Suraj Ramanathan at GBI Research reviews the autoimmune disease therapeutics market across Europe
Europe occupies a substantial portion of the global pharmaceutical market and has contributed extensively to the therapeutic and diagnostic space, both in terms of research and market value. At present, the European pharmaceutical market is being influenced by various intrinsic and extrinsic factors, such as fluctuations in healthcare spending, alterations to different governments’ regulations, parallel importing and changes in population demography. The withdrawal of a number of drugs, such as COX-2 inhibitors, from the market due to safety concerns in the past few years has caused regulatory bodies such as the EMA to impose stricter requirements for drug approvals. This, in turn, is putting immense pressure on European drug manufacturers to provide safer and more efficacious drugs. Key disease areas which are showing an increase in R&D initiatives within Europe include central nervous system (CNS) disorders, autoimmune diseases and oncology. Among these, autoimmune diseases represent a substantial portion of the total therapeutics market within Europe.
AUTOIMMUNE DISEASES – AN OVERVIEW
Autoimmune diseases encompass nearly 80 complications, of which the major ones include rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), autoimmune inflammatory bowel disorders (including Crohn’s disease and ulcerative colitis) and multiple sclerosis (MS). These complications arise primarily due to an overactive immune response of the body against cells and tissues normally present within it. Most diseases within this sector are multi-symptomatic, making it difficult for physicians to provide a standard treatment. However, the development of targeted therapeutics and biologics over the past decade has helped researchers to formulate new therapeutic approaches to treat these complications. Autoimmune disorders are monitored and diagnosed through a combination of blood tests incorporating auto-antibodies, measurement of organ function and inflammation, and clinical presentation through non-laboratory examinations such as X-rays.
Presently there is no cure for autoimmune disorders but cases have been seen where the complications disappear on their own. Most diseases are characterised by flareups and temporary remissions in symptoms. Current treatments primarily target symptom attenuation, reduction in organ and tissue damage, and preservation of organ function.
KEY FACTORS INFLUENCING THE AUTOIMMUNE THERAPEUTICS MARKET
The major factors influencing the European autoimmune disease therapeutics market are:
The Increasing Incidence Levels of Autoimmune Complications
European countries are being confronted with an increase in the incidence of most immune disorders, including autoimmune and allergic diseases. Converging epidemiological evidence indicates that this increase is linked to the improvement of the socio-economic level of these countries. Epidemiological and clinical data support the hygiene hypothesis, which states that the decrease of infections observed over the last three decades is the main cause of the continual increase in immune disorders.
Increasing Label Extensions for Present Drugs
The therapeutic capabilities of biologics in controlling and treating autoimmune complications has allowed European drug manufacturers to commence label extensions of their present portfolio of biologics for multiple autoimmune complications.
Reduced Influence of Generic Substitutes
With regard to any pharmaceutical sector, generics play an important role in shaping the market. Within the European autoimmune therapeutics market, excluding sectors such as SLE, the market is dominated by primary brands. In 2008, primary brands accounted for nearly 75 per cent of the total revenues generated. This is encouraging the market to continue growing by initiating healthy competition among the existing market players.
High Unmet Clinical Needs Provide Opportunities for R&D Initiatives
The present therapeutic portfolio for the treatment of major autoimmune complications have high unmet needs in terms of safety as well as efficacy. Even though this factor would negatively influence the growth of the market to an extent, it paves the way for the entry of other novel therapies and R&D initiatives.
Presence of Adverse Side Effects with Respect to Existing Drugs
The therapeutic drugs currently used for the treatment of autoimmune complications have been shown to exhibit serious side effects among patients. Long-term usage of the available drugs has led to adverse effects such as malignancies, lymphomas, chronic obstructive pulmonary disease and progressive multifocal leukoencephalopathy, and in some cases has augmented the disease condition.
Reimbursement Restrictions on Certain Drug Classes
There seem to be heavy limitations on the reimbursement policies for biologics within Europe. Patients must fail to respond to at least two conventional therapies, such as corticosteroids and immunosuppressants, before receiving treatment with a biological agent. As a result, only a small percentage of disease patients will be treated with biologics. It remains to be seen whether regional healthcare systems will alter reimbursement policies in response to the expanded labelling.
