Antibody Production Market

Market Overview

The global antibody production market size was valued at USD 16.8 billion in 2023 and is projected to reach USD 54.4 billion by 2032, registering a CAGR of 12.5% during the forecast period (2024-2032). The market has witnessed rapid growth because of the rising incidence of chronic diseases like cancer, diabetes, and cardiovascular diseases, as well as the increasing demand for therapeutic antibodies.

The antibody production market encompasses the whole business ecosystem involved in developing, developing, manufacturing, and distributing antibodies for various purposes, such as research, diagnostics, and therapies. The immune system generates Antibodies, specialized proteins, as a reaction to particular antigens. They are vital in immunological defense, detecting diseases, and administering targeted treatments. Technologies and items that are connected or associated.

Additionally, the primary drivers of the antibody production market's expansion are the growing acceptance of targeted immunotherapy, the escalation in research and development investment by pharmaceutical and biotechnology firms, and the increasing need for therapeutic antibodies.

Highlights

• Consumables generate the highest revenue share based on product type.
• Downstream processing accounts for the largest market share by process.
• Monoclonal antibody generates the highest revenue share based on type.
• Pharmaceutical and biotechnology companies account for the largest market share by end-use.

Market Dynamics

Global Antibody Production Market Drivers

Growing Approvals for Monoclonal Antibodies

The growing number of FDA approvals for monoclonal antibodies is anticipated to provide a profitable opportunity for market expansion during the projected timeframe. In May 2023, the FDA approved EPKINLYTM for treating diffuse large B-cell lymphoma in adult patients. In 2023, the FDA approved 55 new molecular entities (NMEs). These included 38 small-molecule drugs, which encompass peptide- and oligonucleotide-based molecules, as well as five non-antibody biologics and 12 antibody-based biologics (i.e., biologics containing one or more antibody domains).

Additionally, the increasing prevalence of both communicable and non-communicable diseases necessitates regulatory agencies such as the FDA to expedite the approval process for monoclonal antibodies, which can be utilized for research and development. Therefore, the increasing acceptance of monoclonal antibodies is expected to drive the market's growth.

Increasing Investment 

The market expansion is anticipated to be driven by a rise in investment towards research and development of monoclonal antibodies, particularly in cancer treatment, which constitutes about 50% of all research and development programs associated with monoclonal antibodies. The focused strategy of monoclonal antibodies (mAbs) has transformed the field of cancer therapy by minimizing adverse reactions and enhancing patient results. However, continuous research and development are essential to strengthen the effectiveness of monoclonal antibodies (mAb) in cancer treatment. 

In June 2021, the European Commission granted Bristol Myers Squibb's combination therapy of Yervoy and OPDIVO to treat malignant pleural mesothelioma, marking a landmark achievement in mAb therapies. This approval underscores the potential of monoclonal antibodies (mAbs) in treating intricate and severe diseases and emphasizes the necessity for ongoing investment in the research and development of mAb therapies.

Global Antibody Production Market Restraints

Complexity and High Cost of Production

Isolating antibodies from intricate mixtures might present difficulties and consume a significant amount of time. The necessity for high levels of purity and the removal of contaminants might result in labor-intensive and expensive procedures. Moreover, the generation of antibodies, particularly for therapeutic applications, can incur high costs due to the requirement for specialized apparatus, cell culture conditions, and purification techniques. 

Despite the potential of mAb treatments in treating various diseases, their availability to a broader group of patients still needs to be expanded due to several obstacles. A significant obstacle is that the existing techniques for producing large quantities of clinical-grade monoclonal antibodies (mAbs) are laborious and expensive. Due to their vast size, chemical synthesis methods are not feasible for producing monoclonal antibodies (mAbs). Lower organism expression platforms are unsuited for commercial mAb production since they cannot provide the necessary glycosylation and folding.

Moreover, the expenses linked to the production of a significant quantity of antibody-based medicines can affect the availability of these treatments. Therefore, this is anticipated to significantly impede the market's expansion during the projected timeframe.

