Global protein therapeutics market: beefing up towards futuristic growth

Shushmul Maheshwari

RNCOS E-Services Pvt Ltd

The global pharmaceutical market is foreseeing an upcoming era of scientifically engineered proteins in the laboratory, known as ‘Therapeutic Proteins’ for usage in pharmaceutical purposes. These proteins are synthesized by large-scale cultivation of genetically engineered host cells, which translate artificially transected genes encoding for the proteins of interest. The majority of biopharmaceuticals marketed so far are recombinant therapeutic protein drugs, which are used to relieve patients suffering from chronic diseases, such as cancer, diabetes and cardiovascular diseases, infertility, cystic fibrosis, etc.

The launch of first recombinant protein therapeutic “human insulin”, around 25 years ago, has led to a considerable increase in the number of protein therapeutics. According to our new report, “Global Protein Therapeutics Market Analysis”, the therapeutic proteins market is estimated to increase by around 9.6% from 2010, to reach a value of around US$102.4 Billion in 2011. This growth is supported by the high efficiency of therapeutic proteins due to their targeted approach devoid of side effects on the human body to a large extent, the increasing prevalence of chronic diseases, and significant on-going research for improving the drug delivery mechanisms of the therapy.

Figure 1: Global Protein Therapeutics Market (Billion US$), 2010 &amp, 2011

Source: La Merie, RNCOS, Note: e = RNCOS Estimation

Looking at the geographical scenario of the industry, the US continues to dominate the protein therapeutics market, followed by the European countries. While the Asian and Middle-Eastern regions are the emerging protein therapeutics markets, due to improving economic scenario and financial capability of people.

“…the therapeutic proteins market is estimated to increase by around 9.6% from 2010, to reach a value of around US$102.4 Billion in 2011.”

According to our report, the protein therapeutics market is varyingly dispersed among various different segments, each occupying proportional share of the market. The monoclonal antibody (mAb) market was estimated to be holding the largest market share by the end of 2010, almost three times the share of the insulin market, which was the second largest segment. Follicle Stimulating Hormone (FSH), with a market share of around 1.3% had the lowest market share.

Figure 2: Global – Protein Therapeutics Market by Segment (%), 2010

Source: La Merie

As per our segment-wise market analysis, mAbs is also one of the promising segments of the protein therapeutics sector, with an estimated market value of around US$48.5 Billion by the end of 2011. This segment has a wide range of applications including Oncology, Immunologic and Inflammatory Disease, Cardiovascular, Infectious Diseases, and other chronic diseases majorly in the US, European, and Japanese markets. Blockbuster potential, faster development time, and health insurance are the potential driving forces for the segment, in spite of the existing challenges of high therapy costs, manufacturing issues, and a special spectrum of side effects.

Further, due to the rising cases of diabetes, explicitly in India, China, US, Russia, Brazil, and Germany, Insulin is the next market dominating the protein therapeutic industry. Our study indicates that the global sales of major insulin and insulin analogues brands has been estimated to be US$17.9 Billion by the end of 2011 from around US$10.9 Billion in 2008. Other segments of the protein therapeutics sector include EPO, IFN, HGH, blood clotting factor, FSH, and G-CSF.

Coming over to the players, the industry is well-equipped with many key players trying to dominate the market by adopting novel technologies and launching new products. One of the recent developments of Johnson &amp, Johnson, and its subsidiary, Centocor Ortho Biotech Inc. along with Merck include the amendment of distribution rights to REMICADE® (infliximab) and SIMPONI® (golimumab) for the treatment of chronic inflammatory diseases, such as Rheumatoid arthritis.

“…mAbs is also one of the promising segments of the protein therapeutics sector, with an estimated market value of around US$48.5 Billion by the end of 2011.”

Genentech and Biogen Idec also announced that the US FDA has approved Rituxan® (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener’s Granulomatosis and Microscopic Polyangiitis. Other competitors in the market include Eli Lilly &amp, Company, Roche Group, Sanofi-Aventis, and Amgen Inc.

Table 1: Major Key Players and their Drugs in the Protein Therapeutics Market

Emerging market trends and futuristic scope

It is likely that the protein therapeutics market will dominate the pharmaceuticals industry in future. Although the protein therapeutics market is significantly smaller than the pharmaceutical market, the comparative growth of the protein therapeutics market is considerably higher than the overall pharmaceutical market growth. The major factors expected to drive the industry in coming years include aging population and increasing prevalence of chronic diseases, increasing penetration of health insurance, growth of next-generation products with reduced immunogenicity, greater effectiveness, and improved safety of products. As per our research, it is expected that the protein therapeutics market will grow at a CAGR of around 13% during 2012–2014, reaching revenue of around US$145 Billion by 2014.

The protein therapeutics industry will flourish with the advent of ‘synthetic biology’ which involves the development of therapies by designing the required protein structure synthetically. Apart from the private companies, the researchers at the Universities and research centers are also working actively in this field to develop therapies for HIV/AIDS, cancer, and neurological disorders. Further, owing to their higher specificity and effectiveness as compared to other drug forms, protein therapies are rapidly shifting the focus of the pharma industry towards them.

“…global sales of major insulin and insulin analogues brands has been estimated to be US$17.9 Billion by the end of 2011…”

However, there are certain roadblocks in the pathway of large-scale commercialization of protein therapies, which includes the tendency of highly sensitive protein therapies to degrade under normal environmental factors. To overcome this problem, the companies need to initiate redesigning and structural engineering of the protein molecules to make them resistant to environmental changes. Besides, big pharma players should begin adopting the use of nanostructures as an effective delivery system for protein therapies, thereby increasing the dissolution rate of the therapies.

About the Author:

Shushmul Maheshwari is the Chief Executive of RNCOS E-Services Pvt Ltd, a market research and Information analysis company with global presence. He has spent more than 19 years working in the senior management teams of both, Indian and multinational companies. He has gained expertise in research and analysis field and actively participated in various national and international conference and discussions organized by business and trade-related associations.

Email: shushmul@rncos.com

What hurdles need to be overcome in order to achieve large-scale commercialization of protein therapies?