A recent research report published by Technavio, a leading global technology research and advisory company, confirms that the global antibody-drug conjugates (ADC) market will grow at a CAGR of over 41% until 2020.

This report “Global Antibody Drug Conjugates Market 2016-2020,” offers an in-depth analysis of the market in terms of revenue and emerging trends. To calculate the market size, the report considers revenue generated from the sales of currently approved ADCs used to treat cancer.

The importance of ADC is confirmed by the approval of brentuximab vedotin (Adcetris™, Seattle Genetics) and ado-trastuzumab emtansine (Kadcyla™, Genentech/Roche) and the large number of ADCs (>35) currently in clinical trials.[1]

MabPlex
 

Outsourcing development
“Vendors are increasingly outsourcing parts of their R&D process, such as product characterization testing and toxicology testing, to contract research organizations. Similarly, individual vendors are increasingly outsourcing their manufacturing processes,” Barath Palada, one of Technavio’s lead industry analysts for cardiovascular and molecular disorders.

“This decreases the manufacturing cost of originators, and increases profit margins. It is estimated that close to 70%-80% of antibody-conjugate drugs manufacturing is currently being outsourced, and this trend is expected to positively impact the market over the course of the forecast period,” Palada continued.

According to the report’s authors, some of the other driving forces behind the growth of the global antibody-drug conjugates market include a robust late-stage pipeline, an increase in demand for antibody-drug conjugates and relatively favorable reimbursement policies.

Robust late-stage pipeline
There are many products in the late pipeline stage that are likely be launched during the forecast period. Some of these products include glembatumumab vedotin, also known as CDX-011 or CR011-vcMMAE, an ADC designed to target the glycoprotein NMB (gpNMB) being developed by Celldex Therapeutics and SYD985, an investigational HER2-targeting ADC being developed by Synthon Biopharmaceuticals.

Some molecules are in phase I/II, preclinical, and discovery stages. Brentuximab vedotin is currently under clinical trials for additional indications such as frontline mature T-cell lymphomas, B-cell lymphomas, and CD30-expressing conditions. Experts interviewed by the report’s authors believe that these novel drugs form a strong pipeline for ADCs, and their approval in the forecast period is expected to propel market growth significantly.

Increase in demand
Antibody-drug conjugates have a high affinity for specific disease cells and areas that need treatment. The use of antibody-drug conjugates is expected to grow, and include therapies such as radio immunotherapy and antibody-directed enzyme prodrug therapy. A key advantage of using ADCs is that it brings together better characteristics of both antibodies and cytotoxic chemotherapy. This presents a huge opportunity in terms of targeted drug accumulation in tissues or tumor cells.

Over the next few years many new entrants are expected to enter the market, and increase competition in the market. Rising use of antibodies in drug development is expected to further increase revenues of vendors in the global ADCs market, and contribute to its growth until 2020.

Reimbursement policies
Reimbursement plans such as public reimbursement programs reduce the financial burden of treatment, and thereby benefit patients. The reimbursement status of drugs is dynamic in nature with inter-country variations. Factors such as lack of cost-effectiveness can impede reimbursement coverage. However, increased demand and high cost of cancer drugs are important reasons for these drugs to be included in reimbursement plans.

United States
In the United Stares, the Affordable Care Act (ACA) makes premium-priced drugs for the treatment of diseases available to patients at affordable rates. Many vendors also offer patient assistance programs to make these expensive drugs available to all. For instance, Genentech has initiated reimbursement plans for ado-trastuzumab emtansine, a target-specific drug, through Genentech Access Solutions.

These favorable reimbursement policies will positively impact the global antibody conjugates drugs market until 2020.

The European Commissions has approved ado-trastuzumab emtansine (which is in Europe distributed by Roche), in November 2013. The (European) Committee for Medicinal Products for Human Use (CHMP), on the basis of their quality, safety and efficacy data assessment, considers there to be a favourable benefit-to-risk balance for ado-trastuzumab emtansine. As a result, they recommends the granting of the marketing authorization in all European member states.[2]

However, following this positive guidance, not all European member states decide to reimburse innovative drugs.

Fore example, while retained for use through the UK’s Cancer Drugs Fund, ado-trastuzumab emtansine, was not recommended for routine NHS use by the UK’s National Institute for Health and Care Excellence (NICE), an independent body responsible for driving improvement and excellence in the health and social care system.[3]

“We recognise that [ado-trastuzumab emtansine] has a place in treating some patients with advanced breast cancer and we have been as flexible as we can in making our recommendation. However, the price that the manufacturer is asking the NHS to pay in the long-term is too high,” noted Sir Andrew Dillon, NICE Chief Executive in late 2015.

“Despite a growing public campaign for a fair deal on the cost of important new cancer medicines, it is disappointing that there appears to have been no meaningful attempt … to reconsider [the] price to secure [ado-trastuzumab emtansine]’s long-term future in the NHS, outside of the Cancer Drugs Fund,” Dillon added.

In Ireland, the National Centre for Pharmacoeconomics (NCPE) has also issues a negative reimbursement advice.

As a result of these negative recommendations experts are concerned that pioneering and innovative treatment designed to improves and extends the life of patients with are not made available to patients in the UK and Ireland – and, as a result, novel drugs are being stifled at the earliest stage before they can show their value.

In contrast, in 2014 France’s Transparency Commission of the Higher Authority on Healthcare recommended ado-trastuzumab emtansine for reimbursement.  The judgement was based on the available data from the pivotal Phase III EMILIA trial which demonstrated a statistically significant increase in median OS of ado-trastuzumab emtansine compared to lapatinib + capecitabine. Ado-trastuzumab emtansine also demonstrated an increase in PFS of 2.1 months as well as a reduction in side effects, making it clear that the drug brings important clinical value.  As a result, patients in France have access to this treatments with a reimbursement rate between 65–100%. In a similar vein, the German Institute for Quality and Efficiency in Health Care (IQWiG) approved the drug for reimbursement.[5]

Consequences
The bad news for large numbers of Europeans living in countries that do not reimburse, and as a result, limit access to newly patented – approved – medicines such as ado-trastuzumab emtansine,  is that this may ultimately create an unsustainable situation, leading to the polarization of European society, while reinforcing inequality in access to healthcare.  Experts fear that in some countries only those who are wealthy enough to pay will be able to benefit from the latest – most advanced – treatments.

According to a 2015 industry report, the fear is that negative reimbursement recommendations for novel treatments in the United Kingdom and Ireland may also have economic consequences and make it more difficult for a number of pharmaceutical companies to justify their investments in these countries – in what they may view as an increasingly unattractive business environment. In turn, this could lead to the relocation research and development (R&D), as well as clinical trials programs, to other European countries.[6]

While the level of pharmaceutical prices does affect the pharmaceutical sector, which directly employs 633,100 people across Europe and spends in excess of €26 billion (US $ 30 billion) annually on R&D, slightly ahead of the United States, the expectation is that research in novel, innovative drugs, including antibody-drug conjugates and other targeted treatments, will only increase as a result of a better understanding of cancer biology and chemistry.[7]

Furthermore, while the expenditure of European member state on health care per capita varies greatly, these costs are closely correlated with GDP per capita. In turn, there is a positive relationship between health expenditure per capita and GDP per capita.

The higher-income states, including Austria, France, Germany, The Netherlands and Sweden spend, on average, more on health given their GDP per capita, allowing pioneering and innovative treatments – including targeted therapies and personalized medicine  – to be available for patients in these countries. [7]

In these countries, reimbursement programs reduce the financial burden of treatment, and thereby directly benefit patients.