Market Analysis - Biosimilars-euro 2018
The Organizing Committee is delighted to invite you to attend the 11th European Biosimilars Congress one of its remarkable Pharmaceutical conferences, to be held during June 04-06, 2018 in London, UK. European Biosimilars Congress 2018 brings together scientists, researchers and CROs from around the world.
Over the past several years, biologics have gained significant traction in the pharmaceutical industry, representing more than $150 billion in global sales in 2013. By 2020 they are predicted to generate $290 billion in revenue and comprise 27 percent of the pharmaceutical market. Forty-eight percent of sales come from 11 biologics that face loss of exclusivity over the next seven years. This, along with the increasing worldwide focus on improving health care access and the cost of care, presents an attractive opportunity for biosimilars manufacturers.
Analysts expect the worldwide biosimilars market to reach $25-$35 billion by 2020. Since the first biosimilar approval in the European Union (EU) in 2006, there are now more than 700 biosimilars approved (~450) or in the pipeline (~250) globally. In major markets like the EU, regulators and payers have recognized the potential financial benefit of biosimilars and are driving their uptake. For example, France has initiated automatic substitution of select biosimilars over the reference products.
In the United States alone, the cost savings from switching to biosimilars are projected to be between $40 and $250 billion over the next 10 years, with the first biosimilar to hit the US market expected to contribute about $5-7 billion in savings.
The recent recommendation by the United States Food and Drug Administration (FDA) to approve an oncology supportive care drug developed by Sandoz represents a landmark for the United States launch and commercialization of biosimilars.
Early biologics, such as insulin, erythropoietin (EPO), and growth hormones, have been invaluable in the treatment of serious illnesses such as diabetes, anemia, and renal diseases. More complex biologics, such as monoclonal antibodies (mAbs), cytokines, and therapeutic vaccines, are helping to revolutionize treatment of cancer, autoimmune disorders, and other difficult-to-treat diseases. For such higher-cost disease areas, biosimilars should be instrumental in expanding access to populations who need these therapies but are unable to access them today.
A global biosimilars strategy:
Developed markets: Developed markets, with the exception of the United States, represent the greatest biosimilars presence today. Most biosimilars manufacturers have been and remain focused on the developed markets – whether it is for their historic and current opportunities (EU) or for their future market potential (United States, Japan). Dedicated regulatory pathways set the foundation for stringent, abbreviated approval processes which, in turn, have fed investor enthusiasm. Biosimilars adoption in developed markets has been primarily payer-driven, especially in European markets, given payers’ urgent, unmet need to contain public health care expenditures. Further market uptake has been slowed by prescribers’ skepticism and low patient awareness. Still, developed markets continue to have the highest number of biosimilars molecules in development – estimated at 29 in Europe, 19 in the United States and seven in Japan.
Emerging markets: In today’s emerging markets, biosimilars are still nascent, with little to no presence. However, in contrasting emerging markets with developed markets, the limited patient access to affordable biologics and the openness of physicians to low-cost therapies may offer potentially significant opportunities. Today, emerging markets represent a snippet of total world biologic sales in value, less than seven to eight percent (versus 48.6 percent in the United States).ix Treatment rates for flagship biologics are still low compared to developed markets, despite existing demand. For example, the treatment rate of MabThera® in Brazil is three times lower than in the UK and six times lower than in the US.x Additionally, a recent Kantor Health Survey found that 20 percent of emerging market autoimmune patients use a biologic, with the distribution of biologics varying from 29 percent in China to 12 percent in Russia and a mere 6 percent in Brazil.xi This may indicate the presence of large pockets of non-consumption, especially within the growing middle class.
Analysis of selected countries:
- FDA approval of the first biosimilar in March 2015 with Sandoz’s Zarxio (filgrastim)
- About 19 pipeline biosimilar molecules in development
- Represents about 50% of the global biologics market value and generates about 50% of the sales value growth
- Pending legislative decisions on data exclusivity period, naming conventions and interchangeability likely to have important implications
- Most mature biosimilar market representing 80% of global biosimilar spending
- Performance to date viewed as “disappointing” by select manufacturers
- Nineteen biosimilar products authorized in four molecule classes: human growth hormone, erythropoietin, G-CSF and tumour necrosis factor (TNF)-inhibitor
- About 29 pipeline biosimilars molecules in development.
- World-class dedicated pathway leaving questions of substitutability at the pharmacy level to member states
- Payer-driven uptake
- Challenged by continued pressure from strict regulatory decisions, lingering fear from prescribers around biosimilars’ “similarity”, safety and efficacy, debates on automatic substitution and INN prescription.
