Biopharmaceuticals Contract Manufacturing | Current Insight with Future Aspect Analysis

November 15, 2022

The success of the biopharmaceutical industry can be majorly attributed to the contract manufacturers. Reduction in the overall investment required to bring a new drug product to market, providing access to expensive technologies, quick entry of products into the markets, and greater flexibility are some advantages offered by contract manufacturing organizations (CMOs), which have prompted the companies to outsource their biopharmaceutical manufacturing.

Growing biopharmaceutical pipeline and lack of adequate manufacturing capabilities are two key factors that are driving partnership between large molecule manufacturers and Contract Manufacturing Organizations (CMOs). Contract manufacturers are engaged in broadening their service portfolio to meet the companies' demands with respect to regulatory standards and new services. The pandemic has, however, also had some negative knock-on effects as budgets and resources are diverted to “COVID products” at the expense of other biologics projects in development for other therapeutic areas.

The reliance of companies on CMOs for the production of biologics and biosimilars is expected to rise during the forecast period as a consequence of changes adopted by the CMOs. This is evident through growing investment in collaborations of companies with CMOs as well as continuous efforts taken up for expanding the service portfolio. The supply chain of biopharmaceuticals remained robust and was largely unaffected worldwide during the coronavirus outburst. Also, biopharmaceutical contract manufacturers are observing increased demand related to COVID-19 vaccine and therapeutics. Thus, the future holds numerous opportunities for the market. For instance, in 2020, AstraZeneca and Oxford Biomedica signed a one-year clinical and commercial supply agreement for the manufacturing of AstraZeneca’s COVID-19 vaccine candidate, AZD1222.

The future growth of the market is highly dependent on the promising opportunities offered by the biopharmaceutical industry, bioprocessing industry, and contract service industry. Expansion of fill-and-finish services and increasing robustness of venture capital investments for the life science sector are two important opportunities that are anticipated to drive the market. For instance, in 2019, Shanghai HaiHe Biopharma Co. Ltd. raised USD 146.6 million as venture capital for its large cancer drug portfolio, which it shall utilize along with its outsourcing partner Zhejiang Jiuzhou Pharmaceutical Co., Ltd. 

Key Takeaways:

  • Mammalian-based biopharmaceutical contract manufacturing captured the largest market share about 58% in 2021 owing to the high penetration of mammalian expression systems for biologics development
  • Out of all the services offered in this market, process development contributed to the largest share of 35% in 2021, owing to high capital investment, especially in downstream process
  • Biologics contract manufacturing dominated its counterpart segment owing to higher demand for biologics production. However, the biosimilar segment is growing with a lucrative CAGR of 8.9% due to cost-saving advantages associated with biosimilars development
  • The presence of an effective regulatory framework for biologics development in the U.S. has resulted in a large share of the North America market of 3.9% in 2021
  • However, Asia Pacific is expected to emerge as the fastest-growing regional market with a CAGR of 5.18% from 2022 to 2030, owing to developing economies such as India and China incorporating developments to sustain the competition

 Regional Insights

With a high number of biomanufacturing facilities in the U.S., North America dominated with the largest revenue share of 35% in 2021. Furthermore, revenue from biopharmaceutical-based R&D activities held a major percentage of the total R&D carried out in various sectors in the U.S. Furthermore, interventions & conferences conducted in the region for pertinent technologies and issues in the application of biologics for the treatment of various chronic conditions are anticipated to positively influence regional growth.

However, Asian countries are expected to emerge as the attractive outsourcing location for the biomanufacturing of large molecules. Low manufacturing and operating cost offered by countries, like China & India, is one key factor driving the Asian market. Faster growth in the Korean market is expected to boost revenue generation from the APAC region.

Some of the prominent players in the Biopharmaceuticals Contract Manufacturing Market include: Boehringer Ingelheim GmbH; Lonza; Inno Biologics Sdn Bhd; Rentschler Biotechnologie GmbH; JRS Pharma; AGC Biologics; ProBioGen; Fujifilm Diosynth Biotechnologies U.S.A., Inc.; Toyobo Co., Ltd.; Samsung BioLogics; Thermo Fisher Scientific, Inc.; Binex Co., Ltd.; WuXi Biologics; AbbVie, Inc; Novartis AG; ADMA Biologics, Inc.; Catalent, Inc; Cambrex Corporation; Pfizer Inc.; Siegfried Holding AG

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