Global Antibody Production Market Opportunity

Rise in Chronic Disease 

The market growth is predicted to be driven by the increasing prevalence of chronic diseases and the growing aging population. According to PAHO, it is anticipated that there will be 20 million new cases of cancer worldwide.  Over the next two decades, the incidence of cancer is projected to increase by almost 60%, which will impose further pressure on healthcare systems, individuals, and communities. It is projected that by 2040, the global incidence of cancer will increase by around 30 million cases. 

According to the US Department of Health and Human Services, around 129 million individuals in the United States are affected by at least one significant chronic illness, such as heart disease, cancer, diabetes, obesity, or hypertension. Five out of the top 10 primary causes of mortality in the United States are either preventable or closely linked to preventable and manageable chronic illnesses. Prevalence has risen consistently over the last 20 years, and this pattern is projected to persist (4). A growing percentage of individuals in the United States are grappling with numerous chronic ailments; 42% own two or more, while 12% suffer from a minimum of five. 

In addition to its consequences, chronic illness exerts a significant influence on the healthcare system of the United States. Approximately 90% of the yearly USD 4.1 trillion healthcare expenditure is allocated to the management and treatment of chronic diseases and mental health disorders. The increasing prevalence of diseases would compel the industry to enhance its production capacity and research efforts for innovation and progress. Hence, the facts above contribute to the expansion of the market over the projected timeframe.

Regional Analysis

The global antibody production market analysis is conducted across North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global antibody production market shareholder and is estimated to grow at a CAGR of 12.3% over the forecast period. The high frequency of cancer in North America, along with the strong presence of favorable healthcare infrastructure, innovations, and product launches by market players, is projected to contribute to the region's considerable share of antibody manufacturing. The region's success can be ascribed to the significant presence of large biotechnology and pharmaceutical businesses, including Pfizer, Merck, Sanofi, and others. These firms are actively researching and manufacturing monoclonal antibodies for various purposes such as cancer treatment, autoimmune illnesses, infectious diseases, and more.

Addityionally, in August 2023, Pfizer Inc. announced that the US Food and Drug Administration (FDA) granted accelerated clearance to ELREXFIOTM (elranatamab-bcmm) for treating adult patients with relapsed or refractory multiple myeloma. The inclination to embrace cutting-edge technologies in the biotechnology industry additionally fosters the expansion of the market in North America. Hence, the anticipated market expansion is attributed to the escalating investment in corporate research and development and the growing number of FDA approvals.

Europe is anticipated to exhibit a CAGR of 12.6% over the forecast period. The regional market is primarily driven by the need for antibodies in diagnostics, pharmaceuticals, and research applications, fueled by advancements in biotechnology and immunology research. Furthermore, the increasing occurrence of chronic and infectious diseases requires the creation of innovative antibody-based therapies.

Moreover, the partnerships formed between academic institutions, pharmaceutical businesses, and research organizations play a crucial role in fostering innovation and advancing regional product development. The market expansion is further stimulated by regulatory initiatives that aim to promote the use of antibodies in personalized medicine and precision therapies. In summary, these various elements come together to form a constantly evolving and growing European antibody production industry.

Asia-Pacific is projected to expand with the fastest CAGR due to the unexplored prospects in this area. The market is expanding due to a rise in investment in research and development activities, an increased demand for pharmaceuticals and diagnostics, and a growing aging population. Furthermore, the increasing incidence of chronic illnesses such as autoimmune disorders, cancer, and infectious diseases is fueling the need for antibody-based treatments and diagnostics.

Segmental Analysis

The global antibody production market is segmented based on product, process, type, and end-use. 

Based on the product, the market is segmented into Instruments, Consumables, and Software.

The consumables segment dominated the market in 2023. Consumables encompass various goods, including reagents, kits, media, buffers, and other materials utilized to manufacture antibodies. The growing need for antibodies in research, diagnostics, and therapies has increased the need for consumable products. Furthermore, the rising utilization of automated methods for antibody production has also played a role in expanding the consumables category.

The instruments segment is the fastest growing. Antibody manufacture relies heavily on various instruments, including bioreactors, centrifuges, chromatography systems, and other devices crucial for production. Evonik introduced a novel peptide called cQrex AC in June 2022. This peptide offers a highly soluble and chemically defined form of L-cystine, an essential amino acid that can be efficiently supplied to cells. Therefore, this product provides a sufficient quantity of L-cystine, which is crucial for multiple biological processes in the body and enhances the synthesis of antibodies in cell cultures.

