Bi-Specific MAbS Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Bi-Specific MAbS Market is segmented By Type (Catumaxomab, Blinatumomab, Duligotumab, Others), By End User ( Research Institutes, Hospitals, Others), By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Market Size

The Bi-Specific MAbS Market size was valued at US$ YY billion in 2022 and is estimated to reach US$ YY billion by 2031, growing at a high CAGR during the forecast period (2024-2031). 

Bispecific monoclonal antibodies are artificial proteins that have promising applications in the field of immunotherapy of cancer. They contain two monoclonal antibodies held together by a flexible peptide linker. This helps them to bind to two different antigens.

Market Scope

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Market Dynamics

The increasing prevalence of cancer will drive the market

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. According to estimates from the International Agency for Research on Cancer (IARC), in 2018, there were 17.0 million new cancer cases and 9.5 million cancer deaths worldwide.

Developing improved treatment strategies for cancer is a challenging task wherein the balance between increasing clinical efficacy without increasing systemic toxicity determines the success of the drug. mAbs have become an important class of protein-based drugs (> 20 mAbs have been approved by the FDA) for the treatment of cancer and other diseases

Bispecific antibodies act as a bridge between cancer cells and cytotoxic T lymphocytes. They bind CD3 antigens on CTLs and a specific antigen on cancer cells (e.g., CD19), which activates the T cells and promotes the lysis of cancer cells. Some bispecific antibodies, such as bispecific T cell engagers, or BiTEs, target both cancer and immune cells known as T cells. The  BiTEs work to bring T cells into proximity and enable them to eliminate cancer cells. These BiTEs are considered "active" immunotherapies because of their ability to target immune cells directly.

Increasing technological advancements will drive the market of bi-specific monoclonal antibodies

Bispecific antibodies with defined dual-specificity suitable for therapeutic use must be generated through biochemical or genetic means. Bispecific IgG molecules can be produced by somatic hybridization of two antibody-secreting hybridoma cells. They also provide access to new modes of action that have not been possible with single antibodies.

Roche moved a step further and developed the next generation in bispecific antibody engineering: CrossMAb, is a technology that produces one bispecific molecule not ten, nor four, but just what the scientists need. They had to solve the problem of preventing the light antibody chains from binding to the heavy chains in ways they didn't want. Weigand described the above process as being similar to putting together LEGO™ blocks. By exchanging the molecular blocks between the heavy and light chains, each of the two different arms binds to a specific light chain. With this elegant engineering, Roche has developed a technology that can combine two antibodies and create the bispecific antibody they desire—with practically no side products.

Meanwhile, the first CrossMAb molecule, for ophthalmology, is about to enter phase 3 trials. If the treatment for macular edema proves to be significantly more effective than the current standard, it will be submitted to the FDA for approval. At Roche, the large molecule portfolio comprises approximately 80% complex molecules, including bispecific based on the CrossMAb technology.

The FDA has approved three bispecific antibodies, whereas over a hundred more are in development. The latest approval was for Janssen's Rybrevant (Amivantamab-vmjw), the first treatment for adult patients with non-small cell lung cancer, approved on 21 May. 

Availability of various alternative treatment methods for cancer will hamper the market

There are many procedures and drugs available to treat cancer, with many more being studied. Some of them are "local" treatments like surgery and radiation therapy, which treat a specific tumor or area of the body. Systemic treatments include drug treatments (such as chemotherapy, immunotherapy, or targeted therapy) because they can affect the entire body. The most common treatments for cancer are surgery, chemotherapy, radiation therapy, targeted therapy, immunotherapy, stem cell or bone marrow transplants, and hormone therapy. Alternative cancer treatment therapies and methods used for cancer treatment, including dietary treatments, acupuncture, homeopathy, and herbal remedies, are gaining popularity in recent years due to the side effects of chemotherapeutic anticancer agents.