With regard to the various diseased sectors, the RA disease sector is the biggest in terms of revenues generated. With the entry of more biologics, it has also been identified as one of the fastest growing within the European autoimmune disease therapeutics market. On the reimbursement side, countries such as Germany and France have been identified as having the most robust and patientfriendly regulations for autoimmune therapeutics.
AUTOIMMUNE DISEASE THERAPEUTICS MARKET SCENARIO
The global autoimmune disease therapeutics market was valued at approximately $33.5 billion in 2009. In spite of considerable challenges within Europe, the autoimmune disease therapeutics market has shown significant growth in comparison to other disease sectors, and contributed to nearly 34 per cent of the global autoimmune disease therapeutics market. Countries such as Germany, France and the UK have extensive R&D initiatives for the development of therapeutics drugs for most autoimmune disorders. The European autoimmune disease therapeutics market is currently quite fragmented, but is poised for steady growth.
Germany represents the largest therapeutics market for autoimmune diseases within Europe, followed by the UK and France. Though government policies in Germany have hampered the domestic drug market, the export market has definitely expanded. In the past, due to the lack of regulations surrounding the manufacturing and distribution of autoimmune drugs throughout Europe, patient policies were hampering the growth of the sector. The revised regulations have implemented centralised marketing authorisation procedures, free movement of advanced therapy products within the region and special incentives for small- and medium-sized enterprises, thereby increasing the rate of growth. The European autoimmune disease therapeutics market faces generic competition, parallel imports and increasing cost containment measures by the European government but factors such as increased diseased population, unmet clinical needs and increasing prevalence seem to be driving the sector toward expansion. To tap into these opportunities, manufacturers need to focus on product life cycle management and novel drug delivery development methods, in order to see the expected growth of approximately seven per cent per annum in the coming years.
Several European Big Pharma manufacturers such as Sanofi-aventis and Roche have substantial exposure to the autoimmune disease therapeutics market. With the advent of biologics and considerable pricing power manufacturers are in a race to develop novel therapies in order to stay competitive within the present market. In addition to this, manufacturers are also trying to utilise their expertise in other immunology-related diseases to develop new, more convenient and potentially superior therapies to treat diseases such as RA and MS, which seem to have a considerable patient population within this region. However, the EMA have made various changes to their drug approval processes, primarily focusing on safety and efficacy issues. The EMA has expressed a specific intent to target GCP compliance issues with regard to clinical trials conducted in both European and non-EU countries where the data is used to support applications for marketing authorisation. This factor is key to the growth of the European pharmaceutical markets as it could prove to be a barrier to drug approvals for autoimmune complications over the forecast period.
TREATMENT COSTS FOR AUTOIMMUNE DISEASE THERAPEUTICS
Disease progression is associated with deteriorating quality of life and increasing costs, both direct and indirect. It is understood that non-communicable diseases challenge health systems and absorb substantial amounts of resources. Disease costs within Europe are considerably higher that those in the US. The total economic impact of RA within Europe was estimated to be approximately $6 billion in 2009. The mean annual cost per patient for RA is estimated at $15,500 per year and can rise as the severity of the disease increases. With the increase in the development of biologics for autoimmune complications, the average treatment cost would grow steadily. This would directly affect the uptake of biologics within Europe. For example, it has been noticed that there is very limited use of biologic drugs in eastern and central European countries, but among the large European Member States, such as France, Spain and the UK, there is a steady consumption, while Germany’s and Italy’s uptake is average.
The average product purchase frequency for autoimmune disease therapeutics within Europe has been found to be around 225 (suggesting approximately 0.5 pills are taken on a daily basis). With the introduction of biologics as the primary mode of treatment over the coming years, the product purchase frequency would reduce but the average unit cost would increase four-fold. This suggests that the sales volume would increase at a progressive rate. However, drug approval procedures are not the only hurdle for healthcare funding within Europe. Health technology assessments (HTAs), including cost-effectiveness evaluations, are gaining increasing importance for the allocation of healthcare resources, and have a strong influence on reimbursement decisions for autoimmune disorders. Government reimbursement policies are often determined by influential HTAs. Countries like the UK and Germany have HTA agencies which have a strict healthcare cost perspective. This in turn can reduce patient acceptance of autoimmune therapeutics as the average treatment cost increases over the forecast period.
