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The Single-use Bioreactors Market is projected to reach $10.3 billion by 2030, at a CAGR of 15.8% from 2023 to 2030.
Biopharmaceuticals represent a groundbreaking advancement in the treatment of various diseases across multiple medical disciplines. Their ability to target specific molecules, coupled with reduced side effects, enhanced efficacy, and greater specificity compared to traditional synthetic drugs, is significantly propelling the growth of the biopharmaceutical industry.
The demand for and commercialization of biopharmaceutical products are on the rise globally. For example, the U.S. FDA anticipates reviewing over 66 biosimilars set to go off-patent from 2020 to 2025. In February 2020, the U.S. FDA introduced a new regulatory pathway aimed at enhancing competition among biologic products. This transition enables manufacturers to pursue FDA approval for biosimilars, facilitating a more competitive market environment. In Canada, British Columbia is leading the charge in developing biosimilar programs to promote their adoption. Notably, in November 2021, around 30,000 British Columbians using two rapid-acting insulins were provided with a six-month transition period to switch to biosimilar alternatives in order to qualify for PharmaCare coverage. Meanwhile, France’s National Health Strategy has set an ambitious goal of achieving 80% biosimilar penetration by 2022.
Emerging economies such as China, India, and countries in Africa are also making strides in biosimilar production. In China, initiatives like the establishment of multinational clinical centers, expedited approval processes for specialty medications, global sharing of clinical data, and strengthened protections for clinical data are fueling biosimilar development. To double the market share of biosimilars in India, the central government has initiated a financial program to support academic research institutions, biotech firms, and bio-incubators focused on developing therapeutic proteins and monoclonal antibodies, leveraging the financial feasibility and patent expirations of original biotherapeutics. This initiative is backed by the World Bank and the Department of Biotechnology and is executed by the Biotechnology Industry Research Assistance Council (BIRAC).
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In Africa, enhancing the healthcare sector has been a longstanding priority for ensuring long-term health security. A recent effort, the Team Europe Initiative (TEI) on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+), was launched by the European Commission in May 2021 to bolster the region’s vaccine manufacturing capabilities amid the pandemic. Such initiatives by both developed and developing countries are fostering the adoption of biosimilars, thus driving market growth in their upstream processes.
To address this rising demand, numerous biopharmaceutical companies are expanding their production capacities. Noteworthy expansions include:
- Merck KGaA (Germany) announced in June 2022 a $62 million investment to enhance its high-potent active pharmaceutical ingredients (HPAPI) production capacity at its facility in Wisconsin, U.S.
- Thermo Fisher Scientific Inc. (U.S.) expanded its biomanufacturing facility in Massachusetts in September 2022 to accommodate the increasing demand for biologic materials required for vaccines and therapies targeting cancer and other diseases.
- Eppendorf AG (Germany) expanded its bioprocess site in Jülich, Germany, in September 2022, boosting production capacity of bioprocess solutions by up to 20%.
- Sartorius AG (Germany) opened a new manufacturing site in Tunisia in May 2022 to enhance fluid management technology production in response to high demand from the biopharmaceutical sector.
These capacity expansions by biopharmaceutical manufacturers and contract development and manufacturing organizations (CDMOs) are anticipated to generate increased demand for biopharmaceutical manufacturing equipment and consumables, thereby driving growth in the single-use bioreactors market. According to Meticulous Research®, the global single-use bioreactors market is projected to reach $10.3 billion by 2030, growing at a compound annual growth rate (CAGR) of 15.8% from 2023 to 2030.
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