A report published by Persistence Market Research (PMR), a U.S.-based full-service market intelligence firm specializing in syndicated research, shows that the global market for antibody-drug conjugates or ADC is expected to be driven by the advancement in medical technology.[1]

According to the report, the key drivers of the market are the increasing cases prevalence of cancer, growing ageing population and increase in obese population.

Furthermore, the increasing research activities on antibody therapies, pre-clinical research, more research on advanced drug discoveries and increasing research on oncology diseases and the growing collaboration between research institutes, biotechnology and biopharmaceuticals companies is also acting as a fuel to the market and is expected to drive the market of antibody-drug conjugates within the forecast period of 2016-2024 discussed in the report.[1]

MabPlex
 

However, the high cost of the procedures and the lack of fund can be the restraint for the growth of this market.

Three parts- an antibody specific to target
Antibody-drug conjugates or ADCs are composed of three parts- an antibody specific to the target associated antigen, antigen that has restricted expression on normal cell, a cytotoxic agent designed to kill target cancer cells and a chemical linker to attach cytotoxic agent to the antibody.

The report’s authors conform that there are 243 antibody-drug conjugates in clinical pipeline for the treatment of cancer. Majority of these agents are investigational drugs in pre-clinical development followed by a considerable agents in phase I – III clinical trials.

These unique, targeted, drugs have therapeutic potential and contains both technological and developmental challenges. ADCs are considered to be the new age of therapeutic agent. They combine the targeting ability of monoclonal antibody and the target specific cell killing ability of cytotoxic drugs.

Success as a result of Technological advances
The success of this technology has become possible only with the increasing technological advancements. Antibody drug conjugates is the new class of therapeutic agent that is gaining attention from both large and small pharmaceutical companies.

The potency of the cytotoxic drug in antibody drug conjugate is 100-1000 fold more than the potency of cytotoxic drug when it acts alone.

Though this technology provides presence to maximum large pharmaceuticals companies, the capabilities for the development of ADC still lies with very few companies. There are many products under pipeline. Most development today has been carried out under license agreements.

The major advantage of using antibody-drug conjugates is that it brings together the best characteristics of both antibodies and the cytotoxic potential of chemotherapy. This offers significant opportunity for the market in terms of targeted accumulation of drug in the tumor cell or tissue. Apart from this there are several other benefits of antibody drug conjugates which are driving the market and will be accelerating its share in the upcoming future. [2]

Photo 1.0: Packaging/vial gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth). Courtesy: © 2017. Pfizer. Used with permission.

Approved
There are only three antibody drug conjugates that have received approval from the U.S. Food and Drug Administration (FDA).

The first antibody-drug conjugate, gemtuzumab ozogamicin (marketed by Pfizer/Wyeth as Mylotarg®; previously known as CMA-676) was granted accelerated approval by the FDA based on promising phase II data in relapsed older adults with acute myeloid leukemia (AML).

The drug held promise as a new agent that also could be efficacious in newly diagnosed AML with acceptable toxicity. Several phase III studies were designed to test gemtuzumab ozogamicin in this setting.

The results of a randomized study by the Southwest Oncology Group led in 2010 to the voluntary withdrawal by the manufacturer of this agent when improved efficacy could not be demonstrated and toxicity appeared to be excessive.

Since the withdrawal, 4 randomized studies have been completed that, in aggregate, strongly support the efficacy of this agent in newly diagnosed AML with acceptable toxicity. Based on the results of these studies, it seems that there is a very plausible explanation for this discrepancy. When confirmed, researchers believe that there is a compelling case for re-approval of gemtuzumab ozogamicin in the treatment of patients with AML.[3]

In late January 2017 Pfizer’s Biologics License Application (BLA) for gemtuzumab ozogamicin was accepted for filing by the FDA. in addition, a Marketing Authorization Application (MAA) for review by the European Medicines Agency (EMA) was validated in December 2016.[4]

Photo 2.0: Packaging/vial  brentuximab vedotin (Adcertis®; Seattle Genetics/Takeda). Courtesy: © 2017. Seattle Genetics. Used with permission.

Increased investments
The number of companies developing methods for antibody drug conjugates technology has not significantly changed in recent years. The increasing investment by the pharmaceutical and Biotechnology companies is expected to drive the market. Based on the product type the market is segmented to brentuximab vedotin (Adcertis®; Seattle Genetics/Takeda) and ado-trastuzumab emtansine (Kadcyla®; Genentech/Roche).

Brentuximab vedotin
Brentuximab vedotin is indicated for patients suffering with classical Hodgkin lymphoma (HL) after failure from at least two multi-agent chemotherapy regimen in patient who are not auto-HSCT candidates or patient with failure of autologous hematopoietic stem cell transplantation, HL patients at high risk of relapse or progression as post- auto- HSCT consolidation and lymphoma patient after failure of at least one prior multi-agent chemotherapy.

Drugs was granted accelerated approval for Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) for its usage in relapsed and refractory Hodgkin’s lymphoma and large cell lymphoma.

Photo 3.0: ado-trastuzumab emtansine (Kadcyla®; Genentech/Roche). Courtesy: © 2017. Genentech/Roche. Used with permission.

Ado-trastuzumab emtansine
Ado-trastuzumab emtansine it is the first HER2-targeted treatment of its own kind for metastatic breast cancer. It contains two cancer- fighting drugs in one. It contains monoclonal antibody trastuzumab, which the same monoclonal antibody in Herceptin® (Genentech/Roche) and a chemotherapy called DM1.

Ado-trastuzumab emtansine is indicated as a single agent for treatment of HER2-positive, metastatic breast cancer in patients who previously received trastuzumab and a taxane, separately or in combination.

Unprecedented tumor response and clinical benefit
A different report, Global Cancer Antibody Drug Conjugates Market & Clinical Pipeline Insight 2022, published earlier this year by Kuick Research, shows that for a number of cancers where validated predictive biomarkers are available, administration of targeted therapies such as antibody-drug conjugates, PD-1s and others, have been associated with unprecedented tumor response and clinical benefit. [2]

The authors of the report confirm that efforts to design tolerable combination therapies involving antibody-drug conjugate, cancer vaccine, immune checkpoint and kinase inhibition are rational means of maximizing clinical benefit in the targeted delivery of anticancer therapies. [2]

ADC-market
By end user, the global antibody-drug conjugates market has been segmented into Hospitals, Specialized Cancer Centers, Academic Research Institutes, Biotechnology Companies, Biopharmaceutical Companies and others.

By regional presence, antibody drug conjugates market is segmented into five key regions viz. North America, Latin America, Europe, Asia-Pacific, and the Middle East & Africa. North America will continue to dominate the antibody drug conjugates market as it has high experienced professionals and better healthcare facilities. Europe is expected to hold second largest market share in global antibody drug conjugates market.

The growing government initiatives and increasing number of biotechnology and biopharmaceutical companies in the Asia-Pacific region is also driving the market of Antibody-drug Conjugates.

According to Visiongain Ltd, the global next-generation antibody therapies market, which includes antibody-drug conjugates, is expected to grow at a CAGR of 35.9% in the first half of the forecast period. The market is expected to grow at a CAGR of 22.4% from 2016-2027.

The market is estimated at $3.1bn in 2016 and $14.1bn in 2021.