Brazil CMO/CDMO Business Outlook from 2023 to 2033

The Brazil CMO/CDMO ecosystem is expected to surge at a CAGR of 2.7% in the forecast period 2023 to 2033. Its value is projected to increase from USD 697.93 million in 2023 to USD 907.67 million by 2033. The Brazil CMO/CDMO business was valued at USD 679.10 million at the end of 2022 and is anticipated to exhibit a y-o-y growth of 2.8 % in 2023.

Attributes Key Insights
Brazil CMO/CDMO Business Size (2022A) USD 679.10 million
Brazil CMO/CDMO Business Estimated Revenue (2023E) USD 697.93 million
Brazil CMO/CDMO Business Projected Revenue (2033F) USD 907.67 million
Value-based CAGR (2023 to 2033) 2.7%

Brazil is projected to be one of the most prominent pharmaceutical sectors in Latin America. The surging aging population, rising healthcare costs, and increased public knowledge of healthcare have all contributed to a steady increase in the demand for pharmaceuticals in Brazil.

The government of Brazil has implemented stringent rules to promote regional pharmaceutical production. This includes policies, including tax breaks and privileges for domestically produced goods.

The Brazil CMO/CDMO business has placed a substantial emphasis on the manufacturing of biologics and biosimilars. These sophisticated treatments frequently call for specialist production skills.

For contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) operating in Brazil, compliance with international quality standards, such as Good Manufacturing Practices (GMP), is essential. Both domestic and international sales depend on compliance with regulatory regulations.

Biotech and pharmaceutical companies in Brazil are increasingly using CMOs and CDMOs to handle their manufacturing requirements. The necessity for flexible production capacity, access to specialist knowledge, and cost-effectiveness are a handful of the driving forces behind this outsourcing trend.

CMO/CDMO companies are set to offer manufacturing services to the biotechnology, pharmaceutical, and other industries, as well as help with the production of medical equipment. CMOs are also expected to provide their resources, knowledge, and facilities to make goods for their customers.

The CMO and CDMO sector has seen rapid expansion in recent years. The pharmaceutical and biotechnology industries have seen a rise in the outsourcing of production and development services owing to the advantages of cost savings, flexibility, and access to specialized knowledge.

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2018 to 2022 Brazil CMO/CDMO Space Analysis Vs. 2023 to 2033 Forecast

The Brazil CMO/CDMO business recorded a decent CAGR of 2.0% in the historical period from 2018 to 2022. The value for the CMO/CDMO business in Brazil was around 1.2% of the total USD 56,660.60 million of the global CMO/CDMO business.

The growing pharmaceutical sector is the main factor spurring the Brazil CMO/CDMO business landscape. Increasing approval of manufacturing facilities is set to drive growth.

The total production capacity in Brazil rises as more manufacturing facilities are approved. The increased demand for outsourcing services would enable CMOs and CDMOs to take on additional clients and projects.

The approval of multiple manufacturing facilities, such as those for sterile injectables, biologics, or specialized formulations, can increase the variety of services provided by CMOs and CDMOs. Due to this variety, pharmaceutical companies can select partners who meet their particular requirements.

  • For instance, in August 2023, Granules India Limited achieved approval from the Brazilian Health Regulatory Agency (ANVISA) for its Bonthapally facility, located in Bonthapally Village, in recognition of its compliance with Good Manufacturing Practices guidelines.

Manufacturing facilities would become more competitive in the global business landscape as they receive approval. CMOs/CDMOs that can show compliance with international regulatory standards would draw clients from other nations looking for dependable manufacturing partners in addition to Brazil.

The Brazil CMO/CDMO ecosystem has begun to place a lot of emphasis on the manufacturing of biologics and biosimilars. The complexity of these products frequently necessitates specialized production capabilities, and this business category has seen tremendous expansion.

The government of Brazil has also started several programs to encourage expansion in the biotechnology and pharmaceutical sectors. These include tax breaks, research grants, and other forms of assistance to promote industrial investment and innovation.

CMOs and CDMOs in Brazil have started to focus more on research & development services and offering their experience in technological development. They are also aiming to understand analytical testing and process optimization in addition to typical manufacturing services

Trends, Opportunities, and Challenges in Brazil CMO/CDMO Space

The table below provides the latest trends observed in the Brazil CMO/CDMO space, growth obstacles, and upcoming opportunities. Business strategies for pushing CMO/CDMO sales in Brazil would enable stakeholders to invest in the right area and gain profit.

