Biopharmaceuticals are revolutionizing the treatment of a range of diseases and are being used across various branches of medicine. The adoption of biopharmaceuticals is rising compared to conventional synthetic drugs owing to advantages, such as targeting specific sites, lowering the incidences of side effects, and high activity & specificity. Further, biopharmaceuticals are also found to be suitable for the treatment of patients who inadequately respond to conventional synthetic drugs.
At present, antibody-based biopharmaceuticals are dominating the market. Further, there is large number of antibody-based biopharmaceuticals present in the clinical pipeline of various biopharmaceutical companies. As per the data released by an international non-profit antibody-related research and development organization, the Antibody Society, as of January 10, 2021, nearly 21 investigational antibody therapeutics are under regulatory review in the U.S. and European Union. From January 1, 2021, to December 31, 2021, 13 antibody therapeutics were granted first approvals in the U.S. As biopharmaceuticals enter the commercial stage, it will lead to growth in demand for bioprocessing equipment and consumables used in their production.
As per the U.S. FDA, 30 biosimilars have received regulatory approvals, and 21 products have been launched. Biosimilars usually range 15%–37% lower than reference products and have increased the competition. As per Amgen Inc.’s (U.S.) Biosimilar Trends Report, biosimilars have resulted in the cost savings of USD 9.8 billion to the U.S. healthcare system. Further, biosimilars have also resulted in the cost-saving of USD 238 million of the out-of-pocket savings annually to the patients.
The U.S. FDA expects to review over 66 biosimilars as they go off-patent between 2020 and 2025. Knowing the high potential of the biosimilars business, many market players such as Mylan N.V (U.S.), Biocon Limited (India), and Aurobindo Pharma Limited (India) are investing in biosimilars to exploit opportunities in the biosimilars market. For instance, in 2021, Biocon Ltd. (India) and Mylan N.V.(U.S.) planned to combine their biosimilar businesses to create a larger company. Further, in December 2021, FUJIFILM Diosynth Biotechnologies (U.S.) announced an investment of USD 350 million to add a current Good Manufacturing Practice (cGMP) production facility at its U.S. facility to increase the production of vaccine manufacturing and advanced therapy. Developments in the biosimilars space are further fueled by supportive initiatives worldwide.
In February 2020, the U.S. FDA transitioned to a new regulatory pathway for boosting the competition between biologics products in the U.S. This transition will allow manufacturers to seek the U.S. FDA’s approval to bring biosimilars to the market, facilitating greater competition. In February 2020, the U.S. FDA and the Federal Trade Commission (FTC) signed a joint statement regarding an enhanced collaboration to support a robust marketplace for biological products like biosimilars and interchangeable products.
In Canada, British Columbia is at the forefront of developing biosimilar programs to increase their adoption. For instance, in May 2019, a biosimilars program was announced under which nearly 20,700 British Columbians living with diabetes, ankylosing spondylitis, plaque psoriasis, rheumatoid arthritis, or psoriatic arthritis were given a timeline to transition their prescriptions from the biologic to the biosimilar drug.
China and India are among the leading countries in developing and commercializing biosimilars. The Chinese government has undertaken several initiatives to promote the development and adoption of biosimilars. Some of the initiatives driving the adoption of biosimilars in China are the development of multinational clinical centers, acceleration of the approval process for special medicines, global sharing of clinical data, and enhancements in the protection of clinical data. The Marketing Authorization Holder (MAH) pilot scheme was launched in China, allowing license holders to sell drugs in the country using a contract manufacturer. This development is driving innovations and accelerating the speed at which international companies can introduce products in China, facilitating the growth of CDMOs.
To double the market share of biosimilars in India, the central government launched a new financial initiative for academic research institutes, biotech companies, and bio incubators for developing therapeutic proteins and monoclonal antibodies based on the financial feasibility and patent expiry of the original biotherapeutics. The program is supported by the World Bank and the Department of Biotechnology and implemented by the Biotechnology Industry Research Assistance Council (BIRAC).
Additionally, as updated on 26th November 2021, the European and the international organizations representing innovative biopharmaceutical industry in association with the European Commission are exploring opportunities and possible avenues to create stronger vaccine and manufacturing capabilities in Africa. Strengthening health industries in Africa has been a critical objective for long-term health security. In May 2021, the Team Europe Initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+), was announced by the European Commission to strengthen the region’s vaccine manufacturing capabilities during the pandemic.
Thus, various initiatives by public organizations and developments by biopharmaceutical players are driving the adoption of biopharmaceuticals, positively impacting the market.
According to Meticulous Research, the global biopharmaceutical processing equipment and consumables market is expected to grow at a CAGR of 10.3% to reach $70.84 billion by 2029.