Opportunities and Challenges in the Biologics Space

In this interview with Jimin Han, Director of Climate Change in Business Strategy Team at Samsung Biologics (Incheon, South Korea), we discuss trends in the global biologics market, the biggest opportunities and challenges for this sector, and the growing consciousness surrounding sustainable practices for biologics developers and manufacturers.

1. Market reports indicate the global biologics market is set for growth in the coming years. What do you think is driving this?  

Throughout the COVID-19 pandemic, the global population saw the capabilities of drug modality innovations in the form of mRNA vaccines. With continuous technical and molecular engineering advancements, biologics are increasingly breaking into new therapeutic areas, from the treatment of infectious diseases like HIV to heart failure (1). As the potential for biologics is realised, it is clear why a compound annual growth rate (CAGR) of 8.4% is predicted between 2021 and 2028 for this market and is estimated to reach a value of USD $567.96 billion (2).  

This growth is also in part due to changes in the biosimilars space. Between 2020 and 2025, 17 blockbuster molecules with annual peak sales worth USD $60 billion are anticipated to lose exclusivity (3). This has led to increased growth in the biosimilars pipeline. Feeding into biopharma’s increased interest in the biosimilars market, several biosimilars that have been recently approved have gained a major market share, demonstrating their return of investment potential (4). This has driven further innovation in the biologics space, as companies with reference products pivot their approach to incorporate delivery devices or combination products in an effort to maintain a market share.  

2. What do you think is the biggest opportunity in the biologics sector right now?   

With concerns about climate change growing globally, those in the biologics industry are eager to do their part to combat the causes. The Sustainable Markets Initiative has recently reported that the healthcare sector contributes over 4% of global greenhouse gas emissions, highlighting the need for change in order to achieve sustainable growth (5).  

Consequently, sustainable management is the current 'hot topic', not only in the biologics sector but throughout the biopharma industry. Everyone is looking for opportunities and solutions to reduce greenhouse gas emissions and ways to transition to eco-friendly sources of energy. In a sector where people’s lives and health are of the highest priority, it is no surprise that the biopharma sector has embraced these opportunities for change.   

3. What is the biggest challenge in the biologics sector?   

Although tackling climate change by reducing greenhouse gas emissions presents the biologics sector with opportunities for efficiency and cost reduction, the challenges associated with establishing new development and manufacturing processes offering a low-carbon emission profile should not be underemphasized.   

Throughout the entire drug development and manufacturing process, the industry must make the effort to utilize low-carbon products. However, as contract development and manufacturing organizations (CDMOs) are often required to follow the 'recipes' prescribed by their clients, reducing greenhouse gas emissions will increasingly become a shared responsibility. Drug developers must take the initiative to embrace transitions across the process design to implement low-carbon elements from raw materials to logistics.   

A further challenge that must be considered is how low-emission processes could be integrated into the production of already released therapeutics. As the development and manufacturing processes for these products would have already been reviewed and approved by the relevant regulatory agencies, it can be expected that making changes with the aim of lowering emissions will be difficult.   

4. How do you think the COVID-19 pandemic impacted the biologics market?  

The COVID-19 pandemic saw the biologics sector face immense difficulties in securing raw materials due to health-associated human resource shortages and transportation disruptions. These challenges highlighted the need for biologics developers and manufacturers to be proactive in their response to potential local and global disruptions.   

To be prepared for disease outbreaks like that of COVID-19 and physical risks related to potential natural disasters, earthquakes, tsunamis, or even the impact of monsoons and hurricanes, robust risk management is becoming increasingly necessary. As well as building a robust management system, Samsung Biologics also operates under its business continuity management system to ensure a proactive response to any unprecedented risks.   

5. Some within the industry have pointed out that the cold chain is energy-intensive and mitigating the need for a cold chain (where possible) is more sustainable. It has been suggested that biologics producers should focus on reformulating products so they are more stable at ambient temperatures, reducing the need for the cold chain in the long term. Does this play into Samsung Biologics’ ESG strategy at all? If not, how are you focusing on sustainability?  

Cold chain capabilities have played an important role in the production of essential COVID-19 vaccinations throughout the pandemic, but it is clear that it is an energy-intensive solution to maintaining the stability of some biologic drugs. As a result, a long-term solution will be required to reduce the reliance on low-temperature processes. This will necessitate developers to step back and consider how the environment will be impacted from the earliest stages of the development process.   

However, as changes from the R&D stage can take a long time to manifest, activities that could reduce or replace greenhouse gas production should be initiated as a priority and as a matter of urgency in order to respond to the climate crisis. With this in mind, Samsung Biologics plans to establish a variety of reduction/replacement measures throughout the overall value chain as well as the operation site.  

[1] IQVIA Whitepaper. “Disruption and maturity: The next phase of biologics”. https://www.iqvia.com/-/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf 

[2] BioSpace. “Biologics Market Growth – at a CAGR of 8.4% by 2028”. 28 Feb 2022. https://www.biospace.com/article/biologics-market-growth-at-a-cagr-of-8-4-percent-by-2028-/ 

[3] Pharma Boardroom. “Biosimilars: Should I Stay or Should I Go?”. 2 Feb 2022. https://pharmaboardroom.com/articles/biosimilars-should-i-stay-or-should-i-go/#:~:text=Global%20Market%3A%20Surging%20Growth&text=17%20blockbuster%20molecules%20with%20annual,global%20biosimilars%20market%20by%20value. 

[4] Pharma Phorum. “Biosimilars: a rapidly maturing market”. 23 Feb 2022. https://pharmaphorum.com/market-access-2/biosimilars-a-rapidly-maturing-market/ 

[5] Sustainable Markets Initiative. “Health Systems Taskforce. Letter of Intent”. https://www.sustainable-markets.org/taskforces/health-systems-taskforce/