By Joseph Pategou
The hepatitis market is experiencing a revolution due to new types of treatments, and patients are benefitting. Where are we with this global disease?
What is hepatitis, and why is it a problem?
Hepatitis is an acute or chronic inflammation of the liver. It is an international public health problem comparable to that of other major communicable diseases such as HIV, tuberculosis, and malaria. It is caused by five distinct viruses (hepatitis A, B, C, D, and E) that have different modes of transmission and evolve differently. In total, the viruses causes 1.4 million deaths a year. Of these deaths, roughly 47% are due to the hepatitis B virus, 48% to hepatitis C and the remainder to hepatitis A and E. Globally, it is estimated that 240 million people are chronically infected with hepatitis B and 150 million with hepatitis C.
Chronic hepatitis B and C are difficult to diagnose because most people with the disease are asymptomatic. They often go decades without showing any symptoms and therefore do not know that they are infected. Moreover, health workers are often not properly trained to encourage people to get tested or to refer them to appropriate health care services if they are found to be infected.
The current plan
The World Health Organisation has published a draft global health sector strategy on viral hepatitis for 2016-2021. The strategy describes the health sectors contribution toward the elimination of viral hepatitis as a public health threat. The priority measures are organised into five strategic orientations:
- Information for focused action: developing a strong strategic information system to understand the epidemic and focus the response.
- Interventions for impact: defining essential, high-impact interventions on the continuum of hepatitis services that should be included in health benefit packages.
- Delivering for equity: strengthening health and community systems to deliver high-quality services to achieve equitable coverage and maximum impact.
- Financing for sustainability: proposing strategies to reduce costs, improve efficiencies, and minimise the risk of financial hardship for those requiring the services.
- Innovation for acceleration: promoting and embracing innovation to drive rapid progress.
The global hepatitis drugs market
The spending in the global hepatitis drugs market accounted for 22-25 billion USD in 2016 and is expected to grow at a CAGR (compound annual growth rate) of 29.7% during 2016 – 2020. Among the various types, the hepatitis C segment has dominated the global hepatitis drugs market with more than a 70% share in 2014. It is predicted that the value of hepatitis B will increase slowly and reach 3.5 billion USD in 2021 at a CAGR of 2.3%.
The global market for hepatitis drugs is growing. This is due to the increase in incidences of hepatitis, greater support from government organisations, more awareness about various types of hepatitis infections and their management, and the growing number of collaboration and partnerships. The increase in R&D (Research and Development) investments in hepatitis research and drug discovery are also driving the growth of the market. The pharmaceutical industrys R&D pipeline was valued at 493 billion USD, with Gileads combination hepatitis C product the most valuable at 24.8 billion USD.
Market-spurred innovations
The market has seen the emergence of revolutionary treatments for hepatitis. Small biopharmaceutical companies are working hard to treat hepatitis B. ENYO Pharma announced the successful initiation of the Phase 1 clinical program with EYP001, its leading candidate for the treatment of chronic hepatitis. Novira Therapeutics has NVR 3-778, a potential first-in-class treatment which is well-tolerated by patients with chronic hepatitis B. Knowing that 240 million people are infected by hepatitis B virus, this is an exciting time for patients and physicians who will have new treatments option in the future.
In addition, therapeutic progress has made it possible to cure hepatitis C with only a short treatment. Gilead was the first to introduce two revolutionary drugs- Harvoni and Sovaldi. This was a real turning point in the management of hepatitis C. These two drugs were best-selling products within 1 year from launch, helping Gilead in becoming the leading player in the oral HCV market, holding 95% in 2015. AbbVie, with a market share of 5% in 2015, is the second player in this market with two drugs- Viekirax and Exviera.
A new player enters the game
These two leading companies in the hepatitis C landscape have seen the emergence of a strong competitor: Merck & Co with the drug Zepatier. With its clinical profile and highly competitive price 40% lower than Harvoni in France, Zepatier has shaken up the hepatitis C treatment space formerly dominated by Gilead. We have started to see the response of competitors in price negotiation. In particular, AbbVie reduced its price by 32%. Gilead has replied by launching a new drug called Epclusa, which combines the older Sovaldi medication with the newer Velpatasvir. It can be used by patients with any of the six genotypes of hepatitis C for a 12-week treatment. The price offer by Gilead is less than the list prices for both Sovaldi and Harvoni. This new drug may help Gilead reinforce its lead.
The benefits of healthy competition
In France, access to effective treatment for all patients with hepatitis C has received the “favourable” opinion of the Haute Autorité de Santé (HAS). This is a game changer because costs of the newest generation products introduced in late 2013 were high. It also represents a dramatic shift in the allocation of healthcare resources in a short period. In the top 5 European countries estimation of total expenditures for treated patients reached 7.7 billion USD in 2015. Competition is clearly visible both in terms of price and therapeutic innovation. This has brought more patients access to treatments.
Joseph Pategou is a consultant specialising in the pharmaceutical industry at Wavestone.
Featured Image Source: Agoramedia