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Contract API Manufacturing Market Size, Share, Growth Analysis by 2022-2035 | Roots Analysis

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Contract API Manufacturing Market Size, Share, Growth Analysis by 2022-2035 | Roots Analysis

November 02
15:45 2022
During our research, we were able to identify over 70 players that are engaged in offering peptide contract manufacturing services. Most of the players engaged in this domain were established before 2001.

Rise in Demand for Treatment Modalities, coupled to the Requirement of Complex Manufacturing Equipment and Expertise, Medical Device Developers have been Compelled to Outsource their Manufacturing Operations to Contract Service Providers

The in-house development of peptide API requires necessary expertise and capabilities, including design, construction and maintenance of a facility which demands significant capital investments. Therefore, several small drug developers and, at times, certain pharma giants as well, have started outsourcing their manufacturing operations to contract service providers. The increasing demand for companies capable of offering manufacturing and, in certain cases, development services to biopharmaceutical players has resulted in the establishment of several CMOs.

Most of these contract service providers have profound experience in niche and emerging areas. The innate expertise and availability of the required capabilities and infrastructure enables CMOs to effectively fulfil the requirements of their clients, eliminate costly oversights and, thereby, reduce chances of failure. 

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In fact, drug developers are actively collaborating with CMOs that offer improved technology platforms to increase the bioavailability of peptide drugs and enhance the efficacy of the production process. The aforementioned factors are likely to drive growth of the contract manufacturing and provide lucrative opportunities to CMOs in the near future. However, we believe that, in order to cope up with the increasing demand and maintain a competitive advantage, CMOs should further enhance their existing capabilities and capacities, as well as adopt innovative and efficient production technologies.   

More than 70 Companies Currently Claim to Manufacture Peptide-based Therapeutics; The Market Landscape is Fragmented, Featuring the Presence of Both Established Players and New Entrants

During our research, we were able to identify over 70 players that are engaged in offering peptide contract manufacturing services. Most of the players engaged in this domain were established before 2001. However, more than 25 companies were established post 2001, which indicate the growing demand for peptide contract manufacturing services.

In Pursuit of Building a Competitive Edge, Peptide Contract Manufacturers are Actively Upgrading / Expanding their Existing Capabilities in order to Enhance their Respective Portfolios of Offerings

Based on cumulative scores, small companies which are known to possess a relatively stronger peptide therapeutics contract service portfolio are (arranged alphabetically) Company A and Company B. Founded in 2012, Company A is engaged in the production of peptides, using solid phase, as well as liquid phase, synthesis methods. It further claims to be capable of manufacturing peptides across preclinical, clinical and commercial scales of operations. Moreover, the company is offering services for both API and FDF products.

Likewise, Company B was established in 1998 and offers multiple contract manufacturing services for peptides. The firm states to have the required capabilities to purify peptides using various techniques, such as HPLC / UPLC, ion exchange chromatography and size-exchange chromatography.

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The Growing Interest of Stakeholders is Evident from the Rise in Partnership Activity; In Recent Years, a Considerable Share of Deals were Inked for Manufacturing and Product / Process Development Purposes

During our research, we came across several collaborations and expansions that have been undertaken by various stakeholders involved in the peptide therapeutics contract manufacturing domain, during the period 2014-2021 (till September)

Over the past few years, the partnership activity in the peptide contract manufacturing market has increased gradually. It is worth mentioning that, since 2017, more than 4 agreements have been signed each year.

In the Last Decade, Over 1,300 Trials, Enrolling close to 0.43 Million Patients Suffering from a Myriad of Disease Indications, have been Registered across the Globe to Evaluate the Efficacy of Peptide-based Drugs

The number and geographical distribution of clinical trials are important indicators of both the therapeutic viability and future potential of innovative pharmacological interventions. These trials enable CDMOs / CMOs to estimate the clinical demand of peptide therapeutics across different geographies, therapeutic areas and trial phases.

Moreover, the geographical distribution is a direct indicator of the various markets that are conducting trials or enrolling patients for clinical studies. Further, as more product candidates are approved by regulatory authorities across the globe, the number of clinical trials is also anticipated to increase.

65% of the Global Peptide Manufacturing Capacity is Installed in Facilities of Well-Established Service Providers; Stakeholders are Anticipated to Invest in Building Incremental Capacity in the Coming Decade

Currently, Europe is a key contract manufacturing hub for peptide APIs. This can be attributed to the availability of advanced manufacturing technologies and issuance of socio-economic reforms, favoring the growth of peptide therapeutics industries, in the aforementioned region. We further believe that, as more therapeutic peptides are approved, manufacturing demand for such products is likely to grow significantly in the foreseen future. This increase in demand is further anticipated to translate into a huge opportunity for players having the necessary capabilities for the manufacturing of peptide APIs. Finally, as more peptide therapeutics are advancing into later stages of clinical trials, the CMOs would need to increase their manufacturing capacities through internal expansions, acquisitions and mergers. In addition, CMOs need to build upon their technological capabilities to combat the increasing demand for peptide therapeutics.

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