Pharmaceutical Manufacturing Market Size, Share, Growth, Trends, and Global Industry Analysis: By Molecule Type (biologics & Biosimilars, Conventional Drugs), By Drug Development Type (In-House, Outsource), By Formulation (Tablets, Capsules, Injectables, Spray, Suspension, Powder, Others), By Route of Administration (Oral, Topical, Parenteral, Inhalations, Others), By Therapy Area (Cardiovascular Disease, Pain, Diabetes, Cancer, Respiratory Disease, Others) and Region Forecast 2020-2031

Pharmaceutical Manufacturing Market size was valued at approximately US$ 310,000 million in 2024 and is expected to reach US$ 450,000 million by 2031, growing at a significant CAGR of 3.8% from 2025-2031. Moreover, the U.S. market is expected to grow steadily, reaching an estimated value of US$ 180,000 million by 2031. The market refers to the industry segment involved in the large-scale production of pharmaceutical drugs, including both active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). This sector encompasses a range of operations such as drug formulation, synthesis, quality control, packaging, and regulatory compliance. It includes both traditional small-molecule drugs and biologics, produced through chemical synthesis, fermentation, or biotechnological processes.

The market serves as a critical link in the healthcare value chain, supplying medications across therapeutic areas to hospitals, pharmacies, wholesalers, and ultimately, patients worldwide. The market is witnessing steady growth, driven by rising global demand for medications across a broad spectrum of therapeutic areas. Advances in drug development, increasing prevalence of chronic diseases, and the expansion of healthcare access in emerging economies are contributing to sustained industry momentum. Additionally, the shift toward biologics and personalized medicine is encouraging manufacturers to invest in more sophisticated and flexible production technologies. Regulatory support, combined with efforts to localize supply chains and enhance drug security, is also influencing market dynamics. However, the sector faces ongoing challenges such as pricing pressure, supply chain disruptions, and complex regulatory environments, which continue to shape the strategies of manufacturers worldwide.

Facts & Figures 

• Biologics are redefining the manufacturing blueprint: As biologics account for nearly half of all new drug approvals, manufacturers are retrofitting plants to accommodate cell-based, aseptic, and high-potency manufacture operations.
• CDMOs are transforming capacity and innovation cycles: Contract Development and Manufacturing Organizations are no longer overflow partners, they're becoming the focal point of how companies drive innovation, de-risk scaling, and harness specialized technologies
• Single-use systems are driving modular flexibility: Single-use bioprocessing equipment is facilitating quicker changeovers, eliminating contamination risk, and accommodating smaller multiproduct manufacturing lines.
• Digital twins and automation are moving from pilot to core: Companies are taking real-time analytics, AI, and simulation capabilities into production to drive maximum yield, minimize batch failure, and speed regulatory response.

key Developments

• In July 2025, Thermo Fisher acquired Sanofi’s sterile fill-finish facility in New Jersey to expand its U.S. manufacturing capacity, supporting domestic production resilience and sterile injectable scaling.
• In July 2025, Merck & Co. (MSD) confirmed the $10 billion acquisition of Verona Pharma to enhance its pipeline of respiratory drug development and manufacturing.
• In June 2025, Agenus disposed of two U.S.-based biologics CDMO facilities to Zydus Lifesciences in a transaction valued at $125 million, its strategic foray into global biologics manufacturing.
• In May 2025, Roche announced a $700 million investment to build a drug manufacturing plant in North Carolina focused on obesity treatments, along with an additional $550 million for diagnostics expansion in Indianapolis.

