20 July 2011

We sell medicines. Expensive.

Leaders of the drug sales race. Forecast for 2015
Evgenia Lukyanchuk, "Weekly Pharmacy" www.apteka.uaWhen preparing the material, the data published in the reports "Drug trend report 2011" by medco® and "The Global Use of Medicines: Outlook Through 2015" by IMS Institute for Healthcare Informatics were used as a basis.

Drug costs continue to rise. The main drivers of this process are trends characteristic of the population of the developed countries of the world (aging of the population, an increase in the prevalence of chronic diseases), as well as innovative approaches to therapy, actively developed by R&D departments of leading pharmaceutical companies.

Important aspects that will affect the volume of sales of medicines in the future are the aging of the population and the associated increase in the prevalence of chronic diseases.

Thus, according to forecasts published by The Economist in the Healthcare in Europe report, the share of the population over 65 in the EU countries will increase from 18% in 2010 to 24% in 2030.

The same phenomena will be observed with respect to chronic diseases. For example, according to a large-scale study published in the Lancet journal, in the period 1980-2008. the number of diabetic patients worldwide increased from 153 million people to 347 million. It is expected that in 2030, 8% of the EU population will suffer from this pathology.

In addition, according to the information published in the report "Drug trend report 2011" of the company "medco®", it is assumed that a significant contribution to the growth of sales of medicines will be provided by drugs, the launch of which occurred in 2010. So, according to the results of 2010 The US Food and Drug Administration (FDA) has approved 21 medicines and 6 biological preparations (table), and new indications for use have been registered for 33 already approved drugs. It should be noted that only 7 of the approved in 2010 The FDA of medicines was created by large pharmaceutical companies whose R&D expenses exceeded $2 billion. USA in 2009

Drugs approved by the FDA in 2010Quarter

Trade name

Active substance

Companies marketing drugs

Indications for use

I quarter

Ampyra™

dalfampridine

"Acorda Therapeutics Inc."

Movement coordination disorders in multiple sclerosis

Actemra™/Actemra®tocilizumab

"Roche Holding AG"

Rheumatoid arthritis

Victoza®/Victoza®liraglutide

Novo Nordisk A/S

Type II diabetes mellitus

Xiaflex™

Clostridium histolyticum collagenase"Auxilium Pharmaceuticals Inc."

Dupuytren 's contracture

Vpriv™

velaglucerase-alpha

"Shire Pharmaceuticals plc."

Gaucher's disease

Prevenar13®pneumococcal 13-valent conjugate vaccine

"Pfizer Inc."

Prevention of pneumococcal infection and otitis media

Menveo™

tetravalent meningococcal vaccine

"Novartis International AG"

Prevention of meningococcal infection

Carbaglu®*

carglumic acid

"Orphan Europe"

Hyperammonemia and other metabolic disorders

Asclera®polydocanol

"Chemische Fabrik Kreussler&Co."

Varicose veins

Hizentra®immunoglobulin

"CSL Behring"

Primary immunodeficiency

II quarter

Provenge®sipuleitsel-T

"Dendreon Corp."

Prostate cancer

TachoSil®fibrinogen and thrombin

"Nycomed"/ "NPS Pharmaceuticals Inc."

Bleeding control

Natazia®estradiol + dienogest

"Bayer AG"

Oral contraceptive

Lumizyme™

alglucosidase-alpha

"Genzyme Corp."

Type II glycogenosis

Prolia™

denozumab

"Amgen Inc."

Osteoporosis

Jevtana®kabazitaxel

"Sanofi S.A."

Prostate cancer

III quarter

Lastacaft™

ophthalmic solution of alkaphtadine

"Johnson&Johnson Services Inc."/"Allergan Inc."

Conjunctivitis

Xeomin®incobotulinum toxin A

"Merz Pharma Group"

Blepharospasm, idiopathic cervical dystonia

Glassia™

alpha-1 proteinase inhibitor

"Kamada"/ "Baxter International Inc."

Alpha-1 antitrypsin deficiency

ella™

ulipristal

"HRA Pharma"/"Watson Pharmaceuticals Inc."

Emergency contraception

Krystexxa™

pegloticase

"Savient Pharmaceuticals Inc."

Gout

Gilenya™

fingolimod

"Novartis International AG"

Multiple sclerosis

IV quarter

Pradaxa®dabigatran etexilate

"Boehringer Ingelheim GmbH"

Atrial fibrillation

Latuda®lurazidone hydrochloride

"Dainippon Sumitomo Pharma Co. Ltd."

Schizophrenia

Teflaro™

ceftaroline fosamil

"Forest Laboratories Inc."

Bacterial pneumonia

Egrifta™

thesamorelin

"Theratechnologies Inc."

Lipodystrophy

Halaven™

eribulina mesilat

"Eisai Co."

Breast cancer

Moreover, according to the forecasts of the IMS Institute for Healthcare Informatics, the most sold medicines by 2015 may be drugs belonging to the following therapeutic areas (Fig. 1):

  • oncology, which has long held a leading position. However, it is expected that the average annual growth rate of sales of medicines of such therapeutic use will slow down and stop at the level of 5-8%, due to the widespread use of targeted cancer therapy methods;
  • diabetes mellitus. The average annual growth rate of sales of medicines of this therapeutic area will be 4-7%, the main drivers of which will be the increase in morbidity and the availability of new antidiabetic drugs for oral use;
  • asthma and chronic obstructive pulmonary disease. The increase in sales of drugs for the treatment of these diseases will be lower than in the previous 5 years, and will amount to 2-5% annually in 2011-2015.;
  • elevated levels of lipids in the blood. It is expected that the volume of sales of drugs for the control of lipid levels will decrease from $ 37 billion. In 2010, up to $31 billion. USA in 2015;
  • hypertension. The main driver of the growth in spending on medicines to combat hypertension, in particular on drugs based on angiotensin inhibitors, will be their improved pharmacoeconomical characteristics.


