Biosimilar Contract Manufacturing Market

The increasing popularity of biosimilars in treating diseases, such as cancer, autoimmune diseases, blood disorders, and others is driving the market growth

One of the main drivers of the market is the rising use of biosimilars in the treatment of diseases like cancer, autoimmune disorders, blood disorders, and others, as well as their lower cost when compared to biologics. Several biosimilars were authorised to treat COVID-19 during the pandemic. For instance, the COVID-19 treatment biosimilar Tocilizumab from Hetero Healthcare was approved by India's Drug Controller General in September 2021. Such approvals are probably going to increase the adoption of biosimilars in developing nations and hence expand the market in those nations in the upcoming years.

The industry's expansion is largely related to the approaching patent expiration of popular biologics. According to IQVIA, biologic proprietary medications such Chantix, Forteo, Truvada, Ciprodex, and Afinitor were no longer available in the United States as of 2020. The growing need for low-cost, highly effective drugs and the rising number of biologics whose patents are about to expire are both contributing to the industry's expected growth. Diseases like cancer, autoimmune disorders, blood problems, and neurological disorders are becoming more commonplace.

According to Cancer Tomorrow, more cancer cases are anticipated in the upcoming years. Over 19.3 million instances of cancer were reported in 2020, according to Cancer Tomorrow's predictions, and this number is projected to increase to 30.2 million by 2040. The market for cancer biosimilars is anticipated to increase as cancer incidence rises. The industry is anticipated to benefit from this. The pipeline of biosimilar medications has improved recently as a result of the rising need for affordable and highly effective therapies.

For instance, according to the Biosimilars/Biobetters Pipeline Directory, the pipeline for biosimilars will increase by 108% between 2013 and 2020.

The expansion of the biosimilar pipeline is anticipated to increase manufacturing demand and, as a result, to foster industry growth. The majority of medications approved during the COVID-19 pandemic were intended to treat COVID-19. But it had no bearing on whether or not biosimilar medicines were approved. The European Medicines Agency, for instance, approved nine biosimilar medications in 2020 and seven biosimilar medications in 2021. The regulatory clearance of biosimilars is projected to increase demand for them in manufacturing, which will encourage growth. Thus, driving the Biosimilar Contract Manufacturing market revenue.

The Global Biosimilar Contract Manufacturing Market Industry experiences a surge in demand for biologics, driven by their efficacy in treating chronic diseases. As healthcare systems worldwide increasingly adopt biologics, the market is projected to reach 7.73 USD Billion in 2024. This growth is attributed to the rising prevalence of conditions such as cancer and autoimmune disorders, which require advanced therapeutic solutions. Consequently, contract manufacturers are expanding their capabilities to meet this demand, ensuring that they can provide high-quality biosimilars that align with regulatory standards. This trend indicates a robust future for the industry as it adapts to the evolving healthcare landscape.

Cost considerations play a pivotal role in the Global Biosimilar Contract Manufacturing Market Industry. Biosimilars offer a more affordable alternative to expensive biologics, which can significantly reduce healthcare costs for patients and providers. As healthcare expenditures continue to rise, the adoption of biosimilars is likely to increase, with projections suggesting that the market could expand to 51.9 USD Billion by 2035. This shift not only benefits patients through lower drug prices but also encourages healthcare systems to allocate resources more efficiently. The growing acceptance of biosimilars as viable treatment options further solidifies their position in the market.

The Global Biosimilar Contract Manufacturing Market Industry benefits from evolving regulatory frameworks that support the development and approval of biosimilars. Regulatory agencies worldwide are increasingly establishing guidelines that facilitate the entry of biosimilars into the market, thereby enhancing patient access to these therapies. This supportive environment encourages investment in biosimilar development and manufacturing, as companies seek to capitalize on the opportunities presented by a more streamlined approval process. As a result, the industry is likely to witness accelerated growth, with a compound annual growth rate of 18.9% projected for the period between 2025 and 2035.

The Global Biosimilar Contract Manufacturing Market Industry is witnessing a rise in partnerships and collaborations among pharmaceutical companies and contract manufacturers. These strategic alliances enable companies to leverage each other's strengths, such as expertise in regulatory compliance and manufacturing capabilities. By pooling resources and knowledge, partners can accelerate the development and commercialization of biosimilars, ultimately enhancing market access. This collaborative approach is particularly crucial as the industry navigates complex regulatory landscapes and seeks to optimize production processes. The trend of forming partnerships is likely to continue, fostering innovation and growth within the biosimilar sector.

