Active Pharmaceutical Ingredients CDMO Market To Worth USD 260.98 Billion By 2034
| Production Linked Incentive (PLI) Schemes for Bulk Drugs/APIs | Offers a financial outlay of ₹6,940 crore, provides financial incentives for the domestic manufacturing of 41 critical KSMs (Key Starting Materials), DIs (Drug Intermediates), and APIs to minimise import dependence. |
| FDA "PreCheck" Program | Introduced in August 2025, this simplifies the regulatory review process and offers active engagement with manufacturers during the planning and construction of novel domestic facilities. |
Segmental Insights
By product analysis
Why did the Traditional Active Pharmaceutical Ingredient Segment Lead the Market in 2024?
The traditional active pharmaceutical ingredient segment captured a major share of the active pharmaceutical ingredients CDMO market in 2024. Due to the greater demand for drugs treating chronic diseases, affordability and large-scale production of generic and small-molecule drugs are fueling the expansion gene and cell therapies Whereas the antibody-drug conjugate segment will expand significantly in the coming era. The complicated manufacturing process includes the integration of a monoclonal antibody with a cytotoxic payload Get the latest insights on life science industry segmentation with our Annual Membership:By synthesis analysis
How did the Synthetic Segment Dominate the Market in 2024?
In 2024, the synthetic segment accounted for the largest share of the active pharmaceutical ingredients CDMO market. This approach explores the usual affordable production as compared to biological ones, which is driven by minimal raw material expenditure and more simplified production solutions. Also, they facilitate increased control over the API's composition and purity, resulting in more consistent and predictable quality across various batches.
On the other hand, the biotech segment is estimated to expand at a rapid CAGR. Prominently, a rise in complexity of new therapies, especially biologics, gene, and cell therapies, and the expansion of precision medicine are bolstering the overall segmental growth. They are implementing continuous manufacturing, AI, and machine learning, and widely investing in seamless manufacturing, sophisticated fermentation systems, and cell culture technology.
By drug analysis
What Made the Innovative Segment Dominant in the Market in 2024?
The innovative segment held a major share of the active pharmaceutical ingredients CDMO market in 2024. The market is leveraging diverse continuous manufacturing and green chemistry, with expanded strategic partnerships for the development of new therapies. Alongside, the leading players use advanced biologics, genomic APIs, and mRNA for customised medicine, gene editing, and advanced vaccines.
Moreover, the generic segment is anticipated to witness notable expansion. This mainly comprises new strategic FDA product-specific guidances for complex generics, particularly Amikacin Sulfate and Apixaban, and the growing use of highly sophisticated manufacturing technologies (AMTs) and AI/ML to enhance effectiveness. Recently, the FDA approved complex generics, such as cyclosporine ophthalmic emulsion eye drops and budesonide and formoterol fumarate dihydrate inhalation aerosol.
By application analysis
Why did the Oncology Segment Dominate the Market in 2024?
The oncology segment led with the biggest share of active pharmaceutical ingredients CDMO market in 2024. A gradual rise in cancer cases is increasingly demanding immunotherapies and biosimilars, with the increased demand for HPAPIs, peptides, and antibody-drug conjugates, are acting as a crucial catalyst. The recent developments encompass antibody-drug conjugates (ADCs), those encapsulated HPAPIs in payloads for more accurate tumour targeting, and polymer-drug conjugates, by employing EZN-2208 and other advanced polymers, for expanding efficacy and lowering side effects.
Although the glaucoma segment is predicted to witness the fastest growth. The companies are fostering the use of prostaglandin analogues, beta blockers, and combination drugs for treating glaucoma and other chronic eye diseases. Recently, the FDA has approved iDose TR (travoprost intracameral implant, a single-administration implant that consistently releases travoprost for up to three years. Whereas, Ciliary Neurotrophic Factor (CNTF)-secreting implants possess stabilisation of visual function and accelerate retinal nerve fiber layer thickness.
By workflow analysis
How did the Commercial Segment Lead the Market in 2024?
The commercial segment captured a dominant share of the active pharmaceutical ingredients CDMO market in 2024. This mainly encourages scaling up production for approved drugs, confirming regulatory compliance, and managing global supply chains. Currently, the globe is putting efforts into the rising integration of services from drug discovery to commercialisation (CRDMOs), growth in high-growth areas like High-Potency APIs (HPAPIs) and biotech.
Eventually, the clinical segment will expand notably in the coming era. CDMOS are facilitating specialised services, specifically formulation development, analytical testing, and small-batch manufacturing for early-stage drugs. Nowadays, the market is focusing on complex therapies like those for rare diseases and advancing cell and gene therapies. CDMOs are further facilitating expertise and documentation to support clients in navigating the complex regulatory requirements for trial submissions.
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Recent Developments in the Active Pharmaceutical Ingredients CDMO Market
- In October 2025, Hikal Ltd., a global life sciences company, opened its High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at its Integrated Innovation Centre in Pune. In September 2025, Kazan Pharmaceutical Plant Sever Pharmaceuticals, part of the Izvarino Pharma Group, initiated production of active pharmaceutical ingredients (APIs) for cancer drugs. In February 2025, SK Pharmteco, a global contract development and manufacturing organization (CDMO), unveiled an enhanced analytical testing laboratory especially dedicated to High Potency Active Pharmaceutical Ingredients (HPAPIs).
Active Pharmaceutical Ingredients CDMO Market Key Players List
- Cambrex Corporation Recipharm AB Thermo Fisher Scientific Inc. (Pantheon) Corden Pharma International Samsung Biologics Lonza Group Catalent, Inc. Siegfried Holding AG Piramal Pharma Solutions Boehringer Ingelheim
Segments Covered in the Report
By Product
- Traditional Active Pharmaceutical Ingredient (Traditional API) Highly Potent Active Pharmaceutical Ingredient (HP-API) Antibody Drug Conjugate (ADC) Others
By Synthesis
- Synthetic Biotech
By Drug
- Innovative Generics
By Workflow
- Clinical Commercial
By Application
- Oncology Hormonal Glaucoma Cardiovascular Disease Diabetes Others
By Region
- North America
- U.S. Canada
- China Japan India South Korea Thailand
- Germany UK France Italy Spain Sweden Denmark Norway
- Brazil Mexico Argentina
- South Africa UAE Saudi Arabia Kuwait
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