PUBLISHER: Roots Analysis | PRODUCT CODE: 1319260
PUBLISHER: Roots Analysis | PRODUCT CODE: 1319260
The global antibody drug conjugate market is estimated to be worth USD 7.72 billion in 2023 and expected to grow at compounded annual growth rate (CAGR) of 9.63% during the forecast period.
Antibody drug conjugates are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Over the years, various technological advancements, such as antibody engineering for site-specific conjugation and enhanced pharmacokinetic and pharmacodynamic properties, have paved the way for antibody drug conjugates (ADCs) to be recognized as potent therapies targeting a wide range of indications, including solid tumors and hematological malignancies.
14 antibody-drug conjugates, till date, have been approved by the USFDA for therapeutic use; these are ado-trastuzumab emtansine (Kadcyla), brentuximab vedotin (Adcetris), inotuzumab ozogamicin (Besponsa), gemtuzumab ozogamicin (Mylotarg), polatuzumab vedotin-piiq (Polivy), enfortumab vedotin (Padcev), sacituzumab govitecan (Trodelvy), trastuzumab deruxtecan (Enhertu), belantamab mafodotin-blmf (Blenrep), mirvetuximab soravtansine (Elahere), tisotumab vedotin (Tivdak), cetuximab sarotalocan (Akalux), disitamab vedotin (Aidixi) and loncastuximab tesirine-lpyl (Zynlonta).
The success of ADC therapeutics can be attributed to their high tumor selectivity and cell-killing potential of these antibodies, while limiting off target toxicities. Ongoing research in this direction is driven by encouraging results achieved in past clinical trials, which were mostly focused on various solid tumors. Driven by the ongoing pace of innovation in this field, sufficient financial support from investors and encouraging clinical trial results, the antibody drug conjugate market is likely to witness significant growth during the forecast period.
The Antibody Drug Conjugate Market (7th Edition), 2023-2035: Distribution by Target Disease Indication (Breast Cancer, B-cell Lymphoma, Lung Cancer, Multiple Myeloma, Acute Lymphoblastic Leukemia, Gastric Cancer, Renal Cancer, Cervical Cancer and Other Target Disease Indications), Therapeutic Area (Hematological Cancer and Solid Tumor), Linker (Valine-Citrulline, Succinimidyl-4-(N-Maleimidomethyl) Cyclohexane-1-Carboxylate, Tetrapeptide-based Linker, Maleimide, Maleimidocaproyl, Valine-Alanine, Hydrazone (4-(4-Acetylphenoxy) Butanoic Acid (AcBut) and Other Linkers), Payload (Monomethyl Auristatin E, DM1, Duocarmycin, SN-38 / Irinotecan, Monomethyl Auristatin F, SG3199, Ozogamicin, DM4 and Other Payloads), Target Antigens (HER-2 (ERBB2), CD79b, Trop-2, BCMA (TNFRSF17 / BCM), CD19, CD22, Tissue Factor, CD30, CEACAM5, Nectin 4 and Others) And Key Geographical Regions (North America (US, Canada), Europe (Germany, UK, France, Italy, Spain), and Asia-Pacific (China, Australia, Japan)): Industry Trends and Global Forecasts market report features an extensive study of the current market landscape, market size and future opportunities for the antibody drug conjugate companies either developing the drugs or providing the necessary ADC technology, during the forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the antibody drug conjugate market are briefly discussed below.
Antibody drug conjugates landscape features the presence of over 140 very large, large, mid-sized and small drug developers. It is worth mentioning that, currently, more than 280 antibody drug conjugates are either approved or being evaluated in clinical trials, whereas 250 candidates are in preclinical stages of development. All the approved ADC therapeutics have been developed to target either solid tumor or hematological cancer. Majority of the pipeline antibody-drug conjugates are being developed for the treatment of cancer, particularly breast cancer.
ADC therapeutics offer a promising approach by targeting multiple disease pathways simultaneously. Kadcyla was the first HER2 ADC to be approved by FDA for the treatment of patients with breast cancer. Since then, two more ADC therapeutics, Daiichi Sankyo - AstraZeneca's Enhertu and Immunomedics' Trodelvy have received approval for the treatment of metastatic breast cancer as second-line treatment. Further, Daiichi Sankyo - AstraZeneca's Enhertu is expected to get EU approval for the treatment of non-small cell lung cancer in 2023. Presently, there are over 30 antibody drug conjugates that are under development for the treatment of breast cancer. According to the WHO statistics, breast cancer is the most prevalent cancer worldwide with an estimated 7.8 million women living with breast cancer at the end of 2020. In the same year, 2.3 million new cases of women diagnosed with breast cancer were reported.
