Multiple sclerosis (MS) treatment is on the cusp of change. For the last decade, use of interferon betas (Avonex, Betaseron and Rebif) and Copaxone (together commonly known as the ABCRs) have been entrenched in the MS armamentarium. With numerous years on the market, robust efficacy and a favourable safety profile, these first-line agents have grown into significant blockbuster brands for their developers. In 2011, these therapies accounted for over 85 percent of the $12.3-billion global MS market. Since 2004, only two novel disease-modifying therapies have been introduced – Biogen Idec's Tysabri and Novartis' Gilenya - although these drugs have encountered their own safety issues and are yet to break the stranglehold of the ABCRs.
However, over the next few years this dominance will end, beginning with the entry of new pipeline products and eventual biosimilar/generic incursion of the ABCRs. FirstWord takes a look at the 2011 revenues of MS developers and, using consensus forecasts from brokers, compares them to the projected 2016 sales. From research undertaken by FirstWord, for its recent Multiple Sclerosis: Consensus Outlook report, the leading developers in the MS market in 2011 and 2016 are listed below.
Winners: Biogen Idec and Novartis to become future leading MS developers
According to consensus forecasts, Biogen Idec and Novartis will become the leading developers in MS in 2016. In 2011, Biogen Idec stood as the second highest grossing company in the field in terms of revenue behind Teva. However, unlike Teva, Biogen Idec's MS revenue is not dependant on a single product; the company has leading interferon Avonex and Tysabri - the most efficacious approved therapy in MS - generating combined sales of $3.3 billion. Moreover, the drugmaker has a deep and diverse pipeline with the potential blockbuster BG-12, a monthly formulation of Avonex, CD25-monoclonal antibody daclizumab and an interest in ocrelizumab. This ongoing focus and commitment to MS is expected to reap rewards for the biotech company, and by 2016, Biogen Idec will usurp Teva to become the number one player in the MS space.
Novartis is predicted to become the dark horse in MS in the future. With a modest start in the form of the launch of Extavia, an identical interferon beta-1b to Bayer's Betaseron, the Swiss drugmaker is set to become the second highest grossing company in MS in 20126 with worldwide sales of $2.5 billion. The majority of Novartis' revenue will stem from Gilenya - the first oral, disease-modifying therapy in MS - launched in 2010 and 2011 in the US and Europe, respectively. Although, there have been recent cardiac problems encountered, Key Opinion Leaders (KOLs) interviewed by FirstWord expect uptake to slowly increase as neurologists gain more experience with its use and no safety issues break. The need for a less invasive and effective therapy remains, and Gilenya satisfies these requirements.
Losers: Teva, Merck KGaA and Bayer fortunes will fade
In 2011, Teva, Merck KGaA and Bayer generated $7.2 billion from MS sales, accounting for nearly 60 percent of the market. However, by 2016 their combined revenues will decline to $4.7 billion, only 27 percent of the global value. As the dynamic in MS shifts, these companies will be unable to offset the loss of sales from existing products through pipeline therapies. The discontinuation of oral cladribine in 2009 was a major blow to Merck, and along with Bayer, the companies will not launch any MS pipeline products in the upcoming years, while Teva can only expect modest sales from laquinimod at best. This failure to plug the pipeline and protect the MS franchise will make it harder for Teva, Merck and Bayer to retain patients and thus revenue.
New stars: Sanofi will emerge as a key player in 2016
Once in competition with Novartis to launch the first oral disease modifying therapy in MS, Sanofi has steadily been moving towards the commercial arena with the oral, once-daily Aubagio and Lemtrada. Aubagio, approved earlier this week, has somewhat slipped under the radar, but one KOL suggested to FirstWord that Sanofi may have a 'sleeper' product on its hands. While Lemtrada, acquired through the Genzyme takeover, is likely to find a position in the treatment algorithm despite the recent refuse-to-file letter from the FDA. However, for both drugs, commercial success will be dependant on how the French company prices the products, with Sanofi potentially tempted to stay close to the high price of existing therapies. KOLs believe sensitivity on this front will be necessary particularly as uptake is likely to be driven by positioning as a combination agent in the case of Aubagio, or use as a last-line therapy, in the case of Lemtrada. Combined sales from Sanofi and its subsidiary Genzyme are expected to reach just over $2.0 billion by 2016.
Over the next decade, the current dominance of first-line therapies is set to end as competition grows. Unfortunately, developers that have failed to add to their MS franchises are expected to see a decline in revenue as biosimilars and new more efficacious and less invasive therapies cannibalise sales. With end of an era for interferons and Copaxone, those developers that will launch new first-in-class therapies or which offer notable improvements in terms of efficacy and safety over existing therapies will take significant share of the $17.3-billion MS field in 2016. With the lucrative market continuing to grow, the search for new products will persist, predominantly as the desire amongst payers for innovative or more effective products is only going to increase and give patients more choice.
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