Attributes Key Factors
Latest Trends
  • Pharmaceutical and biotechnology companies are progressively outsourcing their manufacturing requirements to CMOs and CDMOs. This trend is driven by aspects such as cost efficiency, access to expert knowledge, and the need for flexible manufacturing capabilities.
  • Biologics and biosimilar manufacturing is a rising segment in the Brazil CMO/CDMO business. This is due to the growing demand for these compound therapies, which often need specialized manufacturing abilities.
  • Regulatory acquiescence and adherence to global quality standards remain important aspects for both CMOs and CDMOs. Companies have focused on upholding high-quality manufacturing processes to meet worldwide regulatory requirements.
  • CMOs and CDMOs are capitalizing on advanced technology and automation to increase efficiency, reduce costs, and improve the quality of the manufacturing process. This includes the adoption of advanced manufacturing systems and equipment.
  • Environmental sustainability has become a significant consideration in the CMO/CDMO space. Businesses are adopting environmentally friendly methods and technologies to diminish their impact on the environment and align with global sustainable development goals.
Upcoming Opportunities
  • High-quality manufacturing by CMO/CDMOs can create a lucrative opportunity in the Brazil CMO/CDMO business. Pharmaceutical companies in Brazil can gain from luring foreign customers looking for partners with a reputation for top-notch production.
  • Customers from all around the world support CMOs/CDMOs that can reliably create pharmaceuticals that adhere to global quality standards, such as Good Manufacturing Practices (GMP), thereby creating new opportunities in Brazil.
  • In a competitive sector, superior manufacturing sets CMOs/CDMOs in particular. The assurance of product quality and safety is valued by companies searching for outsourcing partners, and they are willing to pay more for such services.
  • Pharmaceutical companies that outsource manufacturing aim to reduce risks related to supply chain interruptions, product quality, and regulatory compliance. Reducing these risks involves collaborating with CMOs/CDMOs recognized for high-quality production.
  • Specializing in specific therapeutic areas is the reason for boosting the CMO/CDMO demand in Brazil over the forecast period. Utilizing their experience and expertise, specialized CMOs/CDMOs can accelerate the drug development process. This is expected to result in shorter development cycles, which can hasten the time it takes for pharmaceutical businesses to sell their drugs.
Challenges
  • The Brazil CMO/CDMO business faces a significant restraint in the form of quality assurance, compliance challenges, and supply chain vulnerabilities. The regulatory environment in Brazil frequently necessitates significant documentation through records of production operations and quality control procedures. It can be time- and resource-consuming to ensure accurate and detailed documentation.
  • It is possible that smaller CMOs/CDMOs in Brazil will run into resource issues while attempting to build and maintain effective quality assurance and compliance procedures. Their capacity to compete with bigger, more seasoned players can be limited as a result.
  • Regular compliance inspections by regulatory bodies can hinder productivity and take resources away from it. Findings of non-compliance can result in fines, such as halts in production.
  • Dependence on imported raw materials and active pharmaceutical ingredients (APIs) can put CMOs and CDMOs at risk for supply interruptions brought on by factors, including trade restrictions, transportation problems, or shifts in the dynamics of the world's supply chain.
Sabyasachi Ghosh
Sabyasachi Ghosh

Principal Consultant

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Region-wise Insights

The table below shows the share of the top 5 countries for the review period from 2023 to 2033. South and North Brazil are expected to remain dominant by exhibiting CAGRs of 4.5% and 4.9%, respectively. The Central-west and Northeast Brazil are projected to follow with CAGRs of 3.8% and 3.1%, respectively.

Growth Outlook by Key Region

Regions Value CAGR
Southeast Brazil 2.3%
Northeast Brazil 3.1%
Central-west Brazil 3.8%
South Brazil 4.5%
North Brazil 4.9%

Increasing Research and Development in Southeast Brazil to Drive Demand

Growth in Southeast Brazil’s pharmaceutical sector is expanding steadily. Due to population expansion and improved access to healthcare, there is an increase in local demand for pharmaceuticals and other medical products.

