Bispecific Antibodies Market

Market Overview

The global bispecific antibodies market size was valued at USD 8.2 billion in 2023 and is projected to reach a value of USD 224.6 billion by 2032, registering a CAGR of 44.4% during the forecast period (2024-2032). The rise in cancer incidence is a crucial factor boosting the growth of the bispecific antibodies market.

Bispecific antibodies (BsAbs) are therapeutic proteins that attach to two distinct antigens or epitopes. Unlike standard monoclonal antibodies, which generally target a single antigen, bispecific antibodies have unique capabilities by engaging several targets, allowing for innovative therapeutic modes of action and improved efficacy in treating various disorders.

Several crucial reasons have contributed to bispecific antibodies' colossal market share growth. There is a growing need for novel therapeutic strategies due to the frequency of complicated diseases, especially cancer. Bispecific antibodies are potentially helpful to target cancer cells, strengthen the immune system, and improve therapy outcomes. Biotechnology and antibody engineering developments have made the creation of more effective and more robust bispecific antibodies possible. These advancements have increased the therapeutic potential of bispecific antibodies and made manufacturing easier. 

Highlights

• Immunoglobulin G contributes significantly to the market by drug type.
• Cancer influenced the market by indication.
• Hospital pharmacies dominate the market through distribution channels.

Market Dynamics

Global Bispecific Antibodies Market Drivers

Growing Prevalence of Cancer

The rising cancer incidence worldwide is a significant driver of the bispecific antibodies industry. Bispecific antibodies provide unique therapeutic options for cancer treatment by targeting tumor cells while activating the immune system to build an anti-tumor antitumor response. With the growing desire for more effective and tailored cancer therapies, the discovery and use of bispecific antibodies are increasing. Cancer is the major cause of morbidity and mortality worldwide. The World Health Organization (WHO) estimates that there will be 20 million new cancer diagnoses and 10 million cancer deaths in 2023. Over the next 20 years, the cancer burden is predicted to rise by around 60%, with low- and middle-income nations experiencing the highest increases. According to the American Cancer Society (ACS), the United States is expected to have 1,958,310 new cancer cases and 609,820 cancer deaths by 2023.

Furthermore, as of March 12, 2024, 11 bispecific antibodies (bsAbs) had been approved for cancer treatment and three for other applications. BsAbs are proteins that can target two separate antigens at the same time, allowing the immune system to identify and eliminate tumour cells. They can target tumour-associated antigens (TAAs) on cancer cells while activating immune cells and inhibiting signalling cascades.

Moreover, bispecific antibodies targeting other cancer antigens, such as HER2, EGFR, and PD-L1, are also being studied in clinical trials across various cancer types, including breast, lung, and colorectal cancer. These trials assess bispecific antibodies' safety, efficacy, and therapeutic potential as monotherapy or in combination with other treatments.

Global Bispecific Antibodies Market Restraints

Regulatory Hurdles

Before being approved, bispecific antibody treatments must meet severe regulatory requirements, notably regarding safety, efficacy, and manufacturing quality. Navigating the regulatory road for bispecific antibodies can be difficult due to the novelty of these compounds and the changing regulatory landscape.

Since 2014, the US Food and Drug Administration has authorized nine authorized antibody (BsAb) marketing applications for treating cancer, hematologic, and ophthalmic illnesses. In 2021, the FDA issued advice on BsAb development programs that include chemistry, manufacturing, controls (CMCs), and nonclinical and clinical development programs. The FDA and NMPA released recommendations on BsAbs in 2021 and 2022, which could aid policy regulation. Regulatory approval times for bispecific antibodies may differ based on the complexity of the chemical, clinical indication, and regulatory procedure. According to PMC - NCBI, the primary completion date for a bispecific antibody study that began in October 2021 is July 2024. In 2023, the FDA approved 12 novel antibodies, totalling 145 since 1986, or an average of 3.9 yearly approvals. 

Additionally, an examination of bispecific antibody approvals by the FDA and EMA demonstrates that regulatory agencies assess bispecific antibodies based on safety, effectiveness, pharmacokinetics, pharmacodynamics, and manufacturing quality. Bispecific antibody developers must provide full regulatory submissions to support marketing authorisation, including preclinical data, clinical trial results, chemistry, manufacturing, controls (CMC) information, and risk management plans. 

