The global biosimilars market is expanding rapidly, driven by patent expirations of major biologics and the increasing need for cost-effective alternatives. Notably, 15 of the top marketed biologics without approved biosimilars—accounting for about $150 billion in global sales in 2023—are set to lose patent protection by 2033, creating a sizeable market opportunity for biosimilars. To learn more about the drivers and restraints in biosimilars, as well as predictions for the next decade, we spoke with Christian Hughes, Senior Manager, Transaction Advisory Services at Alira Health and the author of the recently released 2024 Global Biosimilars Market Report.

How would you describe the current global biosimilars market?

Europe leads the global biosimilars market, largely because the region was an early adopter with well-established regulatory frameworks. In North America, particularly the United States (US), the market is growing significantly, thanks to evolving Food and Drug Administration (FDA) regulations and rising demand for lower-cost treatments. The Asia-Pacific region is also experiencing rapid growth, with China and India emerging as key players due to their manufacturing capabilities and supportive government initiatives. Latin America, while still evolving in terms of regulatory infrastructure, shows increasing adoption.

Companies that are active in the biosimilar market make up a very diverse landscape. Big pharma companies like Pfizer, and Amgen, still dominate the space because they have the resources and expertise to handle the complex research and development, regulatory approvals, and global distribution networks that biosimilars require. They’re typically the first to enter the market when patents for blockbuster biologics expire.

Then, there are biotech firms—companies like Biocon, Celltrion, Formycon, and Samsung Bioepis. These firms are often more specialized in biosimilar development. They’ve mastered the art of producing biosimilars efficiently, often at lower costs, and they play a critical role in the global market, particularly in regions like South Korea and India. Many of these companies also form strategic partnerships with Big Pharma to leverage global reach and expertise in commercialization.

Interestingly, generic pharmaceutical companies are also becoming more involved. Companies like Teva, Mylan (now Viatris), and Hikma, which traditionally focused on small-molecule generics, are now entering the biosimilar space. While their biologic experience is more limited, they excel in cost-efficient manufacturing and distribution, especially important in price-sensitive markets.

What are the main drivers for the biosimilar market today?

Several factors drive the growth of the biosimilar market. The most important is the patent expiration of high-cost blockbuster biologics like Humira^® and Herceptin^®. Biosimilars are stepping in as affordable alternatives, opening a significant opportunity for both companies and healthcare systems. In addition, regulatory frameworks are increasingly supportive. In Europe and the US, for example, agencies like the European Medicines Agency and the FDA have created clear pathways for biosimilar approval, which has boosted confidence in their safety and efficacy. Regulatory support goes hand in hand with government incentives and policies to encourage the use of biosimilars in regions like Europe and Asia, with some countries even offering financial incentives to healthcare providers to prescribe them.

What roles do healthcare providers and patients play in driving the biosimilars market growth?

Healthcare providers and patients are absolutely crucial in driving the growth of the biosimilars market. Physicians and pharmacists play a direct role in prescribing and recommending biosimilars. Initially, some healthcare providers were hesitant due to concerns about the safety, efficacy, and interchangeability of biosimilars compared to their reference biologics. But as more clinical data and real-world evidence have become available, confidence has grown significantly, as seen in the improved market uptake rates of recent biosimilar launches. Today, many physicians, especially in Europe, are more comfortable prescribing biosimilars, especially in high-cost areas like oncology, rheumatology, and endocrinology.

Physicians also influence the market through their engagement with patients. Explaining the benefits of biosimilars—such as cost savings without compromising quality—can increase patient acceptance and uptake.

On the patient side, that acceptance is key. Patients want effective and affordable treatments, and biosimilars help address that need, especially for long-term therapies for chronic conditions. As awareness grows, more patients are open to switching to or starting with biosimilars, particularly when educated about cost savings, either through lower co-pays or insurance premiums. In many regions, patients who couldn’t previously afford biologic treatments are now able to access these life-changing therapies.

Ultimately, the adoption and acceptance of biosimilars by both healthcare providers and patients are key to driving demand. The more comfortable they are with these products, the faster the market will grow.

What are the main market restraints?

Regulatory complexities are a major hurdle. While Europe and the US have improved, the approval process for biosimilars is still complex and time-consuming. Manufacturers must conduct rigorous clinical trials to prove that a biosimilar is highly similar to its reference biologic, adding to the cost and time to bring a product to market. In addition, regulatory requirements differ across regions, which can create barriers for companies looking to launch globally. 

High development costs are another big challenge. Unlike traditional generics, biosimilars require advanced manufacturing capabilities and extensive clinical testing, creating a significant deterrent for smaller companies.

There’s also the issue of physician and patient hesitancy. Even though confidence in biosimilars has grown, some doctors and patients remain cautious, especially when it comes to complex conditions. Concerns about safety, efficacy, and interchangeability with the original biologic can still exist, slowing adoption in certain markets.

Pricing and reimbursement are often challenging. In some cases, the cost difference between a biosimilar and the reference biologic isn’t significant enough to drive widespread adoption. Reimbursement policies vary from country to country, and if insurers or government programs aren’t actively incentivizing the use of biosimilars, uptake can be slow.

Another factor is manufacturing and supply chain issues. Producing biosimilars is incredibly complex, and any problems in the production process can lead to shortages or impact product quality. Smaller companies, in particular, struggle with scaling up production to meet global demand.

Lastly, legal and patent disputes are a significant issue. Biosimilar manufacturers often face legal battles from originator biologic companies that try to delay market entry. These patent litigations can drag on for years and create uncertainty for companies trying to bring biosimilars to market.

What are your three predictions for the next 10 years?

With the biosimilar market’s recent evolution, I believe that this is a pivotal moment.

Several blockbuster biologics are reaching the end of their patent life and we are expecting an influx of biosimilars that will enter the market. Combined with supportive regulatory frameworks, this will undoubtedly drive market growth and encourage more companies to invest in biosimilar development, leading to increased product offerings and competition.

As more biosimilars enter the market, more competitive pricing will follow. This is critical for healthcare systems grappling with rising drug costs, especially for chronic diseases requiring long-term treatment with biologics. Lower treatment costs will enhance patient access, particularly in underserved populations where biologics are cost prohibitive.

Finally, this will also change the market dynamics for companies in the biosimilars space. As competition intensifies, I expect that traditional generics companies will play an increasingly important role due to their expertise in lifecycle management. However, their lack of experience in biologics manufacturing and development will mean an inevitable increase in strategic partnerships and other initiatives to acquire those capabilities.

Contact us to learn more about our biosimilars market expertise.