Antibody Drug Conjugates Market By Application (Blood Cancer, Breast Cancer, Ovary Cancer, Lung Cancer, Skin Cancer, Brain Tumor, Other Applications), By Technology (Cleavable Linker, Non-cleavable Linker, Linker less), By Geography, Size, Share & Growth Forecast, 2021-2030

Industry Report and Statistics (Facts & Figures) - Demand & Sales by Application & Technolgy

The global antibody drug conjugates market size was $4.00 Billion in 2021 and is predicted to reach $13.13 Billion by 2030, representing a CAGR of 14.12% during the forecast period 2021-2030.. North America is envisaged as the industry, with a share of around 37%, followed by Europe.

 

Conjugation covalently links prodrugs or drugs to natural or synthetic molecule carriers for the purpose of targeted usage, e.g polypeptides or proteins, lipids, polymers and carbohydrates. Conjugation has become a pivotal tool for drug release and targeted drug delivery of tiny molecules and biotherapeutic modalities, such as protein-drug conjugation, antibody-drug, polymer-drug conjugation and T-cell dual affinity re-targeting conjugation. Conjugating drugs to carriers can improve pharmacokinetics, drug stability, and pharmacodynamic properties and alter toxicity profiles. Antibody-drug conjugates or ADCs are a class of biopharmaceutical drugs formulated as a targeted therapy for treating and curing cancer. As compared to chemotherapy ADCs are used to target and vandalize tumour cells while sparing healthy cells. 

Types of Antibody-based Cancer therapies:

The treatment uses antibodies to help the body fight cancer, infection, or other diseases. Antibodies are proteins made by the immune system bind to specific markers on cells or tissues. In recent years, antibody-based cancer therapy has emerged as one of the efficient therapeutic strategies.

Immune checkpoint inhibitors (ICIs):They block checkpoint proteins from binding with their partner proteins.

Angiogenesis inhibitors: They block the growth of blood vessels that support tumour growth.

Multi-specific antibodies Therapy: These are directed at multiple tumour antigens to eradicate tumour cells more precisely and effectively.

Chimeric antigen receptor T (CAR-T) cells therapy: T cells (a type of immune system cell) from the patient are altered in the lab to attack cancer cells.

Antibody drug conjugates (ADCs):They selectively deliver drugs to cancer cells by chemically joining monoclonal antibody that is chemically linked to a drug. 

Components of ADCs: An antibody-drug- conjugate consists of 3 components: 

Antibody: It targets the ADC and may also elicit a therapeutic response. 

Payload: It elicits the desired therapeutic response. 

Linker: It imparts high stability in the circulation and specific payload release in the target tissue.

 

Monoclonal antibodies targeted to surface antigens found on specific tumour cells are combined with highly effective anti-cancer drugs via a chemical linker in ADCs. The linker is a crucial component in the operation of ADCs because it connects the antibody to the cytotoxic payload.

 

 

Market Dynamics

Drivers (Increasing prevalence of cancer, High Incidence of breast cancer, High demand for Antibody-based Cancer therapies, Technological advancements , High risk in old age, Increase in an obese population and Increased research and clinical trials).

 

The Antibody Drug Conjugates Market Drivers Include:

• Increasing prevalence of cancer: Cancer incidence grows with age, most likely due to an increase in the risk of certain tumours as people get older. The accumulation of risk is compounded by cellular repair systems becoming less effective as a person ages. The higher incidence of cancer is pulling the demand for ADCs. According to GLOBOCAN 2020, worldwide, an estimated 19.3 million new cancer cases and almost 10.0 million cancer deaths occurred in 2020.

 

• High Incidence of breast cancer: The majority of approved ADCs are utilized for breast cancer patients. Age, obesity, hazardous alcohol use, family history of breast cancer, history of radiation exposure, reproductive history (first menstrual cycle age and first pregnancy age) and tobacco use, are all factors that raise the risk of breast cancer. Breast cancer has the highest incidence and the second-highest overall mortality rate among women in the United States, according to the American Cancer Society's cancer statistics.

 

• High demand for Antibody-based Cancer therapies: The demand for various antibody-based cancer therapies is increasing due to their different mechanisms of action like natural properties, engagement of cytotoxic T cells, and delivery of cytotoxic payloads. According to an article published in the Antibody-drug Society, the commercial clinical pipeline of cancer therapies has become increasingly dominated by immune checkpoint modulators, antibody-drug conjugates (ADCs) and bispecific antibodies. Antibody-drug conjugates (ADCs) account for approximately 20% of the clinical pipeline of antibodies for cancer.

 

• Technological advancements: The limited success of first-generation ADCs (developed in the early 2000s) paved the way to bring second-generation ADCs (2010 onwards) to the global antibody drug conjugates market, with higher cytotoxic drug conjugation levels, and lower levels of naked antibodies and more-stable linkers between the drug and the antibody. However, Third-generation ADCs (2019 onwards) use site-specific conjugation methods instead of random coupling, enabling strict control over payload conjugation to generate a homogeneous product.