Top 5 therapeutic areas in terms of sales of medicines 
with an indication of the projected growth rates until 2015.
Source: The report "The Global Use of Medicines: Outlook Through 2015"
companies "IMS Institute for Healthcare Informatics"By 2015, the growth of spending on most types of therapy will slow down (Fig. 2). The growth rate of sales of drugs of the main therapeutic groups will decrease.

Thus, of the 20 therapeutic areas whose medicines are recognized as the best–selling, there is a decrease in growth rates relative to 7 compared to the previous period (2005-2010). The only exceptions are two groups of drugs - for the treatment of epilepsy and osteoporosis, the growth rate of sales of which will increase from 2010 to 2015.


Top 5 therapeutic areas in terms of drug sales growth rates in 2011-2015
compared with 2006-2010 and their volume in monetary terms for 2015
Source: The report "The Global Use of Medicines: Outlook Through 2015"
companies "IMS Institute for Healthcare Informatics"

Specialized medicines are expected to grow steadily in the medium term, due to the development of new mechanisms of action, an increase in the effectiveness of therapy and the number of patients. However, a slowdown in growth rates is observed in many other areas of therapy, the reasons for which are the expiration of patent protection for many drugs, the lack of innovative treatment methods, etc.

Antitumor drugsAccording to the information published in the report "2011 CMR International Pharmaceutical R&D Factbook" on the website www.thomsonreuters.com , in 2010, the costs for the development of antitumor drugs became the largest and accumulated more than 25% of all costs for the R&D segment.

The slowdown in the further growth of sales of medicines of this therapeutic area is due to the widespread use of targeted drug therapy in most developed countries. By 2015, competition from generic medicines will have a significant impact on the growth rate of sales of anticancer drugs. An important factor constraining the growth rate of spending on anticancer drugs will be the adoption of measures aimed at saving public funds. Thus, in the USA, the amount of discounts on medicines under the state program "Medicaid" was increased, and in the EU countries, the maximum amount of reimbursement was limited. The increase in the cost of antitumor drugs in emerging markets will be provided by traditional chemotherapy regimens. Also, for some localizations of malignant neoplasms, new promising medicines are expected to appear, which will be able to improve the condition of patients, but at the same time will not cause a significant increase in costs.

Antidiabetic drugsIt is expected that an increase in the population, especially in the developing pharmaceutical markets of China, India and Brazil, along with the global trend towards lifestyle changes, will lead to an increase in the incidence of type II diabetes.

The volume of expenditures on drugs of this group is expected to increase by 4-7% annually from 2011 to 2015. In addition, the use of antidiabetic drugs for oral administration will increase the effectiveness and availability of therapy. The complex scheme of the use and dosage of insulin preparations for intravenous administration created difficulties for patients, as well as increased the risk of misuse of these drugs. Previously, the FDA initiated increased control over cases of cardiovascular and oncological diseases when using antidiabetic drugs. This caused a delay in regulatory approval of new drugs for the treatment of diabetes mellitus, as the FDA was forced to request additional data.

Medications for the treatment of asthma and chronic obstructive pulmonary diseaseThe main driver of the growth in the cost of medicines for the treatment of asthma and chronic obstructive pulmonary disease will be the chronic nature of the course of these diseases.

In addition, the market still needs innovative drugs with high efficiency, since existing drugs do not give the necessary result. Consumers, most of whom are patients, are willing to pay the appropriate price for innovative medicines with an increased efficacy profile.

Manufacturers of asthma inhalers protected by various patents will continue to take measures to reduce the level of competition. Along with this, generic drugs with devices for spraying the active substance that do not violate patents will be developed. Key medicines of this group, for example Advair™/Seretide®/Seretide™ (fluticasone + salmeterol) and Diskus®/Singulair™ (montelukast), will face competition from generic versions after the loss of patent protection in the United States in 2011 and 2012, respectively. Thus, it is expected that the growth of spending on drugs of this group may slow down to 2-5% per year.

Drugs that regulate the level of lipids in the bloodIt is expected that the increase in spending on medicines that regulate the level of lipids in the blood will decrease to 2-5% per year.

This will mainly be due to the expiration of the patent protection of key drugs of this group. Sales of Lipitor®/Liprimar/Lipitor (atorvastatin) in the USA are expected to suffer from competition from generic versions as early as 2011. Sales of medicines whose patent protection period expired even earlier have already felt pressure from generics. In addition, even the sales of patented drugs are affected by the emergence of new generics, since patients make a choice based on the cost of the drug, and do not always purchase a drug with the same active ingredient as the expensive original. Some innovative medicines that were in the process of development could not receive regulatory approval. However, the launch of several innovative drugs is expected in the near future.

Drugs based on angiotensin inhibitorsThe key driver of the increase in the cost of drugs based on angiotensin inhibitors is their higher efficacy and safety compared to angiotensin receptor blockers.

New drugs, including direct renin inhibitors, as well as various combinations of already existing active substances, the release of which has occurred over the past few years, have not been widely distributed. A large number of patients suffering from hypertension contribute to an increase in the cost of these drugs, but it can be slowed down to 1-4% per year by the end in 2012 of the patent protection period of one of the best–selling drugs in this group - Diovan®.

Portal "Eternal youth" http://vechnayamolodost.ru20.07.2011

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