In addition to breast cancer, the approved ADCs target indications, such as leukemia, lymphoma, urothelial cancer, multiple myeloma, cervical cancer, and ovarian cancer. The increasing prevalence of oncological disorders and a rich pipeline of ADC therapeutics targeting cancer is expected to drive the antibody drug conjugate market during the forecast period.
The global antibody drug conjugate market is estimated to be worth USD 7.72 billion in 2023. These represent the revenues generated by the sales of various ADC therapeutics. Driven by the growing demand for effective therapeutics for treatment of oncological disorders, along with growing developmental pipeline and encouraging clinical trial results, the antibody drug conjugates market is anticipated to grow at a CAGR of 9.63% during the forecast period.
Antibody drug conjugates have emerged as a viable and potent option to selectively eradicate the tumor population, with minimal side effects. Till date, several clinical trials have demonstrated the efficacy and therapeutic superiority (over conventional cancer treatment options) of antibody-drug conjugates. Therefore, the increasing prevalence of various oncological disorders is one of the key drivers for the antibody drug conjugate market.
Currently, more than 70 antibody drug conjugates are either approved or being evaluated in clinical trials targeting HER2 for the treatment of various oncological disorders, particularly breast cancer. Roche's Kadcyla was the first HER2 ADC to receive FDA approval in 2013, followed by Daiichi Sankyo / AstraZeneca's Enhertu in 2019. Another HER2 ADC, Aidixi, received conditional marketing approval from China's National Medical Products Administration for treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two types of systemic chemotherapy. The drug has been developed by China based RemeGen Biosciences. Seagen acquired exclusive worldwide license, outside of Greater China, for development and commercialization of Aidixi from RemeGen. The antibody drug conjugate market for HER2 ADC is anticipated to grow at a CAGR of 8.16% during the forecast period.
In the past few years, several well-funded start-ups / small companies, offering antibody drug conjugate having advanced linkers and more potent warheads have been established. Of these, majority of the companies are based in North America. Additionally, FDA has been actively reviewing and approving ADC therapeutics for cancer. The rising incidence of cancer in the US will drive the adoption of antibody drug conjugates. As per the American Cancer Society, over 1.9 million cancer patients were estimated to be diagnosed in the US in 2022.
The major risk factors for cancer include tobacco use, excess body weight, excess alcohol consumption, and infectious agents. All these factors will drive the market growth of the North American antibody drug conjugate market during the forecast period. In order to increase the adoption of antibody-drug conjugates among target population, ADC developers are offering several patient assistance / support programs which help the patient to deal with medical expenses. Examples of such programs include Ambrx patient assistance program, Bayer oncology patient assistance program and Genentech patient assistance program.
Antibody drug conjugates are a type of targeted cancer therapy that uses monoclonal antibodies to deliver a toxic payload to cancer cells. The most common cytotoxic payloads used in antibody drug conjugates are MMAE and DM4. The majority of ADCs use valine citrulline (VC) linkers or peptide linkers to attach the antibody to the toxic payload.
The development of novel ADC technologies, such as site-specific conjugation and novel linker technologies are expected to drive the antibody drug conjugate market growth in the coming years.
Over the years, companies involved in the development of antibody drug conjugates (ADCs) have made significant efforts to evaluate the efficacy of antibody drug conjugates in clinical studies, for the treatment of various cancers. Currently, 150 antibody drug conjugates are being evaluated in more than 550 trials across different geographical regions. Majority of these trials (385) were registered in North America. Within this region, the maximum number of trials were / are being conducted in the US (379). Additionally, till February 2023, majority of the patients (39,226) were enrolled in trials conducted in North America, accounting for about 45% of the overall enrollment.
