacting market access.
• Market Trends: Rising investments in biotechnology, increasing clinical trials, adoption of novel therapies.

4. Latin America

• Market Size and Growth: Emerging market with increasing focus on healthcare infrastructure and biopharmaceutical investments.
• Key Players: Regional and global companies expanding their presence.
• Regulatory Landscape: Varied regulations impacting market entry and product approvals.
• Market Trends: Growth in chronic diseases, improving access to healthcare.

5. Middle East & Africa

• Market Size and Growth: Growing healthcare infrastructure and increasing investments in biotechnology.
• Key Players: Global companies expanding into the region, partnerships with local players.
• Regulatory Landscape: Developing regulatory frameworks affecting market growth.
• Market Trends: Rising prevalence of infectious diseases, increasing healthcare expenditure

The market for antibody therapeutics market is consolidated, with key players strategizing to capture the market. Prominent players in the antibody therapeutics market are F. Hoffmann-La Roche Ltd., AbbVie , Johnson & Johnson, Merck KGaA, Darmstadt, Germany, Bristol Myers Squibb, AstraZeneca , Sanofi , Regeneron Therapeutics INC , Novartis , Amgen, Biogen among others.

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