According to Cancer Research U.K., 45% of patients undergo surgery to remove a tumor, 28% opt for chemotherapy and 27% opt for radiotherapy. The availability of different treatment methods and the majority of people opting for them will hamper the Bi-Specific MAbS Market

COVID-19 Impact Analysis

Neutralizing antibodies that target the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein are among the most promising approaches against COVID-19. bispecific IgG1-like molecule (CoV-X2) has been developed based on C121 and C135, two antibodies derived from donors who had recovered from COVID-19 two or more monoclonal antibodies are preferred over a single antibody, as these cocktails result in increased efficacy and the prevention of viral escape. However, this approach requires increased manufacturing costs and volumes, which are problematic when the supply chain is under pressure to meet the high demand for COVID-19 therapeutic agents, vaccines and biologics in general. Hence, there will be an impact on the manufacturing and supply of the Bi-Specific MAbS market due to COVID-19.

Bi-Specific MAbS Market Segmentation Analysis

Catumaxomab (Removab) will dominate the market

Catumaxomab is a monoclonal bispecific trifunctional antibody, which was approved by the European Union. The authorised marketing holder Fresenius Biotech GmbH developed catumaxomab (Removab®) and its partner TRiOn Pharma GmbH, Germany. It is the first substance used worldwide with a regulatory label for the treatment of malignant ascites due to epithelial carcinomas. Since the peritoneum is of mesothelial origin and lacks epCAM expression, the intraperitoneal administration of catumaxomab is an attractive targeted immunotherapeutic approach. Catumaxomab can destroy epCAM positive tumor cells in the peritoneal cavity, known as the leading cause of malignant ascites. In addition, it is a potential therapeutic option for several primary tumors since the epCAM molecule is expressed on most epithelial carcinomas.

The first bispecific antibody to win regulatory approval, Removab (catumaxomab), was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China's NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer.

Research Institutes will dominate the market growth in the forecast period

A bispecific antibody (BsAb) is an engineered antibody that targets two or more different epitopes simultaneously on the same or different antigens, with merits that the conventional monospecific antibody cannot achieve. Until now, three BsAb drugs (Catumaxomab, Blinatumomab and Emicizumab) have been approved by FDA, and more than 110 BsAb drugs are being developed around the world. Bispecific antibodies (bsAbs) are antibodies that bind two distinct epitopes to cancer. For use in oncology, one bsAb has been approved, and 57 bsAbs are in clinical trials, none of which has reached phase 3. The further research being conducted and developments will drive the growth of this segment in the Market

Bi-Specific MAbS Market Geographical Share

North America will dominate the market

North America region will dominate the Bi-Specific MAbS market mainly due to the growing prevalence of cancer incidence. According to the American Cancer Society, in 2021, 1,898,160 new cancer cases and 608,570 cancer deaths are projected in the United States. Moreover, the government initiatives will further fuel the bi-specific MAbs Market As of November 2019, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, crizanlizumab) had been granted the first approval in the U.S. On October 7, 2019, FDA approved brolucizumab-dbll (BEOVU®) for the treatment of neovascular age-related macular degeneration (nAMD).

Bi-Specific MAbS Market Key Players

 Some prominent key players in this market are Amgen, Inc., Bayer AG, Dow Pharmaceutical Solutions, ImmunGene, Inc., Immunocore Limited, Merck & Co., Inc., Novartis AG, Pfizer, Inc., F. Hoffmann-La Roche AG, Hengrui Medicine, SYSVAX and Hisun Pharmaceutical

Bi-Specific MAbS Market Key Companies to Watch

Amgen, Inc.

Overview: Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. The approach of the company begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Product Portfolio: The Company offers to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Key Development: Recently, Amgen announced the long-term efficacy of the company's bispecific antibody Blincyto (blinatumomab) in the treatment of patients with Catumaxomab (Removab) lymphoblastic leukemia (ALL) at the European Hematology Association (EHA) conference. The median overall survival (O.S.) of patients receiving Blincyto was 36.5 months at a median follow-up of 59.8 months.

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