May 29, 2024

Biosimilar Pipeline Analysis Market High Growth Opportunities, Emerging Trends, Industry Review, Forecast Till 2031

Market Overview:

Biosimilar pipeline analysis involves analyzing biosimilar drugs in pipeline and those that are under development. This helps biopharma companies in identifying opportunities and analyzing competitors.

Market Dynamics:

The biosimilar pipeline analysis market is expected to witness significant growth over the forecast period owing to two key drivers-

There is an increasing number of blockbuster biologics losing patent protection over the coming years. For instance, rheumatoid arthritis drug Humira’s patent is set to expire in 2023 in Europe. This will open doors for biosimilar development and commercialization. Secondly, biosimilars provide significant cost savings compared to their reference biologics. This makes them an attractive alternative for biopharma companies. The growing focus on reducing healthcare costs will further drive the demand for biosimilars.

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Market Driver 1: Patent Expiries of Blockbuster Biologics Driving Patent Cliff

As the patents of blockbuster biologic drugs start expiring, it opens up the opportunity for biosimilars to enter the market. Some of the top-selling biologics whose patents have recently expired or will expire soon include Humira, Remicade, Herceptin, Rituxan, Avastin and MabThera. The expiry of patents on these biologics worth billions in annual sales is expected to create a “patent cliff” and drive significant growth of biosimilars. Manufacturers are rapidly developing biosimilar versions of these biologics to gain a share of the market before competitors. This provides a massive commercialization opportunity for biosimilar makers and is a key factor fueling investments and advancements in biosimilar drug development and pipeline growth.

Market Driver 2: Significant Cost Savings Potential Driving Healthcare System Adoption

Biosimilars offer significant cost savings compared to their reference biologics since they have reduced development and manufacturing costs after the innovative biologic has paved the way. Healthcare systems and payers are increasingly adopting biosimilars to help control rapidly rising drug budgets and make biologic treatments more affordable and accessible to patients. It is estimated that the use of biosimilars in the EU alone has led to savings of over €1.25 billion between 2014 to 2018. The potential for biosimilars to slash healthcare expenditures is a powerful incentive driving their increased usage. Regulatory agencies and governments worldwide are now offering incentives and policies to promote biosimilar uptake, which is positively impacting their development and market potential.

Market Restrain: Complex Regulatory Pathway Delaying Biosimilar Approvals

Despite the gains, biosimilars still face a complex and lengthy regulatory pathway for approval that remains a key challenge holding back their market growth. Demonstrating biosimilarity and interchangeability is more difficult than generic small molecule drugs due to the larger size and greater structural complexity of biologics. Regulators also require more extensive comparability data than generics. These stringent approval requirements have resulted in approval delays and unpredictable timelines that disincentivize research in some cases. While policies are improving, inconsistent global regulations also complicate approval and market access processes. Overcoming regulatory hurdles and achieving more harmonized and predictable regulatory standards worldwide is essential to fully unleashing the biosimilars industry potential.

Market Opportunity: Transition to Self-Administration Expanding Addressable Patient Base

One significant growth opportunity for biosimilars lies in the shift towards more self-administrable products like pre-filled syringes, autoinjectors and pens. An increasing number of original biologics are making the transition to more user-friendly delivery systems to improve patient convenience and compliance. This expansion into self-administration broadens the treatable patient population beyond healthcare settings to include those managing their conditions at home. As biosimilar versions mimic the administration of reference products, they too can benefit from this transition by accessing more patients. Biocon/Mylan’s Fulphila, the first interchangeable biosimilar for Herceptin, exemplifies this opportunity through its compatible syringe delivery. The self-administration trend represents an opportunity to reach untapped patients and volumes.

Market Trend: Increasing Focus on Specialty and Novel Modalities

While initial biosimilars largely replicated off-patent blockbuster molecules, a trend emerging is the development of complex “biobetters” and biosimilars of specialty biologics in niche or complex disease areas. This includes molecules generated via newer modalities like monoclonal antibodies, fusion proteins, antibody-drug conjugates and gene/cell therapies. Examples include proposed biosimilars of rheumatoid arthritis biologic Orencia (abatacept) and Roche’s melanoma drug Alecensa (alectinib). Another area attracting research is follow-on biologics, which are highly similar but non-identical to reference products. This shifting focus on specialty and novel modalities represents an evolution within the biosimilars space towards complex molecules with large market opportunities. It signals industry increasing confidence and expanding R&D capacities


  1. Source: Coherent Market Insights, Public sources, Desk research
  2. We have leveraged AI tools to mine information and compile it