Technological innovations are transforming the Global Biosimilar Contract Manufacturing Market Industry, enabling more efficient and scalable production processes. Advances in bioprocessing technologies, such as single-use systems and continuous manufacturing, are enhancing productivity and reducing costs. These innovations allow contract manufacturers to produce high-quality biosimilars more rapidly, meeting the increasing global demand. As the industry embraces these technologies, it is expected to experience significant growth, driven by the need for faster and more cost-effective manufacturing solutions. This trend underscores the importance of technological adaptation in maintaining competitiveness within the biosimilar market.

By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. Europe Biosimilar Contract Manufacturing market dominated this market in 2022 (45.80%). The presence of important biopharmaceutical contract development and manufacturing companies like Lonza, Boehringer Ingelheim GmbH, Rentschler Biopharma SE, and Element Materials Technology as well as a clearly defined regulatory environment for biosimilars are to thank for this. The regional market has also grown as a result of a robust healthcare infrastructure and an increase in product releases.

Further, the German market of Biosimilar Contract Manufacturing held the largest market share, and the U.K market of Biosimilar Contract Manufacturing was the fastest growing market in the European region

Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: BIOSIMILAR CONTRACT MANUFACTURING MARKET SHARE BY REGION 2022 (USD Billion)

Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

The North America Biosimilar Contract Manufacturing Market accounted for the healthy market share in 2022. The widespread use of biosimilar medications in the area is being facilitated by the recent high number of biosimilar drug approvals, which is also fostering the region's development. Further, the U.S. market of Biosimilar Contract Manufacturing held the largest market share, and the Canada market of Biosimilar Contract Manufacturing was the fastest growing market in the North America region.

The Asia Pacific Biosimilar Contract Manufacturing market is expected to register significant growth from 2023 to 2032. The main drivers of the region's growth are the high prevalence of chronic diseases and the expanding desire for less priced therapeutic items. Another significant aspect that is projected to contribute significantly to the region's growth is the growing emphasis on contract projects in nations like China, India, and South Korea. In Asia Pacific, the incidence of non-communicable diseases like cancer, diabetes, and autoimmune disorders has also increased due to rapid urbanisation, the expanding geriatric population, and lifestyle changes.

This is boosting the region's need for affordable therapies and fostering regional growth. Moreover, China’s market of Biosimilar Contract Manufacturing held the largest market share and the Indian market of Biosimilar Contract Manufacturing was the fastest growing market in the Asia-Pacific region.

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the market of Biosimilar Contract Manufacturing, grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, Biosimilar Contract Manufacturing industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global Biosimilar Contract Manufacturing industry to benefit clients and increase the market sector. In recent years, the Biosimilar Contract Manufacturing industry has offered some of the most significant advantages to medicine.

Major players in the Biosimilar Contract Manufacturing market, including Boehringer Ingelheim GmbH, Lonza, Catalent Inc., Biocon, IQVIA Inc., AGC Biologics., Samsung Biologics., WuXi Biologics., Element Materials Technology, Rentschler Biopharma SE, Avid Bioservice, Inc., Alcami Corporation, Inc., Fujifilm Kyowa Kirin Biologics Co., Ltd., Thermo Fisher Scientific Inc., and Almac Group, are attempting to increase market demand by investing in research and development Applications.

A contract development and manufacturing organisation (CDMO), Recipharm AB (Recipharm) provides services in manufacturing, development, and technology. In addition to clinical trial materials like APIs and other medications, the company's manufacturing capabilities include contract manufacturing of pharmaceuticals including semi-solids, oral liquids, solid dosages, and sterile items. Customers are helped by Recipharm's technology and development services from the first product concept to the licenced commercial pharmaceutical product. It comprises, among other things, services like the provision of raw materials and the development of formulations.

The company Baxter International Inc. (Baxter) offers a variety of medical supplies. Dialysis for both acute and chronic illnesses, sterile intravenous solutions, generic injectable medications, parenteral nutrition therapies, infusion systems and devices, inhaled anaesthetics, and surgical hemostat and sealant products are among the company's product and service offerings. Hospitals, rehabilitation facilities, kidney dialysis clinics, nursing homes, and patients' homes all use the company's products. Baxter distributes its goods through a network of independent distributors, medication wholesalers, specialty pharmacies, and other providers of alternate sites in addition to its own direct sales staff.