 Pharmaceutical Manufacturing Market Segmentation

Based on the Molecule Type 

• Biologics & Biosimilars (Large Molecules)
• Monoclonal Antibodies
• Vaccines
• Cell & Gene Therapy
• Others
• Conventional Drugs (Small Molecules)

Biologics and biosimilars are revolutionizing pharma production by infusing complexity, precision, and enhanced clinical value onto the shop floor. Of those, monoclonal antibodies are the category du jour, thanks to their triumph with oncology, autoimmune conditions, and emerging viral diseases. These large molecules demand proprietary up- and down-stream processes, from cell culture systems to aseptic fill-finish facilities. Manufacturers are spending increasingly on single-use bioreactors, cold chain management, and quality-by-design systems to deal with the strict requirements of monoclonal antibody manufacturing. While regulatory organizations open the gates of biosimilar pathways and medical establishments are promoting targeted therapies, the sub-segment is poised at the intersection of scientific progress and marketability, bringing long-term transformation across the pharmaceutical manufacturing value chain.

Based on the Drug Development

• In-house
• Outsource

Outsourcing is gathering even more momentum with pharma companies seeking agility, efficiency, and exposure to specialized expertise. Pharmaceutical development conducted through CDMOs is especially common in the area of biologics, where fixed assets need large amounts of capital to scale and regulatory hurdles get in the way of in-house scaling. Aside from cost economies, outsourcing shortens time-to-market, particularly for smaller biotech firms that lack internal GMP-qualified facilities. Leading CDMOs today offer end-to-end services: from formulation and clinical batch manufacturing to commercial-scale manufacture and regulatory service. Strategic outsourcing also allows pharma companies to modulate production levels, change between products, and de-risk supply chain reliance worldwide. With the growing need for personalized medicine and small-lot production, outsourcing is no longer a tactical move, it's a part of pharma's innovation and delivery strategy.

Based on the Formulation 

• Tablets
• Capsules
• Injectable
• Sprays
• Suspensions
• Powders
• Other Formulations

Injectables have emerged as the most essential dosage form in the pharmaceutical industry, particularly for biologics, vaccines, and potent drugs. Their quick action, ability to bypass the gastrointestinal tract, and excellent bioavailability make them very suitable for both acute and chronic therapies. Development of mRNA platforms, monoclonal antibodies, and targeted therapies has propagated demand for parenteral and sterile formulations. Manufacturers are pushing back with isolator-based aseptic systems, pre-filled syringe lines, and lyophilization capacity to meet stability and delivery needs. Wearables like wearable auto-injectors and long-acting injectables platforms are also expanding therapeutic reach beyond the hospital. The injectable market isn't all about delivery, there's also biologic science, device innovation, and regulatory precision in today's manufacturing.

Based on the Route of Administration 

• Oral
• Topical
• Parenteral
• Inhalations
• Other Routes of Administration

Most common and universally practiced route is still oral administration due to convenience, patient compliance, and economics. It dominates in the scenario of small molecules such as chronic disorders for hypertension, diabetes, and depression. Oral solid dosage forms like tablets and capsules exhibit highly scalable manufacturing with the use of established technologies like high-speed granulation, compression, and coating systems. While oral administration is restricted in bioavailability in certain drugs, ongoing innovation in excipient design, controlled-release matrices, and nanoparticle formats is circumventing most of them. With growing self-medication and home treatment, especially in elderly populations, oral dosage manufacture continues to be strategically crucial, offering dependability, scalability, and minimum barrier to global distribution.

Based on the Therapy Area

• Cardiovascular Diseases (CVDs)
• Pain
• Diabetes
• Cancer
• Respiratory Diseases
• Other Diseases

Oncology treatments are the most advanced and challenging therapeutic area in pharmaceutical production. The direction of the industry toward precision medicine and immuno-oncology has fueled demand for targeted therapies such as antibody-drug conjugates, checkpoint inhibitors, and cell therapies. Oncology pharmaceutical manufacturing requires rigorous containment, clean rooms, and rigorous regulatory oversight. Unlike chronic treatments, oncology production often includes specialty volumes with high potency, single-use systems and closed-loop production to ensure safety and efficiency. In addition, the complexity of combination treatments and being required to react swiftly to resistance patterns necessitated agility as a manufacture requirement. As cancer instances are on the rise worldwide and innovation is being hastened, oncology manufacture is spearheading high-value, high-impact pharmaceutical manufacture.