 

• High risk in old age: Advancing age is the most important risk factor for cancer and many individual cancer types. Cancer risk increases exponentially with age. According to research published in NCBI, about 60% of cancers occur in people 65 years of age or older. Furthermore, about 70% of the deaths caused by cancers occur in this stage.

 

• Increase in an obese population: Obesity has been linked to worsening quality of life, cancer recurrence, cancer progression, prognosis (survival), and the chance of some "second primary cancers." Obesity in cancer survivors is mostly studied in people who have had breast, prostate, or colorectal cancer. As per the research done by the National Health And Nutrition Examination Survey (NHANES), 30.7% of adults are overweight, 42.4% have obesity, and About 9.2% of adults have severe obesity.

 

• Increased research and clinical trials: ADCs have become an important class of anti-cancer drugs, with a dramatically increasing number of ADCs in clinical studies for treating hematologic malignancies and solid tumours over the past five years. According to NCBI, Nearly 60% (7 out of 12) of ADCs were approved by Food and Drug Administration in the past three years alone, indicating that the maturing of ADC technology brings more productive clinical outcomes. The recently approved ADCs include Polivy (2019), Padcev (2019), EnHertu (2019), Trodelvy (2020), Blenrep (2020), Zynlonta (2021), and Tivdak(2021).

 

Restraints (Stringent FDA guidelines and side effects)

• Stringent FDA guidelines for the drug approval: A pharmaceutical firm must go through a five-step procedure to get FDA clearance to commercialize a new prescription drug: discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. According to the FDA Review Project, The FDA approval process is complex and time-consuming for drugs (9 to12 years) and devices(7 years).

 

• Side-effects: Because of their great selectivity, ADCs have a manageable side-effect profile, with nausea and vomiting being the most common toxicities. However, this varies depending on the ADC and the accompanying payload. Fever, nausea, infection, vomiting, and stomatitis are other adverse effects. These serious adverse effects are low blood counts, liver damage, including hepatic veno-occlusive disease, infusion-related reactions (IRRs), and bleeding.

 

Opportunities 

Increase in product launches and approvals: The agency's Center for Drug Evaluation and Research (CDER) approved 50 novel therapeutics in 2021. The FDA's 5-year average approval count increased from 24 to 51 drugs per year in this decade. As per the article published in Science Direct, More than 80 ADCs have been investigated in different clinical stages from approximately 600 clinical trials. To date total of 12 ADCs have been approved by the FDA.

 

Rising old age population: Certain cancers are more common among the senior population. Some of the most common cancers like colon cancer and breast cancer are easily detected at nascent stages and are easily treatable. Other cancers, such as lung cancer, are more daunting to detect, and treatment can be more complex and crucial. The Rise in the old age population is likely to boost the demand for ADCs. According to World Bank data and World Population Prospects, The share of the old age population (65 years and more) will rise from 9.32% in 2020 to 16% by 2050. In the next 30 years, the number of people aged 65 and above will double, while those aged 80 and above will triple.

Global Antibody Drug Conjugates Market Segments Analysis

The industry has been broadly bifurcated based on Application, Technology and Region.

By Application

• Blood Cancer

• Ovary Cancer

• Breast Cancer

• Skin Cancer

• Lung Cancer

• Brain Tumor

• Other Applications

 

By Technology 

• Non-cleavable Linker

• Cleavable Linker

• Linker less

 

By Region

North America

• United States of America

• Canada

• Rest of North America

 

Europe

• Spain

• Germany

• United Kingdom

• Italy

• Russia

• France

• Rest of Europe

 

Asia-Pacific

• China

• Japan

• South Korea

• Australia

• India

• Singapore

• Rest of Asia-Pacific

 

LAMEA

• Brazil

• Argentina

• South Africa

• Saudi Arabia

• United Arab Emirates

• Rest of LAMEA

 

 

By Application, Breast Cancer dominates the segment due to increased patient awareness, growing breast cancer cases in females, technological advancements, and increased research and clinical trials. According to the fact sheet of the Food and Drugs Administration, the majority(25%) of approved ADCs (3 out of 12) were approved for breast cancer treatment.

 

By Technology, Cleavable Linker Technology Segment Accounted for Largest Revenue Share. With the awareness of plasma stability, greater therapeutic window, and higher stability and tolerability, Cleavable linkers are becoming more popular. Non-cleavable linkers are defined by higher stability in circulation and lower off-target activity which is due to its reduced "bystander effect" – killing antigen-negative cells. In contrast, cleavable linkers are accepted for their capability of being adapted to different usages and ability to exploit distinct mechanisms of action. According to the article published in Science Direct, More than 80% of the clinically approved ADCs employ cleavable linkers such as inotuzumabozogamicin (Besponsa) and brentuximabvedotin (Adcetris).

 

By Region, North America is poised to remain the antibody drug conjugates market, owing to the new product launches, rising frequency of cancer-related illnesses, active new drug pipeline projects, and significant industry players such as Pfizer, Inc., AstraZeneca, and Gilead Sciences. However, Asia-Pacific is poised to be the fastest growing industry.

