Production of biological products: who does not take risks, he does not win

Biofarmation through the prism of market realitiesAnna Shibaeva, "Weekly PHARMACY"
Over the past few centuries, science has made great strides.

In this regard, the XX century has broken all records, in its second half every subsequent decade, the amount of scientific knowledge has doubled. In the conditions of rapid development of biotechnologies, pharmacy was inevitably involved in these processes. It is behind the so-called living biopharmaceutical technologies that the vital interests of the people of the modern world and the key demands of our century stand. Among the main advantages of the biopharmaceutical market is the rapid and efficient development of production capacities, the development of effective drugs.

History of the development of biotechnologies in pharmacy

Ten years after the discovery of deoxyribonucleic acid (DNA) in 1953, Francis Crick and James Watson proposed the structure of the DNA double helix. In the 60s of the last century, a technique was developed for breaking and forming bonds between molecules in the DNA chain and isolating its individual fragments. This technique made it possible to extract certain genes (and even synthesize proteins) from various organisms (in particular bacteria). In 1973, for the first time, experiments were conducted to obtain recombinant DNA – a DNA molecule obtained as a result of combining in vitro foreign (never existing together in nature) DNA fragments as part of a vector using genetic engineering methods. The first biotech company, Genentech, was established in 1976.

In the 1980s, the commercial production of the first biological products, recombinant human insulin, started. In 1982, a recombinant DNA vaccine for animals was developed.

The revolutionary technique of medical DNA diagnostics - polymerase chain reaction – was invented in 1983. This technique made it possible to diagnose all diseases and their pathogens, including mutated DNA cells. In particular, with the help of polymerase chain reaction, it was possible to diagnose diseases such as cystic fibrosis, Duchenne myodystrophy, Huntington's disease and others. In 1986, the first biopreparation for the treatment of oncological diseases, interferon, was released.

I would also like to mention such an important milestone in the history of biotechnologies as the Human Genome project, which paved the way for the development of gene therapy. In 1999, human stem cells were cultured in laboratory conditions. In 2003, the gene studies were completed.

Risk is a noble cause

Biofarmation can be safely attributed to one of the most risky business directions in the investment aspect of the modern economy. However, thanks to the revolutionary solutions that this industry offers to Big Pharma, its positions are getting stronger day by day.

If in 1998 the volume of the global pharmaceutical market, including biologics, was US$ 304 billion, then by the end of 2009 this figure was almost three times higher – US$ 810 billion. In 1998, the share of biologics in the global pharmaceutical market was only 5%, and 11 years later, due to the advanced pace of development of the segment, it reached 11% (Fig. 1).

According to IMS Health forecasts, in 2012 the total volume of global sales of pharmaceutical products will amount to $ 937 billion, and the share of biologics will reach 14%. Moreover, in 2009-2012, the average annual growth rate of sales of the global pharmaceutical market as a whole is projected at 5.4%, at the same time for the segment of biological products, this indicator is much higher – more than 12% per year.

Literally at the end of the last century, biotechnologies were associated mainly with recombinant biologics and antibodies, and today biotechnological companies are paying more and more attention to developments in the field of genetics and other areas of biology to create so-called small molecules. After the expiration of the license for these drugs, their chemical structure is easily reproduced by generic companies. In fact, the whole process from the development to the introduction of the drug to the market consists of 2 main stages – clinical and industrial (Fig. 2).

It takes an average of about 10-15 years and about $1 billion to develop a new drug (taking into account the costs of unsuccessful attempts). The process of testing the safety and effectiveness of a new drug is extremely complex and consists of many stages. It usually begins with laboratory and animal testing, followed by human clinical trials, regulatory testing and, if the product is approved, post-marketing studies and observations. Each new drug goes through several stages of clinical trials. Early trials (phase 1) consist of testing the safety of the drug on small groups of healthy volunteers. The purpose of the larger interim trials (Phase 2) is to obtain preliminary performance data. The final stage of pre-marketing testing (phase 3) is carried out to obtain convincing data on the effectiveness of the drug in relation to the target population of patients for whose treatment it is intended. In case of successful completion of clinical trials, the next step is to request official approval from the U.S. Food and Drug Administration (FDA). Each approved drug receives an official standard form instruction, the content of which the FDA develops together with the marketing company.