Currently, several partnerships have been inked by various industry and non-industry players engaged in the development of antibody-drug conjugates. It is worth highlighting that over 50 partnerships were inked in 2022 alone. Majority of such deals are focused on product and technology licensing. Further, in one of the largest acquisitions in the biopharmaceutical industry, Pfizer acquired Seagen in March 2023 for a total enterprise value of approximately USD 43 billion, with an aim to accelerate cancer breakthroughs in this market. This deal intends to bring new solutions to patients by combining Seagen's ADC technology with Pfizer's global reach. In addition to this, monetary assistance from angel investors, venture capitalists, and funding schemes of various public and private organizations / funds, along with assistance from regulatory authorities, have allowed start-ups / small companies to progress their R&D efforts related to the development of novel ADC therapeutics.
Examples of the key antibody drug conjugate companies (the complete list of players is available in the full report) include ADC Therapeutics, Astellas Pharma, AstraZeneca, Byondis, Daiichi Sankyo, Genentech, Gilead Sciences, ImmunoGen, Pfizer, RemeGen. This market report includes an easily searchable excel database of all the antibody drug conjugate companies worldwide.
The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. Amongst other elements, the report includes:
One of the key objectives of this market report was to estimate the current market size and the future growth potential of antibody drug conjugates over the forecast period. Based on several parameters, such as target consumer segments, region-specific adoption rates, and expected prices of such products, we have developed informed estimates of the likely evolution of the ADC market over the forecast period 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as target disease indication (breast cancer, B-cell lymphoma, lung cancer, multiple myeloma, acute lymphoblastic leukemia, gastric cancer, renal cancer, cervical cancer and other target disease indications), therapeutic area (hematological cancer and solid tumors), linker (valine-citrulline, succinimidyl-4-(N-maleimidomethyl) cyclohexane-1-carboxylate, tetrapeptide-based linker, maleimide, maleimidocaproyl, valine-alanine, hydrazone (4-(4-acetylphenoxy) butanoic acid (AcBut) and other linkers), payload (monomethyl auristatin E, DM1, duocarmycin, SN-38 / irinotecan, monomethyl auristatin F, SG3199, ozogamicin, DM4 and other payloads), target antigens (HER-2 (ERBB2), CD79b, TROP-2, BCMA (TNFRSF17 / BCM), CD19, CD22, tissue factor, CD30, CEACAM5, nectin 4 and others) and key geographical regions (North America (US, Canada), Europe (Germany, UK, France, Italy, Spain), and Asia-Pacific (China, Australia, Japan)). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry's evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice, and other associations) to solicit their opinions on emerging trends in the market. This information is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Answer: Antibody drug conjugates are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the small molecule (cytotoxic) drugs. Antibody drug conjugates are designed to selectively deliver a potent cytotoxic drug to cancer cells and minimize the toxic side effects associated with traditional chemotherapy.
Answer: Currently 14 antibody-drug conjugates have been approved by various regulatory organizations for therapeutic use, across the globe, namely Kadcyla, Adcetris, Besponsa, Mylotarg, Polivy, Padcev, Trodelvy, Enhertu, Blenrep, Elahere, Tivdak, Akalux, Aidixi and Zynlonta.
Answer: Antibody drug conjugates (ADCs) are a class of cancer drugs that combine the targeting specificity of monoclonal antibodies with the cytotoxic potency of small-molecule drugs. ADCs bind to their target antigens such as HER-2 (ERBB2), Trop-2, EGFR on the surface of cancer cells and are internalized through receptor-mediated endocytosis. This process releases the cytotoxic drug from the antibody drug conjugates, which kills the cancer cell with high specificity and minimizes toxicity to healthy cells.
Answer: HER-2 (ERBB2), Trop-2, EGFR, FOLR1 (Folate receptor alpha) and CD30, emerged as the most popular antigens targeted by various antibody drug conjugates.
Answer: Close to 140 players are currently engaged in the evaluation and development of over 300 antibody drug conjugates in various stages of development.
Answer: Some of the key companies in the antibody drug conjugates market include ADC Therapeutics, Astellas Pharma, AstraZeneca, Byondis, Daiichi Sankyo, Genentech, Gilead Sciences, ImmunoGen, Pfizer and RemeGen.
Answer: Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of antibody drug conjugates.
Answer: The global antibody drug conjugate market is estimated to be worth USD 7.72 billion in 2023.
Answer: Kadcyla is the top selling antibody-drug conjugate with sales revenues of around USD 2.2 billion in the year 2022.
Answer: The antibody drug conjugate market is expected to grow at a CAGR of ~10% during the forecast period.
Answer: Asia-pacific is likely to grow at the highest CAGR, over the period 2023-2035.