Summary
The global pharma R&D outsourcing market is expected to grow at a CAGR of 9.56% during 2022-2027.
MARKET INSIGHTS
In a world of exponentially growing information, increasingly sophisticated technology, and an unstable economic environment, pharmaceutical corporations are increasingly outsourcing research efforts to academia and private contract research organizations (CROs). The pharmaceutical R&D outsourcing market is expected to grow as pharmaceutical and biotechnology companies spend more on outsourced services. Outsourced R&D activities span basic research through late-stage development, including genetic engineering, target identification, target validation, assay creation, hit discovery and lead optimization (hit candidates-as-a-service), safety and efficacy assessments in animal studies, and human clinical trials.
MARKET DYNAMICS
Paradigm Shift Towards Virtual Clinical Trials
• Virtual clinical trials or decentralized clinical trials can bring significant digital changes to clinical research methods and enhance the patient-centric ecosystem. These solutions include countless benefits such as technology, advanced applications, electronic devices, online social engagement platforms, artificial intelligence (AI), robotic process automation, and machine learning (ML).
• Patient recruitment is the most prominent cause of clinical delay, followed by significant patient absenteeism. Approximately 30% of phase 3 study discontinuances are said to be due to difficulty recruiting patients. These delays can cost pharmaceutical companies/sponsors up to USD 8 million daily. However, a complete digital or cross model of patient enrolment is employed in decentralized clinical trials. This helps reach the recruitment target easily and rapidly, making the entire process easy, and engaging.
The Emergence of Artificial intelligence (AI) in Drug Discovery & Development
• Artificial intelligence (AI) is used in numerous areas across the world. In healthcare, especially in the pharmaceutical industry, AI is making a notable change as it has varied uses in drug discovery & development, clinical trials, and pharmaceutical productivity. The life cycle of a new drug from a lab to a store is a chain of many complex events that take time and development. Such difficult circumstances can be minimized with the help of AI, and the target can be achieved in a short time.
• Many pharmaceutical companies implement innovative technologies such as AI and machine learning to achieve high-quality results in a short amount of time. In pharmaceutical product development, AI can manage the drug designing, decision making, and therapy determination for patients with personalized medicines; the generated clinical data can be stored for future drug development.
• Global key players from the pharma and biotech industry, such as Eli Lilly Amgen, Merck, LEO, AstraZeneca, Bayer, Novartis, J&J, and BASF, are now a part of machine learning for pharmaceutical discovery.
Increasing Collaboration and partnership among CROs and Stakeholders of the Pharmaceutical Ecosystem
• New models are emerging, and the first innovation comes from the Clinical Research Organization (CRO). CROs establish early chemical / biological entry points for the disease, approach potential interested companies, and collaborate on integrated drug discovery projects that they have identified. Strategic partnerships have long been an essential feature of the pharmaceutical industry. Numerous in-licenses, out-licenses, joint research, and joint development agreements exist between biopharmaceutical companies and academic research institutes.
• In recent years, several significant outsourcing partnerships were done, such as the UK-based AstraZeneca partnering with academic organizations, the Cambridge University, focusing on drug development. It partnered with the University of Texas MD Anderson Cancer Center in the United States to develop immunotherapy.
Some of the examples of significant strategic partnerships of outsourcing are:
a) Allied Minds & Bristol-Myers Squibb
b) GSK & University of Leicester
c) Actelion Pharmaceuticals & Enamine
SEGMENTATION ANALYSIS
The pharma R&D outsourcing market is segmented on the product, stage of development, size of companies, therapy areas, and geography.
Insights by Product
Among all products, the small molecules segment reported a significant pharma R&D outsourcing market share. The small molecules segment is estimated to be higher because small molecules are likely to play a crucial part in easing the burden of chronic disease. This diverse group of small chemical compounds offers many benefits for scientists and researchers:
a) They have a wide-ranging use.
b) They are comparatively low in cost.
c) They allow for easy administration, including an oral route of administration.
d) They can pass within cell membranes to achieve their targets due to their small size.
e) They provide consistent results.
Pharmaceutical companies planning small molecule clinical studies need to work with the appropriate contract research organization (CRO) to conduct valuable research using reliable data. The food and Drug Administration (FDA) approved 50 novel drugs in 2021. 36 are small molecules which is 72% of the total approval of pharmaceutical drugs by the FDA.
Segmentation by Product Type
• Small Molecules
• Biologics
Insights by Stage of development
a) Among stages of development, the clinical segment reported a major share of around 64.13% in 2021. The clinical segment is estimated to be higher because, according to World Health Organization (WHO), approximately 47,689 clinical trials are in Phase I. The high number of clinical trials in phase 1 is highly outsourced. In outsourcing well-established data about patient recruitment, activities of clinical trials related to phase 1 and other procedures such as analysis and documentation are the easy thing done in the phase.
b) Phase 1 clinical trials required more than USD 30 million in capital investment. Compounds in oncology, respiratory diseases, and other therapeutic areas require a lot of money. Around 70% of drugs move from Phase I to the next phase states by US FDA.
c) Phase II can last for several years; as per the WHO, around 88,530 compounds in phase 2 clinical trials till 2022. As per US FDA, approximately 33% of new drugs are moved from phase II to the next.
d) The number of subjects usually ranges from hundreds to about 3,000. If the FDA agrees that the study results are positive, the FDA will approve the experimental drug or equipment. As per the WHO, around 68,999 drugs came to phase III till 2022. In this phase, doctors, physicians, or professionals do not know whether the treatment is better, so random participants are picked up to get the approval for new treatment and sent into the next phase. This procedure is often done in many places across the region/world at the same time to analyze the efficacy of drugs in different geography and demography.
