Biopharmaceuticals Contract Manufacturing Market - Forecast(2024 - 2030)

Biopharmaceuticals Contract Manufacturing Market Overview

Biopharmaceuticals Contract Manufacturing Market Size is estimated to reach $26.32 billion by 2027 and is poised to grow at a CAGR of 8.4% over the forecast period of 2022-2027. The biopharmaceutical contract manufacturing process involves pharmaceutical machinery and drug manufacturers contracting a firm for finished products or components. North America held a dominant market share of 34% in the year 2021. This result of increasing research and development owing to better healthcare infrastructure and high healthcare expenditure in the region is increasing the Biopharmaceuticals Contract Manufacturing market share. In the pharmaceutical sector investment is high and demand is continuously growing for better healthcare services, to provide such services in time bound period with assured results. Many pharmaceutical companies preferred a contract manufacturing organization (CMO) for the development of new products and services. According to the US Food and Drug Administration (FDA)’s latest report, 74% (34 out of 50) of the novel drugs approved by the FDA in 2021 used some form of expedited development or review pathway, specifically Fast Track Designation 36%, Breakthrough Therapy Designation 28%, Priority Review 68% and Accelerated Approval 28%. It is also useful to overcome skilled labor shortages and allow flexibility in manufacturing, according to European Pharmaceutical Review.

Biopharmaceuticals Contract Manufacturing Market Report Coverage

The report: “Biopharmaceuticals Contract Manufacturing Market Forecast (2022-2027)" by Industry ARC, covers an in-depth analysis of the following segments in the Biopharmaceuticals Contract Manufacturing Market.

Key Takeaways

• Geographically, North America held a dominant market share in the year 2021, owing to advanced health infrastructure in countries like the United States and Canada and R&D in the biopharmaceutical sector that help to grow the Biopharmaceuticals Contract Manufacturing Market Size in this region.
• The Biopharmaceuticals Contract Manufacturing Market is predicted to increase owing to the increasing healthcare expenditure, growing demand for recombinant proteins and expanding pharmaceutical business. However, the regulatory restrictions, IP rights, prices and timeliness are major restrictions that may limit market growth over the forecast period 2022-2027.
• A detailed analysis of strengths, weaknesses, opportunities and threats will be provided in the Biopharmaceuticals Contract Manufacturing Market Report.

Biopharmaceuticals Contract Manufacturing Market Segment Analysis - by Service

Biopharmaceuticals Contract Manufacturing Market based on service can be further segmented into Process development (Downstream Processing, Upstream Processing), Fill & Finish Operation, Analytical and QC Studying and Packaging. The Process Development segment held a dominant market share in the year 2021. This is owing to high capital expenditure in downstream processing. In the year 2021, CMO in downstream processing brought innovations in pH-sensitive monoclonal antibody purification, single-use fermentation separators and more. In September 2021, Repligen joined Navigo Proteins, a scaffold protein engineering and custom affinity resin development firm, to develop NGL-Impact A Hi pH, a new protein A ligand. This is the first protein intended for use in antibody aggregation in low pH elution buffers, according to the business and it addresses issues with Fc-fusion proteins. Such developments in downstream processing assist the growth of the Biopharmaceuticals Contract Manufacturing Market Share.

However, the Analytical and QC Studying segment is estimated to grow with the fastest CAGR of 9.2% over the forecast period 2022-2027. In August 2021, Pharmaceutics International, Inc developed QC friendly analytical method. Also, another company CellCarta in therapeutic development provide highly customized solution in specialized precision medicine laboratory services with integrated platforms in immunology, histopathology, proteomics, genomics and related specimen collection and logistics services. Such increasing development in Analytical and QC Studying in Contract Manufacturing fuels the growth of Biopharmaceuticals Contract Manufacturing Market Share over the forecast period 2022-2027.

Biopharmaceuticals Contract Manufacturing Market Segment Analysis - by Source

Biopharmaceuticals Contract Manufacturing Market based on the source can be further segmented into Mammalian and Non-Mammalian. The mammalian segment held a dominant market share in the year 2021 and is estimated to grow with the fastest CAGR of 9.4% over the forecast period 2022-2027. This is owing to the high penetration of mammalian expression systems for biologics development. Owing to the higher cost of getting products from these sources, mammalian-based biomanufacturing contributed to a higher revenue share. AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals Gmbh and Catalent Pharma Solutions are among the companies that provide contract services utilizing mammalian cell culture. In June 2022, Avid Bio service expanded its process development capacity for its mammalian cell business which will cost $6 million for expansion and will generate annual revenue of about $20 million. Such increasing demand for mammalian cell contract manufacturing drives Biopharmaceuticals Contract Manufacturing Market Share over the forecast period 2022-2027.

Biopharmaceuticals Contract Manufacturing Market Segment Analysis - by Geography

The Biopharmaceuticals Contract Manufacturing Market based on Geography can be further segmented into North America, Europe, Asia-Pacific, South America and the Rest of the World. North America held a dominant market share of 34% in the year 2021. This result of increasing research and development owing to better healthcare infrastructure and high healthcare expenditure in the region is increasing the Biopharmaceuticals Contract Manufacturing market share. According to data released by Investopedia in January 2022, the U.S. healthcare expenditure is rapidly expanding than other developed countries and is projected to reach $6.2 trillion by 2028. Such increasing healthcare expenditure and the presence of leading CMO help to drive North America Biopharmaceuticals Contract Manufacturing Market Size.