The Southeast area of Brazil is benefiting from initiatives the government has put in place to encourage pharmaceutical business expansion. This includes financial incentives and tax breaks for businesses setting up shop in the region.

Southeast Brazil dominated the CMO/CDMO business and generated a 68.6% share in 2022. It is projected to continue experiencing high growth throughout the forecast period.

The economic center of Brazil is in the southeast, which is home to important cities, such as Sao Paulo and Rio de Janeiro. It is a popular site for CMOs and CDMOs to serve these clients because of its significant industrial base and the large number of pharmaceutical and biotech companies that call it home.

Prestigious universities and research institutions in Southeast Brazil offer a skilled labor pool and chances for collaboration between CMOs/CDMOs and academia on research & development projects. Also, several CMOs/CDMOs based in Southeast Brazil have expanded their operations globally, enabling them to serve clients both domestically and internationally.

Increasing Focus on Biotechnology to Surge Demand in Northeast Brazil

A handful of states in Northeast Brazil, such as Pernambuco, have taken special initiatives to draw in investments in the fields of biotechnology and life sciences. This has caused a cluster of biotech businesses to expand, opening doors for CMOs and CDMOs that focus on biologics.

Biotechnology and pharmaceutical research and development have received more attention in the region. This involves the development of formulations, analytical testing, and process optimization, areas in which CMOs and CDMOs can be particularly skilled.

Northeast Brazil dominates the Brazil CMO/CDMO business and held a 19.8% share in 2022. It is projected to continue experiencing high growth throughout the forecast period. Northeast Brazil has special environmental features or natural resources that make biopharmaceutical research and development possible.

Northeast Brazil is also the perfect location for companies focused on biotech and their manufacturing partners backed by these resources. Also, the region is home to eminent research facilities and academic hubs with a focus on biotechnology and pharmaceuticals.

They can promote cooperation between these institutions and CMOs/CDMOs. Such collaborations are frequently necessary to expand research and development initiatives.

Rising Investments in Infrastructure Fuel Sales in Central-west Brazil

Central-west Brazil held about a 5.1% share of the Brazil CMO/CDMO business in 2022. It is projected to increase during the forecast period.

Central-west Brazil's center geographic location offers a logistical advantage, enabling effective pharmaceutical product distribution to multiple regions across Brazil and adjacent nations. For CMOs and CDMOs aiming to serve a large space, this can be a crucial draw.

Investments in infrastructure, including transportation networks and industrial parks, can further enhance the region's attractiveness for pharmaceutical manufacturing and supply chain operations. The government supports domestic medicinal product production.

CMOs and CDMOs in the region would have the chance to serve the home ecosystem and export goods. Several colleges and research facilities in Central-west Brazil offer a pool of qualified workers in fields related to pharmaceutical development and manufacturing. CMOs and CDMOs can benefit from this in terms of hiring new personnel.

Category-wise Insights

The table below signifies leading sub-categories under product, expression, and company size categories in the Brazil CMO/CDMO business. Stand-alone services are expected to dominate the ecosystem for Brazil CMO/CDMO at a CAGR of 3.4% by 2033. Under the company size category, the mid-sized segment is projected to lead the Brazil CMO/CDMO space with a CAGR of 2.3% by 2033.

Growth Outlook by Key Segments

Segment Value CAGR
Stand-alone Services (Services) 3.4%
API Substrate (Product) 1.9%
Mid-sized (Company Size) 2.3%
Mammalian (Expression System) 2.7%
Commercial (Scale of Operation) 2.9%

Stand-alone Services are to be Preferred Amid High Cost-cutting Needs

Stand-alone services under the service category held a share of 42.5% in 2022. It is expected to remain at the forefront over the forecast period.

Stand-alone services focus on specific aspects of drug development and manufacturing, such as formulation development, analytical testing, or sterile manufacturing. This specialization can attract companies seeking expertise in a particular area.

Companies decide to use stand-alone services to cut costs by outsourcing only a portion of the production or development of drugs while maintaining control over the remaining portions. This factor is anticipated to lead the stand-alone service segment in the Brazil CMO/CDMO business.

API Substrates are the Most Popular Type of Product

API substrate under the product category held a considerable share of 41.4% in 2022. The main components of pharmaceutical formulations are APIs.

