ADC Market to Triple Growth By 2030 Driven By Big Pharma?

After two decades of trial and error in antibody drug-conjugate (ADC) development, the field is poised to deliver a broad range of targeted medicines to treat a variety of tumor types. These are a large emerging class of highly effective drugs that combine immunotherapy and chemotherapy. In ADCs, the most commonly targeted antigens are ERBB2, CD33, CD19, CD22, and MSLN (mesothelin), and more than 50 different known antigens have been used as targets in ADCs.

But the important question here is: Do ADCs have the potential to be game-changers that can revolutionize oncology treatment?

ADCs have been a promising class of targeted tumor therapies for more than 20 years, but their development has been challenged by several factors. A key challenge is the complexity of ADC design, which requires the combination of cytotoxic drugs, antibodies, linkers, and conjugation techniques to link the various components. Each of these components must be optimized in different ways depending on the tumor type or target. Developing an ADC with the desired therapeutic effect can take years.

Despite these challenges, recent advances in ADC technology have revived interest in the field. For example, the development of site-specific conjugation techniques has enabled the creation of more precise and stable ADCs, reducing off-target effects and increasing the concentration of “magic drugs” that can reach tumor sites. In fact, many promising ADCs are currently in late-stage clinical trials, and many more are in preclinical development.

According to the latest analysis by DataM Intelligence, the global ADC market size is estimated at USD 5 billion in 2022 and is expected to witness lucrative growth to reach USD 16.5 billion by 2030. The market is expected to register a CAGR of 16.6% during the forecast period (2023-2030). Some of the major players in the ADC market include Takeda Pharmaceuticals, Roche, Pfizer, AstraZeneca, Gilead Sciences, Seagen, Astellas, Daiichi Sankyo, GlaxoSmithKline, and ADC Therapeutics.

Pfizer launched its first ADC, Mylotarg, in 2000, and it appeared to be the long-awaited panacea for treating cancer: a drug that could go directly to a tumor and release a toxic payload there. As exciting and promising as it was, it took another 11 years for the next ADC (Seagen’s Adcetris) to hit the market. Mylotarg was withdrawn from the market in 2010 after postmarketing trials raised toxicity concerns. The drug was relaunched in 2017 after the FDA approved a lower dose for some leukemia patients.

Currently, there are about a dozen ADCs approved by the FDA, the latest being Elahere for ovarian cancer in 2022 and Tivdak for cervical cancer in 2021. Recent reports show that several ADC drugs, including Seagen/Takeda’s ADCETRIS, Roche’s KADCYLA and POLIVY, Gilead’s TRODELVY, and Daiichi Sankyo/AstraZeneca’s ENHERTU, have been approved for new indications, accelerating their occupation of the tumor market.

Our analysis estimates that more than 30 ADCs are in advanced clinical development and approximately 100 to 150 ADCs are in preclinical development. In addition, more than 50 different putative antigens have been used as targets for ADCs. The concept of ADC is to utilize the best possible carrier to deliver a highly efficient payload to the target. ADC is injected intravenously into the circulatory system to avoid the monoclonal antibody being broken down by gastric acid and proteolytic enzymes.

Big Pharma has made encouraging investments in small biotech ADC companies, including major deals between Seagen and Pfizer, GlaxoSmithKline and Mersana. The field is expected to experience significant growth as newer, more potent ADCs are approved and the development of next-generation ADCs, including improved targeting, potency, and safety, continues.
Rising incidence of oncology across the globe is an important driving force for the market. As the number of tumor cases continues to grow, there is a growing need for more effective and targeted treatments that ADCs can provide. ADCs provide personalized cancer therapy by targeting specific antigens expressed on tumor cells. This targeted therapy approach can improve efficacy and reduce toxicity compared with traditional chemotherapy, making ADCs an attractive option for both patients and healthcare providers.

1 Challenges Associated With ADCs

One of the major challenges of ADCs is off-target toxicity, which results from the premature release of cytotoxic small molecules into the blood circulation. The increased risk depends on the toxicity profile associated with the cytotoxic small molecule. In addition, ADCs are prone to aggregation, resulting in structural changes that impede their ability to bind antigen. ADC aggregation is an early hurdle in ADC development. In addition to this, aggregate degradation presents significant challenges in meeting stability testing guidelines to qualify for drug registration.

Another challenging factor is drug resistance. ADCs are still subject to tolerance, so their effectiveness is limited in duration. Resistance to ADCs has been one of the issues limiting the clinical success of these drugs. The modular nature of ADCs allows modification of some of their components to create novel compounds capable of overcoming drug resistance. Increased expression of drug efflux pumps is one of the most common mechanisms of ADC resistance.

2 The Latest Progress Of ADC

In July 2023, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan is considered the next big ADC project. But reports of “some” patient deaths in the first phase 3 trial of a TROP2-targeting drug spooked investors. The study itself met its goals, showing that the drug improved progression-free survival over standard chemotherapy in second-line NSCLC.
In May 2023, Sony and Astellas signed a collaborative research agreement to discover a novel antibody-drug conjugate (ADC) platform in the field of tumor therapy based on Sony’s unique polymer materials. KIRAVIA ADC is expected to selectively Deliver anti-tumor drugs to target cells in patients, thereby improving efficacy and reducing side effects caused by anti-tumor drugs attacking normal cells.

In April 2023, Germany’s BioNTech signed an agreement with Chinese biotechnology company DuualityBio to jointly develop and commercialize two tumor antibody candidate drugs, DB-1303 and DB-1311, as a combination therapy for solid tumors. DualityBio will retain commercial rights in Mainland China, Hong Kong SAR and Macau SAR, while BioNTech will retain commercial rights in the rest of the world.

In January 2023, Bridge Biotherapeutics and Pinotbio signed a Memorandum of Understanding (MoU) to develop new therapeutic oncology drug candidates using antibody drug conjugate platform technology. Bridge Biotherapeutics will provide the anti-tumor targets, while Pinotbio will provide the linkers and drugs.

In August 2022, GSK paid Mersana Therapeutics $100 million in cash to add a second ADC to its portfolio, which currently includes approved multiple myeloma drug Blenrep. The deal includes XMT-2056, Mersana’s preclinical ADC asset, designed to treat a range of HER-2 tumors. The global agreement provides GSK with an exclusive option to co-develop and commercialize XMT-2056.

3 Conclusion

The development of ADC is a major breakthrough in the field of tumor therapy. While most approved ADC therapies target liquid tumors, the focus is now shifting to solid tumors. With the development of personalized medicine, ADCs tailored to specific tumor subtypes hold great promise in fighting tumors.

As research and innovation continue to advance, the potential of ADCs to revolutionize oncology treatment remains unparalleled. Therefore, the question of whether ADCs can address unmet medical needs brings great hope and optimism to patients, caregivers, and the medical community. ADC embraces this cutting-edge technology and embarks on a journey of progress and promise in the relentless pursuit of defeating cancer and improving the lives of patients.