Based on the process, the market is segmented into Upstream and Downstream Processing.

The downstream segment dominated the market in 2023. The procedure guarantees the quality, safety, effectiveness, purity, and identification of antibodies. Furthermore, a range of technical developments bolster the efficiency of the downstream process, hence stimulating innovations in bio-manufacturing. Recent processing developments encompass disposable sensors, membrane chromatography technologies, remote monitoring, and data analytics. In March 2019, GE Healthcare and Amgen partnered to create a collaborative program for exchanging digital data. The goal of this program is to gain a better understanding of how advancements in the bio-manufacturing process affect the variability of different raw materials.

The upstream process segment is the fastest growing. This can be ascribed to several firms' multiple developments and investments in their production infrastructure. Leading manufacturers are employing state-of-the-art bioreactors in the initial stages of production to ensure a higher final product standard. Cytiva, a subsidiary of Danaher, introduced the X-platform single-use bioreactors on April 18, 2023. The new platform is precisely engineered to enhance operational efficiency in the initial stages of bioprocessing activities. The X-platform can manufacture cell and gene treatments, protein-based pharmaceuticals such as monoclonal antibodies, and viral vectors.

Based on the type, the market is segmented into Monoclonal Antibodies and Polyclonal Antibodies.

The monoclonal antibody segment dominated in 2023. The segment's rise is attributed to the rising investments in monoclonal antibody research and the introduction of innovative antibody-based products. In March 2023, Eli Lilly, a pharmaceutical firm in the United States, invested approximately USD 1 billion in a manufacturing unit in Ireland specifically to generate monoclonal antibodies (mAbs). The plant is expected to begin producing new clinical products by 2026.

The polyclonal antibody segment is the fastest growing due to its advantages, such as streamlined production, affordability, and the rising demand for diagnostic tests for prevalent diseases. Moreover, the advancement of novel technologies and methodologies, such as recombinant DNA technology and transgenic animal models, is anticipated to enhance the expansion of this particular sector, which is significantly focused on polyclonal antibody production. Additionally, the synthesis of polyclonal antibodies is faster and more cost-efficient than monoclonal antibodies, as it does not entail the intricate cell culture and screening procedures required for monoclonal antibody production.

Based on the end-user, the market is segmented into Research Laboratories, Pharmaceutical and Biotechnology Companies, and CROs and CDMOs.

The pharmaceutical and biotechnology companies dominated the market in 2023. The expanding use of antibodies in biopharmaceutical companies' production processes is an essential driver of the segment's growth. Pharmaceutical and biotechnology businesses have been driving the market, with many top companies investing substantially in research and development endeavors. These companies possess significant financial resources and state-of-the-art technologies, enabling them to create groundbreaking products that cater to the changing requirements of healthcare practitioners and patients. Roche, a Swiss multinational healthcare corporation, is a prominent market player with diverse antibody-based pharmaceuticals. The company's products diagnose and manage many ailments, including cancer, autoimmune disorders, and infectious infections.

The CROs and CDMOs segment is the fastest growing. The main reason is the growing need for pharmaceutical and biotechnology businesses to outsource services. These organizations aim to lower operational expenses and concentrate on their key strengths. Moreover, the COVID-19 pandemic has escalated the need for outsourcing services from CMOs and CROs, as numerous companies are urgently striving to expedite the production and development of antibody-based therapies and vaccines for the disease.

Recent Developments

• March 2024- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that QIAstat-Dx Analyzer 2.0, together with the Software 1.6 upgrade, is a notable improvement to the popular QIAstat-Dx Analyzer 1.0. It offers a dependable, rapid, and economical method for diagnosing intricate disorders.
• January 2024– QIAGEN received clearance from the FDA for the NeuMoDx CT/NG Assay 2.0. This certification allows QIAGEN to expand its test menu for the NeuMoDx 96 and 288 systems used for clinical molecular testing in the United States.