| Study Period | 2019 - 2030 |
| 2024 Market Size | USD 2,686.2 Million |
| 2025 Market Size | USD 2,875.8 Million |
| 2030 Forecast | USD 4,139.1 Million |
| Growth Rate (CAGR) | 7.6% |
| Largest Region | North America |
| Fastest Growing Region | Asia-Pacific |
| Nature of the Market | Consolidated |
| Largest Therapeutic Area Category | Oncology |
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The global next-generation antibody therapeutics market stood at USD 2,686.2 million in 2024 and is expected to reach USD 4,139.1 million by 2030, advancing at a CAGR of 7.6% during 2025–2030. This will predominantly be due to advancements in monoclonal antibody technology, which displays high safety and efficacy.
The promulgating investments in the healthcare sector are set to expand the market size in the upcoming period as well. This will mainly be due to the high success rate of antibodies in treating various chronic diseases, such as autoimmune diseases and cancer. Apart from mAbs, antibody-drug conjugates (ADCs) are being developed to combat the surge in the incidence of chronic diseases. The increase in government grants further encourages the prominent players to increase their R&D activities, which would yield higher revenue in the industry once the candidates have been approved for marketing.
Furthermore, the advancements in the biopharmaceutical field are leading to a high demand for antibodies for the treatment of infectious diseases, neurological disorders, and cancer. Biopharmaceuticals are extremely useful for the management of various neurodegenerative disorders, as these conditions require the drugs to be administered directly into the brain, which is not possible with traditional medications.
The advancements in glycoengineered antibodies, ADCs, and bispecific antibodies have led to the development of antibody therapeutics with improved characteristics.
The ADC technology is gaining traction in the next-generation antibody therapeutics market, as the cytotoxic nature of antibodies is considered to have a potential benefit in chemotherapy. This property is expressed and its efficacy and specificity are regulated by these conjugates. Owing to the high efficiency delivered by ADCs, pharmaceutical and biotechnology companies across the world are increasingly focusing on their development.
Cancer is one of the major application areas of ADC-based next-generation antibody therapeutics. Several pharma companies, including Seagen Inc. and F. Hoffmann-La Roche Ltd., are engaged in the development of next-generation antibody therapeutics that are based on this technology. The surge in the demand for antibodies due to the continuous increase in chronic disease incidence has led to the rapid approval of ADCs by the FDA.
MediLink Therapeutics, in 2024, presented preliminary information on its ADC YL202/BNT326, which it co-developed with BioNTech. This ADC targets HER3, works as an agonist to topoisomerase 1, and blocks DNA duplication, thus boosting cell apoptosis. Advanced NSCLC, along with breast cancer, was the focus of the Phase I study. Early responses were encouraging: one patient had a complete response, 16 showed improvement, and 26 remained stable. The drug was reported to be safe and efficient with a few mild side-effects, including nausea, amenia, low blood cell counts, and fatigue.
The ADC technology is being advanced by adjusting payload and improving linker stability. For example, AstraZeneca’s Enhertu displays an improved hydrophobic linker system and high drug–antibody ratios, which enhance the outcome of therapy.
Government initiatives play a critical role in enabling research on next-generation antibody therapeutics. The National Institutes of Health (NIH) and the U.S. Department of Defense aid research in oncology, novel antibodies, autoimmune diseases, and infectious diseases. Collaborations between governments and the academia facilitate R&D through the creation of public–private alliances and provide access to advanced technologies, such as artificial intelligence and high-throughput screening.
Regulatory authorities, for instance, the FDA and EMA, have made the approval process for biologics and small-molecule drugs smoother by announcing the Fast-Track, Breakthrough Therapy, and Orphan Drug designations. For instance, this year, the FDA awarded the Fast-Track and Orphan Drug designations to the novel NECTIN-4–targeted ADC 9MW2821 for the treatment metastatic and recurrent esophageal cancer.
Moreover, governments in numerous countries promote innovation through tax credits, favorable policies, grants, and support for clinical trials, lessening the financial burden on biotech and biopharma firms. International partnerships, such as Global Health Innovative Technology Fund, Cancer Research UK, and the Leukemia & Lymphoma Society, aid in R&D for next-generation antibodies.
Although next-generation antibody therapeutics have significant capabilities, their high production cost poses challenges. This is because complex manufacturing procedures, advanced technology, and prolonged clinical trials are required to market novel treatments, including mAbs and ADCs. All these associated expenses are likely to limit the accessibility and adoption of these therapies in low- and medium-income countries, which suffer from low incomes and a scarcity of advanced health resources. Healthcare providers and patients are also reluctant to adopt these therapeutics owing to their high prices. Additionally, startups and small enterprises face financial burdens, which can considerably hamper innovation.
