Biopharmaceuticals are the revolutionary treatment of many diseases across various branches of medicine. Owing to the advantages like targeting specific molecules, lower side effects, high activity, and specificity compared to conventional synthetic drugs support the growth of the biopharmaceuticals industry.
The demand & commercialization of biopharma products is increasing across various countries. For instance, the U.S. FDA expects to review over 66 biosimilars as they will go off-patent between 2020 and 2025. In February 2020, the U.S. FDA transitioned to a new regulatory pathway for boosting the competition between biologic products in the U.S. This transition allows manufacturers to seek the U.S. FDA’s approval for biosimilars to bring biosimilars to the market, facilitating greater competition. In Canada, British Columbia is at the forefront of developing biosimilar programs to increase their adoption. In November 2021, about 30,000 British Columbians on two rapid-acting insulins were given six months transition period to shift to two biosimilar versions to be eligible for PharmaCare coverage. In 2018, France’s National Health Strategy aimed at achieving 80% biosimilar penetration in the country by 2022.
Developing counties like China, India, and Africa are also focusing on biosimilar production. For instance, 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 by the Chinese government are accelerating the production of biosimilars. To double the market share of biosimilars in India, the central government has 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).
Strengthening health industries in Africa has been a critical objective for long-term health security. One of the recent initiatives, the Team Europe Initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+), was announced by the European Commission in May 2021 to strengthen the region’s vaccine manufacturing capabilities during the pandemic. Thus, such initiatives by both developed & developing nations support the adoption of biosimilars, thereby driving the market for their upstream processes.
To meet this growing demand, many biopharma companies are expanding their capacity. For instance,
- In June 2022, Merck KGaA (Germany) expanded its Life Science business sector’s high-potent active pharmaceutical ingredients (HPAPI) production capacity with the expansion of its facility in Wisconsin, U.S., by investing USD 62 million (EUR 59 million).
- In September 2022, Thermo Fisher Scientific Inc. (U.S.) expanded its biomanufacturing facility in Massachusetts, U.S., to meet the growing demand for the biologic materials needed to produce vaccines and therapies for cancer and other diseases.
- In September 2022, Eppendorf AG (Germany) expanded its bioprocess site in Jülich, Germany. This helped to increase its production capacity of bioprocess solutions by up to 20%.
- In May 2022, Sartorius AG (Germany) opened a new manufacturing site in Tunisia to increase the production of fluid management technologies and meet the high demand from the biopharmaceutical industry.
These capacity expansions from biopharmaceutical manufacturers and CDMOs are expected to generate additional demand for biopharmaceutical manufacturing equipment and consumables, thereby propelling the growth of the single-use bioreactors market. According to Meticulous Research®, the global single-use bioreactors market is projected to reach $10.3 billion by 2030, at a CAGR of 15.8% during the forecast period of 2023–2030.
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