Segmentation by Stage of Development
• Clinical
• Non-Clinical
Insights by Size of Company
a) Among the size of the company, the small & mid-sized companies segment reported a major share of around 57.54% in 2021. The small & mid-sized companies market segment is estimated to be higher because, in 2019, the emerging therapeutic companies (ETC) were responsible for 73% (5,067 of 6,984) of global industrial, and pharmaceutical projects at all clinical stages, either alone or in collaboration with partners, with the rest being carried out by large companies.
b) SMEs will account for 71%, 76%, 68%, and 62% of Phase I, II, III, and new drug applications, respectively, compared to large companies. 45% of all clinical ETC pipeline projects are carried out in collaboration with other partners. Oncology is the main disease focus of these SME clinical projects.
c) In 2018, the Market researcher identified that 74 small pharmaceutical companies have total sales of $159 billion and 446 pharmaceuticals drugs in their R&D pipeline, 9 medium-sized companies with sales of $50 billion and 181 products, and sales of $139 billion in the R& D pipeline.
d) A 2017 BIO industry analysis shows that small biotechnology companies are responsible for 70% of all bio pharmacy clinical trials worldwide, representing 6,679 programs, 43% of which partner with other companies. It was carried out. Large companies conducted the remaining 30% of these clinical trials.
Segmentation by Company Size
• Small & Mid-Sized Companies
• Large Companies
Insights by Therapy Areas
a) Among therapy areas, the oncology segment reported a major share of around 30.71% in 2021. The oncology segments are estimated to be higher because there are 19.3 million new cancer instances and approximately 10 million fatalities worldwide in 2020, accounting for nearly one out of every six deaths as per Globocan 2020 report.
b) Oncology is one of the most dominant therapy areas for industry and non-industry-sponsored clinical trials. The rising prevalence of cancer conditions significantly contributed to oncology therapeutic area clinical trials. Changing the paradigm for testing cancer treatment in the world increased the global efforts toward generating evidence for oncology clinical trials.
c) In 2019 only around 30 FDA approvals were registered for chemotherapeutic drugs. In the US, about 361,628 clinical trials have been reported only for cancer in the past 20 years. Cancer clinical trial drug development activities increased significantly, leading to increased clinical trial volume.
d) Global spending on anticancer medications climbed by 14.3% in 2020, reaching $164 billion. Spending is expected to reach $269 billion by 2025. The high prices of novel anticancer medicines drive much of this growth. The direct and indirect expenses of oncological treatments severely affect patients’ treatment success and financial well-being worldwide.
e) In the US, around 361,628 clinical trials registered only for cancer in the past 20 years. Cancer clinical trial drug development activities increased significantly, leading to increased clinical trial volume.
Segmentation by Therapy Area
• Oncology
• Cardiovascular Diseases
• Infectious Diseases
• Musculoskeletal Disorders
• Central Nervous System Disorders
• Gastrointestinal Disorders
• Other Therapy Areas
GEOGRAPHY ANALYSIS
The North America region reported a significant share of around 36.23% in 2021. The North America region is estimated to be higher because considerable investment by companies in R&D to strengthen the pipeline for chronic diseases is projected to boost the launch of novel therapeutics in North America. North America witnesses prominent start-up CROs working in the pharmaceutical R&D outsourcing market. The region also saw collaborations and partnerships among the pharmaceutical ecosystem’s stakeholders.
Segmentation by Geography
• North America
o US
o Canada
• Europe
o Germany
o UK
o France
o Italy
o Spain
• APAC
o China
o Japan
o India
o Australia
o South Korea
• Latin America
o Brazil
o Mexico
o Argentina
• Middle East & Africa
o South Africa
o Saudi Arabia
o Turkey
o UAE
VENDOR ANALYSIS
Vendors in the pharma R&D outsourcing market compete based on the wide range of services offered, quality, and scale-up development of pharmaceuticals. The market is so competitive that vendors aim to implement different strategies to maintain their competitive advantage over other vendors. The market players focus on acquisitions, partnerships, diversifying their outsourcing services, and strengthening their distribution networks to increase their market share. There are around 33 vendors in the pharmaceutical R&D outsourcing market, including key players and other prominent players.
Key Vendors
• Charles River Laboratories
• ICON
• IQVIA
• Labcorp Drug Development
• Medpace
• Parexel International Corporation
• Syneos Health
• Thermo Fisher Scientific
• Wuxi AppTec
• Lonza
• Boehringer Ingelheim
• Samsung Biologics
Other Prominent Vendors
• AbbVie
• Advanced Clinical
• BioAnalytix
• Asymchem
• Alcami
• Bavarian Nordic
• Catalent
• Curia Global
• ChemPartner
• CMED
• Criterium
• Cromos Pharma
• Evotec
• Jubilant HollisterStier
• KBI Biopharma
• KCR S.A.
• Kemwell Biopharma
• Mesned Pharma Consult Center
• Midas Pharma
• Medelis
• Merck KGaA
• OCT Clinical
• Pharmaceutics International
• ProTrials Research
• PROMETRIKA
• QPS
• Singota Solutions
• Sofpromed
• Sanofi
• Taros chemicals
• Veristat
• Worldwide Clinical Trials
• WuXi Biologics
• Wacker Biotech B.V
KEY QUESTIONS ANSWERED
1. How big is the pharmaceutical R&D outsourcing market?
2. What is the growth rate of the global pharmaceutical R&D outsourcing market?
3. Who are the key players in the global pharma R&D outsourcing market?
4. Which geographical region leads in the pharma R&D outsourcing market?
5. What are the growth factors in the global pharmaceutical R&D outsourcing market?
