New Zealand Biosimilar Monoclonal Antibodies Market Analysis

The New Zealand Biosimilar Monoclonal Antibodies Market stood at around xx Bn in 2023 and is projected to reach US $xx Bn by 2033, exhibiting a CAGR of xx% during the forecast period.

The New Zealand Biosimilar Monoclonal Antibodies Market Analysis Executive Summary

The biosimilar monoclonal antibodies are the biologic products intended to provide the therapeutic properties that are similar to the original therapeutic monoclonal antibodies and are often referred to as the innovator products at a comparatively lower cost. Unlike small-molecule generics, biosimilars are not identical to their reference products since they are derived from living organisms and can exhibit variations due to the complexity of biologic products. Minor structural changes that do not compromise the functional aspects of the product are acceptable. The biosimilar drugs include Rituximab for non-Hodgkin Lymphoma and Rheumatoid arthritis, Trastuzumab for HER2 positive breast and Gastric cancer and Adalimumab for Rheumatoid arthritis and other Inflammatory diseases. In 2018, there were about 18.1 million new cancer cases globally, resulting in 9.6 million deaths, with lung, breast, prostate, colon, and non-melanoma skin cancers being the most common. The first mAbs started getting the patent expiration from 2017 and biosimilars got the approval including targeting Rituximab and Trastuzumab by the end of 2019. Biosimilar mAbs for cancer treatment are projected to increase the patient’s ability to get appropriate treatment and possibly lead to reduced expenditure.

The overall biosimilar monoclonal antibodies market is growing at a higher pace due to patent expiration of best-selling biologics, escalation in healthcare spending, and favorable regulations for biosimilar monoclonal antibodies. Although biosimilar development is a complicated and expensive process, there is growing acceptance of biosimilars because they are cheaper to produce and are gradually gaining acceptance among healthcare professionals. Market leaders including Amgen, Pfizer and Sandoz among others are continuously engaged in biosimilars across different therapeutic areas like oncology and auto-immune diseases. Though there are drawbacks with respect to market entry and regulation issues, the market is capable of gaining broad expansion as more biologics go off patent, leading to increased product availability and accessibility of these cost-effective products.    

New Zealand Biosimilar Monoclonal Antibodies Market Dynamics

Market Growth Drivers

Due to the increasing rates of chronic diseases and high costs of biologic therapies, there is a need for affordable therapies such as biosimilar mAbs. In addition, the expiration of patents associated with mega mAbs is creating entry-way to biosimilars, while debated policies put forward by key regulatory organizations such as the FDA and the EMA are making it easy for biosimilars to be approved. These markets are also growing, especially in the Asia-Pacific region attributed to increased healthcare access and relatively cheap production costs. Such partnerships between the pharmaceutical companies and CROs as well as CMOs are further driving biosimilar development. Other factors that are steering growth in the biosimilar mAbs market include the pursuit of controlling cost, and a growing appreciation of biosimilars.

Opportunity

Some future opportunities in the biosimilar monoclonal antibody market include exploring its use in the oncology segment given the need for affordable cancer therapies. New markets, such as Asia-Pacific, offer great prospects due to elevated expenditures on healthcare and population growth. At the same time, a higher investment in research in development will lead to the development of efficient and superior biosimilars that will enable players to gain a competitive advantage, thus promoting growth in the market. 

Market Restraints

The development and market access of biosimilar monoclonal antibodies are still constrained by related issues in regulation cost, complicated manufacturing procedure, and potential patent disputes. Moreover, there are challenges such as the attainment of acceptance from the physician and the patient, the pressure on the price, and issues relating to interchangeability and substitution that have created difficulties in the expansion of the market. Such challenges need to be addressed systematically by manufacturers, regulators and other stakeholders in the health sector. 

Competitive Landscape Biosimilar Monoclonal Antibodies Market in New Zealand

Key Players

• Pfizer Inc.
• Novartis AG
• Amgen Inc.
• Celltrion Healthcare Co., Ltd.
• Allergan (a subsidiary of AbbVie)
• Boehringer Ingelheim
• Coherus BioSciences
• Biocon Limited

Recent Developments

May 2024, Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S. Ophthalmology Market.

March 2024, Pharma major Dr Reddy’s Laboratories Ltd announced the rollout of its first biosimilar in the highly-regulated UK market -- Versavo (bevacizumab) Versavo, which is a monoclonal antibody, is a biosimilar of Genentech’s Avastin.

March 2024, The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

March 2024, Bio-Thera Solution a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, announced that its partner, Biogen Inc. officially launched TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA, in the United States.

Mergers and Acquisitions

January 2024, Sandoz US acquisition of ranibizumab biosimilar from Coherus.

September 2023, Coherus BioSciences, Inc. today announced the closing of the previously announced acquisition of Surface Oncology, Inc. a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.

November 2022, Biocon Biologics Completes Acquisition of Viatris’ Global Biosimilars Business.

Healthcare Policies and Regulatory Landscape for Biosimilar Monoclonal Antibodies Market in New Zealand

Policy changes and Reimbursement scenario

The biosimilar monoclonal antibodies market is growing due to the constant changes in the regulatory guidance of approval procedures, especially when the patent of the original monoclonal antibodies is expiring. Healthcare authorities and governments are focusing on the inexpensive solutions, which, in this case, explains the implementation of the policies stimulating the usage of biosimilars and, thus, cutting expenses. Other factors that are in favor of making biosimilars are reforms in reimbursement policies, deep and broad reduction in price and cost, and provisions made for the growing ability to bargain for better prices as per the capability of health care budgets and to improve access to critical therapies for patients.