DEMOGRAPHIC ANALYSIS OF AUTOIMMUNE DISEASES WITHIN EUROPE
Prevalence patterns within Europe are similar to those of the US, with women being more susceptible to autoimmune complications. Looking into individual countries, Italy has been noted to have highest prevalence of MS within Europe, and the UK and Germany have been shown to have high prevalence of RA and SLE. Germany has an estimated autoimmune diseased population of 2.8 million, while in the UK that figure is 2.5 million. For Italy and Spain, the collective diseased population was 3.2 million and France recorded a diseased population of approximately 2.2 million for autoimmune disorders. A major cause for the increase in incidence levels of autoimmune disorders within Europe has been attributed to changes in the eating habits of people. Excessive intake of cholesterol and vitamin food products (especially vitamin D) has shown to increase the chances of contracting these disorders. Environmental factors such as climate change and exposure to hazardous materials are also contributing to the increase in incidence.
Treatment-Seeking Behaviour
The treatment-seeking pattern within Europe is primarily influenced by patient awareness. Low awareness levels are primarily attributed to the clinical manifestations of the disease. Many European countries are tackling this by educating the public about the diseases. In the UK, for example, the National Heath Service (NHS) conducts regular awareness programmes for the public providing free check-ups. Also influencing the treatmentseeking population are the regulatory and reimbursement bodies within each country. Countries like France have one of the most robust and well-defined healthcare regulatory bodies and have the highest reimbursement coverage for autoimmune therapeutics. Consequently, patients tend to opt for drug therapy.
Diagnosis Patterns
It is well known that the diagnosis of autoimmune disorders is relatively complex when compared to other diseases. A major concern for patients is the shortage of trained physicians specialising in autoimmune disorders across Europe. The access for autoimmune disorder patients to specialists such as rheumatologists, and through them early diagnosis and treatment, differ substantially across Europe. It is estimated that there is one rheumatologist per 25,000 people in France and one per 50,000 in the US, but only one per 150,000 in the UK and one for every 200,000 in Germany. This directly affects patients’ ability to receive proper diagnosis and rapid treatment changes according to their response to different drugs, further hampering their access to effective treatment. From the diagnostic companies’ perspective, the development of novel biomarker panels has accelerated the diagnosis of many autoimmune complications. Exhaustive R&D by many universities and research organisations has yielded promising results in the use of multiple biomarkers for autoimmune disease diagnosis, which will drive developments in detection and diagnosis technologies over the next decade.
Impact of Biologics
The introduction of biologics has influenced the autoimmune disease therapeutics market significantly. Despite the fact that biologics have greater efficacy than chemotherapeutic drugs, the average price for biologics is relatively high. Bearing in mind that the number of patients being prescribed autoimmune therapeutics is relatively moderate, the increase in biologics as the first line of treatment would cause a further reduction in prescription rates. For example, within Europe, the majority of prescription claims for biologics are paid through private insurance companies who only provide partial reimbursements. This presents a large problem in terms of choosing effective therapeutics, and the majority of patients primarily switch to other forms of treatment. However, changes in reimbursement policies under various regional health organisations to allow greater coverage for biologics could turn out to positively influence the growth of the prescription population.
CONCLUSION
The European market for autoimmune disease therapeutics is growing at a significant pace. With the increasing acceptance of biologics as a primary therapeutic option, the market is poised to show increased growth over the next decade. The major factors that would influence this growth would be the steady increase in the incidence of autoimmune complications and increasing disease awareness. Extensive consolidations are taking place within pharmaceutical manufacturers in Europe, who are cutting down on their costs by outsourcing drug production to contract manufacturers, particularly within south Asian and eastern European countries. There is an emergence of numerous R&D hubs for autoimmune disease research and this has yielded drug manufacturers with strong drug pipelines which will, in turn, enhance their therapeutic portfolios. The restructuring of regulatory norms, especially with respect to drug importing and reimbursements over the next few years, will encourage further growth within the industry.
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