Global Bispecific Antibodies Market Opportunity

Expanding Therapeutic Applications

Bispecific antibodies can potentially cure diseases other than cancer, such as inflammatory disorders, autoimmune diseases, viral diseases, and neurological ailments. As disease biology advances and novel therapeutic targets emerge, there is a growing interest in investigating the therapeutic potential of bispecific antibodies across a wide range of illness indications. Biopharmaceutical companies are aggressively researching and developing to uncover novel targets and build bispecific antibody therapies customized to specialised disease pathways, creating market expansion and therapeutic innovation prospects.

Additionally, developing bispecific antibodies (BsAb) for treating B-cell and T-cell hematologic malignancies marks a significant step forward in disease management. The medicines have shown antitumor effectiveness as a monotherapy in strongly pretreated patients. However, further research is needed to discover the ideal environment, including their usage in combination therapy, approaches to reduce toxicity, and preventing the development of resistance mechanisms.

Furthermore, Xencor, Inc. (NASDAQ: XNCR) is a clinical-stage biopharmaceutical firm that develops tailored antibodies to treat cancer and other critical diseases. The company also disclosed promising preliminary results from its Phase 2 study of vudalimab monotherapy for patients with clinically defined high-risk metastatic castration-resistant prostate cancer (mCRPC).

Thus, as research continues to clarify the underlying processes of autoimmune illnesses and find new therapeutic targets, bispecific antibodies are positioned to play a critical role in offering targeted and customized treatments for autoimmune patients.

Regional Analysis

The global bispecific antibodies market analysis is conducted in 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 bispecific antibodies market shareholder and is estimated to grow at a CAGR of 43.9% over the forecast period. North America held the most important market share of 85% in 2023. The presence of multiple market participants and their diverse advances are essential drivers of the region's growth. Furthermore, technical improvements, significant R&D expenditure, and increased demand for bispecific antibodies contribute to the regional market's growth. 

Furthermore, rising regulatory approval for various bispecific antibodies has increased corporations' interest and confidence in investing in R&D. For example, in October 2022, the FDA authorized teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen. Furthermore, firms are increasingly collaborating and forming partnerships to use complementary skills and technology in developing bispecific antibodies. These collaborations have increased research and development activity, supporting overall market growth.

Additionally, the growing emphasis on personalized and targeted medicines is a crucial factor boosting the bispecific antibody market in North America. This individualized approach is essential for uncommon diseases, where typical medication may not be available or practical.

Europe is anticipated to exhibit a CAGR of 44.7% over the forecast period. The region has a favorable regulatory environment and an emphasis on precision medicine, which complements the unique characteristics of bispecific antibodies. Collaborations and partnerships between local and international players increase the region's growth. These characteristics present the region as a promising market with great development potential for bispecific antibodies.

The Asia-Pacific region has had extraordinary growth and holds great promise in the global market for bispecific antibodies. Nations such as China, Japan, and South Korea significantly contributed to research, development, and manufacturing. Asia Pacific's dominance in the market for bispecific antibodies was partly due to the region's thriving biotechnology industry, rising healthcare spending, and growing patient population.

Segmental Analysis

The global bispecific antibodies market is segmented based on drug type, indication, and distribution channel.

The market is further segmented by drug type into Immunoglobulin G and non-immunoglobulin G.

Immunoglobulin G holds the most significant market share. Immunoglobulin G (IgG) bispecific antibodies are intended to harness the immune system's natural effector activities, specifically antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). IgG-based bispecific antibodies typically have two antigen-binding domains produced from separate monoclonal antibodies joined within a single IgG scaffold. This format enables precise antigen targeting while taking advantage of IgG antibodies' favorable pharmacokinetic characteristics and effector activities. IgG bispecific antibodies have proven therapeutic potential in oncology, autoimmune illnesses, and infectious diseases, with higher potency and tissue penetration than non-IgG forms.

Non-Immunoglobulin G (Non-IgG) bispecific antibodies include many antibody forms and scaffolds beyond the standard IgG structure. These formats could consist of single-chain variable fragments (scFv), Fab fragments, nanobodies, or modified antibody fragments designed for specific therapeutic uses. Non-IgG bispecific antibodies have benefits such as smaller size, lower immunogenicity, and different binding modalities, making them ideal for targeting intracellular antigens, penetrating solid tumors, or influencing non-traditional immune pathways. Non-IgG bispecific antibodies are an emerging area of research and development, with potential applications in oncology, inflammatory illnesses, and neurodegenerative disorders, where traditional IgG-based therapy may be limited.

