Market & Prevalence
The global pharmaceutical industry has experienced an unpredicted amount of challenges and changes over the past several years. Global market growth is trending down and the current pace is below the historical 5 year average. The slowing trend is noteworthy along with the stark contrast between the slowing overall growth of the developed markets of Europe and North America which are expanding at the rates below the 3% and the significantly higher growth rates of pharmaceutical markets in developing countries.
The total level of pharmaceutical revenue worldwide has reached nearly US$ 1 Trillion. North America is responsible for the largest portion and generating more than 40% of these revenues. This is mostly due to the leading role of the U.S. pharmaceutical industry. The other industries like the Chinese pharmaceutical sector shows the highest growth rates over the last years.
The leading pharmaceutical companies come from the United States and Europe. In 2013, Johnson and Johnson (J&J) was the largest pharmaceutical company based on annual revenues. J&J generated revenues of over US$70 Billion. The other top global players from the United States are Pfizer Merck & Co. and AbbVie. Novartis and Roche from Switzerland, GlaxoSmithKline and AstraZeneca from the United Kingdom, and French Sanofi are the European big five.
The total sales generated by anti-TNF drugs was 18% of the total therapeutic market revenue in 2015. Humira, generated over US$ 16 Billion of revenue worldwide. Oncologic continue to be the leading therapeutic class based on revenue. In 2015 the cancer drugs market surpassed US$ 100 Billion of revenue globally. Other major therapy classes were pain drugs, antihypertensives and antidiabetics.
Among all the diseases which are treated by the anti-TNF drugs, the rheumatoid arthritis disease market is the largest. Rheumatoid arthritis is a chronic, debilitating disease which affects around 2-3% of the world’s population.
The market for disease modifying rheumatoid arthritis therapeutics is expected to increase from US$ 56.6 Billion in 2013 to US$ 80.7 Billion in 2020, at a Compound Annual Growth Rate (CAGR) of 5.2%. First line Disease Modifying Anti Rheumatic Drugs (DMARDs) are expected to remain stagnant, as the late stage pipeline mainly constitutes the second line therapies. The high number of clinically and commercially strong products in the current market represents a barrier for the market infiltration of such emerging therapies.
The prevalence is expected to grow to just over 8.5 Million individuals by 2023. The anti-TNFs have been effective in treating the signs and symptoms of rheumatoid arthritis and inhibit progression to erosive bone diseases. Anti-TNFs are extremely effective therapies for rheumatoid arthritis and the market is extremely competitive for new entrants.
Market of Anti-TNF Blockbuster Drugs
Cytokine modulators, such as Rituxan and Xeljanz are growing in popularity as promising substitutes to TNF-α inhibitors. It is becoming far more difficult to find a place in this market for emerging companies and their candidate drugs. The three TNF specific monoclonal antibodies, Humira, Remicade and Enbrel, ranked among the ten best selling drugs in the world in 2015 and ranking in revenues amounting to US$ 14.01 Billion, US$ 8.3 Billion and US$ 9.47 Billion respectively. Appendix 1 outlines the global revenues for Enbrel, Humira and Remicade in 2015, 2016 and expected global revenues for these therapies in 2020. It also illustrates potential royalty revenues based on different royalty assumptions for these drugs.