Global In Vitro Monoclonal Antibodies Market - 2024-2031

Overview

The global in vitro monoclonal antibodies market reached US$ 5.41 billion in 2023 and is expected to reach US$ 8.4 billion by 2031, growing at a CAGR of 5.7% during the forecast period 2024-2031.

Monoclonal antibodies (mAbs) are laboratory-engineered proteins that mimic the immune system's ability to neutralize harmful microbes including viruses and cancer cells. They are produced by cloning a single white blood cell, yielding identical antibodies that target a specific epitope on an antigen. Monoclonal antibodies have numerous and significant applications in both diagnostic and therapeutic fields. In medicine, they are commonly used to diagnose and treat a variety of diseases, including cancer, autoimmune disorders, and infectious infections.

The global in vitro monoclonal antibodies market is driven by the increasing prevalence of chronic diseases. For instance, according to the Pan American Health Organization, globally, there were an expected 20 million new cancer diagnoses and 10 million cancer deaths. Over the next two decades, the cancer burden will rise by almost 60%, putting a further burden on healthcare systems, individuals, and communities.

Market Dynamics: Drivers & Restraints

Increasing prevalence of chronic diseases

The increasing prevalence of chronic diseases is expected to be a significant factor in the growth of the global in vitro monoclonal antibodies market. Due to the increasing prevalence of various chronic diseases such as cancer, autoimmune diseases, chronic eye diseases, bone-related diseases, and inflammatory diseases, the demand for their treatment by using various monoclonal antibodies for various treatments increases which drives the monoclonal antibodies market.

For instance, according to the National Institute of Health, in 2023, the United States is expected to see 1,958,310 new cancer cases and 609,820 cancer deaths. Prostate cancer incidence climbed by 3% every year from 2014 to 2019, after two decades of reduction, resulting in an additional 99,000 new cases. The annual cancer incidence rate is 440.5 per 100,000 men and women (based on cases from 2017 to 2021). The cancer death rate (cancer mortality) is 146.0 per 100,000 men and women annually (based on deaths from 2018-2022). In 2024, a projected 14,910 children and adolescents between the ages of 0 and 19 will be diagnosed with cancer, with 1,590 deaths from the condition.

High costs of development and treatment

Factors such as high costs of development and treatment are expected to hamper the global in vitro monoclonal antibodies market. For instance, according to the National Institute of Health, The average annual price of a mAb was $96,731, more than $100,000 for 34 mAb-indication combinations. Oncology and hematology mAbs accounted for 40% of all mAb-indication combinations approved, but more than 85% of those priced at $100,000 or above. The annual cost of mAb treatments in cancer and hematology is approximately $100,000 greater than in other disease conditions. Thus owing to the above factors, the market is expected to restrain over the forecast period.

Segment Analysis

The global in vitro monoclonal antibodies market is segmented based on MAB functionality, MAB structure, technology, application, end-user, and region

Technology:

Hybridoma technology segment is expected to dominate the in vitro monoclonal antibodies market share

The hybridoma technology segment is expected to dominate the global in vitro monoclonal antibodies market share due to its proven efficacy, dependability, and high specificity of the monoclonal antibodies (mAbs) produced. This approach combines antibody-producing B lymphocytes from immunized animals with immortal myeloma cells, creating hybrid cells that may reproduce indefinitely while producing huge amounts of a specific antibody. One of the most significant advantages of hybridoma technology is its ability to produce very pure and constant mAbs.

For instance, more than 90% of all therapeutic mAbs approved by the FDA today are produced from hybridoma technology, demonstrating its dominance in the area.

Single B-cell antibody technology segment is the fastest growing segment in the in vitro monoclonal antibodies market share.

Single B-cell antibody technology segment is the fastest growing segment in the global in vitro monoclonal antibodies market. This novel strategy has gained popularity because of its capacity to quickly identify and manufacture highly specific antibodies from individual B cells, which is critical for developing targeted therapeutics for a variety of diseases, including cancer and autoimmune disorders. It enables researchers to isolate and analyse antibodies directly from an individual's immunological repertoire, resulting in the discovery of unusual and high-affinity antibodies that would not be easily accessible using standard approaches.

Application:

Oncology segment is expected to dominate the global in vitro monoclonal antibodies market share

The oncology segment is expected to hold the dominant position in the global in vitro monoclonal antibodies market share. This is due to the increasing incidence of cancer, the increasing number of approvals, and extensive research work on cancer treatment using MABs. The high prevalence of cancer increases the demand for the treatment and makes oncology the dominating segment.

