BA/BE Studies

BA/BE Studies Global Market Outlook:

• The global demand is expected to be at $5.3 billion in 2022 and grow at approx. 6–8 percent CAGR through 2021–2027

• Increasing complexity associated with Phase I trials, in terms of protocol, study procedures, trial design, volunteer recruitment, and globalization of clinical trials demanding regional regulatory compliance are the major factors driving the market

• Availability of a large patient pool, coupled with cost-saving opportunity, due to reduced labor wage, is shifting the focus to the emerging nations

• Large CROs have been continuously expanding their supply base through acquisitions and partnerships to provide integrated services

BA/BE Studies Growth Drivers and Constraints

Drivers

High Trial Complexity:

• Early phase trials has the highest protocol complexity (14 percent) and a high work burden of 9.5 percent, since it involves healthy volunteers and patients. In-house facilities needs to have sufficient beds, equipment's and access to patient to carry out these trials.

Patient Recruitment & Regulations

• Country-specific regulations and access to patient populations can be managed efficiently by suppliers as they have local presence and have dedicated patient database

Cost reduction

• Due to loss of patents for many drugs in the upcoming years and increase in R&D spend, pharma are looking to reduce costs. Reduction in fixed costs over the long run of the Phase I Unit can be obtained through outsourcing.

Constraints

High Supplier Fees

• High short-term R&D costs due to high supplier fees can be a problem over a short-term period; however, can result in savings over the long term.

Unforeseen Events

• Provisions for unforeseen events (early termination of a project) could cause a sudden pause in trials creating a major delay in trial conduct.

Quality Issues

• If a supplier with the right operational capability is not selected, they will be unable to deliver; resulting in increased need for pharma to oversee supplier operations.

BA/BE Studies Cost Drivers and Cost Structure

• FTE rates (staff) contribute to 42 percent of cost and can be negotiated through assurance of long-term contracts. Data management and patient recruitment, which contribute to 24 percent, can be negotiated through bundled outsourcing and consolidation of supply base. Clinical unit and facility contributing to 16 percent could be negotiated by increasing partnership with academia and hospital networks.

Porter's Analysis on BA/BE Studies:

Supplier Power

• Several acquisitions by established early phase providers of niche specialists shows the supplier base consolidation,growth in patient pool availability and the growing demand for Phase I studies among pharmaceutical companies

• Niche specialists compete with established CROs by having access to a focused patient pool and HV studies.

• However, since they have a smaller client base, their power is comparatively lesser than that of established players

Barriers to New Entrants

• Increased regulatory demand, varying regional regulatory compliance, as well as the cost for conducting phase I trials make it more difficult for suppliers to pose competition to large suppliers

• Niche specialists have a medium level of barrier as they have access to specialists population (e.g. Renal) focusing on a specific therapeutic area

Intensity of Rivalry

• Since greater than 50 percent of engagement between pharma and Phase I provider is project based with only around 10 percent strategic in nature, there exists immense competition among the suppliers

• The suppliers are leveraging market price through competitive discount structure, ability to provide specific patient pool to beat competition

Threat of Substitutes

• Specialization, in terms of therapeutic areas, technology, along with bundling of support services will be the key differentiating factors among the suppliers

• For both established and niche specialists, the patient pool availability and number of CPU beds will be the key differentiator with experience and risk considered along side

Buyer Power

• The supplier market consists of multiple suppliers who are able to cater to several big pharmaceutical companies. Pharma companies have a greater choice and ability to switch between suppliers, hence increasing the buyer power