The fastest growing segment of the biological pharmaceutical market is the treatment of chronic inflammatory conditions. These conditions include diseases of ageing, which are increasing as the population grows older. This trend is evident in affluent Western societies and in high-growth economies in Asia.
Chronic inflammation can be caused by autoimmune diseases. Autoimmune diseases affect millions of people globally. The market is large in terms of patients requiring treatment, and potential to generate revenue.
Although the current use of anti-tumour necrosis factor (TNF) for a selection of autoimmune diseases is well established, there are still large resources devoted to finding other drugs to treat rheumatoid arthritis and other autoimmune diseases.
Anti-tumour necrosis factor drugs are also coming off patent, and there are indications that generic antibodies are being developed in the US, Europe and China to enter this market. New drugs under patent will have a significantly longer life of premium pricing compared to existing biological treatments.
In 2017, three of the top 10 drugs globally were for the treatment of autoimmune diseases, specifically rheumatoid arthritis, psoriasis and Inflammatory Bowel Disease (IBD).
These three drugs alone represented approximately $US35 billion in global sales.
NEW DRUG DEVELOPMENT
A major issue with the use of proteins or other biological drugs is that the body eventually compensates for the induced metabolic imbalance, so new or different drugs are required.
Also, existing biological drugs used for treating autoimmune diseases appear to work only in 50% to 70% of patients. Furthermore, current immunosuppressive drugs used in the treatment of autoimmune diseases have demonstrated some significant adverse side effects.
This represents a medical problem and a commercial opportunity. Assuming each patient can continue with a biological drug even for five years, there is a need for new and better drugs to supplant an existing drug over the remaining lifespan of the patient – typically somewhere between 20 and 40 years.
The immune system is the body’s defence against bacteria, viruses and foreign substances generally. The immune system’s response includes the release of antibodies and proteins.
Autoimmune disease occurs when the immune system attacks healthy organs and tissues instead of attacking bacteria, viruses or other sources of infection.
Autoimmune diseases include:
Rheumatoid arthritis – Perhaps the best known and most prevalent autoimmune disease. It attacks the lining of the joints and causes inflammation, typically resulting in pain, reduced mobility and loss of dexterity. The condition is chronic, debilitating and progressive.
Psoriasis – The immune system mistakenly identifies areas of the skin as pathogens and reacts to accelerate skin cell replacement.
Inflammatory Bowel Disease (IBD) and Colitis - IBD is an inflammatory disease of the colon which results in severe diarrhoea, abdominal pain, fatigue, weight loss and potentially life-threatening complications. Types of IBD include ulcerative colitis.