The market can be further bifurcated into Cancer and autoimmune Diseases by indication.

The cancer segment dominated the market, accounting for 75%. Cancer is the largest cause of death worldwide, having a significant frequency in many populations. According to a World Health Organization (WHO) report, cancer will cause roughly 609,360 deaths in the United States in 2022. The high cancer burden creates a desire for novel medicines, such as bispecific antibodies, which can target numerous tumor-associated antigens at the same time, increasing therapeutic efficacy. 

Currently, various therapeutic options are available to treat cancer-related disorders; nevertheless, certain forms of cancer continue to have restricted treatment options. Bispecific antibodies present a viable strategy for tackling this difficulty because they target multiple pathways or antigens implicated in cancer growth, potentially leading to better patient outcomes. Bispecific antibodies target cancer cells or tumor-associated antigens while preserving healthy cells. This high target specificity reduces off-target effects and toxicity compared to standard medicines, making bispecific antibodies a promising choice for cancer treatment.

The autoimmune disorders sector is predicted to increase at a considerable CAGR throughout the forecast period. In autoimmune disorders, bispecific antibodies seek to modify dysregulated immune responses and restore immunological tolerance to self-antigens. These antibodies could target specific cell types, cytokines, or signaling pathways implicated in autoimmune disease. Bispecific antibodies targeting B-cell surface markers and inhibitory receptors (e.g., CD19 and FcγRIIb) can reduce autoantibody synthesis and B-cell hyperactivity in illnesses like RA and SLE. Bispecific antibodies can treat autoimmune diseases and reduce inflammation by altering immune cell activities or cytokine signaling.

Based on distribution channels, the market is fragmented into Hospital Pharmacies, Retail Pharmacies, Drugstores, and Online Pharmacies.

Hospital pharmacies are an essential distribution channel for bispecific antibodies, particularly for inpatient treatments and specialized infusion regimens. Hospitals often stock a diverse spectrum of biologic medicines, including bispecific antibodies, to satisfy the needs of patients being treated for cancer, autoimmune disorders, and infectious infections. Hospital pharmacies ensure the safe storage, preparation, and delivery of bispecific antibodies by adhering to strict standards and guidelines that protect pharmaceutical integrity and patient safety.

Additionally, due to the high demand for these commodities in hospitals and clinics, the hospital pharmacies sector is expected to dominate the market throughout the forecast period. Retail pharmacies are expected to grow significantly during the predicted period as these drugs become more widely available through multiple channels. Online pharmacies have grown in popularity in recent years due to its accessibility and convenience for patients. Wholesalers and distributors are included in the other sector.

Retail pharmacies provide patients convenient access to prescription drugs, such as bispecific antibodies, for outpatient usage. Patients prescribed bispecific antibody treatments for chronic disorders or maintenance therapy can refill their prescriptions at retail pharmacies, where pharmacists can advise and help them with medication adherence, potential side effects, and drug interactions. Retail pharmacies can work with healthcare practitioners and specialty pharmacies to give prompt access to bispecific antibodies and coordinate care for patients on complex treatment regimens.

Recent Developments

• April 2024- Roche (SIX: RO, ROG; OTCQX: RHHBY) has approved Alecensa® (alectinib) for adjuvant treatment after tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors≥ 4 cm or node-positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor licensed for patients with ALK-positive early-stage NSCLC who have had surgery to remove their tumors.
• January 2024- Akeso, Inc. (9926. HK) ("Akeso," "we," or the "Company") announced today that it has presented promising phase II results for cadonilimab (a tetravalent PD-1/CTLA-4 bispecific antibody) and Lenvatinib (Len) combined with TACE for the treatment of mid- and advanced-stage hepatocellular carcinoma (HCC). Based on the encouraging results, the business intends to pursue this combination therapy for mid- and advanced-stage HCC.
• April 2024- Janssen-Cilag International NV, a Johnson & Johnson firm, stated that the European Commission (EC) accepted a Type II variation for CARVYKTI®. (ciltacabtagene autoleucel; cilta-cel). This latest approval is for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have disease progression on the most recent treatment, and are resistant to lenalidomide.