Market overview

Connecting our markets

The unlicensed market in which the Group operates can be split into three areas, clinical trial supply, Managed Access programmes and global ‘point of care’ access.

We are market leaders in each of the markets we operate with a strategic priority of being recognised as the “go to” global market leader in ethical access to unlicensed medicines.

Access to Medicines

There is a high and ever increasing global unmet need for ethical supply of good quality unlicensed medicines from a trusted source. 80% of the world’s population, an estimated 5.5bn people, have low or nonexistent access to medicines1. Population growth, an increasingly elderly population, growing incidences of chronic diseases, increasing patient knowledge, and concerns around counterfeit medicines are all driving increasing demand for quality medicines which are unlicensed at the ‘point of care’.

Clinigen is the only company to provide global access to medicines across all three routes available to a patient, through clinical trials, unlicensed or licensed supply. Each market has unique market drivers and barriers to entry. However a common theme that exists in all the markets in which we operate is the relatively high growth rate and the increasing demand for a global solution.

Emerging Pharmaceutical Markets

As many economies become wealthier, populations increase and awareness of available healthcare improves, there is a significant growth opportunity in emerging markets. By 2010 healthcare spending in emerging markets had overtaken that of the EU5 (Germany, France, Italy, Spain and the UK) with spending expected to amount to 30% of the global pharmaceutical market by the end of 2016 (20% in 2011)2

Due to the complexity, particularly regulatory, of the diverse infrastructure, the approach in commercialising such opportunities require a niche and specialist service provider. The acquisition of Link in October 2015 has provided the Group with access to a wider customer base and an increased global reach enabling more efficient distribution to healthcare professionals in the AAA region. We supply a global reach with local expertise and have a track record of excellence through understanding of complex regulatory environments and specialist knowledge.

Counterfeit medicines

Counterfeit or sub-standard medicines are becoming increasing prevalent. In March 2016 Clinigen became a full member of the European Alliance for Access to Safe Medicines (EAASM) and Alliance for Safe Online Pharmacy in the EU (ASOP EU), two key European alliances in the fight to protect patients from the threat of counterfeit drugs. A key focus in tackling the threat is educating patients and healthcare professionals of the dangers of internet pharmacies. Some estimates indicate that the global threat of counterfeit pharmaceutical drugs is up to $75bn, a 90% rise in five years3. Often, the pharmacies appear legitimate but are often unethical, selling substandard, falsified or counterfeit medicines and drugs that are untested and unapproved or even banned. Many products don’t require a prescription to supply a prescription-only drug and can be dangerous and pose a serious health risk if self-prescribed.

Access to unlicensed medicines, which include drugs that have received regulatory approval but may not be available in a patient’s own country, can help to meet this unmet need. Clinigen is dedicated to providing an ethical, compliant route for healthcare professionals to source medicines, meeting this need through its Idis Global Access division. We manage our supply chain closely and guard against the risk of counterfeit products reaching the patient.

Real World Data

There is increased demand for data within the pharmaceutical industry about patients’ use of medicines in a realistic healthcare setting, otherwise known as Real World (RW) data. The adoption of new medicines is increasingly reliant on evidence based criteria. Traditional randomised clinical trials, which for a long time were seen as the best method of obtaining clinical data, now are considered to have limitations.

The capture of RW data is beginning to become significant in the approval and adoption of medicines. Demand for RW data is universal with many countries now realising its importance. The gathering of RW data plays a significant role in ensuring patients have ethical access to innovative medicines, a key strategic priority for Clinigen. As a response to this market trend, the Group has developed the Clinigen Consulting Services offering within its Idis Managed Access division. This offering advises the pharmaceutical industry on policy and is important to future growth.

Clinical Trial Supply

Managed by our Clinigen Clinical Trial Services division.

Market Drivers Differentiators
Trend is to outsource clinical trials Deep well-established relationship with pharmaceutical companies
Comparator drugs increasingly used over placebos Global supply chain and distribution network
Increase in more expensive biologic/biosimilar drugs Certify product is authentic
Growth in IITs Superior pharmacovigilance and quality management knowledge
Clients increasingly requiring a global solution Deep understanding of complexity of regulatory environment
  Expanded services and IIT offering

Unlicensed

Covers exclusive Managed Access programmes managed by Idis Managed Access and the ethical on-demand unlicensed supply managed by Idis Global Access and Link Healthcare.

Market Drivers 

Differentiators
Structural growth in emerging pharmaceutical markets Broad and embedded relationships with pharmaceutical companies and pharmacists
Increased role of patient advocacy groups demanding best treatments Focus on mature, hospital only products
Demand for RW data Certify product for authenticity
Geography specific drug shortages Deep understanding of complexity of regulatory environment
Increase in counterfeit products Centralised customer services
Clients increasingly requiring a global solution  

 

Licensed

Managed by our Clinigen Specialty Pharmaceuticals and Link Healthcare divisions.

Market Drivers 

Differentiators
Mature product divestment by large Pharmaceutical companies Broad and embedded relationships with pharmaceutical companies 
Clients increasingly requiring a global solution Local market knowledge 
  Global supply chain and distribution network
  Not reliant on sales force
  Revitalisation capability