5 min readThe European HIV/AIDS Market – an Outlook
Europe is the second largest market for HIV/AIDS therapeutics after the US market. However, it is also a very challenging market for pharmaceutical manufacturers because of the differences in policies across the region. The European HIV/AIDS market poses unique challenges to the manufacturers as well as the public health authorities.
Ever since the first detection of HIV in humans, billions of dollars have been invested in research and development of therapies to counter the virus. HIV/AIDS, which was previously a fatal disease, has now been reduced to a chronic disease which can be managed with the help of anti-retroviral drugs. The primary goal of the antiretroviral therapy is to interfere with the different stages in the lifecycle of the virus. Acquisition of HIV in itself does not guarantee death, whereas it is caused by the complications associated with the degeneration of the immune system. The most common complications resulting from the infection of HIV are Pneumocystis carinii pneumonia, Tuberculosis, Toxoplasmosis, Cytomegalovirus infection, Kaposi’s sarcoma and Hepatitis C.
Different classes of drugs are used to treat HIV/AIDS including the Entry inhibitors, Integrase inhibitors, Protease inhibitors, Nucleoside Reverse Transcriptase inhibitors (NRTI), Non-nucleoside Reverse Transcriptase inhibitors (NNRTI) and Maturation inhibitors. After the introduction of protease inhibitors in 1995, a combination of two or three antiretroviral drugs formed the highly active antiretroviral therapy (HAART) which played a key role in suppressing the viral load in patients. NNRTIs, introduced after the protease inhibitors, also play a vital role in antiretroviral therapies. Some NRTIs including zidovudine and stavudine have gone generic after their patents expired and the HIV/AIDS market will be affected by further patent expiries in the near future.
However, the European HIV/AIDS therapeutics market is expected to grow despite the effect of patent expiries of key products on the market growth. This growth is expected to be fuelled primarily by an increase in awareness of and diagnoses rates in the European region. The expected introduction of new HIV drugs is expected to augment the growth of the anti-retroviral therapies.
Despite the presence of pronounced growth drivers in the market, their effect is nullified by the social stigma and low awareness levels associated with the disease. Low awareness leads to late presentation by patients and it reduces the chances of the patient receiving benefits from the treatment. Low awareness levels coupled with increasing prevalence of HIV infections is a cause of concern to the European Health authorities, however it presents a challenge as well as an opportunity to the HIV/AIDS drugs manufacturers.
It has been estimated that more than half of the newly diagnosed HIV cases came from heterosexual transmission and 40 per cent were diagnosed in men who have sex with men. In Eastern Europe injectable drug usage is the cause of nearly two-thirds of all newly diagnosed infections. Early detection also reduces the chances of transmission of the virus. It is estimated that people who are unaware of their infection are 3.5 times more likely to transmit the virus than people who are aware.
Early detection in injectable drug users (IDUs) is low because of the social stigma associated with the disease. European authorities are also worried regarding fears amongst physicians about IDUs developing resistance, due to poor adherence, and transmitting the virus. In the Eastern Europe diagnosis rates are low because of concerns with regard to the lack of confidentiality of the tests. Uninsured individuals and undocumented migrant populations are unable to get diagnosed and treated for their infections.
Healthcare budget restraints in Europe are key restraints for the growth of expensive therapies. Development of resistance to antiretroviral drugs requires costlier therapies which treat patients with drug-resistant strains. Restriction in budget forces physicians to restrain from prescribing expensive therapies and diagnosis procedures.
Challenges facing the industry
- According to WHO estimates, nearly 800,000 people are infected with HIV in the European Union. However, nearly half of the infected population is not aware of the infection and hence is not presenting themselves to physicians for diagnosi.
- Social stigma and discrimination associated with HIV infected population makes it difficult to arrive at reasonably accurate epidemiology statistics. Since market participants are dependent on statistics to formulate strategies for growth, societal factors impede the growth of the market.
- Late diagnosis is one of the major problems faced by the European industry. Early diagnosis and initiation of treatment not only benefit the patients but also the industry. It has been estimated that nearly 30% of the patients are diagnosed at a stage, when they should have already begun treatment. Early diagnosis implies prolongation of life span where patients will be on treatment until death. It is also estimated that nearly 24% of all HIV positive deaths are due to late presentation of patients.
- The most important challenge facing the industry is the development of resistance by the virus to antiretroviral drugs. Drugs like lamivudine and non-nucleoside transcriptase inhibitors such as efavirenz have a low genetic barrier to resistance. A single mutation in the virus can give it high level resistance against these medications. HIV replicates and mutates at a rapid rate and hence strict adherence to treatment is necessary to keep the viral load down. Strict adherence decreases the chances of the virus developing resistance to mutation. Increasing prevalence of drug resistant strains increases the pressure on the manufacturers to develop drugs that target drug resistant HIV strains.
- Although the prevalence of HIV/AIDS is expected to remain stable, increasing diagnosis rates and application of uniform testing guidelines across Europe is expected to boost the uptake of antiretroviral drugs.
- Introduction of new drugs is expected to be an important driving factor for the HIV market growth. Atripla, Fuzeon, Prezista, Selzentry and Isentress are expected to drive revenue growth in the future.
- The HIV market is primarily driven by the NRTI class of drugs and is expected to remain the main growth driver. The market will also be driven by the Protease inhibitors which are a fast growing class of drugs. If the entry inhibitors, currently in pipeline, prove to be efficient therapies, they could be used as first-line treatment and the existing successful treatments could be used for treatment experienced patients.
- European policies for HIV testing vary across the region and there is inconsistency in adoption of standard testing methods. Recent reports suggest that there is an increasing trend in Europe towards adopting routine and opt-out testing – where individuals are tested unless they specifically decline. Diagnosis rates have been found to be higher in countries where opt-out testing has been adopted.
Adherence to therapies is important to prevent development of resistance in patients. Poor adherence is often caused by the difficulty involved in treatment regimens which requires taking a number of pills every day. Efforts are being made to provide once-daily medications such as Truvada (Gilead) which significantly increases ease of intake along with several other medications the patients might be on.
Combination therapies will be competing against each other primarily based on ease of use, efficacy and safety. Gilead’s Truvada has been proven to be much safer and effective than GSK’s Combivir and has already generated revenues for Gilead. GSK previously leading the market with its combination products has now been overtaken by Gilead’s HIV franchise.
Increasing awareness levels about HIV is on top of the agenda for both the public health authorities and the market players. Since direct-to-consumer advertising is banned in Europe, physicians are the sole point of contact for patients requiring education about the disease. However, HIV/AIDS can often go unnoticed in the eyes of the physician because of slow progression of the disease.
Manufacturers need to understand policies, epidemiology statistics and societal challenges facing the industry in individual countries to formulate and execute strategies for growth. The European HIV/AIDS market is expected to grow strongly aided by the strong performances of combination therapies and new drug classes. New treatments for drug-resistant strains are expected to make their way into the market.