ANTIBODY DRUG CONJUGATES: THE RECENT APPROVALS

Antibody-Drug Conjugates (ADCs) have captured the attention of both large and small pharmaceutical companies, and academic / research institutions, engaged in the ADC contract manufacturing market. For the past few years, several failures of clinical trials were blamed for the lack of interest of some companies in this therapeutic approach. However, after a decade-long dribble of antibody-drug conjugates, FDA has approved three new drugs in 2019.
Recently, in April 2020, the FDA approved another ADC, named TRODELVY™ by Immunomedics for the treatment of patients suffering with metastatic triple-negative breast cancer, who have received at least two prior therapies for patients with relapsed or refractory metastatic disease. As per the recent updates, around 90 ADCs are being evaluated under more than 600 clinical trials. Further, it is believable from the fact that, an increase in the recent FDA approvals portends a comeback for antibody-drug conjugates.
The recent FDA approvals brought the total number of marketed ADCs to nine. These include, ADCETRIS® (2011, Seattle Genetics / Takeda Oncology), KADCYLA® (2013, Roche / Genentech), BESPONSA® (2017, Pfizer), MYLOTARG™ (2017, Pfizer), LUMOXITI® (2018, AstraZeneca / MedImmune), POLIVY™ (2019, Roche / Chugai Pharmaceuticals), PADCEV™ (2019, Astellas / Seattle Genetics), ENHERTU® (2019, AstraZeneca and Daiichi Sankyo) and TRODELVY™ (2020, Immunomedics).

SIGNIFICANT CAPITAL INVESTMENT IN ANTIBODY-DRUG CONJUGATES

Over the years, 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 further their R&D efforts related to the Antibody-drug conjugates. According to our research, more than 80% of the total investment (in terms of the amount invested) was made in last five years alone; a total amount of nearly USD 4 billion has been invested since 2015.

In terms of grants, Tulane university and Scripps Research were awarded the maximum amount, which account for USD 3.2 million, each. Additionally, Children’s Hospital of Philadelphia was awarded approximately USD 3.1 million.

RESEARCH & DEVELOPMENT AGREEMENTS ARE THE MOST PROMINENT IN THIS AREA

Several companies active in the Antibody-drug conjugates domain have entered into partnerships with other stakeholders in the last decade to provide better technologies and develop efficient products. Our findings depicted that, research and development agreements (40%) were the most popular type of agreement, which were inked between the companies present in this domain. This is followed by product / technology licensing agreements, which accounted of 35% of the total collaborations. Further, we observed that, majority of the collaborations were inked by the stakeholders which were headquartered in North America.

WHICH TYPE OF STRATEGIES ARE BEING ADOPTED BY THE COMPANIES FOR THE COMMERCIALIZATION OF THEIR ANTIBODY-DRUG CONJUGATES PRODUCTS?

In order to understand the commercialization strategies being adopted by companies focused on development of antibody drug conjugates, we considered the marketed drugs that were approved during the period 2011-2019 (till August). We observed that the stakeholders involved in this domain were found to adopt several different strategies to promote the drug, before and after the regulatory approval.

LIKELY ADOPTION OF ANTIBODY-DRUG CONJUGATES BY 2030
By 2030, the major contribution to the antibody drug conjugate market is expected to be made by North America (56%), followed by EU5 (29%). However, in terms of target indication, major proportion (more than 55%) of the total market (USD 15.2 billion), is likely to be held by Antibody-drug conjugates therapeutics developed for the treatment of therapeutic areas, such as breast cancer (28%), urothelial cancer (10%), DLBCL (9%) and Hodgkin’s lymphoma (9%).

In terms of type of linker, more than 65% of the share, the market is likely to be dominated by the Antibody-drug conjugates using the linkers, namely VC (32%), SMCC (21%) and Hydrazone linker (15%).

A detailed information on the key players, recent developments, number of grants awarded, number of patents filed, key opinion leaders in this domain and the likely market evolution, was done by Roots Analysis in H2 2019. For Further, information visit this link.

Several other companies are supporting ADC manufacturing by providing the necessary ADC technologies related to linkers and conjugation, ensuring necessary technological advancements for the success of this drug class.

More insights on the market size, share, growth, forecasts and trends, you can also download the SAMPLE REPORT on antibody drug conjugate by Roots Analysis.