Biologics Contract Manufacturing: Changing Promise into Reality

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics have made a significant impact in the pharmaceutical domain, delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological and rare disorders. In this context, it is worth highlighting those 14 biopharmaceutical products (including cell and gene therapy, monoclonal antibodies and recombinant proteins) were approved in the US alone, in 2021. As a result, biologics contract manufacturing has picked up pace in the recent years.

Growing demand for biologics

Further, promising results from ongoing clinical research initiatives have encouraged various government and private firms to make significant investments in the biologics contract manufacturing market. For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain.

Overview of Biopharmaceuticals

Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources. These are essentially complex biological macromolecules, having high molecular weights, or cell-based products, which are not directly extracted from native biological sources, rather are produced using biotechnology tools and methods. The below given figure provides an illustrative summary of the various types of biopharmaceuticals.

Overview of Biopharmaceuticals

What are the Benefits of Biologics Contract Manufacturing?

Currently, a significant number of players engaged in the biopharmaceutical domain prefer to outsource various operations to contract service providers. In fact, currently over 275 companies claim to offer contract manufacturing services for biologic therapeutics, in compliance with the regulatory standards. It is also worth highlighting that biopharmaceutical contract manufacturers are actively trying to consolidate their presence in this field by entering into strategic alliances in order to meet the indubitably rising demand for biologics. For this purpose, substantial expansions, and mergers and acquisitions have been reported in this market, as service providers strive to become one-stop-shops, to cater to the diverse needs of their clientele.

Benefits of Outsourcing in Biopharmaceutical Contract Manufacturing

Biologics Contract Manufacturing: Current Market Landscape

Owing to technical, regulatory and financial superiority, developed nations, such as the US and UK, have always dominated the contract manufacturing market. The same is true for the biopharma contract manufacturing market. However, in recent years, developing nations, such as India and China, have emerged as full-fledged biologics contract development and manufacturing service provider to the global biopharmaceutical industry. During our research, we came across 276 industry players that claim to be engaged in the biologics contract manufacturing market for therapeutic purposes.

Biopharmaceuticals Contract Manufacturers: Current Market Landscape

The Increasing Interest in Biologics Contract Manufacturing Field is also Reflected in Recent Partnership Activity

Over the past few years, there has been a steady increase in the partnership activity within this domain, growing at a CAGR of 42%, during the given period (2015-2022). It is worth mentioning that the maximum number of partnerships (154) were inked in 2022. Notable examples include (in reverse chronological order) those signed between Astorg and CordenPharma (May 2022), FUJIFILM Diosynth Biotechnologies and Chimeron Bio (April 2022), and IDT Biologika and Exothera (March 2022).

Recent Partnership Activity

Companies are actively investing in upgrading existing biologics contract manufacturing infrastructure and expanding their respective manufacturing capacities in order to enhance their core competencies

Companies are known to either invest in expanding their existing infrastructure and constructing new facilities or acquiring the facilities of other industry stakeholders in order to accommodate the growth in this respective business. Further, the globalization of healthcare practices and standards has opened up opportunities for such players even in the developing markets of the world. During our research, we identified various expansion initiatives undertaken by players engaged in the biologics contract manufacturing market, over the period 2016-2022 (till June).

Recent Expansions in Biopharmaceutical Contract Manufacturing

Majority of the expansion initiatives undertaken in this domain were reported in 2021. Further, there has been a continuous and significant increase in the expansion activities since 2019. This can be attributed to the fact that several CMOs are investing in facilities to meet the growing demand for biologics, specifically for biopharmaceuticals targeting the coronavirus infection. Furthermore, as more biotherapeutics move to higher phases of development and subsequently, reach the market, the demand for manufacturing partners is anticipated to grow in the foreseen future.

Likely Growth of the Biologics Contract Manufacturing Market

During our research, we estimated the market under conservative, base and optimistic scenarios. As per the base case forecast scenario, market for biopharmaceutical contract manufacturing is estimated to grow at an annualized rate of over 9.6%, during the period 2022-2035. The opportunity is likely to be well distributed in terms of service revenues, across various type of service(s), types of expression systems, types of biologics, scales of operation, company sizes and key geographical regions.

Likely Growth of the Biopharmaceutical Contract Manufacturing Market

Concluding Remarks

It is worth highlighting that there is a significant rise in the interest of stakeholders in biopharmaceutical contract manufacturing segment; this can be validated by the increase in partnership and funding activity within this domain. Further, the growing demand for biologics has compelled the players engaged in this domain to expand their existing capabilities / capacities in order to accommodate the future needs of their clients. In addition, as mentioned earlier, innovation in this field, coupled to the development of novel fermentation technologies, has further expediated the growth of biologics contract manufacturing market.

You can also download the SAMPLE REPORT on biologics contract manufacturing by Roots Analysis.