As already noted, the vast majority of biological products are subject to the jurisdiction of the FDA and are regulated by the Law on Public Health Services. For the release of new drugs to the market, it is necessary to obtain approval for their use.

According to forecasts, over 80 new biologics are expected to be introduced to the market in 2009-2012, as a result of which the total number of biologics approved by the FDA on the world market will reach 231 (Fig. 3).

Biopharmaceutical capacities

The biopharmaceutical market, as one of the most knowledge-intensive, has a high potential for further development. What does the prospect of developing production capacities look like? By 2011, the world's biopharmaceutical capacity is expected to increase to 4.05 million liters (Fig. 4). Note that in 2009-2010, the annual growth rate of capacity is projected at about 10%, and in 2011 – 11%.

According to estimates, until now, the volume of market capacity has constantly prevailed over demand, which indicates the growing needs for biotechnologies in the pharmaceutical market. Such a gap between demand and capacity is characteristic of the emerging market. However, already in 2009-2011, it is expected that the demand for biologics will develop at a faster pace relative to the capacity of the biopharmaceutical market – by 41 and 35%, respectively. In this case, it will be possible to talk about further harmonization of the biopharmaceutical market and its stabilization.

According to the announced projects, in 2009-2012, about 10 billion euros will be invested in the construction of new and expansion of existing capacities for the production of biopharmaceutical products. The key regions in this direction will be North America (3.8 billion euros), Europe (3.0 billion euros) and Asia (3.2 billion euros). It should be noted that while in the first two regions, capital investments will mainly be directed to expanding existing capacities, in Asia - to construction. Moreover, half of the projects in the Asian region involve the construction of production facilities in Singapore.

The ways of generics are inscrutable

Due to the rapid development of the generic direction of the pharmaceutical industry, when considering the market of biological products, it is also necessary to take into account the very capacious potential of the segment of similar biological products.

Bioengineering – bioequivalent products based on similar substances that are used in the manufacture of generic biological drugs. The main biological products were classified into such classes as growth hormones, colony stimulating factor and erythropoietin.

The formation of the market for similar biological products is not very fast due to regulatory peculiarities in this area, in particular, in many countries, the policy of protectionism of the patented segment of the biopharmaceutical market is still supported. However, in the conditions of rapid development of the market of branded biopharmaceuticals, as well as due to the loss of patent protection by some blockbusters, the potential of the segment of similar biologics will increase in the near future. In addition, the regulation of the bioengineering market is expected to ease in the USA and the European Union.

According to estimates in 2009 the volume of the global market for similar biological products amounted to about $ 2.1 billion. In 2009-2014, this indicator is projected to increase to $19.4 billion.

Why biologics?

The aging of the population and the accompanying increase in morbidity are serious prerequisites for the further development of the biopharmaceutical market. The spread of numerous diseases of various therapeutic groups encourage manufacturers to continuously search for new methods of treatment. In particular, the powerful potential of the biopharmaceutical industry lies in the oncological field.

Further development of the biopharmaceutical market will take place through the introduction of new products to the market, as well as remarketing of existing ones as their patent protection expires.

The lack of innovative solutions in the pharmaceutical industry and the high level of competition from generic drugs generates additional demand for biologics, which, however, are characterized by higher development and production costs compared to conventional pharmaceuticals. Therefore, recently there has been a significant increase in the inflow of investment capital into the field of biopharmaceutical technologies.

The publication is based on data on the development of the global biopharmaceutical market published in the report of the French Association of Pharmaceutical Companies LEEM (Les Entreprises du Medicament), as well as data from the MarketsandMarkets website.

Portal "Eternal youth" http://vechnayamolodost.ru18.03.2010