By: Saranraj Sivabushnam -- Senior Research Analyst, CMO Formulations and Drug Delivery devices
29 August, 2017
Over the past several years, biologics have gained significance in the pharmaceutical industry, representing more than $210 billion in global sales in 2016 and is expected to reach $480 billion in 2024 by growing at a CAGR of 10-11 percent. By 2020, 11 biologics drug patents will expire which account for global sales of more than $60 billion. In addition to this, with the increasing worldwide focus on improving health care access and the cost of healthcare provides an attractive opportunity for biosimilars manufacturers.The global biosimilars market is about $3.4 billion in 2016 and is expected to reach $10.9 billion by 2021 by growing at a CAGR of 26-27 percent. By 2020, biosimilars have the potential to compete with a number of key biologics drugs that have current sales of more than $40 billion.
This whitepaper focuses on the huge potential available in the emerging markets for biosimilars which pharma MNCs can utilize for their benefit. Major opportunities exist in emerging markets, especially in India and South Korea. Although selling low cost biosimilars in emerging markets may appear to be a less attractive strategy when compared to developed markets, venturing into emerging markets would reap long-term success for biosimilar companies.
While many pharma MNCs want a presence in developed markets, considerable opportunity exists in emerging markets for biosimilars.
Adopting a long-term strategy to provide affordable products can help biosimilars players to increase their sales and be successful in the emerging markets. They need to select the therapeutic area for biosimilars that have the largest potential impact for the local population. Some of the best approaches for capitalizing on the emerging markets include participation in joint ventures, licensing arrangements and other types of alliances. Partnership with a domestic pharmaceutical or biotechnology firm is often necessary to gain access to the market.
Less stringent or relaxed regulatory requirements for biosimilars in emerging markets are driving the growth of biosimilars. The emerging pharmaceutical markets of Asia, Latin America and Eastern Europe would turn as attractive locations for biosimilars research and commercialization. Growing middle class income, increasing healthcare expenditure and generics-driven pharmaceutical markets in these emerging nations provide a positive medical and commercial environment for biosimilars.
Key factors to consider for big pharma to enter India’s Biosimilars market
Few examples of biosimilar launches in India
South Korea Biosimilars Market
Key factors to consider for big pharma to enter South Korea’s biosimilars market
Few examples of biosimilar launches in South Korea
The large untapped demand characterized by poor physical and financial access to currently high-priced biologics provides favorable long-term growth opportunities. Additionally, macroeconomic factors such as high GDP growth rates, increasing purchasing power and health care spending, strong regulatory focus on reducing costs and increasing treatment access also contribute to the growth of the biologics segment.
Cost is a huge barrier for the use of biologics in the emerging markets, and physicians would increase prescription rates if less expensive biosimilar alternatives were available. In most of these countries, patients are unable to afford branded biologics which is a powerful driver for biosimilars. In addition, many of these countries already have biosimilar approval pathways in place or are finalizing guidelines.
Lower margins, higher volumes
Big pharma companies need to adapt traditional business models in several ways when entering/expanding in emerging markets. Emerging markets will not provide huge profit margins as earned in developed markets. Margins will be lower due to lower prices and upfront investments required to build the markets. Manufacturers will need to shift approaches to hunt for higher volumes at a lower margin.
Big pharma should not look to promote biosimilars by any differentiation (other than price) because differentiation from the branded drug could create fears in customers, especially in markets where counterfeiting can be widespread. 75 percent of pharmaceutical growth is expected to come from branded generics in emerging markets. Moreover, 80 percent of consumers in developing Asian markets and 60 percent of consumers in Latin American markets buy products and services from a trusted brand.
Patient- and physician-driven uptake
In emerging markets, physicians and patients are expected to play a bigger role in biosimilars uptake. In many emerging markets, physicians are the sole decision makers of patient therapy based on their perception of a patient’s ability to pay for high-priced therapies.
One challenge facing biosimilars in emerging markets is low physician awareness of biosimilars. Hence, biosimilars manufacturers should develop education programs to educate physicians (and nurses) on the need to treat patients, how to administer the product, and the side-effects and benefits.
Patient awareness may be another way to drive biosimilars adoption. Direct-to-patient marketing is not permitted in most markets, many emerging markets have growing ‘patient advocacy groups’ that can drive market access, and physician and patient awareness. This provides an opportunity for biosimilars companies to work with these groups to educate patients on the therapy options available, including the price advantage of biosimilars and the long-term benefits of the medication.
How to Win
While most players want a presence in developed markets, a considerable opportunity exists in emerging markets for biosimilars. Biosimilar players need to chart a long-term strategy to provide affordable products to capture these markets. They also need to select therapeutic areas with the largest potential impact for the local population. Although the strategy of selling low-cost biosimilars in emerging markets may appear less attractive, it helps to achieve long-term success for biosimilars players.