For instance, in May 2024, The FDA has approved Trastuzumab Deruxtecan for any HER2-positive solid cancer. T-DXd is the first cancer therapy (antibody-drug conjugate) to be approved for "tumor agnostic" use. T-DXd is already licensed to treat a variety of malignancies, including breast and stomach.

Autoimmune diseases are the fastest growing segment in the global in vitro monoclonal antibodies market share

The rapid growth of the autoimmune diseases segment in the global in vitro monoclonal antibodies market can be attributed to the increasing prevalence of autoimmune diseases and recent breakthroughs in biotechnology have resulted in the development of highly targeted mAb treatments capable of modulating immune responses. These medicines provide a more specific approach to treatment, which improves patient results while minimizing side effects.

For instance, in June 2024, Johnson & Johnson announced that it had submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for approval of TREMFYA (guselkumab) for the treatment of individuals with moderately to severely active Crohn's disease. TREMFYA is the first approved fully human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells that makes IL-23.5 IL-23, a cytokine released by activated monocytes/macrophages and dendritic cells, is recognized to be a driver of immune-mediated conditions.

Geographical Analysis

North America is expected to hold a significant position in the global in vitro monoclonal antibodies market share

North America is expected to hold a significant position in the market share during the forecast period. The rising incidence of chronic diseases, and recent launches, in this region, help to propel the market. So, as the prevalence of chronic diseases increases, the demand for the treatment of chronic diseases by monoclonal antibodies gradually gets upsurged which drives the global in vitro monoclonal antibodies market.

For instance, according to an article published by the National Institute of Health, in 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the United States. Cancer mortality continued to decline through 2021, averting over 4 million deaths since 1991 because of reductions in smoking, earlier detection for some cancers, and improved treatment options in both adjuvant and metastatic settings. However, these gains are threatened by increasing incidence for 6 of the top 10 cancers.

Moreover, according to the National Health Council, Autoimmune conditions affect more than 50 million Americans. Furthermore, autoimmunity has reached pandemic proportions, with some studies suggesting an annual increase of 3-12%. Over the last 30 years, the prevalence of celiac disease in the United States has increased fivefold, roughly doubling every 15 years.

Asia Pacific is growing at the fastest pace in the global in vitro monoclonal antibodies market

Asia Pacific is experiencing the fastest growth in the global in vitro monoclonal antibodies market. The rapid expansion of the ADHD market in the Asia Pacific is being driven by the rising incidence of chronic diseases, increasing healthcare access, increased investments in the research and development of in vitro monoclonal antibodies, and recent launches.

For instance, according to the National Institute of Health, the expected number of cancer cases in India for 2022 is 14,61,427 (crude rate: 100.4 per 100,000). In India, one out of every nine people is likely to develop cancer over his or her lifetime. Males and females were most likely to develop lung and breast cancer, respectively.

Competitive Landscape

The major global players in the global in vitro monoclonal antibodies market include Amgen Inc., Biogen, Bristol-Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, GlaxoSmithKline plc, Novartis AG, Pfizer Inc., Sanofi, Merck & Co., Inc. among others.

Emerging Players

Zenas BioPharma, Inc., Aulos Bioscience, and Alentis Therapeutics AG among others.

Key Developments

• In January 2023, Amgen announced that AMJEVITA(TM) (adalimumab-atto), a biosimilar to Humira(R)* (adalimumab), is now available in the United States. The US Food and Drug Administration (FDA) authorized AMJEVITA as the first Humira biosimilar. AMJEVITA is a biosimilar of Humira(R)* (adalimumab), an anti-TNF-a monoclonal antibody. AMJEVITA contains an anti-TNF-a monoclonal antibody, which shares the same amino acid sequence as Humira.
• In April 2024, Pfizer Inc. and Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of recurrent or metastatic cervical cancer with disease progression during or after chemotherapy. TIVDAK (tisotumab vedotin-tftv) is an antibody-drug conjugate (ADC) made up of Genmab's human monoclonal antibody directed to tissue factor (TF) and Pfizer's ADC technology, which uses a protease-cleavable linker to covalently attach the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.

Why Purchase the Report?

• To visualize the global in vitro monoclonal antibodies market segmentation based on MAB functionality, MAB structure, technology, application, end-user, and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of global in vitro monoclonal antibodies market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global in vitro monoclonal antibodies market report would provide approximately 53 tables, 47 figures, and 176 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies