Contract GMP Manufacturing Market Driven by Global Biopharma Demand

Contract GMP Manufacturing Market Size, Trends and Key Players with Growth

The contract GMP manufacturing market is experiencing significant expansion, with projections indicating a revenue increase reaching several hundred million dollars by the end of the forecast period, spanning 2026 to 2035. This growth is driven by emerging trends and strong demand across key sectors.

The contract GMP manufacturing market is experiencing robust growth, driven by increasing research and development activities, growing investments by government and private bodies, and technological advancements. Contract manufacturing organizations (CMOs) possess suitable facilities and specialized equipment for conducting pharmaceutical manufacturing. The growing demand for personalized medicines and innovative medical devices also contributes to market growth.

Key Takeaways

• North America held a major revenue share of the market in 2025.
• Asia-Pacific is expected to host the fastest-growing market in the coming years.
• By therapy/product type, the small molecules segment accounted for the highest revenue share of the contract GMP manufacturing market in 2025.
• By therapy/product type, the biologics segment is expected to witness the fastest growth in the market over the forecast period.
• By end-use industry, the pharmaceutical companies segment led the market in 2025.
• By end-use industry, the biotechnology companies segment is expected to expand rapidly in the market in the coming years.
• By regulatory compliance, the cGMP (pharmaceutical grade) segment held a dominant revenue share of the market in 2025.
• By regulatory compliance, the specialized regulatory certifications segment is expected to grow at the fastest CAGR in the market during the forecast period.

From Molecule to Market: The Contract GMP Manufacturing Ecosystem

The contract GMP manufacturing market refers to providing manufacturing services to pharmaceutical and biotechnology companies for their proprietary products. Companies must comply with Good Manufacturing Practices (GMP) guidelines to maintain product quality, security, and effectiveness throughout the manufacturing process. Contract development and manufacturing organizations (CDMOs) and CMOs provide GMP manufacturing services for APIs , key intermediates, and other commercial pharmaceutical products to ensure that products fulfill GMP requirements.

Automating Assurance: Role of AI in Contract Manufacturing

By leveraging artificial intelligence (AI) in contract manufacturing, manufacturers can streamline the process and develop high-quality products with high efficiency and reproducibility. AI and machine learning (ML) algorithms can analyze vast amounts of data and perform a wide range of functions, from intelligent process optimization to predictive maintenance. They can allow manufacturers to estimate material requirements, avoid shortages, and reduce risks. They can bolster regulatory compliance and reduce manual errors.

Trends & Future Outlook in the Contract GMP Manufacturing Market

• Growing Research Activities: The rising prevalence of chronic disorders encourages researchers to develop novel pharmaceutical products for their prevention, diagnosis, and treatment.
• Increasing Collaboration: Pharma & biotech companies collaborate with CDMOs and CMOs to access advanced manufacturing facilities and accelerate time-to-market of drugs.
• Technological Advancements: Advanced tools, such as IoT-enabled sensors, predictive analytics, and blockchain technology, empower real-time monitoring and supply chain optimization.

Investment Landscape: Contract GMP Manufacturing Market

• In October 2025, Eli Lilly and Co. announced an investment of over $1 billion in India to expand its manufacturing and supply through local drugmakers, enhancing access to key drugs for obesity, diabetes, Alzheimer’s, cancer, and autoimmune conditions.
• In March 2025, LGM Pharma invested over $6 million to expand its Rosenberg, Texas, manufacturing facility as part of its Phase I CDMO growth strategy, increasing capacity for liquid, suspension, semi-solid, and suppository drug products.
• In February 2025, Axplora invested €50 million in its Mourenx site to enhance its capabilities for contract manufacturing of APIs and drug substances for FDA-approved biologics.
• In January 2025, Aragen Life Science raised an investment of $100 million from Quadra Capital, a Singapore-based private equity. This will help Aragen to set up new infrastructure and strengthen its capabilities in niche segments, such as oligonucleotides, peptides, and ADCs.

New Product Approvals Across Agencies in 2024

Segmental Insights

Therapy/Product Type Insights

Which Therapy/Product Type Segment Dominated the Contract GMP Manufacturing Market?

The small molecules segment held a dominant position in the market in 2025, due to the demand for small molecules as therapeutics. Small molecules are in high demand due to their faster absorption, lower production costs, and easy customization. They have provided medical breakthroughs for human diseases for over a century. They are comparatively cost-effective and eliminate the need for a complex manufacturing facility. The DrugBank database has a record of around 15,480 small molecules.

Biologics

The biologics segment is expected to grow at the fastest CAGR in the market during the forecast period. Biologics offer superior benefits over small molecules, such as targeted therapy and fewer side effects. They require specialized equipment and infrastructure to manufacture complex therapeutics, necessitating biotech companies to collaborate with CDMOs/CMOs. They can target the immune system that is not functioning properly and prevent it from causing inflammation.

End-Use Industry Insights

How the Pharmaceutical Companies Segment Dominated the Contract GMP Manufacturing Market?

The pharmaceutical companies segment held the largest revenue share of the market in 2025, due to the increasing development of small molecules for a wide range of diseases. Pharmaceutical companies rely on chemical and synthetic processes for producing small molecules. The growing number of pharma startups also boosts the segment’s growth. Pharma startups collaborate with major firms to get products to market faster and gain access to large markets.

Biotechnology Companies

The biotechnology companies segment is expected to grow with the highest CAGR in the market during the studied years. Biotech firms develop medicines or biologics from natural sources. The increasing development of precision medicines potentiates the segment’s growth. Biotech companies can enjoy longer patent protections compared to pharmaceuticals, offering potential marketplace advantages. They collaborate with CDMOs/CMOs to fulfill the unmet medical needs of patients with rare and genetic disorders.

Regulatory Compliance Insights

Why Did the cGMP (Pharmaceutical Grade) Segment Dominate the Contract GMP Manufacturing Market?

The cGMP (pharmaceutical grade) segment contributed the biggest revenue share of the market in 2025, due to stringent guidelines for the proper design, monitoring, and control of manufacturing processes and facilities. cGMP guidelines are universal regulations that are complied with by companies across diverse geographical locations. This enables companies to export their products anywhere in the world, without making any significant changes in manufacturing operations.

Specialized Regulatory Certifications

The specialized regulatory certifications segment is expected to expand rapidly in the market in the coming years. Every country releases specific manufacturing guidelines for companies based on the climate of that region. By complying with such regulatory conditions, pharma & biotech companies can distribute their products within that particular region or country. Companies can avoid unnecessary legal issues, foster healthy competition, gain better branding, and reduce risk.

Regional Distribution

• North America registered dominance in the market in 2025.
• The U.S. led the market by capturing the largest revenue share in 2025.
• Asia Pacific is expected to be the fastest-growing region in the studied years.
• China is anticipated to grow at a rapid CAGR during the forecast period.
• Europe is expected to grow at a significant CAGR during the forecast period.
• The UK is anticipated to grow at a rapid CAGR over the upcoming years.

Which Factors Govern the Contract GMP Manufacturing Market in North America?

North America dominated the global market in 2025. The presence of key players, the availability of a robust manufacturing infrastructure, and favorable regulatory support are factors that govern market growth in North America. Government organizations provide funding and launch initiatives to support the manufacturing of medicinal products and adopt advanced tools. North American countries have a strong presence of biopharmaceutical companies.

The U.S. is home to over 5,000 pharmaceutical companies and over 3,000 biotechnology companies. The Food and Drug Administration (FDA) provides stringent regulations and guidelines for manufacturing high-quality pharmaceutical products. There are around 210 CDMOs in the U.S. Numerous private companies, such as Boehringer Ingelheim, Johnson & Johnson, and Novartis, announced investments in the U.S. to boost the local manufacture, spanning manufacturing and R&D.

How is Asia-Pacific Growing in the Contract GMP Manufacturing Market?