Furthermore, Asia-Pacific is estimated to grow with the fastest CAGR over the forecast period 2022-2027. Owing to the increasing demand for healthcare services by the rapidly expanding healthcare sector in this region. In past years an outbreak of coronavirus in China and later spread in various countries around the world create an immediate need for CMO. Countries like India play a major role in providing vaccines and essential medicines to the world with help of CMO. According to the Ministry of External Affairs of India, India provides a total number of 2291.564 lakhs vaccines to other countries. Such capacity of the pharmaceutical industry in India and favorable government policies surge the growth of the Biopharmaceuticals Contract Manufacturing Market Size over the forecast period 2022-2027.

Biopharmaceuticals Contract Manufacturing Market Drivers

Increase in Demand for Injectable Dose Formulation Drives Market Growth.

The increasing prevalence of novel viruses, diseases and infections creates global demand for injectable vaccines and drugs. In May 2022, World Health Organisation (WHO) announced an alert about the outbreaks of monkeypox virus in non-endemic countries, Acute Hepatitis in 33 countries, Dengue in Sao Tome and Principe, Lasa fever in Guinea, Avian Influenza A (H3N8) in China, Avian Influenza A (H5N1) in America. Such increasing outbreaks of various virus diseases and infections create demand for contract manufacturing organizations across the world. In March 2022, Novartis signed a preliminary agreement to produce Carisma Therapeutics' HER2-targeted CAR-M cell therapy, which is now undergoing clinical trials for the treatment of solid malignancies. In June 2021, privately held contract manufacturer Selkirk Pharma has designed a $90 million headquarters and production plant in Spokane, Washington, with a focus on injectable drugs, including vaccines and biologics. The production plant is expected to be finished by the second quarter of 2022. Such increasing demand for injectable drugs or vaccines drives the growth of the Biopharmaceuticals Contract Manufacturing Industry over the forecast period 2022-2027.

Increasing Number of Hospitals and Care Centers Drives The Market Growth.

With the raising global population and the increasing threat of disease or infections to humankind, there is simultaneously an increase in demand for better healthcare facilities and to provide that leading market players in the healthcare industry expand their network across various countries on the globe. For instance, leading contract manufacturing company Lonza Group delivered its service to more than 30 sites according to the company website. The pharmaceutical industry has to pay a long time and investment for the production of drugs or services which is not practical for the small business group. In June 2022, Ten23 Health announced plans to establish a new 5,000-square-meter manufacturing facility in Visp, Switzerland. The project will create around 100 jobs and allow the company to add around 30 million units in annual filling capacity. According to World Health Organisation ‘South-East Asia regional strategy for primary health care: 2022-2030’ published in December 2021, aims to accelerate progress in all countries of the Region toward universal health coverage (UHC), health security and the health-related Sustainable Development Goals (SDGs) which support the growth of Biopharmaceuticals Contract Manufacturing Industry.

Biopharmaceuticals Contract Manufacturing Market Challenges

High Initial Investment, Time Bounded Operation, Talent Shortage and Strict Regulatory Framework is Hampering Market Growth.

Contracts are a substantial source of revenue, but they can also be a major burden if they are improperly managed. To deal with the increasing complexities, pharmaceutical businesses want technologies that will streamline their contracting process and improve operational efficiency. Also, contract manufacturing organization has to follow various licenses such as quality agreements to follow the Current Good Manufacturing Practice (CGMP) that is enforced by FDA. License Agreement, Product supply agreement, R&D agreement and Collaboration agreement. To set up a production plant by a contract manufacturing organization requires high capital and an imbalance in supply and demand impacts the delivery of product in stipulated time with an increase in the final cost of the product. Also, the new and innovative method used for product development demands specialized people for operation but the lack of quality and quantity of skilled people in health care poised growth of the market. In earlier years, global organizations such as Lonza, SwedenBIO, pharma recruitment service Lead Candidate and Cell and Gene Therapy Catapult stated their concerns about a skills shortage. In the pharmaceutical sector, the job of the Qualified Person (Mq) is critical. According to a report published in May 2022 in the European Pharmaceutical Review, there are just 350 QPs in the UK, where more than 60,000 people work in the pharmaceutical business. Such factors may hamper market growth over the forecast period 2022-2027.

Biopharmaceuticals Contract Manufacturing Industry Outlook

Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the Biopharmaceuticals Contract Manufacturing Market. The top 10 companies in the Biopharmaceuticals Contract Manufacturing Market are:

1. Catalent Inc.
2. Baxter Pharmaceutical Solutions LLC
3. AbbVie Contract Manufacturing
4. Pfizer Centre Source Ltd.
5. Biomeva GmbH
6. Kemwell Biopharma
7. Rentschler Biotechnologie GmbH
8. JRS Pharma
9. Inno Biologics Sdn Bhd
10. Lonza Group

Recent Developments

• In June 2022, Pfizer completed the acquisition of ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). The acquisition is complete for $525 million including upfront and development milestones.
• In March 2022, JRS Pharma (Celonic) signed a contract with The Federal Republic of Germany to supply long-term vaccines for Covid-19 along with four other partners. Celonic will provide the capacity and expertise for the production of protein-based vaccines at its Heidelberg site at least until 2029. If required, production of up to 80 million doses per year can begin immediately.
• In August 2021, Cipla a global pharmaceutical company and Kemwell Biopharma, a biopharmaceutical contract development and manufacturing organization (CDMO), entered a joint venture agreement to develop, manufacture and commercialize biosimilars for global markets.

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