APIs, often referred to as the dynamic components of medications, underlie their therapeutic effectiveness. The process of crafting APIs holds a pivotal role in the production of pharmaceuticals, marking a critical step in the journey of creating therapeutic solutions.

Pharmaceutical companies find it more affordable to outsource API production. The volume and efficiency of CMOs and CDMOs would allow them to create APIs more cheaply than in-house labs.

Mammalian Expression Systems to be Chosen Primarily by Suppliers

For the manufacturing of biologics, such as monoclonal antibodies, recombinant proteins, and vaccines, mammalian expression systems are frequently chosen. Due to their success in treating a wide range of ailments, biologics have grown in terms of popularity in the operating of the pharmaceutical sector.

Mammalian expression systems are set to be necessary for the manufacturing of several advanced and sophisticated medicines, including cell and gene therapies. These treatments are projected to make up a rapidly expanding area for pharmaceuticals. This factor is expected to stimulate the mammalian segment over the forecast timeline.

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Competitive Landscape

Geographic expansions are a priority for leading CMO/CDMO companies in Brazil as they work to create new product lines and expand their global consumer base. Expansion and acquisition among key companies or brands is the leading strategy of manufacturers such as Catalent and Fragon.

They aim to enhance their presence in the business landscape and compete with other players during the forecast period. Following are a handful of recent developments:

For instance,

  • In May 2021, Lonza inaugurated a new laboratory, marking a significant step in the Swiss Contract Development and Manufacturing Organization's (CDMO) strategy to bolster its presence in North America. It also plans to advance its Early Development Services (EDS) segment.
  • In February 2022, Pharma Nobis, LLC completed its acquisition of Fagron’s contract manufacturing business and manufacturing facility.
  • In August 2022, Catalent made an announcement regarding its acquisition of Metrics Contract Services. Metrics Contract Services is a specialized Contract Development and Manufacturing Organization (CDMO) known for its 333,000-square-foot facility located in Greenville.

Report Scope

Attribute Details
Brazil CMO-CDMO Revenue (2022) USD 679.10 million
Projected Brazil CMO-CDMO Revenue (2033) USD 907.67 million
Value-based CAGR (2023 to 2033) 2.7%
Forecast Period 2023 to 2033
Historical Data Available for 2018 to 2022
Business Analysis Value (USD million)
Key Regions Covered North Brazil; Northeast Brazil; Central-west Brazil; Southeast Brazil; and South Brazil
Key Segments Covered Services, Product, Expression System, Company Size, Scale of Operation, Region

Key Companies Profiled

Lonza AG; Unither Pharmaceuticals; Catalent Inc.; Fagron; Eurofarma; Pfizer CentreOne; Patheon N.V. (Thermo Fisher Scientific, Inc.); NUVISAN; Societal CDMO; Bio-Manguinhos; Biotimize; Pierre Fabre group; Ajinomoto Co., Inc.

Brazil CMO/CDMO Industry Outlook by Category

By Services:

  • Stand-alone Services
    • Cell Line Development
    • Development and Bio Manufacturing
    • Analytical Services
    • Fill Finish
    • Packaging
    • Clinical Supply Services
  • Integrated Development
  • Scale-up and Tech Transfer
  • Technology and Innovation
  • Quality Control and Quality Assurance
  • Regulatory Assistance

By Product:

  • API Substrate
  • Large Molecule
    • Monoclonal Antibodies
    • Antibody Fragments
    • Recombinant Therapeutic Proteins
    • Viral Vector
    • Cell and Gene Therapy
    • Vaccine
    • Peptides
    • Antibody Drug Conjugates (ADCs)
  • Small Molecule

By Expression System:

  • Mammalian
  • Microbial
    • Bacteria
    • Yeast

By Company Size:

  • Small
  • Mid-sized
  • Large
  • Very Large

By Scale of Operation:

  • Preclinical
  • Clinical
    • Phase I
    • Phase II
    • Phase III
  • Commercial

By Region:

  • North Brazil
  • Northeast Brazil
  • Central-west Brazil
  • Southeast Brazil
  • South Brazil

Frequently Asked Questions

How large was the Brazil CMO/CDMO ecosystem in 2022?