 

 

Report Attribute	Details
Forecast Period	2021-2030
Market size value in 2021	$4.00 Billion
Revenue forecast in 2030	$13.13 Billion
Growth rate	14.12%
Base year for estimation	2021
Historical data	2015-2019
Unit	USD Billion, CAGR (2021 - 2030)
Segmentation	By Application,By Technology and By Region
Based on Technology	Non-cleavable Linker,Cleavable Linker,Linker less
Based on Application	Blood Cancer,Ovary Cancer,Breast Cancer,Skin Cancer,Lung Cancer,Brain Tumor,Other Applications
By Region	U.S, Mexico, Canada and Rest of North America
Country Scope	U.S., Canada, France, Germany, U.K., China, Japan, India, South Korea, Mexico, Brazil, U.A.E. etc.
Company Usability Profiles	Takeda Pharmaceutical Company Ltd,Hoffmann-La Roche Ltd,Pfizer, Inc,AstraZeneca,Gilead Sciences, Inc,Seagen, Inc.Astellas Pharma
Forecast Period	2021-2030

 

 

Global Antibody Drug Conjugates Market Competitive Landscape Analysis

The Research Report has the competitive landscape analysis that highlights the companies operating in a industry. The comparison is based on overall revenue generation, market initiatives, company overview, production analysis, value chain optimization, industry share financials, production capacity, company strengths and weaknesses, global presence, production sites and facilities, and other variables.

• Takeda Pharmaceutical Company Ltd.

• Hoffmann-La Roche Ltd.

• Pfizer, Inc.

• AstraZeneca

• Gilead Sciences, Inc. 

• Seagen, Inc.

• Astellas Pharma

• Seagen, Inc.

• Daiichi Sankyo Company Ltd.

• GlaxoSmithKline Plc

• ADC Therapeutics

 

Recent Developments

• On June 2022, Roche successfully received the conditional approval from European Commission for mosunetuzumab/Lunsumio for the treatment of the patients suffering from follicular lymphoma who at least underwent therapies twice earlier.

 

• On May 2022, Mersana Therapeutics announced the FDA approval of Orphan Drug Designation to XMT 2056 to treat gastric cancer.

 

• On May 2022, ImmunoGen Inc. one of the industry leaders of ADC (Antibody-Drug Conjugates) in cancer treatment declared that it has successfully submitted a BLA (Biologics License Application) for receiving an FDA approval to launch its mirvetuximab soravtansine monotherapy in patients for the treatment of ovarian cancer. The PDUFA Date is scheduled for 28th Nov, 2022.

 

• On March 2022, Seagen & Sanofi announced their collaboration for the development and commercialization of several antibody-drug conjugates. The main objective of this collaboration is to employ technologies used by both companies in manufacturing ADCs.

 

• In February 2022, for sponsors interested in developing ADCs, the US FDA released draft guidance on clinical pharmacology concerns. This guidance provides recommendations to assist the industry and other parties in developing antibody-drug conjugates (ADCs). In several aspects of ADC clinical research, the agency advises sponsors to examine current advice. Bioanalytical methodologies, dosing regimens, dosage and exposure-response analyses, QTc assessments, immunogenicity, and drug-drug interactions (DDIs) are all covered in the guidelines.

 

• In January 2022, ADC Therapeutics and Mitsubishi Tanabe Pharma Corporation signed an exclusive license agreement to develop and commercial loncastuximabtesirine (Zynlonta), a CD19-directed antibody-drug conjugate (ADC). Under the agreement terms, ADC Therapeutics will receive a US $ 30 million upfront payment and up to US $ 205 million in milestones and double-digit royalties based on net sales in Japan.

 

• In September 2021, The FDA gave expedited approval to tisotumabvedotin-tftv, a tissue factor-directed antibody and microtubule inhibitor combination, for adult patients with recurrent or metastatic cervical carcinoma progressing on or after chemotherapy. The suggested dose is 2 mg/kg (up to 200 mg for individuals < 100 kg) given as a 30-minute intravenous infusion (IV therapy) every three weeks until the condition progresses or toxicity becomes unbearable.

 

• In April 2021, ADC Therapeutics confirmed that it has received its 1st FDA clearance to launch ZYNLONTA. It is used to treat adult patients with refractory or relapsed large B cell lymphoma.

 

• In May 2020, AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumabderuxtecan) was granted Breakthrough Therapy Designation (BTD) by FDA for treatment of patients with metastatic, HER2-mutated non-small cell lung cancer (NSCLC) after platinum-based therapy, and priority review for the treatment of HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

 

Various products that key market leaders develop

Product	Functions	Key Players
Mylotarg (Gemtuzumabozogamicin)	For  Acute Myelogenous Leukemia treatment (AML)	Pfizer
Tivdak (Tisotumabvedotin-tftv)	For recurrent or metastatic cervical cancer.	Seagen Inc
Kadcyla (Trastuzumabemtansine )	For HER2-positive metastatic breast cancer.	Roche
Trodelvy (Sacituzumabgovitecan)	For metastatic triple-negative breast cancer (mTNBC).	Immunomedics