The oncology category accounts for the largest revenue share, of approximately 90%, in 2024, and it is expected to showcase the highest CAGR, of around 8%, in the forecast period. This is because of the rising incidence of breast cancer, colorectal cancer, prostate cancer, brain cancer, and lung cancer, where antibody therapeutics offer benefits throughout the therapies.
These treatments provide enhanced efficiency by targeting cancer cells and ensuring optimal damage is caused to healthy tissues, resulting in better results and fewer side-effects. In addition, the availability of various next-generation antibody therapeutics, such as Kadcyla, ADCETRIS, and Poteligeo, for the treatment of cancers including breast cancer, lymphoma, and melanoma has intensified the domain revenue.
The therapeutic areas analyzed here are:
The ADC category dominates the market in 2024, and the same category is set to register the highest CAGR, of around 10%, in the forecast period. The category growth is mainly due to the high demand for antibody-based cancer therapy, coupled with the rising incidence of breast cancer, technological advancements, and a rapid increase in the number of these conjugates under clinical trials.
Additionally, the adoption of the cleavable linker technology is expected to provide significant growth opportunities to the eponymous category, due to its high stability in the bloodstream for a prolonged duration and effective release of cytotoxins from ADCs at the targeted tumor site. In developing countries, such as China, the technology is extensively being used for the treatment of relapsing systemic anaplastic large-cell lymphoma and relapsing Hodgkin's lymphoma.
Several key players, such as Janssen Pharmaceutical Companies, ADC Therapeutics, Seagen Inc., and AstraZeneca plc, are actively involved in collaborations, to enhance their revenue and customer base. For instance, in April 2024, the therapeutic research branch of Caris Life Sciences, Caris Discovery signed an agreement with Merck KGaA to facilitate the detection and development of ADCs against cancer. Under this agreement, USD 1.4 billion has been allocated for research funding and an international license to Merck to manufacture ADC therapies and provide an orthogonal multi-omics approach to eliminate tumors.
Furthermore, the increase in pharma funding by both private as well as public organizations, for the production of novel ADCs, is expected to drive the next-generation antibody therapeutics market growth in the forecast period. In recent years, there has been a swift increase in the incidence of multiple myeloma all over the world, which is driving the demand for ADCs. Additionally, the several initiatives taken by federal agencies in support of these therapeutic candidates are expected to boost the revenue for pharma and biopharma firms.
The technologies analyzed here are:
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North America dominates the market in 2024 with a value of around USD 1.1 billion, primarily ascribed to the surge in the funds for R&D by government as well as non-government organizations. In addition, the escalation in the prevalence of chronic diseases in the region is driving the sector size. In the region, the U.S., followed by Canada, is expected to dominate the regional market during the forecast period, propelled by the increasing per capita healthcare expenditure.
Furthermore, the presence of prominent key players in the region, the surge in the approval of next-generation antibody therapeutics, and the existence of well-established research facilities drive the market growth.
APAC is set to register the highest CAGR, of around 9%, in the forecast period, primarily attributed to the rising number of strategic partnerships among the prominent players in the region. In addition, the accelerating R&D activities in the field of next-generation antibodies in China, India, and Japan are driving the regional sector development. Furthermore, the increase in government support for drug R&D and for establishing pharma manufacturing facilities in the region are snowballing the market growth.
Europe is another significant market, driven by the increasing investments in biotechnology in the region. This has led to the high acceptance of next-generation antibody therapeutics for chronic inflammatory and autoimmune diseases. In addition, the rising number of drug approvals in the region intensifies the sector development. Moreover, in the European market, the oncology category held the largest share in 2021, owing to the extensive product innovations, which have raised their utility for treating a diversity of malignant tumors.
The geographical breakdown of the market is as follows:
The next-generation antibody therapeutics market is consolidated, owing to the presence of large corporations, biotech firms, and research institutions. Major companies, such as F. Hoffmann-La Roche, AstraZeneca plc, and ImmunoGen Inc., lead the market with cutting-edge ADCs and mAbs targeting oncological and autoimmune diseases. The ongoing technological innovations and research accelerate the creation of new therapeutic targets. The collaborations and mergers between biotech firms and pharma companies further lead to market consolidation and the expansion of offerings. This diverse landscape makes the market competitive and brings significant prospects that drive the market.
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