- Limited maturity of the biosimilar market
- Dedicated regulatory pathway
- About seven pipeline biosimilar molecules in development
- Growth potential considered limited today based on the reluctance from both prescribers and patients as well as the general mistrust toward “generic makers”
- A push from payers, which has yet to be seen, may help open up the market.
- Led the way with the development of biosimilars regulations in Latin America and released biosimilars guidance in 2010
- Reducing the reliance on imported (and high-cost) medicines through policies that favor the expansion of the domestic pharmaceutical industry and public-private partnerships to expand access to drugs
- International companies have entered the market through partnerships and acquisitions (e.g., Pfizer’s 40% stake in Teuto, Sanofi’s acquisition of Medley and Merck’s joint venture with Supera, co-owned by Cristalia and Eurofarma)
- The regulatory environment and interest of domestic and international manufacturers are major drivers in expanding the biosimilars market.
- Approximately five biosimilar molecules in the development pipeline.
- Seventy-five percent of physicians surveyed in Brazil considered rituximab difficult to access due to high costs and 77% said they would increase prescription of rituximab if a cheaper alternative were available.
- Aims to boost its domestic pharmaceutical market and increase the market share of domestic players from 20% in 2012 to 50% by 2020
- The strong preference for local manufacturers will require international companies to engage in cooperative partnerships with Russian companies
- Indicative of the burgeoning domestic industry, a rituximab biosimilar, developed by Russian company Biocad, was the first mAb biosimilar approved in Russia in April 2014
- About eight biosimilar molecules in the development pipeline.
- Biosimilar guidelines established in 2012
- 80% of pharmaceutical spend is out of pocket
- Indian companies have extensive experience with generics and have made in-roads in other countries as well through exports
- Indian companies grapple with the image of manufacturing as unsafe with poor quality drugs
- Partnerships between global pharmaceutical companies and domestic companies are helping to improve the quality of biosimilars marketed in India
- Approximately 19 biosimilars in the development pipeline; large proliferation of non-original biologics
- Large middle class with growing disposable income who prefer brand name products, so there is a good opportunity for branded Biosimilars.
Approximately 70% of the country’s population is considered rural and will focus on the cost of therapy – a 20-30% discount on originator biologics may not be sufficient.
- Issued draft biosimilars guidelines in 2014; once a clear regulatory pathway for biosimilar approval is established, the market will be very attractive – not only due to the volume potential but also the growing ability to pay
- Similar to the tight controls requiring international companies to create partnerships or use domestic pharmaceutical distributors, the successful manufacturing and marketing of biosimilars will also require partnerships with domestic companies
- Lack of physician trust and enthusiasm for non-branded drugs exacerbated by unsafe and counterfeit drugs
- Sophisticated market; generics make up more than 50% of the market
- Biosimilars guidelines were established in 2010
- There is a financial pressure on the system overall, and great pressure to utilize generics including biosimilars
- Several Indian companies have entered the South African market and are key to keeping drug costs low
- There is a cost containment focus from the government and payer side and a quality focus from the physician and patient side
- Companies will have to bring in a cost structure that is lower than what currently exists along with the highest quality and safety profiles of their biosimilars
- Established, government-incentivized market for biosimilars
- Demand spurred by high out-of-pocket health care spending (estimated at +90%)
- Significant presence of non-original biologicals known as “biolimbos” who have not undergone marketing authorization review consistent with globally accepted standards.
- Biosimilars development led locally by Probiomed which won six biosimilars approvals, including a version of Rituxan®
- Most mature biosimilar “development” market
- Enabled by unprecedented support from the South Korean government: 35% of the national medical R&D budget was invested into biosimilars development in 2012xvi
- Government-set goal for domestic biopharmaceutical companies to win 22% of the global biosimilars market by 2020
- Twelve biosimilars have been approved and another 36 biosimilars are in the pipelinexvii
- Leading the race in the high-risk and complex development of monoclonal antibody (mAb) biosimilars with 17 mAbs in the pipeline
A recent study revealed that a third of anti-malaria drugs sold were found to be counterfeit, and 100,000 deaths per year in Africa were linked to counterfeit drugs. Physicians and patients in emerging markets are particularly wary of non-brand name drugs. 75% of emerging markets pharmaceutical growth is expected to come from branded generics. According to a 2013 Roper Report, 79 percent of consumers in developing Asian markets and 61 percent of consumers in Latin American markets only buy products and services from a trusted brand.