Evolution in Biosimilars, Opportunities and Market size Growth Ahead

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Figure 4: Evolution of Biosimilars and rising approvals

Source: Bill of Health – Harvard Law

Biosimilars have a bright future if additional work is done to be attractive to prescribers and payers. Trends show that providers are already aware of biosimilars and are interested in learning more about them.Similarly, payers are showing a desire to adopt biosimilars to foster a successful marketplace and realize savings. From the above chart we can see the evolution in Biosimilar approvals that have accelerated in past years and will continue for Long term in future. This thesis can be supported by the below (Figure: 4) that shows the increase in biotechnology % Prescription & OTC Sales.

Worldwide Prescription Drug & OTC Pharmaceutical Sales

Figure 4 : Biotech vs. Conventional Technology 

Source: Evaluate Pharma -World Preview 2020

Biotechnology products are forecast to take majority share in the top 100 drugs by sales by 2026, with 55% of the total top 100 product sales in 2026, up 16% compared to 2012.Global prescription sales of biotech products to grow with a CAGR of 9.6% between 2019 & 2026, compared to conventional product growth of 5.5%. Biotech products are forecast to take 55% share of the total top 100 product sales in 2026. The above chart justifies the increasing trend of biotechnology in coming years whose evolution has already started from the year 2017 onwards. 

5. Opportunities & Market Size for Biosimilars

The global biosimilars market size is expected to grow $240 billion by 2030. 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.

Industry continues to shift towards Biotechnology

Figure 5: Worldwide Prescription Drug & OTC Sales by Technology (2012-2026) 
Source: Evaluate Pharma -World Preview 2020

As the number of prescription drugs expected to rise from $940bn (FY20) to $1432 bn (FY26) there is a positive outlook for biosimilars. The FDA appears to recognize the need to evolve standards over time. As biosimilar manufacturers and regulators gain experience and confidence, and technology advances, this kind of flexibility – grounded in science – will be important for fostering a thriving US biosimilars market. A maximally streamlined development, application, and approval process will be all the more vital for biosimilars of orphan or small-market biologics. 

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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). 

There are listed Indian companies that have shown remarkable progress in biosimilars and have an exponential pipeline for the same that will result in good fortune in coming times. To name the few they are:

  1. Biocon – U.S, Europe and ROW

  2. Lupin – Europe

  3. Dr. Reddy’s – Domestic Market

  4. Cadila Healthcare – Domestic Market

  5. Syngene (CRO,CDMO & Biologics) – U.S, Europe and ROW

References: ESMO Munich 2018

                        Lessons for the United States from Europe’s Biosimilar Experience – Matrix Global Advisors

                        AMGEN Biosimilars

                        Deloitte – Biosimilars Research Report

                        Evaluate Pharma – World Outlook 2020

                        BIOCON – Fulphila  BiosimilarDrug Approval Process

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Shuchi Nahar

Shuchi Nahar

Shuchi is NISM Certified Equity Research Analyst, CFA - Level 1, a student of Law and Finance, and an aspiring CS.
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