Brazil was valued at around USD 679.10 million in 2022.

What is the Brazil CMO/CDMO ecosystem projected value for 2033?

Brazil is set to reach a valuation of around USD 907.67 million by 2033.

Which product segment is set to lead the Brazil CMO/CDMO business?

The API substrate segment held around 41.4% share in 2022.

What was the historical CAGR for the Brazil CMO/CDMO space?

Brazil's CMO/CDMO space increased at a 2.0% CAGR from 2018 to 2022.

What value is the Brazil CMO/CDMO business estimated to reach by 2023?

The Brazil CMO/CDMO business is set to reach USD 697.93 million by 2023.

What is the Southeast Brazil CMO/CDMO space outlook?

Southeast Brazil CMO/CDMO business held a 68.6% share in 2022.

Which are the leading companies in Brazil's CMO/CDMO business?

Lonza AG and Unither Pharmaceuticals are the key exporters of CMO/CDMO in Brazil.

Table of Content
	1. Executive Summary
	2. Overview
	3. Key Trends
	4. Value Added Insights
	5. Background
	6. Demand Value or Size (USD million) Analysis 2018 to 2022 and Forecast, 2023 to 2033
	7. Sales Analysis 2018 to 2022 and Forecast 2023 to 2033, By Services
		7.1. Stand-Alone Services
			7.1.1. Cell Line Development
			7.1.2. Development and Bio Manufacturing
			7.1.3. Analytical Services
			7.1.4. Fill Finish
			7.1.5. Packaging
			7.1.6. Clinical Supply Services
		7.2. Integrated Development
		7.3. Scale-up and Tech Transfer
		7.4. Technology and Innovation
		7.5. Quality Control and Quality Assurance
		7.6. Regulatory Assistance
	8. Sales Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product
		8.1. API Substrate
		8.2. Large Molecule
			8.2.1. Monoclonal Antibodies
			8.2.2. Antibody Fragments
			8.2.3. Recombinant Therapeutic Proteins
			8.2.4. Viral Vector
			8.2.5. Cell and Gene Therapy
			8.2.6. Vaccine
			8.2.7. Peptides
			8.2.8. Antibody Drug Conjugates (ADCs)
		8.3. Small Molecule
	9. Sales Analysis 2018 to 2022 and Forecast 2023 to 2033, By Expression System
		9.1. Mammalian
		9.2. Microbial
			9.2.1. Bacteria
			9.2.2. Yeast
	10. Sales Analysis 2018 to 2022 and Forecast 2023 to 2033, By Company Size
		10.1. Small
		10.2. Mid-sized
		10.3. Large
		10.4. Very Large
	11. Sales Analysis 2018 to 2022 and Forecast 2023 to 2033, By Scale of Operation
		11.1. Preclinical
		11.2. Clinical
			11.2.1. Phase I
			11.2.2. Phase II
			11.2.3. Phase III
		11.3. Commercial
	12. Sales Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
		12.1. North
		12.2. Northeast
		12.3. Central-west
		12.4. Southeast
		12.5. South
	13. Business: Cross Section Analysis-Product Vs Services
	14. North Sales Analysis 2018 to 2022 and Forecast 2023 to 2033
	15. Northeast Sales Analysis 2018 to 2022 and Forecast 2023 to 2033
	16. Central-west Sales Analysis 2018 to 2022 and Forecast 2023 to 2033
	17. Southeast Sales Analysis 2018 to 2022 and Forecast 2023 to 2033
	18. South Sales Analysis 2018 to 2022 and Forecast 2023 to 2033
	19. State Level Sales Analysis 2022 and Forecast 2033
	20. Structure Analysis
	21. Competition Analysis
		21.1. Lonza AG
		21.2. Unither Pharmaceuticals
		21.3. Catalent Inc.
		21.4. Fagron
		21.5. Eurofarma
		21.6. Pfizer CentreOne
		21.7. Patheon N.V. (Thermo Fisher Scientific, Inc.)
		21.8. NUVISAN
		21.9. Societal CDMO
		21.10. Bio-Manguinhos
		21.11. Biotimize
		21.12. Pierre Fabre group
		21.13. Ajinomoto Co., Inc.
	22. Assumptions and Acronyms Used
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