The pharmaceutical industry has been growing at a rate of more than 8% a year since 2003. In future, there are signs of continued growth driven by aging populations, demand for ever-improving healthcare, and the expanding markets in emerging countries.
As people live longer in developed countries, the percentage of the population consisting of elderly people is increasing. For example, more than one in five of the population in Japan, Italy, France, and Germany will be 65 years or older by 2020 (see Fig. 1). An aging population has a significantly greater need of healthcare and so represents a big potential market for pharmaceuticals.
Meanwhile, in emerging countries, sections of the population are demanding the kind of healthcare standards found in the richer countries. India, for example, has a growing middle class with high spending power. Diet is changing too – sometimes for the worse. As Indians move away from their traditional foods, the prevalence of type 2 diabetes is soaring, caused by poor diet and lack of exercise. About two thirds of all cases worldwide are now found in the Asia Pacific region with China alone having 40 million sufferers.
Type 2 diabetes is just one of the metabolic diseases that is increasing around the world. Obesity is also rising, and according to one estimate, two out of three Americans are overweight or obese and 12% of US healthcare costs is related to obesity.
Role of biopharmaceuticals
Here are some of the treatment areas targeted for future growth by pharmaceutical companies:
- Obesity/diabetes/metabolic diseases
- Alzheimer’s disease & memory
- Antiaging
- Anti-infectives (because of rising antibiotic resistance)
- Wellness (preventive/predictive cure)
Many new treatments will be based on biopharmaceuticals, not conventional synthetic drugs developed by chemical routes. Biopharmaceuticals have the advantage that they can be specifically targeted towards a particular disease or area of the body. Biopharmaceuticals constitute 11% of the current drugs on the market and 32% of all
drugs under development. The drug development process, however, is long and expensive: The average time for development is 12 years, and the average cost is USD 1.2 billion.
Not surprisingly, the biopharmaceutical industry is seeking to reduce costs and the time to market. Novozymes Biopharma is uniquely positioned to address the needs of this industry through its innovative products and technologies. These improve the safety and stability of a drug product while streamlining drug development.
One solution for the future is the development of single reliable host expression and
manufacturing platforms to produce a number of molecule entities across a biotherapeutics portfolio including proteins, peptides, antibodies, domain antibodies, etc. Such systems can help to lower production costs in commercial-scale manufacturing.
Formed in 2007
Novozymes has huge knowledge and expertise developed over the years in the industrial biotech field. The company is ranked as the seventh largest biotech company in the world in terms of sales and is best known as the market leader in industrial enzymes. Novozymes Biopharma was formed in 2007 to become a dedicated force within Novozymes for serving the pharmaceutical industry. Novozymes’ core capabilities in recombinant protein production and large-scale biotech processes are equally applicable to the production of biopharmaceuticals as to the production of enzymes.
Novozymes supports pharmaceutical companies with innovative recombinant products and technologies. Novozymes Biopharma also has a large manufacturing capacity with cGMP (current good manufacturing practice) capabilities around the world in Denmark, Sweden, the UK, and China (under construction). For example in the UK, Novozymes has developed its own safe and reliable high-yielding yeast expression systems that can be outlicensed or used for contract manufacturing.
Novozymes Biopharma operates in four main areas:
- Recombinant albumin is used in drug formulation to make better drugs and medical devices
- Albumin fusion technology for extended drughalf-life and greater compliance
- Hyaluronic acid is used to make superior drugs and medical devices
- Various recombinant proteins plus Protein A for better drug production in mammalian cell culture
The different areas are unified by leveraging Novozymes’ industrial microbial biotechnology capabilities and biopharma insight.
Recent successes
In the last 12 months, there have been some notable successes. In August 2008, Novozymes Biopharma launched CellPrime® rTransferrin AF – the world’s first microbially expressed recombinant human transferrin made to cGMP standards. The new product provides an animal-free alternative to current products used in mammalian cell culture
for the production of biopharmaceuticals.
Then CellPrime rAlbumin AF-G was launched in April 2009. This supplement is used in largescale mammalian cell culture for biopharmaceutical production and is produced under ISO certification.
In addition, a licensing and collaboration agreement was signed in December 2008 with
sanofi-aventis for the further development and marketing of the antimicrobial peptide plectasin. The drug candidate Plectasin NZ2114/SAR215500, discovered by Novozymes in 2002, targets the treatment of severe infections such as pneumonia and septicemia caused by Staphylococcus and Streptococcus. This is the first drug candidate that
Novozymes has outlicensed for further preclinical and clinical development. The expertise of sanofiaventis in the development, marketing, and sales of pharmaceuticals complements Novozymes’ expertise in protein discovery, gene modification, and the expression of proteins and peptides. Plectasin comes from the fungus Pseudoplectania
nigrella. It was isolated from other proteins secreted by the fungus using the screening and selection procedures refined by Novozymes for use in its enzyme business area.
Another recent deal was with ConjuChem for the supply of Recombumin®, the world’s first commercial animal-free recombinant human albumin approved for use in the manufacture of human therapeutics.
New cGMP HA facility
In April 2009, Novozymes conducted the groundbreaking for a dedicated new cGMP
facility in Tianjin in China for the production of pharmaceutical-grade hyaluronic acid (HA). HA is a polysaccharide that occurs naturally in the body and is found in certain tissues. It has exceptional water-binding and remarkable viscoelastic properties, making it useful as an excipient in drugs and medical devices. Production of pharmaceutical-grade HA will start in 2011 but pilot process samples are already available.
A growing market
Novozymes Biopharma is in a strong position to benefit from the growing wave of biopharmaceuticals by supplying and partnering with companies that produce this type of drug. The goal is to build a world-class business that will impact the biopharmaceutical world by delivering innovative solutions. Novozymes Biopharma aims to carve a niche for itself as a leading provider of recombinant products and technologies. Recent successes
show that it is already on the way.