4 min readChanging Dynamics in the European Non-Hodgkin’s Lymphoma Market
Over the years, MabThera has been recognised as a ‘wonder drug’ for NHL treatment. Consequently, it has become the biggest cash cow for Roche/Genentech/Biogen Idec with global sales of about $5 billion in 2007. In fact, the penetration of MabThera for the treatment of first line aggressive cases in the key five European countries of U.K, France, Germany, Spain and Italy is about a staggering 84%.
CHOP chemotherapy is the major therapy indicated for most forms of NHL. The drugs used in this regimen are: Cyclophosphamide, Adriamycin,Vincristine, Prednisone. However, it is highly genericised with limited prospects for revenue growth. Currently MabThera with CHOP chemotherapy is the standard treatment for NHL. However, market dynamics are poised to change in the near future due to the anticipated launch of many promising pipeline drugs.
European NHL Market
Non-Hodgkin’s Lymphoma Therapeutics Market: Market Share Analysis by Revenues (Europe), 2006
Monoclonal antibody immunotherapy clearly dominates the European NHL market with almost 81% market share in terms of revenues. Large number of generic players in chemotherapy space is the reason for just 18% revenue share. Radioimmunotherapies are yet to gain any significant acceptance among oncologists.
The European sales of MabThera grew at about 23% in 2006. However, this growth is expected to decrease over the coming years, since MabThera has already hit maturity phase in US & Japan. This could potentially hinder the overall market growth in terms of revenues. In order to maintain its lion’s share of the market, Roche has launched life cycle maximisation by positioning MabThera for other indications of NHL, as well as positioning it for Maintenance therapy. MabThera has also been recently approved for the treatment of rheumatoid arthritis which could boost its future growth. If Roche finds success in its life cycle maximisation efforts for MabThera, it can easily retain market leadership position at least for the next 5-6 years. Furthermore, it must be noted that most drugs in the pipeline are being positioned as add-on combination therapies with MabThera or CHOP chemotherapy.
Stringent regulatory regime policies could prolong the market entry time for new drugs. Despite efforts by the FDA and EMEA to accelerate the drug approval process, there exists a backlog for new drug approvals. This backlog seems to hamper innovative drug research and development process, since it has an adverse impact on investor’s confidence. For instance, companies such as Favrille and Genitope are facing mounting operating expenses due to high investments in research. Any regulatory setback could jeopardise their business sustainability.
Entry of Radio-immunotherapies
Another promising radio-immuno therapy is Bexxar from GSK. It is marketed in Europe by Amersham Health which has been recently accquired by GE Healthcare. In the US it is marketed by GSK.
Way to go
The EMEA and US FDA have indicated that true survival benefits would be the standard for regulatory approvals. Hence, pharmaceutical or biotech companies should focus only on those drugs which truly improve patient survival rates. This would bolster their regulatory approval process.
Big Pharma should evaluate opportunities to in license or acquire molecules in order to supplement their pipeline. It must be noted that major investments in the oncology space are coming from small to medium sized biotech companies. Investments in R&D by big pharma are not yielding desired results. Hence, in-licensing would be a viable option for them. In fact, this would be a win-win situation for both.
For instance, in December 2006, GlaxoSmithKline and Genmab entered into a worldwide agreement to co-develop and commercialize HuMax-CD20 (ofatumumab). This not only strengthens GSK’s existing pipeline but also compliments their NHL drug Bexxar, since both these drugs are for the same target population. HuMax-CD20 is the most promising piple line drug for NHL, and a potential block buster candidate. It is eagerly watched by the industry players.
On the other hand, small sized biotechnology companies should focus on their core competency in research. Though NHL is a niche market and may not require huge marketing budget, small sized research focused biotech companies should look for marketing alliance with a stronger partner to ensure commercial success of their promising drugs. Furthermore, many of the small sized research-focused biotech companies are already in huge debts. Their sales & marketing experience is limited. Hence, such strategic alliances would minimise drug development risk and maximize product reach.