Soaring drug development costs and increasingly complex therapies have pharma and biopharma companies outsourcing to contract development and manufacturing organizations (CDMOs) to help keep costs down and to gain access to comprehensive solutions.

With the growth in the sterile injectable market, high potency compounds, and antibody drug conjugates, sponsors are seeking out advanced technologies and expertise, driving demand for integrated services from proof-of-concept to commercialization.

Vivek Sharma, chief executive officer of Piramal Pharma Solutions (PPS) discusses outsourcing trends, opportunities for CDMOs, and the capabilities needed for today’s pharma/biopharma pipelines.

Contract Pharma (CP): How has the CDMO market evolved over the last few years?

Vivek Sharma (VS): The pharmaceutical industry is evolving towards targeted drug delivery platforms, complex molecules such as biologics and niche indications, all of which require a wider range of development capabilities and manufacturing capacity to ensure accelerated speed to market. As a result pharmaceutical companies, both large and small, look for strategic, integrated partners, who can seamlessly deliver on multiple verticals, thereby reducing complexity of their supplier network.

The CDMO industry is consolidating on a large scale to become integrated in capabilities, capacities and geographies. The top five CDMOs account for 15% of the total CDMO market size, growing between 5-7% over the next five years, faster than their big pharma counterparts.¹ CDMOs in niche areas might forward and/or back integrate, to offer more integrated value chains to customers.

Integrated CDMOs are also developing new service models focused on resource flexibility and shared risk. Innovative business models may include pharma site divestiture to a CMO with committed volumes for a set number of years, risk-share models lowering upfront costs with success tied to milestone events, and fixed price early development projects. Customers are also now more willing to co-invest with the CDMO, when capital requirements are high; moving from vendor transactions to strategic partnerships. Private equity is also playing a significant role in the CDMO industry, providing the capital for capability and capacity expansion and management expertise.

CP: What is the biggest opportunity you see for the company in the CDMO space?

VS: Piramal constantly tracks market dynamics and engages with customers to collaboratively identify future needs. The high growth sterile injectable space is expected to reach $657 billion by 2024 at a growth rate of 8%. Additionally, oncology continues to grow, with 60% of all high potency drugs being developed for cancer. We see these as prime opportunities and hence in response to this, we have expanded our North American network, acquiring Coldstream Laboratories for injectable capabilities and Ash Stevens for high potency API capabilities.

With respect to parenterals, the bigger opportunities lie in complex formulations like liposomes and lyophilization. Apart from this, biologics are also making a mark in industry. Antibody drug conjugates (ADCs) are now proven targeted therapies in oncology and we see a healthy pipeline in this area for our Grangemouth, UK facility serving customers from proof-of-concept to commercialization of ADC.

CP: What are some of the latest motivators for sponsors with respect to outsourcing?

VS: As pharmaceutical companies face increasing cost pressures and as the complexity of drug candidates rises, they turn to CDMOs with a motivation of reducing capital investment and at the same time gaining access to specialized expertise. The major motivation for sponsors apart from cost reduction is the impeccable track record the CDMOs carry in terms of product quality, on-time delivery, regulatory compliance, safety, and value.

Also, CDMOs offer long-term supply security and share the risks due to their robust financial structures. Sponsors also get access to advanced technologies and expertise like high potent manufacturing and isolator technology for injectables, which otherwise requires investment for separate containment area. This helps the sponsor to focus on their core competencies.

In addition, CDMOs take care of end-to-end supply chain needs that reduces a sponsor’s effort associated with management of inventory and logistics. This in turn helps to eliminate penalties associated with rescheduling due to delays. CDMOs offering integrated services help reduce time to market by performing all steps under one roof.

CP: What new capabilities are required for today’s drug products? What specific services are increasingly being outsourced?

VS: The pharmaceutical contract manufacturing market is projected to grow at an annualized rate of 4.8% between 2018 and 2028.⁴ At the same time, pharmaceutical and biotech companies are increasingly selective while choosing a CDMO partner due to risks associated with development of new chemical entities (NCEs). Hence, CDMOs with diverse and advanced capabilities are a top priority.

The new capabilities required for today’s drug products are laid on the principles of patient compliance, reduced costs and of course better efficacy of the drug. The shift from ampoules to vials and now pre-filled syringes (PFS) is a classic example in sterile injectables. Also, few technologies categorized as complex injectables have been proven to be better drug delivery systems like liposomes, nanoparticles, microemulsion, microparticles, micelles, PEGylation, etc. These are termed as New Drug Delivery Systems (NDDS). There are also capability advancements in oral solids (OSDs), like controlled/modified release dosages. The examples of NDDS for OSDs are Osmotic Drug Delivery Systems (OROS) with laser drill technology, encapsulation, layered tablets, etc.

Out of the total outsourced API market, generic APIs hold the major share of the market (84%) while the remaining (16%) are branded APIs. Within the contract formulations market, solid dose compounds lead with ~50% followed by injectables (33%) and semi-solid/liquid compounds (17%). The growth is likely to be driven by injectables due to increased focus on targeted therapies in disease areas like oncology.

CP: What is your perspective on where R&D is going and where do you think some of the biggest opportunities lie?

VS: The pharmaceutical industry has seen a surge in NME approvals, from 46 in 2017 to 59 in 2018, with biologics, particularly antibodies forming a large portion. Research and development is now moving beyond traditional small molecules and conventional biologics to newer modalities such as ADCs, nucleic acid therapeutics and peptides.

Additionally, owing to the necessity and higher likelihood of regulatory approval of niche drugs for orphan indications, we see a focused research effort towards rare diseases. Orphan drugs are forecasted to grow at a rate of ~11% by 2024²; at double the rate of the non-orphan drug market. Both Big Pharma and biotech companies recognize the value of making these drugs accessible to patients at shortened timelines, thereby gaining a higher return on investment.

Oncology is another area of focus, forming ~11% of the global therapeutics market as per research by IQVIA.³  Drugs for oncology are composed of high-potency active pharmaceutical ingredients (HPAPIs) which require containment and specialized infrastructure. We will continue to see significant investment of both CDMOs and pharmaceutical companies to manufacture high potency drugs.

While biologics and orphan drugs are on the rise, we also expect R&D efforts on oral solid drugs to remain consistent owing to their ease of patient compliance and reduced manufacturing complexity. Innovation in oral solid drugs is likely to be in the areas of improved drug delivery and bioavailability, while enhancing efficacy. 

1. Kurmann Partners. Pharma M&A Report 2018  http://www.kurmannpartners.com/fileadmin/user_upload/_temp_/KP_Pharma_M_A_Report_2018_-_medium.pdf
2. Evaluate Pharma, 2018. Orphan Drug Report 2018  http://info.evaluategroup.com/rs/607-YGS-364/images/OD18.pdf
3. IQVIA. Global Oncology Trends 2018:Innovation, Expansion and Disruption  https://www.iqvia.com/institute/reports/global-oncology-trends-2018
4. Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028  https://www.researchandmarkets.com/reports/4542472/pharmaceutical-contract-manufacturing-market-2nd