Asia-Pacific is expected to grow at the fastest CAGR in the market during the forecast period. The increasing number of pharma and biotech startups, the burgeoning biopharma sector, and venture capital investments propel the market. Countries like China, India, Japan, and South Korea have a suitable manufacturing infrastructure and an affordable workforce, motivating foreign companies to set up their facilities in the region. Government bodies launch initiatives like “Made in China” and “Atmanirbhar Bharat” to promote the indigenous manufacturing of healthcare products.

The Chinese government established a new procurement policy to introduce a 20% price evaluation advantage for qualifying domestic products and set clearer standards. China has more than 10,000 pharmaceutical industrial enterprises, and the country’s ability to ensure medical supplies has improved. The pharmaceutical industry’s investment in R&D is booming, with annual average R&D expenditure exceeding 20% over the past three years.

Will Europe Grow in the Contract GMP Manufacturing Market?

Europe is expected to grow at a considerable CAGR in the upcoming period. Favorable government support, growing research activities, and the rising adoption of advanced technologies propel the market. Manufacturers in the European region need to adhere to stringent EU GMP guidelines to ensure that products are of high quality and are appropriate for their intended use. People are becoming increasingly aware of personalized medicines owing to rapidly changing demographics and the growing geriatric population.

ILS Group, Northway Biotech, and Crystal Pharmatech are some companies that provide CDMO services in the UK. According to a recent study, nearly two-thirds of UK adults believe that access to both standard and personalized medicine is essential, as GP-prescribed medicines fail to meet their health needs. In addition, the UK aims to become a leading life sciences economy in Europe, and the third largest in the world after the U.S. and China.

Global Leaders Steering Pharmaceutical Exports in 2023

Top Companies & Their Offerings in the Contract GMP Manufacturing Market

SWOT Analysis in the Contract GMP Manufacturing Market

Strengths

• The growing research activities lead to the development of novel and innovative pharmaceutical products.
• Contract manufacturers have skilled professionals to provide relevant expertise for complex manufacturing problems.
• Numerous manufacturers offer customized services, enabling pharma companies to develop proprietary products.

Weaknesses

• Companies need to rely on a third-party manufacturer to deliver products on time.
• The high cost of contract manufacturing associated with shipping and logistics, inventory management, and quality control visits limits the affordability of numerous companies from low- and middle-income countries.

Opportunities

• The integration of AI and ML in contract manufacturing introduces automation and enhances manufacturing efficiency and accuracy.
• Contract manufacturers are increasingly adopting sustainable practices for energy conservation, solvent recovery, and waste recycling.
• The shifting trend toward personalized medicines enables CDMOs to adapt smaller, more targeted production runs.

Threats

• Companies may face the risk of intellectual property theft as they need to share their proprietary designs, formulas, or technologies.
• Manufacturers face regulatory challenges due to high complexities across diverse nations.

Recent Developments in the Contract GMP Manufacturing Market

• In November 2025, AGC Biologics collaborated with AAVantgrade to accelerate the development of adeno-associated virus. AGC Biologics will provide GMP manufacturing for AAVantgrade’s two novel candidates to address progressive and irreversible vision loss.
• In October 2025, Syngene International established its GMP bioconjugation suite at its commercial biologics facility in Bengaluru. It will offer fully integrated, end-to-end services for ADCs, from discovery to GMP manufacturing. The OEB-5-rated suite will accelerate the development of ADC.

Segments Covered in the Report

By Therapy/Product Type

• Small Molecules
• Biologics
• Vaccines
• Cell & Gene Therapies
• Peptides & Oligonucleotides
• Biosimilars
• APIs (Active Pharmaceutical Ingredients)
• Excipients & Formulation Services

By End-Use

• Pharmaceutical Companies
• Biotechnology Companies
• Generic Drug Manufacturers
• Research & Academic Institutes
• Contract Research Organizations (CROs)

By Regulatory Compliance

• cGMP (Pharmaceutical Grade)
• ISO/Other Global GMP Standards
• Specialized Regulatory Certifications (e.g., FDA, EMA, and PMDA)

By Region

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA